4–13–04 Tuesday Vol. 69 No. 71 Apr. 13, 2004

Pages 19311–19752

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1 II Federal Register / Vol. 69, No. 71 / Tuesday, April 13, 2004

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2 III

Contents Federal Register Vol. 69, No. 71

Tuesday, April 13, 2004

Agriculture Department Environmental Protection Agency See Forest Service RULES See Natural Resources Conservation Service Air pollutants, hazardous; national emission standards: Packaging Corp. of America’s pulp and paper mill; site- Centers for Disease Control and Prevention specific rule, 19733–19742 NOTICES PROPOSED RULES Grants and cooperative agreements; availability, etc.: Air pollutants, hazardous; national emission standards: Genetic testing; quality and appropriate integration into Packaging Corp. of America’s pulp and paper mill; site- clinical and public health practice, 19421–19425 specific rule, 19742–19744 National Trauma Information and Exchange Program, Superfund program: 19425–19428 National oil and hazardous substances contingency Pathology and laboratory medicine; standardized quality plan— assurance activities; best practices assessment, National priorities list update; correction, 19363 19428–19431 NOTICES Superfund; response and remedial actions, proposed Children and Families Administration settlements, etc.: NOTICES Riverhills Battery Site, FL, 19417 Agency information collection activities; proposals, Water pollution control: submissions, and approvals, 19431 National Pollutant Discharge Elimination System— Organization, functions, and authority delegations: Alaska; log transfer facilities; general permits, 19417– Developmental Disabilities Administration, 19419 Commissioner, 19431–19432

Coast Guard Executive Office of the President RULES See Presidential Documents Drawbridge operations: Louisiana, 19325–19326 Federal Aviation Administration Ports and waterways safety: RULES Chesapeake and Delaware Canal, Delaware Bay, Delaware Airworthiness directives: River, et al.; security zones, 19326–19328 NOTICES Boeing, 19313–19314 Agency information collection activities; proposals, Boeing; correction, 19618 submissions, and approvals, 19446–19448 Airworthiness standards: Special conditions— Commerce Department Learjet Models 24 and 25 airplanes, 19311–19313 See Foreign-Trade Zones Board Class D and Class E airspace, 19314–19315 See Industry and Security Bureau Class E airspace, 19316–19320 See International Trade Administration Class E airspace; correction, 19315–19316 See National Oceanic and Atmospheric Administration PROPOSED RULES Class D and Class E airspace, 19359–19360 Defense Department Class E airspace, 19360–19361 NOTICES NOTICES Agency information collection activities; proposals, Advisory circulars; availability, etc.: submissions, and approvals, 19408–19409 Transport category airplanes— Meetings: Electrical equipment and installation, 19603–19604 Science Board task forces, 19409 Electrical system components; fire protection, 19603 Aeronautical land-use assurance; waivers: Education Department Martin County /Witham Field, FL, 19604 NOTICES Commercial space transportation: Agency information collection activities; proposals, Suborbital rocket launches; public notice requirement submissions, and approvals, 19409–19412 waiver, 19604–19605 Environmental statements; availability, etc.: Employment and Training Administration O’Hare , IL; Category II/III NOTICES approaches installation upgrade; hearing, 19605– Agency information collection activities; proposals, 19606 submissions, and approvals, 19450–19451 Exemption petitions; summary and disposition, 19606– Grants and cooperative agreements; availability, etc.: 19607 Workforce Investment Act— Meetings: Grassroots organizations; correction, 19451–19452 Research, Engineering, and Development Advisory Committee, 19607 Energy Department Passenger facility charges; applications, etc.: See Federal Energy Regulatory Commission Portland, ME, et al., 19607–19610

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Federal Communications Commission Food and Drug Administration RULES RULES Radio stations: table of assignments: Animal drugs, feeds, and related products: Oklahoma and Texas, 19328 Natamycin, 19320–19321 PROPOSED RULES NOTICES Digital television stations; table of assignments: Agency information collection activities; proposals, Puerto Rico, 19363–19364 submissions, and approvals, 19432–19433 Radio stations: table of assignments: Medical devices: Oklahoma, 19364 Semicritical reprocessed single-use devices; premarket NOTICES notification exemptions terminated; validation data Meetings: submission requirements, 19433–19435 Diversity for Communications in Digital Age Advisory Meetings: Committee, 19419 Drug development process; agency/industry Meetings; Sunshine Act, 19420 communication improvement; fifth joint project management workshop, 19435 Federal Election Commission Reports and guidance documents; availability, etc.: NOTICES Absorbable powder for lubricating surgeon’s glove; Meetings; Sunshine Act, 19420 premarket approval applications, 19435–19436 Federal Energy Regulatory Commission Foreign-Trade Zones Board NOTICES NOTICES Hydroelectric applications, 19414 Applications, hearings, determinations, etc.: Meetings; Sunshine Act, 19414–19417 Maine, 19387–19388 Applications, hearings, determinations, etc.: AES Ocean Express, LLC, 19413 Forest Service El Paso Natural Gas Co., 19413 NOTICES Northern Natural Gas Co., 19412 Meetings: Texas Eastern Transmission, LP, 19413–19414 Resource Advisory Committees— Wilbur Power LLC, 19412 Siskiyou County, 19387 Federal Housing Finance Board Health and Human Services Department NOTICES See Centers for Disease Control and Prevention Agency information collection activities; proposals, See Children and Families Administration submissions, and approvals, 19420–19421 See Food and Drug Administration See National Institutes of Health Federal Law Enforcement Training Center See Public Health Service NOTICES See Substance Abuse and Mental Health Services Committees; establishment, renewal, termination, etc.: Administration National Center for State and Local Law Enforcement Training Advisory Committee, 19446 Homeland Security See Federal Law Enforcement Training Center Federal Motor Carrier Safety Administration NOTICES Homeland Security Department Agency information collection activities; proposals, See Coast Guard submissions, and approvals, 19610–19611 Motor carrier safety standards: Housing and Urban Development Department Driver qualifications— PROPOSED RULES Adams, Louis N., et al.; vision requirement exemptions, Government National Mortgage Association (Ginnie Mae): 19611–19612 Mortgage-backed securities guaranty; minimum face value of securities; regulation removed, 19745–19747 Federal Railroad Administration NOTICES NOTICES Agency information collection activities; proposals, Grants and cooperative agreements; availability, etc.: submissions, and approvals, 19448–19449 Amtrak and non-Amtrak operators of state-supported intercity passenger rail routes; fair competitive Industry and Security Bureau bidding procedure; development and NOTICES implementation, 19612–19614 Meetings: Information Systems Technical Advisory Committee, Fish and Wildlife Service 19388 PROPOSED RULES Endangered and threatened species: Interior Department Critical habitat designations— See Fish and Wildlife Service California red-legged frog, 19619–19642 See Land Management Bureau California tiger salamander, 19364–19365 See Surface Mining Reclamation and Enforcement Office NOTICES Endangered and threatened species: Internal Revenue Service Bull trout; 5-year review, 19449–19450 NOTICES Meetings: Meetings: Aquatic Nuisance Species Task Force, 19450 Taxpayer Advocacy Panels, 19617

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International Trade Administration Caribbean, Gulf, and South Atlantic fisheries— NOTICES Gulf of Mexico and South Atlantic coastal migratory Antidumping: pelagic resources, 19346–19347 Hot-rolled carbon steel flat products from— West Coast States and Western Pacific fisheries— Thailand, 19388–19390 Pacific Coast groundfish, 19347–19358 Light-walled rectangular pipe and tube from— PROPOSED RULES Mexico, 19400–19407 Marine mammals: Turkey, 19390–19399 Commercial fishing authorizations— Steel concrete reinforcing bar from— Fisheries categorized according to frequency of Korea, 19399–19400 incidental takes; 2004 list, 19365–19386 Wooden bedroom furniture from— NOTICES China, 19390 Agency information collection activities; proposals, submissions, and approvals, 19407–19408 Labor Department Fishery conservation and management: See Employment and Training Administration Alaska; fisheries of Exclusive Economic Zone— See Labor Statistics Bureau Bering Sea and Aleutian Islands king and tanner crabs; See Occupational Safety and Health Administration overfished fisheries rebuilding; correction, 19408 See Veterans Employment and Training Service National Science Foundation Labor Statistics Bureau NOTICES NOTICES Meetings; Sunshine Act, 19559 Agency information collection activities; proposals, submissions, and approvals, 19452–19453 Natural Resources Conservation Service Land Management Bureau NOTICES NOTICES Environmental statements; availability, etc.: Meetings: Cavalry Creek Watershed Site 6, OK, 19387 Resource Advisory Councils— Dakotas, 19450 Nuclear Regulatory Commission NOTICES Medicare Payment Advisory Commission Meetings: NOTICES Nuclear Waste Advisory Committee; revised, 19561 Meetings, 19558 Meetings; Sunshine Act, 19561 Operating licenses, amendments; no significant hazards National Archives and Records Administration considerations; biweekly notices, 19561–19582 NOTICES Regulatory guides; issuance, availability, and withdrawal, Meetings: 19582 Preservation Advisory Committee, 19558–19559 Applications, hearings, determinations, etc.: Nuclear Management Co., LLC, 19559–19561 National Institutes of Health NOTICES Occupational Safety and Health Administration Agency information collection activities; proposals, submissions, and approvals, 19436–19437 PROPOSED RULES Longshoring and marine terminals safety and health Inventions, Government-owned; availability for licensing, standards: 19437–19438 Vertical tandem lifts, 19361–19363 Meetings: Advisory Committee to Director, 19438 Director’s Council of Public Representatives, 19438– Postal Service 19439 PROPOSED RULES National Cancer Institute, 19439 Domestic Mail Manual: National Center for Research Resources, 19439 Packaging and closure requirements, mailing containers, National Institute of Allergy and Infectious Diseases, and parcel sorting equipment; changes, 19363 19439–19441 National Institute of Environmental Health Sciences, Presidential Documents 19442 National Institute of Neurological Disorders and Stroke, PROCLAMATIONS Special observances: 19442 National Former Prisoner of War Recognition Day (Proc. National Institute on Deafness and Other Communication 7770), 19749–19751 Disorders, 19441–19442 Scientific Review Center, 19442–19444 Public Health Service National Oceanic and Atmospheric Administration NOTICES RULES National Toxicology Program: Fishery conservation and management: Center for Evaluation of Risks to Human Reproduction— Alaska; fisheries of Exclusive Economic Zone— Methylphenidate and Adderall, magnesium sulfate, and Alaska plaice in Bering Sea and Aleutian Islands, genistein and soy formula; expert panel 19358 evaluations, 19444–19445

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Securities and Exchange Commission Treasury Department NOTICES See Internal Revenue Service Securities: NOTICES Suspension of trading— Agency information collection activities; proposals, BioCurex, Inc., 19583 submissions, and approvals, 19614–19617 Self-regulatory organizations; proposed rule changes: Boycotts, international: Chicago Stock Exchange, Inc., 19583–19584 Countries requiring cooperation; list, 19617 National Association of Securities Dealers, Inc., et al., 19584–19592 New York Stock Exchange, Inc., 19592–19593 Veterans Employment and Training Service Pacific Exchange, Inc., 19593–19600 NOTICES Philadelphia Stock Exchange, Inc., 19600–19601 Grants and cooperative agreements; availability, etc.: Applications, hearings, determinations, etc.: Homeless Veterans’ Reintegration Program, 19453–19488 Essex Corp., 19582–19583 Non-Urban Homeless Veterans’ Reintegration Program, 19488–19523 Small Business Administration Urban Homeless Veterans’ Reintegration Program, 19523– NOTICES 19558 Agency information collection activities; proposals, submissions, and approvals, 19601 State Department Separate Parts In This Issue RULES Acquisition regulations: Miscellaneous amendments, 19329–19346 Part II Interior Department, Fish and Wildlife Service, 19619– Substance Abuse and Mental Health Services 19642 Administration NOTICES Part III Agency information collection activities; proposals, Health and Human Services Department, Substance Abuse submissions, and approvals, 19445–19446 and Mental Health Services Administration, 19643– Federal Workplace Drug Testing Program; Mandatory 19732 Guidelines: Urine specimens validity determination standards, 19643–19673 Part IV Federal Workplace Drug Testing Program; Proposed Environmental Protection Agency, 19733–19744 Mandatory Guidelines: Hair, sweat, oral fluid, and urine specimens testing; scientific and technical guidelines, 19672–19732 Part V Housing and Urban Development Department, 19745–19747 Surface Mining Reclamation and Enforcement Office RULES Part VI Permanent program and abandoned mine land reclamation Executive Office of the President, Presidential Documents, submissions: New Mexico, 19321–19325 19749–19751 Transportation Department See Federal Aviation Administration Reader Aids See Federal Motor Carrier Safety Administration See Federal Railroad Administration Consult the Reader Aids section at the end of this issue for NOTICES phone numbers, online resources, finding aids, reminders, Agency information collection activities; proposals, and notice of recently enacted public laws. submissions, and approvals, 19601–19602 To subscribe to the Federal Register Table of Contents Aviation proceedings: LISTSERV electronic mailing list, go to http:// Certificates of public convenience and necessity and listserv.access.gpo.gov and select Online mailing list foreign air carrier permits; weekly applications, archives, FEDREGTOC-L, Join or leave the list (or change 19602–19603 settings); then follow the instructions.

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CFR PARTS AFFECTED IN THIS ISSUE

A cumulative list of the parts affected this month can be found in the Reader Aids section at the end of this issue.

3 CFR 679...... 19358 Proclamations: Proposed Rules: 7770...... 19751 17 (2 documents) ...... 19364, 19620 14 CFR 229...... 19365 25...... 19311 39 (3 documents) ...... 19313, 19618 71 (7 documents) ...... 19314, 19315, 19316, 19317, 19318, 19319 Proposed Rules: 71 (2 documents) ...... 19359, 19360 21 CFR 573...... 19320 24 CFR Proposed Rules: 320...... 19746 29 CFR Proposed Rules: 1917...... 19361 1918...... 19361 30 CFR 931...... 19321 33 CFR 117...... 19325 165...... 19326 39 CFR Proposed Rules: 111...... 19363 40 CFR 63...... 19734 Proposed Rules: 63...... 19743 300...... 19363 47 CFR 73...... 19328 Proposed Rules: 73 (2 documents) ...... 19363, 19364 48 CFR 601...... 19329 602...... 19329 603...... 19329 604...... 19329 605...... 19329 606...... 19329 609...... 19329 611...... 19329 612...... 19329 613...... 19329 616...... 19329 617...... 19329 619...... 19329 622...... 19329 623...... 19329 625...... 19329 626...... 19329 628...... 19329 630...... 19329 632...... 19329 636...... 19329 637...... 19329 642...... 19329 651...... 19329 652...... 19329 653...... 19329 50 CFR 622...... 19346 660...... 19347

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Rules and Regulations Federal Register Vol. 69, No. 71

Tuesday, April 13, 2004

This section of the FEDERAL REGISTER Renton, Washington, 98055–4056; or postcard on which the docket number contains regulatory documents having general delivered in duplicate to the Transport appears. We will stamp the date on the applicability and legal effect, most of which Airplane Directorate at the above postcard and mail it back to you. are keyed to and codified in the Code of address. All comments must be marked: Background Federal Regulations, which is published under Docket No. NM276. 50 titles pursuant to 44 U.S.C. 1510. FOR FURTHER INFORMATION CONTACT: Mr. On August 22, 2003, Flight Test The Code of Federal Regulations is sold by Steve Edgar, FAA, Standardization Associates, Incorporated, Mojave, the Superintendent of Documents. Prices of Branch, ANM–113, Transport Airplane California, applied to the FAA, Los new books are listed in the first FEDERAL Directorate, Aircraft Certification Angeles Aircraft Certification Office, for REGISTER issue of each week. Service, 1601 Lind Avenue SW., a supplemental type certificate (STC) to Renton, Washington, 98055–4056; modify Learjet Models 24 B/D/E/F and telephone (425) 227–2025; facsimile 25 B/C/D/F airplanes. The proposed DEPARTMENT OF TRANSPORTATION (425) 227–1149. modification incorporates the installation of a dual Innovative Federal Aviation Administration SUPPLEMENTARY INFORMATION: Systems and Solution Air Data Display Comments Invited Unit (ADDU) system as primary 14 CFR Part 25 altimeters. The information presented is The FAA has determined that the flight critical. The ADDU systems [Docket No. NM276, Special Conditions No. notice and opportunity for prior public installed in this airplane have the 25–259–SC] comment is impracticable because these potential to be vulnerable to HIRF. procedures would significantly delay Special Conditions: Learjet Models 24 certification of the airplane and delivery Type Certification Basis and 25 Airplanes; High Intensity Radiated Fields (HIRF) of the affected airplane. In addition, the Under the provisions of 14 CFR substance of these special conditions 21.101, Flight Test Associates, AGENCY: Federal Aviation has been subject to the public comment Incorporated, must show that the Administration (FAA) DOT. process in several prior instances with airplane, as changed, continues to meet ACTION: Final special conditions; request no substantive comments received. The the applicable provisions of the for comments. FAA therefore finds that good cause regulations incorporated by reference in exists for making these special Type Certificate No. A10CE, or the SUMMARY: These special conditions are conditions effective upon issuance; applicable regulations in effect on the issued for Learjet Models 24 B/D/E/F however, the FAA invites interested date of application for the change. The and 25 B/C/D/F airplanes, modified by persons to participate in this rulemaking regulations incorporated by reference in Flight Test Associates, Incorporated. by submitting written comments, data, the type certificate are commonly These modified airplanes will have or views. The most helpful comments referred to as the ‘‘original type novel and unusual design features when reference a specific portion of the certification basis.’’ compared to the state of technology special conditions, explain the reason The regulations incorporated by envisioned in the airworthiness for any recommended change, and reference in Type Certificate No. A10CE standards for transport category include supporting data. We ask that include 14 Code of Federal Regulations airplanes. The modification you send us two copies of written (CFR) part 25, as amended by incorporates the installation of a dual comments. Amendments 25–2 through 25–18. Innovative Systems and Support Air We will file in the docket all If the Administrator finds that the Data Display Unit system. The comments we receive, as well as a applicable airworthiness regulations applicable airworthiness regulations do report summarizing each substantive (i.e., part 25, as amended) do not not contain adequate or appropriate public contact with FAA personnel contain adequate or appropriate safety safety standards for the protection of concerning these special conditions. standards for the modified Learjet these systems from the effects of high- The docket is available for public Models 24 B/D/E/F and 25 B/C/D/F intensity radiated fields (HIRF). These inspection before and after the comment airplanes, because of a novel or unusual special conditions contain the closing date. If you wish to review the design feature, special conditions are additional safety standards that the docket in person, go to the address in prescribed under the provisions of Administrator considers necessary to the ADDRESSES section of this preamble § 21.16. establish a level of safety equivalent to between 7:30 a.m., and 4 p.m., Monday In addition to the applicable that provided by the existing through Friday, except Federal holidays. airworthiness regulations and special airworthiness standards. We will consider all comments we conditions, the Learjet Models 24 B/D/ DATES: The effective date of these receive on or before the closing date for E/F and 25 B/C/D/F airplanes must special conditions is March 31, 2004. comments. We will consider comments comply with the fuel vent and exhaust Comments must be received on or filed late if it is possible to do so emission requirements of 14 CFR part before May 13, 2004. without incurring expense or delay. We 34 and the noise certification ADDRESSES: Comments on these special may change these special conditions requirements of 14 CFR part 36. conditions may be mailed in duplicate based on the comments we receive. Special conditions, as defined in 14 to: Federal Aviation Administration, If you want the FAA to acknowledge CFR 11.19, are issued in accordance Transport Airplane Directorate, Attn: receipt of your comments on these with § 11.38 and become part of the type Rules Docket (ANM–113), Docket No. special conditions, include with your certification basis in accordance with NM276, 1601 Lind Avenue SW., comments a pre-addressed, stamped § 21.101.

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Special conditions are initially 1. A minimum threat of 100 volts rms Models 24 B/D/E/F and 25 B/C/D/F applicable to the model for which they (root-mean-square) per meter electric airplanes modified by Flight Test are issued. Should Flight Test field strength from 10 KHz to 18 GHz. Associates, Incorporated. It is not a rule Associates, Incorporated, apply at a later a. The threat must be applied to the of general applicability and affects only date for a supplemental type certificate system elements and their associated the applicant who applied to the FAA to modify any other model included on wiring harnesses without the benefit of for approval of these features on the the same type certificate to incorporate airframe shielding. airplane. the same novel or unusual design b. Demonstration of this level of feature, these special conditions would protection is established through system The substance of the special also apply to the other model under the tests and analysis. conditions for these airplanes has been provisions of § 21.101. 2. A threat external to the airframe of subjected to the notice and comment the field strengths indicated in the procedure in several prior instances and Novel or Unusual Design Features following table for the frequency ranges has been derived without substantive The modified Learjet Models 24 B/D/ indicated. Both peak and average field change from those previously issued. E/F and 25 B/C/D/F will incorporate strength components from the table are Because a delay would significantly new dual primary altimeters that will to be demonstrated. affect the certification of the airplane, perform critical functions. These which is imminent, the FAA has systems may be vulnerable to HIRF Field strength determined that prior public notice and external to the airplane. Frequency (volts per meter) comment are unnecessary and impracticable, and good cause exists for Discussion Peak Average adopting these special conditions There is no specific regulation that 10 kHz–100 kHz 50 50 immediately. The FAA is requesting addresses protection requirements for 100 kHz–500 comments to allow interested persons to electrical and electronic systems from kHz ...... 50 50 submit views that may not have been 500 kHz–2 MHz 50 50 HIRF. Increased power levels from submitted in response to the prior ground-based radio transmitters and the 2 MHz–30 MHz 100 100 30 MHz–70 MHz 50 50 opportunities for comment described growing use of sensitive avionics/ 70 MHz–100 above. electronics and electrical systems to MHz ...... 50 50 command and control airplanes have 100 MHz–200 List of Subjects in 14 CFR Part 25 made it necessary to provide adequate MHz ...... 100 100 protection. 200 MHz–400 Aircraft, Aviation safety, Reporting and recordkeeping requirements. To ensure that a level of safety is MHz ...... 100 100 400 MHz–700 achieved equivalent to that intended by I The authority citation for these the regulations incorporated by MHz ...... 700 50 700 MHz–1 GHz 700 100 special conditions is as follows: reference, special conditions are needed 1 GHz–2 GHz ... 2000 200 for the Learjet Models 24 B/D/E/F and Authority: 49 U.S.C. 106(g), 40113, 44701, 2 GHz–4 GHz ... 3000 200 44702, 44704. 25 B/C/D/F. These special conditions 4 GHz–6 GHz ... 3000 200 require that new primary altimeters that 6 GHz–8 GHz ... 1000 200 The Special Conditions perform critical functions be designed 8 GHz–12 GHz 3000 300 and installed to preclude component 12 GHz–18 GHz 2000 200 I Accordingly, pursuant to the authority damage and interruption of function 18 GHz–40 GHz 600 200 delegated to me by the Administrator, due to both the direct and indirect The field strengths are expressed in terms the following special conditions are effects of HIRF. of peak of the root-mean-square (rms) over issued as part of the supplemental type the complete modulation period. High-Intensity Radiated Fields (HIRF) certification basis for the modified The threat levels identified above are Learjet Models 24 B/D/E/F and 25 B/C/ With the trend toward increased the result of an FAA review of existing D/F airplanes modified by Flight Test power levels from ground-based studies on the subject of HIRF, in light Associates, Incorporated. transmitters, plus the advent of space of the ongoing work of the 1. Protection From Unwanted Effects and satellite communications coupled Electromagnetic Effects Harmonization with electronic command and control of of High-Intensity Radiated Fields Working Group of the Aviation (HIRF). Each electrical and electronic the airplane, the immunity of critical Rulemaking Advisory Committee. digital avionics/electronics and system that performs critical functions electrical systems to HIRF must be Applicability must be designed and installed to established. As discussed above, these special ensure that the operation and It is not possible to precisely define conditions are applicable to Learjet operational capability of these systems the HIRF to which the airplane will be Models 24 B/D/E/F and 25 B/C/D/F to perform critical functions are not exposed in service. There is also series airplanes. Should Aircraft adversely affected when the airplane is uncertainty concerning the effectiveness Systems & manufacturing apply at a exposed to high intensity radiated of airframe shielding for HIRF. later date for a change to the type fields. Furthermore, coupling of certificate to include another model 2. For the purpose of these special electromagnetic energy to cockpit- incorporating the same novel or unusual conditions, the following definition installed equipment through the cockpit design feature, these special conditions applies: window apertures is undefined. Based would apply to that model as well as Critical Functions: Functions whose on surveys and analysis of existing HIRF under the provisions of 14 CFR 21.101. emitters, an adequate level of protection failure would contribute to or cause a exists when compliance with the HIRF Conclusion failure condition that would prevent the protection special condition is shown This action affects only certain novel continued safe flight and landing of the with either paragraph 1 or 2 below: or unusual design features on the Learjet airplane.

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Issued in Renton, Washington, on March in a reference to an incorrect effective seats to ensure that the seats lock in 31, 2004. date in the compliance time specified in position and to verify that lock nuts and Kalene C. Yanamura, Table 1 of the AD for Group 1 airplanes. bolts of adequate length are installed on Acting Manager, Transport Airplane This AD is applicable to certain Boeing the rear track lock bracket, and Directorate, Aircraft Certification Service. Model 737 series airplanes. This AD corrective action, if necessary. [FR Doc. 04–8355 Filed 4–12–04; 8:45 am] requires a one-time general visual As published, that final rule BILLING CODE 4910–13–P inspection of the seat locks and seat incorrectly specifies ‘‘September 26, tracks of the flightcrew seats to ensure 2001’’ as the effective date for AD 2000– that the seats lock in position and to 10–21 in the compliance time specified DEPARTMENT OF TRANSPORTATION verify that lock nuts and bolts of for Group 1 airplanes in Table 1 of that adequate length are installed on the rear final rule. The correct effective date of Federal Aviation Administration track lock bracket, and corrective action, AD 2000–10–21 is ‘‘June 12, 2000.’’ It if necessary. was the FAA’s intent that operators use 14 CFR Part 39 DATES: Effective March 24, 2004. June 12, 2000, to determine the [Docket No. 2002–NM–174–AD; Amendment compliance time for Group 1 airplanes FOR FURTHER INFORMATION CONTACT: 39–13483; AD 2004–04–03 as specified in Table 1 of that final rule, Shannon Lennon, Aerospace Engineer, as evidenced by the explanatory RIN 2120–AA64 Cabin Safety and Environmental parenthetical reference ‘‘(the effective Systems Branch, ANM–150S, FAA, date of AD 2000–10–21, amendment 39– Airworthiness Directives; Boeing Seattle Aircraft Certification Office, 11745).’’ Model 737–300, –400, and –500 Series 1601 Lind Avenue, SW., Renton, Airplanes Since no other part of the regulatory Washington; telephone (425) 917–6436; information has been changed, the final fax (425) 917–6590. AGENCY: Federal Aviation rule is not being republished in the Administration, DOT. SUPPLEMENTARY INFORMATION: Federal Register. ACTION: Final rule; correction. Airworthiness Directive (AD) 2004–04– The effective date of this AD remains 03, amendment 39–13483, applicable to March 24, 2004. SUMMARY: This document corrects a certain Boeing Model 737 series typographical error that appeared in airplanes, was published in the Federal § 39.13 [Corrected] airworthiness directive (AD) 2004–04– Register on February 18, 2004 (69 FR On page 7566, the second column of 03 that was published in the Federal 7565). That AD requires a one-time Table 1 of AD 2004–04–03 is corrected Register on February 18, 2004 (69 FR general visual inspection of the seat to read as follows: 7565). The typographical error resulted locks and seat tracks of the flightcrew * * * * *

TABLE 1.—COMPLIANCE TIME/SERVICE BULLETIN

Airplanes— Compliance time— Service bulletin—

For Group 1 airplanes listed in Boeing Alert Serv- Within 90 days after June 12, 2000 (the Boeing Alert Service Bulletin 737–25A1363, ice Bulletin 737–25A1363, Revision 1, dated effective date of AD 2000–10–21, dated November 5, 1998. March 28, 2002. amendment 39–11745). For Group 2 airplanes listed in Boeing Alert Serv- Within 90 days after the effective date Boeing Alert Service Bulletin 737–25A1363, Revi- ice Bulletin 737–25A1363, Revision 1, dated of this AD. sion 1, dated March 28, 2002. March 28, 2002.

* * * * * DEPARTMENT OF TRANSPORTATION grace period for the initial compliance Issued in Renton, Washington, on April 1, time. This AD is applicable to all Boeing Federal Aviation Administration 2004. Model 737–600, –700, –700C, –800, and –900 series airplanes. This AD requires Kalene C. Yanamura, 14 CFR Part 39 an inspection of the rear spar attach Acting Manager, Transport Airplane pins and front spar attach bolts that Directorate, Aircraft Certification Service. [Docket No. 2004–NM–03–AD; Amendment 39–13514; AD 2004–05–19] attach the horizontal stabilizers to the [FR Doc. 04–8296 Filed 4–12–04; 8:45 am] horizontal stabilizer center section for BILLING CODE 4910–13–P RIN 2120–AA64 damage; and follow-on or corrective Airworthiness Directives; Boeing actions, as applicable. Model 737–600, –700, –700C, –800, and DATES: Effective March 24, 2004. –900 Series Airplanes FOR FURTHER INFORMATION CONTACT: Nancy Marsh, Aerospace Engineer, AGENCY: Federal Aviation Administration, DOT. Airframe Branch, ANM–120S, FAA, Seattle Aircraft Certification Office, ACTION: Final rule; correction. 1601 Lind Avenue, SW., Renton, SUMMARY: This document corrects an Washington 98055–4056; telephone error that appeared in airworthiness (425) 917–6440; fax (425) 917–6590. directive (AD) 2004–05–19 that was SUPPLEMENTARY INFORMATION: published in the Federal Register on Airworthiness Directive (AD) 2004–05– March 9, 2004 (69 FR 10921). The error 19, amendment 39–13514, applicable to resulted in the omission of the phrase all Boeing Model 737–600, –700, –700C, ‘‘whichever occurs first’’ in a certain –800, and –900 series airplanes, was

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published in the Federal Register on Issued in Renton, Washington, on April 6, action necessary. This action was March 9, 2004 (69 FR 10921). That AD 2004. originally scheduled to become effective requires an inspection of the rear spar Kevin M. Mullin, on November 28, 2002; however, an attach pins and front spar attach bolts Acting Manager, Transport Airplane unforeseen delay in beginning that attach the horizontal stabilizers to Directorate, Aircraft Certification Service. construction on the tower required the the horizontal stabilizer center section [FR Doc. 04–8297 Filed 4–12–04; 8:45 am] effective date of this action to be for damage; and follow-on or corrective BILLING CODE 4910–13–P delayed. Construction is now nearing actions, as applicable. completion. The FAA has determined that this As published, in the second row of DEPARTMENT OF TRANSPORTATION regulation only involves an established the ‘‘Grace Period’’ column of Table 1 of body of technical regulations for which AD 2004–05–19, the phrase ‘‘whichever Federal Aviation Administration frequent and routine amendments are occurs first’’ was inadvertently omitted. necessary to keep them operationally The correct grace period should have 14 CFR Part 71 current. It, therefore, (1) is not a read, ‘‘For airplanes on which Boeing [Docket No. FAA–2004–17341; Airspace ‘‘significant regulatory action’’ under Service Bulletin 737–55–1074, dated Docket No. 02–ASO–4] Executive Order 12866; (2) is not a August 15, 2002, has been done as of the ‘‘significant rule’’ under DOT Regulatory effective date of this AD: Within 24 Establishment of Class D Airspace; Policies and Procedures (44 FR 11034; months or 6,000 flight cycles since Greenville Donaldson Center, SC, February 26, 1979); and (3) so minimal. accomplishment of the service bulletin, Amendment of Class E Airspace; Since this is a routine matter that will whichever occurs first.’’ Greer, Greenville-Spartanburg Airport, only affect air traffic procedures and air SC, and Amendment of Class E Since no other part of the regulatory navigation, it is certified that this rule, Airspace; Greenville, SC when promulgated, will not have a information has been changed, the final significant economic impact on a rule is not being republished in the AGENCY: Federal Aviation Administration (FAA), DOT. substantial number of small entities Federal Register. under the criteria of the Regulatory ACTION: Final rule; confirmation of The effective date of this AD remains Flexibility Act. effective date. March 24, 2004. List of Subjects in 14 CFR Part 71 SUMMARY: This action confirms the new § 39.13 [Corrected] effective date for the establishment of Airspace, Incorporation by reference, On page 10922, in the third column, Class D airspace at Greenville Navigation (Air). and on page 10933, in the first column, Donaldson Center, SC, the amendment Confirmation of Effective Date Table 1 of paragraph (a) of AD 2004–05– of Class E2 airspace at Greer, Greenville- I 19 is corrected to read as follows: Spartanburg Airport, SC, and the The effective date on Airspace Docket No. 02–ASO–4 is hereby confirmed to * * * * * amendment of Class E5 airspace at Greenville, SC. The construction of a be August 5, 2004. (a) * * * new federal contract tower with a Authority: 49 U.S.C. app. 1348(a), 1354(a), weather reporting system was delayed; 1510; E.O. 10854, 24 FR 9565, 3 CFR, 1959– TABLE 1.—INITIAL COMPLIANCE TIME therefore, the effective date of the 1963 Comp., p. 389; 49 U.S.C. 106(g); 14 CFR establishment of Class D and E2 11.69. Threshold Grace period airspace and amendment of Class E5 * * * * * airspace was also delayed. Issued in College Park, Georgia, on March Prior to the accumula- For airplanes on 24, 2004. tion of 15,000 total which Boeing Serv- EFFECTIVE DATE: The effective date of flight cycles or 60 ice Bulletin 737– November 28, 2002, published on May Jeffrey U. Vincent, months since the 55–1074, dated Au- 1, 2002, (67 FR 21575), and Acting Manager, Air Traffic Division, date of issuance of gust 15, 2002, has subsequently delayed indefinitely (67 Southern Region. the original Air- not been done as FR 65872), is now 0901 UTC, August 5, [FR Doc. 04–8360 Filed 4–12–04; 8:45 am] worthiness Certifi- of the effective date 2004. BILLING CODE 4910–13–M cate or the date of of this AD: Within FOR FURTHER INFORMATION CONTACT: issuance of the Ex- 90 days after the Walter R. Cochran, Manager, Airspace port Certificate of effective date of DEPARTMENT OF TRANSPORTATION Airworthiness, this AD. Branch, Air Traffic Division, Federal Aviation Administration, P.O. Box whichever occurs Federal Aviation Administration first. 20636, Atlanta, Georgia 30320; telephone (404) 305–5586. For airplanes on 14 CFR Part 71 which Boeing Serv- SUPPLEMENTARY INFORMATION: ice Bulletin 737– [Docket No. FAA–2004–16861; Airspace 55–1074, dated Au- History Docket No. 04–ASO–1] gust 15, 2002, has Airspace Docket No. 02–ASO–04, been done as of published in the Federal Register on Amendment of Class D and E4 the effective date of May 1, 2002 (67 FR 21575), established Airspace; Homestead, FL this AD: Within 24 months or 6,000 Class D airspace at Greenville AGENCY: Federal Aviation flight cycles since Donaldson Center, SC, amended Class Administration (FAA), DOT. accomplishment of E2 airspace at Greer, Greenville- ACTION: Final rule. the service bulletin, Spartanburg Airport, SC, and amended whichever occurs Class E5 airspace at Greenville, SC. The SUMMARY: This action amends Class D first. construction of a federal contract tower and E4 airspace at Homestead, FL. The with a weather reporting system at name of the airport has changed from * * * * * Donaldson Center Airport made this Dade County—Homestead Regional

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Airport to Homestead Air Reserve Base preparation of a Regulatory Evaluation Issued in College Park, Georgia on March (ARB). As a result of an evaluation, it as the anticipated impact is so minimal. 31, 2004. has been determined a modification Since this is a routine matter that will Jeffrey U. Vincent, should be made to the Homestead, FL, only affect air traffic procedures and air Acting Manager, Air Traffic Division, Class D and E4 airspace areas to contain navigation, it is certified that this rule, Southern Region. the Tactical Air Navigation (TACAN) or when promulgated, will not have a [FR Doc. 04–8357 Filed 4–12–04; 8:45 am] Instrument Landing System (ILS) significant economic impact on a BILLING CODE 4910–13–M (RWY) 5, Standard Instrument substantial number of small entities Approach Procedure (SIAP) to the under the criteria of the Regulatory Homestead ARB. Additional surface Flexibility Act. DEPARTMENT OF TRANSPORTATION area airspace is needed to contain the SIAP. List of Subjects in 14 CFR Part 71 Federal Aviation Administration EFFECTIVE DATE: 0901 UTC, June 10, Airspace, Incorporation by reference, 14 CFR Part 71 2004. Navigation (Air). FOR FURTHER INFORMATION CONTACT: [Docket No. FAA–2004–16904; Airspace Adoption of the Amendment Walter R. Cochran, Manager, Airspace Docket No. 04–ASO–2] Branch, Air Traffic Division, Federal I In consideration of the foregoing, the Establishment of Class E5 Airspace; Aviation Administration, P.O. Box Federal Aviation Administration Jamestown, KY; Correction 20636, Atlanta, Georgia 30320; proposes to amend 14 CFR Part 71 as telephone (404) 305–5627. follows: AGENCY: Federal Aviation SUPPLEMENTARY INFORMATION: Administration (FAA), DOT. History PART 71—DESIGNATION OF CLASS A, ACTION: Correcting amendment. CLASS B, CLASS C, CLASS D, AND On February 19, 2004, the FAA CLASS E AIRSPACE AREAS; SUMMARY: This document contains a proposed to amend part 71 of the AIRWAYS; ROUTES; AND REPORTING correction to the final rule (FAA–2004– Federal Aviation Regulations (14 CFR POINTS 16904; 04–ASO–2), which was part 71) by amending Class D and E4 published in the Federal Register on airspace at Homestead ARB, FL (69 FR I 1. The authority citation for Part 71 March 23, 2004, (69 FR 13470), 7713). This action provides adequate continues to read as follows: establishing Class E5 airspace at Class D and E4 airspace for IFR Jamestown, KY. This action corrects an Authority: 49 U.S.C. 106(g); 40103, 40113, operations at Homestead ARB, FL. error in the legal description for the Designations for Class D airspace areas 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– 1963 Comp., p. 389. Class E5 airspace at Russell County extending upward from the surface of Airport, KY. the earth and Class E airspace § 71.1 [Amended] EFFECTIVE DATE: Effective 0901 UTC, designations for airspace designated as June 10, 2004. surface areas are published in I 2. The incorporation by reference in FOR FURTHER INFORMATION CONTACT: Paragraphs 5000 and 6004 respectively, 14 CFR 71.1 of Federal Aviation Walter R. Cochran, Manager, Airspace of FAA Order 7400.9L, dated September Administration Order 7400.9L, Airspace Branch, Air Traffic Division, Federal 2, 2003, and effective September 16, Designations and Reporting Points, Aviation Administration, P.O. Box 2003, which is incorporated by dated September 2, 2003, and effective 20636, Atlanta, Georgia 30320; reference in 14 CFR part 71.1. The Class September 16, 2003, is amended as telephone (404) 305–5627. D and E designations listed in this follows: document will be published SUPPLEMENTARY INFORMATION: subsequently in the Order. Paragraph 5000 Class D Airspace Background Interested parties were invited to * * * * * participate in this rulemaking Federal Register Document 04–6453, proceeding by submitting written ASO FL D Homestead, FL [Revised] Docket No. FAA–2004–16904; Airspace comments on the proposal to the FAA. Homestead ARB, FL Docket 04–ASO–2, published on March No comments objecting to the proposal (Lat. 25°29′18″ N., long. 80°23′01″ W.) 23, 2004, (69 FR 13470), establishes were received. That airspace extending upward from the Class E5 airspace at Russell County surface to and including 2,500 feet MSL Airport, KY. An error was discovered in The Rule within a 5.5-mile radius of Homestead ARB. the legal description, describing the Class E5 airspace area. The word ‘‘mile’’ This amendment to part 71 of the * * * * * Federal Aviation Regulations (14 CFR was inadvertently omitted after 6.5 and part 71) amends Class D and E4 airspace Paragraph 6004 Class E Airspace Areas before the word radius. This action at Homestead ARB, FL. Designated as an Extension to a Class D or corrects the error. The FAA has determined that this Class E Surface Area Designations for Class E Airspace proposed regulation only involves an * * * * * Areas Extending Upward from 700 feet established body of technical or More Above the Surface of the Earth ASO FL E4 Homestead, FL [Revised] regulations for which frequent and are published in Paragraph 6005 of FAA routine amendments are necessary to Homestead ARB, FL Order 7400.9L, Airspace Designations keep them operationally current. It, (Lat. 25°29′18″ N., long. 80°23′01″ W.) and Reporting Points, dated September therefore, (1) is not a ‘‘significant That airspace extending upward from the 2, 2003, and effective September 16, regulatory action’’ under Executive surface within 1.5 miles each side of the 50° 2003, which is incorporated by Order 12866; (2) is not a ‘‘significant bearing and the 230° bearing from Homestead reference in 14 CFR 71.1. The Class E rule’’ under DOT Regulatory Policies ARB extending from the 5.5-mile radius to 7 airspace designation listed in this and Procedures (44 FR 11034; February miles northeast and southwest of the airport. document will be published 26, 1979); and (3) does not warrant * * * * * subsequently in the Order.

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Need for Correction DEPARTMENT OF TRANSPORTATION of the Department of Transportation NASSIF Building at the above address. As published, the final rule contains Federal Aviation Administration An informal docket may also be an error, which inadvertently omits the examined during normal business hours word ‘‘mile’’. Accordingly, pursuant to 14 CFR Part 71 at the office of the Regional Air Traffic the authority delegated to me, the legal [Docket No. FAA–2004–17295; Airspace Division, Federal Aviation description for the Class E5 airspace Docket No. 04–AEA–02] Administration, Eastern Region, 1 area at Jamestown, KY, incorporated by Aviation Plaza, Jamaica, NY 11434– reference at § 71.1, 14 CFR 71.1, and Amendment of Class E Airspace; 4890. published in the Federal Register on District of Columbia, , FOR FURTHER INFORMATION CONTACT: Mr. March 23, 2004, (69 FR 16904), is Virginia, and West Virginia Francis Jordan, Airspace Specialist, corrected by making the following AGENCY: Federal Aviation Airspace Branch, AEA–520, Aviation correcting amendment. Administration (FAA), DOT. Plaza, Jamaica, NY 11434–4809, List of Subjects in 14 CFR Part 71 ACTION: Final Rule; request for telephone: (718) 553–4521. comments. SUPPLEMENTARY INFORMATION: Although Airspace, Incorporation by reference, this action is a final rule, which Navigation (air). SUMMARY: This action removes the involves the amendment of Class E description of the Class E airspace I airspace within District of Columbia, In consideration of the foregoing, the designated for , Maryland, Virginia, and West Virginia, Federal Aviation Administration MD; , MD; Baltimore by consolidating that airspace into one corrects the adopted amendment, 14 Washington International Airport, MD; description, and was not preceded by CFR Part 71, by making the following , MD; College Park notice and public procedure, comments correcting amendment: Airport, MD; Maryland State Police are invited on the rule. This rule will Heliport, Ft. McHenry, MD; Tipton become effective on the date specified PART 71—DESIGNATION OF CLASS A, Airport, MD; Frederick Municipal in the DATES section. However, after the CLASS B, CLASS C, CLASS D, AND Airport, MD; Potomac Airport, MD; review of any comments, if the FAA CLASS E AIRSPACE AREAS; Montgomery County Airport, MD; finds that further changes are AIRWAYS; ROUTES; AND REPORTING , MD; Bay Bridge appropriate, it will initiate rulemaking POINTS Airport, MD: Cowley Shock Trauma proceedings to extend the effective date Center Heliport, Baltimore, MD; Carroll or to amend the regulation. I 1. The authority citation for Part 71 County Airport, MD; , Comments that provide the factual continues to read as follows: MD; , MD; Davison basis supporting the views and Army Airfield, Ft. Belvoir, VA; Birch Authority: 49 U.S.C. 106(g); 40103, 40113, suggestions presented are particularly Hollow, VA; Washington Dulles 40120; E.O. 10854, 24 FR 9565, 3 CFR 1959– helpful in evaluating the effects of the International Airport, VA; Leesburg 1963 Comp., p. 389. rule, and in determining whether Executive Airport, VA; Manassas additional rulemaking is required. § 71.1 [Corrected] Municipal/Harry P. , VA; Comments are specifically invited on Mobile Business Resources Corporation I 2. The incorporation by reference in the overall regulatory, aeronautical, Heliport, VA; Upperville Airport, VA; economic, environmental, and energy- 14 CFR 71.1 of Federal Aviation Eastern West Virginia Regional/ Administration Order 7400.9L, Airspace related aspects of the rule which might Shepherd Field Airport, WV. The suggest the need to modify the rule. Designations and Reporting Points, affected Class E–5 airspace for the dated September 2, 2003, and effective included in these descriptions The Rule September 16, 2003, is amended as will be consolidated into the amended This amendment to Part 71 of the follows: Paragraph 6005 Class E Washington, DC airspace description Federal Aviation Regulations (14 CFR Airspace Areas Extending Upward from contained in Docket No. FAA–2004– Part 71) amends the description of Class 700 feet or More Above the Surface of 17295; Airspace Docket No. 04–AEA– E airspace in the Washington, DC area the Earth. 01, effective August 5, 2004. by removing the airspace designations * * * * * DATES: Effective date: August 5, 2004. for Andrews Air Force Base, MD; Lee Comment Date: Comments must be Airport, MD; Baltimore Washington ASO KY 5E Jamestown, KY [Corrected] received on or before June 30, 2004. International Airport, MD; Martin State Russell County Airport, KY ADDRESSES: Send comments on the rule Airport, MD; , MD; (Lat. 37°00′32″ N., long. 85°06′10″ W.) to the Docket Management System, U.S. Maryland State Police Heliport, Ft. That airspace extending upward from 700 Department of Transportation, Room McHenry, MD; , MD; feet above the surface within a 6.5-mile Plaza 401, 400 Seventh Street, SW., Frederick Municipal Airport, MD; radius of Russell County Airport. Washington, DC 20590–0001. You must Potomac Airport, MD; Montgomery * * * * * identify the docket number FAA–2004– County Airpark, MD; Freeway Airport, 17295; Airspace Docket No. 04–AEA–02 MD; , MD; Cowley Issued in College Park, Georgia on March at the beginning of your comments. You Shock Trauma Center Heliport, 31, 2004. may also submit comments on the Baltimore, MD; Carroll County Airport, Jeffrey U. Vincent, Internet at http://dms.dot.gov. You may MD; Clearview Airpark, MD; Maryland Acting Manager, Air Traffic Division, review the public docket containing the Airport, MD; Davison Army Air Field, Southern Region. rule, any comments received, and any Ft. Belvoir, VA; Birch Hollow, VA; [FR Doc. 04–8359 Filed 4–12–04; 8:45 am] final disposition in person in the Docket Washington Dulles International BILLING CODE 4910–13–M Office between 9 a.m. and 5 p.m., Airport, VA; Leesburg Executive Monday through Friday, except Federal Airport, VA; Manassas Municipal/Harry holidays. The Docket Office (telephone P. Davis Airport, VA; Mobil Business 1–800–647–5527) is on the plaza level Resources Corporation Heliport, VA;

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Upperville Airport, VA; Eastern West Authority: 49 U.S.C. 106(g), 40103, 40113, necessary to increase the area controlled Virginia Regional/Shepherd Field 40120; E.O. 10854; 24 FR 9565, 3 CFR, 1959– airspace. This additional controlled Airport, WV. It consolidates those 1963 Comp., p. 389. airspace extending upward from 1,200 airspace areas into the amended § 71.1 [Amended] feet above the surface of the earth is Washington, DC description. The necessary for the containment and I 2. The incorporation by reference in proliferation of airports with Instrument safety of Instrument Flight Rules (IFR) 14 CFR 71.1 of the Federal Aviation Flight Rule (IFR) operations within the aircraft transitioning to/from the en Administration Order 7400.9L, Airspace Washington, DC metropolitan area has route environment and executing these Designations and Reporting Points, resulted in the overlap of numerous SIAP procedures. dated September 2, 2003 and effective Class E airspace areas that complicate EFFECTIVE DATE: September 16, 2003, is amended as 0901 UTC, August 5, the chart depictions. This action follows: 2004. clarifies the airspace and diminishes the FOR FURTHER INFORMATION CONTACT: Ed Paragraph 6005 Class E airspace areas scope and complexity of charting. The Haeseker, Federal Aviation IFR airports within those areas will be extending from 700 feet or more above the surface of the earth. Administration, Air Traffic Division, incorporated into the Washington, DC 1601 Lind Avenue SW., Renton, WA * * * * * Class E airspace area. Accordingly, since 98055–4056; telephone (425) 227–2527. this action merely consolidates these AEA MD E5 Annapolis, MD [Removed] SUPPLEMENTARY INFORMATION: airspace areas into one airspace AEA MD E5 Baltimore, MD [Removed] AEA MD E5 College Park, MD [Removed] designation and has inconsequential AEA MD E5 Edgewood, MD [Removed] History impact on aircraft operations in the area, AEA MD E5 Fort McHenry, MD [Removed] On October 21, 2003, the FAA notice and public procedure under 5 AEA MD E5 Fort Meade, MD [Removed] proposed to amend Title 14 Code of U.S.C. 553(b) are unnecessary. AEA MD E5 Frederick, MD [Removed] Federal Regulations part 71 (CFR part Class E airspace designations for AEA MD E5 Friendly, MD [Removed] 71) to modify Class E airspace at AEA MD E5 Gaithersburg, MD [Removed] airspace extending upward from 700 AEA MD E5 Indian Head, MD [Removed] Kalispell, MT (68 FR 60049). An feet or more above the surface of the AEA MD E5 Mitchellville, MD [Removed] increase in RNAV GPS SIAP operations earth are published in paragraph 6005 of AEA MD E5 Stevensville, MD [Removed] at Glacier Park International Airport, FAA Order 7400.9L, dated September 2, AEA MD E5 University of Maryland, Kalispell, MT, makes it necessary to 2003, and effective September 16, 2003, Baltimore, MD [Removed] increase the area controlled airspace. which is incorporated by reference in 14 AEA MD E5 Westminster Carroll County This additional controlled airspace is CFR 71.1. The Class E airspace Airport, MD [Removed] necessary for the containment and AEA MD E5 Westminster Clearview safety of IFR aircraft transitioning to/ designation listed in this document will Airpark, MD [Removed] be published subsequently in the Order. AEA VA E5 Birch Hollow, VA [Removed] from the en route environment and The FAA has determined that this AEA VA E5 Chantilly, VA [Removed] executing these SIAP procedures. regulation only involves an established AEA VA E5 Fairfax, VA [Removed] Interested parties were invited to body of technical regulations for which AEA VA E5 Upperville, VA [Removed] participate in this rulemaking frequent and routine amendments are AEA WVA E5 Martinsburg, WV [Removed] proceeding by submitting written necessary to keep them operationally * * * * * comments on the proposal to the FAA. current. Therefore, this regulation: (1) Is No comments were received. Class E Issued in Jamaica, New York, on April 5, airspace designations are published in not a ‘‘significant regulatory action’’ 2004. paragraph 6005 of FAA Order 7400.9L under Executive Order 12866; (2) is not John G. McCartney, a ‘‘significant rule’’ under DOT dated September 02, 2003, and effective Assistant Manager, Air Traffic Division, September 16, 2003, which is Regulatory Policies and Procedures (44 Eastern Region. FR 11034; February 26, 1979); and (3) incorporated by reference in 14 CFR [FR Doc. 04–8363 Filed 4–12–04; 8:45 am] does not warrant preparation of a 71.1. The Class E airspace designations Regulatory Evaluation as the anticipated BILLING CODE 4910–13–M listed in this document will be impact is so minimal. Since this is a published subsequently in that Order. routine matter that will only affect air DEPARTMENT OF TRANSPORTATION The Rule traffic procedures and air navigation it This amendment to 14 CFR part 71 is certified that this rule will not have Federal Aviation Administration significant economic impact on a revises Class E airspace at Kalispell, MT. An increase in RNAV GPS SIAP substantial number of small entities 14 CFR Part 71 under the criteria of the Regulatory operations at Glacier Park International Flexibility Act. [Docket No. FAA 2003–16214; Airspace Airport, Kalispell, MT, makes it Docket 02–ANM–11] necessary to increase the area controlled List of Subjects in 14 CFR Part 71 airspace. This additional controlled Revision of Class E Airspace; airspace extending upward from 1,200 Airspace, Incorporated by reference, Kalispell, MT feet above the surface of the earth is for Navigation (air). AGENCY: Federal Aviation the containment and safety of IFR Adoption of the Amendment Administration (FAA), DOT. aircraft transitioning to/from the en ACTION: Final rule. route environment and executing these I In consideration of the foregoing, the SIAP procedures. Federal Aviation Administration SUMMARY: This final rule will revise The FAA has determined that this amends 14 CFR part 71 as follows: Class E airspace at Kalispell, MT. An reguation only involves an established increase in Area Navigation (RNAV) body of technical regulations for which PART 71—[AMENDED] Global Position System (GPS) Standard frequent and routine amendments are Instrument Approach procedures (SIAP) necessary to keep them operationally I 1. The authority citation for Part 71 operations at Glacier Park International current. Therefore, this regulation: (1) Is continues to read as follows: Airport, Kalispell, MT, makes it not a ‘‘significant regulatory action’’

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under Executive Order 12866; (2) is not International Airport Class D airspace, Class missed approach procedures will a ‘‘significant rule’’ under DOT E2 airspace, and that airspace within Federal increase airport efficiency during peak Regulatory Policies and Procedures (44 Airways. arrival periods. * * * * * FR 11034; February 26, 1979); and (3) Interested parties were invited to does not warrant preparation of a Issued in Seattle, Washington, on April 2, participate in this rule making regulatory evaluation as the anticipated 2004. proceeding by submitting written impact is so minimal. Since this is a Carla J. Mawhorter, comments on the proposal to the FAA. routine matter that will only affect air Acting Manager, Air Traffic Division, No comments were received. Class E traffic procedures and air navigation, it Northwest Mountain Region. is certified that this rule, when airspace designations are published in [FR Doc. 04–8361 Filed 4–12–04; 8:45 am] FAA Order 7400.9L dated September promulgated, will not have a significant BILLING CODE 4910–13–M economic impact on a substantial 02, 2003, and effective September 16, number of small entities under the 2003, which is incorporated by criteria of the Regulatory Flexibility Act. DEPARTMENT OF TRANSPORTATION reference in 14 CFR 71.1. The Class E airspace designations listed in this List of Subjects in 14 CFR Part 71 Federal Aviation Administration document will be published Airspace, Incorporation by reference, subsequently in that Order. Navigation (air). 14 CFR Part 71 The Rule Adoption of the Amendment [Docket No. FAA–2003–16266; Airspace This amendment to 14 CFR part 71 I Docket 01–ANM–11] In consideration of the foregoing, the will modify the Class E airspace at Federal Aviation Administration Amendment to Class E Airspace; Yakima, WA, to accommodate aircraft amends 14 CFR Part 71 as follows: Yakima, WA executing the radar missed approach PART 71—DESIGNATION OF CLASS A, AGENCY: Federal Aviation procedures. The radar missed approach CLASS B, CLASS C, CLASS D, AND Administration (FAA), DOT. procedures for ILS Runway 27 requires a course reversal that makes it necessary CLASS E AIRSPACE AREAS; ROUTES; ACTION: Final rule. AND REPORTING POINTS. to increase the area of controlled SUMMARY: This amendment modifies the airspace at the Yakima Air Terminal/ I 1. The authority citation for 14 CFR Class E airspace at Yakima, WA. New McAllister Field Airport, Yakima, WA. part 71 continues to read as follows: radar directed missed approach This additional Class E airspace Authority: 49 U.S.C. 106(g), 40103, 40113, procedures have been developed at extending upward from the surface of 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– Yakima Air Terminal/McAllister Field, the earth is necessary for the 1963 Comp., p. 389. Yakima, WA, making it necessary to containment and safety of aircraft § 71.1 [Amended] increase the area of controlled airspace. executing these procedures. This additional controlled airspace I The FAA has determined that this 2. The incorporation by reference in extending upward from the surface of 14 CFR part 71.1 of the Federal Aviation the earth is necessary for the safety of regulation only involves an established Administration Order 7400.9L, Airspace Instrument Flight Rules (IFR) aircraft body of technical regulations for which Designations and Reporting Points, executing new radar detected missed frequent and routine amendments are dated September 02, 2003, and effective approach procedures. necessary to keep them operationally September 16, 2003, is amended as current. It, therefore, (1) is not a EFFECTIVE DATE: follows: 0901 UTC, August 5, 2004. ‘‘significant regulatory action’’ under Paragraph 6005 Class E Airspace area Executive Order 12866; (2) is not a extending upward from 700 feet or more FOR FURTHER INFORMATION CONTACT: Ed ‘‘significant rule’’ under DOT Regulatory above the surface of the earth. Haeseker, Air Traffic Division, Federal Policies and Procedures (44 FR 11034; Aviation Administration, 1601 Lind * * * * * February 26, 1979); and (3) does not Avenue, SW., Renton, Washington warrant preparation of a regulatory ANM MT E5 Kalispell, MT [Revised] 98055-4556; telephone (425) 227-2527. evaluation, as the anticipated impact is Kalispell/Glacier Park International Airport, SUPPLEMENTARY INFORMATION: On August so minimal. Since this is a routine MT 23, 2001, the FAA proposed to amend ° ′ ″ ° ′ ″ matter that will only affect air traffic (Lat. 48 18 41 N., long. 114 15 18 W.); Title 14 Code of Federal Regulations, procedures and air navigation, it is Smith Lake Non Directional Beacon (NDB) part 71 (14 CFR part 71) by modifying (Lat. 48°06′30″N., long. 114°27′40″W.) certified that this rule will not have a the airspace at Yakima, WA (66 FR significant economic impact on a That airspace extending upward from 700 44327). This proposal would modify feet above the surface of the earth within a substantial number of small entities 7 mile radius of Kalispell/Glacier Park controlled airspace extending upward from the surface of the earth to contain under the criteria of the Regulatory International Airport, and within 4.8 miles Flexibility Act. each side of the 035° and 215° bearings from IFR operations within controlled the Smith Lake NDB extending from the 7 airspace when executing radar missed List of Subjects in 14 CFR Part 71 mile radius to 10.5 miles southwest of the approach procedures. The published NDB; that airspace extending upward from missed approach procedure for Airspace, Incorporation by reference, 1,200 feet above the surface of the earth Instrument Landing System (ILS) Navigation (air). bounded by a line from lat. 47°30′00″N., long. ° ′ ″ ° ′ ″ Runway 27 at the Yakima Air Terminal/ 112 37 30 W.; to lat. 47 43 30 N., long. McAllister Field Airport requires a Adoption of the Amendment 112°37′30″W.; to lat. 48°07′30″N., long. course reversal. Application of radar 113°30′00″W., to lat 48°30′00″N., long. I In consideration of the foregoing, the missed approach procedures introduces 113°30′00″W., to lat 48°30′00″N., long. Federal Aviation Administration ° ′ ″ ° ′ ″ alternative radar directed courses and 116 03 35 W.; to lat 47 30 00 N., long. amends 14 CFR part 71 as follows: 114°54′23″W.; thence to point of origin; will eliminate conflicts with subsequent excluding Kalispell/Glacier Park Runway 27 arrivals. Radar vector

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PART 71—DESIGNATION OF CLASS A, surface bounded by a line beginning at lat. incorporating those areas into the CLASS B, CLASS C, CLASS D, AND 46°10′00″N., long. 119°45′00″W.; thence to Washington, DC description was lat. 46°10′00″N., long. 121°00′00″W.; to lat. CLASS E AIRSPACE AREAS; ° ′ ″ ° ′ ″ published in the Federal Register (69 46 50 00 N., long. 121 00 00 W.; to lat. FR 8581–8582). Interested parties were AIRWAYS; ROUTES; AND REPORTING 46°50′00″N., long. 119°45′00″W.; thence to POINTS the point of origin, excluding that airspace invited to participate in this rulemaking proceeding by submitting written I 1. The authority citation for 14 CFR within Federal Airways and the Ellensburg, WA, Class E airspace area. comments on the proposal to the FAA. part 71 continues to read as follows: * * * * * No comments to the proposal were Authority: 49 U.S.C. 106(g), 40103, 40113, received. The rule is adopted as 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– Issued in Seattle, Washington, on April 2, proposed. 1963 Comp., p. 389. 2004. The coordinates for this airspace Carla J. Mawhorter, § 71.1 [Amended] docket are based on North American Acting Manager, Air Traffic Division, Datum 83. Class E airspace area I 2. The incorporation by reference in Northwest Mountain Region. designations for airspace extending 14 CFR part 71.1 of the Federal Aviation [FR Doc. 04–8356 Filed 4–12–04; 8:45 am] upward from the surface are published Administration Order 7400.9L, Airspace BILLING CODE 4910–13–M in paragraph 6005 of FAA Order Designations and Reporting Points, 7400.9L, dated September 2, 2003 and dated September 2, 2003, and effective effective September 16, 2003, which is September 16, 2003, is amended as DEPARTMENT OF TRANSPORTATION incorporated by reference in 14 CFR follows: Federal Aviation Administration 71.1. The Class E airspace designation Paragraph 6004 Class E airspace areas listed in this document will be amended designated as an extension to a Class D 14 CFR Part 71 in the order. surface area. The Rule * * * * * [Docket No. FAA–2004–17081; Airspace Docket No. 04–AEA–01] This amendment to Part 71 of the ANM WA E4 Yakima, WA [Revised] Federal Aviation Regulations (14 CFR Yakima Air Terminal/McAllister Field Amendment of Class E Airspace; Part 71) provides controlled Class E Airport Washington, DC airspace extending upward from 700 ft (Lat. 46°34′05.4″N., long. 120°32′38.6″W.) AGENCY: Federal Aviation above the surface for aircraft conducting That airspace extending upward from the IFR operations within the Washington, surface within 2.5 miles each side of the 287° Administration [FAA], DOT. bearing from the Yakima Air Terminal ACTION: Final rule. DC Class E–5 airspace description. extending from the 4.2 mile radius of Yakima The FAA has determined that this Air Terminal to 9 miles northwest of the SUMMARY: This action amends Class E regulation only involves an established airport, and within 3.5 miles northeast and airspace at Washington, DC. The body of technical regulations for which 1.8 miles southwest of the 107° bearing from development of multiple area navigation frequent and routine amendments are the airport extending from the 4.2 mile radius (RNAV) Standard Instrument Approach necessary to keep them operationally of the airport to 11.2 miles southeast of the Procedures (SIAP) and the proliferation current. Therefore, this regulation: (1) Is airport. of airports within the metropolitan not a ‘‘significant regulatory action’’ * * * * * Washington, DC area with approved under Executive Order 12866; (2) is not I 3. The incorporation by reference in Instrument Flight Rules (IFR) operations a ‘‘significant rule’’ under DOT 14 CFR 71.1 of the Federal Aviation and the resulting overlap of designated Regulatory Policies and Procedures (44 Administration Order 7400.9L, Airspace Class E–5 airspace have made this FR 11034; February 26, 1979); and (3) Designations and Reporting Points, action necessary. This action does not warrant preparation of a dated September 2, 2003, and effective consolidates the Class E–5 airspace Regulatory Evaluation as the anticipated September 16, 2003, is amended as designations for twenty four airports impact is so minimal. Since this is a follows: and results in the recision of twenty routine matter that will only affect air Paragraph 6005. Class E airspace areas Class E–5 descriptions through separate traffic procedures and air navigation it extending upward from 700 feet or more rulemaking action. The area will be is certified that this rule will not have above the surface of the earth. depicted on aeronautical charts for pilot significant economic impact on a * * * * * reference. substantial number of small entities EFFECTIVE DATE: 0901 UTC August 5, under the criteria of the Regulatory ANM WA E5 Yakima, WA [Revised] 2004. Flexibility Act. Yakima Air Terminal/McAllister Field Airport FOR FURTHER INFORMATION CONTACT: Mr. List of Subjects in 14 CFR Part 71 (Lat. 46°34′05.4″N., long. 120°32′38.6″W.) Francis Jordan, Airspace Specialist, Airspace, Incorporation by reference, Yakima VORTAC Airspace Branch, AEA–520, Air Traffic Navigation (air). (Lat. 46°34′13.0″N., long. 120°26′40.6″W.) Division, Eastern Region, Federal That airspace extending upward from 700 Aviation Administration, 1 Aviation Adoption of the Amendment Plaza, Jamaica, New York 11434–4809, feet above the surface within a 7.5 mile I In consideration of the foregoing, the radius of the Yakima Air Terminal, and telephone: (718) 553–4521. Federal Aviation Administration within 4.5 miles northeast and 9.5 miles SUPPLEMENTARY INFORMATION: southwest of the Yakima VORTAC 094° amends 14 CFR part 71 as follows: bearing extending from the 7.5 mile radius of History PART 71—[AMENDED] the airport to 21 miles southeast of the On February 25, 2004, a notice VORTAC, and within 4.0 miles north and 5 I 1. The authority citation for 14 CFR miles south of the 287° bearing from the proposing to amend Part 71 of the Yakima Air Terminal extending from the 7.5 Federal Aviation Regulations (14 CFR Part 71 continues to read as follows: mile radius of the airport to 16 miles Part 71) by consolidating existing Class Authority: 49 U.S.C. 106(g), 40103, 40113, northwest of the airport; that airspace E–5 airspace designations in the 40120; EO 10854, 24 FR 9565, 3 CFR, 1959– extending upward from 1,200 feet above the Washington, DC metropolitan area and 1963 Comp., p. 389.

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§ 71.1 [Amended] addition of natamycin. This action is in Life Sciences, 3521 Silverside Rd., The incorporation by reference in 14 response to a food additive petition filed Wilmington, DE 19810. The transfer of CFR 71.1 of Federal Aviation by Arkion Life Sciences of Wilmington, sponsorship was announced in the Administration Order 7400.9L, airspace DE. Federal Register of May 22, 2003 (68 FR Designations and Reporting Points, DATES: This rule is effective April 13, 28010). Data submitted by the sponsor dated September 2, 2003, and effective 2004. Submit written objections and in support of the petition permit an September 16, 2003, is amended as requests for a hearing by June 14, 2004. independent evaluation of the ability of follows: ADDRESSES: Submit written objections natamycin to achieve the intended and requests for a hearing to the purpose in a safe manner. The sponsor Paragraph 6005 Class E airspace areas Division of Dockets Management (HFA– submitted data that show that this level extending upward from 700 ft above the 305), Food and Drug Administration, of natamycin will not present a human surface of the earth. 5630 Fishers Lane, rm. 1061, Rockville, food safety concern. The petition also * * * * * MD 20852. Submit electronic objections includes satisfactory information about AEA DC E5 Washington, DC (Revised) to http://www.fda.gov/dockets/ the chemical identity of natamycin and indicates that natamycin will achieve its That airspace extending upward from 700 ecomments. intended effect in a manner that is safe feet above the surface within an area FOR FURTHER INFORMATION CONTACT: to broiler chickens consuming the bounded by a line beginning at lat. 38°55′19″ Karen Ekelman, Center for Veterinary N., long. 76°12′28″ W., to lat. 38°27′18″ N., treated feed. ° ′ ″ ° ′ ″ Medicine (HFV–222), Food and Drug long. 77 03 51 W., to lat. 38 36 30 N., long. Administration, 7500 Standish Pl., II. Conclusion 77°15′17″ W., to lat. 38°35′12″ N., long. 77°37′06″ W., to lat. 38°57′17″ N., long. Rockville, MD 20855, 301–827–6653, e- FDA concludes that the data establish 78°02′29″ W., to lat. 39°30′00″ N., long. mail: [email protected]. the safety and utility of natamycin (CAS 78°09′00″ W., to lat. 39°44′36″ N., long. SUPPLEMENTARY INFORMATION: No. 7681–93–8) for use as proposed and 77°36′08″ W., to lat. 39°43′28″ N., long. that the regulations should be amended ° ′ ″ ° ′ ″ I. Background 77 00 00 W., to lat. 39 36 08 N., long. as set forth in this document. 76°28′38″ W., to lat. 39°19′38″ N., long. In a notice published in the Federal 76°04′04″ W., to the point of beginning Register of September 20, 1995 (60 FR III. Public Disclosure excluding the airspace that coincides with 48715), FDA announced that a food In accordance with § 571.1(h), the the Aberdeen, MD, Hagerstown, MD, additive petition (animal use) (FAP petition and the documents that FDA Winchester, VA, Midland, VA Class E 2234) had been filed by DuCoa L.P., P. airspace areas and P–56A, P–56B, P–73, P– considered and relied upon in reaching 40, R–4009, R–4001A, R–4001B, R–6608A, O. Box 219, Highland, IL 62249–1105. its decision to approve the petition are R–6608B and R–6608C when they are in The petition proposed that part 573— available for inspection at CVM (see effect. FoodAdditives Permitted in Feed and ADDRESSES) by appointment with the * * * * * Drinking Water of Animals (21 CFR part information contact person (see FOR 573) be amended to provide for the safe FURTHER INFORMATION CONTACT). As Issued in Jamaica, New York, on April 5, use of natamycin in broiler chicken 2004. provided in § 571.1(h), the agency will feeds, at the rate of 11 ppm, for delete from the documents any John G. McCartney, retarding growth of A. parasiticus, materials that are not available for Assistant Manager, Air Traffic Division, Penicillium rubrum, and Fusarium public disclosure before making the Eastern Region. moniliforme. The notice of filing of FAP documents available for inspection. [FR Doc. 04–8364 Filed 4–12–04; 8:45 am] 2234 provided for a 60-day comment BILLING CODE 4910–13–M period. No comments have been IV. Environmental Impact received. The agency has determined under 21 On June 6, 1996, the Center for CFR 25.32(r) that this action is of a type DEPARTMENT OF HEALTH AND Veterinary Medicine (CVM) denied the that does not individually or HUMAN SERVICES petition because data submitted in cumulatively have a significant effect on support of some sections (utility, the human environment. Therefore, Food and Drug Administration proposed purposes and amounts, neither an environmental assessment proposed regulation, and proposed nor an environmental impact statement 21 CFR Part 573 label) of the petition were determined to is required. be inadequate. At that time, CVM [Docket No. 1995F–0221] V. Objections and Hearing Requests informed DuCoa L.P., that the company Food Additives Permitted in Feed and could either amend the petition by Any person who will be adversely Drinking Water of Animals; Natamycin submitting additional data to address affected by this regulation may file with concerns expressed in the letter, or the Division of Dockets Management AGENCY: Food and Drug Administration, withdraw the petition as provided for in (see ADDRESSES) written or electronic HHS. § 571.7 (21 CFR 571.7). objections. Each objection shall be ACTION: Final rule. On July 31, 2001, the sponsor separately numbered, and each amended the petition to seek approval numbered objection shall specify with SUMMARY: The Food and Drug for the use of natamycin in broiler particularity the provisions of the Administration (FDA) is amending the chicken feeds, at a level of 11 ppm to regulation to which objection is made regulations for food additives permitted retard the growth of A. parasiticus in and the grounds for the objection. Each in feed and drinking water of animals to the feeds for up to 14 days. numbered objection on which a hearing provide for the safe use of natamycin in In a letter that CVM received from the is requested shall specifically so state. broiler chicken feeds. Natamycin will be petitioner on March 20, 2003, the Failure to request a hearing for any added to broiler chicken feed at a level petitioner informed FDA that particular objection shall constitute a of 11 parts per million (ppm) to retard sponsorship of natamycin for the waiver of the right to a hearing on that the growth of Aspergillus parasiticus in intended use had been transferred from objection. Each numbered objection for the feed for up to 14 days after the DuCoa L.P., Highlands, IL, to Arkion which a hearing is requested shall

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include a detailed description and components of the broiler chicken feed permit modifications; public hearings analysis of the specific factual before adding the liquid components. for permit modifications; and additional information intended to be presented in Broiler feeds to which the natamycin requirements for temporary cessation of support of the objection in the event premix is added shall be used within 4 operations. New Mexico revised its that a hearing is held. Failure to include weeks of addition of the premix. program to provide additional such a description and analysis for any (e) To assure the safe use of the safeguards, clarify ambiguities and particular objection shall constitute a additive, the label or labeling of the improve operational efficiency. waiver of the right to a hearing on the additive shall bear, in addition to other EFFECTIVE DATE: April 13, 2004. objection. Three copies of all documents information required by the Federal FOR FURTHER INFORMATION CONTACT: are to be submitted and are to be Food, Drug, and Cosmetic Act, the Willis L. Gainer, Telephone: 505–248– identified with the docket number following: 5096, Internet address: found in brackets in the heading of this (1) The name and CAS number of the [email protected]. document. Any objections received in additive, and its purpose. response to the regulation may be seen (2) A listing of ingredients consisting SUPPLEMENTARY INFORMATION: in the Division of Dockets Management of calcium carbonate, the additive, and I. Background on the New Mexico Program between 9 a.m. and 4 p.m., Monday lactose and their proportions in the II. Submission of the Proposed Amendment through Friday. premix as prescribed under paragraph III. Office of Surface Mining Reclamation and (d) of this section. Enforcement’s (OSM’s) Findings List of Subjects in 21 CFR Part 573 (3) Adequate directions for use to IV. Summary and Disposition of Comments Animal feeds, Food additives. ensure a broiler chicken feed that is in V. OSM’s Decision VI. Procedural Determinations I Therefore, under the Federal Food, compliance with the limitations Drug, and Cosmetic Act and under prescribed in paragraph (d) of this I. Background on the New Mexico authority delegated to the Commissioner section. Program of Food and Drugs and redelegated to (4) An appropriate cautionary Section 503(a) of the Act permits a ‘‘ the Center for Veterinary Medicine, 21 statement: Caution: Store in a tightly- State to assume primacy for the CFR part 573 is amended as follows: closed, light-resistant container in a regulation of surface coal mining and cool, dry place.’’ reclamation operations on non-Federal PART 573—FOOD ADDITIVES (5) An expiration date of 1 year from PERMITTED IN FEED AND DRINKING and non-Indian lands within its borders the date of manufacture. by demonstrating that its State program WATER OF ANIMALS (6) A contact address and telephone includes, among other things, ‘‘a State number for reporting adverse reactions I 1. The authority citation for 21 CFR law which provides for the regulation of experienced by users, or to request a part 573 continues to read as follows: surface coal mining and reclamation copy of the Material Safety Data Sheet operations in accordance with the Authority: 21 U.S.C. 321, 342, 348. for natamycin. requirements of this Act * * *; and I 2. Section 573.685 is added to read as Dated: March 24, 2004. rules and regulations consistent with follows: Stephen F. Sundlof, regulations issued by the Secretary § 573.685 Natamycin. Director, Center for Veterinary Medicine. pursuant to this Act.’’ See 30 U.S.C. The food additive natamycin (CAS [FR Doc. 04–8249 Filed 4–12–04; 8:45 am] 1253(a)(1) and (7). On the basis of these No. 7681–93–8) may be safely used in BILLING CODE 4160–01–S criteria, the Secretary of the Interior broiler chicken feeds in accordance with conditionally approved the New Mexico the following specifications: program on December 31, 1980. You can (a) The additive is a stereoisomer of DEPARTMENT OF THE INTERIOR find background information on the 22-[(3-amino-3,6,dideoxy-B-D- New Mexico program, including the mannopyranosyl)oxy]-1,3,26- Office of Surface Mining Reclamation Secretary’s findings, the disposition of trihydroxy-12-methyl-10-oxo-6,11,28- and Enforcement comments, and conditions of approval trioxatricyclo[22.3.1.05, 7] octacosa- in the December 31, 1980, Federal 8,14,16,18,20-pentaene-25-carboxylic 30 CFR Part 931 Register (45 FR 86459). You can also find later actions concerning New acid with the empirical formula [NM–043–FOR] C33H47NO13. Mexico’s program and program (b) The additive shall conform to New Mexico Regulatory Program amendments at 30 CFR 931.10, 931.11, U.S.P. specifications. 931.13, 931.15, 931.16 and 931.30. (c) The additive (as part of a premix AGENCY: Office of Surface Mining II. Submission of the Proposed composed of calcium carbonate, Reclamation and Enforcement, Interior. Amendment natamycin, and lactose) is used for ACTION: Final rule; approval of retarding the growth of Aspergillus amendment. By letter dated October 27, 2003, New parasiticus in broiler chicken feeds for Mexico sent us an amendment to its up to 14 days after the addition of SUMMARY: We are approving a proposed program (Administrative Record No. natamycin. amendment to the New Mexico NM–869) under SMCRA (30 U.S.C. 1201 (d) Each pound (454 grams (g)) of the regulatory program (the ‘‘New Mexico et seq.). New Mexico sent the premix shall contain 434 (g) of calcium program’’) under the Surface Mining amendment to include the changes carbonate, 10 g of natamycin activity, Control and Reclamation Act of 1977 made at its own initiative. and 10 g of lactose. The premix shall be (SMCRA or the Act). New Mexico We announced receipt of the mixed into broiler chicken feed at the proposed revisions to rules about proposed amendment in the December rate of 1 pound (0.454 kilograms (kg)) definitions of permit modification, 19, 2003, Federal Register (68 FR per ton (908 kg) of feed to provide permit revision, and temporary 70749). In the same document, we natamycin at a level of 11 parts per cessation of operations; permit fees; opened the public comment period and million (ppm). The premix shall be administrative review of decisions; provided an opportunity for a public thoroughly mixed into the dry review of permits; requirements for hearing or meeting on the amendment’s

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adequacy (Administrative Record No. $25 per acre for the estimated area to be modification be obtained for all other NM–871). We did not hold a public disturbed during the first year of changes to a permit not classified as a hearing or meeting because no one mining, (2) increase the maximum limit permit revision; (2) to state that the requested one. The public comment for an annual permit fee to $17,500 and operator may not implement any permit period ended on January 20, 2004. We include a formula for the annual fee revision or permit modification before received comments from one Federal based on a charge of $25 per disturbed obtaining the written approval of the agency. acre, (3) increase the fee for a permit New Mexico Program Director; and (3) transfer to $1000, (4) increase the fee for state that (a) within 10 days after the III. OSM’s Findings a permit revision that adds disturbed filing of a complete application for a Following are the findings we made acreage to $4,000 plus $25 per acre for permit modification, the Director of the concerning the amendment under the estimated area to be disturbed New Mexico Program shall issue a SMCRA and the Federal regulations at during the first year of mining in the decision approving or denying the 30 CFR 732.15 and 732.17. We are expanded area, (5) add a flat fee of application in whole or in part and approving the amendment. $4000 to cover revisions with limited or promptly provide a written copy of the no surface disturbance (e.g., changing decision to the permittee and other A. Minor Revisions to New Mexico’s the method of mining from surface interested parties and (b) within 30 days Rules stripping to underground or highwall after the decision notification New Mexico proposed minor editorial mining), and (6) increase the fees for concerning the permit modification, the changes to the following previously- filing a notice of intention to explore permittee or any person may request a approved rules: and an application for exploration of formal hearing in regard to the New 19.8.13.1301.A(4) New Mexico greater than 250 tons of coal to, Mexico Program Director’s decision, in Annotated Code (NMAC) (30 CFR respectively, $100 and $200. accordance with 19.8.12.1200 NMAC. 774.13(b)(2)), concerning permit Section 507(a) of SMCRA states that The Federal regulations at 30 CFR revisions, and each application for a surface coal 774.13(b)(2) require that the regulatory 19.8.13.1301.E(1) NMAC (30 CFR mining and reclamation permit, authority establish the scale or extent of 774.13(b)(2)), concerning public hearing pursuant to an approved State program revisions for which all permit and notice requirements. or a Federal program, shall be application information requirements Because these changes are minor, we accompanied by a fee as determined by and procedures shall apply (including find that they will not make New the regulatory authority and that this fee the public notice, public participation, Mexico’s rules less effective than the may be less than but shall not exceed and notice of decision requirements of corresponding Federal regulations. the actual or anticipated cost of 30 CFR 773.6, 773.19(b)(1) and (3) and reviewing, administering, and enforcing 778.21). Such requirements and B. Revisions to New Mexico’s Rules That permits issued. This section also procedures shall apply at a minimum to Have the Same Meaning as the provides that the regulatory authority all significant revisions. Corresponding Provisions of the Federal may develop procedures so as to enable Although the Federal regulations do Regulations or SMCRA the cost of the fee to be paid over the not contain a definition of ‘‘significant New Mexico proposed revisions to the term of the permit. (The Federal revisions’’ or revisions that are not following rules containing language that regulation at 30 CFR 736.25 sets forth significant, New Mexico’s program has is the same as or similar to the permitting fees for Federal programs been revised to clarify that ‘‘permit corresponding sections of the Federal implemented by OSM.) revisions’’ are the same as revisions that regulations or statute: New Mexico has increased fees that are termed ‘‘significant’’ in the Federal 19.8.12.1200.A NMAC (30 CFR were part of the approved New Mexico regulations. New Mexico’s existing 775.11(a)), concerning the permittee’s or program. New Mexico explained that program contains all procedural interested party’s opportunity to request just over half of the cost of requirements required by the Federal a hearing after the decision on a permit administering the New Mexico program regulation at 30 CFR 774.13(b)(2) for modification, and is covered by collected fees (including significant revisions. Therefore, New 19.8.13.1300.B NMAC (30 CFR the proposed fee increases); the Mexico’s proposed definitions of 774.10(a)), concerning the authority of remaining cost is covered by a Federal ‘‘permit revision’’ and ‘‘permit the New Mexico Program Director to grant. modification’’ at 19.8.1.7.P(8) and (9) require revision or modification of an The Director of OSM (Director) finds NMAC and clarification of the approved permit. that New Mexico’s proposed revisions procedures that apply to ‘‘permit Because these proposed rules contain to increase the fees collected for revisions’’ are consistent with the language that is the same as or similar permitting exploration and surface coal Federal regulations at 30 CFR to the corresponding Federal mining and reclamation operations are 774.13(b)(2). regulations, we find that they are no less in accordance with and no less stringent New Mexico added procedural effective than the corresponding Federal than Section 507(a) of SMCRA. requirements concerning permit regulations. Therefore, the Director approves New modifications. The Federal regulation Mexico’s proposed revisions at does not specify the procedures that C. Revisions to New Mexico’s Rules That 19.8.5.506.A, B, D, E, F, and G NMAC. apply to non-significant revisions, only Are Not the Same as the Corresponding 2. Permit Modifications and that established procedures for revisions Provisions of the Federal Regulation(s) Revisions. New Mexico proposed to add shall apply at a minimum to all 1. Permit and Exploration Fees. New definitions of ‘‘permit modification’’ and significant revisions; this Federal Mexico proposed to revise 19.8.5.506.A, ‘‘permit revision,’’ at, respectively, regulation clearly allows the regulatory B, D, E, F, and G NMAC to raise the 19.8.1.7.P(8) and (9) NMAC. New authority to establish procedures for existing permit and exploration fees. Mexico also proposed to revise non-significant revisions. Therefore, the New Mexico proposed to increase all 19.8.13.1301.B, C, and E(2) NMAC to (1) Director finds that New Mexico’s fees collected from operators. New clarify that 19.8.13.1301.A NMAC proposed procedures at 19.8.13.1301.B, Mexico proposed to (1) increase the defines when a permit revision is C, and E(2) NMAC for ‘‘permit original permit filing fee to $2,500 plus required and to require that a permit modifications’’ are also consistent with

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the Federal regulations at 30 CFR authority a notice of intention to cease IV. Summary and Disposition of 774.13(b)(2). or abandon mining and reclamation Comments Based on the above discussion, the operations. This regulation specifies Public Comments Director finds that the proposed New that the notice shall include a statement Mexico rules at 19.8.1.7.P(8) and (9) of the exact number of acres which will We asked for public comments on the NMAC and 19.8.13.1301.B, C, and E(2) have been affected in the permit area, amendment (Administrative Record No. NM–870), but did not receive any. NMAC are no less effective than the prior to such temporary cessation, the Federal regulation at 30 CFR extent and kind of reclamation of those Federal Agency Comments 774.13(b)(2) and approves them. 2. Temporary Cessation of areas which will have been Under 30 CFR 732.17(h)(11)(i) and Operations. New Mexico proposed to accomplished, and identification of the section 503(b) of SMCRA, we requested add a definition of ‘‘temporary cessation backfilling, regrading, revegetation, comments on the amendment from of operations’’ at 19.8.1.7.T(2) NMAC to environmental monitoring, and water various Federal agencies with an actual mean the cessation of mining or treatment activities that will continue or potential interest in the New Mexico reclamation operations for more than during the temporary cessation. program (Administrative Record No. thirty days and where a reasonable New Mexico’s proposed definition of NM–870). expectation of the continuation of ‘‘temporary cessation of operations’’ The U.S. Fish and Wildlife Service (FWS), commented by letter dated mining can be demonstrated by the includes the same 30 day period, permittee. New Mexico also proposed to December 29, 2003 (Administrative beyond which an operator must declare Record No. NM–872). FWS stated that it revise 19.8.20.2073 NMAC, concerning a temporary cessation of operations, that temporary cessation of operations, by supported the changes to the New is in the Federal regulation at 30 CFR Mexico program and commended the adding new C, D, E, and F, to state (1) 816.131(b). New Mexico’s inclusion in at the New Mexico Program Director’s New Mexico Mining Commission for its definition and/or in the performance discretion, the permittee may be taking proactive steps to revise its standards of the requirements that the directed to take other reasonable actions program and improve safeguards for the ‘‘ consistent with 19.8 NMAC to ensure operator demonstrate a reasonable people and environment of New the protection of public safety and the expectation for the continuation of Mexico. FWS further commented, environment while the operation is mining following temporary cessation’’ ‘‘[w]hile we are not aware of any under temporary cessation; (2) that no and not use temporary cessation as a problems with birds becoming trapped temporary cessation of mining and means to ‘‘justify a lengthy delay to final and or killed by ponded waters at coal reclamation operations shall extend reclamation or to preserve facilities mines in New Mexico, this has been, beyond the current permit term, unless beyond what may be considered and continues to be a significant the Director of the New Mexico Program appropriate for their use’’, is implicit problem for hard rock mining approves an extension of the temporary though not stated in the Federal operations and oil and gas facilities. We cessation during the permit renewal regulations; the Federal regulation at 30 encourage you and your staff to keep in process conducted in accordance with CFR 816.131(a) describes temporary mind the potential for bird (and other 19.8.13 NMAC; (3) that to continue cessation, in part, as those situations ‘‘in wildlife) entrapment and exposure to under a temporary cessation beyond an which operations are to be resumed hazardous chemicals in open waters, existing permit term, the permittee must under an approved permit’’. and would appreciate your support in demonstrate that the mining operation eliminating these hazards. The Service has a reasonable expectation of Section 505(b) of SMCRA provides for has experience in dealing with continuing operations; and (4) that a provisions of State law or rules that hazardous, ponded waters, and general temporary cessation may not be used to provide for more stringent potential sources of impacts to justify a lengthy delay to final environmental controls and regulations migratory birds (e.g., power poles, reclamation or to preserve facilities of surface coal mining and reclamation towers), and can provide you and your beyond what may be considered operations than do the provisions of staff with approaches to protect appropriate for their use in association SMCRA or the Federal regulations. migratory birds and other wildlife. We with an existing permit. Therefore, New Mexico has the would rather prevent the loss of There is no Federal definition of authority to adopt the proposed migratory birds before more formal legal ‘‘temporary cessation of operations.’’ additional safeguards concerning the actions are necessary under the The Federal regulation at 30 CFR discretion of the Director of the New Migratory Bird Treaty Act (MBTA), 816.131(a) requires that each person which prohibits the taking of migratory Mexico Program to require other who conducts surface mining activities birds, nests, and eggs, except as reasonable actions to ensure the shall effectively secure surface facilities permitted by the Service. If your staff in areas in which there are no current protection of public safety and the becomes aware of an actual or potential operations but in which operations are environment, and the relationship hazard to birds or other wildlife, please to be resumed under an approved between temporary cessation and the contact us and we can work with you permit and states that temporary permit term. and/or the company to ameliorate these abandonment shall not relieve a person Based on the discussion above, the hazards.’’ of their obligation to comply with any Director finds that New Mexico’s New Mexico’s existing rules at provisions of the approved permit. The proposed rules concerning temporary 19.8.809.A and B NMAC require that an Federal regulation at 30 CFR 816.131(b) cessation of operations at 19.8.1.7.T(2) application for a permit to mine coal states that before temporary cessation of and 19.8.20.2073.C, D, E, and F are in include a study of fish and wildlife and mining and reclamation operations for a accordance with Section 505(b) of their habitats within the proposed period of thirty days or more, or as soon SMCRA and no less effective than the permit area and the portions of the as it is known that a temporary Federal regulations at 30 CFR 816.131(a) adjacent areas where effects on such cessation will extend beyond 30 days, and (b) and approves them. resources may reasonably be expected to persons who conduct surface mining occur, and, that the applicant must activities shall submit to the regulatory consult with the appropriate State and

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Federal fish and wildlife management, V. OSM’s Decision purposes of SMCRA is to ‘‘establish a conservation, or land management Based on the above findings, we nationwide program to protect society agencies having responsibilities for fish approve New Mexico’s October 27, and the environment from the adverse and wildlife or their habitats, to 2003, amendment. effects of surface coal mining determine the level of detail and the To implement this decision, we are operations.’’ Section 503(a)(1) of areas for such studies. In addition, New amending the Federal regulations at 30 SMCRA requires that State laws Mexico’s rules at 19.8.9.905.A and B CFR Part 931, which codify decisions regulating surface coal mining and NMAC require that each application concerning the New Mexico program. reclamation operations be ‘‘in contain a fish and wildlife plan We find that good cause exists under 5 accordance with’’ the requirements of demonstrating how the applicant will U.S.C. 553(d)(3) to make this final rule SMCRA, and section 503(a)(7) requires minimize disturbances and adverse effective immediately. Section 503(a) of that State programs contain rules and impacts on fish and wildlife, and, that SMCRA requires that the State’s regulations ‘‘consistent with’’ the applicant describe methods the program demonstrates that the State has regulations issued by the Secretary applicant will utilize to protect or the capability of carrying out the pursuant to SMCRA. enhance threatened or endangered provisions of the Act and meeting its Executive Order 13175—Consultation species of plants or animals and their purposes. Making this regulation critical habitats; species such as eagles, and Coordination With Indian Tribal effective immediately will expedite that migratory birds or other animals Governments process. SMCRA requires consistency of protected by State or Federal Law and State and Federal standards. In accordance with Executive Order their habitats, or other species identified 13175, we have evaluated the potential through the consultation process VI. Procedural Determinations effects of this rule on Federally- pursuant to 19.8.8.809 NMAC; or Executive Order 12630—Takings recognized Indian Tribes and have habitats of unusually high value for fish determined that the rule does not have and wildlife. This rule does not have takings substantial direct effects on one or more New Mexico did not propose implications. This determination is Indian Tribes, on the relationship revisions to these or other rules based on the analysis performed for the between the Federal government and concerning fish and wildlife in this counterpart Federal regulation. Indian Tribes, or on the distribution of amendment. New Mexico’s approved Executive Order 12866—Regulatory power and responsibilities between the program provides, through the Planning and Review Federal government and Indian Tribes. consultation and application The rule does not involve or affect This rule is exempted from review by requirements described above, the Indian Tribes in any way. coordination requested in the FWS the Office of Management and Budget comment. The Director is not requiring (OMB) under Executive Order 12866 Executive Order 13211—Regulations New Mexico to further revise its (Regulatory Planning and Review). That Significantly Affect the Supply, Distribution, or Use of Energy program in response to these comments. Executive Order 12988—Civil Justice Environmental Protection Agency (EPA) Reform On May 18, 2001, the President issued Concurrence and Comments The Department of the Interior has Executive Order 13211 which requires Under 30 CFR 732.17(h)(11)(i) and conducted the reviews required by agencies to prepare a Statement of (ii), we are required to get concurrence section 3 of Executive Order 12988 and Energy Effects for a rule that is (1) from EPA for those provisions of the has determined that this rule meets the considered significant under Executive program amendment that relate to air or applicable standards of subsections (a) Order 12866, and (2) likely to have a water quality standards issued under and (b) of that section. However, these significant adverse effect on the supply, the authority of the Clean Water Act (33 standards are not applicable to the distribution, or use of energy. Because U.S.C. 1251 et seq.) or the Clean Air Act actual language of State regulatory this rule is exempt from review under (42 U.S.C. 7401 et seq.). programs and program amendments Executive Order 12866 and is not None of the revisions that New because each program is drafted and expected to have a significant adverse Mexico proposed to make in this promulgated by a specific State, not by effect on the supply, distribution, or use amendment pertains to air or water OSM. Under sections 503 and 505 of of energy, a Statement of Energy Effects quality standards. Therefore, we did not SMCRA (30 U.S.C. 1253 and 1255) and is not required. ask EPA to concur on the amendment. the Federal regulations at 30 CFR National Environmental Policy Act Under 30 CFR 732.17(h)(11)(i), OSM 730.11, 732.15, and 732.17(h)(10), requested comments on the amendment decisions on proposed State regulatory This rule does not require an from EPA (Administrative Record No. programs and program amendments environmental impact statement NM–870). EPA did not respond to our submitted by the States must be based because section 702(d) of SMCRA (30 request. solely on a determination of whether the U.S.C. 1292(d)) provides that agency submittal is consistent with SMCRA and decisions on proposed State regulatory State Historic Preservation Officer its implementing Federal regulations program provisions do not constitute (SHPO) and the Advisory Council on and whether the other requirements of major Federal actions within the Historic Preservation (ACHP) 30 CFR Parts 730, 731, and 732 have meaning of section 102(2)(C) of the Under 30 CFR 732.17(h)(4), we are been met. National Environmental Policy Act (42 required to request comments from the U.S.C. 4332(2)(C)). Executive Order 13132—Federalism SHPO and ACHP on amendments that Paperwork Reduction Act may have an effect on historic This rule does not have Federalism properties. On December 2, 2003, we implications. SMCRA delineates the This rule does not contain requested comments on New Mexico’s roles of the Federal and State information collection requirements that amendment (Administrative Record No. governments with regard to the require approval by OMB under the NM–870), but neither responded to our regulation of surface coal mining and Paperwork Reduction Act (44 U.S.C. request. reclamation operations. One of the 3507 et seq.).

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Regulatory Flexibility Act costs or prices for consumers, determination made that the Federal The Department of the Interior individual industries, Federal, State, or regulation did not impose an unfunded certifies that this rule will not have a local government agencies, or mandate. geographic regions; and c. does not have significant economic impact on a List of Subjects in 30 CFR Part 931 substantial number of small entities significant adverse effects on Intergovernmental relations, Surface under the Regulatory Flexibility Act (5 competition, employment, investment, mining, Underground mining. U.S.C. 601 et seq.). The State submittal, productivity, innovation, or the ability which is the subject of this rule, is based of U.S.-based enterprises to compete Dated: March 15, 2004. upon counterpart Federal regulations for with foreign-based enterprises. Allen D. Klein, which an economic analysis was This determination is based upon the Regional Director, Western Regional prepared and certification made that fact that the State submittal which is the Coordinating Center. subject of this rule is based upon such regulations would not have a I For the reasons set out in the counterpart Federal regulations for significant economic effect upon a preamble, 30 CFR part 931 is amended which an analysis was prepared and a substantial number of small entities. In as set forth below: making the determination as to whether determination made that the Federal this rule would have a significant regulation was not considered a major PART 931—NEW MEXICO economic impact, the Department relied rule. I 1. The authority citation for part 931 upon the data and assumptions for the Unfunded Mandates counterpart Federal regulations. continues to read as follows: This rule will not impose an Authority: 30 U.S.C. 1201 et seq. Small Business Regulatory Enforcement unfunded mandate on State, local, or I Fairness Act 2. Section 931.15 is amended in the tribal governments or the private sector table by adding a new entry in This rule is not a major rule under 5 of $100 million or more in any given chronological order by ‘‘Date of Final U.S.C. 804(2), the Small Business year. This determination is based upon Publication’’ to read as follows: Regulatory Enforcement Fairness Act. the fact that the State submittal, which This rule: a. does not have an annual is the subject of this rule, is based upon § 931.15 Approval of New Mexico effect on the economy of $100 million; counterpart Federal regulations for regulatory program amendments. b. will not cause a major increase in which an analysis was prepared and a * * * * *

Original amendment submission date Date of final publication Citation/description

*******

October 27, 2003 ...... April 13, 2004 ...... 19.8.1.7.P(8) and (9); 19.8.1.7.T(2); 19.8.5.506.A, B, D, E, F, and G; 19.8.12.1200.A; 19.8.13.1300.B; 19.8.13.1301.A(1), B, C, and E(1) and E(2); 19.8.20.2073 (C), (D), (E), and (F) NMAC

[FR Doc. 04–8381 Filed 4–12–04; 8:45 am] repair and replace damaged portions of are necessary to ensure the safety of the BILLING CODE 4310–05–P the bridge. bridge. This temporary deviation will DATES: This deviation is effective from allow the bridge to remain in the closed- 8 a.m. until 2 p.m. on Thursday, April to-navigation position from 8 a.m. until DEPARTMENT OF HOMELAND 29, 2004. 2 p.m. on Thursday, April 29, 2004. SECURITY ADDRESSES: Materials referred to in this As the bridge has no vertical document are available for inspection or Coast Guard clearance in the closed-to-navigation copying at the office of the Eighth Coast position, vessels will not be able to Guard District, Bridge Administration 33 CFR Part 117 transit through the bridge site when the Branch, Hale Boggs Federal Building, bridge is closed. Navigation at the site [CGD08–04–014] room 1313, 500 Poydras Street, New of the bridge consists mainly of tows Orleans, Louisiana 70130–3310 between with barges and some recreational Drawbridge Operation Regulations; 7 a.m. and 3 p.m., Monday through pleasure craft. Due to prior experience, Gulf Intracoastal Waterway—Bayou Friday, except Federal holidays. The as well as coordination with waterway Boeuf, Amelia, LA telephone number is (504) 589–2965. users, it has been determined that this The Bridge Administration Branch of AGENCY: Coast Guard, DHS. the Eighth Coast Guard District closure will not have a significant effect ACTION: Notice of temporary deviation maintains the public docket for this on these vessels. An alternate route is from regulations. temporary deviation. available by using the GIWW, Morgan City to Port Allen Alternate Route. SUMMARY: The Commander, Eighth FOR FURTHER INFORMATION CONTACT: Coast Guard District, has issued a David Frank, Bridge Administration In accordance with 33 CFR 117.35(c), temporary deviation from the regulation Branch, telephone (504) 589–2965. this work will be performed with all due governing the operation of the BNSF RR SUPPLEMENTARY INFORMATION: The BNSF speed in order to return the bridge to Swing Bridge across Bayou Boeuf, mile RR has requested a temporary deviation normal operation as soon as possible. 10.2, at Amelia, St. Mary Parish, LA. in order to remove and replace damaged This deviation from the operating This deviation allows the bridge to portions of the Bayou Boeuf Swing regulations is authorized under 33 CFR remain closed to navigation for six Bridge across Bayou Boeuf, mile 10.2, at 117.35. hours. The deviation is necessary to Amelia, St. Mary Parish, LA. The repairs

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Dated: April 6, 2004. Regulatory Information a 500-yard radius of an underway, Marcus Redford, We did not publish a notice of escorted passenger vessel, nor come or Bridge Administrator. proposed rulemaking (NPRM) for this remain within a 100-yard radius of a [FR Doc. 04–8318 Filed 4–12–04; 8:45 am] regulation. Under 5 U.S.C. 553(b)(B), the moored or anchored passenger vessel BILLING CODE 4910–15–P Coast Guard finds that good cause exists without the permission of the Captain of for not publishing a NPRM. Publishing the Port, Philadelphia, Pennsylvania or a NPRM and delaying the effective date his designated representative. These zones will be enforced around DEPARTMENT OF HOMELAND would be contrary to the public interest, moving escorted passenger vessels and SECURITY since immediate action is needed to stationary passenger vessels while they continue to protect the public, ports and Coast Guard are within the Captain of the Port of waterways of the United States. Philadelphia zone. A Broadcast Notice Under 5 U.S.C. 553(d)(3), the Coast 33 CFR Part 165 to Mariners will be issued to notify Guard finds good cause exists for mariners to aid them in making making this rule effective less than 30 alternate plans for transiting the affected [CGD05–04–066] days after publication in the Federal waterway. Register. Publishing a NPRM and RIN 1625–AA00 delaying the effective date would be Regulatory Evaluation Security Zone; Atlantic Ocean, contrary to the public interest, since This rule is not a ‘‘significant Chesapeake & Delaware Canal, immediate action is needed to continue regulatory action’’ under section 3(f) of Delaware Bay, Delaware River and Its to protect the public, ports and Executive Order 12866, Regulatory Tributaries waterways of the United States. The Planning and Review, and does not Coast Guard was notified on March 29, require an assessment of potential costs AGENCY: Coast Guard, DHS. 2004, of scheduled port calls by and benefits under section 6(a)(3) of that ACTION: Temporary final rule. passenger vessels, making it Order. The Office of Management and impracticable for the safety of passenger Budget has not reviewed it under that SUMMARY: The Coast Guard is vessels and mariners to delay Order. It is not ‘‘significant’’ under the establishing 500-yard temporary publishing this security zone. regulatory policies and procedures of security zones throughout the Captain of The Coast Guard plans to publish a the Department of Homeland Security the Port Philadelphia’s area of NPRM proposing a permanent rule for (DHS). responsibility around escorted security zones around passenger vessels The primary impact of this rule will passenger vessels in transit and 100- and requesting public comment. be on vessels wishing to transit the yard security zones around moored or Background and Purpose affected waterway in the vicinity of anchored passenger vessels. The passenger vessel security zone. security zones are needed to ensure The terrorist attacks of September 11, Although this rule restricts traffic from public safety and the safe transit of the 2001 highlighted the need for freely transiting portions of the Atlantic passenger vessels in the Atlantic Ocean, heightened security measures at United Ocean, Chesapeake & Delaware Canal, Chesapeake & Delaware Canal, Delaware States seaports. The President has Delaware Bay, Delaware River and its Bay, Delaware River and its tributaries. found, pursuant to law, including the tributaries, the restrictions are limited in The temporary moving security zones Act of June 15, 1917, as amended by the duration and affect only a limited area. prohibit vessels from entering within a Magnuson Act of August 9, 1950 (50 500-yard radius of the escorted U.S.C. 191 et seq.), that the security of Small Entities passenger vessels while in transit, and the United States is and continues to be Under the Regulatory Flexibility Act within a 100-yard radius of passenger endangered following the attacks. The (5 U.S.C. 601–612), we have considered vessels while moored or anchored, Captain of the Port of Philadelphia has whether this rule would have a unless authorized by the Captain of the determined that security zones are significant economic impact on a Port, Philadelphia, Pennsylvania, or his necessary to protect the public, the substantial number of small entities. designated representative. These waterway, and passenger vessels from The term ‘‘small entities’’ comprises security zones are limited in duration potential subversive acts. small businesses, not-for-profit and affect only certain passenger vessels Discussion of the Regulation organizations that are independently and a small area at any given time. owned and operated and are not DATES: This rule is effective from April This temporary rule establishes 100- dominant in their fields, and 2, 2004, through September 1, 2004. yard security zones around moored or governmental jurisdictions with anchored passenger vessels and 500- ADDRESSES: Documents as indicated in populations of less than 50,000. yard security zones around escorted The Coast Guard certifies under 5 this preamble are available as part of passenger vessels while transiting the docket CGD05–04–066 and are available U.S.C. 605(b) that this rule will not have Atlantic Ocean, Chesapeake & Delaware a significant economic impact on a for inspection or copying at Coast Guard Canal, Delaware Bay, Delaware River Marine Safety Office Philadelphia, One substantial number of small entities. and its tributaries. The Captain of the This rule may affect the following Washington Avenue, Philadelphia, Port, Philadelphia, Pennsylvania’s zone entities, some of which may be small Pennsylvania, 19147, between 8 a.m. extends out in the Atlantic Ocean from entities: owners or operators of vessels and 4 p.m., Monday through Friday, the shoreline to 12 miles. For purposes wishing to transit the affected except Federal holidays. of this rule, ‘‘passenger vessel’’ is waterways of the Atlantic Ocean, FOR FURTHER INFORMATION CONTACT: defined as a vessel greater than 100 feet Chesapeake & Delaware Canal, Delaware Lieutenant Junior Grade Kevin Sligh or in length, over 100 gross tons, and that Bay, Delaware River and its tributaries. Ensign Jill Munsch, Coast Guard Marine is authorized to carry 500 or more The rule will not have a significant Safety Office/Group Philadelphia, at passengers, making voyages lasting impact on a substantial number of small (215) 271–4889. more than 24 hours, except for a ferry. entities for the following reasons: the SUPPLEMENTARY INFORMATION: No vessels or persons may come within restrictions are limited in duration and

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affect only a limited area. A broadcast Civil Justice Reform available in the docket where indicated ADDRESSES. notice to mariners will be issued to This rule meets applicable standards under notify mariners to make alternate plans in sections 3(a) and 3(b)(2) of Executive List of Subjects in 33 CFR Part 165 for transiting the affected waterway. Order 12988, Civil Justice Reform, to Harbors, Marine safety, Navigation Assistance for Small Entities minimize litigation, eliminate (water), Reporting and recordkeeping ambiguity, and reduce burden. Under section 213(a) of the Small requirements, Security measures, and Business Regulatory Enforcement Protection of Children Waterways. I Fairness Act of 1996 (Public Law 104– We have analyzed this rule under For the reasons discussed in the 121), we offered to assist small entities Executive Order 13045, Protection of preamble, the Coast Guard amends 33 in understanding the rule so that they Children from Environmental Health CFR part 165 as follows: could better evaluate its effects on them Risks and Security Risks. This rule is and participate in the rulemaking PART 165—REGULATED NAVIGATION not an economically significant rule and AREAS AND LIMITED ACCESS AREAS process. does not create an environmental risk to Small businesses may send comments health or risk to security that may I 1. The authority citation for part 165 on the actions of Federal employees disproportionately affect children. continues to read as follows: who enforce, or otherwise determine compliance with, Federal regulations to Indian Tribal Governments Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapters 701; 50 U.S.C. 191, 195; 33 CFR the Small Business and Agriculture This rule does not have tribal 1.05–1(g), 6.04–1, 6.04–6, and 160.5; Pub. L. Regulatory Enforcement Ombudsman implications under Executive Order 107–295, 116 Stat. 2064; Department of and the Regional Small Business 13175, Consultation and Coordination Homeland Security Delegation No. 0170.1. Regulatory Fairness Boards. The with Indian Tribal Governments, I Ombudsman evaluates these actions because it does not have a substantial 2. From April 2, 2004, through annually and rates each agency’s direct effect on one or more Indian September 1, 2004, add §165.T05–066. responsiveness to small business. If you tribes, on the relationship between the § 165.T05–066 Security Zone; Atlantic wish to comment on actions by Federal Government and Indian tribes, Ocean, Chesapeake & Delaware Canal, employees of the Coast Guard, call 1– or on the distribution of power and Delaware Bay, Delaware River and its 888–REG–FAIR (1–888–734–3247). responsibilities between the Federal tributaries. Collection of Information Government and Indian tribes. (a) Location. All navigable waters within 500 yards of escorted passenger Energy Effects This rule calls for no new collection vessels when they are in the Captain of of information under the Paperwork We have analyzed this rule under the Port, Philadelphia zone, as Reduction Act of 1995 (44 U.S.C. 3501– Executive Order 13211, Actions established in 33 CFR 3.25–05. 3520). Concerning Regulations That (b) Regulations. (1) All persons are Federalism Significantly Affect Energy Supply, required to comply with the general Distribution, or Use. We have regulations governing security zones in A rule has implications for federalism determined that it is not a ‘‘significant § 165.33 of this part. under Executive Order 13132, energy action’’ under that order because (2) The 500-yard moving security Federalism, if it has a substantial it is not a ‘‘significant regulatory action’’ zones prohibit a person or a vessel from direct effect on State or local under Executive Order 12866 and is not transiting or remaining within a 500- governments and would either preempt likely to have a significant adverse effect yard radius of an escorted passenger State law or impose a substantial direct on the supply, distribution, or use of vessel while the passenger vessel is cost of compliance on them. We have energy. The Administrator of the Office transiting in the Captain of the Port analyzed this rule under that Order and of Information and Regulatory Affairs Philadelphia area of responsibility, have determined that it does not have has not designated it as a significant unless authorized by the Captain of the implications for federalism. energy action. Therefore, it does not Port Philadelphia, PA or designated require a Statement of Energy Effects Unfunded Mandates Reform Act representative. under Executive Order 13211. (3) No person or vessel may come The Unfunded Mandates Reform Act within 100 yards of a moored or Environment of 1995 (2 U.S.C. 1531–1538) requires anchored passenger vessel, unless Federal agencies to assess the effects of We have analyzed this rule under authorized by the Captain of the Port their discretionary regulatory actions. In Commandant Instruction M16475.1D, Philadelphia, PA, or designated particular, the Act addresses actions which guides the Coast Guard in representative. that may result in the expenditure by a complying with the National (4) Any person or vessel authorized to State, local, or tribal government, in the Environmental Policy Act of 1969 enter a security zone must operate in aggregate, or by the private sector of (NEPA) (42 U.S.C. 4321–4370f), and strict conformance with any directions $100,000,000 or more in any one year. have concluded that there are no factors given by the Captain of the Port Though this rule will not result in such in this case that would limit the use of Philadelphia, PA or designated expenditure, we do discuss the effects of a categorical exclusion under section representative and leave the security this rule elsewhere in this preamble. 2.B.2 of the Instruction. Therefore, this zone immediately if the Captain of the rule is categorically excluded, under Port Philadelphia, PA or designated Taking of Private Property figure 2–1, paragraph (34)(g), of representative so orders. This rule will not effect taking of Commandant Instruction M16475.lD, (5) When a passenger vessel private property or otherwise have from further environmental approaches within 500 yards of any taking implications under Executive documentation. moored or anchored stationary vessel, Order 12630, Governmental Actions and A final ‘‘Environmental Analysis the stationary vessel must remain Interference with Constitutionally Checklist’’ and a final ‘‘Categorical moored or anchored. The 500-yard Protected Property Rights. Exclusion Determination’’ will be security zone around the passenger

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vessel will remain in effect while the FEDERAL COMMUNICATIONS Bennington, OK, at reference passenger vessel is transiting near the COMMISSION coordinates 34–04–00 and 95–59–52; (4) stationary vessel. The stationary vessel reallots and changes the community of must remain moored or anchored unless 47 CFR Part 73 license for Station KACO(FM) from it is either ordered by or given [DA 04–782, MM Docket No. 01–293, RM– Channel 253C3 at Ardmore, OK, to permission by the Captain of the Port, 10302, RM–10547] Channel 253C3 at Apache, OK, at Philadelphia or designated reference coordinates 34–53–34 and 98– representative to do otherwise. Radio Broadcasting Services; Apache, 14–01; (5) downgrades Station Ardmore, Bennington, OK; Bonham, KTIJ(FM), Elk City, OK, from Channel (6) The Coast Guard official enforcing Bridgeport, TX; Cache, OK; Crowell, 253C to Channel 295C1 at reference this section can be contacted on VHF TX; Elk City, Lawton, OK; Palestine, coordinates 35–15–36 and 99–33–08; Marine Band Radio, channels 13 and 16. Ranger, Stephenville, Wellington, TX and (6) substitutes Channel 253C3 for The Captain of the Port can be contacted vacant Channel 298C3 at Wellington, at (215) 271–4807. AGENCY: Federal Communications TX, at reference coordinates 34–49–13 (c) Maneuver-restricted vessels. When Commission. and 100–14–29. The FM Table of conditions permit, the on-scene official ACTION: Final rule. Allotments currently lists Channel 253A patrol or Captain of the Port, or at Ardmore, Oklahoma. In 1997, the SUMMARY: This document grants a designated representative may: Audio Division granted Station counterproposal to upgrade Station KACO(FM) a construction permit to (1) Permit vessels constrained by their KBOC(FM), Bridgeport, TX, from specify operation on Channel 253C3 in navigational draft or restricted in their Channel 252A to Channel 252C0. To lieu of Channel 253A, BMPH–970307IC, ability to maneuver to pass within the accommodate this upgrade, six other to which a license was granted to cover 500-yard zone around the transiting changes to the FM Table of Allotments this construction permit in 1998, BPH– passenger vessel in order to ensure safe are being made. The document also 19971010KI. passage in accordance with the dismisses a mutually exclusive proposal Navigation Rules as seen in 33 CFR to allot Channel 250C3 at Crowell, TX, List of Subjects in 47 CFR Part 73 chapter I, subchapters D and E; and and approves a settlement agreement between the parties. See 66 FR 53755, Radio, Radio broadcasting. (2) Permit vessels constrained by their October 24, 2001. See also navigational draft or restricted in their I Part 73 of Title 47 of the Code of SUPPLEMENTARY INFORMATION. ability to maneuver that must transit via Federal Regulations is amended as DATES: a navigable channel or waterway to pass Effective May 10, 2004. follows: FOR FURTHER INFORMATION CONTACT: within 100 yards of an anchored PART 73—RADIO BROADCAST passenger vessel. Andrew J. Rhodes, Media Bureau, (202) 418–2180. SERVICES (d) Definitions. As used in this SUPPLEMENTARY INFORMATION: This is a section— I 1. The authority citation for Part 73 synopsis of the Commission’s Report continues to read as follows: Captain of the Port means the and Order, MM Docket 01–293, adopted Commanding Officer of the Coast Guard March 24, 2004, and released March 26, Authority: 47 U.S.C. 154, 303, 334 and 336. Marine Safety Office/Group 2004. The full text of this decision is § 73.202 [Amended] Philadelphia or any Coast Guard available for inspection and copying commissioned, warrant, or petty officer during normal business hours in the I 2. Section 73.202(b), the Table of FM who has been authorized by the Captain FCC’s Reference Information Center at Allotments under Oklahoma, is of the Port to act as a designated Portals II, CY–A257, 445 12th Street, amended by adding Apache, Channel representative on his behalf. SW., Washington, DC. The complete 253C3, by removing Channel 253A at Ardmore, by adding Bennington, Passenger vessel means a vessel text of this decision may also be Channel 251A, by adding Cache, greater than 100 feet in length, over 100 purchased from the Commission’s copy contractor, Qualex International, Portals Channel 250A, by removing Channel gross tons, and is authorized to carry II, 445 12th Street, SW., Room CY–B402, 253C and adding Channel 295C1 at Elk 500 or more passengers, making voyages Washington, DC 20554, telephone 202– City, and by removing Channel 251C1 at lasting more than 24 hours, except for 863–2893, facsimile 202–863–2898, or Lawton. a ferry. via e-mail [email protected]. I 3. Section 73.202(b), the Table of FM Dated: April 2, 2004. The reference coordinates for Channel Allotments under Texas, is amended by Jonathan D. Sarubbi, 250C0 at Bridgeport, TX, are 33–26–13 removing Bonham, Channel 252C3, by Captain, U.S. Coast Guard, Captain of the and 97–29–05. To accommodate this removing Channel 252A and adding Port Philadelphia. upgraded allotment, the document (1) Channel 252C0 at Bridgeport, by [FR Doc. 04–8350 Filed 4–12–04; 8:45 am] reallots and changes the community of removing Channel 252C2 and adding license for Station KCUB(FM) from BILLING CODE 4910–15–P Channel 252C3 at Palestine, by adding Channel 252A at Stephenville, TX, to Ranger, Channel 253A, by removing Channel 253A at Ranger, TX, at Stephenville, Channel 252A, and by reference coordinates 32–22–55 and 98– removing Channel 298C3 and adding 45–55; (2) downgrades Station Channel 253C3 at Wellington. KYYK(FM), Palestine, TX, from Channel 252C2 to Channel 252C3 at reference Federal Communications Commission. coordinates 31–46–17 and 95–37–54; (3) John A. Karousos, downgrades, reallots, and changes the Assistant Chief, Audio Division, Media community of license for Station Bureau. KFYZ(FM) from Channel 252C3 at [FR Doc. 04–8330 Filed 4–12–04; 8:45 am] Bonham, TX, to Channel 251A at BILLING CODE 6712–01–P

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DEPARTMENT OF STATE Governmentwide Point of Entry (GPE). Executive Order 12866 Since this waiver is extended The Office of Management and Budget 48 CFR Parts 601, 602, 603, 604, 605, periodically, it makes sense to not has reviewed this rule under Executive 606, 609, 611, 612, 613, 616, 617, 619, publish the actual date. This will ease Order 12866. 622, 623, 625, 626, 628, 630, 632, 636, administration of the regulation so that 637, 642, 651, 652, and 653 changes do not have to be published Paperwork Reduction Act [Public Notice 4685] each time the date changes. Information collection requirements • DOSAR 605.202–70(d) is revised to have been approved under the RIN 1400–AB06 state that the GPE waiver authority also Paperwork Reduction Act of 1980 by does not apply to any contracts OMB, and have been assigned OMB Department of State Acquisition Control Number 1405–0050. The Regulation (DOSAR) exceeding $5 million. The proposed rule limited this to only construction Department is currently seeking AGENCY: Department of State. contracts. A decision has been made approval for the information collection requirements associated with Form DS– ACTION: Final rule. that all contracts exceeding $5 million must be synopsized in the GPE. 4053, Department of State Mentor- SUMMARY: This rule makes final a Prote´ge´ Program Application. These amendments do not affect the proposed rule published for comment public, and therefore good cause exists List of Subjects in 48 CFR Parts 601, on November 13, 2003 amending the to publish them without first soliciting 602, 603, 604, 605, 606, 609, 611, 612, Department of State Acquisition 613, 616, 617, 619, 622, 623, 625, 626, Regulation (DOSAR). No public public comment because prior public comment is unnecessary. 628, 630, 632, 636, 637, 642, 651, 652, comments were received. The proposed and 653 rule is therefore adopted as final. This Regulatory Findings final rule also contains three Department of State Acquisition miscellaneous amendments not Administrative Procedure Act Regulation. published on November 13, 2003, as I Accordingly, for the reasons set forth The Department is publishing this outlined below. in the preamble, title 48, chapter 6 of rule as a final rule after it was published the Code of Federal Regulations is EFFECTIVE DATE: This rule is effective as a proposed rule on November 13, April 13, 2004. amended as follows: 2003 (see SUPPLEMENTARY INFORMATION). I 1. The authority citation for 48 CFR FOR FURTHER INFORMATION CONTACT: parts 601, 602, 603, 604, 605, 606, 609, Gladys Gines, Procurement Analyst, Regulatory Flexibility Act 611, 612, 613, 616, 617, 619, 622, 623, Department of State, Office of the The Department of State, in 625, 626, 628, 630, 632, 636, 637, 642, Procurement Executive, 2201 C Street, accordance with the Regulatory 651, 652, and 653 continues to read as NW., Suite 603, State Annex Number 6, Flexibility Act (5 U.S.C. 605(b)), has follows: Washington, DC 20522–0602; telephone reviewed this regulation and, by (703) 516–1691; e-mail address: Authority: 40 U.S.C. 486(c); 22 U.S.C. approving it, certifies that this rule will [email protected]. Persons with access 2658. not have a significant economic impact to the Internet may also view this notice Subchapter A—General on a substantial number of small by going to the regulations.gov Web site at: http://www.regulations.gov/ entities. PART 601—DEPARTMENT OF STATE index.cfm. Unfunded Mandates Act of 1995 ACQUISITION REGULATION SUPPLEMENTARY INFORMATION: On This rule will not result in the I 2. Section 601.105–3 is revised to read November 13, 2003 (Public Notice 4525 expenditure by State, local, and tribal as follows: at 68 FR 64297), the Department of State governments, in the aggregate, or by the proposed numerous amendments to the 601.105–3 Copies. private sector, of $1 million or more in DOSAR to reflect recent changes in the The DOSAR is available through the any year and it will not significantly or Federal Acquisition Regulation (FAR), Department’s Intranet system at http:// uniquely affect small governments. as well as organizational and other aope.a.state.gov, or through the Internet Therefore, no actions were deemed policy changes within the Department. from A/OPE’s Acquisition Web site. The necessary under the provisions of the The rule was discussed in detail in Internet address is: http:// Unfunded Mandates Reform Act of Public Notice 4525, as were the www.statebuy.state.gov/. Department’s reasons for the changes to 1995. 601.106 [Amended] the regulation. The Department is now Small Business Regulatory Enforcement promulgating a final rule with the Fairness Act of 1996 I 3. Section 601.106 is amended by following minor changes from the removing from the last sentence proposed rule: This rule is not a major rule as ‘‘225,302 hours’’ and inserting ‘‘225,503 • DOSAR 601.603–70 is further defined by section 804 of the Small hours’’ in its place. revised to delete one more acquisition Business Regulatory Enforcement Act of I 4. Section 601.603–1 is added to read office (the Diplomatic 1996. This rule will not result in an as follows: Telecommunications Service—Program annual effect on the economy of $100 Office). The acquisition responsibilities million or more; a major increase in 601.603–1 General. of this office have been transferred to costs or prices; or significant adverse Details of the Department’s the Office of Acquisition Management. effects on competition, employment, acquisition career management program • DOSAR 605.202–70 (a) is revised to investment, productivity, innovation, or are described in 6 FAH–6, the delete the last sentence. This sentence on the ability of United States-based Acquisition Career Management established an end date (March 12, companies to compete with foreign Program Handbook, which is available 2004) for the waiver for synopsizing based companies in domestic and on the Intranet from the A/OPE Web site foreign acquisitions in the import markets. (see 601.105–3 for address).

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I 5. Section 601.603–3 is amended by statutory authority of that agency and Department of State contracting activity revising paragraph (d) to read as any special contract terms or other on behalf of INL. follows: requirements necessary for compliance * * * * * with any conditions or limitations 601.603–3 Appointment. applicable to the funds of that agency. PART 602—DEFINITIONS OF WORDS * * * * * The agency’s authorization shall cite the AND TERMS (d) Personal services agreements. statute(s) and state any special contract Individuals who may sign personal terms or other requirements with which I 7. Section 602.101–70 is amended by services agreements (PSAs) are limited the acquisition so authorized must adding, in alphabetical order, a to the following: comply. In view of the contracting definition of ‘‘Chief of Mission’’; and, by (1) The Human Resources Officer; officer’s responsibility for the legal, revising the definition of ‘‘Despatch (2) The Human Resources/Financial technical, and administrative Agency’’, as follows: Management Officer; or, sufficiency of contracts, questions (3) The Management Officer or an 602.101–70 DOSAR definitions. regarding the propriety of contracting American Foreign Service Officer * * * * * actions that the post is required to take designated to perform human resource Chief of Mission means the principal pursuant to this authority may be functions. officer in charge of a diplomatic mission referred to the Department for resolution I of the United States or of a United States 6. In section 601.603–70, paragraph with the headquarters of the agency (a) is revised and a sentence is added at office abroad which is designated by the concerned. Secretary of State as diplomatic in the end of paragraph (b)(6) to read as (2) Office of Logistics Management; follows: nature, including any individual Office of Acquisition Management (A/ assigned under section 502(c) of the 601.603–70 Delegations of authority. LM/AQM). The authority to enter into Foreign Service Act of 1980 (Public Law (a) Delegations. As stated in 601.603– and administer contracts for the 96–465) to be temporarily in charge of 3(a), there is no contracting officer expenditure of funds involved in the such a mission or office. authority conferred by virtue of acquisition of supplies and services, including construction, is delegated to * * * * * position. Pursuant to 601.602–1(b), the Despatch Agency means the office the Director or designee as the HCA. Procurement Executive has designated responsible for the transportation of (3) Foreign Service Institute. The the following as contracting activities as supplies between the U.S. and posts authority to enter into and administer defined in FAR 2.101. These authorities within its specific geographic area as contracts pursuant to Chapter 7, Title I, are not redelegable. In addition, specific assigned by the Office of Logistics of the Foreign Service Act of 1980, as individuals are designated as heads of Operations. There are six Despatch amended (22 U.S.C. 4021 et seq.), is contracting activities (HCAs) (see FAR Agencies, one each in Iselin, New delegated to the Director of the Foreign 2.101): Jersey; Baltimore, Maryland; Miami, Service Institute, the Executive Director, (1) Overseas posts. Each overseas post Florida; Seattle, Washington; the Deputy Executive Director, and the shall be regarded as a contracting Brownsville, Texas; and the European Supervisory Contracting Officer as the activity to enter into and administer Logistical Support Office in Antwerp, HCA. contracts for the expenditure of funds Belgium. (4) Office of Foreign Missions. The involved in the acquisition of supplies, * * * * * equipment, publications, and services. authority to enter into and administer The Principal Officer, the Management contracts pursuant to Title II of the State PART 603—IMPROPER BUSINESS Officer, or the Supervisory General Department Basic Authorities Act of PRACTICES AND PERSONAL Services Officer are designated as HCAs; 1956, as amended (22 U.S.C. 4301 et CONFLICTS OF INTEREST provided, that he/she has a contracting seq.), is delegated to the Director, Office officer’s warrant issued by the of Foreign Missions, and the I 8. Section 603.104–5 is redesignated Procurement Executive. The Administrative Officer as the HCA. as section 603.104–4. Procurement Executive (or authorized (5) U.S. Mission to the United I 9. Section 603.104–10 is redesignated A/OPE staff) may delegate to a Nations. The authority to enter into and as section 603.104–7. New section contracting officer, on a case-by-case administer contracts pursuant to the 603.104–7 is amended in paragraph basis, the authority to award a contract United Nations Participation Act of (d)(2)(ii)(B) by correcting the citation at or modification which exceeds the 1945, as amended (22 U.S.C. 287), is the end of the paragraph to read ‘‘FAR contracting officer’s warrant level. delegated to the Counselor for 3.104–7(d)(2)(ii)(B).’’ (i) No authority is delegated to enter Administration as the HCA. I 10. Section 603.204 is amended by into cost-reimbursement, fixed-price (6) Regional Procurement Support revising paragraph (b) to read as set incentive, or fixed-price redeterminable Offices. The authority to enter into and forth below, and by removing paragraph contracts. Design/build solicitations and administer contracts for the expenditure (c): contracts may only be entered into with of funds involved in the acquisition of the written approval of A/OPE and supplies, equipment, publications, and 603.204 Treatment of violations. OBO. Proposed construction contracts services on behalf of overseas posts is * * * * * exceeding $500,000 and any related delegated to each Director, Regional (b) Upon completion of the architect-engineer contracts must have Procurement Support Office (RPSO) as investigation and/or prosecution or with prior A/OPE approval. the HCA at the following locations: the consent of the U.S. Department of (ii) When expressly authorized by a (i) RPSO Frankfurt in conjunction Justice, the Assistant Inspector General U.S. Government agency which does not with Consulate General Frankfurt; and for Investigations shall provide to the have a contracting officer at the post, the (ii) RPSO Florida in conjunction with Procurement Executive a report, officers named in paragraph (a)(1) the Florida Regional Center. together with all pertinent introductory text of this section may (b) * * * documentation, concerning the enter into contracts for that agency. Use (6) * * * These authorities extend to suspected violation. The Office of the of this authority is subject to the any acquisition performed by any Procurement Executive shall provide to

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the contractor a written notice by drawings or other materials that are not I (b) By removing the words ‘‘CBD certified mail, return receipt requested, in an automated format, the contracting synopsis’’ and inserting ‘‘GPE notice’’ in presenting the findings, and shall officer shall: their place in paragraph (c)(1)(ii); and, establish a schedule, including location, (A) Post as much of the solicitation as I (c) By removing the words ‘‘Commerce for an investigative hearing for the possible on the Internet; and, Business Daily’’ and inserting ‘‘GPE’’ in purposes described in FAR 3.204(b). (B) Make hard copies available for their place in paragraph (c)(2). * * * * * those parts of the solicitation that are not in an automated format. 606.370 [Amended] I 11. Section 603.601 is amended by (iii) Posting solicitations for overseas I adding the following sentence to the 18. Section 606.370 is amended by contracting activities. Contracting end of paragraph (a): removing the word ‘‘Administrative’’ officers at overseas contracting activities and inserting the word ‘‘Management’’ 603.601 Policy. shall post competitive local guard in its place in the third sentence of (a) * * * This policy also applies to solicitations on the Internet using the paragraph (b). individuals hired under personal Statebuy Interactive Platform if U.S. I 19. Section 606.501 is amended by services agreements and personal firms may be competing. Posting of inserting the following sentence after services contracts. other solicitations is optional. the first sentence in paragraph (b): I 12. A new Subpart 603.8, consisting of Subchapter B—Competition and section 603.804, is added to read as Acquisition Planning 606.501 Requirement. follows: * * * * * PART 605—PUBLICIZING CONTRACT (b) * * * A/LM/AQM’s competition Subpart 603.8—Limitations on the ACTIONS advocate is also designated the Payment of Funds To Influence Federal contracting activity competition I Transactions 14. Section 605.202–70 is amended— advocate for the Regional Procurement I (a) By removing ‘‘CBD’’ in the first Support Offices. * * * 603.804 Policy sentence of paragraph (a); (b) The contracting officer shall I (b) By adding the words ‘‘in the 606.501–70 [Amended] forward a copy of all contractor Governmentwide point of entry (GPE)’’ I 20. Section 606.501–70 is amended by disclosures furnished pursuant to the after the word ‘‘notices’’ in the first removing the word ‘‘Administrative’’ clause at FAR 52.203–12 to the Office of sentence of paragraph (a); and inserting the word ‘‘Management’’ I ‘‘ the Legal Adviser, Employment Law, (c) By removing CBD’’ and inserting in its place. Senior Ethics Counsel (L/EMP/Ethics). ‘‘GPE’’ in its place in the second sentence of paragraph (a); PART 609—CONTRACTOR PART 604—ADMINISTRATIVE I (d) By removing the last sentence of QUALIFICATIONS MATTERS paragraph (a); I (e) By removing ‘‘CBD’’ and inserting I 21. A new section 609.404–70 is I 13. Subpart 604.5 is revised to read as ‘‘GPE’’ in its place in paragraph (b); and, added to read as follows: follows: I (f) By revising paragraph (d) to read as follows: 609.404–70 Specially Designated Subpart 604.5—Electronic Commerce Nationals List. in Contracting 605.202–70 Foreign acquisitions. Contracting officers shall not award to * * * * * any of the entities listed on the 604.502 Policy. (d) Policy exclusions. GPE waiver Specially Designated Nationals (SDN) (b) The Assistant Secretary of State for authority does not apply to local guard List, available on the Department of Administration is the head of the agency service contracts exceeding $250,000, or Treasury’s Office of Foreign Assets for the purpose of FAR 4.502(b). any contracts exceeding $5 million. Control Web site at http:// (1)(i) Posting solicitations for Local guard service contracts that www.treas.gov/ofac/. Contracting domestic contracting activities. exceed $250,000 and other contracts officers shall consult this list prior to Contracting officers at domestic that exceed $5 million shall be award for any dollar amount. This list contracting activities shall post all open published in the GPE. Option year may also be accessed through the EPLS market competitive, unclassified prices shall be included when Web site at http://epls.arnet.gov. Requests for Proposals and Invitations computing the applicability of this I 22. Section 609.405 is amended— for Bids exceeding the simplified threshold. I (a) By removing paragraphs (d) acquisition threshold on the Internet, I 15. Section 605.207–70 is amended by introductory text and (d)(1)(i); unless an exception has been approved removing the word ‘‘synopsis’’ and I (b) By adding a new paragraph (d)(3) by the head of the contracting activity. inserting the word ‘‘notice’’ in its place. to read as indicated below; and, Contracting officers may post Requests I (c) By removing paragraphs (d)(4)(i) for Quotations and noncompetitive 605.303 [Amended] and (d)(4)(ii). acquisitions if desired. Solicitations I 16. Section 605.303 is amended by 609.405 Effect of listing. shall be posted through the Statebuy removing the word ‘‘Office’’ and Interactive Platform (SIP) at https:// inserting the word ‘‘Bureau’’ in its place * * * * * state.monmouth.army.mil/ If the SIP is in the first sentence of paragraph (a). (d)(3) The Procurement Executive is temporarily unavailable (due either to the agency head’s designee for the problems with the SIP system or the PART 606—COMPETITION purposes of FAR 9.405(d)(3). Internet connections), the solicitation REQUIREMENTS I 23. Section 609.406–3 is amended by shall be posted on the Governmentwide revising the last two sentences of 606.302 [Amended] point of entry (GPE), and immediately paragraph (a)(1) to read as follows: posted on the SIP when the SIP again I 17. Section 606.302–6 is amended— becomes available. I (a) By removing the words ‘‘Commerce 609.406–3 Procedures. (ii) Materials not in automated Business Daily’’ and inserting ‘‘GPE’’ in (a)(1) * * * The Office of the format. For solicitations containing their place in paragraph (c)(1)(i); Inspector General shall investigate the

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matter, as appropriate, and provide a doors, windows, and related facilities PART 612—ACQUISITION OF copy of its investigation report to the and items that can provide the COMMERCIAL ITEMS Procurement Executive for necessary time to protect Government consideration of debarment action, if personnel from attack. I 25. A new part 612, consisting of and when appropriate. The contracting (D) Armored vehicles. This includes subpart 612.3 and section 612.302, is officer shall provide to the Procurement passenger vehicles with appropriate added to subchapter B as follows: Executive and the Office of the armoring. Inspector General a copy of his or her PART 612—ACQUISITION OF intended actions in response to the (E) Entry control and building COMMERCIAL ITEMS Office of the Inspector General report. surveillance equipment. This includes Subpart 612.3—Solicitation Provisions * * * * * walk-through metal detectors, X-ray equipment, surveillance cameras, and Contract Clauses for the PART 611—DESCRIBING AGENCY explosive detection equipment, and Acquisition of Commercial Items NEEDS other features to enhance the protection 612.302 Tailoring of provisions and of Government personnel and facilities. clauses for the acquisition of commercial I 24. A new subpart 611.6 is added to items. read as follows: (2) DOC has assigned the following priority rating to DOSESPP contracts or (c) The head of the contracting Subpart 611.6—Priorities and orders: DO–H8. activity shall approve any request for a Allocations waiver to tailor a clause or otherwise 611.603 Procedures. include any additional terms or Sec. conditions in a solicitation or contract 611.600 Scope of subpart. (f) Department of State contracting officers are authorized to sign DO–H8 in a manner that is inconsistent with 611.602 General. customary commercial practice. 611.603 Procedures. rated contracts or orders. It is the responsibility of the requirements office Subchapter C—Contracting Methods and Subpart 611.6—Priorities and to determine which contracts or orders Contract Types Allocations should be rated. All contracts with U.S. PART 613—SIMPLIFIED ACQUISITION firms under the DOSESPP will not 611.600 Scope of subpart. PROCEDURES necessarily need to be assigned a On September 18, 2001, the priority rating. Department of Commerce (DOC) I 26. Section 613.303–5 is amended by authorized the Department of State to (g) The contracting officer should adding a new paragraph (b) to read as use the Defense Priorities and place a DO-H8 rating on any contract or follows: Allocations System (DPAS). This order if there is any doubt as to whether 613.303–5 Purchases under BPAs. authority expires on October 1, 2006. a contractor doing work for Embassy The Department of Defense has security protection will be able to (b) Individual purchases under BPAs approved the Department’s Embassy deliver on time. If an unrated contract for commercial items may exceed the Security Protection Program (DOSESPP) or order is not completed on time, the simplified acquisition threshold; as a national defense program eligible contracting officer may modify the however, the higher threshold must be for the priorities support under the contract or order to add the rating; consistent with the requirements of FAR DPAS. however, the rating shall only be 13.303–5(b)(1) and (2). * * * * * 611.602 General. effective for the newly established delivery date, not the original delivery (c)(1) Authority to use the DPAS is PART 616—TYPES OF CONTRACTS limited to the following circumstances: date. (i) The contract or order must be (1) DOC can provide special 616.505 [Amended] placed with a U.S. firm; and, assistance to implement the DPAS I 27. Section 616.505 is amended by (ii) The contract or order must be in program in specific cases. For example, correcting the paragraph designation of support of the DOSESPP, which consists the Department may request a higher ‘‘(b)(4)’’ to read ‘‘(b)(5)’’. of work involving the security of priority rating, or request that DOC issue overseas posts. The DOSESPP includes a written directive to a contractor that PART 617—SPECIAL CONTRACTING a wide range of elements of both is not complying with the DPAS METHODS physical and technical security, such as: regulations. In addition, although the I 28. Section 617.204 is amended by (A) New Embassy/Consulate DPAS program normally applies only to adding the following sentence to the Compound (NEC/NCC) Program. This U.S. firms, if the Department has a end of paragraph (e): program involves the construction of prime contract with a foreign firm that new secure Embassies, Consulates, and will be awarding subcontracts with U.S. 617.204 Contracts. related facilities, as well as renovations firms, the Department may request from (e) * * * The Procurement Executive of newly acquired buildings when used DOC authorization to place a rating on as alternatives to the construction of may delegate this approval authority to the prime contract. new secure buildings. individuals within the Office of the (B) Physical security upgrade. This (2) Contracting officers or Procurement Executive. includes installation of forced entry/ requirements offices who wish to I 29. Section 617.504–70 is amended by ballistic resistant (FE/BR) windows and request special assistance from DOC adding the words ‘‘and Bureau doors, walls/fences, active anti-ram must complete DOC Form BXA–999, Executive Directors’’ after the words barriers, bollards (concrete and steel Request for Special Priorities ‘‘deputy assistant secretaries’’ in barriers), and related items. Assistance, and submit it to A/OPE, paragraph (a) and by removing the (C) Forced entry/ballistic resistant which will arrange for submission of the parenthetical ‘‘(illustrated in part 653)’’ (FE/BR) components. This includes request to DOC. in the first sentence of paragraph (b).

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Subchapter D—Socioeconomic Programs multiple award contracts exceeding $2 that the firm may be able to qualify for million, to assure that small business, future awards; PART 619—SMALL BUSINESS small disadvantaged business, women- (13) Participating in Government- PROGRAMS owned small business, HUBZone small industry conferences to assist small business, veteran-owned small business, business concerns, including Business I 30. Section 619.201 is revised to read and service-disabled veteran-owned Opportunity/Federal Acquisition as follows: small business concerns will be afforded Conferences, Minority Business 619.201 General policy. an equitable opportunity to compete Enterprise Acquisition Seminars and (a) The Operations Director, Office of and, as appropriate, initiating Business Opportunity Committee Small and Disadvantaged Business recommendations for small business, meetings; Utilization (A/SDBU), is responsible for 8(a), or HUBZone set-asides. This (14) Maintaining a list of supplies and performing all functions and duties includes proposed contract services that have been placed as prescribed in FAR 19.201(c) and (d). modifications for new or additional repetitive small business set-asides; (b) In addition to the requirements of requirements that do not fall within the (15) Participating in the development, FAR 19.201(b), each head of the original scope of the contract and which implementation, and review of contracting activity, or designee, is exceed the simplified acquisition automated source systems to assure that responsible for establishing in limitation. This does not include the the interests of small business concerns coordination with the A/SDBU exercising of contract options; are included; Operations Director annual goals for the (6) Assuring that contract financing (16) Advising potential sources how DOS small business program. available under existing regulations is they can obtain information about (c) The Assistant Secretary of State for offered when appropriate and that competitive acquisitions; Administration is the agency head for requests by small business concerns for (17) Providing small business, small the purposes of FAR 19.201(c). such financing are not treated as a disadvantaged business, women-owned (d) Pursuant to FAR 19.201(d), each handicap in the award of contracts; small business, HUBZone small Small and Disadvantaged Business (7) Providing assistance to the business, veteran-owned small business, Utilization Specialist (SDBUS) is contracting officer in making and service-disabled veteran-owned responsible for— determinations concerning small business concerns information (1) Maintaining a program to locate responsibility of prospective contractors regarding assistance available from capable small business, small whenever small business concerns are Federal agencies such as the Small disadvantaged business, women-owned involved; Business Administration, Minority small business, HUBZone small (8) Participating in the evaluation of Business Development Agency, Bureau business, veteran-owned small business, a prime contractor’s small, small of Indian Affairs, Economic and service-disabled veteran-owned disadvantaged, woman-owned small, Development Administration, National small business sources to fulfill DOS HUBZone small, veteran-owned small, Science Foundation, Department of acquisition requirements; and service-disabled veteran-owned Labor and others, including State (2) Coordinating inquiries and small business subcontracting plans; agencies and trade associations; and requests for advice from small business, (9) Assuring that the participation of (18) Participating in interagency small disadvantaged business, women- small business, small disadvantaged programs relating to small business owned small business, HUBZone small business, women-owned small business, matters as authorized by the A/SDBU business, veteran-owned small business, HUBZone small business, veteran- Operations Director. (f)(1) The Procurement Executive is and service-disabled veteran-owned owned small business, and service- the agency designee for the purposes of small business concerns on DOS disabled veteran-owned small business FAR 19.201(f)(1). The written contracting and subcontracting concerns is accurately reported; determination shall be forwarded to the opportunities and other acquisition (10) Attending, as appropriate, Procurement Executive through the A/ matters; debriefings to unsuccessful small SDBU Operations Director. (3) Advising contracting activities on business, small disadvantaged business, new or revised small business policies, women-owned small business, I 31. A new section 619.202, and regulations, procedures, and other HUBZone small business, veteran- subsection 619.202–70 are added to read related information; owned small business, and service- as follows: (4) Assuring that small business, disabled veteran-owned small business 619.202 Specific policies. small disadvantaged business, women- concerns to assist those firms in owned small business, HUBZone small understanding requirements for 619.202–70 The Department of State business, veteran-owned small business, responsiveness and responsibility so Mentor-Prote´ge´ Program. and service-disabled veteran-owned that the firm may be able to qualify for (a) Purpose. The Mentor-Prote´ge´ small business concerns are provided future awards; Program is designed to motivate and adequate specifications or drawings by (11) Making available to SBA copies encourage firms to assist small initiating, in writing, with appropriate of solicitations when so requested; businesses with business development, technical and contracting personnel to (12) When a bid or offer from a small including small disadvantaged ensure that all necessary specifications business, small disadvantaged business, businesses, women-owned small or drawings for current and future women-owned small business, businesses, HUBZone small businesses, acquisitions, as appropriate, are HUBZone small business, veteran- veteran-owned small businesses and available; owned small business, and service- service-disabled veteran-owned small (5) Reviewing all proposed disabled veteran-owned small business businesses. The program is also acquisitions in excess of the simplified has been rejected for non- designed to improve the performance of acquisition threshold, including responsiveness or non-responsibility, DOS contracts and subcontracts, foster commercial items using the simplified upon request, aid, counsel, and assist the establishment of long-term business acquisition procedures of FAR Subpart that firm in understanding requirements relationships between small businesses 13.5, and task and delivery orders under for responsiveness and responsibility so and prime contractors, and increase the

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overall number of small businesses that (3) A non-monetary award may be mentoring activity for each agency’s receive DOS contract and subcontract presented annually (or as often as program. awards. The program is limited to non- appropriate) to the mentoring firm (i) Selection of prote´ge´ firms. (1) commercial item acquisitions. providing the most effective Mentor firms are solely responsible for (b) Definitions. The definitions of developmental support of a prote´ge´. The selecting prote´ge´ firms. The mentor is small business (SB), HUBZone small Mentor-Prote´ge´ Program Manager will encouraged to identify and select a business concern (HUBZone), small recommend an award winner to the broad base of prote´ge´ firms whose core disadvantaged business (SDB), women- Operations Director, A/SDBU. competencies support DOS’s mission. owned small business (WOSB), veteran- (f) Measurement of program success. (2) Mentors may have multiple owned small business (VOSB), and The success of the DOS Mentor-Prote´ge´ prote´ge´. service-disabled veteran-owned small Program will be measured by: (3) The selection of prote´ge´ firms by business (SDVOSB) are the same as (1) The increase in the number and mentor firms may not be protested, found in FAR 2.101. dollar value of contracts awarded to except that any protest regarding the Mentor means a prime contractor that prote´ge´ firms under DOS contracts from size or eligibility status of an entity elects to promote and develop small the date the prote´ge´ enters the program; selected by a mentor shall be handled in business subcontractors by providing (2) The increase in the number and accordance with FAR and SBA developmental assistance designed to dollar value of contracts and regulations. enhance the business success of the subcontracts awarded to the prote´ge´ (j) Application and agreement process prote´ge´. under other Federal agencies and for mentor-prote´ge´ teams to participate Prote´ge´ means a small business, commercial contracts; and, in the program. (1) Firms interested in HUBZone small business, small (3) The developmental assistance becoming a mentor firm shall apply in disadvantaged business, women-owned provided by the mentor firm and the writing to A/SDBU. The application small business, veteran-owned small resulting increase in the technical, (Form DS–4053, Department of State business, or service-disabled veteran- managerial, financial or other Mentor-Prote´ge´ Program Application), owned small business that is the capabilities of the prote´ge´ firm, as shall be evaluated by the nature and recipient of developmental assistance reported by the prote´ge´. extent of technical and managerial pursuant to a mentor-prote´ge´ program. (g) Eligibility of mentor firms. A support proposed as well as the extent (c) Non-affiliation. For purposes of mentor firm: of financial assistance in the form of the Small Business Act, a prote´ge´ firm (1) May be either a large or small equity investment, loans, joint-venture is not considered an affiliate of a mentor business; support, and traditional subcontracting firm solely because the prote´ge´ firm is (2) Must be eligible for award of U.S. support proposed. receiving developmental assistance from Government contracts; (2) A proposed mentor shall submit the mentor firm under the program. (3) Must be able to provide the application form and associated (d) General policy. (1) Eligible developmental assistance that will information to A/SDBU. business prime contractors not included enhance the ability of prote´ge´ to (k) A/SDBU review of application. (1) on the ‘‘List of Parties Excluded from perform as subcontractors; and, A/SDBU shall review the information to Federal Procurement and (4) Will be encouraged to enter into ensure the mentor and prote´ge´ are Nonprocurement Programs’’ that are arrangements with prote´ge´ and firms eligible and the information provided is approved as mentor firms may enter with whom they have established complete. A/SDBU shall consult with into agreements with eligible prote´ge´. business relationships. the contracting officer on the adequacy (2) A firm’s status as a prote´ge´ under (h) Eligibility of prote´ge´ firms. (1) A of the proposed mentor-prote´ge´ a DOS contract shall not have an effect prote´ge´ firm must be: arrangement, and its review shall be on the firm’s ability to seek other prime (i) A SB, HUBZone, SDB, WOSB, complete no later than 30 calendar days contracts or subcontracts. VOSB, or SDVOSB as those terms are after receipt of the application by A/ (e) Incentives for prime contractor defined in FAR 2.101; SDBU. participation. (1) Under the Small (ii) Small in the NAICS code for the (2) Upon completion of the review, A/ Business Act (15 U.S.C. 637(d)(4)(E)), services or supplies to be provided by SDBU will advise the mentor if its DOS is authorized to provide the prote´ge´ to the mentor; and, application is acceptable. The mentor appropriate incentives to encourage (iii) Eligible for award of U.S. may then implement the developmental subcontracting opportunities for small Government contracts. assistance program in accordance with businesses consistent with the efficient (2) Except for SDB and HUBZone the approved agreement. (3) The agreement defines the and economical performance of the firms, a prote´ge´ firm may self-certify to relationship between the mentor and contract. This authority is limited to a mentor firm that it meets the prote´ge´ firms only. The agreement itself negotiated acquisitions. requirements set forth in paragraph (2) Before awarding a contract that (h)(1) of this subsection. Mentors may does not create any privity of contract ´ ´ requires a subcontracting plan, the rely in good faith on written between the mentor or protege and the existence of a mentor-prote´ge´ representations by potential prote´ge´ that DOS. (1) Developmental assistance. The arrangement, and performance, if any, they meet the specified eligibility requirements. SDB status eligibility and forms of developmental assistance a under an existing arrangement, may be ´ ´ documentation requirements are mentor can provide to a protege include: considered by the contracting officer in: (1) Management guidance relating to: (i) Evaluating the quality of a determined by FAR 19.304. HUBZone (i) Financial management; proposed subcontracting plan under status eligibility and documentation (ii) Organizational management; FAR 19.704–5; and, requirements are determined by FAR (iii) Overall business management/ (ii) Assessing the prime contractor’s 19.1303. planning; compliance with the subcontracting (3) Prote´ge´ may have multiple (iv) Business development; and, plans submitted in previous contracts as mentors. prote´ge´ participating in (v) Technical assistance. a factor in determining contractor mentor-prote´ge´ programs in addition to (2) Loans; responsibility under FAR 19.705– DOS’s program should maintain a (3) Rent-free use of facilities and/or 5(a)(1). system for preparing separate reports of equipment;

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(4) Property; (o) Solicitation provision and contract small business concerns are afforded the (5) Temporary assignment of clause. (1) The contracting officer shall maximum practicable opportunity to personnel to prote´ge´ for purpose of insert the provision at 652.219–72, participate as subcontractors. A/SDBU training; and, Department of State Mentor-Prote´ge´ shall recommend to the contracting (6) Any other types of permissible, Program, in all unrestricted solicitations officer changes needed to mutually beneficial assistance. exceeding $500,000 ($1,000,000 for subcontracting plans found to be (m) Obligation. (1) A mentor or construction) that offer subcontracting deficient. prote´ge´ firm may voluntarily withdraw opportunities. I 36. Section 619.705–6–70 is amended from the program. However, in no event (2) The contracting officer shall insert by revising the first sentence in shall such withdrawal impact the the clause at DOSAR 652.219–73, paragraph (b) to read as follows: program mission and contractual Mentor Requirements and Evaluation, in requirements under the prime contract. all contracts where the prime contractor 619.705–6–70 Reporting responsibilities. (2) Mentor and prote´ge´ firms shall has signed a Mentor-Prote´ge´ Agreement * * * * * submit to A/SDBU annual reports on with the Department of State. (b) Contracting officers shall collect program progress of the mentor-prote´ge´ I 32. Subpart 619.7 is amended by subcontracting data from contractors agreements. Large business mentors may revising the subpart heading to read as required to establish subcontracting submit these reports as part of their SB, follows: plans in support of small, small HUBZone, SDB, WOSB, VOSB, and disadvantaged, women-owned small, SDVOSB plan submission in accordance Subpart 619.7—The Small Business HUBZone small, veteran-owned small, with the due date on the SF–295. DOS Subcontracting Program and service-disabled veteran-owned shall consider the following in small business concerns. * * * evaluating these reports: I 33. Section 619.705–1 is revised to (i) Specific actions taken by the read as follows: 619–708–70 [Amended] contractor, during the evaluation period, I 37. Section 619.708–70 is amended by ´ ´ 619.705–1 General support of the removing the words ‘‘and Small to increase the participation of proteges program. as suppliers to the U.S. Government and Disadvantaged Business’’. It is the Department’s policy to to commercial entities; 619.801 [Removed] (ii) Specific actions taken by the incorporate its current fiscal year goals mentor, during the evaluation period, to as negotiated with the SBA into all I 38. Section 619.801 is removed. develop the technical and corporate pertinent Department solicitations, in I 39. Section 619.805–2 is amended by administrative expertise of a prote´ge´ as addition to the standard subcontract adding a new paragraph (a)(2) to read as defined in the agreement; clauses. Incorporation of the goals does follows: (iii) To what extent the prote´ge´ has not require that large prime contractors met the developmental objectives in the must subcontract, but does require that 619.805–2 Procedures. agreement; and, to the extent they plan to subcontract, (a) * * * (iv) To what extent the mentor firm’s specific goals be established for doing (2) In accordance with a waiver participation in the Mentor-Prote´ge´ business with small, small approved by SBA, contract actions for Program resulted in the prote´ge´ disadvantaged, women-owned small, services exceeding $3 million and receiving contract(s) and subcontract(s) HUBZone small, veteran-owned small, supplies exceeding $5 million that from private firms and agencies other and service-disabled veteran-owned supplement the security of U.S. than the DOS. small business firms. Where funds are diplomatic posts and protect the lives of (3) The DOS A/SDBU shall submit the available, an incentive clause such as Department personnel may be awarded annual reports to the cognizant that found in FAR 52.219–10, Incentive non-competitively. Contracting officers contracting officer regarding Subcontracting Program, is encouraged. do not need to compete 8(a) acquisitions participating prime contractor(s) I 34. Section 619.705–3 is revised to as stated when those acquisitions performance in the program. read as follows: exceed the 8(a) competition thresholds. (4) Mentor and prote´ge´ firms shall This waiver is in effect for the duration submit an evaluation to the A/SDBU at 619.705–3 Preparing the solicitation. of the national state of emergency as the conclusion of the mutually agreed To further promote the use of small, declared by the President of the United upon program period, the conclusion of disadvantaged, women-owned small, States. If a contracting officer has a the contract, or the voluntary HUBZone small, veteran-owned small, question as to whether a particular withdrawal by either party from the and service-disabled veteran-owned action falls under this waiver, the program, whichever comes first. small business firms by large prime contracting officer should contact A/ (n) Internal controls. (1) A/SDBU shall contractors, contracting officers are SDBU. oversee the program and shall work encouraged to consider the adequacy of * * * * * with the cognizant contracting officer to the subcontracting plans, and/or past achieve program objectives. performance in achieving negotiated PART 622—APPLICATION OF LABOR (2) DOS may rescind approval of an subcontract goals, as part of the overall LAWS TO GOVERNMENT existing Mentor-Prote´ge´ agreement if it evaluation of the technical proposals. ACQUISITION determines that such an action is in the I 35. Section 619.705–4 is revised to I 40. Subpart 622.13 is amended by Department’s best interest. The recission read as follows: revising the subpart heading to read as shall be in writing and sent to the follows: mentor and prote´ge´ firms after approval 619.705–4 Reviewing the subcontracting plan. by the A/SDBU Operations Director. Subpart 622.13—Special Disabled Recission of an agreement does not A/SDBU shall review subcontracting Veterans, Veterans of the Vietnam Era, change the terms of the subcontract plans to determine if small, small and Other Eligible Veterans between the mentor and the prote´ge´ or disadvantaged, women-owned small, the prime contractor’s obligations under HUBZone small, veteran-owned small, I 41. Section 622.1303 is redesignated its subcontracting plan. and service-disabled veteran-owned as section 622.1305. Newly designated

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622.1305 is amended by revising the PART 625—FOREIGN ACQUISITION Subchapter E—General Contracting citation ‘‘FAR 22.1303’’ at the end of the Requirements sentence to read ‘‘FAR 22.1305.’’ 625.102 [Removed] PART 628—BONDS AND INSURANCE I 42. Section 622.1308 is redesignated I 48. Section 625.102 is removed. as section 622.1310. Newly designated 628.203 [Amended] I 49. A new section 625.103 is added to 622.1310 is amended by revising the read as follows: I 58. Section 628.203 is amended in ‘‘ citation FAR 22.1308(a)(2) and (c)’’ at paragraph (g) by removing the words ‘‘ the end of the sentence to read FAR 625.103 Exceptions. ‘‘Office of the Inspector General’’ and 22.1310(a)(1)(ii) and (a)(2).’’ (a) The authority to make the inserting the words ‘‘Assistant Inspector I 43. A new subpart 622.15, consisting determination prescribed in FAR General for Investigations’’ in their of section 622.1503, is added to read as 25.103(a) is delegated, without power of place. follows: redelegation, to the head of the Subpart 628.70 [Removed] contracting activity. Subpart 622.15—Prohibition of 628.7001 [Removed] Acquisition of Products Produced by I 50. Section 625.105 is revised to read Forced or Indentured Child Labor as follows: I 59. Subpart 628.70, consisting of section 628.7001, is removed. 622.1503 Procedures for acquiring end 625.105 Determining reasonableness of cost. products on the List of Products Requiring PART 630—COST ACCOUNTING Contractor Certification as to Forced or (a)(1) The authority to make the Indentured Child Labor. STANDARDS ADMINISTRATION determinations prescribed in FAR (e) The contracting officer shall refer 25.105(a)(1) is delegated, without power I 60. A new part 630 is added to read to the DOS Inspector General for of redelegation, to the head of the as follows: Investigation any instances where the contracting activity. contracting officer has reason to believe PART 630—COST ACCOUNTING that forced or indentured child labor 625.108 [Removed] STANDARDS ADMINISTRATION was used to mine, produce, or I 51. Section 625.108 is removed. manufacture an end product furnished Subpart 630.2—CAS Program pursuant to a contract awarded subject I 52. Section 625.202 is revised to read Requirements as follows: to the certification required in FAR 630.201 Contract requirements. 22.1503(c). 625.202 Exceptions. 630.201–5 Waiver. PART 623—ENVIRONMENT, ENERGY (a)(1) The authority to make the AND WATER EFFICIENCY, determination prescribed in FAR (a) The Procurement Executive is the head of the agency for the purposes of RENEWABLE ENERGY 25.202(a)(1) is delegated, without power FAR 30.201–5(a) and (b). TECHNOLOGIES, OCCUPATIONAL of redelegation, to the head of the SAFETY, AND DRUG-FREE contracting activity. PART 632—CONTRACT FINANCING WORKPLACE 625.203 [Removed] 632.006–2 [Amended] I 44. Part 623 is amended by revising I 53. Section 625.203 is removed. the heading to read as set forth above. I 61. Section 632.006–2 is amended by I 54. Section 625.204 is revised to read removing the words ‘‘Assistant Inspector Subpart 623.1 [Removed] as follows: General for Investigations’’ and inserting the words ‘‘Procurement Executive’’ in I 45. Subpart 623.1, consisting of 625.204 Evaluating offers of foreign their place. construction material. sections 623.104 and 623.107, is I 62. Subpart 632.4 is amended by removed. (b) The head of the contracting revising the Subpart heading to read as activity is the agency head for the follows: 623.400 [Amended] purposes of FAR 25.204(b). I 46. Section 623.400 is amended by Subpart 632.4—Advance Payments for Subpart 625.3 [Removed] removing the words ‘‘made and/or Non-Commercial Items performed’’ and inserting the word I 632.903 [Removed] ‘‘awarded’’ in their place in the second 55. Subpart 625.3, consisting of sentence. sections 625.300, 625.300–70, 625.302, I 63. Section 632.903 is removed. and 625.304 is removed. I 47. Section 623.404 is revised to read I 64. A new section 632.906 is added to as follows: Subpart 625.7 [Removed] read as follows: 632.906 Making payments. 623.404 Agency affirmative procurement I 56. Subpart 625.7, consisting of programs. section 625.703, is removed. (a) General. The authority to make the (a) The Department’s affirmative determination prescribed in FAR procurement program has been PART 626—OTHER SOCIOECONOMIC 32.906(a) is delegated, without power of established by A/OPE. It is available on PROGRAMS redelegation, to the head of the the A/OPE Internet and Intranet Web contracting activity. Before making this sites at http://www.statebuy.state.gov/ I 57. Part 626, consisting of subpart determination, the head of the green.htm and http://aope.a.state.gov/ 626.2 and section 626.200–70, is contracting activity shall consult with green2.htm, respectively. removed. the appropriate financial office.

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Subchapter F—Special Categories of Security and Antiterrorism Act of 1986 design solicitations exceeding $10 Contracting applies to the following, as determined million; or, diplomatic construction by the Assistant Secretary for projects abroad at any dollar amount PART 636—CONSTRUCTION AND Diplomatic Security: that involve technical security, unless ARCHITECT-ENGINEER CONTRACTS (1) Diplomatic construction or design the project involves low-level I 65. Section 636.101–70 is revised to projects abroad exceeding $10 million; technology, as determined by the read as follows: or, Assistant Secretary of Diplomatic (2) Diplomatic construction projects Security. 636.101–70 Exception. abroad at any dollar amount that 636.602–4 [Removed] Contracts for overseas construction, involve technical security, unless the including capital improvements, project involves low-level technology. I 70. Section 636.602–4 is removed. alterations, and major repairs, may be (b) Exception. This preference shall excepted where necessary from the not apply with respect to any PART 637—SERVICE CONTRACTING provisions of the FAR (48 CFR Chapter diplomatic construction or design project in a foreign country whose I 71. Section 637.102 and section 1) under the authority of section 3 of the 637.102–70 are added to read as follows: Foreign Service Buildings Act of 1926, statutes prohibit the use of United States as amended (22 U.S.C. 294). The contractors on such projects. 637.102 Policy. Director/Chief Operating Officer of the (c) Subcontracting limitation. With 637.102–70 Special requirements for the Bureau of Overseas Buildings respect to a diplomatic construction project, a prime contractor may not acquisition of local guard services Operations is authorized to approve overseas. such exceptions. subcontract more than 50 percent of the total value of the contract for that (a) Policy. Section 136 of the Foreign I 66. Sections 636.104, 636.104–70 and project. Relations Authorization Act, Fiscal 636.104–71, are added to read as I Years 1990 and 1991 (22 U.S.C. 4864) follows: 67. Section 636.202 is added to read as follows: encourages the participation of United 636.104 Policy. States persons and qualified United 636.202 Specifications. States joint venture persons in local 636.104–70 Foreign Service Buildings Act (d) The Director/Chief Operating guard contracts overseas under of 1926, as amended. Officer of the Bureau of Overseas diplomatic security programs. (a) Policy. Section 11 of the Foreign Building Operations is the head of the (b) Evaluation preference. For Service Buildings Act of 1926, as agency for the purposes of FAR purposes of determining competitive amended (22 U.S.C. 302) limits 36.202(d)(3) and (4). status, proposals of United States competition for the construction, I 68. Section 636.513 is amended by persons and qualified United States alteration, or repair of buildings or adding the following sentence to the joint venture persons shall receive a ten grounds abroad exceeding $5 million to: end of paragraph (a): (10) percent price preference reduction. (1) American-owned firms; or (2) Firms from countries which permit 636.513 Accident prevention. 637.104–70 [Amended] or agree to permit substantially equal (a) * * * The contracting officer shall I 72. Section 637.104–70 is amended by access to American firms for comparable confer with OBO/OM/SHEM if there are removing the words ‘‘Office of Foreign diplomatic and consular building any questions on any factors listed in Buildings’’ and inserting the words projects. paragraph (4) of the clause, or if the ‘‘Bureau of Overseas Buildings (b) Limitation. This participation may contracting officer has any questions Operations’’ in their place, and by be permitted by or limited to: regarding construction safety issues. removing the words ‘‘and the Moscow (1) Host-country firms where required I 69. Section 636.570 is added to read Embassy Buildings Control Office’’ in by international agreement; or as follows: paragraph (f). (2) By the laws of the host country; or I 73. Section 637.110 is amended by 636.570 Additional DOSAR provisions. (3) Where determined by the adding a new paragraph (d) to read as Secretary of State to be necessary in the (a) The contracting officer shall insert follows: interest of bilateral relations or the provision at 652.236–71, Foreign necessary to carry out the construction Service Buildings Act, As Amended, in 637.110 Solicitation provisions and project. all contracts exceeding $5,000,000 for contract clauses. (c) Evaluation preference. For the construction, alteration, or repair of * * * * * purposes of determining competitive buildings and grounds overseas, unless: (d) The contracting officer shall insert status, American-owned firms shall (1) An international agreement with the provision at 652.237–73, Statement receive a ten (10) percent price or laws of the host country government of Qualifications for Preference as a U.S. preference reduction, provided that two permits or limits the participation to Person, in all overseas local guard prospective responsible bidders/offerors host-country firms; or, solicitations. submit a bid/offer. (2) The Secretary of State determines I 74. A new Subpart 637.6, consisting of that it is necessary to the interest of section 637.601, is added to read as 636.104–71 Omnibus Diplomatic Security bilateral relations or to carry out the follows: and Antiterrorism Act. project to either permit or limit the (a) Preference for United States participation to host-country firms; or, Subpart 637.6—Performance-Based contractors. The Omnibus Diplomatic (3) The provision at DOSAR 652.236– Contracting Security and Antiterrorism Act of 1986 72 applies. (Public Law 99–399; 22 U.S.C. 4852) (b) The contracting officer shall insert 637.601 General. limits certain construction projects the provision at 652.236–72, Statement It is the Department’s policy that all abroad to United States persons or of Qualifications for the Omnibus new service contracts be performance- qualified United States joint venture Diplomatic Security and Antiterrorism based, with clearly defined deliverables persons. The Omnibus Diplomatic Act, in all diplomatic construction or and performance standards. Any

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deviations from this policy shall be fully (c) Form DS–1771, Contractor Past lllllllllllllllllllll justified in writing and approved by the Performance Evaluation, shall be used (4) Goal for subcontracting to HUBZone Departmental Competition Advocate. only: Firms: (1) When the CPS is temporarily lllllllllllllllllllll Subchapter G—Contract Management (5) Goal for subcontracting to SDVO: unavailable. When the CPS becomes lllllllllllllllllllll PART 642—CONTRACT available, data from any DS–1771 (6) Omnibus goals (if applicable): ADMINISTRATION AND AUDIT created in the interim shall be promptly lllllllllllllllllllll SERVICES entered into the CPS; or (i) 10% to minority business (2) At overseas locations where access (ii) 10% to small business I to the Internet is not practicable. (End of provision) 75. Section 642.271 is redesignated as (d) Heads of contracting activities I 80. Section 652.219–72 is added to section 642.272. A new section 642.271 shall send a list of the names, work read as follows: is added to read as follows: addresses, and phone numbers of all 642.271 Government Technical Monitor acquisition personnel whom they wish 652.219–72 Department of State Mentor- (GTM). to have access to the CPS to A/LM/ Prote´ge´ Program. AQM. As prescribed in 619.202–70(o)(1), (a) Policy. The contracting officer may insert the following provision: appoint a Government Technical PART 651—USE OF GOVERNMENT Monitor (GTM) to assist the Contracting SOURCES BY CONTRACTORS Department of State Mentor-Prote´ge´ Program Officer’s Representative (COR) in (APR 2004) monitoring a contractor’s performance. 651.701 [Amended] (a) Large and small businesses are The contracting officer may appoint a I 77. Section 651.701 is amended by encouraged to participate in the Department GTM because of physical proximity to removing the last sentence of paragraph of State Mentor-Prote´ge´ Program. Mentor ´ ´ the contractor’s work site, or because of firms provide eligible small business proteges (c). with developmental assistance to enhance special skills or knowledge necessary Subchapter H—Clauses and Forms their business capabilities and ability to for monitoring the contractor’s work. obtain Federal contracts. The contracting officer may also appoint PART 652—SOLICITATION (b) Mentor firms are large prime a GTM to represent the interests of PROVISIONS AND CONTRACT contractors or eligible small businesses another requirements office or post CLAUSES capable of providing developmental concerned with the contractor’s work. A assistance. Prote´ge´ firms are small GTM shall be a direct-hire U.S. I 78. Section 652.216–70 is amended by businesses, as defined in 13 CFR parts 121, Government employee. revising the clause date and by revising 124, and 126. (c) Developmental assistance is technical, paragraph (b) to read as follows: I 76. Subpart 642.15, consisting of managerial, financial, and other mutually sections 642.1503 and 642.1503–70, is 652.216–70 Ordering—Indefinite-Delivery beneficial assistance that aids prote´ge´s. Firms added to read as follows: Contract. interested in participating in the program are encouraged to contact the Department of * * * * * Subpart 642.15—Contractor State OSDBU for further information. (End of provision) Performance Information 642.1503 Ordering—Indefinite-Delivery Contract I Procedures. (APR 2004) 81. Section 652.219–73 is added to * * * * * read as follows: 642.1503–70 Contractor Performance (b) The DS–2076, Purchase Order, 652.219–73 Mentor Requirements and System (CPS). Receiving Report and Voucher, and DS–2077, Evaluation. Continuation Sheet. (a) The Department of State subscribes As prescribed in 619.202–70(o)(2), I 79. Section 652.219–70 is revised to to the Contractor Performance System insert the following clause: (CPS) maintained by the National read as follows: Mentor Requirements and Evaluation (APR Institutes of Health. CPS is an Internet- 652.219–70 Department of State 2004) based tool allowing contracting officers Subcontracting Goals. to input past performance information (a) Mentor and prote´ge´ firms shall submit As prescribed in 619.708–70, insert a an evaluation to the Department of State’s and view past performance information provision substantially the same as OSDBU at the conclusion of the mutually input by other contracting officers in follows: agreed upon program period, the conclusion other locations and agencies. of the contract, or the voluntary withdrawal Department of State Subcontracting Goals by either party from the program, whichever (b) All DOS contracting officers with (APR 2004) access to the Internet shall use CPS to occurs first. At the conclusion of each year (a) The offeror shall provide a Small, Small in the mentor-prote´ge´ program, the prime evaluate contractor’s past performance Disadvantaged, Woman-Owned Small, contractor and prote´ge´ will formally brief the for all contracts exceeding $100,000, HUBZone Small, and Service-Disabled Department of State Mentor-Prote´ge´ Program including options. Contracting officers Veteran-Owned Small Enterprise Manager regarding program accomplishments shall also use the CPS to evaluate the Subcontracting Plan that details its approach under their mentor-prote´ge´ agreement. past performance of offerors on all to selecting and using Small, Small (b) A mentor or prote´ge´ shall notify the competitive negotiated acquisitions Disadvantaged, Woman-Owned Small, OSDBU and the contracting officer, in exceeding $100,000, including options, HUBZone Small, and Service-Disabled writing, at least 30 calendar days in advance unless the contracting officer documents Veteran-Owned Small Business Enterprises. of the effective date of the firm’s withdrawal (b) For the fiscal year [insert appropriate from the program. A mentor firm shall notify in the contract file why past fiscal year], the Department’s subcontracting the OSDBU and the contracting officer upon performance is not an appropriate goals are as follows: receipt of a prote´ge´’s notice of withdrawal evaluation factor. The CPS may also be (1) Goal for subcontracting to SB: from the program. used for evaluating acquisitions not lllllllllllllllllllll (End of clause) exceeding $100,000 to conform to the (2) Goal for subcontracting to SDB: 652.226–70 [Removed] general principle of considering past lllllllllllllllllllll performance in all acquisitions. (3) Goal for subcontracting to SWB: I 82. Section 652.226–70 is removed.

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652.228–70 [Removed and Reserved] American firms for comparable diplomatic 652.236–72 Statement of Qualifications for I 83. Section 652.228–70 is removed and consular building projects. the Omnibus Diplomatic Security and Antiterrorism Act. and reserved. (b) To qualify as an American-owned firm for purposes of this solicitation, the bidder/ I As prescribed in 636.570(b), insert the 84. Section 652.236–70 is amended— offeror must demonstrate evidence of: I following provision: (a) By revising the date of the clause; (1) Performance of similar construction I (b) By revising paragraph (a)(4) to read work in the United States; and Statement of Qualifications for the Omnibus as set forth below; and, (2) Either— Diplomatic Security and Antiterrorism Act I (c) By revising paragraph (d)(1) to read (i) Ownership in excess of 50% by U.S. (APR 2004) as set forth below: citizens or permanent residents; or (a) This solicitation is subject to Section (ii) Incorporation in the United States for 402 and Section 406(c) of the Omnibus 652.236–70 Accident Prevention. more than three (3) years and employment of Diplomatic Security and Antiterrorism Act of * * * * * U.S. citizens or permanent residents in more 1986 (P.L. 99–399; 22 U.S.C. 4852). The Act limits certain construction projects abroad to Accident Prevention (APR 2004) than half of the company’s permanent full- time professional and managerial positions in United States persons or United States joint (a) * * * the United States. venture persons, and excludes organizations (4) For overseas construction projects, the (c) For purposes of determining that have business arrangements with Libya. contracting officer shall specify in writing competitive status, offers submitted by This Statement of Qualifications shall be additional requirements regarding safety if used to determine if a bidder/offeror meets American-owned firms shall be reduced by the work involves: the definition of a ‘‘United States person’’ or ten (10) percent, provided that two (i) Scaffolding; a ‘‘United States joint venture person’’ and (ii) Work at heights above two (2) meters; responsible bidders/offerors submit a bid/ whether they have any business (iii) Trenching or other excavation greater offer. arrangements with Libya that may disqualify than one (1) meter in depth; (d) Evidence of qualification. (1) them from participating in this solicitation. (iv) Earth moving equipment; Performance of similar construction work in (b) Definition. As used in this provision— (v) Temporary wiring, use of portable the United States. The bidder/offeror must U.S. person means a company, partnership, electric tools, or other recognized electrical describe below one or more similar projects or joint venture that the Government hazards. Temporary wiring and portable completed in the United States. For each determines, after consideration of all electric tools require the use of a ground fault project, provide the following information: available information, including but not circuit interrupter (GFCI) in the affected Location: llllllllllllllll limited to that provided by the bidder/offeror circuits; other electrical hazards may also (City and State) lllllllllllll in response to this solicitation, to be require the use of a GFCI; Complexity: lllllllllllllll qualified pursuant to Section 402. (vi) Work in confined spaces (limited exits, lllllllllllllllllllll (c) Representation. The bidder/offeror potential for oxygen less than 19.5 percent or (Office building, etc.) represents as part of its bid/offer that it b combustible atmosphere, potential for solid Type of construction: llllllllll does b does not meet the qualifications as a or liquid engulfment, or other hazards Value of project: lllllllllllll U.S. person as set forth in Section 402 of the considered to be immediately dangerous to Location: llllllllllllllll Act. life or health such as water tanks, transformer (City and State) lllllllllllll [Complete a Statement of Qualifications for vaults, sewers, cisterns, etc.); Complexity: lllllllllllllll Purposes of Determining Status as a U.S. (vii) Hazardous materials—a material with lllllllllllllllllllll Person if the offeror represents that it is a physical or health hazard including but not (Office building, etc.) eligible. See paragraph (d) of this provision.] limited to, flammable, explosive, corrosive, Warning: Any material misrepresentation Type of construction: llllllllll toxic, reactive or unstable, or any operations made in the Statement of Qualifications may Value of project: lllllllllllll which creates any kind of contamination be the basis for disqualification of a bidder/ Location: llllllllllllllll inside an occupied building such as dust offeror and reference for consideration of lllllllllllll from demolition activities, paints, solvents, (City and State) suspension or debarment or for prosecution lllllllllllllll etc.; or Complexity: under Federal law (cf. 18 U.S.C. 1001). (viii) Hazardous noise levels. lllllllllllllllllllll Bidder/offeror qualifications will be (Office building, etc.) * * * * * determined primarily on the basis of Type of construction: llllllllll information submitted in the Statement of (d)* * * Value of project: lllllllllllll (1) Submit a written plan to the contracting Qualifications, including attachments If the bidder/offeror’s participation was as officer for implementing this clause. The thereto, but the Government may, at its a partner or co-venture, indicate the plan shall include specific management or discretion, rely on information contained percentage of the project performed by the technical procedures for effectively elsewhere in the bidder’s/offeror’s bid/ bidder/offeror: lll % controlling hazards associated with the proposal or obtained from other sources. (2) Corporate location or ownership. project; and, (d) Statement of Qualifications for (i) The bidder/offeror certifies that it b is Purposes of Determining Status as a U.S. * * * * * b is not owned in excess of fifty (50) percent Person (22 U.S.C. 4852). A bidder/offeror that I 85. Section 652.236–71 is added to by United States citizens or permanent represents that it is a U.S. person must read as follows: residents. provide the following information. (ii) The bidder/offeror certifies that it b has Statement of Qualifications for Purposes of 652.236–71 Foreign Service Buildings Act, b has not been incorporated in the United Determining Status as a U.S. Person (22 as Amended. States for more than three years and that it U.S.C. 4852) As prescribed in 636.570(a), insert the b employs b does not employ United States Name and address of U.S. person following provision: citizens or permanent residents in more than organization providing this information: half of its permanent full-time professional lllllllllllllllllllll Foreign Service Buildings Act, as Amended and managerial positions in the United lllllllllllllllllllll (APR 2004) States. lllllllllllllllllllll (a) This solicitation is subject to Section 11 (e) By signing this bid/offer, the bidder/ Introduction. Section 402 of the Omnibus of the Foreign Service Buildings Act of 1926, offeror certifies to the best of its knowledge, Diplomatic Security and Antiterrorism Act as amended (22 U.S.C. 302). This statute all of the representations and certifications (Public Law 99–399) provides that a ‘‘United limits competition under this solicitation to: provided in this provision are accurate, States person’’ or a ‘‘qualified United States (1) American-owned firms, as described in current and complete. (End of provision) joint venture’’ must meet certain paragraph (b) of this provision; and, requirements, listed in sections 402(c)(2) and (2) Firms from countries that permit or I 86. Section 652.236–72 is added to (3) of the Act, to be eligible to compete. To agree to permit substantially equal access to read as follows: assist business entities to determine whether

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they qualify as a U.S. person or U.S. joint 2. Section 402(c)(2)(B): ‘‘The term ‘United business for purpose of contractual venture person, guidance is hereby provided. States person’ means a person which—(B) obligations. For ease of reference, the statutory language has its principal place of business in the Issuance date means the date in Block 3 of is quoted immediately before the definitions United States.’’ the Standard Form 1442 accompanying this that apply to it. Space for the required Definitions for purposes of Section 402 solicitation. information is provided immediately determinations of eligibility— Years means calendar years measured from following each definition. Principal place of business means the main day of the month to day of the month. For example, January 1, 2002 through December Note: The Statement of Qualifications shall location of the prospective bidder/offeror. 31, 2002 is one calendar year, as is July 1, provide information correctly applicable to For purposes of this section, a prospective 2002 through July 1, 2003. the U.S. person whose qualifications are bidder/offeror shall identify only one Question 3: being certified, and shall not include principal place of business, and such location shall include at least the offices of (i) On what date was the organization information pertaining to corporate affiliates the chief operating officer and headquarters seeking eligibility incorporated or legally or subsidiaries. Organizations that wish to staff. The named location must be a United organized? ______use the experience or financial resources of States jurisdiction from which a tax return (ii) If this date is less than the required any other legally dependent organization or has been filed or will be filed during the number of years before the issuance date, on individual, including parent companies, calendar year in which the prospective the basis of what documentation does the subsidiaries, or other related organizations, bidder/offeror submits this bid/offer. organization seeking eligibility claim that it must do so by way of a joint venture. A United States means any jurisdiction that has been in business for the requisite period prospective bidder/offeror may be an is one of the fifty States, the District of of time? ______(Identify, and forward individual organization or firm, a formal joint Columbia, a United States territory, a United copies as an Attachment to this Statement. venture in which the co-venturers have States possession, or the Commonwealths of This material may include such items as reduced their arrangement to writing, or a de Puerto Rico and the Northern Mariana certificates of incorporation, partnership facto joint venture where no formal Islands. agreements, resolutions of boards of agreement has been reached, but the offering Question 2(a). The organization seeking directors, etc.). entity relies upon the experience of a related eligibility has its principal place of business 4. Section 402(c)(2)(D): ‘‘The term ‘United U.S. firm that guarantees performance. To be in what city and state? States person’ means a person which has considered a ‘‘qualified United States joint lllllllllllllllllllll performed within the United States or at a United States diplomatic or consular venture person,’’ the joint venture must have Question 2(b). What kind of tax return was establishment abroad administrative and at least one firm or organization that itself or will be filed, and in what jurisdiction, meets all the requirements of a U.S. person technical, professional, or construction during the current calendar year? services similar in complexity, type of listed in Section 402. By signing this bid/ (i) Jurisdiction: llllllllllll proposal, the U.S. person co-venturer agrees construction, and value to the contract being (e.g., federal, state, city) bid.’’ to be individually responsible for (ii) Type of return (e.g., income tax, performance of the contract, notwithstanding Definitions for purposes of Section 402 franchise tax, etc.). Include all that apply: determination of eligibility— the terms of any joint venture agreement. lllllllllllllllllllll Administrative and technical, professional, ‘‘ lllllllllllllllllllll 1. Section 402(c)(2)(A): The term ‘United or construction services means the kind of States person’ means a person which—(A) is 3. Section 402(c)(2)(C): ‘‘The term ‘United work in which the prospective bidder/offeror incorporated or legally organized under the States person’ means a person which has is interested. If the proposed contract is for laws of the United States, including the been incorporated or legally organized in the construction management services, the District of Columbia, and local laws.’’ United States— prospective bidder/offeror will be expected Definitions for purposes of Section 402 (i) for more than 5 (five) years before the to demonstrate construction management determinations of eligibility— issuance date of the invitation for bids or expertise. In general, ‘‘administrative’’ means Incorporated means the successful de jure request for proposals with respect to a the capacity or ability to manage; ‘‘technical’’ incorporation of a business organization construction project under subsection (a)(1); means the specific skills peculiar to the type pursuant to the laws of any United States and, of work required; ‘‘professional’’ means jurisdiction or component thereof. (ii) for more than 2 (two) years before the expert services resulting from advanced Legally organized means the legally issuance date of the invitation for bids or training in the type of work required; and recognized existence of an organization other request for proposals with respect to a ‘‘construction’’ experience if it has not than a de jure corporation (e.g., a construction or design project abroad that directly performed all of the actual partnership) under the laws of any United involves technical security under subsection construction activities. Thus, an entity whose States jurisdiction or component thereof. (a)(2).’’ only construction work experience was Only organizations that have a legal status, Definitions for purposes of Section 402 performed by its legally distinct subsidiary or including the right to bring suit, to sign determinations of eligibility— parent will not be considered to have contracts, and to hold property under the law Has been incorporated or legally organized construction experience. of the jurisdiction where they are doing means that the organization can show Complexity means the physical size and business will qualify as legally organized. A continuity as an ongoing business. technical size and demands of the project. natural person who is a United States citizen Organizations that have changed only their ‘‘Performed’’ means projects that have been acting in his or her entrepreneurial capacity names meet the continuity requirement of fully completed by the prospective bidder/ will be deemed to be a ‘‘person legally this subsection. Organizations that have been offeror and accepted by the owner or other organized’’ within the scope of this bought, sold, merged, or otherwise party to the transaction. Projects still in definition, provided that the prospective substantially altered or enlarged their progress have not yet been performed for bidder/offeror holds all required licenses to principal business activities will have the purposes of this definition. do business in the jurisdiction where he or burden of proving that there have been Type of construction means the overall she is located. ongoing operations by the same business nature of the facilities to be built, including United States means any jurisdiction that entity for the required period of time. If the the kinds of materials to be used. Thus, if the is one of the fifty States, the District of successor entity has acquired all of the assets contract will require the construction of a Columbia, a United States territory, a United and liabilities of the predecessor business multi-story office building, the prospective States possession, or the Commonwealths of and the predecessor business has no further bidder/offeror will be expected to Puerto Rico and the Northern Mariana existence, the successor may claim the demonstrate experience with facilities of this Islands. incorporation date of the predecessor. In any type. Question 1. The organization seeking other circumstance, the prospective bidder/ Value means the total contract price of the eligibility under Section 402 is b offeror must show that the law of the project, not to the profit or loss to the bidder/ incorporated or is b legally organized under jurisdiction in which it operates regards the offeror. the laws of what jurisdiction? prospective bidder/offeror as the complete Within the United States means a United lllllllllllllllllllll successor in interest of the predecessor States jurisdiction that is the place where the

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subject matter of the contract or other citizens in at least 80 percent of the (iii) Individual(s) expected to have primary arrangement was in fact completed. It does supervisory positions on the foreign management oversight responsibility for not mean the place where the contract or buildings office project site.’’ contract if it is awarded: other arrangement was negotiated or signed. Definitions for purposes of Section 402 lllllllllllllllllllll The term ‘‘United States’’ means any determinations of eligibility— (name) jurisdiction that is one of the 50 states, the In the United States refers to those lllllllllllllllllllll District of Columbia, a United States positions that the prospective bidder/offeror (citizenship) territory, a United States possession, or the maintains within all jurisdictions which are Question 6(b): Number of permanent, full- Commonwealth of Puerto Rico and the one of the 50 states, the District of Columbia, time positions in the United States: llll Northern Mariana Islands. a United States territory, a United States Question 6(c): Number of United States Question 4: List on this page, and an possession, or the Commonwealths of Puerto citizens currently employed in permanent, attachment (if necessary), one or more similar Rico and the Northern Mariana Islands. full-time positions in the United States: projects completed by the prospective Permanent, full-time positions means llll bidder/offeror. For each project, provide the positions with the prospective bidder/offeror Question 6(d): Certification of intent to following information: that are intended to be indefinite, as opposed employ U.S. citizens in a minimum of 80 lllllllllllllllllllll to limited, seasonal, or project-duration percent of the supervisory positions Location: periods. The term ‘full-time’ refers to identified by the Government on this project: (City and State, or Country) positions in which the occupants are I so certify: lllllllllllllll lllllllllllllllllllll expected to and ordinarily work 40 hours a (signature) Type of service: week. The term ‘permanent, full-time lllllllllllllllllllll (administrative, etc.) positions’ covers the portion of the (name typed or printed) lllllllllllllllllllll prospective bidder’s/offeror’s workforce that lllllllllllllllllllll Complexity: continues to be employed without regard to (position) (office building, etc.) the fluctuating requirements of production or lllllllllllllllllllll lllllllllllllllllllll projects. (date) Type of construction: Principal management positions refers to 7. Section 402(c)(2)(G): ‘‘The term ‘United lllllllllllllllllllll chief operating officer and those management States person’ means a person which has the Value of project: officials reporting directly to him or her. In existing technical and financial resources in If the prospective bidder/offeror’s the case of a partnership, the term refers to the United States to perform this contract.’’ participation was as a partner or co-venturer, every general partner. In the case of a Definitions for purposes of Section 402 indicate the percentage of the project corporation, the term refers to those officers determinations of eligibility— performed by the prospective offeror: of the corporation who are active in running Existing technical and financial resources ______% its day-to-day operations. Members of means the capability of the prospective 5. Section 402(c)(2)(E): ‘‘The term ‘United corporation boards of directors who do not bidder/offeror to mobilize adequate staffing States person’ means a person which—with have operational responsibilities do not and monetary arrangements from within the respect to a construction project under occupy ‘‘principal management positions’’ United States sufficient to perform the subsection (a)(1)—has achieved a total simply by virtue of their service on the board. contract. Adequate staffing levels may be business volume equal to or greater than the In all cases, the term ‘‘principal management demonstrated by presenting the resumes of value of the project being bid in 3 years of positions’’ also includes the position or current United States citizens and resident the 5-year period before the date specified in positions held by the individual or aliens with skills and expertise necessary for subparagraph (C)(i).’’ individuals who will have primary corporate the work in which the prospective bidder/ Definitions of purposes of Section 402 management oversight responsibility for this offeror is interested or some other indication determination of eligibility— contract if the prospective bidder/offeror is of available United States citizen or 3 years of the 5-year period before the date awarded the contract. Each prospective permanent legal resident human resources. specified in subparagraph (C)(i) means the bidder/offeror is responsible for listing all of Demonstration of adequate financial three to five calendar year period its principal management positions and resources must be issued by entities that are immediately preceding the issuance date of identifying their current occupants by name subject to the jurisdiction of United States this solicitation. and citizenship. courts and have agents located within the Total business volume means the U.S. Supervisory positions means all positions United States for acceptance of service of dollar value of the gross income or receipts with significant authority to direct the work process. reported by the prospective bidder/offeror on of others as well as those for which access Question 7: Submit, as an Attachment to its annual federal income tax returns. to classified or controlled documents is this Statement, materials demonstrating Years means the business year of the required. Such positions will be identified in existing technical and financial resources in prospective bidder/offeror, as reflected on its each contract. the United States. annual federal income tax returns. United States citizen means natural 8. Section 402(c)(3): ‘‘The term ‘qualified Question 5: Please complete the persons with United States citizenship by United States joint venture person’ means a information below for at least three of the virtue either of birth or of naturalization. joint venture in which a United States person five listed years. Question 6(a): The bidder/offeror has the or persons owns at least 51 percent of the The gross receipts for the business year: following staff: assets of the joint venture.’’ (list year and amount). (i) Principal management positions in the Definitions for purposes of Section 402 The gross receipts for the business year: United States: determinations of eligibility— (list year and amount). Assets means tangible and intangible The gross receipts for the business year: Chief Operating Officer: things of value conveyed or made available (list year and amount). lllllllllllllllllllll to the joint venture by the co-venturers. The gross receipts for the business year: (name) Joint venture means a formal or de facto (list year and amount). lllllllllllllllllllll arrangement by and through which two or The gross receipts for the business year: (citizenship) more persons or entities associate for the (list year and amount). (ii) For each individual reporting directly purpose of carrying out the prospective 6. Section 402(c)(2)(F): ‘‘The term ‘United to the above-named Chief Operating Officer, contract. Prospective bidders/offerors are States person’ means a person which—(i) list position, name, and citizenship: advised that a joint venture may not be employs United States citizens in at least 80 lllllllllllllllllllll acceptable to projects requiring a Department percent of its principal management Position: of Defense facility security clearance because positions in the United States; (ii) employs lllllllllllllllllllll each co-venturer may post particular United States citizens in more than half of its Name: problems in obtaining security clearances. To permanent, full-time positions in the United lllllllllllllllllllll be acceptable, all members of a joint venture States; and (iii) will employ United States Citizenship: must be individually and severally liable for

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the full performance of and resolution of any renegotiation of the terms of a loan, and (vi) Contracting Officer’s Representative and all matters arising out of the contract, refinancing an amount owed or owing. (COR); and, notwithstanding any provision of the joint Person means any individual or legal (vii) Contract number. venture agreement of law of the jurisdiction entity, whether U.S. or foreign. (3) DS/ISP/INB shall process and approve under which the joint venture was created. Subcontractors and others who do not have the VAR letter, if appropriate. The approved Question 8(a): The bidder/offeror b is b is a direct contractual relationship with the VAR letter shall be forwarded to the not a joint venture. United States are not covered by this section. contractor for their records. Question 8(b): If the bidder/offeror is a With Libya means transactions between (4) The contractor employee shall hand- joint venture, the U.S. person participant is: any person and the Government of Libya, carry the following documentation to the lllllllllllllllllllll government entities of Libya, or any other Building Pass Office, Department of State, (name) organization wholly owned or effectively 520 23rd Street, courtyard of Columbia Plaza, lllllllllllllllllllll controlled by the Government of Libya. It is Washington, DC: (address) the responsibility of the entity submitting (i) A Department of State sponsorship letter Question 8(c): If the bidder/offeror is a Section 406 information to disclose existing from the COR, addressing the following: joint venture, the names and countries of relationships with the entities that it has (A) The purpose for which the pass is citizenship for all co-venturers are as follows: reasonable grounds to believe are or may be being requested; lllllllllllllllllllll Libyan. In case of doubt or dispute, the (B) The employee’s valid security clearance (name) Department of State shall determine, at its level (reflected on the VAR); lllllllllllllllllllll sole discretion, whether any organization is (C) Contract number and period of (citizenship) a governmental entity of Libya, wholly performance; lllllllllllllllllllll owned by the Government of Libya, or (D) Type of access (24/7, normal business (name) effectively controlled by the Government of hours, escort authority or no escort authority lllllllllllllllllllll Libya. granted); and (citizenship) Certification (E) Expiration date of building pass (1 year lllllllllllllllllllll Based on the foregoing, I hereby certify on or 3 years); (name) behalf of this organization that it b is b is (ii) Letter on company letterhead to lllllllllllllllllllll not doing business with Libya as those terms accompany the application, containing the (citizenship) are used in Section 406(c) of the Omnibus following information: Question 8(d): If the bidder/offeror is a Diplomatic Security and Antiterrorism Act of (A) The purpose for which the pass is joint venture, the U.S. person will own at 1986. being requested; least 51 percent of the assets of the joint (e) Signature: By signing this document, (B) Verification of employment; venture. the offeror indicates that to the best of his or (C) The employee’s valid security clearance I so certify: lllllllllllllll her knowledge, all of the representations and level; and, (signature) certifications provided in response to the (D) Contract number and period of lllllllllllllllllllll questions contained in this Statement of performance; (name typed printed) Qualifications are accurate, current, and (iii) The DS–1838, Request for Building lllllllllllllllllllll complete and that the offeror is aware of the Pass Identification Card. (position) penalty prescribed in 18 U.S.C. 1001 for (b) Contractors working in domestic lllllllllllllllllllll making false statements. facilities where security clearances are not (title) (End of provision) required. 9. Libya. Section 406(c) states ‘‘No person (1) The contractor shall obtain a doing business with Libya may be eligible for I 87. Section 652.237–71 is revised to Department of State building pass for all any contract awarded pursuant to this Act.’’ read as follows: employees performing under this contract Definitions for purposes of Section 406 who require frequent and continuing access eligibility— 652.237–71 Identification/Building Pass. to Department of State facilities. The Bureau Contract awarded establishes a time frame As prescribed in 637.110(b), insert the of Diplomatic Security, Office of Domestic for the bar on doing business with Libya. The following clause. Facilities Protection, shall issue passes. They time during which a relationship with Libya shall be used for the purpose of facility is prohibited begins on the date the Section Identification/Building Pass (APR 2004) access only, and shall not be used for any 406 information is submitted. For bidders/ (a) Contractors working in domestic other purpose. offerors not selected for contract award, the facilities who already possess a security (2) The contractor shall submit the prohibition ceases on the date of award. For clearance. following paperwork, in original, to the the bidder/offeror that is awarded the (1) The contractor shall obtain a Bureau of Diplomatic Security, Information contract, the bar continues through the life of Department of State building pass for all Security Programs Division, Industrial the contract, ending on the date of final employees performing under this contract Security Branch (DS/ISP/INB): acceptance of the work. who require frequent and continuing access (i) SF–85P, Questionnaire for Public Trust Doing business means all transactions of to Department of State facilities. The Bureau Positions; any kind agreed to or performed after the of Diplomatic Security, Office of Domestic (ii) SF–85P/S, Supplemental Questionnaire earlier of the date on which a bid/proposal Facilities Protection, shall issue passes. They for Selected Positions; and, is submitted to the Department of State under shall be used for the purpose of facility (iii) DOS Credit Release, which may be this solicitation or on which the contract, access only, and shall not be used for any obtained from DS/ISP/INB via mail or subcontract, program, or other arrangement other purpose. facsimile. with the Department of State is awarded or (2) The contractor shall submit a Visitor (3) DS/ISP/INB shall conduct a preliminary becomes effective. Any transaction Authorization Request (VAR) Letter to the background check. If the background check is commenced prior to the date of submittal or Bureau of Diplomatic Security, Information favorable, DS/ISP/INB will forward a letter to award and not yet completed must be Security Programs Division, Industrial the company Facility Security Officer (FSO) reported. Transactions that call for continued Security Branch (DS/ISP/INB) on its cleared notifying them that the individual may or future performance shall be disqualifying. employees containing the following proceed to the Building Pass Office to Transactions that have been completely information: continue the badging process. DS/ISP/INB performed but for which payment has not yet (i) Contractor employee’s full name, social will forward a copy of this letter to the been made must be reported, but shall not be security number, and date of birth; Building Pass Office. disqualifying unless any event other than (ii) Contractor’s company name; (4) When a contractor employee is payment of a previously-agreed upon sum (iii) Security clearance level; approved to receive a building pass, he/she occurs. Examples of disqualifying actions (iv) Date the clearance was granted; shall hand-carry the following include any pending litigation arising out of (v) Name of the contractor’s Facility documentation to the Contractor Building business transactions with Libya, Security Officer; Pass Office, Department of State, 520 23rd

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Street, NW., courtyard of Columbia Plaza, ‘‘(APR 2004)’’ and by removing the Statement of Qualifications for Purposes of NW., Washington, DC.: words ‘‘the preceding Friday is Obtaining Preference as a U.S. Person (22 (i) A Department of State sponsorship letter observed; when any such day falls on a U.S.C. 4864) from the COR, addressing the following: Sunday’’ and by inserting the words ‘‘or Name and address of U.S. person or (A) The purpose for which the pass is organization providing this information: being requested; Sunday’’ in their place in the first sentence of paragraph (b). lllllllllllllllllllll (B) Whether or not the employee has a lllllllllllllllllllll valid security clearance; I 89. Section 652.237–73 is added to (C) Contract number and period of read as follows: Introduction. Section 136 of the Foreign performance; Relations Authorization Act for Fiscal Years (D) Type of access (24/7, normal business 652.237–73 Statement of Qualifications for 1990 and 1991, Public Law 101–246 (22 hours, escort authority or no escort authority Preference as a U.S. Person. U.S.C. 4864), as amended, provides that a ‘‘ ‘‘ granted); and United States person’’ or a qualified United As prescribed in 637.110(d), insert the States joint venture’’ must meet certain (E) Expiration date of building pass (1 year following provision: or 3 years); requirements, listed in the Act, to be eligible (ii) DS Form 1838, Request for Building Statement of Qualifications for Preference as for the statutory preference. To assist Pass Identification Card; a U.S. Person (APR 2004) business entities to determine whether they (iii) Letter on company letterhead to qualify as a U.S. person or U.S. joint venture (a) This solicitation is subject to Section person entitled to preference under Section accompany the application, containing the 136 of the Foreign Relations Authorization following information: 136, guidance is hereby provided. Only those Act, Fiscal Years 1990 and 1991 (22 U.S.C. prospective offerors submitting a properly (A) The purpose for which the pass is 4864). The Act encourages the participation being requested; completed and certified Volume 5 with their of United States persons and qualified United initial proposals will be considered in the (B) Verification of employment; States joint venture persons in the provision (C) Whether or not the applicant has a determination of eligibility for assignment of of local guard services overseas, and provides preference as a U.S. person or U.S. joint valid security clearance; and, for a preference for eligible offers. (D) Contract number and period of venture person. For ease of reference, (b) Definitions. As used in this provision— statutory language is quoted immediately performance; Eligible offer means an offer that (1) is (iv) Original SF–85P or a copy of the SF– before the definitions that apply to it. Space otherwise responsive to the solicitation; and for the required information is provided 85P, with an original signature and current (2) contains a fully prepared Statement of immediately following each definition. date; Qualifications (see paragraph (d) of this (v) Original SF–85P/S or a copy of the SF– provision), which upon review is determined Note: The Statement of Qualifications shall 85P/S, with an original signature and current by the Government to meet the requirements provide information correctly applicable to date; of Section 136 for assignment of preference the U.S. person whose qualifications are (vi) Copy of the DOS Credit Release, with as a U.S. person. being certified, and shall not include an original signature and current date; and, Preference means subtraction by the information pertaining to corporate affiliates (vii) Original proof of U.S. citizenship, Government of ten percent (10%) from the or subsidiaries. Organizations that wish to such as a birth certificate or valid U.S. total evaluated price of an offer. use the experience or financial resources of passport. Non-U.S. citizens must submit a U.S. person means a company, partnership, another organization or individual, including valid photo Immigration and Naturalization or joint venture that the Government parent companies, subsidiaries, or local, Service Employment Authorization determines, after consideration of all national or offshore organizations, must do so Document (INS EAD). available information, including but not by way of a joint venture. The contract (5) Applicants shall be fingerprinted at the limited to that provided by the offeror in resulting from this solicitation shall not Building Pass Office and the process for a response to the solicitation, to be qualified allow subcontracting. A prospective offeror building pass shall be initiated. The approval for assignment of preference pursuant to may be a sole proprietorship, a formal joint process shall take at least 48 hours. Section 136. venture in which the co-venturers have Applicants shall not return to the Building (c) Representation. The offeror represents reduced their arrangement to writing, or a de Pass Office until they receive notification as part of its offer that it b is, b is not eligible facto joint venture with no written from DS/ISP/INB that the process is for preference as a U.S. person. [Complete a agreement. To be considered a ‘‘qualified complete. Once DS/ISP/INB receives Statement of Qualifications for Purposes of joint venture person,’’ the joint venture must notification from the Building Pass Office Obtaining Preference as a U.S. Person if the have at least one firm or organization that that a building pass can be issued, DS/ISP/ offeror represents that it is eligible. See itself meets all the requirements of a U.S. INB shall notify the FSO and the COR that paragraph (d) of this provision.] joint venture person listed in Section 136. By the applicant has been approved for initial Warning: Any material misrepresentation signing this proposal, the U.S. person co- contract performance. made in the Statement of Qualifications may venturer agrees to be individually (c) Contractors working in overseas be the basis for disqualification of an offeror responsible for performance of the contract, facilities. Contractors shall submit and reference for consideration of suspension notwithstanding the terms of any joint appropriate documentation to obtain or debarment or for prosecution under venture agreement. building passes as specified in the contract. Federal law (cf. 18 U.S.C. 1001). The 1. Section 136(d)(1): ‘‘The term ‘United (d) All contractor employees, both Government will determine offeror States person’ means a person which—(A) is domestic and overseas, shall wear the passes qualifications primarily on the basis of incorporated or legally organized under the in plain sight at all times while in information submitted in the Statement of laws of the United States, including the laws Department of State buildings. All contractor Qualifications, including Attachments of any State, locality, or the District of employees shall show their passes, where thereto, but the Government may, at its Columbia.’’ appropriate, when entering these buildings discretion, rely on information contained Definitions for purposes of Section 136 and upon request of uniformed guards or any elsewhere in the offeror’s proposal or determinations of eligibility— other authorized personnel. obtained from other sources. Incorporated means the state of legal (e) All passes shall be returned to the COR (d) Statement of Qualifications for recognition as an artificial person that may be upon separation of the employee, or Purposes of Obtaining Preference as a U.S. afforded to a business entity pursuant to the expiration or termination of the contract. Person (22 U.S.C. 4864). An offeror that laws of any United States jurisdiction or Final payment under this contract shall not represents that it is eligible for preference as component thereof. be made until all passes are returned to the a U.S. person must provide the following Legally organized means the state of legal COR. information. This Statement of Qualifications recognition that may be afforded to a (End of clause) must be a complete and certified document, business entity that is other than a and submitted as a separate Volume 5, with corporation pursuant to the laws of any I 88. Section 652.237–72 is amended by all necessary attachments, as defined in United States jurisdiction or component revising the date of the clause to read Section L of this solicitation. thereof. This is the least form of legal

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recognition that will qualify an offeror for substantially altered or enlarged their or other arrangement was in fact completed. this preference. Only those prospective principal business activities will have the The place where the contract or other offerors that have legal status, including the burden of proving that there have been arrangement was negotiated or signed is not right to bring suit, to sign contracts, and to ongoing operations by the same business relevant to this definition. hold property under the law of the entity for the required period of time. If the Question 4: Describe in an Attachment to jurisdiction under which they are doing successor entity has acquired all of the assets this Statement (see L.1.3.5), the qualifying business will qualify as legally organized. A and liabilities of the predecessor entity and similar contracts or other arrangements natural person who is a United States citizen the predecessor entity has no further performed by the prospective offeror. Provide acting in his or her entrepreneurial capacity existence, the successor may claim the required information on a sufficient number will be deemed to be a ‘‘person legally incorporation or legal organization date of of arrangements to show that similar services organized’’ within the scope of this the predecessor. In any other circumstance, have been performed overseas or in the definition, provided that the prospective the prospective offeror must show that the United States. The description must consist offeror holds all required licenses to do law of the jurisdiction in which it operates of the following information on each business in the jurisdiction where he or she regards the prospective offeror as the arrangement, which shall be submitted as an is located. complete successor in interest of the Attachment to this Statement: United States means any jurisdiction that predecessor entity for purpose of contractual Location: (city and state or country). is one of the fifty States, the District of obligations. Type of service: (for example, stationary Columbia, a United States territory, a United Issuance date means the date in Block 5 of guards, roving patrol, quick-reaction force, States possession, or the Commonwealth of the Standard Form 33 accompanying this etc.). Puerto Rico and the Northern Mariana solicitation. Complexity: (type of facilities guarded, and Islands. Years means calendar years measured from number or extent of facilities, number of Question 1. The organization seeking day of the month to day of the month. For guards, etc.). eligibility under Section 136 is b example, January 1, 2002 through December 5. Section 136(d)(1): ‘‘The term ‘United incorporated or is b legally organized under 31, 2002 is one calendar year, as is July 1, States person’ means a person which—(E) the laws of what jurisdiction? 2002 through July 1, 2003. with respect to the contract under subsection lllllllllllllllllllll Question 3: (c) of this section, has achieved a total business volume equal to or greater than the 2. Section 136(d)(1): ‘‘The term ‘United (i) On what date was the organization value of the project being bid in 3 years of States person’ means a person that—(B) has seeking eligibility incorporated or legally the 5-year period before the date specified in its principal place of business in the United organized? subparagraph (C).’’ States.’’ lllllllllllllllllllll (ii) If this date is less than two years before Definitions of purposes of Section 136 Definitions for purposes of Section 136 determination of eligibility— the issuance date, on the basis of what determinations of eligibility— 3 years of the 5-year period before the date documentation does the organization seeking Principal place of business means the specified in subparagraph (C) means the eligibility claim that it has been in business geographic location of the main office or seat three to five calendar year period for the requisite period of time? of management of the prospective offeror. For immediately preceding the issuance date of lllllllllllllllllllll purposes of this Statement, a prospective this solicitation. offeror shall identify only one principal place (Identify, and forward copies as an Total business volume means the U.S. of business, and such location shall include Attachment to this Statement). dollar value of the gross income or receipts ‘‘ at least the offices of the chief operating 4. Section 136(d)(1): The term ‘United reported by the prospective offeror on its officer and headquarters staff. The named States person’ means a person which—(D) annual federal income tax returns. location must be a United States jurisdiction has performed within the United States or Years means calendar years. in which the prospective offeror may bring overseas security services similar in Question 5: Describe in an Attachment to suit and be sued and in which service of complexity to the contract being bid.’’ this Statement (see L.1.3.5), for at least three process shall be accepted. Definitions for purposes of Section 136 of the five twelve-month income tax periods Question 2(a). The organization seeking determination of eligibility— (fiscal years) defined below, the gross eligibility has its principal office in what city Complexity means the physical size or receipts of the organization seeking and state? extent of the effort, as described in Section eligibility. lllllllllllllllllllll B and Exhibit A of this solicitation; (i) The fiscal year ending during the Question 2(b). What kind of tax return was combined with the required quality of the calendar year that includes the date of this or will be filed, and in what jurisdiction, effort as described in Sections C and H of this solicitation. during the current calendar year? The solicitation. (ii) The fiscal year ending in the calendar jurisdiction identified herein need not be the Overseas means within any jurisdiction year immediately prior to the calendar year same jurisdiction identified in Question 2(a). that is not a part of the United States as that includes the date of this solicitation. lllllllllllllllllllll defined below. (iii) The fiscal year ending in the calendar (i) Jurisdiction: Performed means contracts that have been year two years before the calendar year that lllllllllllllllllllll fully completed by the prospective offeror includes the date of this solicitation. (ii) Type of return (e.g., income tax, and accepted by the other party to the (iv) The fiscal year ending in the calendar franchise tax, etc.). Include all that apply: transaction. Contracts still in progress have year three years before the calendar year that lllllllllllllllllllll been performed for purposes of this includes the date of this solicitation. 3. Section 136(d)(1): ‘‘The term ‘United definition if performance in complexity to (v) The fiscal year ending in the calendar States person’ means a person which—(C) the contract being bid has been ongoing for year four years before the calendar year that has been incorporated or legally organized in at least one year. Contracts need not have includes the date of this solicitation. the United States—(i) for more than 2 (two) been with the U.S. Government. An entity will be deemed to have met this years before the issuance date of the Security services means work of a kind as requirement if the total cumulative business invitation for bids or request for proposals to fall within or compare closely with those volume for the three years presented exceeds with respect to the contract under subsection described in the Statement of Work in the contract price at time of award under this (c) of this section.’’ Section C of this solicitation. An entity solicitation for the full term for which prices Definitions for purposes of Section 136 whose only security services experience was are solicited, including any option periods. determinations of eligibility— performed by its legally distinct parent or 6. Section 136(d)(1): ‘‘The term ‘United Has been incorporated or legally organized subsidiary organization will not be States person’ means a person which ‘‘ (F)(i) means that the organization can show considered to have security services employs United States citizens in at least 80 continuity as an ongoing business. experience. percent of its principal management Organizations that have changed only their Within the United States means within the positions in the United States; and (F)(ii) names meet the continuity requirement of legal geographic boundaries of a United employs United States citizens in more than this subsection. Organizations that have been States jurisdiction that is the place where the half of its permanent full-time positions in bought, sold, merged, or otherwise subject matter (e.g., services) of the contract the United States.’’

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Definitions for purposes of Section 136 Name: Question 8(a): The prospective offeror b is determinations of eligibility— lllllllllllllllllllll b is not a joint venture. Full-time (positions) means those Citizenship: Question 8(b): If the prospective offeror is personnel positions in which the occupants (iii) Individual(s) in the United States a joint venture, the U.S. person participant is: are expected to and ordinarily work for 40 or expected to have primary management lllllllllllllllllllll more hours per week. oversight responsibility for contract if it is (name) In the United States refers to those awarded: lllllllllllllllllllll personnel positions that are encumbered as lllllllllllllllllllll (address) of the date of this solicitation and that the (name) Question 8(c): If the prospective offeror is prospective offeror maintains in geographic lllllllllllllllllllll a joint venture, the names and countries of locations within the jurisdictions defined (citizenship) citizenship for all co-venturers are as follows: above as constituting the United States. Question 6(b): Number of permanent, full- lllllllllllllllllllll Permanent (positions) means personnel time, currently encumbered personnel (name) positions that are intended to be indefinite as positions that are located in the United States lllllllllllllllllllll to length of employment, as opposed to (good faith estimates acceptable): lllll (citizenship) limited, seasonal, or project-length personnel Question 6(c): Number of United States lllllllllllllllllllll appointments. citizens currently employed in permanent, (name) Permanent, full-time positions means that full-time positions that are located in the lllllllllllllllllllll portion of the prospective offeror’s workforce United States (good faith estimates (citizenship) that continues to be employed without regard acceptable): lllll lllllllllllllllllllll to the ordinary fluctuations of production or 7. Section 136(d)(1): ‘‘The term ‘United (name) projects. States person’ means a person which—(G) lllllllllllllllllllll Principal management positions means has the existing technical and financial (citizenship) those personnel positions including at least resources in the United States to perform the Question 8(d): If the prospective offeror is the chief executive officer (if any) and the contract.’’ a joint venture, the U.S. person will own at chief operating officer (whether by title or by Definitions for purposes of Section 136 least 51 percent of the assets of the joint function) of the organization seeking determinations of eligibility— venture. eligibility, together with all those Existing technical and financial resources lllllllllllllllllllll management officials who constitute the means technical and financial capability I so certify: (name) highest levels of management authority within the United States to mobilize lllllllllllllllllllll within the organization. In the case of a adequate staffing, equipment and (position) partnership, all general partners are deemed organizational arrangements to perform the lllllllllllllllllllll to hold principal management positions. In contract. Adequate technical resources may (title) the case of a corporation, those officers of the be demonstrated by presenting an (e) Signature: By signing this document, corporation who are principally responsible organization chart, and re´sume´s of current the offeror indicates that to the best of his or for the day-to-day operation of the officers and employees in the United States her knowledge, all of the representations and corporation. Members of corporation boards who possess skills and expertise necessary to certifications provided in response to the of directors do not occupy ‘‘principal provide management and oversight of the questions contained in this Statement of management positions’’ simply by virtue of work. Other indicia will be considered if Qualifications are accurate, current, and their service on the board. In all cases, the offered to demonstrate that the prospective complete and that the offeror is aware of the term ‘‘principal management positions’’ also offeror has available resources in the United penalty prescribed in 18 U.S.C. 1001 for includes the position or positions held by the States adequate to provide home office making false statements. individual or individuals in the United States management and oversight of the work. lllllllllllllllllllll who will have primary corporate Adequate financial resources may be (End of provision) management oversight responsibility for this demonstrated by proof of possession of a 652.242–70 [Amended] contract if the prospective contractor is combination of net worth, bank lines of awarded the contract. credit, or bank guarantees. If lines of credit I 90. Section 652.242–70 is amended by United States citizen means natural or bank guarantees are used to demonstrate removing ‘‘642.271’’ and inserting persons with United States citizenship by adequate financial resources, they must be ‘‘642.272(a)’’ in its place in the clause virtue either of birth or of naturalization. from entities within the United States. prescription. Question 6(a): The organization seeking Question 7: Submit, as an Attachment to eligibility shall list all of its principal this Statement, materials demonstrating 652.242–73 [Amended] management positions and identify the existing technical and financial resources in I 91. Section 652.242–73 is amended by current occupant of each listed position by the United States (see L.1.3.5). removing ‘‘642.271(b)’’ and inserting name and citizenship. Provide the 8. Section 136(d)(2): ‘‘The term ‘qualified information as an Attachment to this United States joint venture person’ means a ‘‘642.272(b)’’ in its place in the clause Statement in the following format: joint venture in which a United States person prescription and in Alternate 1. (i) Principal management positions in the or persons owns at least 51 percent of the United States: assets of the joint venture.’’ PART 653—FORMS Chief Executive Officer (if any): Definitions for purposes of Section 136 653.101–70 [Amended] lllllllllllllllllllll determinations of eligibility— (name) Assets means tangible and intangible I 92. Section 653.101–70 is amended by lllllllllllllllllllll things of value conveyed or made available adding a sentence at the end reading as (citizenship) to the joint venture by the co-venturers. To follows: ‘‘The State Department forms Chief Operating Officer: be qualified for U.S. preference, 51 percent are available through the Department’s lllllllllllllllllllll of the assets of the joint venture must be Intranet Web site at http:// (name) owned by the U.S. person co-venturer(s). arpsdir.a.state.gov/eforms.html.’’ lllllllllllllllllllll Joint venture means a formal or de facto (citizenship) association of two or more persons or entities I 93. Section 653.219–71 is added to (ii) For each additional corporate officer to carry out a single business enterprise for read as follows: having principal responsibility for the day-to- profit, for which purpose they combine their day operations of the corporation, list property, money, effects, skills, and 653.219–71 DOS form DS–4053, ´ ´ position, name, and citizenship. knowledge. To be acceptable, all members of Department of State Mentor-Protege lllllllllllllllllllll a joint venture must be jointly and severally Program Application. Position: liable for full performance and resolution of As prescribed in 619.102–70(i), DS– lllllllllllllllllllll matters arising out of the contract. 4053 is prescribed for use in applying

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for an agreement under the Department Based on the Councils’ recommended 2003 (68 FR 55554, September 26, of State Mentor-Prote´ge´ Program. total allowable catch and the allocation 2003). Subsequently, NMFS determined ratios in the FMP, on April 30, 2001 (66 that the commercial quota for Gulf Subpart 653.3 [Removed] FR 17368, March 30, 2001), NMFS group king mackerel in the northern implemented a commercial quota of Florida west coast subzone was reached I 94. Subpart 653.3, consisting of 2.25 million lb (1.02 million kg) for the and closed that segment of the fishery sections 653.000 and 653.303, is eastern zone (Florida) of the Gulf on November 13, 2003 (68 FR 64820; removed. migratory group of king mackerel. That November 17, 2003). Thus, with this Dated: March 11, 2004. quota is further divided into separate closure, all commercial fisheries for Corey M. Rindner, quotas for the Florida east coast subzone Gulf group king mackerel in the EEZ are Procurement Executive, Bureau of and the northern and southern Florida closed from the U.S./Mexico border Administration, Department of State. west coast subzones. On April 27, 2000, through the southern Florida west coast [FR Doc. 04–8107 Filed 4–12–04; 8:45 am] NMFS implemented the final rule (65 subzone through June 30, 2004, except BILLING CODE 4710–05–P FR 16336, March 28, 2000) that divided for vessels fishing with run-around the Florida west coast subzone of the gillnets in the southern Florida west eastern zone into northern and southern coast subzone. subzones, and established their separate Except for a person aboard a charter DEPARTMENT OF COMMERCE quotas. The quota implemented for the vessel or headboat, during the closure, no person aboard a vessel for which a National Oceanic and Atmospheric southern Florida west coast subzone is 1,040,625 lb (472,020 kg). That quota is commercial permit for king mackerel Administration further divided into two equal quotas of has been issued may fish for Gulf group 520,312 lb (236,010 kg) for vessels in king mackerel in the EEZ in the closed 50 CFR Part 622 each of two groups fishing with hook- zones or subzones. A person aboard a [Docket No. 001005281-00369-02; I.D. and-line gear and run-around gillnets vessel that has a valid charter vessel/ 040704B] (50 CFR 622.42(c)(1)(i)(A)(2)(i)). headboat permit for coastal migratory Under 50 CFR 622.43(a), NMFS is pelagic fish may continue to retain king Fisheries of the Caribbean, Gulf of required to close any segment of the mackerel in or from the closed zones or Mexico, and South Atlantic; Coastal king mackerel commercial fishery when subzones under the bag and possession Migratory Pelagic Resources of the its quota has been reached, or is limits set forth in 50 CFR 622.39(c)(1)(ii) Gulf of Mexico and South Atlantic; projected to be reached, by filing a and (c)(2), provided the vessel is Closure notification at the Office of the Federal operating as a charter vessel or Register. NMFS has determined that the headboat. A charter vessel or headboat AGENCY: National Marine Fisheries commercial quota of 520,312 lb (236,010 that also has a commercial king Service (NMFS), National Oceanic and kg) for Gulf group king mackerel for mackerel permit is considered to be Atmospheric Administration (NOAA), vessels using hook-and-line gear in the operating as a charter vessel or headboat Commerce. southern Florida west coast subzone when it carries a passenger who pays a ACTION: Closure. was reached on April 6, 2004. fee or when there are more than three Accordingly, the commercial hook-and- persons aboard, including operator and SUMMARY: NMFS closes the commercial line fishery for king mackerel in the crew. hook-and-line fishery for king mackerel southern Florida west coast subzone is During the closure, king mackerel in the exclusive economic zone (EEZ) in closed effective 12:01 a.m., local time, from the closed zones or subzones taken the southern Florida west coast April 9, 2004, through June 30, 2004, in the EEZ, including those harvested subzone. This closure is necessary to the end of the fishing year. under the bag and possession limits, protect the Gulf group king mackerel The Florida west coast subzone is that may not be purchased or sold. This resource. part of the eastern zone south and west prohibition does not apply to trade in ° ′ DATES: Effective 12:01 a.m., local time, of 25 20.4 N. lat. (a line directly east king mackerel from the closed zones or April 9, 2004, through June 30, 2004. from the Miami-Dade County, FL subzones that were harvested, landed FOR FURTHER INFORMATION CONTACT: boundary). The Florida west coast ashore, and sold prior to the closure and Mark Godcharles, telephone: 727-570- subzone is further divided into northern were held in cold storage by a dealer or 5727, fax: 727-570-5583, e-mail: and southern subzones. The southern processor. subzone is that part of the Florida west [email protected]. Classification coast subzone which from November 1 SUPPLEMENTARY INFORMATION: The through March 31 extends south and This action responds to the best fishery for coastal migratory pelagic fish west from 25°20.4′ N. lat. to 26°19.8′ N. available information recently obtained (king mackerel, Spanish mackerel, cero, lat.(a line directly west from the Lee/ from the fishery. The Assistant cobia, little tunny, dolphin, and, in the Collier County, FL boundary), i.e., the Administrator for Fisheries, NOAA, Gulf of Mexico only, bluefish) is area off Collier and Monroe Counties. (AA), finds good cause to waive the managed under the Fishery From April 1 through October 31, the requirement to provide prior notice and Management Plan for the Coastal southern subzone is that part of the opportunity for public comment Migratory Pelagic Resources of the Gulf Florida west coast subzone which is pursuant to the authority set forth at 5 of Mexico and South Atlantic (FMP). between 26°19.8′ N. lat. and 25°48′ N. U.S.C. 553(b)(B), as such prior notice The FMP was prepared by the Gulf of lat.(a line directly west from the and opportunity for public comment is Mexico and South Atlantic Fishery Monroe/Collier County, FL boundary), unnecessary and contrary to the public Management Councils (Councils) and is i.e., the area off Collier County. interest. Such procedures would be implemented under the authority of the NMFS previously determined that the unnecessary because the rule itself Magnuson-Stevens Fishery commercial quota for king mackerel already has been subject to notice and Conservation and Management Act from the western zone of the Gulf of comment, and all that remains is to (Magnuson-Stevens Act) by regulations Mexico was reached and closed that notify the public of the closure. at 50 CFR part 622. segment of the fishery on September 24, Allowing prior notice and opportunity

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for public comment is contrary to the plans as FMPs, FMP amendments, or December 5, 2003 (68 FR 67998), public interest because of the need to regulations, per the Magnuson-Stevens requesting public comment through immediately implement this action in Act. January 5, 2004. During the Amendment order to protect the fishery since the DATES: Effective May 13, 2004. 16–2 and proposed rule comment capacity of the fishing fleet allows for period, NMFS received four letters of ADDRESSES: Copies of Amendment 16– comment. These letters are addressed rapid harvest of the quota. Prior notice 2 and the final environmental impact later in the preamble to this final rule. and opportunity for public comment statement/regulatory impact review/ The preamble to the proposed rule for will require time and would potentially initial regulatory flexibility analysis this action provides additional result in a harvest well in excess of the (FEIS/RIR/IRFA) are available from background information on the fishery established quota. Donald McIsaac, Executive Director, and on this final rule. Further detail on For the aforementioned reasons, the Pacific Fishery Management Council Amendment 16–2 also appears in the AA also finds good cause to waive the (Council), 7700 NE Ambassador Place, FEIS/RIR/IRFA for this action which 30 day delay in the effectiveness of this Portland, OR 97220, phone: 503–820– was prepared by the Council. action under 5 U.S.C. 553(d)(3). 2280. These documents are also This action is taken under 50 CFR After consideration of the public available online at the Council’s website 622.43(a) and is exempt from review comments received on the amendment, at http://www.pcouncil.org. under Executive Order 12866. NMFS approved Amendment 16–2 on FOR FURTHER INFORMATION CONTACT: Authority: 16 U.S.C. 1801 et seq. January 30, 2004. As required by the Becky Renko (Northwest Region, standards established by Amendment Dated: April 8, 2004. NMFS), phone: 206–526–6150; fax: 206– 16–1, the rebuilding plans adopted Alan D. Risenhoover, 526–6736 or; e-mail: under Amendment 16–2 for lingcod, Acting Director, Office of Sustainable [email protected]. canary rockfish, darkblotched rockfish, Fisheries, National Marine Fisheries Service. SUPPLEMENTARY INFORMATION: and POP specified the following [FR Doc. 04–8352 Filed 4–8–04; 4:15 pm] rebuilding parameters in the FMP: Electronic Access BILLING CODE 3510–22–S unfished biomass (B0) and target The proposed and final rules for this biomass (BMSY), the year the stock action are accessible via the Internet at would be rebuilt in the absence of DEPARTMENT OF COMMERCE the Office of the Federal Register’s fishing (TMIN), the year the stock would website at http://www.gpoaccess.gov/fr/ be rebuilt if the maximum time period National Oceanic and Atmospheric index.html. Background information permissible under national standard Administration and documents are available at the guidelines were applied (TMAX), and the NMFS Northwest Region website at target year in which the stock would be 50 CFR Part 660 http://www.nwr.noaa.gov/1sustfsh/ rebuilt under the adopted rebuilding [Docket No. 031125288–4102–02; I.D. gdfsh01.htm and at the Council’s plan (TTarget). Other information relevant 110303A] website at http://www.pcouncil.org. to rebuilding was also included. The estimated rebuilding parameters will Background RIN 0648–AR35 serve as management benchmarks in the Amendment 16–2 revised the FMP to Fisheries Off West Coast States and in FMP and the FMP will not be amended include overfished species rebuilding the Western Pacific; Pacific Coast if the values for these parameters change plans for lingcod, canary rockfish, Groundfish Fishery; Amendment 16–2 after new stock assessments and darkblotched rockfish, and POP. This rebuilding analyses are completed, as is AGENCY: National Marine Fisheries final rule implements Amendment 16– likely to happen. Service, National Oceanic and 2 by adding two rebuilding parameters, Amendment 16–1 specified two Atmospheric Administration (NOAA), the target year in which the stock would rebuilding parameters, TTARGET and Commerce. be rebuilt under the adopted rebuilding the harvest control rule for the ACTION: Final rule. plan (TTARGET) and the harvest control rebuilding period, that are to be codified rule, to the CFR at 50 CFR 660.370 for in Federal regulations for each SUMMARY: NMFS issues this final rule to each overfished stock. individual species rebuilding plan. This implement Amendment 16–2 to the Amendment 16–2 addressed the final rule adds these rebuilding Pacific Coast Groundfish Fishery requirements of the Magnuson-Stevens parameters to the CFR at 50 CFR Management Plan (FMP). Amendment Act) to protect and rebuild overfished 660.370 for lingcod, canary rockfish, 16–2 amended the FMP to include species managed under a Federal FMP. darkblotched rockfish, and POP. overfished species rebuilding plans for Amendment 16–2 also responded to a TTARGET is the year in which there is a lingcod, canary rockfish, darkblotched Court order in Natural Resources 50–percent likelihood that the stock will rockfish, and Pacific ocean perch (POP) Defense Council, Inc. v. Evans, 168 F. have been rebuilt with a given mortality within the FMP. This final rule adds Supp. 2d 1149 (N.D. Cal 2001,), in rate. The harvest control rule expresses two rebuilding parameters to the Code which NMFS was ordered to provide a given fishing mortality rate that is to of Federal Regulations (CFR) for each Pacific Coast groundfish rebuilding be used over the course of rebuilding. overfished stock, the target year for plans as FMPs, FMP amendments, or These parameters will be used to rebuilding and the harvest control rule. regulations, per the Magnuson-Stevens establish the optimum yields (OYs- Amendment 16–2 addressed the Act. harvest specifications) for species with requirements of the Magnuson-Stevens A Notice of Availability for rebuilding plans. Conservation and Fishery Conservation and Management Amendment 16–2 was published on management goals defined in the FMP Act (Magnuson-Stevens Act) to protect November 7, 2003 (68 FR 63053). NMFS require the Council and NMFS to and rebuild overfished species managed requested comments on the amendment manage to the appropriate OY for each under a Federal FMP. Amendment 16– under the Magnuson-Stevens Act FMP species or species groups, including 2 also responded to a Court order, in amendment review provisions for a 60– those OYs established for rebuilding which NMFS was ordered to provide day comment period, ending January 6, overfished species. The OYs and Pacific Coast groundfish rebuilding 2004. A proposed rule was published on management measures will be set on an

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annual or biennial basis, and will requires the time for rebuilding to be as a reasonable accommodation to meet the address the fisheries as a whole. short as possible, taking into account needs of the fishing communities. Regulations implemented through the certain factors. The Magnuson-Stevens According to the national standard harvest specifications and management Act, section 304 (e)(4)(A), and the guidelines at 50 CFR measures are based on the most recently national standard guidelines at 50 CFR 600.310(e)(ii)(B)(3), if TMIN is 10 years or available scientific information and are 600.310 (e)(4)(A) recognize the greater, ‘‘then the specified time period intended to address all of the fisheries following factors that enter into the for rebuilding TTARGET may be that take groundfish and to keep the specification of a time period for adjusted upward to the extent warranted total catch of groundfish, including rebuilding: the status and biology of the by the needs of fishing communities and overfished species, within their stock or stock complex; interactions recommendations by international respective OYs. The FMP addresses how between stocks or stock complexes and organizations in which the U.S. the fisheries as a whole are to be the marine ecosystem; the needs of participates, except that no such managed, whereas rebuilding plans are fishing communities; recommendations upward adjustment can exceed the species-specific and define the of international organizations in which rebuilding period calculated in the parameters that govern the rebuilding of the U.S. is a participant; and absence of fishing mortality, plus one a particular species. management measures under an mean generation time or equivalent If, after a new stock assessment, the international agreement in which the period based on the species’ life-history Council and NMFS conclude that either U.S. participates. characteristics (TMAX).’’ All of the or both of the parameters defined in According to the national standard rebuilding periods for canary rockfish, regulation should be revised, the guidelines at 50 CFR darkblotched rockfish and POP are less revision will be implemented through 600.310(e)(ii)(B)(2), if the year the stock than TMAX. the Federal rulemaking process, and the would be rebuilt in the absence of The rebuilding probabilities (PMAX, updated values codified in the Federal fishing (TMIN)is 10 years or less, then the which are estimated probabilities of regulations. NMFS believes that the specified time period for rebuilding may rebuilding the stock by TMAX) for canary FMP with the newly added rebuilding be adjusted upward to the extent rockfish, darkblotched rockfish and POP plans will be sufficient ‘‘to end warranted by the needs of fishing range between 60 percent and 80 overfishing in the fishery and to rebuild communities and recommendations of percent. This represents a better than 50 affected stocks of fish’’ (16 U.S.C. international organizations in which the percent likelihood that each of these 1854(e)(3)(A). U.S. is a participant. However, the stocks will be rebuilt (reach the BMSY Amendment 16–2 will be followed by rebuilding period may not exceed 10 biomass) by TMAX, while allowing Amendment 16–3. A notice of intent to years unless international agreements, sufficient access to overfished stocks, so prepare an Environmental Impact which the United States is a party to, that healthy groundfish stocks that co- Statement (EIS) was published on dictate otherwise. occur with overfished species can be September 12, 2003 (68 FR 53712) for Of the four overfished stocks affected harvested. Canary rockfish are relatively Amendment 16–3. If approved, by this rulemaking, lingcod was the unproductive but occur in a wide range Amendment 16–3 will contain only species in which TMIN was of fisheries. The Council chose a rebuilding plans for bocaccio, cowcod, estimated to be 10 years or less. As TTARGET closer to TMAX (reflected in the widow rockfish and yelloweye rockfish. permitted by the Magnuson-Stevens Act relatively lower 60–percent rebuilding The Council is scheduled to take final and the national standard guidelines, probability) in order to allow some action on the Amendment 16–3 the needs of the fishing community bycatch in all of the various fisheries. rebuilding plans at its April 5–9, 2004 were taken into consideration when the The EIS for this amendment has further meeting. The notice of availability of the rebuilding period for lingcod was information regarding the reasons for Draft EIS is scheduled for publication in established that would rebuild the stock the adopted rebuilding periods. June 2004. by 2009. It should be noted, that the Comment 2: Rebuilding target dates difference between the TMIN rebuilding for lingcod and canary rockfish are Comments and Responses year of 2007 (the Maximum based upon a 60 percent probability of NMFS received four letters of Conservation Alternative) and the achieving rebuilding within TMAX. This comment on the proposed rule to rebuilding year of 2009 under Council’s low probability results in target implement Amendment 16–2: three preferred alternative was 2 years. rebuilding dates that are close to TMAX, letters were received from Lingcod are caught in wide range of which leaves little room for environmental advocacy organizations, commercial and recreational fisheries uncertainties in stock status, and one letter was received from the both on the continental shelf and recruitment success, accounting and U.S. Department of the Interior. These nearshore areas. To achieve rebuilding management of fishing mortality and comments are addressed here: by TMIN, management measures would other factors. The rebuilding Comment 1: The proposed target dates need to be designed to prohibit the probabilities for Amendment 16–2 for rebuilding Amendment 16–2 species catch of lingcod until the stock was species should be closer to those are inconsistent with the Magnuson- rebuilt. Any fishery in which bycatch suggested by the Technical Guidance on Stevens Act because the target occurs would need to be curtailed or the Use of the Precautionary rebuilding dates are not as short as eliminated to completely prevent Approaches to Implementing National possible. bycatch of lingcod. The Maximum Standard 1 of the Magnuson-Stevens Response: NMFS believes that the Conservation Alternative which would Fishery Conservation and Management specified rebuilding time periods for the have achieved rebuilding by TMIN, was Act (Technical Guidance). four overfished species are consistent expected to result in a significant Response: As explained above in the with the legal requirements of the adverse socioeconomic impact due to response to comment 1, if TMIN is 10 Magnuson-Stevens Act and with the the reduction in profits, personal years or greater, the national standard national standard guidelines. The income, and employment. NMFS guidelines at 50 CFR Magnuson-Stevens Act does not state believes that choosing the Council- 600.310(e)(ii)(B)(3), allow TTARGET to be that rebuilding must be completed in preferred alternative, which results in a adjusted upward to the extent warranted the shortest time possible, rather it target year for rebuilding of 2009, was by the needs of fishing communities and

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recommendations by international better estimate fleetwide impacts; RecFIN database system. The MRFSS organizations in which the U.S. replacement of the old Marine was not initially designed for the participates, except that no such Recreational Fishery Statistical Survey purpose of estimating catch and effort at upward adjustment can exceed TMAX. (MRFSS) with new and more accurate the level of precision needed for The Technical Guidance recommends statistical surveys; and the management or assessment, rather it that TTARGET be set no higher than the implementation of a vessel monitoring was designed to provide a broad picture midpoint between TMIN and TMAX. program to monitor compliance with look of national fisheries. Comparisons Adopting the midpoint as a binding depth-based management measures. with independent and more precise criterion in all cases would not be NMFS believes that these data estimation procedures has shown wide consistent with the Magnuson-Stevens collection methods and enforcement variance in catch estimates. Inseason Act because it would not allow the mechanisms, which are discussed management of recreational fisheries factors in the Act at section 304(e)(4) below, improve the agency’s ability to using MRFSS has been complicated by and the national standard guidelines at monitor and enforce the harvest large inseason variance of catch 50 CFR 600.310(e)(4)(ii), which include management measures specified for the estimates. Washington and Oregon have the needs of fishing communities, to be fishery, and thereby keep the overfished used the MRFSS system as a taken into account. The Technical species within the harvest levels supplement to the port sampling Guidance is not a binding regulation established for rebuilding. programs from which most of their that must be followed; the Technical NMFS recognizes that effective recreational catch estimates are derived. Guidance itself acknowledges that it bycatch accounting and control Because California has had a greater deals only with biological issues, and mechanisms are necessary for staying dependence on MRFSS in estimating not with socioeconomic issues, which within the total catch OYs established their recreational catch, catch estimates fishery management councils must for rebuilding. NMFS agrees with the of California recreational catch have consider, per the Magnuson-Stevens commenter that estimates of catch have varied considerably. Act. improved over time for the commercial In recent years, many efforts have Canary rockfish and lingcod are fishery. Since the inception of the been made to improve the MRFSS caught in a wide range of commercial WCGOP in August 2001, substantial system. In 2001 the Pacific States and recreational fisheries both on the improvements have been made in the Marine Fisheries Commission (PSMFC), continental shelf and nearshore areas. data and models used to estimate fleet- with support from NMFS, began a new The Council recognized the wide discards in commercial fisheries. survey to estimate party/charter boat socioeconomic importance of the Following the release of the first year of (CPFV) fishing effort in California. This fisheries for co-occurring species to WCGOP data in January 2003, NMFS survey differed from the traditional harvesters and communities and incorporated observer program data on MRFSS telephone survey of anglers to recommended target rebuilding periods the bycatch of overfished species into determine CPFV trips by 2-month that would allow the harvest of the the bycatch model. The Council began period. The survey sampled 10 percent healthy stocks while providing a strong to use observer data to inform inseason of the active CPFV fleet each week to likelihood the overfished stocks will groundfish management at its April determine the number of trips taken and recover within the targeted time period. 2003 meeting. For the 2004 fishing year, the anglers carried on each trip. This NMFS agrees with the Council’s NMFS has further revised the bycatch 10–percent sample was then expanded recommended rebuilding goals. model to incorporate discard rates on to make estimates of total angler trips Comment 3: The groundfish fishery both overfished and targeted species, as for Southern California and Northern suffers from a variety of factors that generated by observer data. Because the California. However, increased sampling create uncertainty in the rebuilding second year of the WCGOP increased coverage is needed to improve the process. While estimates of catch have coverage of the limited entry nontrawl precision in estimates necessary for improved over time for the commercial fleet, NMFS plans to further modify the managing for the low OYs of overfished fishery, the recreational fishery catch 2004 bycatch model to incorporate species like canary rockfish and estimates remain problematic. nontrawl data once it has been compiled bocaccio. In any statistical sampling Inadequate enforcement means some into a usable form. The agency expects program, a greater sample size is needed catch is never recorded. A standardized that data from the second year of the to more accurately predict rare events reporting methodology to assess the WCGOP will be incorporated into such as the catch of overfished species. amount and type of bycatch in each inseason groundfish fisheries Therefore, the Council and West Coast West Coast fishery is incomplete. management by the April 2004 Council states requested a different system to Without adequate enforcement and data meeting, and will be used in the replace MRFSS on the West Coast. collection methods, it is unlikely that development of 2005–2006 management NMFS agreed, and a new catch and the total mortality of the four overfished measures. [For further information on effort estimation system is being species will be consistent with the the bycatch model, see the preamble to developed. limits necessary to rebuild these the 2003 and 2004 proposed rules to The MRFSS has been or is being species. implement specifications and phased out on the West Coast. Changes Response: Many recent improvements management measures, 68 FR 936, listed below are expected to result in have been made to the information January 7, 2003, and 69 FR 1380, improved recreational catch estimates. systems used to manage the groundfish January 8, 2004.] Beginning in January 2004, the MRFSS fishery. The improvements that are Recreational catch data are compiled and State of California State Ocean expected to reduce the types of in the Recreational Fisheries Salmon Project were replaced by one all uncertainty identified by the commenter Information Network (RecFIN) database. inclusive survey, the California include: the implementation of a West The types of data compiled in RecFIN Recreational Survey which will sample Coast Groundfish Observer Program include sampled biological data, all fisheries and fishing modes. Since (WCGOP) to collect commercial fishery estimates of landed catch plus discards, July 2003, Oregon has continued to use data to improve discard and total catch and economic data. The MRFSS, which its Oregon Recreational Boat Survey and estimates in the commercial fishery; the includes field surveys and a random- replaced MRFSS with a new inland boat development of a new bycatch model to daily phone survey, has been part of the and shore survey using the state’s angler

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licenses to estimate effort. Since July commingling of overfished and more are necessary to rebuild the stock by 2003, Washington MRFSS has abundant stocks, the varied fisheries controlling harvest mortality, habitat maintained its Ocean Sampling Program that take groundfish all tend to have impacts, or other effects of fishing and replaced Puget Sound MRFSS boat some effect on at least one of the nine activities that are subject to regulation and shore sampling with a new Puget species that has been declared under the biennial process. These Sound Boat Survey. The State’s angler overfished. management measures will be licenses will be used to estimate angler The FMP addresses how the fisheries consistent with any approved rebuilding effort in the Puget Sound. Shore as a whole are to be managed, whereas plan.’’ Most management measures used sampling was discontinued in July rebuilding plans are species-specific in the fishery are described in section 6 2003. RecFIN funds formerly used to and define the parameters that govern of the FMP. The existing emergency rule conduct MRFSS in the three states have the rebuilding of a particular species. for groundfish for January and February been redirected to support, along with The harvest specifications and 2004, (69 FR 13222; January 8, 2004), state funding, the cost of these new management measures, on an annual or implements the first four rebuilding programs. biennial basis, address the fisheries as a plans, and the interim rebuilding In January 2004, NMFS implemented whole. Regulations implemented strategies for the remaining overfished a vessel monitoring program to monitor through the harvest specifications and species for January and February. The compliance with closed and restricted management measures are intended to proposed rule for groundfish for 2004 areas, including the rockfish address all of the fisheries that take (69 FR 1380; January 8, 2004), proposes conservation areas. The Pacific Coast groundfish and include measures to ABCs/OYs and management measures vessel monitoring program consists of implement rebuilding plans for that implement the rebuilding plans. declaration reports and a vessel overfished species. Management The management of overfished species monitoring system (VMS). The measures in these regulatory packages for 2004 is summarized at 69 FR 1380. declaration reports, which aid are based on the most recently available The FMP as a whole provides enforcement in identifying vessels scientific information on the status of direction on rebuilding overfished operating in a closed or restricted area, the various groundfish stocks and species in several places and includes, are reports sent by fishermen before fisheries. in Chapter 6, management measures and leaving port on a fishing trip. The In managing a multi-species fishery, it regulatory programs the Council uses purpose of the declaration report is to is not necessary or practical to include and intends to use to meet its varied identify their intent to legally fish all of the management measures that fishery management responsibilities. within a Rockfish Conservation Area will be used to rebuild a particular Section 6.1 describes a series of (RCA -large-scale depth-related areas overfished species in that species’ management measures that the Council where low overfished rockfish species rebuilding plan. Rebuilding plans will uses to control fishing mortality, are commonly found), the gear that will provide the specific time period and including but not limited to: permits, be used, and the fishery they are fishing mortality rate that management licenses and endorsements; restrictions participating in. The VMS is used to measures implemented under the on trawl mesh size; landing limits and track an individual vessel’s geographic authority of the FMP be consistent with. trip frequency limits; quotas, including position through a satellite It is important for the FMP as a whole individual transferable quotas; escape communication system. VMS to provide the structure to implement a panels or ports for pot gear or trawl or transceiver units are required aboard all variety of different management other net gear; size limits; bag limits; vessels registered to limited entry measures to rebuild overfished stocks, time/area closures; other forms of effort permits and will be used to track vessel and to manage the fisheries as a whole control including input controls on activity in relation to closed areas in accordance with the Magnuson- fishing gear such as restrictions on trawl within 200 nautical miles along the Stevens Act. Relying on the whole FMP size or longline length or number of Pacific coast. to protect overfished stocks within a hooks or pots; and allocation of species NMFS expects that, taken together, multi-species fishery, does not violate or species groups between fishing these various improvements to the Magnuson-Stevens Act. sectors. Section 6.2 among other things commercial and recreational fisheries The FMP and its rebuilding plans are authorizes the Council to close fishing monitoring and sampling methodologies sufficient ‘‘to end overfishing in the seasons, either as time/area closures set should greatly improve estimates of fishery and to rebuild affected stocks of pre-season or inseason, in order to total mortality of overfished and other fish’’ (16 U.S.C. 1854(e)(3)(A). They are protect overfished species. Section 6.3 species. neither vague nor meaningless. This of the FMP deals with bycatch Comment 4: Amendment 16–2 does Amendment 16 1 sets out the required management and measures the Council not contain management measures to elements for a rebuilding plan. The FMP has taken in recent years to reduce rebuild overfished species. To ensure states in section 4.6.1.5. that ‘‘OY bycatch. Essential fish habitat (EFH) is rebuilding goals are met, rebuilding recommendations will be consistent addressed in section 6.6. As described plans need to include management with established rebuilding plans and below in the response to this comment, measures to (1) ensure rebuilding targets achievement of their goals and NMFS is in the process of reviewing the are met, (2) account for and reduce objectives. . . . (b) In cases where a stock FMP’s approach to EFH. Nonetheless, it bycatch, (3) reduce impacts of current or stock complex is overfished, Council is the FMP as a whole that sets the fishing on habitats that are important to action will specify OY in a manner that Council’s management philosophies and the overfished stocks and their prey complies with rebuilding plans practices for all groundfish species and species, and (4) aid in the enforcement developed in accordance with Section protects overfished species, not just the of the management measures. 4.5.2.’’ The Plan further states at 5.1.4 specific rebuilding plans for those Response: West Coast groundfish ‘‘For any stock the Secretary has species. fisheries are multi-species fisheries and declared overfished or approaching the The Magnuson-Stevens Act at section the FMP covers over 80 species of fish. overfished condition, or for any stock 303(a) describes the required provisions The four overfished species affected by the Council determines is in need of of any Federal fishery management this action co-occur with many other rebuilding, the Council will implement plan. Sub-paragraph 303(a)(7) requires more abundant stocks. Because of this such periodic management measures as that the FMP describe and identify

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essential fish habitat and ‘‘minimize to protects habitat within the RCAs from http://www.nwr.noaa.gov/1sustfsh/ the extent practicable adverse effects on the effects of groundfish fishing gear. groundfish/eislefh/pseis/. such habitat caused by fishing...’’ Sub- NMFS anticipates that the new EFH EIS NMFS has implemented numerous paragraph 303(a)(11) requires that the will allow the Council to incorporate bycatch reduction measures since the FMP ‘‘establish a standardized reporting more data-rich descriptions of the EFH Council’s approval of Amendment 13 in methodology to assess the amount and of individual groundfish species into its 2000. Through the issuance of exempted type of bycatch occurring in the fishery, groundfish fishery management fishing permits (EFPs), the agency has and include conservation and planning. Section 303(a) of the supported the collection of data needed management measures that, to the Magnuson-Stevens Act requires that the to assess the feasibility of full retention extent practicable and in the following FMP as a whole include a description of measures in the following fisheries: priority: (A) minimize bycatch; and (B) EFH and EFH protection measures. It Pacific whiting, arrowtooth flounder, minimize the mortality of bycatch does not require that each amendment yellowtail rockfish, nearshore flatfish, which cannot be avoided.’’ to the FMP describe EFH and provide and the dogfish fishery. NMFS has also Amendment 11 to the FMP provided EFH protection measures. supported the use of EFPs to test the a description within the FMP of EFH for Amendment 13 to the FMP addressed effectiveness of flatfish selective trawl West Coast groundfish. Amendment 11 bycatch in the West Coast groundfish gears. Shorter-than-year-round fishing was challenged in American Oceans fisheries and was also challenged in seasons have been set for various Campaign v. Daley 183 F. Supp. 2d1 Court, Pacific Marine Conservation species and sectors of the groundfish (D.C.C. 2000), along with challenges to Council, Inc. v. Evans, 200 F. Supp. fleet in order to protect different fisheries managed by the Caribbean, 2d1194 (N.D. Calif. 2002). The Court overfished groundfish species. Gulf of Mexico, New England, and held that Amendment 13 failed to Amendment 14 to the FMP North Pacific Fishery Management establish an adequate bycatch reporting implemented a permit stacking program Councils. For West Coast groundfish, methodology, did not comply with the for the limited entry fixed gear fleet that the Court found that NMFS had not duty to minimize bycatch and bycatch reduced the number of vessels conducted an adequate National mortality, and violated NEPA because participating in the primary sablefish Environmental Policy Act (NEPA) NMFS did not take ‘‘hard look’’ at the fishery by about 40 percent. In 2003, analysis on the effects of fishing on environmental consequences of NMFS implemented a buyback of groundfish EFH. NMFS is in the midst Amendment 13, and failed to consider limited entry trawl vessels and their of drafting an EIS on groundfish EFH a reasonable range of alternatives and permits, reducing the groundfish trawl and plans to release the draft EIS for their environmental consequences. In fleet by about one-third. NMFS has public review in February 2005. Further particular, the Court concluded that implemented gear modification information on this EIS is available at: Amendment 13 failed to establish a requirements that restrict the use of http://www.nwr.noaa.gov/1sustfsh/ standardized reporting methodology trawl gear in rocky habitat and that groundfish/eislefh/efh/. because it failed to establish either a constrain the catching capacity of Amendment 11 described EFH for mandatory or an adequate observer recreational fishing gear. Higher West Coast groundfish based on program. Further, it failed to minimize groundfish landings limits have been information that was available in 1998, bycatch and bycatch mortality because made available for trawl vessels using when the amendment was completed. it failed to include all practicable gear or operating in areas where Since that time, there have been notable management measures in the FMP itself. overfished species are less likely to be increases in funding for EFH research The Court also found a lack of reasoned taken. and improvements in ocean habitat decisionmaking because four specific Implementation of the NMFS WCGOP mapping technologies. These research bycatch reduction measures (fleet size in August 2001 addressed the Court’s and mapping improvements are reduction, marine reserves, vessel order that NMFS implement an informing the drafting of the new EFH incentives, and discard caps) were adequate bycatch assessment DEIS. Until the completion of that DEIS, rejected without consideration on their methodology, which uses a Amendment 11’s descriptions of EFH merits. With respect to NEPA, the EA standardized reporting methodology. for each of the overfished species must prepared for Amendment 13 failed to NMFS believes that the WCGOP serve to characterize species-specific address adequately the ten criteria for comprises an adequate reporting EFH and to inform management an action’s significance set forth in the methodology for estimating the amount measures intended to rebuild those Council on Environmental Quality and type of bycatch occurring in the species. For example, the EFH appendix regulations at 40 CFR 1508.27(b), and fishery. Amendment 16–1 added to Amendment 11 (online at http:// also failed to analyze reasonable provisions to the FMP that made this www.nwr.noaa.gov/1sustfsh/ alternatives, particularly the immediate program mandatory. efhappendix/page1.html) provides implementation of an adequate at-sea In 2002, a bycatch model was first descriptions of the habitats used by the observer program and bycatch reduction used to examine species-to-species 80+ species in the FMP, including the measures. landings limit ratios. Data from this ocean depths where those species are NMFS is in the process of drafting an observer program, from historic observer commonly found. The Council used EIS to address the Court’s requirement programs, and from fishery-dependent these habitat descriptions in the for a new NEPA analysis on bycatch in data are used in the bycatch model for development of Rockfish Conservation the groundfish fisheries and is West Coast groundfish fisheries. Areas (RCAs), which are intended to scheduled to release the draft EIS for WCGOP data are used in analyzing protect the suite of continental and public review through the where and when different sectors of the slope overfished species in waters Environmental Protection Agency on groundfish fleet have targeted and may where they are commonly found. RCAs February 27, 2004. The draft EIS on target groundfish. Each intervening year are primarily intended to protect bycatch provides information necessary since 2002, the bycatch model has been overfished stocks from being to further improve the bycatch modified to incorporate new WCGOP incidentally harvested by vessels reduction program for West Coast data. The bycatch model has been used targeting more abundant species. groundfish fisheries. Further in the development of Rockfish Closure of these areas, however, also information on this EIS is available at: Conservation Areas (RCAs - large time/

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area closures that affect the entire West landings inseason. Commercial fisheries recreational fisheries, the Recreational Coast and are specifically designed to landings are monitored by a fish ticket Fisheries Information Network reduce the incidental catch of system managed by the three states. (RecFIN). Estimates of recreational overfished groundfish species in State fish ticket data is compiled by the fisheries catch and landings are fisheries targeting more abundant Pacific States Marine Fisheries available on the internet at http:// stocks) which were implemented Commission (PSMFC). Estimated www.recfin.org/. All three states deploy through 50 CFR 660.304 and the harvest commercial landings amounts are port samplers for at-dock sampling of specifications and management provided to the agencies and the public recreational groundfish fisheries. Even measures. via the Pacific Fisheries Information more so than in commercial fisheries, Comment 5: NMFS should, at a Network (PacFIN). Depending on state recreational fisheries data may not be minimum, include measures to compare funding and staffing levels, groundfish available to fisheries managers until total mortality estimates at the end of landings may be recorded in PacFIN several months after the subject fishing each year with that year’s OY values to anywhere from several days to a few trips have occurred. Because the states determine if any overages have months after the landings have been of Washington and Oregon have smaller occurred. If so, an adjustment should be made. For this reason, fishery managers coastlines and smaller populations than made in the following year’s OY as early must estimate current landings levels of California, they tend to directly sample in that year as possible to compensate a particular species by extrapolating a much greater proportion of their for the overages. Such measures would what we know has already been landed recreational fisheries catch than be consistent with recommendations in out to an estimate based on several California does. the Technical Guidance to make different variables, such as past harvest In past years, California has relied on downward adjustments of subsequent rates in particular months, number of NMFS’ MRFSS for its estimates of year fishing mortality rates in response vessels participating in the fishery in recreational fisheries catch. MRFSS uses to OY overages for overfished species. those months, etc. With the time delays a telephone survey of the general Response: The Magnuson-Stevens Act in this landings monitoring system, the population to determine which persons requires NMFS to annually report to Council does not have fully up-to-date in the population are anglers, and, of the Congress on the status of the fisheries landings information when making its anglers, how much of which species and to identify those fisheries that are inseason adjustments or ABC/OY they are catching and landing. MRFSS overfished or approaching a condition recommendations. was initially designed as an annual of being overfished. Each year, NMFS The state fish ticket system and sampling program that would provide a prepares The Annual Report to Congress PacFIN monitor commercial fisheries snapshot of an entire year’s harvest of on the Status of the Fisheries which landings. These systems do not include different recreational species. Because provides the mandated information and fish taken at sea and lost or discarded. MRFSS was the only tool for estimating also identifies any stocks for which While NMFS monitors total catch levels recreational catch, the Council has used overfishing has occurred. Overfishing through at-sea observer sampling it for inseason management in recent occurs when a stock or stock complex programs, the agency does not have the years. is subjected to a rate of fishing mortality staff, funding, or technology to monitor Recreational fisheries data needs have that jeopardizes the stock’s ability to the thousands of trawl tows and trap increased notably since the Council first produce maximum sustainable yield and longline hauls that result in the began managing the fisheries to rebuild (MSY) on a continuing basis. For West fishery’s total commercial catch. overfished stocks in 2000. All three Coast groundfish, the ABC is set at Instead, NMFS monitors a portion of the states, the Council, and NMFS have FMSY and exceeding the ABC is commercial fleet through observers and been concerned that data generated from overfishing. uses a model based on the observer data MRFSS was not accurate or timely When looking at whether ABC values with fish ticket and other data to enough to support inseason have been exceeded, NMFS also notes estimate total catch for the fleet. management of recreational fisheries. whether OY values have been exceeded In the preamble to the proposed rule Over 2002–2003, the agencies met and works with the Council to revise for the 2004 Annual Specifications and through the PSMFC’s RecFIN Data management measures so as to reduce Management Measures (January 8, 2004, Committee and worked together to the likelihood that OYs for the same 69 FR 1380), NMFS described a bycatch update their monitoring programs so as species will be exceeded in subsequent model that is used both pre-season to to better meet the coastwide need for years. Management measures for healthy develop management measures and improved recreational fisheries catch stocks are intended to achieve OYs inseason to modify management data. PSMFC reported to the Council on without exceeding them, unless the measures. This model is a ‘‘total catch’’ the planned changes to recreational achievement of a particular species’ OY model, i.e. it calculates the total fisheries data gathering in the three would negatively affect the rebuilding of expected catch, not just fish that are states at the Council’s November 2003 a co-occurring overfished species. In actually landed. The model is updated meeting. All three states have such a case, management measures annually with new WCGOP data. eliminated MRFSS as a sampling tool, would be designed to keep the harvest Observer data from the 2001–2002 focusing instead on at-dock sampling under the OY of the healthy stock in fisheries was used to develop 2004 and angler interviews. While California order to rebuild the overfished stock. management measures and discard will continue to use telephone NMFS will continue to monitor whether estimates. NMFS just completed its interviews as one of its data-gathering the fisheries have exceeded acceptable analysis of 2002–2003 WCGOP data methods, its survey population will be biological catches (ABCs) or OYs and (http://www.nwfsc.noaa.gov/research/ licensed California anglers, not the will continue to work with the Council divisions/fram/observers/), and that entire population of the State of to make inseason adjustments to analysis will be available to the Council California. California will also be management measures to prevent the for the development of the 2005–2006 increasing its at-dock sampling presence fisheries from continually exceeding OY fishery specifications and management and providing some on-board target levels. measures. observation of charterboats. Oregon and NMFS, the state fisheries agencies, As with the commercial fisheries, Washington will also be replacing their and the Council monitor fisheries PSMFC maintains a database for MRFSS general-population surveys with

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surveys specific to licensed anglers, and Comment 6: In the preamble to the results with the preamble discussions in with increased at-dock and at-sea proposed rule, NMFS states that the future proposed rules to implement the monitoring. target year for rebuilding should only be harvest specifications and management The Technical Guidance at section 3.4 changed in unusual circumstances, such measures. The harvest specifications states that ’’...Stock rebuilding should be as if, based on new information, the and management measures is a Federal monitored closely so that adjustments rebuilding target is greater than the rulemaking with a notice and comment can be made when rebuilding maximum allowable time frame (TMAX) period. This information will also be milestones are not being met for and if socio-economic reasons dictate available within the annual Stock whatever reason. For example, if target otherwise. These are inappropriate Assessment and Fishery Evaluation rebuilding fishing mortality rates are reasons for changing the target (SAFE) document. As explained earlier exceeded due to quota over-runs, rebuilding date because: (1) Shortening in this document under ‘‘changes from subsequent target fishing mortality rates the rebuilding period to account for a the proposed rule,’’ this final rule should typically be adjusted downwards revised TMAX provides no assurance that implements the most up-to-date to put the stock back on the rebuilding the species will be rebuilt in as short a rebuilding parameters for the four time table.’’ NMFS makes adjustments time as possible, and (2) target Amendment 16–2 overfished species. to OYs after conducting a stock rebuilding dates have already been Any changes to these rebuilding assessment of the population of a lengthened for socio-economic reasons, parameters will be through a notice-and- particular species; these assessments further lengthening target rebuilding comment rulemaking. occur every 2–4 years. (Previously, periods for socio-economic reasons will Comment 8: Amendment 16–2 should NMFS had been on a 3–year stock prevent rebuilding of the overfished be brought into compliance with the assessment cycle. With the adoption of populations. Magnuson-Stevens Act requirement at Amendment 17, the science and Response: NMFS believes that the 304(e)(3)(a) that a rebuilding plan be management cycle has shifted from specified rebuilding time periods for the designed ‘‘to end overfishing in the annual to biennial management. Under four overfished species need to be fishery and to rebuild affected stocks of the biennial management cycle, stock consistent with the legal requirements fish.’’ To do so, rebuilding plans should assessments will be conducted every 2– of the Magnuson-Stevens Act and with include specific conservation and 4 years.) The decisions on which stock the national standard guidelines. If a management measures designed to assessments to do which year will new stock assessment and rebuilding rebuild each species. The EIS for depend on the status of the stocks, and analysis result in a TMAX being a shorter Amendment 16–2 should have included the availability of data and stock duration than that previously predicted, a range of management measures assessment personnel. In the years NMFS would be required to keep alternatives necessary to achieve the between assessments, NMFS and the TTARGET below TMAX. Discussion on proposed rebuilding targets and time Council address over-and under- setting target rebuilding dates can be periods. harvests by adjusting management found in the responses to Comment 1 Response: The rebuilding plans for measures to try to achieve, but not and Comment 2, where we explain the the four overfished species are exceed, OYs of several of the more Magnuson-Stevens Act and the national consistent with the Magnuson-Stevens abundant stocks will, of necessity, not standard guideline requirements Act requirements at 304(e)(3)(a) and, be achieved in order to protect co- regarding rebuilding duration and when considered as part of the FMP as occurring overfished species. factors that may affect the rebuilding a whole, are sufficient to ‘‘to end Stock assessments take harvest period, as well as the Technical overfishing in the fishery and to rebuild overages and underages into account in Guidance recommendations. affected stocks of fish.’’ evaluating the status of a stock and Comment 7: The proposed rule The FMP is the Council’s policy whether rebuilding milestones are being presents the status of each Amendment vehicle for addressing how the fisheries met. New fishing mortality rates set 16–2 stock when it was declared as a whole are to be managed, whereas subsequent to each new stock overfished, but omits the status of those rebuilding plans are species-specific assessment will keep the stock on its species as of their most recent stock and are intended to define the rebuilding trajectory. NMFS does not assessments. Those stock statuses parameters the Council will use to plan to adopt a policy of regularly should be shown, since the rebuilding govern the rebuilding of a particular adjusting ABCs and OYs either inseason parameters provided in the regulations species. The harvest specifications and or annually to account for catch reflect information from the most recent management measures, on an annual or overages or underages from the previous stock assessments. biennial basis, address the fisheries as a year. Such a policy, if carried out over Response: The proposed rule reflects whole. Regulations implemented a period of several years, could result in the rebuilding parameters that were through the harvest specifications and wild fluctuations in harvest levels, adopted by the Council in June 2003. management measures are intended further de-stabilizing fishing These parameters were based on the both to address all of the fisheries that communities. Overages or underages most recent stock assessments that were take groundfish and to implement the will continue to be incorporated into available at that time. Since June 2003, requirements of rebuilding plans. new stock assessments and the new stock assessments and rebuilding Management measures in these appropriate adjustments to fishing analyses were prepared and approved regulatory packages are based on the mortality rates to remain on the by the Council for POP and most recently available scientific rebuilding trajectories will be made at darkblotched rockfish. The most recent information on the status of the various that time. As the Technical Guidance status of each overfished species can be groundfish stocks and fisheries. The notes in several places, its guidance is found in the overfished species section response to Comment 4 further intended to address the biological of the preamble to the proposed rule for describes the components of the FMP aspects of national standard 1 and does the 2004 harvest specifications and that can be used to manage the fishery not incorporate the socio-economic management measures January 8, 2004 and rebuild overfished stocks. considerations addressed by the (69 FR 1380). It is NMFS’s intention to Comment 9: Accounting mechanisms Magnuson-Stevens Act and the other provide the most recent stock must be established to accurately count national standards. assessment and rebuilding analysis bycatch of overfished species and other

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marine life such as the use of an September 2002–August 2003 in early circumstances in which higher levels of observer program with adequate 2004. precision may be desired, particularly coverage, Federal permit or licensing Following the release of the first year when management is needed on fine requirements, or other appropriate data of WCGOP data in January 2003, NMFS spatial or temporal scales; (3) there are collection methods. Bycatch accounting incorporated WCGOP data on the circumstances under which meeting the measures must also ensure that all bycatch of overfished species into the precision goal would not be an efficient sources of mortality data are made bycatch model. The Council began to use of public resources; and (4) there available to the public and incorporated use observer data to inform inseason may be significant logistical constraints into the annual specifications process in groundfish management at its April to achieving the goal.’’ a timely manner. 2003 meeting. For the 2004 fishing year, The ‘‘Evaluating Bycatch’’ report Response: At 16 U.S.C. 1853(a)(11), NMFS has further revised the bycatch characterizes the WCGOP as a the Magnuson-Stevens Act requires that model to incorporate discard rates on ‘‘developing’’ observer program, FMPs, among other things, ‘‘establish a both overfished and targeted species, as meaning that it is a program ‘‘in which standardized reporting methodology to generated by observer data. Because the an established stratification design has assess the amount and type of bycatch second year of the WCGOP increased been implemented and alternative occurring in the fishery...’’ Adequate coverage of the limited entry nontrawl allocation schemes [for observer bycatch accounting is necessary for fleet, NMFS plans to further modify the coverage] are being evaluated to managing a fishery, and for keeping 2004 bycatch model to incorporate optimize sample allocations by strata to total catch within specified OYs. nontrawl data. The agency expects that achieve the recommended goals of An observer program is one means for data from the second year of the precision of bycatch estimates for the obtaining bycatch information in WCGOP will be incorporated into major species of concern.’’ The next step commercial fisheries. In August 2001, inseason groundfish fisheries beyond a developing observer program NMFS implemented the WCGOP which management by the April 2004 Council is a ‘‘mature’’ program ‘‘in which some uses a standardized bycatch reporting meeting, and will be used in the form of an optimal sampling allocation methodology. The availability of the development of 2005–2006 management scheme has been implemented. The WCGOP observer coverage plan was measures. Amendment 16–1 of the FMP program is flexible enough to achieve announced on January 10, 2002 (67 FR added language that made the WCGOP the recommended goals of precision of 1329) and is available via the internet at: a mandatory program for the groundfish bycatch estimates for the major species http://www.nwfsc.noaa.gov/research/ fishery. The commenter also wishes the of concern considering changes in the divisions/fram/observers/. FMP to discuss the scope and adequacy fishery over time.’’ In the first year of the WCGOP of an observer program, whereas the As discussed above, NMFS will be (August 2001–August 2002,) NMFS FMP defers the design of the WCGOP to releasing the second year of observer focused observer coverage largely on the NMFS. data in January 2004. Because observer non-whiting groundfish trawl fleet, with Over the past year, NMFS has been coverage in the groundfish fishery has some pilot effort in the nontrawl limited reviewing the agency’s approach to been largely focused on the trawl entry and open access fleets. Observer standardized bycatch monitoring fishery, NMFS expects that it will have coverage for the nontrawl fleet, programs for all federally managed achieved the NMFS precision goals of particularly for limited entry vessels fisheries. The report, ‘‘Evaluating 20–30 percent CV for estimates of total with sablefish endorsements, expanded Bycatch: A National Approach to discards in the trawl fishery and of 20– during the second year of the observer Standardized Bycatch Monitoring 30 percent CV for estimates of species- program (September 2002–August Programs,’’ is available on the internet specific discards of those overfished 2003). In September 2003, NMFS at: http://www.nmfs.noaa.gov/ species that are commonly taken in the reported to the Council on bycatch bycatch.htm. Also available at that trawl fishery. For overfished species modeling and observer data website is the ‘‘NOAA Fisheries that are either not commonly taken in developments. Objectives, Protocol, and Recommended the trawl fishery, such as yelloweye WCGOP has focused its coverage on Precision Goals for Standardized rockfish, or species that are unavailable the limited entry trawl fleet because that Bycatch Reporting Methodologies.’’ This to the fisheries because of large area fleet annually makes greater than 95 latter report addresses the question of closures, such as cowcod, NMFS percent (by weight) of West Coast the adequacy of an observer program or expects that the current trawl-focused commercial groundfish landings other standardized reporting sampling program will not achieve the coastwide (PacFIN, 1999–2003). Under methodology by setting ‘‘precision 20–30 percent CV precision goal. As it the WCGOP coverage plan, the program goals’’ for monitoring programs. works toward becoming a mature has a goal of 10 percent coverage of According to this report, the levels of observer program, the WCGOP will trawl landings in any one year. With its precision NMFS strives to achieve for likely increase observer coverage of 30–40 observers available each year, the fishery resources caught as bycatch in a nontrawl vessels in order to get a more WCGOP has been able to select each fishery, excluding species protected precise estimate of yelloweye rockfish trawl fleet participant for coverage for at under the ESA or MMPA, is a 20–30 bycatch. For cowcod, a rare event least one cumulative limit period in percent CV [coefficient of variation] for species with large portions of its habitat each year. The observer coverage levels estimates of total discards (aggregated closed to fishing, evaluation of annual are dependent upon the number of over all species) for the fishery; or if mortality may have to take some form vessels actively participating in the total catch cannot be divided into other than a fishery observation fishery and on available program discards and retained catch then the program. funding. Data from the first year of the recommended goal for estimates of total At section 6.3.3, the FMP identifies observer program are available on the catch is a CV of 20–30 percent.’’ In the management need for an observer WCGOP site, mentioned earlier in this setting these precision goals, NMFS program or other bycatch measurement paragraph. NMFS is evaluating data recognizes that ‘‘(1) there are program as an aid for the Council to from the second year of observer intermediate steps in increasing ‘‘better identify and prioritize the coverage and plans to release a data precision which may not immediately bycatch problems in the groundfish report on the WCGOP activities over achieve the goals; (2) there are fishery, based on the expected benefits

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to the U.S. and on the practicality of toward rebuilding goals every two years, as areas of the marine environment addressing these problems.’’ The per the Magnuson-Stevens Act at 16 which have special conservation, Council has used data from WCGOP to U.S.C. 304(e)(7).’’ NMFS’s review of the recreational, ecological, historical, re-shape its landings limits and time/ adequacy of progress on rebuilding cultural, archeological, scientific, area closures. The Council has also used plans will be primarily be done through educational, or esthetic qualities that WCGOP data to evaluate species-to- stock assessment updates and are will improve the conservation, species landings limit ratios, as well as expected to follow the schedule defined understanding, management, and wise species-to species catch ratios in the by the Magnuson-Stevens Act. and sustainable use of marine resources; bycatch model. NMFS expects that the FMP Section 4.5.3.2, Contents of enhance public awareness, WCGOP will continue to meet the Rebuilding Plans, states that generally, understanding, and appreciation of the Council’s need to identify and prioritize ‘‘rebuilding plans will contain ... 4. The marine environment; and maintain for bycatch problems in the groundfish process, and any applicable standards, future generations the habitat, and fishery, and that WCGOP data will that will be used during periodic review ecological services, of the natural continue to directly inform both annual to evaluate progress in rebuilding the assemblage of living resources that and inseason management measures. stock to the target biomass.’’ While inhabit these areas. In January 2004, NMFS implemented adopting these rebuilding plans, the Section 303(a) of the Magnuson- a vessel monitoring program to monitor Council and NMFS realized that Stevens Act requires that the FMP as a compliance with closed areas, including standards for measuring the progress of whole include a description of EFH and the groundfish conservation areas. The rebuilding needed to be refined. EFH protection measures, but does not Pacific Coast vessel monitoring program Therefore, at the Council’s November provide authority to implement marine consists of declaration reports and VMS. 2003 meeting, NMFS asked the sanctuaries. Further, it does not require With VMS, vessels registered to limited Council’s SSC to review and develop that each individual amendment to the entry trawl vessels are required to standards for measuring the progress of FMP describe EFH and provide EFH install and use a mobile transceiver unit rebuilding. NMFS also made this protection measures such as marine whenever the vessel is used to fish in request to the Council in its letter of protected areas. The commenter is state or Federal waters off the west approval for Amendment 16–1 and correct in stating that Amendment 16– coast. The VMS equipment records the reminded the Council of this request in 2 does not contain requirements for vessel’s geographic position and sends it its letter of approval for Amendment marine sanctuaries. However, the to NMFS through a satellite 16–2. In these letters, NMFS commenter is incorrect in then communication system where it is recommended that setting standards for concluding that overfished species are stored in a database. VMS position data measuring the progress of rebuilding not adequately protected by the FMP. can be used in combination with plans be included in the SSC’s Terms of Comment 13: Commercial fisheries observer data to better understand total Reference for the Stock Assessment are causing stock depletion. fishing effort, shifts in fishing effort, and Review (STAR) processes. By including Response: NMFS agrees that potential bycatch levels. the setting of rebuilding plan progress commercial fishing results in fishing Comment 10: Amendment 16–2 does standards in the STAR processes for mortality, as does recreational fishing. not include provisions for the overfished species, the NMFS/Council rebuilding plans of its subject species process for developing and reviewing Declines below the overfished levels in that would set standards for reviewing stock assessments would continue the the 1990s were due in large part to progress toward rebuilding for those link between stock assessments and harvest rate policies that were based on species. This is a requirement of rebuilding plans for overfished species. the best scientific information at the rebuilding plans according to NMFS fully expects that these standards time, but were later discovered to not be Amendment 16–1. NMFS, as the agent will be defined before the Secretary’s sustainable. More recent stock of the Secretary of Commerce, has the review in January 2006 and the assessments indicate that West Coast duty to review rebuilding plans every standards will be included in the groundfish stocks likely have lower two years to ensure adequate progress. Council’s annual SAFE document. levels of productivity than other similar Without established standards for Comment 11: Amendment 16–2 species worldwide. A retrospective determining adequacy of progress and improperly opens the door for use of the analysis determined that harvest rate triggers for modifying rebuilding mixed-stock exception, which is policies in the 1990s, though based on parameters, there is a high probability contrary to the requirements of the the best available information at the that rebuilding plans will ultimately fail Magnuson-Stevens Act. time, were too high to maintain stocks to achieve rebuilding. Response: Amendment 16–2 does not at BMSY. Response: NMFS believes that the open the door for what the commenter A 2000 review of groundfish harvest rebuilding plans under Amendment 16– allege is the ‘‘illegal use of the mixed- rates by the Council’s SSC showed that 2 are consistent with the requirements stock exception.’’ Amendment 16–2 has then-current scientific information of the Magnuson-Stevens Act. The no effect on the mixed-stock exception. indicated both lower than historically Magnuson-Stevens Act requires the Although the mixed-stock exception estimated recruitment levels for West Secretary to review rebuilding plans at currently exists in the national standard Coast groundfish and a corresponding intervals that may not exceed two years. guidelines, the Council has never need for lower than historically used During the Amendment 16–1 process, exercised the exception. Amendment harvest rates. Since 2000, NMFS and the for the purpose of clarity, NMFS worked 16–2 makes no change in the condition Council have set ABCs for groundfish with the Council staff to add a sentence of its possible application. species at more precautionary rates to the FMP at the end of section 4.5.3.6 Comment 12: Marine sanctuaries are (F40% for flatfish, F50% for rockfish, to read, ‘‘Regardless of the Council’s needed where fishing is prohibited. The and F45% for other groundfish such as schedule for reviewing overfished rebuilding policy does not provide sablefish and lingcod). species rebuilding plans, the Secretary enough protection for fish stocks. Comment 14: To ensure rebuilding, of Commerce, through NMFS, is Response: Marine sanctuaries are fishing mortality rates and rebuilding required to review the progress of defined under the National Marine strategies should be upheld even when overfished species rebuilding plans Sanctuaries Act (16 U.S.C. 1431–1445) new information suggests that the stock

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size is increasing more rapidly than the final rule will be revised to F=0.032 rebuilding plans for canary rockfish, expected. from F=0.027. darkblotched rockfish, POP, and lingcod. For each overfished species Response: Rebuilding plans are Classification expected to be revised only when rebuilding plan, the following reviews reveal a significant discrepancy The Administrator, Northwest Region, parameters would be specified in the between current stock status and that NMFS, has determined that Amendment FMP: estimates of unfished biomass (B0) projected in the original rebuilding plan 16–2 is necessary for the conservation and target biomass (BMSY), the year the or in earlier reviews. It is NMFS’s and management of the Pacific Coast stock would be rebuilt in the absence of intention that any changes to rebuilding groundfish fishery and that it is fishing (TMIN), the year the stock would strategies be made during the annual or consistent with the Magnuson-Stevens be rebuilt if the maximum time period biennial setting of harvest specifications Act and other applicable laws. permissible under national standard A Final Environmental Impact and management measures and be guidelines were applied (TMAX) and the established through a Federal Statement (FEIS) for this action was target year in which the stock would be rulemaking with a notice and comment filed with the Environmental Protection rebuilt under the rebuilding plan Agency on December 12, 2003. A notice period. (TTARGETt). No new management of availability for the FEIS was measures are proposed in Amendment Changes From the Proposed Rule published on December 19, 2003 (68 FR 16–2, Amendment 16–1 describes and On January 8, 2004, NMFS published 70795). In approving Amendment 16–2, authorizes the use of numerous types of a proposed rule to implement the 2004 on January 30, 2004, NMFS issued a management measures intended to fishery specifications and management Record of Decision identifying the achieve rebuilding. These management measures January 8, 2004 (69 FR 1380). selected alternative (see ADDRESSES). measures will be implemented through This final rule has been determined to This proposed rule contained revisions the biennial management process and be not significant for purposes of to the harvest control rules for POP and will be used to constrain fishing to the Executive Order 12866. darkblotched rockfish that had targets identified in the rebuilding NMFS prepared a final regulatory originally been published in the plans. flexibility analysis (FRFA) as part of the Amendment 16–2 proposed rule. These The FEIS/RIR/IRFA for this final rule regulatory impact review. The FRFA revisions are now in place under the defines six alternative actions that were incorporates the IRFA, the comments final 2004 fishery specifications and considered for each of the four and responses to the proposed rule, and management measures that were overfished species. The alternatives a summary of the analyses completed to published on March 9, 2004 at 69 FR present a range of rebuilding strategies support the action. A copy of this 11064. in terms of rebuilding probabilities for analysis is available from NMFS (see each species. The no action alternative The POP rebuilding parameters in the ADDRESSES). would be based on the ‘‘40 10 harvest Amendment 16–2 proposed rule were During the comment period for the policy’’, which is the default rebuilding based on a 2000 stock assessment that proposed rule, NMFS received four policy for setting OYs. Under the 40 10 had resulted in a target rebuilding year letters of comment, but none of these harvest policy, stocks with biomass of 2027 and a harvest control rule of comments addressed the IRFA or levels below B40% have OYs set in F=0.0082. The 2004 OY presented in the impacts on small businesses. There are relation to the biomass level. At B40%, 2004 fishery specifications and no recordkeeping, reporting, or other an OY may be set equal to the ABC. management measures was based on a compliance issues forthcoming from However, if a stock’s spawning biomass new stock assessment prepared in 2003. this proposed rule. This rule does not declines below B40%, the OY is scaled Because POP rebuilding parameters duplicate, overlap, or conflict with other downward until at 10 percent (B10%) such as the unfished biomass and BMSY Federal rules. the harvest OY is set at zero unless were updated with the new stock This action is needed because the modified for a species-specific assessment, the POP harvest control rule Magnuson-Stevens Act at 304 (e)(3) rebuilding plan. In comparison to the in the final rule will be revised to requires rebuilding plans for species other alternatives, (except the maximum F=0.0257 from F=0.0082. However, the that have been declared overfished. conservation alternative) the 40 10 target rebuilding year (2027) will remain These plans must be in the form of policy can result in lower OYs in the the same as was announced for POP in FMPs, FMP amendments, or regulations. short term, when a stock is at a low the Amendment 16–2 proposed rule. The objective of this proposed rule is to biomass level, but allow greater harvests Similarly, the darkblotched rockfish implement rebuilding parameters that when a stock is at higher biomass levels. rebuilding parameters in the will result in lingcod, canary rockfish, For further information on the 40 10 Amendment 16–2 proposed rule were darkblotched rockfish and POP stocks policy see the preamble for the annual based on a 2000 stock assessment that returning to their MSY biomass levels. specifications and management had resulted in a target rebuilding year Amendment 16–2 responds to a Court measures published on January 8, of 2030 and a harvest control rule of order in Natural Resources Defense 1999(64 FR 1316) or section 5.3 of the F=0.027. The 2004 OY presented in the Council, Inc. v. Evans, 168 F. Supp. 2d FMP. 2004 fishery specifications and 1149 (N.D. Cal 2001,), in which NMFS The 40–10 policy alternative could management measures was based on a was ordered to provide Pacific Coast require short-term reductions in OYs for new stock assessment that was prepared groundfish rebuilding plans as FMPs, stocks at lower biomass levels than in 2003 and results in the same target FMP amendments, or regulations, per would be required under the other rebuilding year (2030) as was the Magnuson-Stevens Act. On October alternatives, except the maximum announced in the Amendment 16–2 27, 2003, the Court ordered NMFS to conservation alternative. Such proposed rule for the darkblotched approve rebuilding plans for lingcod, reductions could result in reduced rockfish rebuilding plan. However, canary rockfish, darkblotched rockfish, profits, income, and employment in a because other rebuilding parameters and POP by January 31, 2004. wide range of groundfish fisheries over such as the unfished biomass and BMSY Amendment 16–2 follows the a longer period of time than would were updated with the new stock framework established by Amendment occur with the other alternatives. The assessment, the harvest control rule in 16–1 and amends the FMP to include maximum conservation alternative,

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based on a harvest mortality rate of zero, stocks), relaxing this constraint under purchase groundfish, 38 buyers would be in place for each stock until any of the alternatives would allow a purchased groundfish product in excess the individual stock was rebuilt, higher harvest level in some fisheries. of $1,000,000 in 2002. In the 2001 resulting in the target rebuilding period However, fisheries with little or no recreational fisheries, there were 106 for each stock being equal to TMIN. Each canary rockfish bycatch, but with Washington charter vessels engaged in stock could be expected to rebuild bycatch of other overfished species, salt water fishing outside of Puget fastest under this alternative, but at would not necessarily benefit. This Sound, 232 charter vessels active on the considerable socioeconomic cost. alternative was not considered for POP Oregon coast and 415 charter vessels Because canary and darkblotched or lingcod, since they do not constrain active on the California coast. NMFS rockfish are caught in a wide range of stocks in fisheries where they are does not know the proportion of other fisheries, a zero harvest mortality targeted or incidentally caught. The last recreational charter vessel operations rate would likely result in the closure of set of alternatives considered were the that would be considered large other fisheries. The rebuilding of these Council’s preferred alternatives for each businesses, but the agency believes that stocks, even in the absence of fishing, is species and are as follows: lingcod - 60– the majority of these businesses would likely to result in many current percent probability of rebuilding the be considered ‘‘small’’ businesses by the participants in the commercial stock to its MSY biomass by TMAX with SBA. This rule is not expected to yield recreational fisheries as well as a TTARGET of 2009 and a harvest rate of disproportionate economic impacts supporting businesses going out of 0.0531 in the North and 0.0610 in the between those small and large entities. business. The maximum harvest south; canary rockfish - 60–percent Implementation of specific rebuilding alternative for each overfished species probability of rebuilding the stock to its plans may entail substantial economic was based on a 50–percent probability MSY biomass by T with a T MAX TARGET impacts on some groundfish buyers, of rebuilding the stocks to their MSY of 2074 and a harvest rate of 0.0220, commercial harvesters, and recreational biomass levels by T . This alternative darkblotched rockfish - 80 percent MAX operators. The Council preferred would delay rebuilding for the longest probability of rebuilding the stock to its rebuilding alternatives specify annual period of time with the intent of keeping MSY biomass by T with a T MAX TARGET OY levels for the overfished species that harvests at the highest allowable levels of 2030 and a harvest rate of 0.027, and allow some harvest of healthy stocks to for the duration of rebuilding. As a POP - 70 percent probability of result, this alternative would have the rebuilding the stock to its MSY biomass continue and are sufficient to mitigate some of the adverse economic impacts least socioeconomic impact, in the short by TMAX with a TTARGET of 2027 and a term. Delaying the rebuilding period harvest rate of 0.0082. The Council’s on these entities, while not under the maximum harvest alternative preferred alternatives, were taken from compromising the statutory requirement can also be expressed as the level of the range of intermediate alternatives for for timely rebuilding. increased risk to the overfished stocks. each species. This action was developed after Further delay in rebuilding could have Rebuilding parameters associated meaningful consultation and a greater socioeconomic impact than the with PMAX values less than 50 percent collaboration with tribal representatives other alternatives, if currently healthy were considered, but rejected because on the Council who have agreed with stocks were overfished. they were not considered to be the provisions that apply to tribal Intermediate alternatives were compliant with the requirements of the vessels. This action is, therefore, presented only as the rebuilding Magnuson-Stevens Act as interpreted in compliant with Executive Order 13175 parameter values for the harvest rate, a 2000 Federal Court ruling (Natural (Consultation and coordination with PMAX, and TTARGET. While keeping the Resources Defense Council v. Daley, Indian tribal governments). number of alternatives manageable April 25, 2000, U.S. Court of Appeals for (recognizing that the five primary the District of Columbia Circuit, ). A List of Subjects in 50 CFR Part 660 alternatives encompass the full range of mixed stock exception alternative was Administrative practice and reasonable alternatives) these additional considered for darkblotched rockfish, procedure, American Samoa, Fisheries, alternatives were presented in the FEIS but was rejected because the Council Fishing, Guam, Hawaiian Natives, to support decision making and were indicated that it should not be applied Indians, Northern Mariana Islands, structured around 10 percent to darkblotched rockfish. Reporting and recordkeeping increments in PMAX between 60 A fish-harvesting business is requirements. percent and 80 percent for each of the considered a ‘‘small’’ business by the four overfished stocks. The 90 percent Small Business Administration (SBA) if Dated: April 6, 2004. PMAX value was not evaluated because it has annual receipts not in excess of William T. Hogarth, the effects were not significantly $3.5 million. The economic impacts of Assistant Administrator for Fisheries, different from the Maximum implementing these rebuilding plans National Marine Fisheries Service. Conservation Alternative. will be shared among the participants. I For the reasons set out in the The socioeconomic impacts of the Approximately 1,560 vessels participate preamble, 50 CFR part 660 is amended intermediate values fall within the range in the West Coast groundfish fisheries. as follows: of the other alternatives that were fully Of those, about 410 vessels are analyzed in the FEIS analysis. registered to limited entry permits PART 660—FISHERIES] OFF WEST Quantifying the differences between issued for either trawl, longline, or pot COAST STATES AND IN THE these alternatives is difficult given the gear. About 1,150 vessels land WESTERN PACIFIC lack of detailed socioeconomic data. groundfish against open access limits The mixed stock exception alternative while either directly targeting I 1. The authority citation for part 660 would allow higher harvests of canary groundfish or taking groundfish continues to read as follows: rockfish and could be combined with incidentally in fisheries directed at Authority: 16 U.S.C. 1801 et seq. any of alternatives (except the no action nongroundfish species. All but 10 20 of alternative). Since the demands of those vessels are considered small I 2. Section 660.370, ‘‘Overfished rebuilding canary rockfish will affect a businesses by the SBA. Of the 450 species rebuilding plans’’ is revised to range of fisheries, (because it constrains groundfish buyers that regularly read as follows:

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§ 660.370 Overfished species rebuilding Atmospheric Administration (NOAA), fisheries. In accordance with plans. Commerce. § 679.20(d)(1)(iii), the Regional (a) Canary rockfish. The target year for ACTION: Closure. Administrator finds that this directed rebuilding the canary rockfish stock to fishing allowance has been reached. SUMMARY: BMSY is 2074. The harvest control rule NMFS is prohibiting directed Consequently, NMFS is prohibiting to be used to rebuild the canary rockfish fishing for Alaska plaice in the Bering directed fishing for Alaska plaice in the stock is an annual harvest rate of Sea and Aleutian Islands management BSAI. F=0.022. area (BSAI). This action is necessary to Classification (b) Darkblotched rockfish. The target prevent exceeding the 2004 total allowable catch (TAC) of Alaska plaice year for rebuilding the darkblotched This action responds to the best in the BSAI. rockfish stock to BMSY is 2030. The available information recently obtained DATES: harvest control rule to be used to Effective 1200 hrs, Alaska local from the fishery. The Assistant rebuild the darkblotched rockfish stock time (A.l.t.), April 10, 2004, until 2400 Administrator for Fisheries, NOAA, is an annual harvest rate of F=0.032. hrs, A.l.t., December 31, 2004. (AA), finds good cause to waive the (c) Lingcod. The target year for FOR FURTHER INFORMATION CONTACT: Josh requirement to provide prior notice and rebuilding the lingcod stock to BMSY is Keaton, 907–586–7228. opportunity for public comment 2009. The harvest control rule to be SUPPLEMENTARY INFORMATION: NMFS pursuant to the authority set forth at 5 used to rebuild the lingcod stock is an manages the groundfish fishery in the U.S.C. 553(b)(B) as such a requirement annual harvest rate of F=0.0531 in the BSAI exclusive economic zone is impracticable and contrary to the area north of 40°10′ N. lat. and F=0.061 according to the Fishery Management public interest. This requirement is for the area south of 40° 10′ N. lat. Plan for the Groundfish Fishery of the impracticable and contrary to the public (d) Pacific ocean perch (POP). The Bering Sea and Aleutian Islands Area interest as it would prevent the Agency target year for rebuilding the POP stock (FMP) prepared by the North Pacific from responding to the most recent to BMSY is 2027. The harvest control rule Fishery Management Council under fisheries data in a timely fashion and to be used to rebuild the POP stock is authority of the Magnuson-Stevens would delay the closure of Alaska plaice an annual harvest rate of F=0.0257. Fishery Conservation and Management fishery in the BSAI. Act. Regulations governing fishing by [FR Doc. 04–8382 Filed 4–12–04; 8:45 am] The AA also finds good cause to BILLING CODE 3510–22–S U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 waive the 30–day delay in the effective and 50 CFR part 679. date of this action under 5 U.S.C. 553(d)(3). This finding is based upon DEPARTMENT OF COMMERCE The 2004 TAC specified for Alaska plaice in the BSAI is 9,250 metric tons the reasons provided above for waiver of National Oceanic and Atmospheric (mt) as established by the 2004 harvest prior notice and opportunity for public Administration specifications for groundfish of the comment. BSAI (69 FR 9242, February 27, 2004). This action is required by § 679.20 50 CFR Part 679 In accordance with § 679.20(d)(1)(i), and is exempt from review under the Administrator, Alaska Region, Executive Order 12866. [Docket No. 031124287–4060–02; I.D. NMFS (Regional Administrator), has Authority: 16 U.S.C. 1801 et seq. 040604B] determined that the 2004 TAC specified Dated: April 7, 2004. Fisheries of the Exclusive Economic for Alaska plaice will soon be reached. Alan D. Risenhoover, Zone Off Alaska; Alaska Plaice in the Therefore, the Regional Administrator is Bering Sea and Aleutian Islands establishing a directed fishing Acting Director, Office of Sustainable allowance of 6,250 mt, and is setting Fisheries, National Marine Fisheries Service. AGENCY: National Marine Fisheries aside the remaining 3,000 mt as bycatch [FR Doc. 04–8353 Filed 4–8–04; 4:15 pm] Service (NMFS), National Oceanic and to support other anticipated groundfish BILLING CODE 3510–22–S

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Proposed Rules Federal Register Vol. 69, No. 71

Tuesday, April 13, 2004

This section of the FEDERAL REGISTER Administration, Room 550, 1701 Airspace Management, ATA–400, 800 contains notices to the public of the proposed Columbia Avenue, College Park, Georgia Independence Avenue, SW., issuance of rules and regulations. The 30337. Washington, DC 20591, or by calling purpose of these notices is to give interested FOR FURTHER INFORMATION CONTACT: (202) 267–8783. Communications must persons an opportunity to participate in the rule making prior to the adoption of the final Walter R. Cochran, Manager, Airspace identify both docket numbers for this rules. Branch, Air Traffic Division, Federal notice. Persons interested in being Aviation Administration, P.O. Box placed on a mailing list for future 20636, Atlanta, Georgia 30320; NPRMs should contact the FAA’s Office DEPARTMENT OF TRANSPORTATION telephone (404) 305–5586. of Rulemaking, (202) 267–9677, to SUPPLEMENTARY INFORMATION: request a copy of Advisory Circular No. Federal Aviation Administration 11–2A, Notice of Proposed Rulemaking Comments Invited Distribution System, which describes 14 CFR Part 71 Interested parties are invited to the application procedure. participate in this proposed rulemaking [Docket No. FAA–2004–17345; Airspace The Proposal Docket No. 04–ASO–5] by submitting such written data, views or arguments as they may desire. The FAA is considering an Proposed Amendment of Class D and Comments that provide the factual basis amendment to Part 71 of the Federal E Airspace; Goldsboro, NC supporting the views and suggestions Aviation Regulations (14 CFR Part 71) to presented are particularly helpful in AGENCY: amend Class D and E5 airspace at Federal Aviation developing reasoned regulatory Administration (FAA), DOT. Goldsboro, NC. Class D airspace decisions on the proposal. Comments designations for airspace areas ACTION: Notice of proposed rulemaking. are specifically invited on the overall extending upward from the surface of regulatory, aeronautical, economic, SUMMARY: This notice proposes to the earth and Class E airspace environmental, and energy-related amend Class D and E5 airspace at designations for airspace areas aspects of the proposal. Goldsboro, NC. As a result of an extending upward from 700 feet or more Communications should identify both evaluation, it has been determined a above the surface of the earth are docket numbers and be submitted in modification should be made to the published in Paragraphs 5000 and 6005 triplicate to the address listed above. Goldsboro, NC Class D and E5 airspace respectively, of FAA Order 7400.9L, Commenters wishing the FAA to areas to contain the Tactical Air dated September 2, 2003, and effective acknowledge receipt of their comments Navigation (TACAN) or Instrument September 16, 2003, which is on this notice must submit with those Landing System (ILS) Standard incorporated by reference in 14 CFR comments a self-addressed, stamped Instrument Approach Procedures 71.1. The Class D and E airspace postcard on which the following (SIAPs) to Seymour Johnson AFB. designations listed in this document statement is made: ‘‘Comments to Additional surface area airspace is would be published subsequently in the Docket No. FAA–2004–17345/Airspace needed to contain the SIAPs. Order. Docket No. 04–ASO–5.’’ The postcard The FAA has determined that this DATES: Comments must be received on will be date/time stamped and returned proposed regulation only involves a or before May 13, 2004. to the commenter. All communications established body of technical ADDRESSES: Send comments on this received before the specified closing regulations for which frequent and proposal to the Docket Management date for comments will be considered routine amendments are necessary to System, U.S. Department of before taking action on the proposed keep them operationally current. It, Transportation, Room Plaza 401, 400 rule. The proposal contained in this therefore, (1) is not a ‘‘significant Seventh Street, SW., Washington, DC notice may be changed in light of the regulatory action’’ under Executive 20590–0001. You must identify the comments received. A report Order 12866; (2) is not a ‘‘significant docket number FAA–2004–17345/ summarizing each substantive public rule’’ under DOT Regulatory Policies Airspace Docket No. 04–ASO–5, at the contact with FAA personnel concerned and Procedures (44 FR 11034; February beginning of your comments. You may with this rulemaking will be filed in the 26, 1979); and (3) does not warrant also submit comments on the Internet at docket. http://dms.dot.gov. You may review the preparation of a Regulatory Evaluation public docket containing the proposal, Availability of NPRMs as the anticipated impact is so minimal. any comments received, and any final An electronic copy of this document Since this is a routine matter that will disposition in person in the Dockets may be downloaded through the only affect air traffic procedures and air Office between 9 a.m. and 5 p.m., Internet at http://dms.dot.gov. Recently navigation, it is certified that this rule, Monday through Friday, except Federal published rulemaking documents can when promulgated, will not have a holidays. The Docket Office (telephone also be accessed through the FAA’s Web significant economic impact on a 1–800–647–5527) is on the plaza level page at http://www.faa.gov or the substantial number of small entities of the Department of Transportation Superintendent of Document’s Web under the criteria of the Regulatory NASSIF Building at the above address. page at http://www.access.gpo.gov/nara. Flexibility Act. An informal docket may also be Additionally, any person may obtain a List of Subjects in 14 CFR Part 71 examined during normal business hours copy of this notice by submitting a at the office of the Regional Air Traffic request to the Federal Aviation Airspace, Incorporation by reference, Division, Federal Aviation Administration, Office of Air Traffic Navigation (Air).

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The Proposed Amendment DEPARTMENT OF TRANSPORTATION Comments Invited Interested parties are invited to In consideration of the foregoing, the Federal Aviation Administration Federal Aviation Administration participate in this proposed rulemking by submitting such written data, views, proposes to amend 14 CFR Part 71 as 14 CFR Part 71 follows: or arguments as they may desire. [Docket No. FAA–2004–17296; Airspace Comments that provide the factual basis PART 71—DESIGNATION OF CLASS A, Docket No. 04–AEA–03] supporting the views and suggestions CLASS B, CLASS C, CLASS D, AND presented are particularly helpful in CLASS E AIRSPACE AREAS; Proposed Amendment to Class E developing reasoned regulatory AIRWAYS; ROUTES; AND REPORTING Airspace; Lynchburg, VA decisions on the proposal. Comments POINTS are specifically invited on the overall AGENCY: Federal Aviation regulatory, economic, environmental, 1. The authority citation for Part 71 Administration (FAA), DOT. and energy-related aspects of the continues to read as follows: ACTION: Notice of proposed rulemaking. proposal. Communications should Authority: 49 U.S.C. 106(g); 40103, 40113, identify both docket numbers and be 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– SUMMARY: This notice proposes to submitted in triplicate to the address 1963 Comp., p. 389. amend the Class E airspace area at listed above. Commenters wishing the Lynchburg, VA. The development of a § 71.1 [Amended] FAA to acknowledge receipt of their standard Instrument Approach comments on this notice must submit 2. The incorporation by reference in Procedure (SIAP) based on area with those comments a self-addressed, 14 CFR 71.1 of Federal Aviation navigation (RNAV) to serve flights into stamped postcard on which the Administration Order 7400.9L, Airspace Falwell Airport, Lynchburg, VA under following statement is made: Designations and Reporting Points, Instrument Flight Rules (IFR) has made ‘‘Comments to Docket No. FAA–2004– dated September 2, 2003, and effective this proposal necessary. Controlled 17296; Airspace Docket No. 04–AEA– September 16, 2003, is amended as airspace extending upward from 700 03.’’ The postcard will be date/time follows: feet Above Ground Level (AGL) is stamped and returned to the needed to contain aircraft executing the Paragraph 5000 Class D Airspace. commenter. approach. The area would be depicted * * * * * on aeronautical charts for pilot Availability of NPRMs ASO NC D Goldsboro, NC [REVISED] reference. An electronic copy of this document Goldsboro, Seymour Johnson AFB, NC DATES: Comments must be received on may be downloaded through the (Lat. 35°20′22″ N., long. 77°57′38″ W.) or before May 13, 2004. Internet at http://dms.dot.gov. Recently That airspace extending upward from the ADDRESSES: published rulemaking documents can surface to and including 2,600 feet MSL Send comments on the proposal to the Docket Management also be accessed through the FAA’s Web within a 5.7-mile radius of Seymour Johnson page at http://www.faa.gov or the AFB. System, U.S. Department of Superintendent of Documents Web page * * * * * Transportation, Room Plaza 401, 400 Seventh Street, SW., Washington, DC at http://www.access.gpo.gov/nara. Paragraph 6005 Class E Airspace Areas 20590–0001. You must identify the Additionally, any person may obtain Extending Upward From 700 Feet or More docket number FAA–2004–17296; a copy of this notice by submitting a Above the Surface of the Earth. Airspace Docket No. 04–AEA–03 at the request to the Federal Aviation * * * * * beginning of your comments. You may Administration, Office of Air Traffic Airspace Management, ATA–400, 800 ASO NC E5 Goldsboro, NC [REVISED] also submit comments on the Internet at Independence Avenue, SW., Goldsboro, Seymour Johnson AFB, NC http://dms.dot.gov. ° ′ ″ ° ′ ″ You may review the public docket Washington, DC 20591, or by calling (Lat. 35 20 22 N., long. 77 57 38 W.) (202) 267–8783. Communications must Seymour Johnson TACAN (Lat. 35°20′06″ containing the proposal, any comments N., long. 77°58′18″ W.) received, and any final disposition in identify both docket numbers for this Goldsboro-Wayne Municipal Airport person in the Dockets Office between 9 notice. Persons interested in being (Lat. 35°27′38″ N., long. 77°57′54″ W.) a.m. and 5 p.m., Monday through placed on a mailing list for future Mount Olive Municipal Airport Friday, except Federal holidays. The NPRMs should contact the FAA’s Office ° ′ ″ ° ′ ″ (Lat. 35 13 20 N., long. 78 02 16 W.) Docket Office (telephone 1–800–647– of Rulemaking, (202) 267–9677, to That airspace extending upward from 700 5527) is on the plaza level of the request a copy of Advisory Circular No. feet above the surface within a 6.6-mile Department of Transportation NASSIF 11–2A, Notice of Proposed Rulemaking radius of Seymour Johnson AFB and within Building at the above address. Distribution System, which describes 2.5 miles each side of the Seymour Johnson the application procedure. TACAN 265° radial extending from the 6.6- An informal docket may also be mile radius to 12 miles west of the TACAN; examined during normal business hours The Proposal at the office of the Regional Air Traffic within a 5-mile radius of the Goldsboro- The FAA is considering an Wayne Municipal Airport and within a 5- Division, Federal Aviation mile radius of Mount Olive Municipal Administration, Eastern Region, 1 amendment to Part 71 of the Federal Airport. Aviation Plaza, Jamaica, NY 11434– Aviation Regulations (14 CFR Part 71) to amend the Class E airspace area at * * * * * 4809. Lynchburg, VA. The development of a Issued in College Park, Georgia, March 24, FOR FURTHER INFORMATION CONTACT: Mr. SIAP to serve flights operating IFR into 2004. Francis T. Jordan, Jr., Airspace Falwell Airport make this action Jeffrey U. Vincent, Specialist, Airspace Branch, AEA–520, necessary. Controlled airspace Acting Manager, Air Traffic Division, Eastern Region, 1 Aviation Plaza, extending upward from 700 feet AGL is Southern Region. Jamaica, NY 11434–4809, telephone: needed to accommodate the SIAPs. [FR Doc. 04–8358 Filed 4–12–04; 8:45 am] (718) 553–4521. Class E airspace designations for BILLING CODE 4910–13–M SUPPLEMENTARY INFORMATION: airspace areas extending upward from

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700 feet or more above the surface are That airspace extending upward from 700 level of the Frances Perkins Building, published in Paragraph 6005 of FAA feet above the surface within a 6.5-mile U.S. Department of Labor, 200 Order 7400.9L, dated September 2, radius of Lynchburg Regional-Preston Glenn Constitution Avenue, NW., Washington, Field and within 2.7 miles each side of the 2003, and effective September 16, 2003, ° DC. Lynchburg VORTAC 200 radial extending Notice of Intention to Appear at the which is incorporated by reference in 14 from the 6.5-mile radius to 7.4 miles south CFR 71.1. The Class E airspace of the VORTAC and within 3.1 miles each hearing. Notices of Intention to Appear designation listed in this document side of the Lynchburg VORTAC 022° radial at the informal public hearing should be would be published subsequently in the extending from the 6.5-mile radius to 21.3 submitted in triplicate (3 copies) to the Order. miles northeast of the VORTAC and within Docket Office, Docket No. S–025A, The FAA has determined that this a 6-mile radius of Falwell Airport. Room N–2625, OSHA, U.S. Department proposed regulation only involves an * * * * * of Labor, 200 Constitution Avenue, established body of technical NW., Washington, DC 20210. These Issued in Jamaica, New York, on April 5, regulations for which frequent and 2004. notices also may be faxed to the Docket routine amendments are necessary to Office at (202) 693–1648, or submitted John G. McCartney, keep them operationally current. electronically at http:// Therefore, this proposed regulation—(1) Assistant Manager, Air Traffic Division, ecomments.osha.gov. OSHA Docket Eastern Region. is not a ‘‘significant regulatory action’’ Office and Department of Labor hours of under Executive Order 12866; (2) is not [FR Doc. 04–8362 Filed 4–12–04; 8:45 am] operation are 8:15 a.m. to 4:45 p.m. a ‘‘significant rule’’ under DOT BILLING CODE 4910–13–M Hearing testimony and documentary Regulatory Policies and Procedures (44 evidence. Testimony and documentary FR 11034; February 26, 1979); and (3) evidence must be submitted in triplicate does not warrant preparation of a DEPARTMENT OF LABOR (3 copies) to the Docket Office at the regulatory evaluation as the anticipated above address. Testimony and Occupational Safety and Health impact is minimal. Since this is a documentary evidence totaling 10 or Administration routine matter that would only affect air fewer pages may be faxed to the Docket traffic procedures and air navigation, it Office at (202) 693–1648. Materials such 29 CFR Parts 1917 and 1918 is certified that this proposed rule as studies or journal articles may not be would not have significant economic [Docket No. S–025A] attached to faxed testimony or impact on a substantial number of small documentary evidence; instead, three RIN 1218–AA56 entities under the criteria of the copies of this material must be mailed Regulatory Flexibility Act. Longshoring and Marine Terminals; to the Docket Office at the above address. Such material must identify List of Subjects in 14 CFR Part 71 Vertical Tandem Lifts clearly the name of the individual who Airspace, Incorporation by reference, AGENCY: Occupational Safety and Health is testifying, date, docket number, and Navigation (air). Administration (OSHA), Labor. subject so that OSHA can attach it to the The Proposed Amendment ACTION: Proposed rule; notice of hearing. appropriate faxed documents. FOR FURTHER INFORMATION CONTACT: For In consideration of the foregoing, the SUMMARY: OSHA is convening an general information and press inquiries, Federal Aviation Administration informal public hearing to receive contact Ms. Layne Lathram, Office of proposes to amend 14 CFR Part 71 as testimony and documentary evidence Communications, Room N–3647, OSHA, follows: on Vertical Tandem Lifts. U.S. Department of Labor, 200 PART 71—[AMENDED] DATES: Informal public hearing. The Constitution Avenue, NW., Washington, Agency will hold the informal public DC 20210 (telephone: (202) 693–1999). 1. The authority citation for 14 CFR hearing in Washington, DC beginning For technical inquiries, contact Mr. Paul Part 71 continues to read as follows: July 29, 2004. The hearing will Rossi, Office of Maritime, Room N– Authority: 49 U.S.C. 106(g), 40103, 40113, commence at 10 a.m. on the first day, 3609, OSHA, U.S. Department of Labor, 40120; E.O. 10854; 24 FR 9565, 3 CFR, 1959– and at 9 a.m. on the second and 200 Constitution Avenue, NW., 1963 Comp., p. 389. subsequent days, which will be Washington, DC 20210 (telephone: (202) scheduled, if necessary. 693–2086; fax: (202) 693–1663). For § 71.1 [Amended] Notice of Intention to Appear to hearing information, contact Ms. Veneta 2. The incorporation by reference in provide testimony at the informal public Chatmon, Office of Communications, 14 CFR 71.1 of Federal Aviation hearing. Parties who intend to present OSHA, U.S. Department of Labor, 200 Administration Order 7400.9L, dated testimony at the informal public hearing Constitution Avenue, NW., Washington, September 2, 2003, and effective must notify OSHA in writing of their DC 20210 (telephone: (202) 693–1999). September 16, 2003, is proposed to be intention to do so no later than May 13, For additional copies of this Federal amended as follows: 2004. Register notice, contact the Office of Paragraph 6005 Class E Airspace Areas Hearing testimony and documentary Publications, Room N–3103, OSHA, Extending Upward From 700 Feet or More evidence. Parties who are requesting U.S. Department of Labor, 200 Above the Surface of the Earth. more than 10 minutes to present their Constitution Avenue, NW., Washington, * * * * * testimony, or who will be submitting DC 20210 (telephone: (202) 693–1888). documentary evidence at the hearing, Electronic copies of this Federal AEA VA E5 Lynchburg, VA (Revised) must provide the Agency with copies of Register notice, as well as news releases Lynchburg Regional-Preston Glenn Field, their full testimony and all documentary and other relevant documents, are Lynchburg, VA ° ′ ″ ° ′ ″ evidence they plan to present by June available at OSHA’s homepage at (lat. 37 19 36 N., long. 79 12 02 W.) 14, 2004. http://www.osha.gov. Falwell Airport, Lynchburg, VA (lat. 37°22′41″ N., long. 79°07′20″ W.) ADDRESSES: Informal public hearing. SUPPLEMENTARY INFORMATION: OSHA Lynchburg VORTAC The informal public hearing will be published a proposed standard for (lat. 37°15′17″ N., long 79°14′11″ W.) held in the Auditorium on the plaza Longshoring and Marine Terminals;

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Vertical Tandem Lifts, in the Federal an informal administrative proceeding individual will present, including a Register on September 16, 2003 (68 FR convened for the purpose of gathering brief summary of the evidence. 54297). On December 10, 2003 (68 FR and clarifying information. The OSHA emphasizes that, while the 68804), OSHA published a notice regulations that govern the hearing, and hearing is open to the public and providing an additional sixty (60) days the pre-hearing guidelines issued for the interested parties are welcome to attend, for the submission of comments and hearing, will ensure that participants are only a party who files a proper Notice hearing requests, extending the treated fairly and have due process; this of Intention to Appear may ask comment period to February 13, 2004. approach will facilitate the development During the comment period, OSHA of a clear, accurate, and complete questions and participate fully in the received two requests for a public record. Accordingly, application of hearing. A party who did not file a hearing (Exs. 40–13 and 43–1). OSHA is these rules and guidelines will be such Notice of Intention to Appear may be granting these requests. The Agency is that questions of relevance, procedures, allowed to testify at the hearing if time placing the Notices of Intention to and participation will be decided in permits, but this determination is at the Appear, hearing testimony, and favor of developing a complete record. discretion of the presiding judge. documentary evidence in the Conduct of the hearing. Conduct of Hearing testimony and documentary rulemaking docket, which will be the hearing will conform to the evidence. The Agency will review each available for inspection and copying at provisions of 29 CFR part 1911 (‘‘Rules submission and determine if the the OSHA Docket Office. of Procedure for Promulgating, information it contains warrants the Public Participation—Comments and Modifying, or Revoking Occupational amount of time requested. OSHA then Hearings Safety and Health Standards’’). will allocate an appropriate amount of Although the judge who presides over OSHA encourages members of the time to each presentation, and will the hearing makes no decision or public to participate in this rulemaking notify the participants of the time recommendation on the merits of the by providing oral testimony and allotted to their presentations. Prior to NPRM or the final rule, the judge has documentary evidence at the informal the hearing, the Agency will notify the the responsibility and authority to public hearing. Accordingly, the Agency participant if the allotted time is less ensure that the hearing progresses at a invites interested parties having than the requested time, and will reasonable pace and in an orderly knowledge of, or experience with, the provide the reasons for this action. manner. To ensure that interested issues raised in the Notice of Proposed OSHA may limit to 10 minutes the parties receive a full and fair informal Rulemaking (NPRM) to participate in presentation of any participant who fails this process, and welcomes any hearing, the judge has the authority and power to: Regulate the course of the to comply substantially with these pertinent data that will provide the procedural requirements. The Agency Agency with the best available evidence proceedings; dispose of procedural requests, objections, and similar may also request a participant to return to use in developing the final rule. This for questions at a later time. section describes the procedures the matters; confine the presentations to public must use to schedule an matters pertinent to the issues raised; Certification of the record and final opportunity to deliver oral testimony use appropriate means to regulate the determination after the informal public and to provide documentary evidence at conduct of the parties who are present hearing. Following the close of the the informal public hearing. at the hearing; question witnesses, and hearing and post-hearing comment Hearing arrangements. Pursuant to permit others to question witnesses; and period, the judge will certify the record section 6(b)(3) of the Occupational limit the time for such questions. At the to the Assistant Secretary of Labor for Safety and Health Act (‘‘the Act’’; 29 close of the hearing, the judge will Occupational Safety and Health. This U.S.C. 655), members of the public must establish a post-hearing comment period record will consist of all of the written have an opportunity at the informal for parties who participated in the comments, oral testimony, documentary public hearing to provide oral testimony hearing. During the first part of this evidence, and other material received concerning the issues raised in the period, the participants may submit during the hearing. Following additional data and information to NPRM. An administrative law judge certification of the record, OSHA will OSHA, and during the second part of will preside over the hearing, and will review the proposed provisions in light this period, they may submit briefs, resolve any procedural matters relating of all the evidence received as part of arguments, and summations. to the hearing on the first day. the record, and then will issue the final Purpose of the hearing. The legislative Notice of Intention to Appear to determinations based on the entire history of Section 6 of the Act, as well provide testimony at the informal public as the Agency’s regulation governing hearings. Hearing participants must file record. public hearings (29 CFR 1911.15), a Notice of Intention to Appear that Authority establish the purpose and procedures of provides the following information: The informal public hearings. Although the name, address, and telephone number of John L. Henshaw, Assistant Secretary presiding officer of the hearing is a each individual who will provide of Labor for Occupational Safety and judge and questions by interested testimony; the capacity (e.g., name of Health, U.S. Department of Labor, 200 parties are allowed on pertinent issues, the establishment/organization the Constitution Avenue, NW., Washington, the hearing is informal and legislative in individual is representing; the DC 20210, directed the preparation of purpose. Therefore, the hearing individual’s occupational title and this document. It is issued under provides interested parties with an position) in which the individual will sections 4, 6, and 8 of the Occupational opportunity to make effective and testify; approximate amount of time Safety and Health Act of 1970 (29 U.S.C. expeditious oral presentations in the requested for the individual’s testimony; 653, 655, 657), Section 41 of the absence of procedural restraints that specific issues the individual will Longshore and Harbor Workers’ could impede or protract the rulemaking address, including a brief description of Compensation Act (33 U.S.C. 941), process. The hearing is not an the position that the individual will take Secretary’s Order 5–2002 (67 FR 65008), adjudicative proceeding subject to the with respect to each of these issues; and and 29 CFR part 1911. technical rules of evidence; instead, it is any documentary evidence the

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Signed at Washington, DC on April 6, destination packages of mailpieces ACTION: Proposed rule. 2004. prepared under DMM M020. SUMMARY: The Commission requests John L. Henshaw, Neva R. Watson, comments on a petition filed by Siete Assistant Secretary of Labor. Attorney, Legislative. Grande Television, Inc., licensee of [FR Doc. 04–8301 Filed 4–12–04; 8:45 am] [FR Doc. 04–8255 Filed 4–12–04; 8:45 am] station WSTE–TV, requesting the BILLING CODE 4510–26–M BILLING CODE 7710–12–P substitution of DTV channel 8c for WSTE’s assigned DTV channel 66. DTV Channel 8c can be allotted to Ponce, ENVIRONMENTAL PROTECTION Puerto Rico, at reference coordinates POSTAL SERVICE AGENCY 18–02–52 N. and 66–39–16 W. with a power of 50, a height above average 39 CFR Part 111 40 CFR Part 300 terrain HAAT of 88 meters. DATES: Comments must be filed on or Packaging Standards and General [FRL–7646–9] before May 24, 2004, and reply Mailability National Priorities List for Uncontrolled comments on or before June 8, 2004. AGENCY: Postal Service. Hazardous Waste Sites, Proposed Rule ADDRESSES: The Commission permits No. 40; Correction the electronic filing of all pleadings and ACTION: Proposed rule; extension of comments in proceeding involving comment period. AGENCY: Environmental Protection petitions for rule making (except in Agency. broadcast allotment proceedings). See SUMMARY: The Postal ServiceTM is ACTION: Proposed rule; correction. Electronic Filing of Documents in Rule extending the comment period for the Making Proceedings, GC Docket No. 97– proposed rule titled ‘‘Packaging SUMMARY: The Environmental Protection 113 (rel. April 6, 1998). Filings by paper Standards and General Mailability’’ that Agency (‘‘EPA’’ or ‘‘the Agency’’) can be sent by hand or messenger was published on February 26, 2004, in published a proposed rule in the delivery, by commercial overnight the Federal Register (69 FR 8899–8905). Federal Register of March 8, 2004 (69 courier, or by first-class or overnight FR 10646), proposing 11 sites to the U.S. Postal Service mail. The DATES: The comment period is extended National Priorities List (NPL). This Commission’s contractor, Natek, Inc., through May 13, 2004. document corrects the name of one of will receive hand-delivered or the sites. ADDRESSES: Mail or deliver written messenger-delivered paper filings for comments to the Manager, Mailing FOR FURTHER INFORMATION CONTACT: the Commission’s Secretary at 236 Standards, Attn: Neil Berger, U.S. Postal Yolanda Singer, phone (703) 603–8835, Massachusetts Avenue, NE., Suite 110, Service, 1735 N. Lynn Street, Room State, Tribal and Site Identification Washington, DC 20002. The filing hours 3025, Arlington, VA 22209–6038. Branch, Assessment and Remediation at this location are 8 a.m. to 7 p.m. All Written comments may also be Division, Office of Superfund hand deliveries must be held together submitted via facsimile transmission to Remediation and Technology with rubber bands or fasteners. Any envelopes must be disposed of before (703) 292–4058. Copies of all written Innovation (Mail Code 5204G); U.S. Environmental Protection Agency; 1200 entering the building. comments will be available for Pennsylvania Avenue NW., Washington, Commercial overnight mail (other inspection and photocopying between 9 DC 20460. than U.S. Postal Service Express Mail a.m. and 4 p.m., Monday through and Priority Mail) must be sent to 9300 Friday, at the Postal Service Correction East Hampton Drive, Capitol Heights, Headquarters Library, 475 L’Enfant In the Federal Register of March 8, MD 20743. U.S. Postal Service first-class Plaza, SW., 11th Floor North, 2004, on page 10652, in Table 1, under mail, Express Mail, and Priority Mail Washington, DC. the site name column, ‘‘Devil’s should be addressed to 445 12th Street, FOR FURTHER INFORMATION CONTACT: Neil Swamp—Ewell Property’’ is corrected to SW., Washington, DC 20554. All filings Berger at (703) 292–3645, Mailing read ‘‘Devil’s Swamp Lake.’’ must be addressed to the Commission’s Standards, United States Postal Service. Dated: April 7, 2004. Secretary, Office of the Secretary, Marianne Lamont Horinko, Federal Communications Commission, SUPPLEMENTARY INFORMATION: On Washington, DC 20554. In addition to February 26, 2004, the Postal Service Assistant Administrator, Office of Solid Waste and Emergency Response. filing comments with the FCC, published a proposed rule containing interested parties should serve the [FR Doc. 04–8315 Filed 4–12–04; 8:45 am] minor changes and editorial petitioner, or its counsel or consultant, reorganization to the Domestic Mail BILLING CODE 6560–50–M as follows: Stuart A. Shorenstein, Wolf, Manual (DMM TM) in order to clarify Block, Schorr & Solis-Cohen LLP, 250 and standardize packaging and closing Park Avenue, New York, New York requirements, types of acceptable FEDERAL COMMUNICATIONS 10177 (Counsel for Siete Grande mailing containers, and mailing COMMISSION Television, Inc.). requirements for certain articles FOR FURTHER INFORMATION CONTACT: 47 CFR Part 73 Pam processed on Postal Service sorting Blumenthal, Media Bureau, (202) 418– equipment. [DA 04–765, MB Docket No. 04–78, RM– 1600. 10866] This proposed rule would also update SUPPLEMENTARY INFORMATION: This is a terminology and reorganize current Digital Television Broadcast Service; synopsis of the Commission’s Notice of standards for better reference and Ponce, PR Proposed Rule Making, MB Docket No. presentation. This proposed rule does 04–78, adopted March 23, 2004, and not affect any of the current standards AGENCY: Federal Communications released April 2, 2004. The full text of for the preparation of presort Commission. this document is available for public

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inspection and copying during regular ACTION: Proposed rule, dismissal. DEPARTMENT OF THE INTERIOR business hours in the FCC Reference Information Center, Portals II, 445 12th SUMMARY: This document dismisses a Fish and Wildlife Service Street, SW., Room CY–A257, pending petition for rulemaking to add Washington, DC 20554. This document an FM allotment in Wynnewood, 50 CFR Part 17 may also be purchased from the Oklahoma. The Commission had requested comment on a petition filed Commission’s duplicating contractor, RIN 1018–AT44 Qualex International, Portals II, 445 by David Garland, proposing the 12th Street, SW., Room CY–B402, allotment of Channel 266A at Endangered and Threatened Wildlife Washington, DC 20554, telephone 202– Wynnewood, Oklahoma. Wynnewood, and Plants; Proposed Designation of 863–2893, facsimile 202–863–2898, or Oklahoma, 17 FCC Rcd 9557 (MB 2002). Critical Habitat for the Santa Barbara via e-mail [email protected]. The petitioner filed comments in County Distinct Population Segment of Provisions of the Regulatory support of the proposal. In addition, a the California Tiger Salamander Flexibility Act of 1980 do not apply to counterproposal was filed by DFWU, AGENCY: Fish and Wildlife Service, this proceeding. Inc., proposing the alternative allotment Members of the public should note of Channel 265A at Konawa, Oklahoma. Interior. that from the time a Notice of Proposed Both the original proposal in this ACTION: Proposed rule; reopening of Rule Making is issued until the matter proceeding and the counterproposal comment period and public hearing is no longer subject to Commission were determined to be in conflict with, announcement. consideration or court review, all ex and outside the comment period for, SUMMARY: We, the U.S. Fish and parte contacts are prohibited in proposals under consideration in MM Wildlife Service (Service) give notice of Commission proceedings, such as this Docket No. 01–180. Holdenville, reopening the public comment period one, which involve channel allotments. Oklahoma, 16 FCC Rcd 14,912 (MM and scheduling one public hearing on See 47 CFR 1.1204(b) for rules 2001). This document therefore the proposed critical habitat designation governing permissible ex parte contacts. dismisses the petition and For information regarding proper counterproposal in this proceeding and for the Santa Barbara County Distinct filing procedures for comments, see 47 terminates the proceeding. Vertebrate Population Segment (DPS) of CFR 1.415 and 1.420. FOR FURTHER INFORMATION CONTACT: the California tiger salamander Deborah A. Dupont, Media Bureau (202) (Ambystoma californiense). List of Subjects in 47 CFR Part 73 418–7072. DATES: The comment period for this Digital television broadcasting, SUPPLEMENTARY INFORMATION: This is a proposal now closes on May 28, 2004. Television. synopsis of the Commission’s Report Any comments received by the closing For the reasons discussed in the and Order, MB Docket No. 02–126, date will be considered in the final preamble, the Federal Communications adopted March 24, 2004, and released decision on this proposal. One public Commission proposes to amend 47 CFR March 26, 2004. The full text of this hearing will be held on May 11, 2004, Part 73 as follows: Commission decision is available for in Santa Maria from 1 p.m. to 3 p.m., inspection and copying during normal and from 6 p.m. to 8 p.m. PART 73—RADIO BROADCAST business hours in the FCC Reference ADDRESSES: The public hearing in Santa SERVICES Information Center (Room CY–A257), Maria will be held at the Radisson 1. The authority citation for part 73 445 12th Street, SW., Washington, DC. Hotel, 3455 Skyway Drive, Santa Maria continues to read as follows: The complete text of this decision may CA 93455. also be purchased from the Written comments and materials may Authority: 47 U.S.C. 154, 303, 334 and 336. Commission’s copy contractor, Qualex be submitted to us by any one of the § 73.622 [Amended] International, Portals II, 445 12th Street, following methods: 2. Section 73.622(b), the Table of SW., Room CY–B402, Washington, DC 1. You may submit written comments Digital Television Allotments under 20554, telephone (202) 863–2893. and information to the Field Supervisor, Puerto Rico is amended by removing The Provisions of the Regulatory U.S. Fish and Wildlife Service, Ventura DTV channel 66 and adding DTV Flexibility Act of 1980 do not apply to Fish and Wildlife Office, 2493 Portola channel 8c at Ponce. this proceeding. Members of the public Road, Suite B, Ventura, CA 93003, or by should note that from the time a Notice facsimile 805/644–3958. Federal Communications Commission. of Proposed Rule Making is issued until 2. You may hand-deliver written Barbara A. Kreisman, the matter is no longer subject to comments to our Ventura Office, at the Chief, Video Division, Media Bureau. Commission consideration or court address given above. [FR Doc. 04–8331 Filed 4–12–04; 8:45 am] review, all ex parte contacts are 3. You may send comments by BILLING CODE 6712–01–P prohibited in Commission proceedings, electronic mail (e-mail) to such as this one, which involve channel [email protected]. allotments. See 47 CFR 1.1204(b) for Comments and materials received, as FEDERAL COMMUNICATIONS rules governing permissible ex parte well as supporting documentation used COMMISSION contacts. in the preparation of this proposed rule, For information regarding proper will be available for public inspection, 47 CFR Part 73 filing procedures for comments, see 47 by appointment, during normal business [DA 04–781, MB Docket No. 02–126, RM– CFR 1.415 and 1.420. hours at the Ventura Fish and Wildlife 10448] Federal Communications Commission. Office, at address given above John A. Karousos, (telephone 805/644–1766). Radio Broadcasting Services; Assistant Chief, Audio Division, Media FOR FURTHER INFORMATION CONTACT: Carl Wynnewood, OK Bureau. Benz, at the above address (telephone AGENCY: Federal Communications [FR Doc. 04–8332 Filed 4–12–04; 8:45 am] 805/644–1766; facsimile 805/644–3958). Commission. BILLING CODE 6712–01–P SUPPLEMENTARY INFORMATION:

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Public Comments Solicited organizations or businesses, available Information regarding this proposal is for public inspection in their entirety. available in alternative formats upon We will accept written comments and request. information during this reopened Background comment period. We solicit comments Author on the original proposed critical habitat On January 22, 2004, we published in the Federal Register a proposed critical The primary author of this notice is designation (January 22, 2004, 69 FR Katie Drexhage (see ADDRESSES section). 3064). Of particular interest to us are habitat rule for the Santa Barbara DPS Authority: The authority for this action is comments on the criteria used to of California tiger salamander listed under the Endangered Species Act of the Endangered Species Act of 1973 (16 identify critical habitat, the special U.S.C. 1531 et seq.). management considerations, and 1973, as amended (Act) (16 U.S.C. 1531 additional suggestions regarding the et seq.). Six critical habitat units, Dated: April 5, 2004. primary constituent elements identified totaling approximately 13,920 acres Craig Manson, for the California tiger salamander in (5,633 hectares), are proposed for Assistant Secretary for Fish and Wildlife and this proposed rule. Please feel free to designation for the Santa Barbara Parks. suggest other sources of information County DPS of California tiger [FR Doc. 04–8328 Filed 4–12–04; 8:45 am] salamander. The proposed critical relevant to this species of which you BILLING CODE 4310–55–U may be aware. habitat is located in Santa Barbara County, CA. For locations of these An analysis of the economic impacts proposed units, please consult the DEPARTMENT OF COMMERCE of proposing critical habitat for the proposed rule (69 FR 3064). California tiger salamander is being The comment period for the proposed National Oceanic and Atmospheric prepared. We will announce the Administration availability of the draft economic critical habitat designation originally closed on March 22, 2004. We are now analysis as soon as it is completed, at 50 CFR Part 229 which time we will seek public review announcing one public hearing and are and comment. At that time, copies of reopening the comment period to allow [Docket No. 040407106–4106–01, I.D. the draft economic analysis will be all interested parties to submit oral or 040104A] available for downloading from the written comments on the proposal. We RIN 0648–AS04 Internet at http://ventura.fws.gov, or by are seeking comments or suggestions contacting the Ventura Fish and from the public, other concerned List of Fisheries for 2004 ADDRESSES agencies, the scientific community, Wildlife Office directly (see AGENCY: National Marine Fisheries section). industry, or any other interested parties concerning the proposed rule. Service (NMFS), National Oceanic and Please submit electronic comments in Comments already submitted on the Atmospheric Administration (NOAA), an ASCII file format and avoid the use proposed rule need not be resubmitted Department of Commerce. of special characters and encryption. as they will be fully considered in the ACTION: Proposed rule. ‘‘ Please also include ttn: RIN 1018– final determination. AT44’’ and your name and return SUMMARY: The National Marine address in your e-mail message. If you Section 4(b)(5)(E) of the Act requires Fisheries Service (NMFS) is publishing do not receive a confirmation from the that a public hearing be held if it is the proposed List of Fisheries (LOF) for system that we have received your e- requested within 45 days of the 2004, as required by the Marine mail message, please contact the publication of a proposed rule. We Mammal Protection Act (MMPA). The Ventura Fish and Wildlife Office (see received numerous requests for an proposed LOF for 2004 reflects new ADDRESSES section and FOR FURTHER extension of the comment period and information on interactions between INFORMATION CONTACT). In the event that for a public hearing. In response to these commercial fisheries and marine our internet connection is not requests, we are reopening the public mammals. NMFS must categorize each functional, please submit your comment period and holding a public commercial fishery on the LOF into one comments by the alternate methods hearing on the date and at the address of three categories under the MMPA mentioned above. described in the DATES and ADDRESSES based upon the level of serious injury section. Our practice is to make comments, and mortality of marine mammals that including names and home addresses of Anyone wishing to make an oral occurs incidental to each fishery. The respondents, available for public review statement for the record is encouraged categorization of a fishery in the LOF during regular business hours. to provide a written copy of their determines whether participants in that Individual respondents may request that statement and present it to us at the fishery are subject to certain provisions we withhold their home addresses from hearing. In the event there is a large of the MMPA, such as registration, the rulemaking record, which we will attendance, the time allotted for oral observer coverage, and take reduction honor to the extent allowable by law. In statements may be limited. Oral and plan requirements. some circumstances, we would written statements receive equal DATES: Comments must be received by withhold from the rulemaking record a consideration. There are no limits to the May 13, 2004. respondent’s identity, as allowable by length of written comments presented at ADDRESSES: Send comments to Chief, law. If you wish for us to withhold your the hearing or mailed to us. Marine Mammal Conservation Division, name and/or address, you must state Persons needing reasonable Attn: List of Fisheries, Office of this prominently at the beginning of accommodations in order to attend and Protected Resources, NMFS, 1315 East- your comments. However, we will not participate in the public hearing should West Highway, Silver Spring, MD consider anonymous comments. We contact Patti Carroll, Region 1, at 503/ 20910. Comments may also be sent via will make all submissions from 231–2080 as soon as possible. In order email to [email protected] organizations or businesses, and from to allow sufficient time to process or to the Federal eRulemaking portal: individuals identifying themselves as requests, please call no later than 1 http://www.regulations.gov (follow representatives or officials of week before the hearing date. instructions for submitting comments).

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Comments regarding the burden-hour reduction plan requirements. NMFS details regarding how the categories estimates, or any other aspect of the must reexamine the LOF annually, were determined are provided in the collection of information requirements considering new information in the preamble to the final rule implementing contained in this proposed rule, should Stock Assessment Reports, other section 118 of the MMPA (60 FR 45086, be submitted in writing to the Chief, relevant sources, and the LOF, and August 30, 1995). Marine Mammal Conservation Division, publish in the Federal Register any Since fisheries are categorized on a Office of Protected Resources, NMFS, necessary changes to the LOF after per-stock basis, a fishery may qualify as 1315 East-West Highway, Silver Spring, notice and opportunity for public one Category for one marine mammal MD 20910 and to David Rostker, OMB, comment (16 U.S.C. 1387 (c)(3)). stock and another Category for a by e-mail at different marine mammal stock. A How Does NMFS Determine in which [email protected] or by fax fishery is typically categorized on the Category a Fishery is Placed? to 202–395–7285. LOF at its highest level of classification See SUPPLEMENTARY INFORMATION for The definitions for the fishery (e.g., a fishery that qualifies for Category information on how to obtain classification criteria can be found in III for one marine mammal stock and for registration information, materials, and the implementing regulations for section Category II for another marine mammal marine mammal reporting forms. 118 of the MMPA (50 CFR 229.2). The stock will be listed under Category II). criteria are also summarized here. FOR FURTHER INFORMATION CONTACT: Other Criteria That May Be Considered Kristy Long, Office of Protected Fishery Classification Criteria In the absence of reliable information Resources, 301–713–1401; Kim The fishery classification criteria Thounhurst, Northeast Region, 978– indicating the frequency of incidental consist of a two-tiered, stock-specific mortality and serious injury of marine 281–9328; Juan Levesque, Southeast approach that first addresses the total Region, 727–570–5312; Cathy Campbell, mammals by a commercial fishery, impact of all fisheries on each marine NMFS will determine whether the Southwest Region, 562–980–4060; Brent mammal stock, and then addresses the Norberg, Northwest Region, 206–526– incidental serious injury or mortality impact of individual fisheries on each qualifies for Category II by evaluating 6733; Bridget Mansfield, Alaska Region, stock. This approach is based on 907–586–7642. Individuals who use a other factors such as fishing techniques, consideration of the rate, in numbers of gear used, methods used to deter marine telecommunications device for the animals per year, of incidental hearing impaired may call the Federal mammals, target species, seasons and mortalities and serious injuries of areas fished, qualitative data from Information Relay Service at 1–800– marine mammals due to commercial 877–8339 between 8 a.m. and 4 p.m. logbooks or fisher reports, stranding fishing operations relative to the data, and the species and distribution of Eastern time, Monday through Friday, Potential Biological Removal (PBR) level excluding Federal holidays. marine mammals in the area, or at the for each marine mammal stock. The discretion of the Assistant SUPPLEMENTARY INFORMATION: MMPA (16 U.S.C. 1362 (20)) defines the Administrator for Fisheries (50 CFR Registration information, materials, and PBR level as the maximum number of 229.2). marine mammal reporting forms may be animals, not including natural obtained from the following regional mortalities, that may be removed from a How Do I Find Out if a Specific Fishery offices: marine mammal stock while allowing is in Category I, II, or III? NMFS, Northeast Region, One that stock to reach or maintain its This proposed rule includes two Blackburn Drive, Gloucester, MA optimum sustainable population. This tables that list all U.S. commercial 01930–2298, Attn: Marcia Hobbs; definition can also be found in the fisheries by LOF Category. Table 1 lists NMFS, Southeast Region, 9721 implementing regulations for section all of the fisheries in the Pacific Ocean Executive Center Drive North, St. 118 at 50 CFR 229.2 (including Alaska). Table 2 lists all of Petersburg, FL 33702, Attn: Teletha Tier 1: If the total annual mortality the fisheries in the Alantic Ocean, Gulf Griffin; and serious injury across all fisheries of Mexico, and Caribbean. NMFS, Southwest Region, Protected that interact with a stock is less than or Am I Required to Register Under the Species Management Division, 501 W. equal to 10 percent of the PBR level of MMPA? Ocean Blvd., Suite 4200, Long Beach, the stock, all fisheries interacting with CA 90802–4213, Attn: Don Peterson; the stock would be placed in Category Owners of vessels or gear engaging in NMFS, Northwest Region, 7600 Sand III. Otherwise, these fisheries are subject a Category I or II fishery are required Point Way NE, Seattle, WA 98115, Attn: to the next tier (Tier 2) of analysis to under the MMPA (16 U.S.C. 1387(c)(2)), Permits Office; or determine their classification. as described in 50 CFR 229.4, to register NMFS, Alaska Region, Protected Tier 2, Category I: Annual mortality with NMFS and obtain a marine Resources, P.O. Box 22668, 709 West and serious injury of a stock in a given mammal authorization from NMFS in 9th Street, Juneau, AK 99802. fishery is greater than or equal to 50 order to lawfully incidentally take a What is the List of Fisheries? percent of the PBR level. marine mammal in a commercial Tier 2, Category II: Annual mortality fishery. Owners of vessels or gear Section 118 of the MMPA requires and serious injury of a stock in a given engaged in a Category III fishery are not that NMFS place all U.S. commercial fishery is greater than 1 percent and less required to register with NMFS or fisheries into one of three categories than 50 percent of the PBR level. obtain a marine mammal authorization. based on the level of incidental serious Tier 2, Category III: Annual mortality injury and mortality of marine mammals and serious injury of a stock in a given How Do I Register? that occurs in each fishery (16 U.S.C. fishery is less than or equal to 1 percent Fishers must register with the Marine 1387 (c)(1)). The categorization of a of the PBR level. Mammal Authorization Program fishery in the LOF determines whether While Tier 1 considers the cumulative (MMAP) by contacting the relevant participants in that fishery may be fishery mortality and serious injury for NMFS Regional Office (see ADDRESSES) required to comply with certain a particular stock, Tier 2 considers unless they participate in a fishery that provisions of the MMPA, such as fishery-specific mortality and serious has an integrated registration program registration, observer coverage, and take injury for a particular stock. Additional (described below). Upon receipt of a

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completed registration, NMFS will issue Am I Required to Submit Reports When and the U.S. Atlantic, Gulf of Mexico, vessel or gear owners physical evidence I Injure or Kill a Marine Mammal and the Caribbean. The SRGs were of a current and valid registration that During the Course of Commercial created by the MMPA to review the must be displayed or in the possession Fishing Operations? science that goes into the stock of the master of each vessel while In accordance with the MMPA (16 assessment reports, and to advise NMFS fishing in accordance with section 118 U.S.C. 1387(e)) and 50 CFR 229.6, any on population status and trends, stock of the MMPA (16 U.S.C. 1387(c)(3)(A)). vessel owner or operator, or fisher (in structure, uncertainties in the science, the case of non-vessel fisheries), research needs, and other issues. What is the Process for Registering in The proposed LOF for 2004 was an Integrated Fishery? participating in a Category I, II, or III fishery must report all incidental based, among other things, on For some fisheries, NMFS has injuries or mortalities of marine information provided in the final SARs integrated the MMPA registration mammals that occur during commercial for 1996 (63 FR 60, January 2, 1998), the process with existing state and Federal fishing operations to NMFS. ‘‘Injury’’ is final SARs for 2001 (67 FR 10671, fishery license, registration, or permit defined in 50 CFR 229.2 as a wound or March 8, 2002), the final SARs for 2002 systems and related programs. other physical harm. In addition, any (68 FR 17920, April 14, 2003), and the Participants in these fisheries are animal that ingests fishing gear or any draft SARs for 2003 (68 FR 51561, automatically registered under the animal that is released with fishing gear August 27, 2003). MMPA and are not required to submit entangling, trailing, or perforating any Summary of Changes to the Proposed registration or renewal materials or pay part of the body is considered injured, LOF for 2004 the $25 registration fee. Following is a regardless of the absence of any wound The following summarizes changes in list of integrated fisheries and a or other evidence of an injury, and must fishery classification including fisheries summary of the integration process for be reported. Instructions on how to listed on the LOF, the number of each Region. Fishers who operate in an submit reports can be found in 50 CFR participants in a particular fishery, and integrated fishery and have not received 229.6. the species and/or stocks that are registration materials should contact Am I Required to Take an Observer incidentally killed or seriously injured their NMFS Regional Office listed in the Aboard My Vessel? in a particular fishery, that are proposed first paragraph of SUPPLEMENTARY Fishers participating in a Category I or for the 2004 LOF. The placement and INFORMATION. II fishery are required to accommodate definitions of U.S. commercial fisheries Which Fisheries Have Integrated an observer aboard vessel(s) upon proposed for 2004 are identical to those Registration Programs? request. Observer requirements can be provided in the LOF for 2003 with the found in 50 CFR 229.7. following exceptions. The following fisheries have integrated registration programs under Am I Required to Comply With Any Commercial Fisheries in the Pacific the MMPA: Take Reduction Plan Regulations? Ocean: Fishery Classification 1. All Alaska Category II fisheries; Fishers participating in a Category I or Hawaii Swordfish, Tuna, Billfish, Mahi II fishery are required to comply with Mahi, Wahoo, Oceanic Sharks Longline/ 2. All Washington and Oregon any applicable take reduction plans. Category II fisheries; Set Line Fishery Sources of Information Reviewed for 3. Northeast Regional fisheries for NMFS proposes to reclassify the the Proposed 2004 LOF which a state or Federal permit is Hawaii Swordfish, Tuna, Billfish, Mahi required. Individuals fishing in fisheries NMFS reviewed the marine mammal Mahi, Wahoo, Oceanic Sharks Longline/ for which no state or Federal permit is incidental serious injury and mortality Set Line Fishery (Hawaii longline required must register with NMFS by information presented in the Stock fishery) as Category I under the MMPA contacting the Northeast Regional Office Assessment Reports (SARs) for all primarily because of the level of (see ADDRESSES); and observed fisheries to determine whether incidental mortality and serious injury changes in fishery classification were that occurs between this fishery and the 4. All North Carolina, , warranted. NMFS SARs are based on the Hawaiian stock of false killer whales Georgia, and Florida Category I and II best scientific information available at (Pseudorca crassidens). However, fisheries for which a state permit is the time of preparation for the NMFS also has information regarding required. information presented in the SARs, incidental mortality and serious injury How Do I Renew My Registration including the level of serious injury and that occurs between this fishery and the Under the MMPA? mortality of marine mammals that Hawaiian stock of Risso’s dolphins occurs incidental to commercial (Grampus griseus), Hawaiian stock of Regional Offices, except for the fisheries and the potential biological bottlenose dolphins (Tursiops Northeast Region, annually send removal (PBR) levels of marine mammal truncatus), Hawaiian stock of spinner renewal packets to participants in stocks. NMFS also reviewed other dolphins (Stenella longirostris), Category I or II fisheries that have sources of new information, including Hawaiian stock of pantropical spotted previously registered; however, it is the marine mammal stranding data, dolphins (Stenella attenuata), Hawaiian responsibility of the fisher to ensure that observer program data, fisher self- stock of short-finned pilot whales registration or renewal forms are reports, and other information that is (Globicephala macrorhynchus), completed and submitted to NMFS at not included in the SARs. NMFS also Hawaiian stock of Blainville’s beaked least 30 days in advance of fishing. took into account the discretion of the whales (Mesoplodon densirostris), Individuals who have not received a Assistant Administrator for Fisheries in Hawaiian stock of sperm whales renewal packet by January 1 or are developing the 2004 proposed LOF. (Physeter macrocephalus) and the registering for the first time should The information contained in the Central North Pacific stock of humpback request a registration form from the SARs is reviewed by regional scientific whales (Megaptera novaeangliae). appropriate Regional Office (see review groups (SRGs) representing In 2002, NMFS surveyed cetacean ADDRESSES). Alaska, the Pacific (including Hawaii), abundance, including the Hawaiian

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stock of false killer whales, in waters available (Forney 2003. Estimates of and have on board a valid protected where the Hawaii longline fishery Cetacean Mortality and Injury in the species workshop certificate. operated, a survey that would allow for Hawaii Based Longline Fishery, 1994– To implement the regulatory a better estimate of abundance and a 2002. 11/4/2003). These mortality and amendment proposed by the Council, more reliable PBR level and better serious injury estimates were based the final rule: (1) Establishes an annual estimates of mortality and serious injury upon a long-term data set, with effort limit on the amount of shallow-set in marine mammal stocks taken by this expanded observer coverage between longline fishing effort north of the fishery. This survey addressed the 2000 and 2002 primarily in tuna-style equator that may be collectively exerted limitations of the earlier survey data, fishing. These data allowed an by Hawaii-based longline vessels (2,120 discussed in the 2001 and 2003 LOFs evaluation of the suggestion that tuna- shallow-sets per year) and (2) divides (66 FR 42780, August 15, 2001; 68 FR style fishing resulted in little to no and distributes this shallow-set annual 41725, July 15, 2003) and the need for (remote likelihood) injury or mortality effort limit each calendar year in equal these data was emphasized in the 2001 of marine mammals. Since 1998, only portions to all holders of Hawaii LOF. The 2002 Pacific and Alaska SARs one false killer whale has been observed longline-limited access permits. The provided data about these stocks of killed in the Hawaiian EEZ. interaction limits for leatherback and marine mammals and calculated a rate As a result of these data, updated loggerhead sea turtles may also limit, of interaction between the Hawaii abundance and mortality estimates have albeit indirectly, interactions with other longline fishery and each stock based on been included in the 2004 draft stock protected species, such as false killer observer data. As a result, false killer assessment report for the Hawaiian whales, in the shallow-set component of whales (Hawaiian stock) were stock of false killer whales (False Killer the Hawaii-based longline fishery. determined to be a strategic stock in Whale (Pseudorca crassidens): Furthermore, under the ESA, when any 2002. However, the surveys were not Hawaiian stock, dated 11/15/2003). This of the incidental take limits is exceeded, completed prior to the 2002 LOF and report describes abundance, mortality NMFS reinitiates consultation under these data were not completely analyzed and status of false killer whales and section 7 of the ESA, at which point the prior to the completion of the 2003 LOF. partitions serious injury and mortality need for more restrictive measures Further, the abundance estimate on of the stock within and outside the US would be considered. The terms and which the PBR was based was EEZ. All of the above reports have been conditions of the incidental take considered an underestimate because it subjected to scientific review within statement in the 2004 biological opinion was based on 1993–98 aerial surveys NMFS and are the best scientific also mandate 100–percent observer conducted only within approximately information available related to coverage in the shallow-set component 25 nautical miles of the main Hawaiian abundance and mortality of false killer of the Hawaii-based longline fishery and at least 20–percent coverage in the deep- Islands, not throughout the entire range whales in the area. of the false killer whale stock. For these set component. NMFS intends to New Management Regime and Effort reasons, NMFS left in place the fishery’s implement these levels of coverage. Reduction for the Fishery: NMFS classification as a Category III fishery in Given the relatively long history of the approved a regulatory amendment 2002 and 2003 based on the limitations deep-set component and our under the Fishery Management Plan for of available information, and the need to understanding of patterns of fishing, the Pelagic Fisheries of the Western review other relevant sources in 2004. catches, and interactions with protected Pacific Region (FMP) submitted by the species, NMFS has determined 20 Information Available for the 2004 LOF Western Pacific Fishery Management percent to be a sufficient level of That was Not Available for the 2003 Council (Council), published a proposed coverage in the deep-set component of LOF rule on January 28, 2004, and issued a the fishery. Abundance information: The results final rule on April 2, 2004 (69 FR 17329) of the 2002 surveys in the Hawaiian EEZ to establish a number of conservation Tier Evaluation are now available (Barlow, 2003. and management measures for the Tier 1 Evaluation: The Hawaii Cetacean Abundance in Hawaiian fisheries managed under the FMP in longline fishery is the only fishery Waters during Summer/Fall of 2002, order to provide adequate protections known to interact with the Hawaiian referenced as PSRG–7), and these have for sea turtles. On February 23, 2004, stock of false killer whales. Based on the been combined with the earlier aerial NMFS concluded consultation and currently available data, total annual surveys within 25 nmi of the main issued a biological opinion under incidental mortality and serious injury Hawaiian Islands (Mobley et al. 2000) to section 7 of the Endangered Species Act across all fisheries (in this case, just the produce an estimate of the abundance of on the pelagic fisheries of the western Hawaii longline fishery) is greater than false killer whales in the Hawaiian EEZ. Pacific region as they would be or equal to 10 percent of the PBR level The methods used in the surveys managed under the measures for the Hawaiian stock of false killer followed standard survey techniques implemented through this final rule. whales. Therefore, the Hawaii longline and are described in the scientific The biological opinion found that the fishery is subject to Tier 2 analysis. papers cited above. The method for fisheries are not likely to jeopardize the Tier 2 Evaluation: Based on combining the results of the two surveys continued existence of any ESA-listed extrapolations from the currently followed standard statistical procedures. species under the jurisdiction of NMFS. available data, total annual mortality The 2002 survey of the entire Hawaiian That final rule reopened the and serious injury (4.4 animals) of the Islands Exclusive Economic Zone (EEZ) swordfish-directed component of the Hawaiian stock of false killer whales resulted in an abundance estimate for Hawaii-based longline fishery with exceeds 50 percent of the PBR level false killer whales (Hawaiian stock) of annual fleet-wide limits on fishery (PBR=1.2). The continued take of false 268 individuals (based on the lower 85– interactions with leatherback and killer whales and other cetaceans, percent confidence interval), a slight loggerhead sea turtles, and an annual including endangered humpback and increase from the previous estimate. fleet-wide limit on fishing effort. The sperm whales, warrant recategorization Mortality information: The results of final rule also requires that operators of of the fishery. Therefore, NMFS an expanded observer program in the general longline vessels annually recommends elevating this fishery to Hawaiian longline fishery are now complete a protected species workshop Category I in the 2004 LOF.

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Justification for Category I mortality and significant injury in this diverse group of fisheries that target Classification fishery to PBR; therefore, the impact of different groundfish species over A mathematical application of the this fishery on false killer whales may distinct geographic areas within the regulations based on the currently be overemphasized. Bering Sea and during different seasons. available data indicates that the total As noted above, the interaction limits Marine mammal interactions likely vary for sea turtles may also limit, albeit annual mortality and serious injury (4.4 among BSAI groundfish trawl fisheries, indirectly, interactions with other animals) of the Hawaiian stock of false based on gear type, time and area of protected species, including false killer killer whales exceeds 50 percent of the operations, and target groundfish whales, that occur in the shallow-set PBR level (PBR=1.2). Therefore, NMFS species. component of the Hawaii-based longline NMFS also reviewed the Gulf of is proposing to recategorize this fishery fishery. The extent to which these Alaska (GOA) Groundfish Trawl, Bering to a Category I under the MMPA. measures reduce interactions with Sea and GOA Finfish Pot, AK However, as explained below, NMFS is marine mammal stocks is not known at Crustacean Pot, BSAI Groundfish concerned that such a categorization this time. Longline/Set Line (federally regulated may not adequately reflect the impact of In summary, the abundance (and waters, including miscellaneous finfish this fishery on false killer whales. subsequently, the PBR) of false killer and sablefish), and GOA Groundfish Accordingly, during the public whales in the North Pacific Ocean is Longline/Set Line (federally regulated comment period for this proposed rule, currently considered the best available waters, including miscellaneous finfish the NMFS Pacific Island Region will estimate. However, it remains a and sablefish) fisheries. Based on this convene a workshop to evaluate the minimum estimate because the surveys review, NMFS proposes to delineate information used in this proposed upon which the abundance estimate are these fisheries by target species and gear categorization. The workshop will based were limited in scope to a portion type. consist of NMFS scientists and of the range, the Hawaiian EEZ, of the NMFS seeks to collect and analyze managers as well as other individuals false killer whale stock. It does indicate data in a manner that provides knowledgeable in marine mammal that the stock abundance is low within information that allows for the most population assessments and interactions the Hawaiian Island EEZ. Mortality effective management of living marine with fishing gear. The workshop will records indicate that false killer whales resources, including marine mammals. provide guidance on the reliability and occupy international waters and the Marine mammal interactions vary adequacy of available information, EEZ around Palmyra, areas outside the among Alaska groundfish fisheries, including information on mortality and 2002 survey area. Clearly, the number of based on time and area of operation, serious injury, used in the tier analysis false killer whales in the North Pacific method of gear deployment, and target and subsequent categorization decision. Ocean subject to injury and mortality by groundfish species. Therefore, this NMFS will consider the results of the the longline fishery exceeds the proposed delineation of fisheries workshop and public comments minimum population estimate included operations is expected to allow for received on this proposed rule in its in Barlow, 2003 but it is not known by improved resolution of factors affecting decision to classify this fishery in the how much it is an underestimate. Such incidental mortality and serious injury final LOF for 2004. a conclusion can be based simply upon of marine mammals in these fisheries. In the case of the Hawaii longline the presence of false killer whales in The proposed newly delineated fishery, the classification is affected international waters and in the EEZ fisheries are currently listed within most by incidental mortality and serious surrounding Palmyra that were hooked fisheries classified as Category III injury of false killer whales. The and killed or seriously injured fisheries on the LOF. NMFS is mortality estimate is considered reliable incidental to the longline fishery. completing an analysis of past in recent years because it is based upon The proposed reclassisfication of the incidental mortality and serious injury a relatively high level of observer Hawaii Longline Fishery to a Category I for each of the proposed newly coverage in the fishery. The single is warranted based on the current delineated fisheries in accordance with mortality of a false killer whale in 1998 information. However, NMFS intends to the fishery classification criteria set within the EEZ is the basis for the address the scientific bases for this forth in the implementing regulations of expanded mortality estimate. The conclusion at a workshop which will be section 118 of the MMPA (50 CFR part average mortality used in the LOF held during the public comment period. 229). NMFS proposes these newly comparisons to abundance are based on As previously provided, NMFS will delineated fisheries be added to the LOF a 5–year average. So if no further consider the results of this workshop as Category III fisheries until completion mortalities occur in 2004, this single and public comments received on this of the analysis of serious injury and event will no longer be considered in proposed rule in its decision to classify mortality for these new fisheries. the 5–year average in 2005. this fishery in the final LOF for 2004. The abundance estimate of 268 Delineation of AK Bering Sea and animals is currently the best available Delineation of Alaska Fisheries Aleutian Islands Groundfish Trawl for this stock and represents a much The List of Fisheries has included the Fishery better estimate for this stock inside the Alaska groundfish fisheries as large NMFS proposes separating the BSAI Hawaiian EEZ than estimates in combinations of fisheries since 1990. In groundfish trawl fishery into four previous years. However, the extent to the 2003 final LOF (68 FR 41725, July fisheries based on target species. These which the abundance estimate may be 15, 2003), NMFS indicated that it would four fisheries are: AK Bering Sea and lower than the actual abundance of false review the existing fishery delineations Aleutian Islands Atka Mackerel Trawl killer whales is unknown. As a result, in the LOF for Federal and state Fishery, AK Bering Sea and Aleutian the extent to which the PBR of 1.2 may fisheries in Alaska. The decision to Islands Flatfish Trawl Fishery, AK also be considered an underestimate is review Alaska fisheries was based, in Bering Sea and Aleutian Islands Pacific unknown for this stock of false killer part, on NMFS’ recognition that the Cod Trawl Fishery, and AK Bering Sea whales. The uncertainty in the Bering Sea and Aleutian Islands (BSAI) and Aleutian Islands Pollock Trawl abundance and PBR estimates likely groundfish trawl fishery is not a Fishery. These fisheries operate in overemphasizes the ratio between homogenous fishery, but rather, a generally different geographic areas and

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seasons, although some overlap may Delineation of GOA Groundfish takes in the fishery, and to continue occur. Where overlap occurs, NMFS is Longline/Set Line Fishery (Federally working on the derelict trap/pot able to differentiate in which fishery a Regulated Waters, Including removal program. The NMFS Southeast vessel is operating when incidental Miscellaneous Finfish and Sablefish) Regional Office has been working mortality and serious injury of a marine NMFS proposes separating the GOA closely with the GSMFC and Sea Grant mammal occurs through a combination groundfish longline/set line fishery into to develop outreach materials of catch data, vessel monitoring systems four fisheries based on target species. throughout the past year and anticipates (VMS) information, and observer data, These four fisheries are: AK Gulf of distributing these materials in the near even when a vessel participates in more Alaska Sablefish Longline Fishery, AK future. NMFS will continue to monitor than one fishery on a given trip. These Gulf of Alaska Pacific Cod Longline strandings and communicate with fishers to determine the effectiveness of fisheries likewise are managed Fishery, AK Gulf of Alaska Flatfish Longline Fishery, and AK Gulf of Alaska outreach efforts. separately by NMFS and the North NMFS has been unable to conduct Rockfish Longline. Pacific Fishery Management Council. abundance surveys or analyze Gulf Delineation of GOA Groundfish Trawl Removal of Fisheries from the LOF bottlenose dolphin stock structure due Fishery NMFS proposes removing the AK to budgetary constraints. Therefore, the Bering Sea and Gulf of Alaska Finfish bottlenose dolphin stock structure in the NMFS proposes separating the GOA Pot Fishery, AK Crustacean Pot Fishery, Gulf of Mexico is still not well defined groundfish trawl fishery into four AK Bering Sea and Aleutian Islands at this time. Currently, the vast majority fisheries based on target species. These Groundfish Longline/Set Line Fishery of NMFS’ resources for bottlenose four fisheries are: AK Gulf of Alaska (federally regulated waters, including dolphin research is being expended in Flatfish Trawl Fishery, AK Gulf of miscellaneous finfish and sablefish), AK the Atlantic Ocean to satisfy needs of Alaska Pacific Cod Trawl Fishery, AK Gulf of Alaska Groundfish Longline/Set the Atlantic Bottlenose Dolphin Take Gulf of Alaska Pollock Trawl Fishery, Line Fishery (federally regulated waters, Reduction Team. As the needs of this existing TRT are met, NMFS hopes to and AK Gulf of Alaska Rockfish Trawl including miscellaneous finfish and shift resources to the Gulf of Mexico to Fishery. sablefish), AK Bering Sea and Aleutian better define bottlenose dolphin stock Islands Groundfish Trawl Fishery, and structure in this area. NMFS will Delineation of Bering Sea and GOA AK Gulf of Alaska Groundfish Trawl reevaluate classification of this fishery Finfish Pot Fishery Fishery from the LOF. After reviewing as relevant information becomes these fisheries, NMFS is proposing to NMFS proposes separating the Bering available. However, NMFS does not differentiate each fishery by target Sea and GOA finfish pot fishery into propose any change to the classification species and gear type, which more four fisheries based on target species. of this fishery because NMFS lacks accurately reflect existing fishery These four fisheries are: AK Aleutian adequate information at this time. management regimes in Alaska. Islands Sablefish Pot Fishery, AK Bering Therefore, removing these fisheries will List of Fisheries Sea Sablefish Pot Fishery, AK Bering not negatively affect NMFS’ ability to Sea and Aleutian Islands Pacific Cod The following two tables list U.S. analyze and assess serious injury and commercial fisheries according to their Pot Fishery, and AK Gulf of Alaska mortality of marine mammals captured Pacific Cod Pot Fishery. assigned categories under section 118 of incidental to these fisheries. A the MMPA. The estimated number of Delineation of Alaska Crustacean Pot description of the proposed delineation vessels/participants is expressed in Fishery of these fisheries can be found above in terms of the number of active the Fishery Classification section for the participants in the fishery, when NMFS proposes separating the Alaska Pacific Ocean. possible. If this information is not crustacean pot fishery into four fisheries Number of Vessels/Persons available, the estimated number of based on target species. These four vessels or persons licensed for a fisheries are: AK Southeast Alaska The estimated number of participants particular fishery is provided. If no Shrimp Pot Fishery, AK Southeast in the ‘‘OR Swordfish Floating Longline recent information is available on the Alaska Crab Pot Fishery, AK Gulf of Fishery’’ is updated to 1 based on 2003 number of participants in a fishery, the Alaska Crab Pot Fishery, and AK Bering permit data. number from the most recent LOF is The estimated number of participants Sea and Aleutian Islands Crab Pot used. in the ‘‘WA Puget Sound Region Salmon Fishery. The tables also list the marine Drift Gillnet Fishery’’ is updated to 210 mammal species and stocks that are Delineation of BSAI Groundfish based on 2003 permit data. incidentally killed or injured in each Longline/Set Line Fishery (Federally Commercial Fisheries in the Atlantic fishery based on observer data, logbook Regulated Waters, Including Ocean, Gulf of Mexico, and Caribbean: data, stranding reports, and fisher Miscellaneous Finfish and Sablefish) Fishery Classification reports. This list includes all species or stocks known to experience injury or NMFS proposes separating the BSAI Gulf of Mexico Blue Crab Trap/Pot mortality in a given fishery, but also groundfish longline/set line fishery into Fishery includes species or stocks for which four fisheries based on target species. In the 2003 LOF (68 FR 41725, July there are anecdotal or historical, but not These four fisheries are: AK Bering Sea 15, 2003), NMFS provided that it would necessarily current, records of and Aleutian Islands Greenland Turbot work with the Gulf States Marine interaction. Additionally, species Longline Fishery, AK Bering Sea and Fisheries Commission (GSMFC) and the identified by logbook entries may not be Aleutian Islands Pacific Cod Longline Sea Grant program to better monitor verified. Not all species or stocks Fishery, AK Bering Sea and Aleutian bottlenose dolphin takes in the ‘‘Gulf of identified are the reason for a fishery’s Islands Rockfish Longline, and AK Mexico Blue Crab Trap/Pot Fishery,’’ to placement in a given category. There are Bering Sea and Aleutian Islands educate fishers about marine mammal a few fisheries that are in Category II Sablefish Longline Fishery. interaction issues and ways to reduce that have no recently documented

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interactions with marine mammals. discussed in the final LOF for 1996 (60 Table 1 lists commercial fisheries in Justifications for placement of these FR 67063, December 28, 1995), and the Pacific Ocean (including Alaska); fisheries are by analogy to other gear according to factors listed in the Table 2 lists commercial fisheries in the types that are known to cause mortality definition of ‘‘Category II fishery’’ in 50 Atlantic Ocean, Gulf of Mexico, and or serious injury of marine mammals, as CFR 229.2. Caribbean.

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BILLING CODE 3510–22–C

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Classification rulemaking actions. Further, if a vessel significant change in the management of The Chief Counsel for Regulation of is requested to carry an observer, fishers reclassified fisheries, and therefore, this the Department of Commerce certified will not incur any economic costs proposed rule is not expected to change to the Chief Counsel for Advocacy of the associated with carrying that observer. the analysis or conclusion of the 1995 Small Business Administration that this This proposed rule contains EA. If NMFS takes a management proposed rule would not have a collection-of-information requirements action, for example, through the significant economic impact on a subject to the Paperwork Reduction Act. development of a Take Reduction Plan substantial number of small entities. For The collection of information for the (TRP), NMFS will first prepare an convenience, the factual basis leading to registration of fishers under the MMPA environmental document as required the certification is repeated below. has been approved by the Office of under NEPA specific to that action. Under existing regulations, all fishers Management and Budget (OMB) under This proposed rule would not affect participating in Category I or II fisheries must OMB control number 0648–0293 (0.25 species listed as threatened or register under the MMPA, obtain an hours per report for new registrants and endangered under the Endangered Authorization Certificate, and pay a fee of 0.15 hours per report for renewals). The $25. Additionally, fishers may be subject to Species Act (ESA) or their associated requirement for reporting marine critical habitat. The impacts of a take reduction plan and requested to carry mammal injuries or moralities has been an observer. The Authorization Certificate numerous fisheries have been analyzed authorizes the taking of marine mammals approved by OMB under OMB control in various biological opinions, and this incidental to commercial fishing operations. number 0648–0292 (0.15 hours per proposed rule will not affect the NMFS has estimated that approximately report). These estimates include the conclusions of those opinions. The 41,600 fishing vessels, most of which are time for reviewing instructions, classification of fisheries on the LOF is small entities, operate in Category I or II searching existing data sources, fisheries, and therefore, are required to not considered to be a management gathering and maintaining the data action that would adversely affect register. However, registration has been needed, and completing and reviewing integrated with existing state or Federal threatened or endangered species. If registration programs for the majority of these the collection of information. Send NMFS takes a management action, for fisheries so that the majority of fishers do not comments regarding these reporting example, through the development of a need to register separately under the MMPA. burden estimates or any other aspect of TRP, NMFS would conduct consultation Currently, approximately 5,800 fishers the collections of information, including under section 7 of the ESA for that register directly with NMFS under the suggestions for reducing burden, to action. MMPA authorization program. NMFS and OMB (see ADDRESSES). This rule proposes to elevate the Hawaii Notwithstanding any other provision This proposed rule would have no Swordfish, Tuna, Billfish, Mahi Mahi, of law, no person is required to respond adverse impacts on marine mammals Wahoo, Oceanic Sharks Longline/Set Line to nor shall a person be subject to a and may have a positive impact on Fishery to Category I in the LOF. Therefore marine mammals by improving participants in this fishery (140 participants) penalty for failure to comply with a would be required to register under the collection of information subject to the knowledge of marine mammals and the MMPA. requirements of the Paperwork fisheries interacting with marine Though this proposed rule would Reduction Act unless that collection of mammals through information collected affect a number of small entities, the $25 information displays a currently valid from observer programs or take registration fee, with respect to OMB control number. reduction teams. anticipated revenues, is not considered This proposed rule has been This proposed rule would not affect a significant economic impact. If a determined to be not significant for the the land or water uses or natural vessel is requested to carry an observer, purposes of Executive Order 12866. resources of the coastal zone, as fishers will not incur any economic An environmental assessment (EA) specified under section 307 of the costs associated with carrying that was prepared under the National Coastal Zone Management Act. observer. As a result of this certification, Environmental Policy Act (NEPA) for an initial regulatory flexibility analysis regulations to implement section 118 of Dated: April 8, 2004. was not prepared. In the event that the MMPA (1995 EA). The 1995 EA William T. Hogarth, reclassification of a fishery to Category concluded that implementation of those Assistant Administrator for Fisheries, I or II results in a take reduction plan, regulations would not have a significant National Marine Fisheries Service. economic analyses of the effects of that impact on the human environment. This [FR Doc. 04–8383 Filed 4–12–04; 8:45 am] plan will be summarized in subsequent proposed rule would not make any BILLING CODE 3510–22–S

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Notices Federal Register Vol. 69, No. 71

Tuesday, April 13, 2004

This section of the FEDERAL REGISTER SUMMARY: M. Darrel Dominick, airport, the complex includes the contains documents other than rules or responsible Federal official for projects Auburn Intermodal facility, as well as proposed rules that are applicable to the administered under the provisions of land planned for industrial park public. Notices of hearings and investigations, Public Law 106–472, in the State of development. An additional site is committee meetings, agency decisions and Oklahoma, is hereby providing located at 123 Rodman Road. The rulings, delegations of authority, filing of petitions and applications and agency notification that a record of decision to complex is owned by public and private statements of organization and functions are proceed with the installation of the companies, and the City of Auburn is in examples of documents appearing in this Cavalry Creek Watershed Site 6 project the process of acquiring the land needed section. is available. Single copies of this record to promote industrial development. The of decision may be obtained from M. Rodman Road site is a privately-owned Darrel Dominick at the address shown site. DEPARTMENT OF AGRICULTURE below. The application indicates a need for FOR FURTHER INFORMATION CONTACT: M. zone services in the Lewiston-Auburn Forest Service Darrel Dominick, State Conservationist, region. Several firms have indicated an Siskiyou County Resource Advisory Natural Resources Conservation Service, interest in using zone procedures for Committee State Office, 100 USDA Suite 206, warehousing/distribution activities. Stillwater, Oklahoma 74074–2655; Specific manufacturing approvals are AGENCY: Forest Service, USDA. telephone (405) 742–1227. not being sought at this time. Requests would be made to the Board on a case- ACTION: Notice of meeting. Dated: April 7, 2004. by-case basis. M. Darrel Dominick, SUMMARY: The Siskiyou County State Conservationist. In accordance with the Board’s regulations, a member of the FTZ Staff Resource Advisory Committee will meet (This activity is listed in the Catalog of in Yreka, California, April 19, 2004. The Federal Domestic Assistance under No. has been designated examiner to meeting will include routine business 10.904, Watershed Protection and Flood investigate the application and report to including a discussion of larger scale Prevention, and is subject to the provisions the Board. projects and a RAC Web site. of Executive Order 12372, which requires As part of the investigation, the intergovernmental consultation with State DATES: Commerce examiner will hold a public The meeting will be held April and local officials). 19, 2004, from 4:30 p.m. until 6:30 p.m. hearing on May 11, 2004, at 1 p.m., [FR Doc. 04–8329 Filed 4–12–04; 8:45 am] Auburn City Hall, Council Chambers, 45 ADDRESSES: The meeting will be held at BILLING CODE 3410–16–P Spring Street, Auburn, ME 04210. the Yreka High School Library, Preece Way, Yreka, California. Public comment on the application is invited from interested parties. FOR FURTHER INFORMATION CONTACT: Don DEPARTMENT OF COMMERCE Submissions (original and 3 copies) Hall, RAC Coordinator, Klamath shall be addressed to the Board’s National Forest, (530) 841–4468 or Foreign-Trade Zones Board Executive Secretary at one of the electronically at [email protected]. [Docket 14–2004] following addresses: SUPPLEMENTARY INFORMATION: The 1. Submissions via Express/Package meeting is open to the public. Public Proposed Foreign-Trade Zone— Delivery Services: Foreign-Trade Zones comment opportunity will be provided Auburn, Maine; Application and Public Board, U.S. Department of Commerce, and individuals will have the Hearing Franklin Court Building—Suite 4100W, opportunity to address the Committee at 1099—14th Street NW., Washington, DC that time. An application has been submitted to the Foreign-Trade Zones (FTZ) Board 20005; or Dated: April 5, 2004. (the Board) by the Lewiston-Auburn 2. Submissions via the U.S. Postal Margaret J. Boland, Economic Growth Council (a Maine not- Service: Foreign-Trade Zones Board, Designated Federal Official. for-profit corporation), to establish a U.S. Department of Commerce, FCB— [FR Doc. 04–8290 Filed 4–12–04; 8:45 am] general-purpose foreign-trade zone in Suite 4100W, 1401 Constitution Avenue BILLING CODE 3410–11–M Auburn (Androscoggin County), Maine, NW., Washington, DC 20230. within the Portland Customs port of The closing period for their receipt is entry. The FTZ application was June 14, 2004. Rebuttal comments in DEPARTMENT OF AGRICULTURE submitted pursuant to the provisions of response to material submitted during the FTZ Act, as amended (19 U.S.C. 81a- the foregoing period may be submitted Natural Resources Conservation 81u), and the regulations of the Board during the subsequent 15-day period (to Service (15 CFR Part 400). It was formally filed June 28, 2004). A copy of the application and Cavalry Creek Watershed Site 6, on April 5, 2004. The applicant is accompanying exhibits will be available Washita County, OK authorized to make the proposal under Maine Revised Code 13062(D). for public inspection at the Office of the AGENCY: Natural Resources The proposed zone consists of 760 Foreign-Trade Zones Board’s Executive Conservation Service, USDA. acres located principally at the Auburn/ Secretary at the first address listed Lewiston Municipal Airport/Industrial above, and at the Lewiston-Auburn ACTION: Notice of availability of record Park complex, on Lewiston Junction Economic Growth Council, 95 Park of decision. Road in Auburn. In addition to the Street, Suite 411, Lewiston, Me 04243.

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Dated: April 5, 2004. 14th St. & Constitution Ave., NW., Background Dennis Puccinelli, Washington, DC 20230. On December 8, 2003, the Department Executive Secretary. The Assistant Secretary for published the preliminary results and [FR Doc. 04–8378 Filed 4–12–04; 8:45 am] Administration, with the concurrence of partial rescission of its administrative BILLING CODE 3510–DS–P the delegate of the General Counsel, review of the antidumping duty order formally determined on March 23, 2004, on certain hot-rolled carbon steel flat pursuant to Section 10(d) of the Federal products from Thailand. See Certain DEPARTMENT OF COMMERCE Advisory Committee Act, as amended (5 Hot-Rolled Steel from Thailand: U.S.C. app. 2 § (10)(d)), that the portion Preliminary Results and Partial Bureau of Industry and Security of this meeting dealing with pre- Rescission of Antidumping Duty decisional changes to the Commerce Information Systems Technical Administrative Review, 68 FR 68336 Control List and U.S. export control Advisory Committee; Notice of (December 8, 2003) (‘‘Preliminary policies shall be exempt from the Partially Closed Meeting Results’’). provisions relating to public meetings We invited parties to comment on the The Information Systems Technical found in 5 U.S.C. app. 2–§§ 10(a)(1) and Preliminary Results. On January 8, 2003, Advisory Committee (ISTAC) will meet 10 (a)(3). we received case briefs from SSI and on April 28 and 29, 2004, 9 a.m., in the For more information, contact Lee Nucor Corporation (‘‘the Petitioner’’). On Herbert C. Hoover Building, Room 3884, Ann Carpenter on 202–482–2583. January 12, 2003, we received rebuttal 14th Street between Pennsylvania Dated: April 7, 2004. briefs from SSI and the Petitioner. A Avenue and Constitution Avenue, NW., hearing was not requested. Washington, DC. The Committee Lee Ann Carpenter, advises the Office of the Assistant Committee Liaison Officer. Partial Rescission Secretary for Export Administration on [FR Doc. 04–8304 Filed 4–12–04; 8:45 am] In our preliminary results, we technical questions that affect the level BILLING CODE 3510–JT–M announced our preliminary decision to of export controls applicable to rescind the review with respect to information systems equipment and Nakornthai and Siam Strip because technology. DEPARTMENT OF COMMERCE these companies had no entries of hot- April 28 International Trade Administration rolled steel from Thailand during the POR. See Preliminary Results. We have Public Session received no new information [A–549–817] 1. Opening remarks and introductions. contradicting the decision. Therefore, 2. Comments or presentations by the Certain Hot-Rolled Carbon Steel Flat we are rescinding the administrative public. Products From Thailand: Final Results review with respect to Nakornthai and 3. Update on graphics processors. and Partial Rescission of Antidumping Siam Strip. 4. Discussion on developments in Duty Administrative Review Scope of the Antidumping Duty Order cryptography. 5. Discussion on system software and AGENCY: Import Administration, The products covered by this encryption. International Trade Administration, antidumping duty order are certain hot- 6. Discussion on wireless technology Department of Commerce. rolled carbon steel flat products of a and standards. rectangular shape, of a width of 0.5 inch 7. Discussion on semiconductors and SUMMARY: The Department of Commerce or greater, neither clad, plated, nor technology. (‘‘the Department’’) has conducted an coated with metal and whether or not 8. Discussion on crypto in networking. administrative review of the painted, varnished, or coated with 9. Discussion on classification and antidumping duty order on certain hot- plastics or other non-metallic crypto for management. rolled carbon steel flat products from substances, in coils (whether or not in April 29 Thailand produced and/or exported by successively superimposed layers), Sahaviriya Steel Industries Public regardless of thickness, and in straight Closed Session Company Limited (‘‘SSI’’), Nakornthai lengths, of a thickness of less than 4.75 10. Discussion of matters determined Strip Mill Public Co., Ltd. mm and of a width measuring at least to be exempt from the provisions (‘‘Nakornthai’’), and Siam Strip Mill 10 times the thickness. Universal mill relating to public meetings found in 5 Public Co., Ltd. (‘‘Siam Strip’’). The plate (i.e., flat-rolled products rolled on U.S.C. app. 2–§§ 10(a)(1) and 10(a)(3). period of review (‘‘POR’’) is May 3, four faces or in a closed box pass, of a A limited number of seats will be 2001, through October 31, 2002. Based width exceeding 150 mm, but not available for the public session. on our analysis of comments received, exceeding 1250 mm, and of a thickness Reservations are not accepted. To the these final results remain unchanged of not less than 4.0 mm, not in coils and extent time permits, members of the from the Preliminary Results. The final without patterns in relief) of a thickness public may present oral statements to results are listed below in the ‘‘Final not less than 4.0 mm is not included the Committee. The public may submit Results of Review’’ section. within the scope of this order. written statements at any time before or EFFECTIVE DATE: April 13, 2004. Specifically included within the after the meeting. However, to facilitate scope of this order are vacuum distribution of public presentation FOR FURTHER INFORMATION CONTACT: degassed, fully stabilized (commonly materials to Committee members, the Helen Kramer at (202) 482–0405 or Ann referred to as interstitial-free (IF)) steels, Committee suggests that public Barnett-Dahl at (202) 482–3833, Import high strength low alloy (HSLA) steels, presentation materials or comments be Administration, International Trade and the substrate for motor lamination forwarded before the meeting to the Administration, U.S. Department of steels. IF steels are recognized as low address listed below: Ms. Lee Ann Commerce, 14th Street and Constitution carbon steels with micro-alloying levels Carpenter, Advisory Committees MS: Ave, NW., Washington, DC 20230. of elements such as titanium or niobium 1009D, U.S. Department of Commerce, SUPPLEMENTARY INFORMATION: (also commonly referred to as

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columbium), or both, added to stabilize and which have assumed the character Memorandum can be accessed directly carbon and nitrogen elements. HSLA of articles or products classified outside on the Import Administration Web site steels are recognized as steels with chapter 72 of the HTSUS. at http://ia.ita.doc.gov/ under the micro-alloying levels of elements such The merchandise subject to this heading Federal Register Notices. The as chromium, copper, niobium, review is classified in the HTSUS at paper copy and electronic version of the vanadium, and molybdenum. The subheadings: 7208.10.15.00, Decision Memorandum are identical in substrate for motor lamination steels 7208.10.30.00, 7208.10.60.00, content. 7208.25.30.00, 7208.25.60.00, contains micro-alloying levels of Changes Since the Preliminary Results elements such as silicon and aluminum. 7208.26.00.30, 7208.26.00.60, Steel products to be included in the 7208.27.00.30, 7208.27.00.60, Based on our analysis of comments scope of this order, regardless of 7208.36.00.30, 7208.36.00.60, received and findings at verification, definitions in the Harmonized Tariff 7208.37.00.30, 7208.37.00.60, our preliminary results remain Schedule of the United States (HTSUS), 7208.38.00.15, 7208.38.00.30, unchanged. are products in which: (i) Iron 7208.38.00.90, 7208.39.00.15, Final Results of predominates, by weight, over each of 7208.39.00.30, 7208.39.00.90, Review We determine that the the other contained elements; (ii) the 7208.40.60.30, 7208.40.60.60, following dumping margins exist for the carbon content is 2 percent or less, by 7208.53.00.00, 7208.54.00.00, period May 3, 2001 through October 31, weight; and (iii) none of the elements 7208.90.00.00, 7211.14.00.90, 2002: listed below exceeds the quantity, by 7211.19.15.00, 7211.19.20.00, weight, respectively indicated: 7211.19.30.00, 7211.19.45.00, 7211.19.60.00, 7211.19.75.30, Manufacturer/Exporter Margin 1.80 percent of manganese, or (percent) 7211.19.75.60, and 7211.19.75.90. 2.25 percent of silicon, or Certain hot-rolled carbon steel flat 1.00 percent of copper, or SSI ...... 0.00 products covered by this review, 0.50 percent of aluminum, or including: Vacuum degassed fully 1.25 percent of chromium, or All other entries of the subject stabilized; high strength low alloy; and 0.30 percent of cobalt, or merchandise during the POR will be the substrate for motor lamination steel 0.40 percent of lead, or liquidated at the antidumping duty rate may also enter under the following tariff 1.25 percent of nickel, or in place at the time of entry. The numbers: 7225.11.00.00, 7225.19.00.00, 0.30 percent of tungsten, or Department will issue appropriate 7225.30.30.50, 7225.30.70.00, 0.10 percent of molybdenum, or assessment instructions directly to the 7225.40.70.00, 7225.99.00.90, 0.10 percent of niobium, or U.S. Customs and Border Protection 7226.11.10.00, 7226.11.90.30, 0.15 percent of vanadium, or (‘‘CBP’’) within 15 days of publication of 7226.11.90.60, 7226.19.10.00, 0.15 percent of zirconium. these final results of review. 7226.19.90.00, 7226.91.50.00, All products that meet the physical 7226.91.70.00, 7226.91.80.00, and Cash Deposit Requirements and chemical description provided 7226.99.00.00. Subject merchandise The following cash deposit above are within the scope of this may also enter under 7210.70.30.00, requirements will be effective upon review unless otherwise excluded. The 7210.90.90.00, 7211.14.00.30, publication of the final results of this following products, by way of example, 7212.40.10.00, 7212.40.50.00, and administrative review for all shipments are outside or specifically excluded 7212.50.00.00. of the subject merchandise entered, or from the scope of this order: Although the HTSUS subheadings are withdrawn from warehouse, for • Alloy hot-rolled steel products in provided for convenience and CBP consumption on or after the publication which at least one of the chemical purposes, the written description of the date, as provided for by section elements exceeds those listed above merchandise is dispositive. 751(a)(1) of the Act: (1) For the (including, e.g., American Society for companies named above, the cash Analysis of Comments Received Testing and Materials (ASTM) deposit rates will be the rates for these specifications A543, A387, A514, A517, The Department has received firms shown above, except that, for A506). comments from SSI and the Petitioner, exporters with de minimis rates (i.e., • Society of Automotive Engineers all of which are addressed in the ‘‘Issues less than 0.5 percent) no deposit will be (SAE)/American Iron & Steel Institute and Decision Memorandum’’ from required; (2) for previously-reviewed (AISI) grades of series 2300 and higher. Joseph A. Spetrini, Deputy Assistant producers and exporters with separate • Ball bearing steels, as defined in the Secretary, Import Administration, to rates, the cash deposit rate will be the HTSUS. James J. Jochum, Assistant Secretary, company-specific rate established for • Tool steels, as defined in the Import Administration, dated April 6, the most recent period for which they HTSUS. 2004 (’’Decision Memorandum’’), which were reviewed; and (3) for all other • Silico-manganese (as defined in the is hereby adopted by this notice. producers and exporters, the rate will be HTSUS) or silicon electrical steel with Attached to this notice as an Appendix 3.86 percent, the ‘‘all others’’ rate a silicon level exceeding 2.25 percent. is a list of the issues that SSI and the established in the less than fair value • ASTM specifications A710 and Petitioner have raised and to which we investigation (66 FR 49622, September A736. have responded in the Decision 28, 2001). These deposit requirements, • USS abrasion-resistant steels (USS Memorandum. Parties can find a when imposed, shall remain in effect AR 400, USS AR 500). complete discussion of all issues raised until publication of the final results of • All products (proprietary or in this review and the corresponding the next administrative review. otherwise) based on an alloy ASTM recommendations in this public This notice also serves as a final specification (sample specifications: memorandum, which is on file in the reminder to importers of their ASTM A506, A507). Department’s Central Records Unit, responsibility under 19 CFR 351.402(f) • Non-rectangular shapes, not in located at 14th Street and Constitution to file a certificate regarding the coils, which are the result of having Avenue, NW., Room B–099. In addition, reimbursement of antidumping duties been processed by cutting or stamping a complete version of the Decision prior to liquidation of the relevant

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entries during this review period. of Commerce, 14th Street and This notice is issued and published Failure to comply with this requirement Constitution Avenue, N.W., pursuant to sections 733(f) and 777(i) of could result in the Secretary’s Washington, DC 20230; telephone: (202) the Act. presumption that reimbursement of 482–3207, (202) 482–3434, respectively. Dated: April 6, 2004. antidumping duties occurred and the SUMMARY: The Department of Commerce James J. Jochum, subsequent assessment of doubled ‘‘ ( Department’’) is postponing the Assistant Secretary for Import antidumping duties. preliminary determination in the Administration. This notice also serves as a reminder antidumping duty investigation of [FR Doc. 04–8374 Filed 4–12–04; 8:45 am] to parties subject to administrative wooden bedroom furniture from the protective orders (‘‘APO’’) of their People’s Republic of China (‘‘PRC’’) from BILLING CODE 3510–DS–S responsibility concerning the return or April 28, 2004, until no later than June destruction of proprietary information 17, 2004. This postponement is made DEPARTMENT OF COMMERCE disclosed under APO in accordance pursuant to section 733(c)(1)(A) of the with 19 CFR 351.305, which continues Tariff Act of 1930, as amended (‘‘the International Trade Administration to govern business proprietary Act’’). information in this segment of the [A–489–812] proceeding. Timely written notification SUPPLEMENTARY INFORMATION: Light-Walled Rectangular Pipe and of the return/destruction of APO Postponement of Preliminary Tube from Turkey; Notice of materials or conversion to judicial Determination Preliminary Determination of Sales at protective order is hereby requested. Less Than Fair Value and Failure to comply with the regulations On December 17, 2003, the Postponement of Final Determination and terms of an APO is a violation, Department published the initiation of the antidumping duty investigation of which is subject to sanction. AGENCY: Import Administration, imports of wooden bedroom furniture We are issuing and publishing this International Trade Administration, from the PRC. See Initiation of determination and notice in accordance Department of Commerce. Antidumping Duty Investigation: with sections 751(a)(1) and 777(i)(1) of ACTION: Notice of preliminary the Act. Wooden Bedroom Furniture from the People’s Republic of China, 68 FR 70228 determination of sales at less than fair Dated: April 6, 2004. (December 17, 2003). The notice of value and postponement of final James J. Jochum, initiation stated that we would make determination. Assistant Secretary for Import our preliminary determination for this EFFECTIVE DATE: Administration. antidumping duty investigation no later April 13, 2004. FOR FURTHER INFORMATION CONTACT: Appendix than 140 days after the date of issuance of the initiation. Paige Rivas (Guven) at (202) 482–0651; List of Comments and Issues in the Decision 1 Timothy Finn or Drew Jackson (MMZ) Memorandum On March 31, 2004, Petitioners made a timely request pursuant to 19 CFR at (202) 482–0065, and (202) 482–4406, 1. Date of Sale §351.205(e) for a fifty-day postponement respectively; and Mark Manning 2. Home Market Duty Drawback (Ozborsan) at (202) 482–5253, AD/CVD 3. Margin Adjustment for Export Subsidy of the preliminary determination, or until June 17, 2004. Petitioners Enforcement Office IV, Group II, Import 4. Slab Costs Administration, Room 1870, 5. Income Offsets to the General and requested postponement of the Administrative Expenses preliminary determination because it International Trade Administration, 6. Financial Expense Offset believes additional time is necessary to U.S. Department of Commerce, 14th [FR Doc. 04–8373 Filed 4–12–04; 8:45 am] allow Petitioners to review the Street and Constitution Avenue, NW., Washington, DC 20230. BILLING CODE 3510–DS–P responses to the supplemental questionnaires and submit comments to SUPPLEMENTARY INFORMATION: the Department, and also to allow the Preliminary Determination DEPARTMENT OF COMMERCE Department time to analyze thoroughly the respondents’ data and to seek The Department of Commerce (the International Trade Administration additional information, if necessary. Department) preliminarily determines that light-walled rectangular pipe and [A-570–890] For the reasons identified by the Petitioners, and because there are no tube (LWRPT) from Turkey is being Notice of Postponement of Preliminary compelling reasons to deny the request, sold, or is likely to be sold, in the Determination of Antidumping Duty we are postponing the preliminary United States at less than fair value Investigation of Wooden Bedroom determination under section 733(c)(1) of (LTFV), as provided in section 733 of Furniture from the People’s Republic the Act. Therefore, the preliminary the Tariff Act of 1930, as amended (the of China determination is now due no later than Act). The estimated margins of sales at June 17, 2004. The deadline for the final LTFV are shown in the Suspension of AGENCY: Import Administration, Liquidation section of this notice. International Trade Administration, determination will continue to be 75 Department of Commerce. days after the date of the preliminary Case History determination. ACTION: Notice of Postponement of On September 9, 2003, the Preliminary Determination of Department received a petition for the 1 Petitioners are: American Furniture Antidumping Duty Investigation. Manufacturers Committee for Legal Trade and its imposition of antidumping duties on individual members; the Cabinet Makers, Millmen LWRPT from Mexico and Turkey, filed EFFECTIVE DATE: April 13, 2004. and Industrial Carpenters Local 721; UBC Southern in proper form by California Steel and FOR FURTHER INFORMATION CONTACT: Council of Industrial Workers Local Union 2305; Tube, Hannibal Industries, Inc., Leavitt United Steel Workers of America Local 193U; Catherine Bertrand or Robert Bolling, Carpenters Industrial Union Local 2093; and Tube Company, LLC, Maruichi Import Administration, International Teamsters, Chauffeurs, Warehouseman and Helpers American Corporation, Northwest Pipe Trade Administration, U.S. Department Local 991. Company, Searing Industries, Inc., Vest

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Inc., and Western Tube and Conduit to be sold in the United States at LTFV. Department requested that Ozdemir Corporation (collectively, the See Light-Walled Rectangular Pipe and submit its response to section A of the petitioners). See Letter from petitioners Tube from Mexico and Turkey, 68 FR questionnaire by March 12, 2004. On to Secretary Evans of the Department 61829 (October 30, 2003). March 17, 2004, the Department notified and Secretary Abbott of the U.S. On November 14, 2003, the Ozdemir that its response to section A International Trade Commission (ITC), Department selected Guven Boru Ve. of the questionnaire was past due and ‘‘Petition for the Imposition of Profil San. Ve. Tic. Ltd. Sti. (Guven), requested that Ozdemir notify the Antidumping Duties: Light-Walled MMZ, Ozborsan Boru San. Ve. Tic. Department by March 22, 2004, if it had Rectangular Pipe and Tube from Mexico (Ozborsan) (collectively, respondents), encountered unexpected difficulties in and Turkey,’’ dated September 9, 2003 as mandatory respondents in this submitting its response. On March 18, (Petition). The Department initiated the investigation. See Memorandum from 2004, Ozdemir sent a letter to the antidumping investigation of LWRPT Mark Manning, Senior Import Department in which it requested a two from Turkey on September 29, 2003. See Compliance Specialist, to Thomas F. week extension of the deadline for Notice of Initiation of Antidumping Futtner, Acting Office Director, submitting its section A response. On Investigations: Light-Walled Rectangular ‘‘Selection of Respondents for the March 22, 2004, Ozdemir provided an Pipe and Tube from Mexico and Turkey, Antidumping Investigation of Light- incomplete response to section A of the 68 FR 57667 (October 6, 2003) Walled Rectangular (LWR) Pipe and Department’s questionnaire. (Initiation Notice). Since the initiation Tube from Turkey,’’ dated November 14, Furthermore, Ozdemir did not provide a of this investigation, the following 2003, (Respondent Selection Memo). response to sections B, C, and D of the events have occurred. On November 21, 2003, the questionnaire, which were due on On October 14 and 15, 2003, the Department issued sections A-E of its March 26, 2004, nor did it request an Department issued a shortened version antidumping questionnaire to the extension of this deadline. of section A 1 of the antidumping respondents, which included the questionnaire to eighteen pipe and tube Department’s final physical product Postponement of the Final producers in Turkey, in which each characteristics to be used to make fair Determination company was asked to provide the value comparisons. Section D of the Section 735(a)(2) of the Act provides quantity and value of its shipments of questionnaire included special that a final determination may be instructions on how to report costs of subject merchandise to the United postponed until not later than 135 days production in an economy experiencing States during the period of investigation after the date of the publication of the (POI). The Department received high inflation. We received responses to section A of preliminary determination if, in the responses from these companies during event of an affirmative preliminary the period October 24, 2003 through the questionnaire from MMZ and Ozborsan on December 17, 2003, and determination, a request for such November 10, 2003. postponement is made by exporters who On October 17, 2003, the Department from Guven on January 12, 2004. We account for a significant proportion of issued to interested parties a set of received responses to sections B, C, and exports of the subject merchandise, or in proposed physical product D of the questionnaire from MMZ and the event of a negative preliminary characteristics that it intends to use to Ozborsan in January 2004, and from determination, a request for such make its fair value comparisons. The Guven in February 2004. We issued postponement is made by the Department received comments on its supplemental questionnaires, pertaining petitioners. The Department’s proposed physical product to sections A through D of the regulations, at 19 CFR 351.210(e)(2), characteristics from MMZ Onur Boru questionnaire, to the respondents from require that requests by respondents for Profil Uretim San. Ve. Tic A.S. (MMZ) January through March 2004. postponement of a final determination and Noksel Celik Boru Sanayi A.S. Respondents replied to these be accompanied by a request for an (Noksel) on October 28, 2003. The supplemental questionnaires in extension of the provisional measures Department received rebuttal comments February and March 2004. Ozborsan from a four-month period to not more from the petitioners and Yucel Boru Ve filed its response and supplemental than six months. Profil A.S. (Yucel Boru) on November 4, responses to the Department’s 2003. questionnaires on a joint basis with its On March 19, 2004, Ozborsan/Onur On October 24, 2003, the ITC sister company, Onur Metal (Onur). requested that, in the event of an preliminarily determined that there is a On January 28, 2004, petitioners affirmative preliminary determination reasonable indication that an industry submitted a letter in support of the in this investigation, the Department in the United States is materially postponement of the preliminary postpone its final determination until injured by reason of imports of LWRPT determination. On February 5, 2004, 135 days after the publication of the from Mexico and Turkey that are alleged pursuant to section 733(c)(1)(B) of the preliminary determination. Ozborsan/ Act, the Department postponed the Onur also included a request to extend 1 Section A of the questionnaire requests general preliminary determination of this the period for any provisional measures information concerning a company’s corporate investigation by 50 days, from February from a period of four months to not structure and business practices, the merchandise 16, 2004, until April 6, 2004. See Light- more than six months after the under investigation, and the manner in which it sells that merchandise in all of its markets. Section walled Pipe and Tube from Mexico and publication of the preliminary B requests a complete listing of all of the company’s Turkey: Notice of Postponement of determination. Accordingly, since we home market sales of foreign like product or, if the Preliminary Antidumping Duty have made an affirmative preliminary home market is not viable, of sales of the foreign Determinations, 69 FR 5487 (February 5, determination, and the requesting like product in the most appropriate third-country market (this section is not applicable to respondents 2004). parties account for a significant in non-market economy cases). Section C requests On February 19, 2004, the Department proportion of exports of the subject a complete listing of the company’s U.S. sales of issued the antidumping duty merchandise, we have postponed the subject merchandise. Section D requests questionnaire to Ozdemir Boru Profil final determination until not later than information on the cost of production of the foreign like product and the constructed value of the San. Ve. Tic. Ltd. Sti. (Ozdemir) in order 135 days after the date of the merchandise under investigation. Section E to examine its relationship with certain publication of the preliminary requests information on further manufacturing. other Turkish respondents. The determination.

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Period of Investigation average individual dumping margins for involvement in production and pricing The POI is July 1, 2002, through June each known exporter and producer of decisions, sharing facilities/employees, 30, 2003. See 19 CFR 351.204(b)(1). the subject merchandise. Where it is not and/or significant transactions between practicable to examine all known the two affiliated producers). Scope Comments producers/exporters of subject Guven, Ozborsan, and Ozdemir are In accordance with the preamble to merchandise, section 777A(c)(2) of the owned by three brothers, each of which the Department’s regulations (see Act permits the Department to owns the largest percentage of shares in Antidumping Duties; Countervailing investigate either (1) a sample of his respective company. In addition, the Duties, 62 FR 27296, 27323 (May 19, exporters, producers, or types of brother who owns the largest percentage 1997)), we set aside a period of time for products that is statistically valid based of shares of Ozborsan is also a parties to raise issues regarding product on the information available at the time significant shareholder of Ozborsan’s coverage of the scope of the of selection, or (2) exporters and sister company, Onur. The Department investigation and encouraged all parties producers accounting for the largest considers these three brothers to be to submit comments on product volume of the subject merchandise from ‘‘affiliated persons’’ pursuant to section coverage within 20 calendar days of the exporting country that can 771(33)(A) of the Act. See Final Results publication of the Initiation Notice (see reasonably be examined. As guidance in of Antidumping Duty Administrative 68 FR 57668). As noted above, no selecting respondents, the petitioners Review: Certain Welded Carbon Steel comments were submitted to the record provided a copy of the chapter on Pipes and Tubes from Thailand, 62 FR of this investigation. However, certain Turkish companies from the 14th 53808 (October 16, 1997). Mexican producers and the petitioners edition of Iron and Steel Works of the Further, the Department considers provided comments regarding the scope World, published by Metal Bulletin Guven, Onur, Ozborsan, and Ozdemir to of these investigations. See the Books, in addition to a list of Turkish be affiliated according to section preliminary determination of the steel tube manufacturers. See Petition at 771(33)(F) of the Act (‘‘two or more antidumping investigation on LWRPT Exhibit 7B. U.S. Customs and Border persons directly or indirectly, controlled from Mexico. Protection (CBP) import statistics by, or under common control with, any identify eighteen exporters/producers of person,’’ shall be considered to be Scope of Investigation subject merchandise during the POI. affiliated). The merchandise covered by this However, due to limited resources, we Section 771(33) of the Act states that investigation is LWRPT from Turkey, determined that we could investigate ‘‘a person shall be considered to control which are welded carbon-quality pipe only the three Turkish producers/ another person if the person is legally or and tube of rectangular (including exporters that accounted for the largest operationally in a position to exercise square) cross-section, having a wall volume of exports to the United States restraint or direction over the other thickness of less than 0.156 inch. These during the POI. See Respondent person.’’ Although this section of the LWRPT have rectangular cross sections Selection Memo. Therefore, we selected statute uses the singular phrase ‘‘any ranging from 0.375 x 0.625 inches to 2 Guven, MMZ, and Ozborsan as person,’’ the Court of International x 6 inches, or square cross sections mandatory respondents in this Trade (CIT) has recognized that ‘‘the ranging from 0.375 to 4 inches, investigation. singular word ‘person’ can be regardless of specification. LWRPT are interpreted to encompass a ‘family’ in Collapsing currently classifiable under item order to carry out the intent of the number 7306.60.5000 of the Section 771(33)(A) of the Act states statute.’’ See Ferro Union, Inv. v. United Harmonized Tariff System of the United that affiliated persons include, States, 44 F. Supp. 2d at 1326 citing St. States (HTSUS). The HTSUS item ‘‘{m}embers of a family, including Louis v. Missouri, 263 U.S. 640, 657, number is provided for convenience and brothers and sisters (whether by the 68L. ED. 486, 44 S. Ct. 213 (1924), customs purposes only. The written whole or half blood), spouse, ancestors, (‘‘words importing the singular may product description of the scope is and lineal descendants.’’ In addition, {not} extend and be applied to several dispositive. section 771(33)(F) of the Act states that, persons or things * * * except where it The term ‘‘carbon-quality’’ applies to ‘‘two or more persons directly or is necessary to carry out the evident products in which (i) iron indirectly controlling, controlled by, or intent of the statute (emphasis added).’’) predominates, by weight, over each of under common control with, any (Ferro Union). As the CIT noted in Ferro the other contained elements, (ii) the person,’’ shall be considered to be Union, ‘‘the intent of 19 U.S.C. 1677(33) carbon content is 2 percent or less, by affiliated. Furthermore, under 19 CFR was to identify control exercised weight, and (iii) none of the elements 351.401(f), we will treat ‘‘two or more through ‘corporate or family groupings.’ listed below exceeds the quantity, by affiliated producers as a single entity SAA {Statement of Administrative weight, respectively indicated: 1.80 where those producers (1) Have Action} at 838. By interpreting ‘family’ percent of manganese, or 2.25 percent of production facilities for similar or as a control person, Commerce was silicon, or 1.00 percent of copper, or identical products that would not giving effect to this intent.’’ See Ferro 0.50 percent of aluminum, or 1.25 require substantial retooling of either Union, 44 F. Supp. 2d at 1325; see also, percent of chromium, or 0.30 percent of facility in order to restructure 19 CFR 351.102(b) (‘‘{i}n determining cobalt, or 0.40 percent of lead, or 1.25 manufacturing priorities and (2) the whether control over another person percent of nickle, or 0.30 percent of Secretary concludes that there is exists, within the meaning of section tungsten, or 0.10 percent of significant potential for the 771(33) of the Act, the Secretary will molybdenum, or 0.10 percent of manipulation of price or production’’ consider the following factors, among niobium (also called columbium), or based on factors such as: (a) The level others: corporate or family groupings 0.15 percent of vanadium, or 0.15 of common ownership; (b) the extent to * * *). Additionally, in past cases percent of zirconium. which managerial employees or board involving control through corporate or members of one firm sit on the board of family groupings, the Department has Selection of Respondents the other firm; and (c) whether noted that the control factors of Section 777A(c)(1) of the Act directs operations are intertwined (e.g., through individual members of the group (e.g., the Department to calculate weight- sharing of sales information, stock ownership, management

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positions, board membership) are 5. On this basis, we find that Onur and Department’s section A of the considered in the aggregate. See Certain Ozborsan satisfy the first criterion. questionnaire, dated January 12, 2004, Cold-Rolled Flat-Rolled Carbon-Quality Guven and Ozborsan/Onur reported at page 5. Lastly, the third brother is the Steel Products From Brazil; Notice of in their respective responses to section founder and Managing Director of Final Determination of Sales at Less D of the questionnaire the use of an Ozdemir. This brother has ‘‘full Than Fair Value, 65 FR 5554, 5566 identical manufacturing process to authorization * * * to establish prices, (February 4, 2000). produce subject merchandise. Both selling and general expenses and With respect to Ozborsan and Onur, companies purchase hot-rolled and production costs.’’ See Ozdemir’s the brother who owns Ozborsan is also cold-rolled steel in coils; the coils are response to the Department’s section A a significant shareholder in Onur. first slit, then formed, welded, and cut of the questionnaire, dated March 22, Moreover, Ozborsan stated that Onur to length. Id. Furthermore, Guven and 2004, at page 2. In addition, this person has the same management structure as Ozborsan/Onur both produce subject has ‘‘full control and is the decision- Ozborsan (see Exhibit A–2 of Ozborsan’s merchandise in a wide variety of sizes marker’’ at Ozdemir. See Collapsing December 17, 2003, submission and and reported sales during the POI of Memorandum at 6. Due to the fact that Ozborsan/Onur’s March 29, 2004, nearly all of the same type of products key senior management positions in submission at 2). The management chart (CONNUMs) in their U.S. and Guven, Ozborsan/Onur, and Ozdemir that Ozborsan provided in Exhibit A–2 comparison-market databases. are held by members of this family, we indicates that the brother who owns the Ozdemir, in its incomplete response conclude that these close management largest percent of shares in Ozborsan is to section A of the questionnaire, stated relationships are another factor also Ozborsan’s ‘‘Head of Company.’’ that it manufactures pipes and tubes indicating a significant potential for the Thus, this person is both a signifcant using coils of hot-rolled and cold-rolled manipulation of price or production shareholder in Onur and is also the steel. Ozdemir also indicated that it between these companies. ‘‘Head of Company’’ for Onur. produces both square and rectangular Third, regarding the intertwining of Furthermore, the brother who owns the pipe and tube, with outside perimeters operations, we have already indicated largest percentage of shares in Guven is and wall thicknesses covering the full that Ozborsan and Onur share the same range of products included in the scope also the President of Guven. The third production facilities and management of this investigation. Since all four brother, who owns the largest executives. Even though domestic sales companies manufacture a wide variety percentage of shares in Ozdemir, is also are credited to Onur, and export sales of sizes of subject merchandise utilizing the founder and Managing Director of are credited to Ozborsan, Onur’s a similar production process, we Ozdemir. employees do not strictly work on The brothers’ leadership positions conclude that Guven, Onur, Ozborsan, products sold in Turkey, and Ozborsan’s within these companies, as well as the and Ozdemir would not require employees do not strictly work on fact that the brothers own the largest substantial retooling of their facilities in products sold in export markets. percentage of shares in their respective order to restructure manufacturing companies, puts these brothers in a priorities. Furthermore, Ozborsan/Onur stated position to directly or indirectly control In analyzing the second criterion, that, on occasion, it and one of the other Guven, Onur, Ozborsan, and Ozdemir, whether there exists significant companies have swapped hot-rolled and thus satisfying the requirements of potential for manipulation of price or cold-rolled coils when size availability affiliation under section 771(33)(F) of production, we first consider the level was an issue. Id. at 7. Additionally, the Act. Based on the Department’s of ownership. We note that the three Ozborsan/Onur stated that all three of practice of considering companies or brothers own the largest percentage of the companies occasionally use each corporate groups under family control to shares in Guven, Ozborsan, and other’s trucks for shipments to the port be affiliated under section 771(33)(A) Ozdemir, respectively, and one of the and for transporting raw materials from and (F) of the Act, the Department three brothers is a significant the port to the factory. According to considers Guven, Onur, Ozborsan, and shareholder in Ozborsan’s sister Ozborsan/Onur, because these swaps Ozdemir to be affiliated. See company, Onur. Based upon this family were even exchanges (i.e., the quantity Memorandum from Thomas F. Futtner, ownership, we find that there is swapped by each company was the Acting Office Director, to Holly A. Kuga, common ownership of Guven, same), there was no financial Acting Deputy Assistant Secretary, Ozborsan/Onur, and Ozdemir and that transaction to record, and Ozborsan/ ‘‘Decision Memorandum: Whether to such ownership is one factor indicating Onur kept no file documenting such Collapse Certain Turkish Pipe and Tube a significant potential for the exchanges. Producers Into A Single Entity,’’ dated manipulation of price or production. The fact that Ozborsan/Onur does not April 6, 2004 (Collapsing See Collapsing Memorandum at 6. record such transactions in its inventory Memorandum). Second, in addition to being the records and freight ledger suggests that Regarding the first collapsing criterion shareholders owning the largest Ozborsan/Onur and the other company listed in 19 CFR 351.401(f) (producers percentage of shares, as indicated above, with which it exchanged coils consider with production facilities for similar or members of this family hold senior each other’s inventory and assets as a identical products), the evidence on the management positions within each pool from which both can freely draw. record indicates that Guven, Onur, company. One brother, who owns the In addition, although Ozborsan/Onur Ozborsan, and Ozdemir produce subject largest percentage of shares in Ozborsan, characterizes such swaps as occurring merchandise. Ozborsan stated that it is a member of Ozborsan’s Board of ‘‘in a few instances’’ and ‘‘occasionally,’’ produces subject merchandise at the Directors and is also the ‘‘Head of the fact that it did not quantify the same production facility as Onur. Company’’ for both Ozborsan and Onur. volume of such transactions leaves open Production by Ozborsan and Onur is Another brother is the President of the question of how often such swaps fully integrated; workers from both Guven and his son is the General occurred. Lastly, since Ozborsan/Onur companies work on the same shifts to Manager of Guven, whose and the other company own their own fulfill the same production orders— responsibilities include ‘‘strategic/ trucks, the fact that they shared these whether for the home market or for economic planning’’ and ‘‘procurement/ trucks with each other during the POI is export. See Collapsing Memorandum at sourcing.’’ See Guven’s response to the evidence of shared facilities.

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In addition, Guven reported that information if all of the following description of its production process; (5) during the POI it had several requirements are met: (1) The detailed cost build-ups for the requested transactions with one of the other two information is submitted by the models sold in the third country and companies owned by the family. established deadline; (2) the information home markets; (6) an explanation of its Specifically, Guven stated that it sold a can be verified; (3) the information is cost response methodology; (7) an significant quantity of subject and non- not so incomplete that it cannot serve as explanation as to whether the reported subject tubes, in addition to a significant a reliable basis for reaching the costs were based on world-wide quantity of hot-rolled coil, to this other applicable determination; (4) the production quantities and not on any company. Guven also purchased a interested party has demonstrated that it specific market; (8) a reconciliation of significant quantity of tubes from this acted to the best of its ability; and (5) the production quantities to the sales company during the POI. Lastly, Guven the information can be used without quantities; and (9) the requested general reported that it purchased a small undue difficulties. and administrative (G&A) and financial amount of galvanized pipes from one of In this case, Guven, Ozborsan/Onur, expense ratios based on the indexed the other companies owned by the and Ozdemir have failed to provide monthly historical G&A and financial family. Id. at 8. pertinent information requested by the expenses and cost of goods sold for the Based upon the intertwined Department that is necessary to properly fiscal year 2003. In addition, Guven did operations described above, the calculate antidumping margins for its not report significant expense items for Department concludes that these preliminary determination. Specifically, months for which production was interactions indicate that there is a Ozborsan/Onur failed to provide the reported. As a result of Guven’s failure significant potential for the following requested information, all of to provide the above requested manipulation of price or production which is necessary to complete the information, the Department is unable between these companies. Department’s calculations: (1) Product- to use the reported cost of Based on these reasons, we find that specific costs by CONNUM; (2) an manufacturing data to test home market Guven, Ozborsan/Onur, and Ozdemir explanation why the company was sales to determine whether the sales are affiliated producers with similar or unable to determine the cost differences prices can form the basis for NV. identical production facilities that between products, or an explanation of Additionally, because of the noted would not require substantial retooling why the company believes that the omissions, the cost data cannot be used in order to restructure manufacturing differences are insignificant enough that for difference in merchandise purposes priorities. We also find that there exists there is no cost difference between or for calculating CV. Additionally, we a significant potential for the products; (3) a reconciliation of the total note that Guven did not respond to the manipulation of price or production. costs in the financial statements to the Department’s supplemental section D See Collapsing Memorandum. total costs reported to the Department; questionnaire by the established Therefore, we have collapsed Guven, (4) separate cost files for Ozborsan and deadline. Ozborsan/Onur, and Ozdemir, and are Onur which reconcile to each With respect to Ozdemir, the treating them as a single entity for company’s financial accounting system; company provided an incomplete purposes of the preliminary (5) a reconciliation of the production section A response, and failed to determination in this antidumping quantities to the sales quantities; (6) provide a response to sections B, C, and investigation. depreciation expense based on the D of the Department’s questionnaire. revaluated fixed asset values; and (7) Because Ozdemir withheld information Facts Available calculation of general and requested by the Department, the For the reasons discussed below, we administrative and financial expense Department will rely on the facts determine that the use of adverse facts ratios based on the fiscal year that most otherwise available in order to available is appropriate for the closely coincides with the period of determine a margin for Ozdemir. preliminary determination with respect investigation. In addition, Ozborsan/ Thus, in reaching our preliminary to Guven, Ozborsan/Onur, and Ozdemir. Onur stated that it ‘‘swapped’’ hot-rolled determination, pursuant to sections 776(a)(2)(A), (B), and (C) of the Act, we A. Use of Facts Available coils with one of the other companies. Ozborsan/Onur claims that no records have based Guven, Ozborsan/Onur, and Section 776(a)(2) of the Act provides are kept of such swaps, and Ozborsan/ Ozdemir’s dumping margin on facts that, if an interested party withholds Onur was unable to quantify these available. information requested by the transactions. As a result of Ozborsan/ Department, fails to provide such B. Application of Adverse Inferences for Onur’s failure to provide the above Facts Available information by the deadline or in the requested information, the Department form or manner requested, significantly is unable to use the reported cost of In applying facts otherwise available, impedes a proceeding, or provides manufacturing data to test home market section 776(b) of the Act provides that information which cannot be verified, sales to determine whether the sales the Department may use an inference the Department shall use, subject to prices can form the basis for the adverse to the interests of a party that section 782(d) and (e) of the Act, facts calculation of normal value (NV). has failed to cooperate by not acting to otherwise available in reaching the Additionally, because of the noted the best of its ability to comply with the applicable determination. Section omissions, the cost data cannot be used Department’s requests for information. 782(d) of the Act provides that if the for difference in merchandise purposes See, e.g., Notice of Final Determination Department determines that a response or for calculating constructed value of Sales at Less Than Fair Value and to a request for information does not (CV). Final Negative Critical Circumstances: comply with the Department’s request, With respect to Guven, the company Carbon and Certain Alloy Steel Wire the Department shall promptly inform failed to provide: (1) Any cost Rod from Brazil, 67 FR 55792, 55794– the responding party and provide an reconciliations; (2) product-specific 96 (August 30, 2002). Adverse opportunity to remedy the deficient costs and worksheets; (3) an explanation inferences are appropriate ‘‘to ensure submission. Section 782(e) of the Act of its cost accounting system and how that the party does not obtain a more further states that the Department shall costs were allocated between subject favorable result by failing to cooperate not decline to consider submitted and non-subject merchandise; (4) a than if it had cooperated fully.’’ See

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Statement of Administrative Action 2000) (the Department applied total information was available, we reviewed accompanying the Uruguay Round adverse facts available (AFA) where the adequacy and accuracy of the Agreements Act, H.R. Rep. No. 103–316, respondent failed to respond to the information in the petition and during at 870 (1994) (SAA). Furthermore, antidumping questionnaires). our pre-initiation analysis for both this ‘‘ preliminary determination. See Office of affirmative evidence of bad faith on the C. Selection and Corroboration of AD/CVD Enforcement Initiation part of a respondent is not required Information Used as Facts Available before the Department may make an Checklist, at 11 (September 29, 2003) adverse inference.’’ See Antidumping Where the Department applies AFA (Initiation Checklist). Also, as discussed Duties; Countervailing Duties, 62 FR because a respondent failed to cooperate below, we examined evidence 27355 (May 19, 1997). Although the by not acting to the best of its ability to supporting the calculations in the Department provided respondents with comply with a request for information, petition to determine the probative notice of the consequences of failure to section 776(b) of the Act authorizes the value of the margins in the petition for adequately respond to the questions, in Department to rely on information use as AFA for this preliminary this case, Guven, Ozborsan/Onur, and derived from the petition, a final determination. In accordance with determination, a previous Ozdemir have failed to timely provide section 776(c) of the Act, to the extent administrative review, or other complete and useable responses to the practicable, we examined the key information placed on the record. See Department’s section D questionnaires. elements of the export price (EP) and also 19 CFR 351.308(c); SAA at 829– See the Department’s letters to NV calculations on which the margins 831. In this case, because we are unable Ozborsan/Onur, Guven, and Ozdemir on in the petition were based. See to calculate margins based on Guven’s, Memorandum from Paige Rivas, February 27, 2004, March 12, 2004, and Ozborsan/Onur’s, and Ozdemir’s own March 17, 2004, respectively. The International Trade Analyst, to Tom data and because an adverse inference is Futtner, Acting Director, Office 4, Re: original questionnaire was issued on warranted, we have assigned to all three November 21, 2003, to which Ozborsan/ Corroboration of Data Contained in the companies the highest margin from the Petition for Assigning Facts Available Onur submitted its section D response proceeding, which is the highest margin on January 12, 2004 and Guven Rates, dated April 6, 2004 alleged for Turkey in the petition, as (Corroboration Memo). submitted its response on February 19, recalculated in the initiation and 2004. In order to address the described in detail below. See Initiation 1. Corroboration of Export Price deficiencies in Ozborsan/Onur’s Notice. The petitioners based EP on prices of response, the Department issued a As noted in the Corroboration of LWRPT obtained from U.S. distributors supplemental section D questionnaire Normal Value section below, the of products that are identical in size to on February 27, 2004. Ozborsan/Onur’s calculation of CV in the petition products manufactured and sold in response was received on March 16, contains an amount of zero for profit Turkey. The petitioners calculated net 2004. On March 12, 2004, the because the Turkish producer relied U.S. price by deducting international Department issued the supplemental upon for the calculation of the financial freight and U.S. import duties for the section D questionnaire to Guven. ratios reported a loss in its financial U.S. price quotes. We compared the U.S. Guven failed to respond to the statements. Although a publicly market price quotes with official U.S. supplemental section D questionnaire available amount for profit is not import statistics and found the prices by the established deadline of March 25, currently on the record of this used by the petitioners to be reliable. 2004. In these supplemental investigation, we will consider adding questionnaires we noted that in the profit to CV for the final determination 2. Corroboration of Normal Value previous submissions, Guven and in the event we are able to identify a With respect to the NV, the Ozborsan/Onur failed to provide publicly available amount for profit that petitioners obtained, through foreign requested detailed cost of is usable given the facts of this market research, two price quotes from manufacturing information necessary proceeding. resellers in Turkey for products for the Department to adequately When using facts otherwise available, manufactured by a major Turkish analyze the response. Guven and section 776(c) of the Act provides that, producer named in the Petition. The Ozborsan/Onur’s failure to provide this when the Department relies on petitioners calculated net Turkish prices critical information in a timely manner secondary information (such as the by deducting the average discount has rendered their entire submissions petition), it must, to the extent offered by the Turkish resellers from the inadequate and unusable for the practicable, corroborate that information price quotes. preliminary determination. In addition, from independent sources that are The petitioners also provided as discussed above, Ozdemir did not reasonably at its disposal. information demonstrating reasonable provide a response to sections B, C, and The SAA clarifies that ‘‘corroborate’’ grounds to believe or suspect that sales D of the questionnaire, which was due means that the Department will satisfy of LWRPT in the home market were on March 26, 2004. This constitutes a itself that the secondary information to made at prices below the fully absorbed failure on the part of these companies to be used has probative value. See SAA at cost of production (COP), within the cooperate to the best of their abilities to 870. The Department’s regulations state meaning of section 773(b) of the Act. comply with a request for information that independent sources used to Pursuant to section 773(b)(3) of the by the Department within the meaning corroborate such evidence may include, Act, COP consists of the cost of of section 776 of the Act. Therefore, the for example, published price lists, manufacturing (COM), selling, general, Department has preliminarily official import statistics and customs and administrative (SG&A) expenses, determined that in selecting from among data, and information obtained from financial expenses, and packing the facts otherwise available, an adverse interested parties during the particular expenses. The petitioners calculated inference is warranted. See, e.g., Notice investigation. See 19 CFR 351.308(d); COP based on the experience of a U.S. of Final Determination of Sales at Less see also SAA at 870. LWRPT producer, adjusted for known than Fair Value: Circular Seamless To assess the reliability of the petition differences between costs incurred to Stainless Steel Hollow Products from margin for the purposes of this produce LWRPT products in the United Japan, 65 FR 42985, 42986 (July 12, investigation, to the extent appropriate States and Turkey using publicly

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available data. To calculate SG&A and Product Comparisons This methodology minimizes the extent financial expenses, the petitioners relied In accordance with section 771(16) of to which calculated dumping margins upon amounts reported in the 2002 the Act, all products manufactured by are overstated or understated due solely financial statements of Borusan Holding the respondents in the home market and to price inflation that occurred in the A.S., which is the parent company of covered by the description contained in intervening period between the U.S. and Mannesman Boru, a major producer of the Scope of Investigation section, home market sales. See Notice of the subject merchandise in Turkey. above, and sold in the home market Preliminary Determination of Sales at Based upon a comparison of the price during the POI are considered to be Less Than Fair Value; Certain Cold- of the foreign like product to the foreign like products for purposes of Rolled Carbon Steel Flat Products From calculated COP, we found reasonable determining appropriate product Turkey, 67 FR 31264 (May 9, 2002); see grounds to believe or suspect that sales comparisons to U.S. sales. We have also Notice of Final Determination of of the foreign like product were made relied upon seven criteria to match U.S. Sales at Less Than Fair Value; Certain below the COP, within the meaning of sales of subject merchandise to Cold-Rolled Carbon Steel Flat Products section 773(b)(2)(A)(i) of the Act. comparison-market sales of the foreign From Turkey, 67 FR 62126 (October 3, 2002). Accordingly, the Department initiated a like product: steel type, galvanized country-wide cost investigation. For coating, whether the merchandise was Export Price painted or primed, outside perimeter, initiation purposes and for the purposes In calculating U.S. price, the wall thickness, shape, and finish. Where of this preliminary determination, we Department used EP, as defined in there were no sales of identical corrected the petitioners’ conversion section 772(a) of the Act, because the merchandise in the home market to from dollars per metric ton to dollars merchandise was sold, prior to compare to U.S. sales, we compared per hundred feet for the 55mm x 50mm importation, by MMZ to unaffiliated U.S. sales to the next most similar x 3mm product. See Initiation Checklist purchasers in the United States. Section foreign like product on the basis of the at 11 and Attachment III. 772(a) of the Act defines EP as the price characteristics listed above. Pursuant to sections 773(a)(4), 773(b) at which the subject merchandise is first and 773(e) of the Act, the petitioners Fair Value Comparisons sold (or agreed to be sold) before the based NV on CV. The petitioners To determine whether sales of date of importation by the exporter or calculated CV using the same COM, LWRPT from Turkey were made in the producer outside the United States to an SG&A and financial expense figures United States at LTFV, we compared the unaffiliated purchaser for exportation to used to compute the COP. Consistent EP to the NV, as described in the Export the United States, as adjusted under with section 773(e)(2) of the Act, the Price and Normal Value sections of this subsection 772(c) of the Act. We petitioners included in CV an amount notice. In accordance with section calculated EP based on the packed for profit. For profit, the petitioners 777A(d)(1)(A)(i) of the Act, we prices charged to unaffiliated customers relied upon amounts reported in calculated weighted-average EPs. We in the United States. In accordance with Borusan Holding A.S.’s 2002 financial compared these to weighted-average section 772(c)(2)(A) of the Act, we made statements. However, the profit home market prices in Turkey. deductions from the starting price, amounted to zero because Borusan Based on our examination of Turkey’s where applicable, for foreign movement reported a loss in its financial inflation indices, we determined that expenses, including brokerage and statements. the Turkish economy was experiencing handling and inland freight. The Department interprets section For purposes of corroborating CV, we high inflation during the POI. ‘‘High 772(c)(1)(B) as requiring that any duty compared the cost data submitted in the inflation’’ is a term used to refer to a drawback be added to EP if two criteria petition to information submitted by high rate of increase in price levels. are met: (1) import duties and rebates MMZ. Specifically, we compared net CV Investigations covering exports from are directly linked to, and dependent for one CONNUM for MMZ to the CV countries with highly inflationary upon, one another, and; (2) raw used to calculate the highest margin the economies require the use of special materials were imported in sufficient petition. This CONNUM is identified in methodologies in comparing prices and calculating CV and COP. See Policy quantities to account for the duty Exhibit C2 of MMZ’s March 24, 2004, drawback received on exports of the submission as containing production Bulletin No. 94.5, ‘‘Differences in Merchandise Calculations in Hyper- manufactured product. Since the normal quantities that are comparable to the criteria appear to have been met in this product with the highest margin in the inflationary Economies,’’ dated March 25, 1994. Generally, the Department case, we made additions to the starting petition. We found the CV used by the price for duty drawback in accordance petitioners to be reliable. considers the annual inflation rate to be high if it is in excess of 25 percent. with section 772(c)(1)(B) of the Act. Therefore, based on our efforts, Based upon our examination of the However, we intend to further described above, to corroborate consumer price and wholesale price scrutinize the appropriateness of information contained in the petition, indices, which indicate that Turkey granting MMZ’s requested duty and in accordance with section 776(c) of experienced an inflation rate over 25 drawback adjustment in light of the the Act, we consider the highest margin percent during the POI, we find facts of this case in making our final in the petition to be corroborated to the Turkey’s economy experienced high determination in this investigation. extent practicable for purposes of this inflation. See 2002 and 2003 issues of Normal Value preliminary determination. the International Monetary Fund’s Accordingly, in selecting AFA with International Financial Statistics. A. Selection of Comparison Market respect to Guven, Ozborsan/Onur, and Because Turkey’s economy Section 773(a)(1) of the Act directs Ozdemir, we have applied the margin experienced high inflation during the that NV be based on the price at which rate of 34.89 percent, which is the POI, as is Department practice, we the foreign like product is sold in the highest estimated dumping margin set limited our comparisons to home home market, provided that the forth in the notice of initiation. See market sales made during the same merchandise is sold in sufficient Initiation Notice, 68 FR 57667. month in which the U.S. sale occurred. quantities (or has sufficient aggregate

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value, if quantity is inappropriate) and costs during to an equivalent currency Act, and (2) based on comparisons of that there is no particular market level using the Wholesale Price Index price to weighted-average COPs for the situation in the home market that for Turkey from the International POI, we determined that the below-cost prevents a proper comparison with the Financial Statistics published by the sales of the product were at prices EP transaction. The statute contemplates International Monetary Fund. We then which would not permit recovery of all that quantities (or value) will normally restated the period-average COMs in the costs within a reasonable time period, in be considered insufficient if they are currency values of each respective accordance with section 773(b)(2)(D) of less than five percent of the aggregate month. the Act. quantity (or value) of sales of the subject In accordance with section 773(b)(3) We found that for certain products, merchandise to the United States. Based of the Act, we calculated a weighted- MMZ made home market sales at prices on a comparison of aggregate quantity of average COP for MMZ based on the sum below the COP within an extended home market sales and U.S. sales by of the cost of materials and fabrication period of time in substantial quantities. MMZ, we determined that the quantity for the foreign like product, plus Further, we found that these sales prices of foreign like product sold in Turkey amounts for the home market G&A did not permit the recovery of costs permitted a proper comparison with the expenses and interest expenses. We within a reasonable period of time. sales of subject merchandise because the relied on the submitted COP data except Therefore, we excluded these sales from quantity of sales in the home market in the specific instances noted below, our analysis in accordance with section was more than five percent of the where the submitted costs were not 773(b)(1) of the Act. quantity of sales to the U.S. market. appropriately quantified or valued. We made the following adjustments to D. Calculation of Normal Value Based Accordingly, for MMZ, we based NV on on Comparison-Market Prices home market sales. In deriving NV, we MMZ’s submitted COP data: (1) made adjustments as detailed in the Increased the reported raw material cost We determined price-based NVs for Calculation of Normal Value Based on to disallow the claimed offset for the MMZ as follows. Where applicable, we Constructed Value section below. sales of second quality merchandise; (2) made adjustments for differences in cost increased the reported raw material attributable to differences in physical B. Affiliated-Party Transactions and costs to include the duty cost which was characteristics of the merchandise Arm’s-Length Test claimed as a duty drawback adjustment pursuant to section 773(a)(6)(C)(ii) of MMZ reported that it sold LWRPT in to U.S. price but which was not the Act, as well as for differences in the comparison market only to included in COM; (3) increased the circumstances of sale (COS) attributed unaffiliated customers. Therefore, reported raw material cost to reflect the to billing adjustments and imputed application of the arm’s-length test is higher of transfer price or market price credit expenses in accordance with unnecessary. as required by section 773(f)(2) of the section 773(a)(6)(C)(iii) of the Act and Act; (4) increased fixed overhead to 19 CFR 351.410. We also made C. Cost of Production Analysis include the full depreciation expense on adjustments, pursuant to 19 CFR In the original petition, the petitioners assets purchased in 2002; (5) increased 351.410(e), for indirect selling expenses alleged that sales of LWRPT in the home G&A expenses to include accrual incurred on comparison-market or U.S. market were made at prices below the adjustments; and (6) revised the sales where commissions were granted fully absorbed COP, and accordingly, reported financial expense ratio to on sales in one market but not in the requested that the Department conduct include total net foreign exchange gains other (the commission offset). Finally, a country-wide sales-below-cost and losses. we deducted home market packing costs investigation. Based upon the and added U.S. packing costs in comparison of the petition’s adjusted 2. Test of Home Market Sales Prices accordance with sections 773(a)(6)(A) prices and COP for the foreign like As required by section 773(b) of the and (B) of the Act. product, and in accordance with section Act, we compared MMZ’a adjusted 773(b)(2)(A)(i) of the Act, we found weighted-average COP to the E. Calculation of Normal Value Based reasonable grounds to believe or suspect comparison-market sales prices of the on Constructed Value that sales of LWRPT in Turkey were foreign like product, in order to Section 773(a)(4) of the Act provides made at prices below the COP. See determine whether these sales had been that, where NV cannot be based on Initiation Notice. As a result, the made at prices below the COP within an comparison-market sales, NV may be Department has conducted an extended period of time in substantial based on CV. Accordingly, for those investigation to determine whether quantities, and whether such prices models of LWRPT for which we could MMZ made sales in the home market at were sufficient to permit the recovery of not determine the NV based on prices below its COP during the POI all costs within a reasonable period of comparison-market sales, either because within the meaning of section 773(b) of time. On a product-specific basis, we there were no sales of a comparable the Act. Our COP analysis is described compared the revised COP to the product or all sales of the comparison below. comparison-market prices, less any products failed the COP test, we based applicable movement charges, taxes, NV on CV. 1. Calculation of Cost of Production rebates, commissions, and other direct In accordance with sections 773(e)(1) We determined that the Turkish and indirect selling expenses. and (e)(2)(A) of the Act, we calculated economy experienced significant CV based on the sum of the cost of inflation during the POI. Therefore, in 3. Results of the COP Test materials and fabrication for the foreign order to avoid the distortive effect of We disregarded below-cost sales like product, plus amounts for selling inflation on our comparison of costs and where (1) 20 percent or more of a expenses, G&A, interest, profit and U.S. prices, we requested that each respondent’s sales of a given product packing costs. We calculated the cost of respondent submit the product-specific during the POI were made at prices materials and fabrication based on the COM incurred during each month of the below the COP and thus such sales were methodology described in the reporting period. We calculated a made within an extended period of time ‘‘Calculation of Cost of Production’’ period-average COM for each product in substantial quantities in accordance section of this notice. In accordance after indexing the reported monthly with sections 773(b)(2)(B) and (C) of the with section 773(e)(2)(A) of the Act, we

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based selling expenses, G&A, and profit that the selling activities performed by further notice. The weighted-average on the amounts incurred and realized by MMZ in the home market are similar to dumping margins are as follows: MMZ, in connection with the those performed in the U.S. market, production and sale of the foreign like with the exception that MMZ provided Manufacturer/exporter Margin product in the ordinary course of trade freight and delivery in the U.S. market (percent) for consumption in the foreign country. but did not provide this service in the Guven ...... 34.89 F. Level of Trade/Constructed Export home market. Specifically, MMZ MMZ ...... 4.75 Price Offset engaged in sales forecasting, strategic/ Ozborsan/Onur ...... 34.89 economic planning, packing, order/ Ozdemir ...... 34.89 In accordance with section input processing, and use of direct sales All Others ...... 4.75 773(a)(1)(B) of the Act, to the extent personnel in both markets. Therefore, practical, the Department determined we have preliminarily determined that Disclosure NV based on sales in the home market the LOTs in the home and U.S. markets at the same level of trade (LOT) as the are the same LOT. Thus, a LOT The Department will disclose EP sales. The NV LOT is that of the adjustment is not required for calculations performed within five days starting-price sales in the home market. comparison of U.S. sales to home of the date of publication of this notice For EP sales, the U.S. LOT is also the market sales. to the parties to the proceeding in level of the starting-price sale. accordance with 19 CFR 351.224(b). To determine whether NV sales are at G. Currency Conversions a different LOT than the EP sales, we International Trade Commission The Department’s preferred source for Notification examined stages in the marketing daily exchange rates is the Federal process and selling activities along the Reserve Bank. However, the Federal In accordance with section 733(f) of chain of distribution between the Reserve Bank does not track or publish the Act, we have notified the ITC of our producer and the unaffiliated customer. exchange rates for Turkish Lira. preliminary sales at LTFV If the home market sales are at a Therefore, we made currency determination. If our final antidumping different LOT, and the difference affects conversions based on exchange rates determination is affirmative, the ITC price comparability, as manifested in a from the Dow Jones News/Retrieval will determine whether the imports pattern of consistent price differences Service. covered by that determination are between the home market sales on materially injuring, or threatening Verification which NV is based and the home market material injury to, the U.S. industry. sales at the LOT of the export In accordance with section 782(i) of The deadline for that ITC determination transaction, we make a LOT adjustment the Act, we intend to verify all would be the later of 120 days after the under section 773(a)(7)(A) of the Act. information relied upon in making our date of this preliminary determination In determining whether separate final determination. or 45 days after the date of our final LOTs exist, we obtained information determination. from MMZ about the marketing stages All Others Rate for the reported U.S. and home market Section 735(c)(5)(A) of the Act Public Comment sales, including a description of the provides for the use of an ‘‘all others’’ Case briefs for this investigation must selling activities performed by MMZ for rate, which is applied to non- be submitted no later than one week each channel of distribution. In investigated firms. See SAA at 873. This after the issuance of the last verification identifying LOTs for EP and home section states that the all others rate report. Rebuttal briefs must be filed market sales, we considered the selling shall generally be an amount equal to within five days after the deadline for functions reflected in the starting price the weighted-average dumping margins submission of case briefs. A list of before any adjustments. See 19 CFR established for exporters and producers authorities used, a table of contents, and 351.412(c)(1)(i) and (iii). We expect that, individually investigated, excluding any an executive summary of issues should if claimed LOTs are the same, the zero and de minimis margins, and any accompany any briefs submitted to the selling functions and activities of the margins based entirely upon the facts Department. Executive summaries seller at each level should be similar. available. Therefore, we have should be limited to five pages total, Conversely, if a party claims that LOTs preliminarily assigned to all other including footnotes. Further, the are different for different groups of exporters of LWRPT from Turkey a Department respectfully requests that all sales, the selling functions and activities margin that is based on the margin parties submitting written comments of the seller for each group should be calculated for the mandatory also provide the Department with an dissimilar. respondent. In its questionnaire responses, MMZ additional copy of the public version of reported that during the POI, it sold the Suspension of Liquidation any such comments on diskette. foreign like product in the home market In accordance with section 733(d) of Section 774 of the Act provides that through one channel of distribution and the Act, we are directing CBP to the Department will hold a hearing to in the United States through two suspend liquidation of all entries of afford interested parties an opportunity channels of distribution. We found that LWRPT from Turkey that are entered, or to comment on arguments raised in case MMZ engaged in similar selling withdrawn from warehouse, for or rebuttal briefs, provided that such a activities for all home market sales. consumption on or after the date of hearing is requested by an interested However, we found that there are also publication of this notice in the Federal party. If a request for a hearing is made no differences in the selling functions Register. We will instruct CBP to in an investigation, the hearing performed in the U.S. channels of require a cash deposit or the posting of normally will be held two days after the distribution. Based on the similarity of a bond equal to the weighted-average deadline for submission of the rebuttal the selling functions, we have amount by which the NV exceeds the briefs, at the U.S. Department of determined that MMZ sold LWRPT at U.S. price, as indicated in the chart Commerce, 14th Street and Constitution one LOT in the home market and one below. These suspension-of-liquidation Avenue, NW., Washington, DC 20230. LOT in the U.S. market. We also found instructions will remain in effect until Parties should confirm by telephone the

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time, date, and place of the hearing 48 FOR FURTHER INFORMATION CONTACT: bending or coating. Although the hours before the scheduled time. Richard Johns or Mark Manning, AD/ HTSUS subheadings are provided for Interested parties who wish to request CVD Enforcement, Office IV, Group II, convenience and customs purposes, the a hearing, or to participate if one is Import Administration, International written description of the merchandise requested, must submit a written Trade Administration, U.S. Department covered by the order is dispositive. request within 30 days of the of Commerce, 14th and Constitution Period of Review publication of this notice. Requests Avenue, NW., Washington, DC 20230; should specify the number of telephone: (202) 482–2305 or (202) 482– The period of review (POR) is from participants and provide a list of the 5253, respectively. January 30, 2001 through August 31, issues to be discussed. Oral SUPPLEMENTARY INFORMATION: 2002. presentations will be limited to issues Verification raised in the briefs. Background As noted above, the Department will On October 7, 2003, the Department As provided in section 782(I) of the make its final determination within 135 published in the Federal Register the Act, we verified the information days after the date of the publication of preliminary results of the administrative submitted by the respondent for use in the preliminary determination. review of the antidumping duty order our final results. We used standard This determination is issued and on rebar from Korea. See Steel Concrete verification procedures including published pursuant to sections 733(f) Reinforcing Bar from The Republic of examination of relevant accounting and and 777(i)(1) of the Act. Korea: Notice of Preliminary Results of production records, and original source documents provided by the DSM/ Dated: April 6, 2004. Antidumping Duty Administrative Review, 68 FR 57883 (October 7, 2003) KISCO. James J. Jochum, (Preliminary Results). During the period Analysis of Comments Received Assistant Secretary for Import October through December 2003, the Administration. All issues raised in the case brief Department received KISCO’s responses submitted by DSM/KISCO and the [FR Doc. 04–8377 Filed 4–12–04; 8:45 am] to sections A–D of the Department’s BILLING CODE 3510–DS–P petitioner are contained in the ‘‘Issues questionnaire, which was issued on and Decision Memorandum’’ from Holly September 15, 2003, as a result of the A. Kuga, Acting Deputy Assistant DEPARTMENT OF COMMERCE Department’s decision to collapse DSM Secretary, to James J. Jochum, Assistant and KISCO. See Memorandum from Secretary for Import Administration International Trade Administration Thomas F. Futtner, Acting Office (Issues and Decision Memorandum). Director, to Holly A. Kuga, Acting The Issues and Decision Memorandum Deputy Assistant Secretary, ‘‘Decision [A–580–844] is dated concurrently with this notice Memorandum: Whether to Collapse and hereby adopted by this notice. A list Steel Concrete Reinforcing Bar From Dongkuk Steel Mill Co., Ltd., and Korea of the issues which the parties have The Republic of Korea: Final Results of Iron and Steel Co., Ltd., Into a Single raised is attached to this notice as an Antidumping Duty Administrative Entity,’’ dated September 12, 2003. In appendix. Parties can find a complete Review January 2004, the Department discussion of all issues raised in this conducted verification of the sales and administrative review in the Issues and AGENCY: Import Administration, cost of production (COP) information Decision Memorandum which is on file International Trade Administration, reported by the collapsed entity, DSM/ in the Central Records Unit, room B–099 Department of Commerce. KISCO. of the main Department of Commerce In response to the Department’s ACTION: Notice of final results of building. In addition, a complete invitation to comment on the antidumping duty administrative version of the Issues and Decision Preliminary Results of this review, review. Memorandum can be accessed directly DSM/KISCO filed a case brief on March on the Web at ‘‘http://ia.ita.doc.gov’’. SUMMARY: On October 7, 2003, the 3, 2004. The petitioner 1 also filed a case The paper copy and electronic version Department of Commerce (the brief on March 3, 2004. On March 10, of the Issues and Decision Department) published the preliminary 2004, DSM/KISCO and the petitioner Memorandum are identical in content. results of the administrative review of filed rebuttal briefs. the antidumping duty order on steel The Department has conducted this Changes Since the Preliminary Results concrete reinforcing bar (rebar) from the administrative review in accordance Based on our analysis of comments Republic of Korea (Korea). The review with section 751 of the Tariff Act of received, we have made certain changes covers rebar exported to the United 1930, as amended (the Act). in the margin calculation. These States by Dongkuk Steel Mill Co., Ltd. Scope of the Review changes are discussed in the relevant (DSM) and Korea Iron and Steel Co., sections of the Issues and Decision The products covered by the Ltd. (KISCO), which have been Memorandum. The Department issued antidumping duty order are all rebar collapsed into a single entity for the antidumping questionnaire to sold in straight lengths, currently purposes of this administrative review, KISCO approximately two weeks before classifiable in the Harmonized Tariff during the period from January 30, the fully extended deadline for the Schedule of the United States (HTSUS) 2001, through August 31, 2002. After preliminary results. Therefore, KISCO’s under item number 7214.20.00 or any analyzing the comments received, we sales and costs of production data were other tariff item number. Specifically have made certain changes in the not available for inclusion in the excluded are plain rounds (i.e., non- margin calculation. The final weighted- preliminary results. KISCO submitted deformed or smooth bars) and rebar that average dumping margin for the its sales and COP data after the has been further processed through reviewed entity is listed below in the preliminary results, and we have section entitled ‘‘Final Results of included this information in our final Review.’’ 1 The petitioner in this proceeding is the Rebar Trade Action Coalition and its individual members results of review. Furthermore, we have EFFECTIVE DATE: April 13, 2004. (collectively, the petitioner). corrected a programming error

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contained in our preliminary results manufacturer is, the cash deposit rate 5. Whether the Department should reverse regarding the calculation of the will be the rate established for the most its decision and reject DSM’s sales, which are constructed export price (CEP) offset. recent period for the manufacturer of a major and significant correction to the sales See Issues and Decision Memorandum. the merchandise; and (4) if neither the listing. Lastly, we have made corrections to the exporter nor the manufacturer is a firm 6. Whether DSM/KISCO’s August 11, 2003 letter supports the acceptance of new factual reported information pursuant to minor covered by any segment of this information. errors found during verification. See proceeding, the cash deposit rate will 7. Whether the Department can Issues and Decision Memorandum. continue to be 22.89 percent, which is retroactively confer timely status. the ‘‘all others’’ rate established in the Final Results of Review LTFV investigation. These deposit [FR Doc. 04–8375 Filed 4–12–04; 8:45 am] We determine that the following requirements, when imposed, shall BILLING CODE 3510–DS–P weighted-average percentage margin remain in effect until publication of the exists for DSM/KISCO for the period final results of the next administrative DEPARTMENT OF COMMERCE January 30, 2001, through August 31, review. 2002. Notification to Importers International Trade Administration Exporter/manufacturer Margin This notice also serves as a final [A–201–832] (percent) reminder to importers of their responsibility under 19 CFR Light-Walled Rectangular Pipe and Dongkuk Steel Mill Co., Ltd./ .... 11.74 Tube from Mexico: Notice of Korea Iron and Steel Co., Ltd. § 351.402(f)(2) to file a certificate regarding the reimbursement of Preliminary Determination of Sales at Less Than Fair Value and Assessment antidumping duties prior to liquidation of the relevant entries during this Postponement of Final Determination The Department shall determine, and review period. Failure to comply with AGENCY: Import Administration, U.S. Customs and Border Protection this requirement could result in the International Trade Administration, (CBP) shall assess, antidumping duties Secretary’s presumption that Department of Commerce. on all appropriate entries. In accordance reimbursement of the antidumping with 19 CFR § 351.212(b)(1), we have duties occurred and the subsequent ACTION: Notice of preliminary calculated importer-specific assessment assessment of double antidumping determination of sales at less than fair rates for merchandise subject to this duties. value and postponement of final review. Since DSM/KISCO reported the determination. entered values and importer for its sales, Administrative Protective Orders we have calculated an importer-specific This notice also serves as the only EFFECTIVE DATE: April 13, 2004. ad valorem duty assessment rate based reminder to parties subject to FOR FURTHER INFORMATION CONTACT: on the ratio of the total amount of administrative protective orders (APOs) Maisha Cryor (Prolamsa) at (202) 482- dumping margins calculated for the of their responsibility concerning the 5831, Richard Johns (Galvak/Hylsa) at examined sales to the entered value of return or destruction of proprietary (202) 482–2305, Magd Zalok (LM) at sales used to calculate those duties. If information disclosed under APO in (202) 482–4162, or Crystal Crittenden the importer-specific assessment rate is accordance with 19 CFR § 351.305. (Regiomontana) at (202) 482–0989; AD/ above de minimis (i.e., greater than 0.50 Timely written notification of the CVD Enforcement, Office IV, Group II, percent ad valorem), we will instruct return/destruction of APO materials or Import Administration, Room 1870, CBP to assess the importer-specific rate conversion to judicial protective order is International Trade Administration, uniformly on all entries made during hereby requested. Failure to comply U.S. Department of Commerce, 14th the POR. The Department will issue with the regulations and terms of an Street and Constitution Avenue, NW., appropriate assessment instructions APO is a violation which is subject to Washington, DC 20230. sanction. directly to the CBP within 15 days of Preliminary Determination publication of the final results of We are issuing and publishing this review. determination and notice in accordance We preliminarily determine that light- with sections 751(a)(1) and 777(i)(1) of walled rectangular pipe and tube Cash Deposit Requirements the Act. (LWRPT) from Mexico is being sold, or The following deposit requirements Dated: April 5, 2004. is likely to be sold, in the United States will be effective upon publication of Joseph A. Spetrini, at less than fair value (LTFV), as provided in section 733 of the Tariff Act this notice of final results of Acting Assistant Secretary for Import administrative review for all shipments Administration. of 1930, as amended (the Act). The of rebar from Korea entered, or estimated margins of sales at LTFV are withdrawn from warehouse, for Appendix 1—Issues in Decision shown in the Suspension of Liquidation consumption on or after the date of Memorandum section of this notice. publication of this notice, as provided Comments and Responses SUPPLEMENTARY INFORMATION: by section 751(a)(1) of the Act: (1) The 1. Whether Dongkuk Steel Mill Co., Ltd. Case History cash deposit rate for DSM and KISCO (DSM), Korea Iron and Steel Co., Ltd. will be the rate shown above; (2) for (KISCO), and Dongkuk Industries Co., Ltd. On September 9, 2003, the previously reviewed or investigated (DKI) are affiliated. Department of Commerce (the companies not listed above, the cash 2. Whether the Department should Department) received a petition for the deposit rate will continue to be the ‘‘collapse’’ DSM and KISCO. imposition of antidumping duties on company-specific rate published for the 3. Whether the Department should classify LWRPT from Mexico, filed in proper DSM’s U.S. sales as weldable rebar. most recent period; (3) if the exporter is 4. Whether the Department should correct form, by California Steel and Tube, not a firm covered in this review, a prior a clerical error in the preliminary margin Hannibal Industries, Inc., Leavitt Tube review, or the original less-than-fair- program to allow for the calculation of the Company, LLC, Maruichi American value (LTFV) investigation, but the CEP offset. Corporation, Northwest Pipe Company,

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Searing Industries, Inc., Vest Inc., and comparisons.1 After setting aside a 3, 2004 (Regiomontana)3, and February Western Tube and Conduit Corporation period of time for all interested parties 4, 2004, (Galvak/Hylsa 4 and LM5). (collectively, petitioners). See Letter to provide comments on the proposed On January 28, 2004, petitioners from petitioners to Secretary Evans of product characteristics, the Department submitted a letter in support of the the Department and Secretary Abbott of received comments from Galvak and postponement of the preliminary the U.S. International Trade petitioners on November 4, 2003, and determination. On February 5, 2004, Commission (ITC), ‘‘Petition for the from Prolamsa on November 5, 2003. On pursuant to section 733(c)(1)(B) of the Imposition of Antidumping Duties: November 10, 2003, Galvak and Act, the Department postponed the Light-Walled Rectangular Pipe and Tube petitioners submitted rebuttal preliminary determination of this from Mexico and Turkey,’’ dated comments. investigation by 50 days, from February 16, 2004, until April 6, 2004. See Light- September 9, 2003 (Petition). The After reviewing interested parties’ Walled Rectangular Pipe and Tube from Department initiated this antidumping comments, the Department revised the Mexico and Turkey: Notice of investigation of LWRPT from Mexico on proposed product characteristics and Postponement of Preliminary September 29, 2003. See Notice of instructed Prolamsa, Galvak, LM, and Antidumping Duty Determinations, 69 Initiation of Antidumping Regiomontana, to report their product FR 5487 (February 5, 2004). Investigations: Light-Walled Rectangular characteristics according to the revised Pipe and Tube from Mexico and Turkey, On February 23, 2004, all of the requirements for sections B and C of the respondents submitted responses to 68 FR 57668 (October 6, 2003) Department’s questionnaire. See (Initiation Notice). Since the initiation section D of the Department’s Memorandum from Maisha Cryor, antidumping questionnaire. The of the investigation, the following Analyst, to the File, RE: Revision to events have occurred. Department issued supplemental Product Characteristics, dated section D questionnaires to respondents, The Department set aside a period for November 21, 2003. and received timely responses in March all interested parties to raise issues In December 2003, we received of 2004. regarding product coverage of the scope responses to sections A-C of the of the investigation. See Initiation antidumping questionnaire from all of Postponement of the Final Notice, at 68 FR 57668. On October 27, the respondents. We issued Determination 2003, Productos Laminados de supplemental questionnaires, pertaining Section 735(a)(2) of the Act provides Monterrey, S.A. de C.V (Prolamsa) and to sections A, B, and C of the that a final determination may be IMSA–MEX, S.A. de C.V. and IMSA, questionnaire, in December 2003, postponed until not later than 135 days Inc. (collectively, IMSA) submitted January 2004 and February 2004. after the date of the publication of the comments on product coverage. Respondents replied to these preliminary determination if, in the Petitioners and Prolamsa submitted supplemental questionnaires in January, event of an affirmative preliminary rebuttal comments in November 2003, February, and March of 2004. On determination, a request for such January 2004, and March 2004. See January 9, 2004, in accordance with 19 postponement is made by exporters who Scope Comments section below. CFR 351.301(d)(2)(i)(B), petitioners account for a significant proportion of On October 23, 2003, the Department submitted allegations that home market exports of the subject merchandise, or in selected Prolamsa, Galvak, S.A. de C.V. sales were made at prices below the cost the event of a negative preliminary (Galvak), Perfiles y Herrajes LM, S.A. de of production (COP) by each respondent determination, a request for such CV (LM), and Regiomontana De Perfiles in this investigation. After reviewing postponement is made by the Y Tubos (Regiomontana) (collectively, petitioners’ allegations, the Department, petitioners. The Department’s respondents), as mandatory respondents in accordance with section regulations, at 19 CFR 351.210(e)(2), in this investigation. See Memorandum 773(b)(2)(A)(i) of the Act, concluded require that requests by respondents for from Maisha Cryor, Analyst, to Thomas that there was a reasonable basis to postponement of a final determination F. Futtner, Acting Office Director, Re: suspect that each respondent is selling be accompanied by a request for an Selection of Respondents for the LWRPT in Mexico at prices below the extension of the provisional measures Antidumping Duty Investigation of COP and initiated cost investigations on from a four-month period to not more Light-Walled Rectangular Pipe and Tube February 2, 2004, (Prolamsa)2, February than six months. from Mexico, dated October 23, 2003 On March 15, 2004, Galvak/Hysla (Respondent Selection Memo), on file in 1 Section A of the questionnaire requests general requested that, in the event of an the Central Records Unit (CRU), Room information concerning a company’s corporate affirmative preliminary determination B–099 of the Main Commerce Building. structure and business practices, the merchandise in this investigation, the Department under investigation, and the manner in which the postpone its final determination until On October 24, 2003, the ITC company sells that merchandise in all markets. preliminarily determined that there is a Section B requests a complete listing of all of the reasonable indication that an industry company’s home market sales on the foreign like 3 See Memo to Thomas Futtner from Crystal product or, if the home market is not viable, sales Crittenden, Trinette Ruffin, and Gina Lee regarding in the United States is materially of the foreign like product in the most appropriate Light-walled Rectangular Pipe and Tube from injured by reason of LWRPT imported third-country market (this section is not applicable Mexico, RE: Petitioners’ Allegation of Sales Below from Mexico that is alleged to be sold to respondents in non-market economy cases). the Cost of Production for Regiomontana de Perfiles in the United States at LTFV. See Light- Section C requests a complete listing of the y Tubos, S.A. de C.V. (Regiomontana Cost Memo). company’s U.S. sales of subject merchandise. 4 See Memo to Thomas Futtner from magd Zalok, Walled Rectangular Pipe and Tube from Section D requests information on the cost of Richard Johns, Gina Lee, and James Balog regarding Mexico and Turkey, 68 FR 61829 production of the foreign like product and the Light-walled Rectangular Pipe and Tube from (October 30, 2003). constructed value of the merchandise under Mexico, RE: Petitioners’ Allegation of Sales Below investigation. Section E requests information on the Cost of Production for Galvak, S.A. de C.V. and On October 28, 2003, the Department further manufacturing. Hylsa, S.A. de C.V. (Galvak/Hylsa Cost Memo). issued to respondents sections A-E of its 2 See Memo to Howard Smith from Maisha Cryor, 5 See Memo to Thomas Futtner from Magd Zalok, antidumping questionnaire, which James Balog and Gina Lee regarding Light-walled Trinette Ruffin,k and Gina Lee regarding Light- included proposed product Rectangular Pipe and Tube from Mexico, RE: walled Rectangular Pipe and Tube from Mexico, RE: Petitioners’ Allegation of Sales Below the Cost of Petitioners’ Allegation of Sales Below the Cost of characteristics that the Department Production for Productos Laminados de Monterrey, Production for Perfiles y Herrajes L.M., S.A. de C.V. intends to use to make its fair value S.A. de C.V. (Prolamsa Cost Memo). (LM Cost Memo).

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135 days after the publication of the domestic petitioning firms produce both has not provided any basis to preliminary determination. Galvak/ pre-primered and galvanized LWRPT distinguish pre-primered LWRPT from Hylsa also included a request to extend and, therefore, they have a legitimate the class or kind of merchandise subject the provisional measures to not more interest in including such products to this investigation. For these reasons, than 135 days after the publication of within the scope of this investigation. we find no reason to exclude pre- the preliminary determination. Petitioners also argue that exclusion of primered LWRPT from the scope of this Accordingly, because we have made an pre-primered LWRPT would enable investigation. See Memorandum from affirmative preliminary determination, respondents to circumvent any Maisha Cryor, Analyst, to Thomas F. and the requesting party accounts for a antidumping order on LWRPT simply Futtner, Acting Office Director Re: significant proportion of exports of the by applying a primer coat to un-coated Consideration of Scope Exclusion subject merchandise, we have LWRPT. Request, dated April 6, 2004 (Scope postponed the final determination until Prolamsa rebutted petitioners Exclusion Request Memo). not later than 135 days after the date of comments in a January 23, 2004, Similarly, we have not adopted the the publication of the preliminary submission, by stating that one of the change to the scope of the investigation determination. petitioning domestic producers, proposed by IMSA. IMSA also argues identified in petitioners’ rebuttal that galvanized LWRPT should be Period of Investigation comments as a producer of pre-primered excluded from the scope of this The period of investigation (POI) is LWRPT (Searing Industries), did not, in investigation because petitioners do not July 1, 2002, through June 30, 2003. See fact, produce pre-primered LWRPT manufacture the product and because 19 CFR 351.204(b)(1). during the POI. In addition, Prolamsa the unique properties of LWRPT Scope Comments included an affidavit from a non- restricts its ability to be interchangeable petitioning domestic producer, who with other products. However, also in In accordance with the preamble to opposes the inclusion of pre-primered this case, petitioners submitted the Department’s regulations (see LWRPT in this investigation. See evidence demonstrating that a Antidumping Duties; Countervailing Prolamsa’s January 23, 2004, rebuttal petitioning domestic producer does, in Duties, 62 FR 27296, 27323 (May 19, comments at Exhibit 1. On March 4, fact, produce galvanized LWRPT. In 1997) (Preamble)), in the Initiation 2004, petitioners submitted an affidavit addition, as indicated above, the statute Notice, we set aside a period of time for from petitioning producer Searing does not require that petitioners parties to raise issues regarding the Industries, stating that Searing produce every type of product covered product coverage of the scope of the Industries does, in fact, produce and sell by the scope of the investigation. See investigation and encouraged parties to pre-primered LWRPT in the normal Hollow Products 65 FR 42985 (July 12, submit comments on product coverage course of business. 2000) and accompanying Issues and within 20 calendar days of publication On March 24, 2004, Prolamsa rebutted Decision Memorandum, at Comments 1 of the Initiation Notice. See Initiation petitioners comments and argued that and 2. Moreover, IMSA has not Notice, 68 FR at 57668. On October 27, the affidavit submitted by petitioners provided any basis to distinguish 2003, Prolamsa requested that the fails to establish that Searing Industries galvanized LWRPT from the class or Department exclude pre-primered has or is currently producing pre- kind of merchandise subject to this products from the scope of the primered LWRPT in the United States. investigation. For these reasons, we find investigation because it claims that In addition, Prolamsa countered no reason to exclude galvanized LWRPT petitioners do not produce pre-primered petitioners argument that exclusion of from the scope of this investigation. See products and, therefore, they do not pre-primered LWRPT from the scope of Scope Exclusion Request Memo. have a legitimate interest in including the investigation would result in With respect to Prolamsa’s request such items in the scope of this circumvention of any antidumping that the Department expressly state investigation. Further, Prolamsa argued order. whether the subject merchandise that pre-primered LWRPT should be We have not adopted the change to includes all specifications and product excluded from the scope because the the scope of the investigation proposed categories of LWRPT, we note that the unique properties of the production by Prolamsa. Prolamsa argues that pre- scope of this investigation reads, in process ensure that it is only purchased primered LWRPT should be excluded relevant part, ‘‘[t]hese LWRPT have by a particular customer type. In from the scope of the investigation rectangular cross sections ranging from addition, Prolamsa requested that the because petitioners do not manufacture 0.375 x 0.625 inches to 2 x 6 inches, or Department expressly state whether the the product and because the unique square cross sections ranging from 0.375 subject merchandise includes all properties of the pre-priming to 4 inches, regardless of specification.’’ specifications and product categories of production process dictate that only (emphasis added). Thus, the scope LWRPT (i.e., mechanical, ornamental, particular customers will purchase it. language explicitly states that LWRPT of etc.). However, petitioners submitted an a certain size is covered by this On October 27, 2003, IMSA requested affidavit by a petitioning domestic investigation, regardless of that the Department exclude galvanized producer which states that it does specification. Moreover, the phrase LWRPT from the scope of the produce pre-primered LWRPT. In ‘‘regardless of specification’’ means that investigation because it claims that addition, the statute does not require the scope covers any product meeting petitioners do not produce such that petitioners produce every type of the physical characteristics described products and that the unique properties product covered by the scope of the therein, regardless of product category. of galvanized LWRPT limit its investigation. See Notice of Final Therefore, there is no need to modify interchangeability with respect to other Determination of Sales at Less Than the scope language as suggested by products. Fair Value: Circular Seamless Stainless Prolamsa. See Scope Exclusion Request On November 3, 2003, petitioners Steel Hollow Products From Japan, 65 Memo. requested that the scope of the FR 42985 (July 12, 2000) and investigation not exclude those products accompanying Issues and Decision Scope of Investigation specified by Prolamsa and IMSA. Memorandum, at Comments 1 and 2 The merchandise covered by this Specifically, petitioners contend that (Hollow Products). Moreover, Prolamsa investigation is LWRPT from Mexico,

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which is welded carbon-quality pipe Memo. Therefore, we selected Prolamsa, because there is a significant potential and tube of rectangular (including Galvak, LM, and Regiomontana as for manipulation of price or production square) cross-section, having a wall mandatory respondents in this given that Galvak and Hylsa are owned thickness of less than 0.156 inch. These investigation. by the same company, have a significant LWRPT have rectangular cross sections overlap of management positions and Collapsing Affiliated Parties ranging from 0.375 x 0.625 inches to 2 have intertwined operations. Therefore, x 6 inches, or square cross sections Section 771(33) of the Act defines we are treating Galvak and Hylsa as a ranging from 0.375 to 4 inches, affiliated persons. Moreover, 19 single entity for purposes of our regardless of specification. LWRPT are CFR 351.401(f) identifies the criteria antidumping analysis. For a more currently classifiable under item that must be met in order to treat two detailed analysis, see Memorandum number 7306.60.5000 of the or more affiliated producers as a single from Maisha Cryor and Richard Johns, Harmonized Tariff System of the United entity (i.e., ‘‘collapse’’ the firms) for Analysts, to Thomas F. Futtner, Acting States (HTSUS). The HTSUS item purposes of calculating a dumping Office Director, Regarding ‘‘Whether to number is provided for convenience and margin. Collapse Galvak, S.A. de C.V. and Hylsa, customs purposes only. The written Specifically, 19 CFR 351.401(f)(1) S.A. de C.V., dated February 13, 2004 product description of the scope is provides that affiliated producers of (Collapsing Memo). This single entity is dispositive. subject merchandise will be treated as a hereafter referred to as Galvak/Hylsa. The term ‘‘carbon-quality’’ applies to single entity (i.e., collapsed), where (1) products in which (i) Iron Those producers have production Product Comparisons predominates, by weight, over each of facilities for similar or identical In accordance with section 771(16) of the other contained elements, (ii) the products that would not require the Act, we considered all products sold carbon content is 2 percent or less, by substantial retooling in order to in the home market as described in the weight, and (iii) none of the elements restructure manufacturing priorities, ‘‘Scope of Investigation’’ section of this listed below exceeds the quantity, by and (2) the Department concludes that notice, above, that were sold in the weight, respectively indicated: 1.80 there is a significant potential for ordinary course of trade for purposes of percent of manganese, or 2.25 percent of manipulation of price or production. 19 determining appropriate product silicon, or 1.00 percent of copper, or CFR 351.401(f)(2) of the Department’s comparisons to U.S. sales. We have 0.50 percent of aluminum, or 1.25 regulations provides factors the relied upon seven criteria to match U.S. percent of chromium, or 0.30 percent of Department may consider in sales of subject merchandise to cobalt, or 0.40 percent of lead, or 1.25 determining whether there is significant comparison-market sales of the foreign percent of nickle, or 0.30 percent of potential for manipulation of price or like product. These criteria, in order of tungsten, or 0.10 percent of production, namely (i) The level of importance are: (1) Steel type, (2) molybdenum, or 0.10 percent of common ownership; (ii) the extent to galvanized coating, (3) whether the niobium (also called columbium), or which managerial employees or board merchandise was painted or primed, (4) 0.15 percent of vanadium, or 0.15 members of one firm sit on the board of outside perimeter, (5) wall thickness, (6) percent of zirconium. directors of an affiliated firm; and (iii) shape, and (7) finish. Where there were whether operations are intertwined, no sales of identical merchandise in the Selection of Respondents such as through the sharing of sales home market made in the ordinary Section 777A(c)(1) of the Act directs information, involvement in production course of trade, we compared U.S. sales the Department to calculate individual and pricing decisions, the sharing of to sales of the most similar foreign like weighted-average dumping margins for facilities or employees, or significant product made in the ordinary course of each known exporter and producer of transactions between the affiliated trade, based on the characteristics listed the subject merchandise. Where it is not producers. above. Where we were unable to match practicable to examine all of the known Galvak and Hylsa are wholly-owned U.S. sales to home market sales of the producers/exporters of subject subsidiaries of Hylsamex, a Mexican foreign like product, we based normal merchandise, section 777A(c)(2) of the holding company, which is 90-percent value (NV) on constructed value (CV). Act permits the Department to owned by Alfa, S.A. de C.V. Galvak and investigate either (1) A sample of Hylsa requested that they be treated as Fair Value Comparisons exporters, producers, or types of affiliated parties. See Galvak/Hylsa’s To determine whether sales of products that is statistically valid based section A questionnaire response at 15. LWRPT from Mexico were made in the on the information available at the time Pursuant to section 771(33)(F) of the United States at LTFV, we compared the of selection, or (2) exporters and Act, the Department has preliminarily export price (EP) or constructed export producers accounting for the largest determined that Galvak and Hylsa are price (CEP) to the NV, as described in volume of the subject merchandise from affiliated because Galvak and Hylsa are the Export Price and Constructed Export the exporting country that can both wholly-owned subsidiaries of Price and Normal Value sections of this reasonably be examined. The petitioners Hylsamex, and thus, are ‘‘two persons notice. In accordance with section identified nine Mexican exporters/ controlled by {a} person.’’.6 777A(d)(1)(A)(i) of the Act, we producers of subject merchandise. See Galvak and Hylsa also satisfy the first calculated weighted-average EPs and Petition at Exhibit 7A. U.S. Customs and requirement of the collapsing test, as CEPs. We compared these to weighted- Border Protection (CBP) import statistics they both possess production facilities average NVs in Mexico. for the POI identified twenty-four of identical or similar types of exporters/producers of subject Export Price and Constructed Export merchandise, and these facilities would Price merchandise during the POI. Due to not require substantial retooling to limited resources, we determined that restructure manufacturing priorities. In For the price to the United States, we we could investigate only the four addition, they also satisfy the second used, as appropriate, EP or CEP as Mexican producers/exporters that requirement of the collapsing test, defined in sections 772(a) and (b) of the accounted for the largest volume of Act, respectively. Section 772(a) of the exports of subject merchandise during 6 See Galvak’s January 5, 2004 supplemental Act defines EP as the price at which the the POI. See Respondent Selection section A response at 2 (supplemental response). subject merchandise is first sold (or

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agreed to be sold) before the date of rebates. Additionally, we made that Galvak/Hylsa’s affiliated reseller in importation by the exporter or producer adjustments to the U.S. starting price for the United States provided certain outside the United States to an billing adjustments. administrative services pertaining to a unaffiliated purchaser for exportation to small percentage of U.S. sales. LM the United States. We based EP on See Galvak/Hylsa’s December 31, 2003, packed and delivered prices to We calculated an EP for all of LM’s questionnaire response at 8. unaffiliated purchasers in the United sales because the merchandise was sold States. In accordance with section directly by LM to the first unaffiliated However, the sales documents 772(c)(2) of the Act, we reduced the purchaser in the United States prior to provided in the questionnaire response starting price by movement expenses importation. We made deductions from indicate that these services were minor and export taxes and duties, if the FOB, duty paid, starting price for and that the invoicing was done by appropriate. These deductions included, movement expenses in accordance with Galvak/Hylsa. Further, the merchandise where appropriate, foreign inland section 772(c)(2)(A) of the Act. These was shipped directly from Galvak/ freight, foreign brokerage and handling, items include expenses incurred for Hylsa’s production facility in Mexico to international freight, marine insurance inland freight, domestic brokerage and the unaffiliated U.S. customer. Id. and U.S. customs duties. U.S. customs duties, when applicable. Therefore, we have preliminarily Section 772(b) of the Act defines CEP In addition, we made deductions from concluded that the sales were, in fact, as the price at which the subject the starting price for discounts, where EP sales. We made deductions from the merchandise is first sold in the United appropriate. FOB starting price for movement States before or after the date of expenses in accordance with section importation, by or for the account of the Regiomontana 772(c)(2)(A) of the Act. These items producer or exporter of the We calculated an EP for all of include inland freight, domestic merchandise, or by a seller affiliated Regiomontana’s sales because the brokerage, U.S. brokerage, and with the producer or exporter, to an merchandise was sold directly by warehousing. In accordance with 19 unaffiliated purchaser, as adjusted Regiomontana to the first unaffiliated CFR 351.401(c), we increased the under sections 772(c) and (d) of the Act. purchaser in the United States prior to starting price for freight fees, brokerage We based CEP on packed prices to importation.7 We made deductions from and handling fees, insurance fees, and unaffiliated purchasers in the United the FOB starting price for movement duty fees, charged to the customer, and States. In accordance with section expenses in accordance with section adjusted for billing adjustments. In 772(c)(2) of the Act, we reduced the 772(c)(2)(A) of the Act. These items addition, we made deductions from the starting price by movement expenses include inland freight, international starting price for discounts, where U.S. duties, if appropriate. Movement freight, and U.S. and domestic brokerage appropriate. expenses include, where applicable, and handling. Additionally, we adjusted Normal Value expenses incurred for foreign inland for billing adjustments in accordance freight, international freight, marine with 19 CFR 351.401(c). A. Selection of Comparison Market insurance, foreign and U.S. brokerage Galvak/Hylsa Section 773(a)(1) of the Act directs the and handling, U.S. customs duties Department to base NV on the price at (including harbor maintenance fees and On December 2, 2003, in accordance which the foreign like product is sold in merchandise processing fees), U.S. with the instructions provided in the the home market, provided that, among inland insurance, U.S. inland freight, Department’s questionnaire regarding other things, the merchandise is sold in and warehousing. In accordance with reporting requirements for affiliated sufficient quantities in the home market section 772(d)(1) of the Act we made companies, Galvak and Hylsa submitted (or has sufficient aggregate value, if additional adjustments to the starting a single response to section A of the quantity is inappropriate). The statute price in order to calculate CEP, by Department’s questionnaire. Galvak and provides that the total quantity of home deducting direct and indirect selling Hylsa, collectively, continued to submit market sales of foreign like product (or expenses related to commercial activity responses to the Department’s value) will normally be considered in the United States. Pursuant to section questionnaire and supplemental sufficient if it is five percent or more of 772(d)(3) of the Act, where applicable, questionnaires. Due to the Department’s the aggregate quantity (or value) of sales we made an adjustment to the starting decision to collapse the two companies, of the subject merchandise. Based on a price for CEP profit. we accepted and conducted an analysis comparison of the aggregate quantity of We determined the EP or CEP for each of the collapsed data. See Collapsing home market sales of foreign like company as follows: Memo. product and U.S. sales of subject Prolamsa We calculated an EP for all of Galvak/ merchandise by Prolamsa, LM, Galvak/ Hylsa’s sales because the merchandise Hylsa, and Regiomontana, we We calculated a CEP for all of was sold directly by Galvak/Hylsa to the determined that the quantity of foreign Prolamsa’s U.S. sales because the first unaffiliated purchaser in the United like product sold in Mexico is more subject merchandise was sold directly to States prior to importation.8 We note than five percent of the quantity of U.S. Prolamsa Inc., Prolamsa’s U.S. affiliate, sales of subject merchandise for each prior to being sold to the first 7 Petitioners requested that the Department treat unaffiliated purchaser in the United Regiomontana’s sales made through unaffiliated for its own sales of subject merchandise during the States. We made deductions from the U.S. commissioned selling agents as CEP sales, and POI. See Petitioners March 25, 2004, letter at 9–10. starting price for movement expenses in deduct the commission expense from the CEP. See However, where the same party is both the foreign Petitioners March 25, 2004, letter at 8–9. However, accordance with section 772(c)(2)(A) of producer/exporter, as well as the importer of because all of Regiomontana’s U.S. sales were made record, the Department’s practice is to treat such the Act. These items include expenses by Regiomontana to the first unaffiliated purchaser sales as EP transactions. See Certain Preserved incurred for inland freight, domestic in the United States prior to importation, in Mushrooms from India: Preliminary Results of brokerage and handling, U.S. brokerage accordance with section 772(a) of the Act we have Antidumping Duty Administrative Review, 69 FR treated all U.S. sales as EP sales. and handling and U.S. customs duties. 10659, 10661–10662 (March 8, 2004). Therefore, 8 Petitioners requested that the Department treat consistent with the Department’s practice, we have In addition, we made deductions from Galvak/Hylsa’s U.S. sales as CEP transactions, continued to treat Galvak/Hylsa’s U.S. sales as EP the U.S. starting price for discounts and because Galvka/Hylsa was the importer of record transactions.

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respondent. Accordingly, for each of the general and administrative (G&A) statements. We adjusted the reported respondents, we based NV on home expenses and interest expenses. We interest expense for the gain on market sales. relied on the submitted COP data, monetary position. See Regiomontana’s In deriving NV, we made adjustments except as noted below: Cost Analysis Memorandum, dated as detailed in the Calculation of Normal April 6, 2004. Galvak/Hylsa Value Based on Comparison-Market 2. Test of Home Market and Third- Prices and Calculation of Normal Value We revised the financial expense ratio Country Market Sales Prices Based on Constructed Value sections by including the full amount of net below. exchange losses and net gain on As required by section 773(b)(1) of the monetary positions instead of the Act, for each respondent subject to a B. Affiliated-Party Transactions and selected portions of the net exchange cost investigation, we compared, on a Arm’s-Length Test losses and net gains that were reported. product-specific basis, the adjusted During the POI, Prolamsa, In addition, we added back certain weighted average COP to the Regiomontana, LM, and Galvak/Hylsa interest income items. We also comparison-market prices, less any sold foreign like product to affiliated recalculated the rate based on the applicable movement charges, taxes, customers. figures from the parent company’s 2002 rebates, commissions, and other direct To test whether these sales were made consolidated income statement instead and indirect selling expenses to at arm’s-length prices, we compared, on of using the average of the parent determine whether these sales had been a model-specific basis, the starting company’s 2002 and 2003 income made at prices below the COP. For those prices of sales to affiliated and statements. sales that we determined were made unaffiliated customers, net of all For both Galvak and Hylsa, we below COP, we examined whether they discounts and rebates, movement revised their G&A ratios by using the had been made within an extended charges, direct selling expenses, administrative expenses, including period of time in substantial quantities, commissions, and home market charges from their parent companies and whether such prices were sufficient packing. Where the price to the and debt restructuring expenses, and to permit the recovery of all costs within affiliated party was, on average, within COGS figures from Hylsa and Galvak’s a reasonable period of time. See sections a range of 98 to 102 percent of the price respective 2002 unconsolidated income 773(b)(1)(A) and (B) of the Act. of the same or comparable merchandise statements instead of an average of their 3. Results of the COP Test sold to unaffiliated parties, we respective 2002 and 2003 income determined that sales made to the statements. See Galvak/Hylsa’s Analysis Pursuant to section 773(b)(2)(C) of the affiliated party were at arm’s-length. See Memorandum, dated April 6, 2004. Act, when less than 20 percent of the respondent’s sales of a given product 19 CFR 351.403(c); see also, Preamble, Prolamsa 69 FR at 69186. Sales to affiliated were at prices less than the COP, we did customers in the home market that were We adjusted the reported total cost of not disregard any below-cost sales of not made at arm’s-length prices were manufacturing to include the that product because the below-cost excluded from our analysis because we depreciation expense related to the sales were not made in substantial considered them to be outside the revaluation of fixed assets recorded in quantities within an extended period of ordinary course of trade. See 19 CFR Prolamsa’s audited financial statements time. When 20 percent or more of the 351.102(b). in accordance with Mexican generally respondent’s sales of a given product accepted accounting principles. See during the POI were at prices less than C. Cost of Production Analysis Prolamsa’s Analysis Memorandum, the COP, we disregarded the below-cost Based on timely allegations filed by dated April 6, 2004. sales because they were made in the petitioners, and in accordance with We adjusted the G&A ratio to reflect substantial quantities within an section 773(b)(2)(A)(i) of the Act, we the 2002 profit sharing costs included in extended period of time pursuant to found reasonable grounds to believe or Prolamsa’s 2002 audited financial sections 773(b)(2)(B) and (C) of the Act suspect that LWRPT sales were made at statements. Id. and because, based on comparisons of prices to weighted-average COPs for the prices below the COP. As a result, we LM initiated sales below cost investigations POI, we determined that these sales on February 2, 2004 (Prolamsa),9 on We adjusted the reported total cost of were at prices which would not permit February 4, 2004 (LM 10 and Galvak/ manufacturing to include the recovery of all costs within a reasonable Hylsa),11 and on February 3, 2004 depreciation expense related to the period of time in accordance with (Regiomontana)12 to determine whether revaluation of fixed assets recorded in section 773(b)(2)(D) of the Act. Based on sales were made at prices below the LM’s audited financial statements in this test, we disregarded below-cost COP. accordance with Mexican generally sales with respect to Galvak/Hylsa. See We conducted the COP analysis as accepted accounting principles. We Analysis Memorandum to the file dated described below. adjusted the G&A ratio to reflect the April 6, 2004, for additional 2002 profit sharing costs included in information. For the remaining 1. Calculation of Cost of Production LM’s 2002 audited financial statements. respondents, less than 20 percent of In accordance with section 773(b)(3) In addition, we adjusted the reported sales of a given product were at prices of the Act, we calculated a weighted- interest expenses for exchange gains and less than COP. Therefore, we did not average COP for each respondent based losses, interest paid to affiliates and the disregard any below-cost sales for these on the sum of the cost of materials and gain on monetary position. See LM’s respondents. Analysis Memorandum, dated April 6, fabrication of the foreign like product, D. Calculation of Normal Value Based 2004. plus amounts for the home market on Comparision-Market Prices Regiomontana 9 See Prolamsa Cost Memo. We determined price-based NVs for 10 See LM Cost Memo. We adjusted the G&A ratio to reflect respondent companies as follows. For 11 See Galvak/Hylsa Cost Memo. the 2002 profit sharing costs included in all respondents, we made adjustments 12 See Regiomontana Cost Memo. Regiomontana’s 2002 audited financial to the starting price for any differences

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in packing costs, in accordance with Galvak/Hylsa each respondent in connection with the section 773(a)(6) of the Act, and we We based NV for Galvak/Hylsa on production and sale of the foreign like deducted from starting prices movement prices to unaffiliated customers or, as product, in the ordinary course of trade, expenses pursuant to section indicated above, affiliated customers, if for consumption in the comparison 773(a)(6)(B)(ii) of the Act. In addition, affiliated party home market sales market to calculate SG&A expenses and profit. For price-to-CV comparisons, we where applicable, we made adjustments satisfied the arm’s-length test. In to starting prices to account for made adjustments to CV for COS accordance with 19 CFR 351.401(c), we differences in cost attributable to differences, pursuant to section increased the starting price for freight differences in the physical 773(a)(8) of the Act. fees charged to the customer and characteristics of the merchandise sold interest revenue, and adjusted for billing F. Level of Trade/Constructed Export in the U.S. and home markets pursuant adjustments. We reduced the home Price Offset to section 773(a)(6)(C)(ii) of the Act, as market starting price for movement well as for differences in circumstances In accordance with section expenses such as inland freight and of sale (COS) in accordance with section 773(a)(1)(B) of the Act, to the extent warehousing pursuant to section 773(a)(6)(C)(iii) of the Act and 19 CFR practicable, we determined NV based on 773(a)(6)(B) of the Act. We also made 351.410. We also made adjustments, sales in the comparison market at the pursuant to 19 CFR 351.410(e), for COS adjustments to the starting price for same level of trade (LOT) as the U.S. indirect selling expenses incurred on imputed credit expenses and warranty sales (either EP or CEP transactions). comparison-market or U.S. sales where expenses in accordance with section The NV LOT is that of the starting-price commissions were granted on sales in 773(a)(6)(C)(iii) of the Act and 19 CFR sale in the comparison market or, when one market but not in the other market, 351.410. We deducted home market the NV is based on CV, that of the sales where applicable. packing costs from, and added U.S. from which we derive SG&A expenses Company-specific adjustments are packing costs to, the starting price in and profit. For EP sales, the U.S. LOT described below. accordance with sections 773(a)(6)(A) is also the level of the starting-price and (B) of the Act. sale, which is usually the price of the Prolamsa Regiomontana sale from the exporter to the importer. We based NV for Prolamsa on prices For CEP sales, it is the level of the to unaffiliated customers or, as We based NV for Regiomontana on constructed sale from the exporter to the indicated above, affiliated customers, if prices to unaffiliated customers or, as importer. affiliated party home market sales indicated above, affiliated customers, if To determine whether comparison satisfied the arm’s-length test. We affiliated party home market sales market sales are at a different LOT than reduced the home market starting price satisfied the arm’s-length test. Where EP or CEP transactions, we examine for rebates in accordance with 19 CFR applicable, we made an adjustment for stages in the marketing process and 351.401(c). In addition, we reduced the inland freight pursuant to section selling functions along the chain of starting price for inland freight pursuant 773(a)(6)(B) of the Act. In accordance distribution between the producer and to section 773(a)(6)(B) of the Act. In with 19 CFR 351.401(c), we increased the unaffiliated customer. If the accordance with 19 CFR 351.401(c), we the starting price for handling fees comparison-market sales are at a increased the starting price for interest charged to the customer and interest different LOT, and the difference affects revenue and adjusted for billing revenue and adjusted for billing price comparability with U.S. sales, as adjustments and discounts. We also adjustments and discounts. We also manifested in a pattern of consistent made COS adjustments to the starting made COS adjustments to the starting price differences between the sales on price for imputed credit expenses in price for imputed credit expenses in which NV is based and comparison- accordance with section 773(a)(6)(C)(iii) accordance with section 773(a)(6)(C)(iii) market sales at the LOT of the export of the Act and 19 CFR 351.410. Finally, of the Act and 19 CFR 351.410. Finally, transaction, we make a LOT adjustment we deducted home market packing costs we deducted home market packing costs pursuant to section 773(a)(7)(A) of the from, and added U.S. packing costs to from, and added U.S. packing costs to, Act. For CEP sales, if the LOT of the the starting price in accordance with the starting price in accordance with home market sale is more remote from sections 773(a)(6)(A) and (B) of the Act. sections 773(a)(6)(A) and (B) of the Act. the factory than the CEP level and there is no basis for determining whether the E. Calculation of Normal Value Based LM difference between the LOT of the home on Constructed Value We based NV for LM on prices to market sale and the CEP transaction unaffiliated customers or, as indicated Section 773(b)(1) of the Act provides affects price comparability, we adjust above, affiliated customers, if affiliated that if, after disregarding all sales made NV pursuant to section 773(a)(7)(B) of party home market sales satisfied the at prices below the COP, there are no the Act (the CEP offset provision). See arm’s-length test. We reduced the home comparison market sales made in the Final Determination of Sales at Less market starting price for rebates in ordinary course of trade, NV shall be Than Fair Value: Greenhouse Tomatoes accordance with 19 CFR 351.401(c). We based on constructed value (CV). We From Canada, 67 FR 8781 (February 26, reduced the home market starting price calculated CV in accordance with 2002). for discounts and inland freight section 773(e) of the Act. Specifically, To determine whether a LOT pursuant to section 773(a)(6)(B) of the section 773(e) of the Act provides that adjustment is warranted, we obtained Act. We also made COS adjustments to CV shall be based on the sum of the cost information from each respondent about the starting price for imputed credit of materials and fabrication for the the marketing stages at which its expenses in accordance with section foreign like product, plus amounts for reported U.S. and comparison-market 773(a)(6)(C)(iii) of the Act and 19 CFR selling, general and administrative sales were made, including a 351.410. Finally, we deducted home expenses (SG&A), profit, and U.S. description of the selling activities market packing costs from, and added packing. performed by the respondent for each of U.S. packing costs to the starting price In accordance with section its channels of distribution. In in accordance with sections 773(a)(6)(A) 773(e)(2)(A) of the Act, we used the identifying LOTs for EP and comparison and (B) of the Act. actual amounts incurred and realized by market sales, we considered the selling

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functions reflected in the starting price LWRPT from Mexico that are entered, or afford interested parties an opportunity before any adjustments. For CEP sales, withdrawn from warehouse, for to comment on arguments raised in case we considered only the selling activities consumption on or after the date of or rebuttal briefs, provided that such a reflected in the price after the deduction publication of this notice in the Federal hearing is requested by an interested of expenses and profit pursuant to Register. We will instruct CBP to party. If a request for a hearing is made section 772(d) of the Act. Generally, if require a cash deposit or the posting of in an investigation, the hearing the claimed LOTs are the same, the a bond equal to the weighted-average normally will be held two days after the functions and activities of the seller amount by which the NV exceeds the deadline for submission of the rebuttal should be similar. Conversely, if a party U.S. price, as indicated below. These briefs, at the U.S. Department of claims that LOTs are different for suspension-of-liquidation instructions Commerce, 14th Street and Constitution different groups of sales, the functions will remain in effect until further notice. Avenue, NW., Washington, DC 20230. and activities of the seller should be The weighted-average dumping margins Parties should confirm by telephone the dissimilar. are as follows: time, date, and place of the hearing 48 In conducting our LOT analysis for hours before the scheduled time. each respondent, we took into account Manufacturer/exporter Margin Interested parties who wish to request the specific customer types, channels of (percent) a hearing, or to participate in a hearing distribution, and selling functions of if one is requested, must submit a Prolamsa ...... 5.56 each respondent. For Galvak/Hylsa, LM ...... 13.61 written request within 30 days of the Regiomontana, Prolamsa and LM, we Galvak/Hylsa ...... 19.89 publication of this notice. Requests found that there was a single LOT in the Regiomontana ...... 4.45 should specify the number of United States and a single, identical, All Others ...... 11.59 participants and provide a list of the LOT in the comparison market. issues to be discussed. Oral Therefore, it was not necessary to make Disclosure presentations will be limited to issues a LOT or CEP offset adjustment. For a raised in the briefs. The Department will disclose to the further discussion of our LOT analysis As noted above, the Department will parties to the proceeding the for each respondent, see their respective make its final determination within 135 calculations performed in the Level of Trade Memorandums, dated days after the date of the publication of preliminary determination within five April 6, 2004. the preliminary determination. days of the date of publication of this This determination is issued and G. Currency Conversions notice, in accordance with 19 CFR published pursuant to sections 733(f) We made currency conversions to 351.224(b). and 777(i)(1) of the Act. U.S. dollars in accordance with section International Trade Commission Dated: April 6, 2004. 773A of the Act based on exchange rates Notification James J. Jochum, in effect on the dates of the U.S. sales, as obtained from the Federal Reserve In accordance with section 733(f) of Assistant Secretary for Import Administration. Bank, the Department’s preferred source the Act, we have notified the ITC of our for exchange rates. preliminary sales at LTFV [FR Doc. 04–8376 Filed 4–12–04; 8:45 am] determination. If our final antidumping BILLING CODE 3510–DS–P Verification determination is affirmative, the ITC In accordance with section 782(i) of will determine whether the imports the Act, we intend to verify all covered by that determination are DEPARTMENT OF COMMERCE information relied upon in making our materially injuring or threatening National Oceanic and Atmospheric final determination. material injury to the U.S. industry. The deadline for the final ITC determination Administration All Others Rate would be the later of 120 days after the [I.D. 040804A] Section 735(c)(5)(A) of the Act date of this preliminary determination provides for the use of an ‘‘all others’’ or 45 days after the date of our final Proposed Information Collection; rate, which is applied to non- determination. Comment Request; Coast Pilot Report investigated firms. See Statement of Public Comment AGENCY: National Oceanic and Administrative Action, H.R. Doc. No. Atmospheric Administration (NOAA). 103–316, Vol. I (1994). This section Case briefs for this investigation must states that the all others rate shall be submitted no later than one week ACTION: Notice. after the issuance of the last verification generally be an amount equal to the SUMMARY: The Department of report. Rebuttal briefs must be filed weighted-average dumping margins Commerce, as part of its continuing within five days after the deadline for established for exporters and producers effort to reduce paperwork and submission of case briefs. A list of individually investigated, excluding any respondent burden, invites the general authorities used, a table of contents, and zero and de minimis margins, and any public and other Federal agencies to an executive summary of issues should margins based entirely upon the facts take this opportunity to comment on accompany any briefs submitted to the available. Therefore, we have proposed and/or continuing information Department. Executive summaries preliminarily assigned to all other collections, as required by the should be limited to five pages total, exporters of LWRPT from Mexico a Paperwork Reduction Act of 1995, including footnotes. Further, the margin that is based on the weighted- Public Law 104-13 (44 U.S.C. Department respectfully requests that all average margins calculated for all 3506(c)(2)(A)). mandatory respondents. parties submitting written comments also provide the Department with an DATES: Written comments must be Suspension of Liquidation additional copy of the public version of submitted on or before June 14, 2004. In accordance with section 733(d)(2) any such comments on diskette. ADDRESSES: Direct all written comments of the Act, we are directing CBP to Section 774 of the Act provides that to Diana Hynek, Departmental suspend liquidation of all shipments of the Department will hold a hearing to Paperwork Clearance Officer,

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Department of Commerce, Room 6625, Dated: April 7, 2004. DEPARTMENT OF DEFENSE 14th and Constitution Avenue, NW, Gwellnar Banks, Washington, DC 20230 (or via the Management Analyst, Office of the Chief Office of the Secretary Internet at [email protected]). Information Officer. [FR Doc. 04–8385 Filed 4–12–04; 8:45 am] Proposed Collection; Comment FOR FURTHER INFORMATION CONTACT: Request Requests for additional information or BILLING CODE 3510–JE–S copies of the information collection AGENCY: Office of the Assistant instrument and instructions should be Secretary of Defense (Health Affairs) directed to Oren Stembel at 301-713- DEPARTMENT OF COMMERCE DoD. 2750, ext. 165, or at National Oceanic and Atmospheric ACTION: Notice. [email protected]. Administration SUMMARY: In compliance with section SUPPLEMENTARY INFORMATION: [I.D. 112803C] 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the I. Abstract RIN 0648–AR74 Assistant Secretary of Defense (Health NOAA produces the U.S. Nautical Fisheries of the Exclusive Economic Affairs) announces a proposed Coast Pilot, a series of nine books that information collection and seeks public supplement marine nautical charts. The Zone Off Alaska; Rebuilding Overfished Fisheries; Correction comment on the provisions thereof. Coast Pilot contains information Comments are invited on: (a) Whether essential to navigators in U.S. coastal AGENCY: National Marine Fisheries the proposed collection of information and intra-coastal waters but that cannot Service (NMFS), National Oceanic and is necessary for the proper performance be shown graphically on charts. The Atmospheric Administration (NOAA), of the functions of the agency, including Coast Pilot Report if offered to the Commerce. whether the information shall have public as a means for recommending ACTION: Correction to a notice. practical utility; (b) the accuracy of the changes to the publication. agency’s estimate of the burden of the SUMMARY: This document corrects a proposed information collection; (c) II. Method of Collection notice published in the Federal Register ways to enhance the quality, utility, and on April 5, 2004, announcing the A paper form is used. clarity of the information to be approval of Amendment 17 to the collected; and (d) ways to minimize the III. Data Fishery Management Plan for Bering Sea burden of the information collection on and Aleutian Islands King and Tanner OMB Number: 0648–0007. respondents, including the use of Crabs. This action is necessary to correct Form Number: NOAA Form 77-6. automated collection techniques or an error made regarding the approval Type of Review: Regular submission. other forms of information technology. Affected Public: Individuals or date of the amendment. All other information remains unchanged. DATES: Written comments and households. recommendations on the continuing FOR FURTHER INFORMATION CONTACT: Estimated Number of Respondents: information collection should be sent to Gretchen Harrington, 907–586–7228 or 100. Lt Col Michael Hartzell, 5111 Leesburg [email protected]. Estimated Time Per Response: 30 Pike, Suite 810, Falls Church, VA, minutes. SUPPLEMENTARY INFORMATION: NMFS 22041–3206. Estimated Total Annual Burden published a notice announcing the FOR FURTHER INFORMATION CONTACT: To Hours: 50. approval of Amendment 17 to the request more information on this Estimated Total Annual Cost to Fishery Management Plan for Bering Sea information collection, please write to Public: $0. and Aleutian Islands King and Tanner the above address or contact LTC Crabs on April 5, 2004 (69 FR 17651, FR IV. Request for Comments Michael Hartzell, by calling 703 681– Doc. 04–7509). While the amendment 3636 or e-mail at Comments are invited on: (a) whether was approved on March 11, 2004, the [email protected]. the proposed collection of information notice announced an approval date of Title Associated Form and OMB is necessary for the proper performance March 18, 2004. This action corrects Number: Viability of TRICARE Standard of the functions of the agency, including this error. Survey; OMB Number 0720—[to Be whether the information shall have Correction Determined]. practical utility; (b) the accuracy of the Needs and Uses: Data will be agency’s estimate of the burden In the Federal Register of April 5, collected from civilian providers to (including hours and cost) of the 2004, in FR Doc. 04–7509, on page determine how many are/are not proposed collection of information; (c) 17651, in the first column, correct the accepting TRICARE Standard patients ‘‘ ways to enhance the quality, utility, and Dates’’ caption to read: and to ascertain the reasons. DATES: The amendment was clarity of the information to be Information will be used to assess the collected; and (d) ways to minimize the approved on March 11, 2004. Also, on page 17652, in the first scope and nature of any problems burden of the collection of information related to beneficiary access to care. on respondents, including through the column, under the heading Response to Comments, in response 5, lines 9 and Affected Public: Individuals. use of automated collection techniques Annual Burden Hours: 2340. 10, ‘‘March 18, 2004.’’ is corrected to or other forms of information Number of Respondents: 9,360. ‘‘ technology. read March 11, 2004.’’ Responses per Respondent: 1. Comments submitted in response to Dated: April 7, 2004. Average Burden per Response: 15 this notice will be summarized and/or Alan D. Risenhoover, minutes. included in the request for OMB Acting Director, Office of Sustainable Frequency: Annual. approval of this information collection; Fisheries, National Marine Fisheries Service. SUPPLEMENTARY INFORMATION: The they also will become a matter of public [FR Doc. 04–8384 Filed 4–12–04; 8:45 am] Health Program Analysis and Evaluation record. BILLING CODE 3510–22–S Directorate (HPAE) under authority of

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the Office of the Assistant Secretary of Title, Form, and OMB Number: Defense announced closed meetings of defense (Health Affairs)/TRICARE Intercontinental Ballistic Missile the Defense Science Board (DSB) Task Management Activity will undertake an Hardened Intersite Cable Right-of-Way Force on Critical Homeland evaluation of the Department of Landowner/Tenant Questionnaire; AF Infrastructure Protection. The meeting Defense’s TRICARE Standard healthcare Form 3951; OMB Number 0701–0141. originally announced for June 17–18, option. HPAE will collect and analyze Type of Request: Extension. 2004, has been rescheduled to June 23– data that are necessary to meet the Number of Respondents: 4,000. 24, 2004. It will be held at SAIC, 4001 requirements outlined in section 723 of Responses per Respondent: 1. N. Fairfax Drive, Suite 500, Arlington, the National Defense Authorization Act Annual Responses: 4,000. VA. Average Burden per Response: 15 for Fiscal Year 2004. Activities include Dated: April 7, 2004. the collection and analysis of data minutes. Annual Burden Hours: 1,000. L.M. Bynum, obtained from civilian physicians Needs and Uses: The information Alternate OSD Federal Register Liaison (M.D.s & D.O.s) within U.S. TRICARE collection requirement is used to report Officer, Department of Defense. market areas. Specifically, telephone changes in ownership/lease [FR Doc. 04–8258 Filed 4–12–04; 8:45 am] surveys of civilian providers will be information, conditions of missile cable BILLING CODE 5001–06–M conducted in the TRICARE market areas route and associated appurtenances, and to determine how many healthcare projected building/excavation projects. providers are accepting new patients The information collected is used to DEPARTMENT OF EDUCATION under TRICARE Standard in each ensure the integrity of the Hardened market area. The telephone surveys will Intersite Cable System (HICS) and to Notice of Proposed Information be conducted in at least 20 TRICARE maintain a close contact public relations Collection Requests market areas in the United States each program with involved personnel and AGENCY: Department of Education. fiscal year until all market areas in the agencies. This information also aids in SUMMARY: The Leader, Regulatory United States have been surveyed. In notifying landowners and tenants when Information Management Group, Office prioritizing the order in which these HICS preventative or corrective of the Chief Information Officer, invites market areas will be surveyed, maintenance becomes necessary to comments on the proposed information representatives of TRICARE ensure uninterrupted Intercontinental collection requests as required by the beneficiaries will be consulted in Ballistic Missile command and control Paperwork Reduction Act of 1995. identifying locations with historical capability. evidence of access-to-care problems Affected Public: Individuals or DATES: Interested persons are invited to under TRICARE Standard. These areas households; farms; State, local or tribal submit comments on or before June 14, will receive priority in surveying. government. 2004. Information will be collected Frequency: Biennially. SUPPLEMENTARY INFORMATION: Section telephonically to determine the number Respondent’s Obligation: Voluntary. 3506 of the Paperwork Reduction Act of of healthcare providers that currently OMB Desk Officer: Ms. Jacqueline 1995 (44 U.S.C. Chapter 35) requires accept TRICARE Standard beneficiaries Zeiher. Written comments and that the Office of Management and as patients under TRICARE Standard in recommendations on the proposed Budget (OMB) provide interested each market area. Providers will also be information collection should be sent to Federal agencies and the public an early asked if they would accept TRICARE Ms. Zeiher at the Office of Management opportunity to comment on information Standard beneficiaries as new patients and Budget, Desk Officer for DoD, Room collection requests. OMB may amend or under TRICARE Standard. Analyses and 10236, New Executive Office Building, waive the requirement for public reports will include all legislative Washington, DC 20503. consultation to the extent that public requirements. DOD Clearance Officer: Mr. Robert participation in the approval process Dated: April 7, 2004. Cushing. Written requests for copies of would defeat the purpose of the L.M. Bynum, the information collection proposal information collection, violate State or should be sent to Mr. Cushing, WHS/ Alternate OSD Federal Register Liaison Federal law, or substantially interfere Officer, Department of Defense. ESCD/Information Management with any agency’s ability to perform its Division, 1225 Jefferson Davis Highway, [FR Doc. 04–8256 Filed 4–12–04; 8:45 am] statutory obligations. The Leader, Suite 504, Arlington, VA 22202–4326. BILLING CODE 5001–06–M Regulatory Information Management Dated: April 7, 2004. Group, Office of the Chief Information L.M. Bynum, Officer, publishes that notice containing DEPARTMENT OF DEFENSE Alternate OSD Federal Register Liaison proposed information collection Officer, Department of Defense. requests prior to submission of these Office of the Secretary [FR Doc. 04–8257 Filed 4–12–04; 8:45 am] requests to OMB. Each proposed BILLING CODE 5001–06–M information collection, grouped by Submission for OMB Review; office, contains the following: (1) Type Comment Request of review requested, e.g. new, revision, DEPARTMENT OF DEFENSE extension, existing or reinstatement; (2) ACTION: Notice. Title; (3) Summary of the collection; (4) Office of the Secretary Description of the need for, and The Department of Defense has proposed use of, the information; (5) submitted to OMB for clearance, the Defense Science Board Respondents and frequency of following proposal for collection of AGENCY: Department of Defense. collection; and (6) Reporting and/or information under the provisions of the Recordkeeping burden. OMB invites Paperwork Reduction Act (44 U.S.C. ACTION: Notice of Advisory Committee Meeting date change. public comment. The Department of chapter 35). Education is especially interested in DATES: Consideration will be given to all SUMMARY: On Tuesday, December 30, public comment addressing the comments received by May 13, 2004. 2003 (68 FR 75219) the Department of following issues: (1) is this collection

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necessary to the proper functions of the Relay Service (FIRS) at 1–800–877– Dated: April 7, 2004. Department; (2) will this information be 8339. Angela C. Arrington, processed and used in a timely manner; [FR Doc. 04–8343 Filed 4–12–04; 8:45 am] Leader, Regulatory Information Management (3) is the estimate of burden accurate; Group, Office of the Chief Information Officer. BILLING CODE 4000–01–P (4) how might the Department enhance Office of Special Education and the quality, utility, and clarity of the Rehabilitative Services information to be collected; and (5) how DEPARTMENT OF EDUCATION might the Department minimize the Type of Review: Extension. burden of this collection on the Notice of Proposed Information Title: Report of Early Intervention respondents, including through the use Collection Requests Services on IFSPs Provided to Infants, of information technology. Toddlers and Their Families in AGENCY: Department of Education. Dated: April 7, 2004. Accordance with Part C and Report of SUMMARY: The Leader, Regulatory Angela C. Arrington, Number and Type of Personnel Information Management Group, Office Employed and Contracted to Provide Leader, Regulatory Information Management of the Chief Information Officer, invites Group, Office of the Chief Information Officer. Early Intervention Services. comments on the proposed information Frequency: Annually. Office of Special Education and collection requests as required by the Affected Public: State, local, or tribal Rehabilitative Services Paperwork Reduction Act of 1995. gov’t, SEAs or LEAs (primary). Type of Review: Extension. DATES: Interested persons are invited to Reporting and Recordkeeping Hour submit comments on or before June 14, Title: Annual Progress Reporting Burden: 2004. Form for Special Demonstration Responses: 56. Programs. SUPPLEMENTARY INFORMATION: Section Burden Hours: 4,760. Frequency: Annually. 3506 of the Paperwork Reduction Act of Abstract: This package provides 1995 (44 U.S.C. Chapter 35) requires Affected Public: Not-for-profit instructions and forms necessary for that the Office of Management and institutions; businesses or other for- States to report, by race and ethnicity, Budget (OMB) provide interested profit, State, local, or tribal gov’t, SEAs the number of infants and toddlers with Federal agencies and the public an early or LEAs. disabilities and their families receiving opportunity to comment on information Reporting and Recordkeeping Hour different types of Part C services, and collection requests. OMB may amend or Burden: the number of personnel employed and waive the requirement for public contracted to provide services for Responses: 41. consultation to the extent that public Burden Hours: 1,148. infants and toddlers with disabilities participation in the approval process and their families. Data are obtained Abstract: This data collection will be would defeat the purpose of the from state and local service agencies conducted annually to obtain program information collection, violate State or and are used to assess and monitor the and performance information from Federal law, or substantially interfere implementation of IDEA and for Rehabilitation Services Administration with any agency’s ability to perform its Congressional reporting. (RSA) grantees on their project statutory obligations. The Leader, Requests for copies of the proposed activities. The data will be collected in Regulatory Information Management accordance with the Government information collection request may be Group, Office of the Chief Information accessed from http://edicsweb.ed.gov, Performance and Results Act. Grantees Officer, publishes that notice containing will submit data via an internet form. by selecting the ‘‘Browse Pending proposed information collection Collections’’ link and by clicking on Requests for copies of the proposed requests prior to submission of these link number 2496. When you access the information collection request may be requests to OMB. Each proposed information collection, click on accessed from http://edicsweb.ed.gov, information collection, grouped by ‘‘Download Attachments’’ to view. by selecting the ‘‘Browse Pending office, contains the following: (1) Type Written requests for information should Collections’’ link and by clicking on of review requested, e.g. new, revision, be addressed to Vivian Reese, link number 2499. When you access the extension, existing or reinstatement; (2) Department of Education, 400 Maryland information collection, click on Title; (3) Summary of the collection; (4) Avenue, SW., Room 4050, Regional ‘‘Download Attachments’’ to view. Description of the need for, and Office Building 3, Washington, DC Written requests for information should proposed use of, the information; (5) 20202–4651 or to the e-mail address be addressed to Vivian Reese, Respondents and frequency of [email protected]. Requests may also Department of Education, 400 Maryland collection; and (6) Reporting and/or be electronically mailed to the Internet Avenue, SW., Room 4050, Regional Recordkeeping burden. OMB invites address [email protected] or faxed to Office Building 3, Washington, DC public comment. The Department of 202–708–9346. Please specify the 20202–4651 or to the e-mail address Education is especially interested in complete title of the information [email protected]. Requests may also public comment addressing the collection when making your request. be electronically mailed to the Internet following issues: (1) Is this collection Comments regarding burden and/or address [email protected] or faxed to necessary to the proper functions of the the collection activity requirements 202–708–9346. Please specify the Department; (2) will this information be should be directed to Sheila Carey at her complete title of the information processed and used in a timely manner; e-mail address Sheila [email protected]. collection when making your request. (3) is the estimate of burden accurate; Individuals who use a Comments regarding burden and/or (4) how might the Department enhance telecommunications device for the deaf the collection activity requirements the quality, utility, and clarity of the (TDD) may call the Federal Information should be directed to Sheila Carey at her information to be collected; and (5) how Relay Service (FIRS) at 1–800–877– e-mail address [email protected]. might the Department minimize the 8339. Individuals who use a burden of this collection on the telecommunications device for the deaf respondents, including through the use [FR Doc. 04–8344 Filed 4–12–04; 8:45 am] (TDD) may call the Federal Information of information technology. BILLING CODE 4000–01–P

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DEPARTMENT OF EDUCATION Dated: April 7, 2004. collection requests as required by the Angela C. Arrington, Paperwork Reduction Act of 1995. Notice of Proposed Information Leader, Regulatory Information Management DATES: Interested persons are invited to Collection Requests Group, Office of the Chief Information Officer. submit comments on or before June 14, Office of Special Education and 2004. AGENCY: Department of Education. Rehabilitative Services SUPPLEMENTARY INFORMATION: Section SUMMARY: The Leader, Regulatory 3506 of the Paperwork Reduction Act of Type of Review: Reinstatment. Information Management Group, Office 1995 (44 U.S.C. chapter 35) requires that Title: Report of Children with the Office of Management and Budget of the Chief Information Officer, invites Disabilities Exiting Special Education (OMB) provide interested Federal comments on the proposed information During the School Year. agencies and the public an early collection requests as required by the Frequency: Annually. Paperwork Reduction Act of 1995. Affected Public: State, local, or tribal opportunity to comment on information collection requests. OMB may amend or DATES: Interested persons are invited to gov’t, SEAs or LEAs (primary). Reporting and Recordkeeping Hour waive the requirement for public submit comments on or before June 14, consultation to the extent that public 2004. Burden: Responses: 60. participation in the approval process SUPPLEMENTARY INFORMATION: Section Burden Hours: 39,420. would defeat the purpose of the 3506 of the Paperwork Reduction Act of Abstract: This package provides information collection, violate State or 1995 (44 U.S.C. chapter 35) requires that instructions and a form necessary for Federal law, or substantially interfere with any agency’s ability to perform its the Office of Management and Budget States to report the number of students statutory obligations. The Leader, (OMB) provide interested Federal aged 14 and older served under IDEA– Regulatory Information Management agencies and the public an early B exiting special education. This form Group, Office of the Chief Information opportunity to comment on information satisfies reporting requirements and is used by OSEP to monitor SEAs, and for Officer, publishes that notice containing collection requests. OMB may amend or proposed information collection waive the requirement for public Congressional reporting. Requests for copies of the proposed requests prior to submission of these consultation to the extent that public information collection request may be requests to OMB. Each proposed rticipation in the approval process accessed from http://edicsweb.ed.gov, information collection, grouped by would defeat the purpose of the by selecting the ‘‘Browse Pending office, contains the following: (1) Type information collection, violate State or Collections’’ link and by clicking on of review requested, e.g. new, revision, Federal law, or substantially interfere link number 2495. When you access the extension, existing or reinstatement; (2) with any agency’s ability to perform its information collection, click on title; (3) summary of the collection; (4) statutory obligations. The Leader, ‘‘Download Attachments’’ to view. description of the need for, and Regulatory Information Management Written requests for information should proposed use of, the information; (5) Group, Office of the Chief Information be addressed to Vivian Reese, respondents and frequency of Officer, publishes that notice containing Department of Education, 400 Maryland collection; and (6) reporting and/or proposed information collection Avenue, SW., Room 4050, Regional recordkeeping burden. OMB invites requests prior to submission of these Office Building 3, Washington, DC public comment. requests to OMB. Each proposed 20202–4651 or to the e-mail address The Department of Education is information collection, grouped by [email protected]. Requests may also especially interested in public comment office, contains the following: (1) Type be electronically mailed to the Internet addressing the following issues: (1) Is of review requested, e.g. new, revision, address [email protected] or faxed to this collection necessary to the proper extension, existing or reinstatement; (2) 202–708–9346. Please specify the functions of the Department; (2) will this information be processed and used title; (3) summary of the collection; (4) complete title of the information in a timely manner; (3) is the estimate description of the need for, and collection when making your request. of burden accurate; (4) how might the proposed use of, the information; (5) Comments regarding burden and/or the collection activity requirements Department enhance the quality, utility, respondents and frequency of and clarity of the information to be collection; and (6) reporting and/or should be directed to Sheila Carey at her e-mail address [email protected]. collected; and (5) how might the recordkeeping burden. OMB invites Individuals who use a Department minimize the burden of this public comment. telecommunications device for the deaf collection on the respondents, including The Department of Education is (TDD) may call the Federal Information through the use of information especially interested in public comment Relay Service (FIRS) at 1–800–877– technology. addressing the following issues: (1) Is 8339. Dated: April 7, 2004. this collection necessary to the proper [FR Doc. 04–8345 Filed 4–12–04; 8:45 am] Angela C. Arrington, functions of the Department; (2) will BILLING CODE 4000–01–P Leader, Regulatory Information Management this information be processed and used Group, Office of the Chief Information Officer. in a timely manner; (3) is the estimate Office of Special Education and of burden accurate; (4) how might the DEPARTMENT OF EDUCATION Rehabilitative Services Department enhance the quality, utility, Type of Review: Reinstatement. and clarity of the information to be Notice of Proposed Information Title: Report of Children with Disabilities collected; and (5) how might the Collection Requests Exiting Special Education During the School Department minimize the burden of this Year. AGENCY: collection on the respondents, including Department of Education. Frequency: Annually. SUMMARY: The Leader, Regulatory through the use of information Affected Public: State, local, or tribal gov’t, Information Management Group, Office technology. SEAs or LEAs (primary). of the Chief Information Officer, invites Reporting and Recordkeeping Hour comments on the proposed information Burden:

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Responses: 60. must file a motion to intervene. All such will be accompanying you, and a Burden Hours: 7,950. motions or protests should be filed on telephone number where you can be Abstract: This package provides or before the comment date, and, to the reached. Northern should be prepared to instructions and a form necessary for States extent applicable, must be served on the to report Personnel serving children with discuss its proposal, including the disabilities served under IDEA–B. This form applicant and on any other person rationale for its proposal and any satisfies reporting requirements and is used designated on the official service list. possible ramifications. Persons by OSEP for monitoring, implementing IDEA, This filing is available for review at the protesting aspects of Northern’s and Congressional reporting. Commission or may be viewed on the proposal should be prepared to answer Requests for copies of the proposed Commission’s Web site at http:// questions and discuss alternatives. information collection request may be www.ferc.gov, using the eLibrary accessed from http://edicsweb.ed.gov, by (FERRIS) link. Enter the docket number The issues to be discussed will selecting the ‘‘Browse Pending Collections’’ excluding the last three digits in the include, but are not limited to: link and by clicking on link number 2494. When you access the information collection, docket number field to access the A. Why does Northern need the more click on ‘‘Download Attachments’’ to view. document. For assistance, please contact stringent gas quality standards it has Written requests for information should be FERC Online Support at proposed in this case? [email protected] or toll- addressed to Vivian Reese, Department of 1. What is the current status of Education, 400 Maryland Avenue, SW., free at (866) 208–3676, or for TTY, Room 4050, Regional Office Building 3, contact (202) 502–8659. Protests and Northern with regard to problems Washington, DC 20202–4651 or to the e-mail interventions may be filed electronically caused by the quality of gas, e.g. have _ address vivian [email protected]. Requests may via the Internet in lieu of paper; see 18 there been ruptures due to corrosion? If also be electronically mailed to the Internet CFR 385.2001(a)(1)(iii) and the so, when did they occur? Has Northern address [email protected] or faxed to 202– instructions on the Commission’s Web had to issue any OFOs due to corrosive 708–9346. Please specify the complete title of conditions on the pipeline? Are there the information collection when making your site under the ‘‘e-Filing’’ link. The request. Commission strongly encourages other Federal regulations affecting its Comments regarding burden and/or the electronic filings. decision to seek more stringent collection activity requirements should be Comment Date: April 20, 2004. standards? directed to Sheila Carey at her e-mail address 2. What are the corresponding carbon [email protected]. Individuals who use a Linda Mitry, telecommunications device for the deaf Acting Secretary. dioxide and oxygen standards on (TDD) may call the Federal Information Relay [FR Doc. E4–804 Filed 4–12–04; 8:45 am] interconnecting pipelines? Service (FIRS) at 1–800–877–8339. BILLING CODE 6717–01–P 3. Why is Northern proposing the [FR Doc. 04–8346 Filed 4–12–04; 8:45 am] changes at this specific time? BILLING CODE 4000–01–P DEPARTMENT OF ENERGY B. How did Northern decide upon the specifics of its gas quality proposal? Federal Energy Regulatory 1. Why change the currently effective DEPARTMENT OF ENERGY Commission carbon dioxide level from 2 percent to Federal Energy Regulatory [Docket Nos. RP04–155–000 and RP03–398– less than or equal to 1 percent, as Commission 000] opposed to some other level? Why change the oxygen tolerance level from [Docket Nos. QF83–168–009 and EL04–86– Northern Natural Gas Company; Notice .2 percent to less than or equal to .02 000] of Technical Conference percent, as opposed to some other level? Wilbur Power LLC; Notice of Filing April 6, 2004. 2. What reports or studies were used Take notice that a technical in making these determinations? (Please April 6, 2004. conference will be held on Tuesday, provide any such reports.) Take notice that on March 31, 2004, April 20, 2004, from 10 a.m. to 5 p.m., 3. What alternatives to these levels Gaylord Container Corporation in a room to be designated at the offices (Gaylord), a corporation with its of the Federal Energy Regulatory did Northern consider? principal place of business at Austin, Commission, 888 First Street, NE., C. What effects will Northern’s Texas, tendered for filing an amended Washington, DC 20426. proposal have on entities upstream or request for Limited Waiver of Qualifying The purpose of the conference is to downstream of Northern, including Cogeneration Operating and Efficiency address Northern Natural Gas interconnecting pipelines or local Standards pursuant to section Company’s (Northern) proposal to lower distribution companies (financial, 292.205(c) of the Commission’s the acceptable levels of oxygen and operational, or otherwise)? regulations. Gaylord requests expedited carbon dioxide in gas received on its D. What alternatives are there to consideration. system. The technical conference was Northern’s proposal (operational or Any person desiring to intervene or to ordered in a February 27, 2004, order 1 protest this filing should file with the accepting and suspending a filing by otherwise)? Federal Energy Regulatory Commission, Northern to increase its rates and make Linda Mitry, 888 First Street, NE., Washington, DC various changes to its tariff. Acting Secretary. 20426, in accordance with rules 211 and All interested persons are permitted 214 of the Commission’s rules of to attend. To assist Staff, attendees are [FR Doc. E4–805 Filed 4–12–04; 8:45 am] practice and procedure (18 CFR 385.211 requested to e-mail BILLING CODE 6717–01–P and 385.214). Protests will be [email protected] stating your considered by the Commission in name, the name of the entity you determining the appropriate action to be represent, the names of the persons who taken, but will not serve to make protestants parties to the proceeding. 1 Northern Natural Gas Co., 106 FERC ¶ 61,195 Any person wishing to become a party (2004).

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DEPARTMENT OF ENERGY instructions on the Commission’s Web Intervention and Protest Date: April site under the ‘‘e-Filing’’ link. The 13, 2004. Federal Energy Regulatory Commission strongly encourages Linda Mitry, Commission electronic filings. Acting Secretary. [Docket No. RP04–249–000] Comment Date: April 15, 2004. [FR Doc. E4–806 Filed 4–12–04; 8:45 am] AES Ocean Express, LLC, Complainant Linda Mitry, BILLING CODE 6717–01–P v. Florida Gas Transmission Company, Acting Secretary. Respondent; Notice of Complaint and [FR Doc. E4–803 Filed 4–12–04; 8:45 am] DEPARTMENT OF ENERGY Request for Fast Track Processing BILLING CODE 6717–01–P April 6, 2004. Federal Energy Regulatory Commission Take notice that on April 5, 2004, DEPARTMENT OF ENERGY AES Ocean Express, LLC (Complainant) submitted a complaint against the Federal Energy Regulatory [Docket No. RP04–239–000] Florida Gas Transmission Company Commission (Respondent). The Complainant asserts Texas Eastern Transmission, LP; Notice of Tariff Filing that for over two years it has attempted [Docket No. RP04–238–000] to establish an agreement that would April 6, 2004. allow it to interconnect its pipeline El Paso Natural Gas Company; Notice Take notice that on March 31, 2004, facilities with those of the Respondent of Revenue Crediting Report in Broward County, Florida. The Texas Eastern Transmission, LP (Texas Complainant alleges that the April 6, 2004. Eastern) tendered for filing as part of its FERC Gas Tariff, Seventh Revised Respondent has violated Commission Take notice that on March 31, 2004, Volume No. 1, First Revised Sheet No. policy by conditioning any El Paso Natural Gas Company (El Paso) 525, to be effective May 1, 2004. interconnection agreement with the tendered for filing its revenue crediting Texas Eastern states that the purpose Complainant on unjust and report for the calendar year 2003. unreasonable terms and conditions. The of this filing is to modify section 3.13(A) El Paso states that the report details of the General Terms and Conditions of Complainant requests that the its crediting of risk sharing revenues for Commission direct the Respondent to its Tariff to reflect the assignment of the calendar year 2003 in accordance establish an interconnection that will North Jersey Energy Associates’ Rate with section 25.3 of the General Terms enable the Complainant to make Schedule FTS–5 Service Agreement to and Conditions of its Volume No. 1–A deliveries at Broward County, Florida, Public Service Electric & Gas Company Tariff. El Paso states that this is its final on terms that are consistent with the effective May 1, 2004. revenue crediting report since the risk Commission’s interconnection policy. Texas Eastern states that copies of its Any person desiring to be heard or to sharing revenue crediting provisions filing have been served upon to all protest this filing should file with the terminated on December 31, 2003. affected customers and interested State Federal Energy Regulatory Commission, Any person desiring to be heard or to commissions. 888 First Street, NE., Washington, DC protest said filing should file a motion Any person desiring to be heard or to 20426, in accordance with rules 211 and to intervene or a protest with the protest said filing should file a motion 214 of the Commission’s rules of Federal Energy Regulatory Commission, to intervene or a protest with the practice and procedure (18 CFR 385.211 888 First Street, NE., Washington, DC Federal Energy Regulatory Commission, and 385.214). Protests will be 20426, in accordance with sections 888 First Street, NE., Washington, DC considered by the Commission in 385.214 or 385.211 of the Commission’s 20426, in accordance with sections determining the appropriate action to be rules and regulations. All such motions 385.214 or 385.211 of the Commission’s taken, but will not serve to make or protests must be filed on or before the rules and regulations. All such motions protestants parties to the proceeding. date as indicated below. Protests will be or protests must be filed in accordance Any person wishing to become a party considered by the Commission in with section 154.210 of the must file a motion to intervene. The determining the appropriate action to be Commission’s regulations. Protests will answer to the complaint and all taken, but will not serve to make be considered by the Commission in comments, interventions or protests protestants parties to the proceedings. determining the appropriate action to be must be filed on or before the comment Any person wishing to become a party taken, but will not serve to make date. This filing is available for review must file a motion to intervene. This protestants parties to the proceedings. at the Commission in the Public filing is available for review at the Any person wishing to become a party Reference Room or may be viewed on Commission in the Public Reference must file a motion to intervene. This the Commission’s Web site at http:// Room or may be viewed on the filing is available for review at the www.ferc.gov using the ‘‘eLibrary’’ link. Commission’s Web site at http:// Commission in the Public Reference Enter the docket number excluding the www.ferc.gov using the eLibrary. Enter Room or may be viewed on the last three digits in the docket number the docket number excluding the last Commission’s Web site at http:// field to access the document. For three digits in the docket number field www.ferc.gov using the eLibrary. Enter assistance, please contact FERC Online to access the document. For assistance, the docket number excluding the last Support at please contact FERC Online Support at three digits in the docket number field [email protected] or toll- [email protected] or toll- to access the document. For assistance, free at (866) 208–3676, or for TTY, free at (866) 208–3676, or TTY, contact please contact FERC Online Support at contact (202) 502–8659. The answer to (202) 502–8659. The Commission [email protected] or toll- the complaint, comments, protests and strongly encourages electronic filings. free at (866) 208–3676, or TTY, contact interventions may be filed electronically See 18 CFR 385.2001(a)(1)(iii) and the (202) 502–8659. The Commission via the Internet in lieu of paper; see 18 instructions on the Commission’s Web strongly encourages electronic filings. CFR 385.2001(a)(1)(iii) and the site under the e-Filing link. See 18 CFR 385.2001(a)(1)(iii) and the

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instructions on the Commission’s Web on the Commission’s Web site under the applicable, and the Project Number of site under the e-Filing link. ‘‘e-Filing’’ link. The Commission the particular application to which the strongly encourages electronic filings. filing refers. Any of the above-named Linda Mitry, Please include the project number (P– documents must be filed by providing Acting Secretary. 3021–086) on any comments or motions the original and eight copies to: The [FR Doc. E4–807 Filed 4–12–04; 8:45 am] filed. Secretary, Federal Energy Regulatory BILLING CODE 6717–01–P The Commission’s rules of practice Commission, 888 First Street, NE., and procedure require all interveners Washington, DC 20426. A copy of any filing a document with the Commission motion to intervene must also be served DEPARTMENT OF ENERGY to serve a copy of that document on upon each representative of the each person in the official service list Applicant specified in the particular Federal Energy Regulatory for the project. Further, if an intervener Commission application. files comments or documents with the o. Agency Comments—Federal, State, Notice of Application for Transfer of Commission relating to the merits of an and local agencies are invited to file License and Soliciting Comments, issue that may affect the responsibilities comments on the described application. Motions To Intervene, and Protests of a particular resource agency, they A copy of the application may be must also serve a copy of the documents obtained by agencies directly from the April 1, 2004. on that resource agency. Applicant. If an agency does not file Take notice that the following j. Description of Application: comments within the time specified for hydroelectric application has been filed Applicants state that, in June 1997, State filing comments, it will be presumed to with the Commission and is available Street purchased Fleet’s interest in the have no comments. One copy of an for public inspection: project as owner-trustee and, in January agency’s comments must also be sent to a. Application Type: Partial transfer of 2003, U.S. Bank purchased State Street’s the Applicant’s representatives. license. interest. Applicants now seek after-the- b. Project No.: 3021–086. fact approval of the two purchases and Magalie R. Salas, c. Date Filed: March 17, 2004. the substitution of State Street for Fleet Secretary. d. Applicants: Allegheny Hydro No. 8, and U.S. Bank for State Street as co- [FR Doc. E4–802 Filed 4–12–04; 8:45 am] L.P., Allegheny Hydro No. 9, L.P. licensee, each solely in its capacity as BILLING CODE 6717–01–P (Allegheny Hydro 8 and 9), and, each owner trustee. solely in its capacity as the owner k. This filing is available for review at trustee for the project, Fleet National the Commission in the Public Reference DEPARTMENT OF ENERGY Bank (formerly the Connecticut National Room or may be viewed on the Bank) (Fleet), State Street Bank and Commission’s Web site at http:// Federal Energy Regulatory Trust Company (State Street) and U.S. www.ferc.gov using the ‘‘FERRIS’’ link. Commission Bank National Association (U.S. Bank). Enter the docket number (P–3021) in the Sunshine Act Meeting e. Name and Location of Project: The docket number field to access the Allegheny River Lock and Dam Nos. 8 document. For assistance, call toll-free April 7, 2004. and 9 Hydroelectric Project is located at 1–866–208–3676 or e-mail The following notice of meeting is the U.S. Army Corps of Engineers’ [email protected]. For TTY, published pursuant to section 3(a) of the Allegheny River Lock and Dam No. 8 call (202) 502–8659. A copy is also Government in the Sunshine Act (Pub. and Allegheny River Lock and Dam No. available for inspection and L. 94–409), 5 U.S.C 552b: 9 on the Allegheny River in Armstrong reproduction at the addresses in item g. AGENCY HOLDING MEETING: Federal County, Pennsylvania. above. Energy Regulatory Commission. f. Filed Pursuant to: Federal Power l. Individuals desiring to be included DATE AND TIME: April 14, 2004, 10 a.m. Act, 16 U.S.C. 791a–825r. on the Commission’s mailing list should g. Applicant Contacts: For Allegheny so indicate by writing to the Secretary PLACE: Room 2C, 888 First Street, NE., Hydro 8 and 9: David L. Schwartz, of the Commission. Washington, DC 20426. Latham & Watkins LLP, Suite 1000, 555 m. Comments, Protests, or Motions to STATUS: Open. Eleventh Street, NW., Washington, DC Intervene — Anyone may submit MATTERS TO BE CONSIDERED: Agenda 20004–1304. (202) 637–2125. For Fleet, comments, a protest, or a motion to *Note: —Items listed on the Agenda may State Street, and U.S. Bank: Thomas F. intervene in accordance with the be deleted without further notice. Steichen, U.S. Bank National requirements of rules of practice and Association, West Side Flats Center, EP– procedure, 18 CFR 385.210, .211, .214. CONTACT PERSON FOR MORE INFORMATION: MN–WS4L, 60 Livingston Avenue, St. In determining the appropriate action to Magalie R. Salas, Secretary, Telephone Paul, MN 55107. take, the Commission will consider all (202) 502–8400 for a Recording Listing h. FERC Contact: James Hunter, (202) protests or other comments filed, but Items Stricken From or Added to the 502–6086. only those who file a motion to Meeting, Call (202) 502–8627. i. Deadline for Filing Comments, intervene in accordance with the This is a List of Matters to be Protests, and Motions to Intervene: May Commission’s rules may become a party Considered by the Commission. It Does 3, 2004. to the proceeding. Any comments, Not Include a Listing of All Papers All documents (original and eight protests, or motions to intervene must Relevant to the Items on the Agenda; copies) should be filed with: Magalie R. be received on or before the specified However, All Public Documents May be Salas, Secretary, Federal Energy comment date for the particular Examined in the Reference and Regulatory Commission, 888 First application. Information Center. Street, NE., Washington, DC 20426. n. Filing and Service of Responsive Administrative Agenda Comments, protests, and interventions Documents — Any filings must bear in A–1. may be filed electronically via the all capital letters the title DOCKET# AD02–1, 000, AGENCY Internet in lieu of paper; see 18 CFR ‘‘COMMENTS’’, ‘‘PROTEST’’, OR ADMINISTRATIVE MATTERS 385.2001(a)(1)(iii) and the instructions ‘‘MOTION TO INTERVENE’’, as A–2.

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DOCKET# AD02–7, 000, CUSTOMER PL02–8, 000, CONFERENCE ON SUPPLY E–13. MATTERS, RELIABILITY, SECURITY MARGIN ASSESSMENT DOCKET# ER04–337, 000, PACIFIC GAS AND MARKET OPERATIONS E–2. AND ELECTRIC COMPANY A–3. DOCKET# RM04–7, 000, MARKET-BASED OTHER#S ER04–337, 001, PACIFIC GAS DOCKET# MO04–3, 000, REGIONAL RATES FOR PUBLIC UTILITIES AND ELECTRIC COMPANY MARKET MONITOR STATE OF E–3. ER04–337, 002, PACIFIC GAS AND MARKET PRESENTATIONS OMITTED ELECTRIC COMPANY E–4. ER04–337, 003, PACIFIC GAS AND Markets, Tariffs and Rates—Electric OMITTED ELECTRIC COMPANY E–1. E–5. E–14. DOCKET# ER96–2495, 016, AEP POWER DOCKET# ER02–2189, 001, SOUTHERN OMITTED MARKETING, INC., AEP SERVICE CALIFORNIA EDISON COMPANY E–15. CORPORATION, CSW POWER E–6. DOCKET# ER03–708, 000, PACIFIC GAS MARKETING, INC., CSW ENERGY DOCKET# PL04–5, 000, POLICY AND ELECTRIC COMPANY SERVICES, INC., AND CENTRAL AND STATEMENT ON MATTERS RELATED E–16. SOUTH WEST SERVICES, INC. TO BULK POWER SYSTEM DOCKET# ER03–901, 000, MIDWEST OTHER#S ER96–2495, 017, AEP POWER RELIABILITY INDEPENDENT TRANSMISSION MARKETING, INC., AEP SERVICE E–7. SYSTEM OPERATOR, INC. CORPORATION, CSW POWER DOCKET# EL04–52, 000, REPORTING BY E–17. MARKETING, INC., CSW ENERGY TRANSMISSION PROVIDERS ON OMITTED SERVICES, INC., AND CENTRAL AND VEGETATION MANAGEMENT E–18. SOUTH WEST SERVICES, INC. PRACTICES RELATED TO DOCKET# ER04–142, 000, PACIFIC GAS ER97–1238, 011, AEP POWER DESIGNATED TRANSMISSION AND ELECTRIC COMPANY MARKETING, INC., AEP SERVICE FACILITIES OTHER#S ER04–143, 000, PACIFIC GAS CORPORATION, CSW POWER E–8. AND ELECTRIC COMPANY MARKETING, INC., CSW ENERGY DOCKET# PL03–1, 000, PRICING POLICY ER04–295, 000, PACIFIC GAS AND SERVICES, INC., AND CENTRAL AND FOR EFFICIENT OPERATION AND ELECTRIC COMPANY SOUTH WEST SERVICES, INC. EXPANSION OF TRANSMISSION GRID E–19. ER97–1238, 012, AEP POWER E–9. OMITTED MARKETING, INC., AEP SERVICE DOCKET# EL00–95, 045, SAN DIEGO GAS E–20. CORPORATION, CSW POWER & ELECTRIC COMPANY V. SELLERS OF DOCKET# ER03–683, 002, CALIFORNIA MARKETING, INC., CSW ENERGY ENERGY AND ANCILLARY SERVICES INDEPENDENT SYSTEM OPERATOR SERVICES, INC., AND CENTRAL AND INTO MARKETS OPERATED BY THE CORPORATION SOUTH WEST SERVICES, INC. CALIFORNIA INDEPENDENT SYSTEM OTHER#S ER03–683, 003, CALIFORNIA ER97–4143, 004, AEP POWER OPERATOR AND THE CALIFORNIA INDEPENDENT SYSTEM OPERATOR MARKETING, INC., AEP SERVICE POWER EXCHANGE CORPORATION CORPORATION, CSW POWER OTHER#S EL00–95, 083, SAN DIEGO GAS E–21. MARKETING, INC., CSW ENERGY & ELECTRIC COMPANY V. SELLERS OF DOCKET# ER01–2201, 004, ENTERGY SERVICES, INC., AND CENTRAL AND ENERGY AND ANCILLARY SERVICES SERVICES, INC. SOUTH WEST SERVICES, INC. INTO MARKETS OPERATED BY THE OTHER#S ER01–2201, 005, ENTERGY ER97–4143, 005, AEP POWER CALIFORNIA INDEPENDENT SYSTEM SERVICES, INC. MARKETING, INC., AEP SERVICE OPERATOR AND THE CALIFORNIA EL02–46, 003, ENTERGY SERVICES, INC. CORPORATION, CSW POWER POWER EXCHANGE EL02–46, 004, ENTERGY SERVICES, INC. MARKETING, INC., CSW ENERGY EL00–95, 087, SAN DIEGO GAS & E–22. SERVICES, INC., AND CENTRAL AND ELECTRIC COMPANY V. SELLERS OF DOCKET# QF86–681, 005, ORMESA LLC SOUTH WEST SERVICES, INC. ENERGY AND ANCILLARY SERVICES E–23. ER98–542, 006, AEP POWER INTO MARKETS OPERATED BY THE DOCKET# ES03–43, 000, AQUILA, INC. MARKETING, INC., AEP SERVICE CALIFORNIA INDEPENDENT SYSTEM OTHER#S ES03–43, 001, AQUILA, INC. CORPORATION, CSW POWER OPERATOR AND THE CALIFORNIA ES03–43, 002, AQUILA, INC. MARKETING, INC., CSW ENERGY POWER EXCHANGE ES03–43, 003, AQUILA, INC. SERVICES, INC., AND CENTRAL AND EL00–98, 042, INVESTIGATION OF ES03–43, 004, AQUILA, INC. SOUTH WEST SERVICES, INC. PRACTICES OF THE CALIFORNIA ES04–13, 000, AQUILA, INC. ER98–542, 007, AEP POWER INDEPENDENT SYSTEM OPERATOR E–24. MARKETING, INC., AEP SERVICE AND THE CALIFORNIA POWER DOCKET# EL00–95, 087, SAN DIEGO GAS CORPORATION, CSW POWER EXCHANGE & ELECTRIC COMPANY V. SELLERS OF MARKETING, INC., CSW ENERGY EL00–98, 071, INVESTIGATION OF ENERGY AND ANCILLARY SERVICES SERVICES, INC., AND CENTRAL AND PRACTICES OF THE CALIFORNIA INTO MARKETS OPERATED BY THE SOUTH WEST SERVICES, INC. INDEPENDENT SYSTEM OPERATOR CALIFORNIA INDEPENDENT SYSTEM ER98–2075, 010, AEP POWER AND THE CALIFORNIA POWER OPERATOR AND THE CALIFORNIA MARKETING, INC., AEP SERVICE EXCHANGE POWER EXCHANGE CORPORATION, CSW POWER EL00–98, 074, INVESTIGATION OF OTHER#S EL00–98, 074, INVESTIGATION MARKETING, INC., CSW ENERGY PRACTICES OF THE CALIFORNIA OF PRACTICES OF THE CALIFORNIA SERVICES, INC., AND CENTRAL AND INDEPENDENT SYSTEM OPERATOR INDEPENDENT SYSTEM OPERATOR SOUTH WEST SERVICES, INC. AND THE CALIFORNIA POWER AND THE CALIFORNIA POWER ER98–2075, 011, AEP POWER EXCHANGE EXCHANGE MARKETING, INC., AEP SERVICE E–10. E–25. CORPORATION, CSW POWER DOCKET# ER04–564, 000, WAYNE-WHITE DOCKET# EL01–93, 007, MIRANT MARKETING, INC., CSW ENERGY COUNTIES ELECTRIC COOPERATIVE AMERICAS ENERGY MARKETING, L.P., SERVICES, INC., AND CENTRAL AND E–11. MIRANT NEW ENGLAND, LLC, SOUTH WEST SERVICES, INC. DOCKET# ER04–517, 000, CALPEAK MIRANT KENDALL, LLC, AND ER91–569, 018, ENTERGY SERVICES, INC. POWER, LLC MIRANT, LLC V. ISO NEW ENGLAND ER91–569, 019, ENTERGY SERVICES, INC. OTHER#S ER04–517, 001 CALPEAK INC. ER97–4166, 010, SOUTHERN COMPANY POWER, LLC E–26. ENERGY MARKETING L.P. E–12. DOCKET# ER03–683, 001, CALIFORNIA ER97–4166, 011, SOUTHERN COMPANY DOCKET# ER04–215, 000 PACIFIC GAS INDEPENDENT SYSTEM OPERATOR ENERGY MARKETING L.P. AND ELECTRIC COMPANY CORPORATION

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E–27. E–46. ER99–1248, 003, HARBOR OMITTED DOCKET# EL04–78, 000, MIDWEST ISO COGENERATION COMPANY E–28. TRANSMISSION OWNERS ER99–2287, 001, BLACK HILLS POWER, DOCKET# EL03–133, 001, AMERICAN OTHER#S EL04–79, 000, MIDWEST INC. REF-FUEL COMPANY, COVANTA STAND-ALONE TRANSMISSION ER00–1952, 001, BLACK HILLS ENERGY GROUP, MONTENAY POWER COMPANIES COLORADO, LLC CORPORATION, AND E–47. ER01–1784, 004, FOUNTAIN VALLEY WHEELABRATOR TECHNOLOGIES, DOCKET# EL03–54, 000, CITIES OF POWER, L.L.C. INC. ANAHEIM, AZUSA, BANNING, ER01–1844, 001, BLACK HILLS E–29. COLTON, AND RIVERSIDE GENERATION, INC. OMITTED CALIFORNIA AND CITY OF VERNON, E–30. CALIFORNIA V. CALIFORNIA Miscellaneous Agenda OMITTED INDEPENDENT SYSTEM OPERATOR M–1. E–31. CORPORATION DOCKET# RM01–10, 001, STANDARDS OMITTED E–48. OF CONDUCT FOR TRANSMISSION E–32. DOCKET# EL04–62, 000, INLAND POWER PROVIDERS DOCKET# ER04–115, 001, CALIFORNIA & LIGHT COMPANY INDEPENDENT SYSTEM OPERATOR OTHER#S EL04–63, 000, EAST TEXAS Markets, Tariffs and Rates—Gas CORPORATION ELECTRIC COOPERATIVE, INC. G–1. OTHER#S EL04–47, 001, CALIFORNIA EL04–64, 000, NORTH WEST RURAL DOCKET# RP04–92, 000, GEORGIA INDEPENDENT SYSTEM OPERATOR ELECTRIC COOPERATIVE PUBLIC SERVICE COMMISSION CORPORATION EL04–67, 000, OREGON TRAIL ELECTRIC G–2. EL04–50, 000, PACIFIC GAS & ELECTRIC CONSUMERS COOPERATIVE, INC. DOCKET# RP03–563, 002, NORTHERN COMPANY EL04–68, 000, BRIDGER VALLEY BORDER PIPELINE COMPANY ER04–242, 000, PACIFIC GAS AND ELECTRIC ASSOCIATION, INC. G–3. ELECTRIC COMPANY EL04–69, 000, WAYNE-WHITE COUNTIES DOCKET# RP04–12, 000, FLORIDA GAS E–33. ELECTRIC COOPERATIVE TRANSMISSION COMPANY OMITTED E–49. OTHER#S RP04–12, 001, FLORIDA GAS E–34. DOCKET# EL02–115, 000, AVISTA TRANSMISSION COMPANY OMITTED CORPORATION, AVISTA ENERGY, RP04–12, 002, FLORIDA GAS E–35. INC., ENRON POWER MARKETING, TRANSMISSION COMPANY OMITTED INC. AND PORTLAND GENERAL G–4. E–36. ELECTRIC COMPANY DOCKET# RP04–156, 000, NORTHWEST DOCKET# ER04–190, 002, MIDWEST E–50. PIPELINE CORPORATION GENERATION EME, LLC DOCKET# EL04–76, 000, BIG RIVERS G–5. OTHER#S EL04–22, 001, MIDWEST ELECTRIC CORPORATION DOCKET# RP04–47, 000, HIGH ISLAND GENERATION EME, LLC V. E–51. COMMONWEALTH EDISON COMPANY OMITTED OFFSHORE SYSTEM, L.L.C. AND EXELON GENERATION E–52. G–6. COMPANY, LLC DOCKET# ER03–689, 000, WPS CANADA DOCKET# RP03–625, 000, CHANDELEUR E–37. GENERATION, INC., MAINE PUBLIC PIPE LINE COMPANY OMITTED SERVICE COMPANY, AND THE G–7. E–38. NORTHERN MAINE INDEPENDENT DOCKET# RP03–460, 000, NORTHERN DOCKET# ER03–836, 001, NEW YORK SYSTEM ADMINISTRATOR, INC. NATURAL GAS COMPANY INDEPENDENT SYSTEM OPERATOR, ER03–689, 001, WPS CANADA G–8. INC. GENERATION, INC., MAINE PUBLIC DOCKET# RP04–87, 000, SOUTHERN E–39. SERVICE COMPANY, AND THE STAR CENTRAL GAS PIPELINE INC. DOCKET# EL04–81, 000, ALLETE, INC. NORTHERN MAINE INDEPENDENT G–9. E–40. SYSTEM ADMINISTRATOR, INC. DOCKET# RP04–136, 002, IROQUOIS GAS DOCKET# EL04–83, 000, MORGAN ER03–689, 002, WPS CANADA TRANSMISSION SYSTEM, L.P. ENERGY CENTER, LLC GENERATION, INC., MAINE PUBLIC G–10. OTHER#S QF01–84, 001, MORGAN SERVICE COMPANY, AND THE OMITTED ENERGY CENTER, LLC NORTHERN MAINE INDEPENDENT G–11. E–41. SYSTEM ADMINISTRATOR, INC. DOCKET# RP96–389, 083, COLUMBIA DOCKET# EL03–221, 000, BOROUGH OF ER04–210, 000, WPS CANADA GULF TRANSMISSION COMPANY ZELIENOPLE, PENNSYLVANIA V. GENERATION, INC., MAINE PUBLIC G–12. AMERICAN TRANSMISSION SERVICE COMPANY, AND THE DOCKET# RP03–280, 001, COLUMBIA SYSTEMS, INC. NORTHERN MAINE INDEPENDENT GAS TRANSMISSION CORPORATION E–42. SYSTEM ADMINISTRATOR, INC. G–13. DOCKET# EL04–54, 000, HAVILAND E–53. OMITTED HOLDINGS, INC. V. SOUTHWEST DOCKET# ID–3966, 001, MICHAEL J. G–14. POWER POOL, INC. CHESSER DOCKET# RP03–64, 001, GULF SOUTH E–43. E–54. PIPELINE COMPANY, LP DOCKET# EL04–55, 000, HAVILAND DOCKET# ER03–343, 004, ITC HOLDINGS OTHER#S RP03–64, 002, GULF SOUTH HOLDINGS, INC. V. PUBLIC SERVICE CORPORATION, ITC HOLDINGS PIPELINE COMPANY, LP COMPANY OF NEW MEXICO LIMITED PARTNERSHIP, G–15. E–44. INTERNATIONAL TRANSMISSION OMITTED DOCKET# EL04–57, 000, FPL ENERGY COMPANY, DTE ENERGY AND G–16. MARCUS HOOK, L.P. V. PJM DETROIT EDISON COMPANY DOCKET# RP03–612, 001, QUESTAR INTERCONNECTION, L.L.C. OTHER#S ER03–576, 002, DETROIT SOUTHERN TRAILS PIPELINE E–45. EDISON COMPANY COMPANY DOCKET# EC99–81, 006, DOMINION E–55. G–17. RESOURCES, INC. AND DOCKET# ER00–3109, 001, ADIRONDACK DOCKET# RP03–343, 002, NORTHERN CONSOLIDATED NATURAL GAS HYDRO DEVELOPMENT NATURAL GAS COMPANY COMPANY CORPORATION OTHER#S RP03–343, 001, NORTHERN OTHER#S MG00–6, 009, DOMINION OTHER#S ER96–1635, 008, BLACK HILLS NATURAL GAS COMPANY TRANSMISSION, INC. PEPPERELL POWER ASSOCIATES, INC. G–18.

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DOCKET# RP97–71, 021, should contact David Reininger or Julia ENVIRONMENTAL PROTECTION TRANSCONTINENTAL GAS PIPE LINE Morelli at the Capitol Connection (703– AGENCY CORPORATION 993–3100) as soon as possible or visit G–19. [FRL–7646–8] OMITTED the Capitol Connection Web site at G–20. http://www.capitolconnection.gmu.edu Final Modified NPDES Permits for Log DOCKET# PR97–1, 002, CONSUMERS and click on ‘‘FERC’’. Transfer Facilities Operating in Alaska POWER COMPANY [FR Doc. 04–8428 Filed 4–9–04; 11:18 am] Prior to October 22, 1985, and G–21. BILLING CODE 6717–01–P Possessing a Section 404 Permit But OMITTED Not a Section 402 permit (AK–G70– G–22. 0000), and All Other Log Transfer DOCKET# OR04–1, 000, AMERIGAS PROPANE, LP, CHS INC., Facilities Operating in Alaska (AK– CONOCOPHILLIPS COMPANY, ENVIRONMENTAL PROTECTION G70–1000) DYNEGY LIQUIDS MARKETING AND AGENCY AGENCY: Environmental Protection TRADE, FERRELLGAS, L.P., AND NATIONAL PROPANE GAS Agency (EPA). ASSOCIATION V. MID-AMERICA [FAL–7647–1] ACTION: Notice of Final Modified NPDES PIPELINE COMPANY, LLC General Permits. OTHER#S IS04–154, 001, MID-AMERICA Riverhills Battery Superfund Site; PIPELINE COMPANY, LLC Notice of Settlement SUMMARY: The Director of the Office of G–23. Water, EPA Region 10, is publishing DOCKET# RP00–336, 018, EL PASO AGENCY: Environmental Protection notice of the availability of two NATURAL GAS COMPANY Agency. modified National Pollutant Discharge OTHER#S RP00–336, 025, EL PASO Elimination System (NPDES) general NATURAL GAS COMPANY ACTION: Notice of settlement. permits (numbers AK–G70–0000 and G–24. AK-G70–1000) for coverage of log DOCKET# RP04–61, 001, EL PASO SUMMARY: Under Section 122(i) of the NATURAL GAS COMPANY transfer facilities (LTFs) operating in G–25. Comprehensive Environmental Alaska, pursuant to the provisions of the OMITTED Response, Compensation, and Liability Clean Water Act, 33 U.S.C. 1251 et seq. G–26. Act (CERCLA), the Environmental General permit AK–G70–0000 (‘‘pre- DOCKET# RP04–218, 000, TRUNKLINE Protection Agency (EPA) has entered 1985 permit’’) includes section 402 GAS COMPANY, LLC into an Agreement for proposed modifications to section 404 permits Energy Projects—Hydro settlement of past and future response issued to LTFs prior to October 22, 1985, in accordance with section 407 of H–1. cost at the Riverhills Battery Superfund DOCKET# P–2017, 020, SOUTHERN Site (Site) located in Tampa, the Water Quality Act of 1987 (Public CALIFORNIA EDISON COMPANY Hillsborough County, Florida, with Gulf Law 100–4). All other LTFs can apply H–2. Coast Lead, and Gulf Coast Recycling, to be authorized to discharge under DOCKET# P–12020, 002, MARSEILLES Inc. EPA will consider public comments general permit number AK-G70–1000 ‘‘ HYDRO POWER, LLC on paragraphs Thirty-Six (36) and ( post-1985 permit’’). OTHER#S P–11863, 001, MARSEILLES Because general permit AK–G70–0000 LAND AND WATER COMPANY Thirty-Seven (37) of the Agreement contains modifications of the existing until May 13, 2004. EPA may withdraw Energy Projects—Certificates permits originally issued under section from or modify the Agreement should 404 of the Clean Water Act for LTFs C–1. such comments disclose facts or operating prior to October 22, 1985, the DOCKET# CP03–350, 000, GEORGIA considerations which indicate the STRAIT CROSSING PIPELINE LP modified permit conditions apply to C–2. Agreement is inappropriate, improper, discharges of bark and wood debris from DOCKET# CP93–117, 003, SAN DIEGO or inadequate. Copies of the Agreement those LTFs upon the effective date of GAS & ELECTRIC COMPANY are available from: Ms. Paula V. the permit. Under modified AK–G70– C–3. Batchelor, U.S. Environmental 0000, to be authorized to discharge bark DOCKET# CP04–10, 000, ENCANA Protection Agency, Region 4, Superfund or wood debris in a project area zone of BORDER PIPELINES LIMITED AND Enforcement & Information Management deposit, a pre-1985 LTF must: Submit a OMIMEX CANADA, LTD. OTHER#S CP04–11, 000, CHINOOK Branch, Waste Management Division, 61 Notification form to EPA and the Alaska PIPELINE COMPANY AND OMIMEX Forsyth Avenue, SW., Atlanta, Georgia Department of Environmental CANADA, LTD. 30303, [email protected], (404 Conservation (ADEC); and, receive a C–4. 562–8887. final decision document and DOCKET# CP04–36, 000, WEAVER’S authorization of a project area zone of Written comments may be submitted COVE ENERGY, LLC deposit from ADEC. General permit AK– to Ms. Batchelor at the above address OTHER#S CP04–41, 000, MILL RIVER G70–1000 authorizes discharges to within 30 days of the date of PIPELINE, LLC marine waters of Alaska (extending from CP04–42, 000, MILL RIVER PIPELINE, LLC publication. CP04–43, 000, MILL RIVER PIPELINE, LLC the Alexander Archipelago west through Dated: March 25, 2004. central Gulf of Alaska and Prince Magalie R. Salas, Rosalind H. Brown, William Sound to Kodiak Island) from Secretary. Chief, Superfund Enforcement & Information LTFs, not possessing pre-1985, section The Capitol Connection offers the Management Branch, Waste Management 404 permits, or from LTFs which have opportunity for remote listening and Division. received a previous individual permit. viewing of the meeting. It is available [FR Doc. 04–8313 Filed 4–12–04; 8:45 am] In order to be authorized to discharge for a fee, live over the Internet, via C- bark or wood debris under AK–G70– BILLING CODE 6560–50–M Band Satellite. Persons interested in 1000, a LTF must: Submit a Notice Of receiving the broadcast, or who need Intent application for permit coverage to information on making arrangements EPA and the Alaska Department of

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Environmental Conservation (ADEC); FOR FURTHER INFORMATION CONTACT: addresses, or viewed on the Region 10 receive a final decision document and Audrey Washington at (206) 553–0523. Web site listed above. authorization of a project area zone of SUPPLEMENTARY INFORMATION: deposit from ADEC; and, receive written Legal Requirements authorization to discharge from EPA. Public Comment Coastal Zone Management Act For LTFs that received written Pursuant to section 402 of the Clean authorization to discharge under AK– Water Act, 33 U.S.C. 1342, EPA The State of Alaska, Office of G70–1000 prior to these modifications, originally proposed and solicited Management and Budget, Division of the modified permit conditions will comments on the draft general permits Governmental Coordination, found the apply to discharges of bark and wood in the Federal Register at 65 FR 11999 original general permits to be consistent debris from those LTFs upon the (March 7, 2000). In response to petitions with the approved Alaska Coastal Zone effective date of the permit. to review the permits brought by the Management Program. The successor Except for those LTFs operating in Natural Resources Defense Council and agency for the coastal zone consistency areas excluded from general permit nine other petitioners, the United States review, the Alaska Department of coverage under the post-1985 permit, Court of Appeals for the Ninth Circuit, Natural Resources, Office of Project the modified general permits authorize on February 13, 2002, ruled that the Management and Permitting, concurred the discharge of bark and wood debris, EPA did not provide adequate notice of that the modified general permits were under the specified terms of the general and opportunity to comment on the not ‘‘major amendments’’ and did not permits, into both near-shore and general NPDES permits, and remanded require a new consistency offshore marine waters in Alaska. Two the permits to EPA to take further determination. modifications were made to both of the comment on the project area ZOD. On general permits. One of the Endangered Species Act and Essential October 22, 2002, EPA proposed Fish Habitat modifications provides that ADEC must modifications to, and requested issue a final decision document additional public comments on, general Consultation under the Endangered authorizing a project area zone of NPDES permits AK-G70–0000 and AK– Species Act was conducted with the deposit (ZOD) to each LTF prior to that G70–1000 (67 FR 64885). The public U.S. Fish and Wildlife Service and LTF discharging bark and wood debris comment period was twice extended (67 National Marine Fisheries Service. The under the permits. The second FR 68869 and 68 FR 2540), and closed EPA determined that the actions are not modification requires that when on January 27, 2003. Notice for public likely to adversely affect any threatened conducting the annual bark monitoring, comment was also published in the or listed species. EPA has also made a if continuous coverage of bark and wood Anchorage Daily News, Ketchikan Daily determination that the actions have no debris is found at minus 60 feet, the News, The Seward Phoenix Log, The adverse effects on Essential Fish bark monitoring survey must continue Valdez Vanguard, and The Cordova Habitat. deeper until the continuous coverage Times. Additionally, copies of the draft ends, or at minus 100 feet in depth, modifications to the permits were sent State Water Quality Standards and whichever occurs first. to all known log transfer facilities State Certification DATES: The modified general NPDES operating under a section 404 permit The State of Alaska, Department of permits shall become effective on April issued prior to October 22, 1985. Environmental Conservation certified 27, 2004. The post-1985 general permit Public comment was solicited on five under section 401 of the Clean Water and the authorization to discharge shall proposed modifications to the general Act, that the subject discharges under expire at midnight on March 21, 2005. permits related to: (1) The timing of both of the original general permits ADDRESSES: The complete final zone of deposit authorization by comply with the Alaska State Water administrative record for the modified the State of Alaska; (2) exclusion of Quality Standards and sections 208(e), general NPDES permits are available for permit coverage in impaired 301, 302, 303, 306 and 307 of the Clean public review by contacting EPA Region waterbodies; (3) a limit on continuous Water Act. The Department determined 10, 1200 Sixth Avenue, Seattle, bark or wood debris coverage of one that the general permit modifications Washington 98101, Telephone: (206) acre and 10 centimeters at any point were of a minor nature and that a new 553–0523 or (206) 553–1643, or via within a project area ZOD; (4) a lower certification was not necessary. EMAIL to the following address: threshold amount for continuous [email protected]. For those coverage to invoke amendments to a Executive Order 12866 with impaired hearing or speech, please facility’s Pollution Prevention Plan; and, contact EPA’s telecommunication (5) increasing the depth of bark surveys EPA has determined that this general device for the deaf (TDD) at 206/553– of continuous coverage on the ocean permit is not a ‘‘significant regulatory 1698. Copies of the modified general bottom to—100 feet. action’’ under the terms of Executive NPDES permits, supporting statement of In response to numerous comments Order 12866 and is therefore not subject basis for the draft general NPDES received from facility representatives, to OMB review. permits, response to public comments, tribal representatives, concerned Paperwork Reduction Act and today’s publication are available citizens, environmental groups, the U.S. from the EPA Alaska Operations Office Forest Service, U.S. Fish and Wildlife The information collection at 222 West 7th Avenue, #19, Service, the National Marine Fisheries requirements of this permit were Anchorage, Alaska 99513–7588, 907/ Service, local municipalities, and the previously approved by the Office of 271–6561 or the Alaska Department of State of Alaska, the Director has decided Management and Budget (OMB) under Environmental Conservation at 410 to make two out of the five proposed the provisions of the Paperwork Willoughby Avenue, Suite 105, Juneau, modifications; e.g., numbers 1 and 5 Reduction Act, 44 U.S.C. 3501 et seq. Alaska 99801. These documents can above. All comments, along with EPA’s and assigned OMB control numbers also be found by visiting the Region 10 responses, are summarized in the 2040–0086 (NPDES permit application) Web site at http://www.epa.gov/ Response to Comments document, and 2040–0004 (discharge monitoring r10earth/water/htm. which may be obtained at the above reports).

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Regulatory Flexibility Act Advisory Committee on Diversity for telecom industries; (b) identify The Regulatory Flexibility Act (RFA), Communications in the Digital Age has recommendations and ‘‘best practices’’ 5 U.S.C. 601 et seq., requires that EPA been established and is holding its third that would facilitate opportunities in prepare a regulatory flexibility analysis meeting, which will be held at the upper level management and for rules subject to the requirements of Federal Communications Commission ownership; and (c) focus both on 5 U.S.C. 553(b) that have a significant in Washington, DC. The Diversity industry-specific measures, as well as impact on a substantial number of small Committee was established by the recommendations extending across the Federal Communications Commission entities. The permit issued today, telecom sectors; Financial Issues, which to examine current opportunities and however, is not a ‘‘rule’’ subject to the aims to (a) identify the obstacles to develop recommendations for policies requirements of 5 U.S.C. 553(b) and is capital access faced by minorities and and practices that will further enhance therefore not subject to the RFA. women in the telecommunications the ability of minorities and women to industries; (b) assess current practices Unfunded Mandates Reform Act participate in telecommunications and regarding the access to capital; (c) Section 201 of the Unfunded related industries. develop recommendations and identify Mandates Reform Act (UMRA), Public DATES: May 10, 2004, 2 p.m. to 5 p.m. ‘‘best practices’’ to address these Law 104–4, generally requires Federal ADDRESSES: Federal Communications obstacles; and (d) focus both on agencies to assess the effects of their Commission, Commission Meeting industry-specific measures, as well as ‘‘regulatory actions’’ (defined to be the Room, Room TW–C305, 445 12th St. issues that extend across the same as ‘‘rules’’ subject to the RFA) on SW, Washington, DC 20554. telecommunications sectors; New tribal, state, and local governments and FOR FURTHER INFORMATION CONTACT: Jane Technologies, which aims to (a) assess the private sector. The permit issued E. Mago, Designated Federal Officer of what ownership and career today, however, is not a ‘‘rule’’ subject the Committee on Diversity, or Maureen advancement opportunities are available to the RFA and is therefore not subject C. McLaughlin, Alternate Designated in new and emerging technologies (e.g., to the requirements of UMRA. Federal Officer of the Committee on broadband, digital television, cable, Diversity, 202–418–2030, e-mail satellite, low power FM) and the Appeal of Permit [email protected], convergence of these technologies; and Any interested person may appeal the [email protected]. Press (b) develop recommendations for modifications of the Log Transfer Contact, Audrey Spivak, Office of Media facilitating opportunities for minorities Facility General NPDES permits in the Relations, 202–418–0512, and women in new industries as they Federal Court of Appeals in accordance [email protected]. form; and Transactional Transparency, which aims to (a) identify what with section 509(b)(1) of the Clean SUPPLEMENTARY INFORMATION: The Water Act. This appeal must be filed Diversity Committee was established by enhancements or additions are needed, within 120 days of the permit effective the Federal Communications and develop suggested ‘‘best practices’’ date. The permit effective date is Commission to examine current in order to increase the participation of defined at 40 CFR 23.2 to be at 1 p.m. opportunities and develop minorities and women; (b) assess eastern time, two weeks after the date of recommendations for policies and current practices of how potential publication in the Federal Register. practices that will further enhance the investment opportunities in telecom Persons affected by a general NPDES ability of minorities and women to industries are identified and how that permit may not challenge the conditions participate in telecommunications and information is disseminated; and (c) of the permit as a right of further EPA related industries. The Diversity focus both on industry-specific proceedings. Instead, they may either Committee will prepare periodic and measures, as well as recommendations challenge the permit in court or apply final reports to aid the FCC in its extending across the telecom sectors. for an individual NPDES permit and oversight responsibilities and its Information concerning the activities then request a formal hearing on the regulatory reviews in this area. In of the Diversity Committee can be issuance or denial of an individual conjunction with such reports and reviewed at the Committee’s Web site NPDES permit. analyses, the Diversity Committee will http://www.fcc.gov/DiversityFAC. Dated: April 5, 2004. make recommendations to the FCC Material relevant to the May 10th Robert R. Robichaud, concerning the need for any guidelines, meeting will be posted there. Members of the general public may attend the Associate Director, Office of Water, Region incentives, regulations or other policy 10. approaches to promote diversity of meeting. The Federal Communications Commission will attempt to [FR Doc. 04–8314 Filed 4–12–04; 8:45 am] participation in the communications accommodate as many people as BILLING CODE 6560–50–P sector. The Diversity Committee will also develop a description of best possible. However, admittance will be practices within the communications limited to the seating available. A live RealAudio feed will be available over FEDERAL COMMUNICATIONS sector for promoting diversity of participation. the Internet; information on how to tune COMMISSION in can be found at the Commission’s Agenda Federal Advisory Committee Act Web site http://www.fcc.gov. Notice of Public Meeting The May 10, 2004 meeting will The public may submit written include reports from the Diversity comments to the Committee’s AGENCY: Federal Communications Committee’s four subcommittees Designated Federal Officer before the Commission. regarding progress towards the final meeting. ACTION: Notice of public meeting. report to the Commission. The four subcommittees are: Career Federal Communications Commission. SUMMARY: In accordance with the Advancement, which aims to (a) assess William F. Caton, Federal Advisory Committee Act, Public current executive training programs and Deputy Secretary. Law 92–463, as amended, this notice other career development programs that [FR Doc. 04–8333 Filed 4–12–04; 8:45 am] advises interested persons that the target minorities and women in the BILLING CODE 6712–01–P

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FEDERAL COMMUNICATIONS For a fee this meeting can be viewed has submitted the information COMMISSION live over George Mason University’s collection entitled ‘‘Members of the Capitol Connection. The Capitol Banks’’ to the Office of Management and Sunshine Act Meeting Connection also will carry the meeting Budget (OMB) for review and approval live via the Internet. To purchase these of a three-year extension of the OMB April 8, 2004. services call (703) 993–3100 or go to control number, which is due to expire The Federal Communications www.capitolconnection.gmu.edu. Audio on May 31, 2004. Commission will hold an open meeting and video tapes of this meeting can be DATES: on the subjects listed below on Interested persons may submit purchased from CACI Productions, 341 Thursday, April 15, 2004, which is comments on or before May 13, 2004. Victory Drive, Herndon, VA 20170, scheduled to commence at 9:30 a.m. in ADDRESSES: Send comments to the (703) 834–1470, Ext. 19; Fax (703) 834– Room TW–C305, at 445 12th Street, Office of Information and Regulatory 0111. Affairs of the Office of Management and SW., Washington, DC. Copies of materials adopted at this Item No.: 1. Budget, Attention: Desk Officer for the meeting can be purchased from the Bureau: Office of Engineering and Federal Housing Finance Board, FCC’s duplicating contractor, Qualex Technology. Washington, DC 20503. International (202) 863–2893; Fax (202) Title: Review of Part 15 and other FOR FURTHER INFORMATION CONTACT: Parts of the Commission’s Rules (ET 863-2898; TTY (202) 863–2897. These Jonathon F. Curtis, Senior Financial Docket No. 01–278; RM–9375, and RM– copies are available in paper format and Analyst, Regulations & Research 10051). alternative media, including large print/ Division, Office of Supervision, by e- Summary: The Commission will type; digital disk; and audio tape. mail at [email protected], by telephone at consider a Third Report and Order Qualex International may be reached by 202/408–2866, or by regular mail at the concerning rule changes for radio e-mail at [email protected]. Federal Housing Finance Board, 1777 F frequency identification systems Federal Communications Commission. Street, NW., Washington, DC 20006. operating at 433 MHz. Marlene H. Dortch, SUPPLEMENTARY INFORMATION: Item No.: 2. Secretary. Bureau: Media A. Need For and Use of the Information [FR Doc. 04–8482 Filed 4–9–04; 1:58 pm] Collection Title: Digital Audio Broadcasting BILLING CODE 6712–01–U Systems and Their Impact on the Section 4 of the Federal Home Loan Terrestrial Radio Broadcast Service (MM Bank Act (Bank Act) establishes the Docket No. 99–325). FEDERAL ELECTION COMMISSION eligibility requirements an institution Summary: The Commission will must meet in order to become a member consider a Further Notice of Proposed Sunshine Act Meeting of a Federal Home Loan Bank (Bank). Rulemaking concerning rule changes for See 12 U.S.C. 1424. Part 925 of the radio stations that broadcast digital PUBLIC HEARING ON POLITICAL COMMITTEE Finance Board regulations—the audio using In-Band On-Channel STATUS. membership rule—implements section 4 (‘‘IBOC’’) technology. PLACE: 999 E Street, NW., Washington, of the Bank Act. See 12 CFR part 925. Item No.: 3. DC (ninth floor). The membership rule provides uniform Bureau: Office of Engineering and PREVIOUSLY ANNOUNCED DATES AND requirements an applicant for Bank Technology. TIMES: Wednesday, April 14 and membership must meet and review Title: Unlicensed Operation in the Thursday, April 15, 2004, 10 a.m. The criteria a Bank must apply to determine Band 3650–3700 MHz; Additional starting time has been changed to 9 a.m. if an applicant satisfies the statutory and Spectrum for Unlicensed Devices Below on Wednesday April 14, 2004. The regulatory membership eligibility 900 MHz and in the 3 GHz Band (ET starting time has been changed to 9:30 requirements. Docket No. 02–380); and Amendment of a.m. on Thursday, April 15, 2004. More specifically, the membership the Commission’s Rules with Regard to PERSON TO CONTACT FOR INFORMATION: rule implements the statutory eligibility the 3650–3700 MHz Government Mr. Robert Biersack, Acting Press requirements and provides guidance to Transfer Band (ET Docket No. 98–237). Officer, Telephone: (202) 694–1220. an applicant on how it may satisfy such Summary: The Commission will requirements. The rule authorizes a consider a Notice of Proposed Darlene Harris, Bank to approve or deny each Rulemaking concerning use of the 3650– Deputy Secretary of the Commission. membership application subject to the 3700 MHz band. [FR Doc. 04–8429 Filed 4–9–04; 8:45 am] statutory and regulatory requirements Note: The summaries listed in this notice BILLING CODE 6715–01–M and permits an applicant to appeal to are intended for the use of the public the Finance Board a Bank’s decision to attending open Commission meetings. deny certification as a Bank member. Information not summarized may also be FEDERAL HOUSING FINANCE BOARD The rule also imposes a continuing considered at such meetings. Consequently obligation on a current Bank member to these summaries should not be interpreted to [No. 2004–N–07] provide information necessary to limit the Commission’s authority to consider determine if it remains in compliance Submission for OMB Review; any relevant information. with applicable statutory and regulatory Comment Request Additional information concerning eligibility requirements. this meeting may be obtained from AGENCY: Federal Housing Finance The information collection, which is Audrey Spivack or David Fiske, Office Board. contained in §§ 925.2 through 925.31 of of Media Relations, (202) 418–0500; ACTION: Notice. the membership rule, 12 CFR 925.2– TTY 1–888–835–5322. 925.31, is necessary to enable a Bank to Audio/Video coverage of the meeting SUMMARY: In accordance with the determine if a respondent satisfies the will be broadcast live over the Internet requirements of the Paperwork statutory and regulatory requirements to from the FCC’s Audio/Video Events Reduction Act of 1995, the Federal be certified initially and maintain its Web page at www.fcc.gov/realaudio. Housing Finance Board (Finance Board) status as a member eligible to obtain

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Bank advances. The Finance Board 18 hours (30 members × 1 filing × 0.6 DEPARTMENT OF HEALTH AND requires and uses the information hours). HUMAN SERVICES collection to determine whether to uphold or overrule a Bank’s decision to 4. Transfer of Membership to Another Centers for Disease Control and deny member certification to an Bank District Prevention applicant. The Finance Board estimates the total The OMB number for the information Improving the Quality of Genetic annual average number of members that Testing and Assuring Its Appropriate collection is 3069–0004. The OMB will file to transfer membership to clearance for the information collection Integration Into Clinical and Public another Bank district at 5, with 1 filing Health Practice expires on May 31, 2004. per member. The estimate for the The likely respondents are average hours per filing is 3.5 hours. Announcement Type: New. institutions that are or want to become The estimate for the total annual hour Funding Opportunity Number: 04137. members of a Bank. burden for membership transfers is 18 Catalog of Federal Domestic Assistance Number: 93.064. B. Burden Estimate hours (5 members × 1 filing × 3.5 hours). Application Deadline: June 14, 2004. The Finance Board has analyzed the C. Comment Request Executive Summary: The number of cost and hour burden for the four facets genetic tests available to the clinical and of the information collection— In accordance with the requirements public health communities is membership application process, of 5 CFR 1320.8(d), the Finance Board increasing, as is the number of tests minimum capital stock calculation, published a request for public being ordered. For many genetic tests, membership withdrawals and transfer of comments regarding this information significant concerns exist related to test membership to another Bank district. collection in the Federal Register on ordering, analytical and clinical The first notice inadvertently omitted February 5, 2004. See 69 FR 5546 (Feb. validation, quality control, result the burden estimates for two of the four 5, 2004). The 60-day comment period reporting, and use of test results in facets of the information collection. As closed on April 5, 2004. The Finance medical decision making. Surveys explained in more detail below, the Board received one comment urging carried out previously have indicated estimate for the total annual hour increased use of electronic information. variability and gaps in each of these burden is 12,346 hours. The Finance Board encourages the use areas with potentially significant implications for the delivery of genetic 1. Membership Application Process of information technology to reduce the information collection burden. testing services to the public. Initially, The Finance Board estimates the total However, the extent of use is to address these issues, the scope of annual average number of applicants for determined by each Bank. The comment work for this project will include a Bank membership at 300, with 1 is available on the Finance Board Web technology and practice assessment response per applicant. The estimate for site at http://www.fhfb.gov/pressroom/ linked to development of a program to the average hours per application is 24.5 improve one, or more aspects of the pressroom_regs.htm. hours. The Finance Board estimates the genetic testing process. total annual average number of Written comments are requested on: The goals of this program are (1) to applications appealed to the Finance (1) Whether the collection of conduct a technology and practice Board at one. The estimate for the information is necessary for the proper assessment within the scope of genetic average hours per appellate application performance of Finance Board testing laboratory services in the United is 10 hours. The estimate for the total functions, including whether the States that will evaluate elements annual hour burden for the membership information has practical utility; (2) the important for assuring the quality, application process is 7450 hours (300 accuracy of the Finance Board’s appropriate use, and to what extent an applicants × 1 application × 24.5 hours estimates of the burdens of the understanding of benefits and + 1 appellant × 1 appeal × 10 hours). collection of information; (3) ways to limitations are applied; (2) to conduct a pilot study to test concepts potentially 2. Minimum Capital Stock Calculation enhance the quality, utility, and clarity of the information collected; and (4) useful for improving the quality of the The Finance Board estimates the total ways to minimize the burden of the genetic testing process; and (3) to annual average number of Bank collection of information on compare relevant international activities members that must calculate the respondents, including through the use (those occurring outside the United minimum capital stock requirement at of automated collection techniques or States) to efforts undertaken in this 8,100, with 1 response per member. The other forms of information technology. project. The focus will be on one, or estimate for the average hours per Comments may be submitted to OMB in more health conditions and/or group of maintenance response is 0.6 hours. The technologies that can provide insights writing at the address listed above. estimate for the total annual hour into a broader spectrum of genetic burden for the minimum capital stock Dated: April 5, 2004. testing issues. The target audiences for calculation is 4860 hours (8100 By the Federal Housing Finance Board. the assessment are laboratories × × members 1 response 0.6 hours). Donald Demitros, performing genetic tests and users of genetic laboratory services (i.e. clinical 3. Membership Withdrawals Chief Information Officer. and public health practitioners who [FR Doc. 04–8254 Filed 4–12–04; 8:45 am] The Finance Board estimates the total order and use genetic tests and results). annual average number of members that BILLING CODE 6725–01–P Important factors to consider include will file to withdraw from Bank technologies employed, methods used membership at 30, with 1 filing per for test validation and quality control, member. The estimate for the average and pre- and post-analytic factors hours per filing is 0.6 hours. The pertinent to the collection and use of estimate for the total annual hour patient/population-based information burden for membership withdrawals is and the use of test results for health-care

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decision-making. This program is also potentially improve the quality of decision making. The recipient is expected to recognize international laboratory practice related to one or expected to provide an analysis of the efforts that address similar issues and more of the issues documented during data that is potentially broadly their potential impact on practices the assessment. Efforts can include applicable to genetic testing in clinical within the U.S. As such, a review of developing and evaluating novel quality and/or public health practice settings. relevant international efforts will be assurance practices, developing b. Conduct a pilot project to test and undertaken as part of this project educational/training programs to evaluate a process for improving the proposed. improve the knowledge and quality of laboratory testing that is based competencies among laboratory and upon findings from the assessment I. Funding Opportunity Description health care professionals (i.e., in the use described above. and communication of genetic tests and c. Where appropriate, educational Authority: This program is authorized efforts should be conducted for under section 317(k)(2) of the Public Health results), or undertaking studies useful Service Act, 42 U.S.C. section 247b(k)(2), as for informing professional groups and laboratory staff and/or health care amended. regulatory bodies toward the professionals as a component of the development, implementation, and research or pilot project proposed. An Purpose: The purpose of the program evaluation of guidelines, standards, evaluation of the educational activity is to improve the quality of laboratory and/or regulatory requirements. As a should be undertaken to assess its genetic testing practices relevant to final component to this program, a usefulness and broader applicability. clinical and public health settings. Particular emphasis should be placed This program will assess current review of international efforts relevant to the work undertaken will be upon the clinical/laboratory interface practices and the impact of technology performed. The intent for this final and/or public health laboratory setting. on the provision of genetic testing requirement is to take a broader look at d. Develop and implement a services within the U.S. The project will what is happening in other parts of the comparative analysis between U.S. and take a quality systems approach in world relevant to the work undertaken non-U.S. practices and policies relevant which technical and management in this program and comment upon to the project proposed. aspects of each component of the system opportunities that may benefit both U.S. e. Convene advisory group(s) is recognized as contributing to the practices as well as those in other (comprised of knowledgeable and overall quality of testing and its countries. Less guidance is provided in experienced persons), as appropriate, to potential impact on clinical and public addressing this part of the program develop recommendations useful for health decision making. The initial part since the nature of the work will depend carrying out the work proposed. of this project must include a U.S. on the direction the applicant proposes In a cooperative agreement, CDC staff technology and practice assessment. for earlier aims and their connectivity is substantially involved in the program The proposed assessment can be with the international community. This activities, above and beyond routine undertaken in several formats. It may be program addresses the ‘‘Healthy People grant monitoring. general in nature with the intent to 2010’’ focus area(s) of ‘‘Access to Quality CDC Activities for this program are as capture data covering a broad spectrum Health Services’’ and ‘‘Public Health follows: of topics or focused on a subset of Infrastructure.’’ a. Serve in an advisory capacity to the health conditions and/or technologies Measurable outcomes of the program awardee in the development of data that can serve as models reflective of will be in alignment with the following collection instruments and not broader genetic testing issues. The performance goals for the Public Health otherwise be involved in the collection, assessment will be used to document Practice Program Office: Increase the use, or ownership of the data. variability in practices and expected to number of frontline public health b. Assist in collaborating with other be helpful in identifying opportunities workers at the state and local level that organizations, government entities, CDC to address shortcomings and improve are competent and prepared to respond staff, and others in carrying out program the quality of genetic testing and to bioterrorism, other infectious disease activities. laboratory practices. This assessment outbreaks, and other public health c. Assist in preparing training and should not be duplicative of past efforts threats and emergencies and prepare education programs. d. Assist forming expert focus groups, but build upon them, or be novel in the frontline state and local health which may be composed of national and areas explored and approaches taken. departments and laboratories to respond international experts, to develop Conclusions made from the to current and emergency health threats. assessment should be relevant to the Activities: This project requires strategies and recommendations. broader community that performs several activities be undertaken and as II. Award Information genetic testing or uses genetic test such it is vital that the applicant clearly Type of Award: Cooperative results. Relevant issues can include test state what is intended to be validation, quality assurance, quality Agreement. accomplished each year, or part thereof, CDC involvement in this program is control, proficiency testing, and the of the three-year proposal. Funding for listed in the Activities Section above. methods by which laboratories years two and three are dependent on Fiscal Year Funds: 2004. communicate with clinical and public the availability of funds and progress Approximate Total Funding: health care providers, payers, policy made. $225,000. makers, and others toward assuring Awardee activities for this program Approximate Number of Awards: appropriate use of their services. As are as follows: One. such, it is also important to consider a. Develop and conduct assessments Approximate Average Award: both the laboratories and users of their of laboratory practices which gather $225,000 (This amount is for the first services (i.e. clinical/public health specific information related to 12-month budget period, and includes professionals) as target populations for technology assessment, test validation, both direct and indirect costs). the assessment and follow up efforts. quality assurance practices, personnel Floor of Award Range: None. The latter part of this program requires competencies, and ways in which tests Ceiling of Award Range: $225,000 that the applicant propose a study or are ordered and results are reported and (This ceiling is for the first 12-month pilot program to test concepts that can used for medical and public health budget period.)

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Anticipated Award Date: September IV. Application and Submission For more information, see the CDC 1, 2004. Information Web site at: http://www.cdc.gov/od/pgo/ Budget Period Length: 12 months. funding/pubcommt.htm. Project Period Length: Three years. IV.1. Address To Request Application Package If your application form does not have Throughout the project period, CDC’s a DUNS number field, please write your To apply for this funding opportunity commitment to continuation of awards DUNS number at the top of the first use application form PHS 5161. will be conditioned on the availability page of your application, and/or include Application forms and instructions are of funds, evidence of satisfactory your DUNS number in your application available on the CDC Web site, at the progress by the recipient (as cover letter. documented in required reports), and following Internet address: http:// the determination that continued www.cdc.gov/od/pgo/forminfo.htm. Additional requirements that may funding is in the best interest of the If you do not have access to the require you to submit additional Federal Government. Internet, or if you have difficulty documentation with your application accessing the forms on-line, you may are listed in section ‘‘VI.2. III. Eligibility Information contact the CDC Procurement and Administrative and National Policy III.1. Eligible Applicants Grants Office Technical Information Requirements.’’ Management Section (PGO–TIM) staff Applications may be submitted by IV.3. Submission Dates and Times at: 770–488–2700. Application forms public and private nonprofit can be mailed to you. organizations and by governments and Application Deadline Date: June 14, their agencies, such as: IV.2. Content and Form of Submission 2004. • Public nonprofit organizations. Application: You must submit a Explanation of Deadlines: • Private nonprofit organizations. project narrative with your application Applications must be received in the • Universities. forms. The narrative must be submitted CDC Procurement and Grants Office by • Colleges. in the following format: 4 p.m. Eastern Time on the deadline • Research institutions. • Maximum number of pages: 25. date. If you send your application by the • Hospitals. • If your narrative exceeds the page United States Postal Service or • Community-based organizations. limit, only the first pages, which are commercial delivery service, you must • State and local governments or their within the page limit, will be reviewed. ensure that the carrier will be able to Bona Fide Agents (this includes the • Font size: 12 point unreduced. guarantee delivery of the application by District of Columbia, the • Paper size: 8.5 by 11 inches. the closing date and time. If CDC Commonwealth of Puerto Rico, the • Page margin size: One inch. receives your application after closing Virgin Islands, the Commonwealth of • Printed only on one side of page. due to: (1) Carrier error, when the the Northern Marianna Islands, • Held together only by rubber bands carrier accepted the package with a American Samoa, Guam, the Federated or metal clips; not bound in any other guarantee for delivery by the closing States of Micronesia, the Republic of the way. date and time, or (2) significant weather Marshall Islands, and the Republic of • Single spaced. delays or natural disasters, you will be Palau). Your narrative should address given the opportunity to submit A Bona Fide Agent is an agency/ activities to be conducted over the documentation of the carriers guarantee. organization identified by the state as entire project period, and must include If the documentation verifies a carrier eligible to submit an application under the following items in the order listed: problem, CDC will consider the The narrative should consist of goals the state eligibility in lieu of a state application as having been received by and objectives, methods and technical application. If you are applying as a the deadline. approach, project management and bona fide agent of a state or local staffing, evaluation plan, and proposed This announcement is the definitive government, you must provide a letter budget for carrying out the recipient guide on application submission from the state or local government as activities consistent with the evaluation address and deadline. It supersedes documentation of your status. Place this criteria listed section ‘‘H’’. The budget information provided in the application documentation behind the first page of justification will be counted in the instructions. If your application does your application form. stated page limit. Additional not meet the deadline above, it will not III.2. Cost Sharing or Matching information may be included in the be eligible for review, and will be application appendices. The appendices discarded. You will be notified that Matching funds are not required for your application did not meet the this program. will not be counted toward the narrative page limit. This additional information submission requirements. III.3. Other includes: CDC will not notify you upon receipt If you request a funding amount • Curriculum Vitaes of your application. If you have a greater than the ceiling of the award • Letters of Support question about the receipt of your range, your application will be You are required to have a Dun and application, first contact your courier. If considered non-responsive, and will not Bradstreet Data Universal Numbering you still have a question, contact the be entered into the review process. You System (DUNS) number to apply for a PGO–TIM staff at: 770–488–2700. Before will be notified that your application grant or cooperative agreement from the calling, please wait two to three days did not meet the submission Federal government. The DUNS number after the application deadline. This will requirements. is a nine-digit identification number, allow time for applications to be which uniquely identifies business processed and logged. Note: Title 2 of the United States Code section 1611 states that an organization entities. Obtaining a DUNS number is IV.4. Intergovernmental Review of described in section 501(c)(4) of the Internal easy and there is no charge. To obtain Applications Revenue Code that engages in lobbying a DUNS number, access http:// activities is not eligible to receive Federal www.dunandbradstreet.com or call 1– Executive Order 12372 does apply to funds constituting an award, grant, or loan. 866–705–5711. this program.

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IV.5. Funding Restrictions b. Does the applicant describe the Preferences may be given to Restrictions, which must be taken into staff qualifications and time allocations organizations that have expertise in account while writing your budget, are of key personnel to be assigned to this heritable human conditions of public as follows: project, facilities and equipment, and health significance that can be applied other resources available for to the efforts described in this program • None. performance of this project? announcement in such a way that If you are requesting indirect costs in results will be broadly applicable to 3. Goals and Objectives (20 points) your budget, you must include a copy other areas of genetic testing. Lastly, of your indirect cost rate agreement. If a. Does the applicant clearly describe preferences will be given to applications your indirect cost rate is a provisional an understanding of the objectives of demonstrating collaboration among rate, the agreement should be less than this project and the relevance of the clinical and public health entities in 12 months of age. proposal to the stated objectives? developing and carrying out the work Awards will not allow reimbursement b. Are the goals and objectives proposed. Entities can include clinical of pre-award costs. measurable, specific, and achievable? and public health academic Guidance for completing your budget departments, state and local public can be found on the CDC Web site, at 4. Evaluation Plan (20 points) health organizations, professional the following Internet address: http:// Does the applicant describe the organizations that focus on clinical and/ www.cdc.gov/od/pgo/funding/ schedule for accomplishing the or public health issues, and other such budgetguide.htm. activities to be carried out in this project groups. IV.6. Other Submission Requirements and methods for evaluating the accomplishments? VI. Award Administration Information Application Submission Address: Submit the original and two hard copies 5. Budget (Reviewed, but not Scored) VI.1. Award Notices of your application by mail or express The proposed budget must be Successful applicants will receive a delivery service to: Technical reasonable, clearly justified, and Notice of Grant Award (NGA) from the Information Management-PA# 04137, consistent with the intended use of CDC Procurement and Grants Office. CDC Procurement and Grants Office, funds. The NGA shall be the only binding, 2920 Brandywine Road, Atlanta, GA authorizing document between the 30341. 6. Performance Measures (Reviewed, but recipient and CDC. The NGA will be Applications may not be submitted not Scored) signed by an authorized Grants electronically at this time. The application should be consistent Management Officer, and mailed to the V. Application Review Information with the Government Performance and recipient fiscal officer identified in the Results Act of 1993. application. V.1. Criteria Unsuccessful applicants will receive V.2. Review and Selection Process You are required to provide measures notification of the results of the of effectiveness that will demonstrate Applications will be reviewed for application review by mail. completeness by the Procurement and the accomplishment of the various VI.2. Administrative and National Grants Office (PGO) staff, and for identified objectives of the cooperative Policy Requirements agreement. Measures of effectiveness responsiveness by the PHPPO. must relate to the performance goals Incomplete applications and 45 CFR Part 74 and Part 92 stated in the ‘‘Purpose’’ section of this applications that are non-responsive to For more information on the Code of announcement. Measures must be the eligibility criteria will not advance Federal Regulations, see the National objective and quantitative, and must through the review process. Applicants Archives and Records Administration at measure the intended outcome. These will be notified that their application the following Internet address: http:// measures of effectiveness must be did not meet submission requirements. www.access.gpo.gov/nara/cfr/cfr-table- submitted with the application and will An objective review panel will search.html. be an element of evaluation. evaluate complete and responsive The following additional Your application will be evaluated applications according to the criteria requirements apply to this project: against the following criteria: listed in the ‘‘V.1. Criteria’’ section • AR–10 Smoke-Free Workplace above. Requirements 1. Methods and Technical Approach (30 In addition, the following factors may • AR–11 Healthy People 2010 points) affect the funding decision: • AR–12 Lobbying Restrictions a. Does applicant clearly and Preference may be given to • AR–15 Proof of Non-Profit Status succinctly describe the steps to be taken organizations that routinely provide Additional information on these in the planning and implementation of and/or utilize clinical or public health requirements can be found on the CDC the proposed cooperative agreement? genetic testing laboratory services. Web site at the following Internet b. Are the methods used to carry out Preference may also be given to address: http://www.cdc.gov/od/pgo/ the responsibilities of the proposed organizations that have contributed to funding/ARs.htm. cooperative agreement must be feasible the development, or use of quality VI.3. Reporting Requirements and explained in sufficient detail? assurance programs for genetic testing, have engaged in research or assessment You must provide CDC with an 2. Project Management and Staffing (30 of new technologies and their original, plus two hard copies of the points) implications for clinical and public following reports: a. Does the applicant describe a health practice, have participated in 1. Interim progress report, no less project management and staffing plan, activities relevant to the translation of than 90 days before the end of the and must demonstrate sufficient research findings to clinical and public budget period. The progress report will knowledge, expertise, and other health applications, and/or participated serve as your non-competing resources required to perform the in efforts to develop domestic and continuation application, and must responsibilities in this project? international genetic testing policies. contain the following elements:

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a. Current Budget Period Activities Opportunity Number: 04075. and trauma care systems to the public, Objectives. Catalog of Federal Domestic researchers and healthcare practitioners. b. Current Budget Period Financial Assistance Number: 93.136. Progress. Key Dates: II. Award Information c. New Budget Period Program Letter of Intent Deadline: May 13, Type of Award: Grant. Proposed Activity Objectives. 2004. Fiscal Year Funds: 2004. d. Budget. Application Deadline: July 12, 2004. Approximate Total Funding: e. Additional Requested Information. $495,000. f. Measures of Effectiveness. I. Funding Opportunity Description Approximate Number of Awards: 2. Financial status report, no more Authority: This program is authorized One. than 90 days after the end of the budget under sections 301(a) and 317(k)(2) of Approximate Average Award: period. the Public Health Service Act, [42 $495,000. 3. Final financial and performance U.S.C. sections 241(a) and 247b(k)(2)] as Floor of Award Range: None. reports, no more than 90 days after the amended. Ceiling of Award Range: $495,000. end of the project period. Purpose: The purpose of the Trauma If you request a funding amount These reports must be mailed to the Information and Exchange Program greater than the ceiling of the award Grants Management or Contract (TIEP) is to make data and information range, your application will be Specialist listed in the ‘‘Agency on trauma care in the United States considered non-responsive, and will not Contacts’’ section of this announcement. more accessible to a broad spectrum of be entered into the review process. You VII. Agency Contacts individuals and organizations, will be notified that your application including trauma care professionals and did not meet the submission For general questions about this professional associations, trauma requirements. announcement, contact: Technical centers and other acute care hospitals, Anticipated Award Date: September Information Management Section, CDC trauma care systems, emergency 1, 2004. Procurement and Grants Office, 2920 medical services (EMS) systems, injury Budget Period Length: 12 months. Brandywine Road, Atlanta, GA 30341, researchers and research organizations, Project Period Length: One year. Telephone: 770–488–2700. public health agencies, health care Throughout the project period, CDC’s For program technical assistance, payers, and the general public. TIEP commitment to continuation of awards contact: Ira Lubin, Ph.D., Centers for will also foster the exchange and use of will be conditioned on the availability Disease Control and Prevention, PHPPO, information to improve trauma care. of funds, evidence of satisfactory DLS, 4770 Buford HWY, MSG23, This program addresses the ‘‘Healthy progress by the recipient (as Telephone: 770–488–8070, Fax: 770– People 2010’’ focus area of Injury and documented in required reports), and 488–8278, E-mail: [email protected]. the determination that continued For financial, grants management, or Violence Prevention. Measurable outcomes of the program funding is in the best interest of the budget assistance, contact: Sharon will be in alignment with the National Federal Government. Robertson, Grants Management Center for Injury Prevention and Control Specialist, CDC Procurement and Grants III. Eligibility Information (NCIPC): Increase the capacity of injury Office, 2920 Brandywine Road, Atlanta, 1. Eligible applicants: Applications prevention and control programs to GA 30341, Telephone: 770–488–2748, may be submitted by public and private address the prevention of injuries and E-mail: [email protected]. organizations, community-based violence. organizations and by governments and VIII. Other Information Activities: Awardee activities for this their agencies, such as: program are as follows: For information about the Centers for • Public nonprofit organizations. Disease Control and Prevention see 1. Provide a full-time director/ • Private nonprofit organizations. http://wwww.cdc.gov. coordinator with authority and • Small, minority, women-owned For information about the genetic responsibility to fulfill the requirements businesses. activities within the Division of the program. • Universities. sponsoring this cooperative agreement, 2. Provide qualified staff, other • Colleges. see http://www.phppo.cdc.gov/dls/ resources, and knowledge to implement • Research institutions. genetics/default.asp. the components of the program. • Hospitals. 3. Develop and implement a • Community-based organizations. Dated: April 7, 2004. comprehensive plan to periodically • Faith-based organizations. William P. Nichols, update a detailed description of trauma • Federally recognized Indian tribal Acting Director, Procurement and Grants centers in the United States, including governments. Office, Centers for Disease Control and key personnel, as well as their • Indian tribes. Prevention. capabilities. • Indian tribal organizations. [FR Doc. 04–8291 Filed 4–12–04; 8:45 am] 4. Develop and implement a plan that • State and local governments or their BILLING CODE 4163–18–P enables an exchange of information Bona Fide Agents (this includes the among trauma centers and trauma District of Columbia, the organizations nationwide. Commonwealth of Puerto Rico, the DEPARTMENT OF HEALTH AND 5. Develop and implement a plan for Virgin Islands, the Commonwealth of HUMAN SERVICES a uniform surveillance system for the Northern Marianna Islands, trauma centers that will enable American Samoa, Guam, the Federated Centers for Disease Control and researchers and research organizations States of Micronesia, the Republic of the Prevention to conduct research on quality of trauma Marshall Islands, and the Republic of care and trauma center and trauma Palau). National Trauma Information and • Exchange Program system effectiveness. Political subdivisions of States (in 6. Develop and implement a plan for consultation with States). Announcement Type: Competing the dissemination of available A Bona Fide Agent is an agency/ Continuation Funding. information on trauma, trauma centers, organization identified by the State as

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eligible to submit an application under Application: You must submit a problem, CDC will consider the the State eligibility in lieu of a State project narrative with your application application as having been received by application. If you are applying as a forms. Your narrative must be submitted the deadline. bona fide agent of a State or local in the following format: This announcement is the definitive government, you must provide a letter • Maximum number of pages: 20. guide on application submission from the State or local government as • If your narrative exceeds the page address and deadline. It supersedes documentation of your status. Place this limit, only the first pages, which are information provided in the application documentation behind the first page of within the page limit, will be reviewed. instructions. If your application does your application form. • Font size: 12 point unreduced. not meet the deadline above, it will not • Paper size: 8.5 by 11 inches. be eligible for review, and will be III.2. Cost Sharing or Matching • Page margin size: One inch. discarded. You will be notified that Matching funds are not required for • Printed only on one side of page. your application did not meet the this program. • Held together only by rubber bands submission requirements. or metal clips; not bound in any other CDC will not notify you upon receipt III.3. Other Eligibility Requirements way. of your application. If you have a If your application is incomplete or Your narrative should address question about the receipt of your non-responsive to the requirements activities to be conducted over the application, first contact your courier. If listed below, it will not be entered into entire project period, and must include you still have a question, contact the the review process. You will be notified the following items in the order listed: PGO-TIM staff at: 770–488–2700. Before that your application did not meet the • Background and Need. calling, please wait two to three days • submission requirements. Methods. after the application deadline. This will • • If you request a funding amount Evaluation. allow time for applications to be • greater than the ceiling of award range. Staff and Resources. processed and logged. • Budget and justification. Note: Title 2 of the United States Code You are required to have a Dun and IV.4. Intergovernmental Review of section 1611 states that an organization Bradstreet Data Universal Numbering Applications described in section 501(c)(4) of the Internal Revenue Code that engages in lobbying System (DUNS) number to apply for a Executive Order 12372 does not apply activities is not eligible to receive Federal grant or cooperative agreement from the to this program. funds constituting an award, grant, or loan. Federal government. The DUNS number is a nine-digit identification number, IV.5. Funding Restrictions IV. Application and Submission which uniquely identifies business Restrictions, which must be taken into Information entities. Obtaining a DUNS number is account while writing your budget, are easy and there is no charge. To obtain as follows: IV.1. Address To Request Application a DUNS number, access http:// • None Package www.dunandbradstreet.com or call If you are requesting indirect costs in To apply for this funding opportunity 1–866–705–5711. For more information, your budget, you must include a copy use application form PHS 5161. see the CDC Web site at: http:// of your indirect cost rate agreement. If Application forms and instructions are www.cdc.gov/od/pgo/funding/ your indirect cost rate is a provisional available on the CDC Web site, at the pubcommt.htm. rate, the agreement must be less than 12 following Internet address: http:// If your application form does not have months of age. Guidance for completing www.cdc.gov/od/pgo/forminfo.htm. a DUNS number field, please write your your budget can be found on the CDC If you do not have access to the DUNS number at the top of the first Web site, at the following Internet Internet, or if you have difficulty page of your application, and/or include address: http://www.cdc.gov/od/pgo/ accessing the forms on-line, you may your DUNS number in your application funding/budgetguide.htm. contact the CDC Procurement and cover letter. IV.6. Other Submission Requirements Grants Office Technical Information Management Section (PGO–TIM) staff IV.3. Submission Dates and Times LOI Submission Address: Phyllis C. at: 770–488–2700. Application forms LOI Deadline Date: May 13, 2004. McGuire, Project Officer, Centers for can be mailed to you. Application Deadline Date: July 12, Disease Control and Prevention, 2004. National Center for Injury Prevention IV.2. Content and Form of Submission Explanation of Deadlines: and Control, 4770 Buford Highway NE., Letter of Intent (LOI): CDC requests Applications must be received in the Mailstop F–41, Atlanta, GA 30341– that you send a LOI if you intend to CDC Procurement and Grants Office by 3724, Telephone: 770–488–1275, E-mail apply for this program. Although the 4 p.m. Eastern Time on the deadline address: [email protected]. LOI is not required, not binding, and date. If you send your application by the Application Submission Address: does not enter into the review of your United States Postal Service or Submit the original and two copies of subsequent application, the LOI will be commercial delivery service, you must your application by mail or express used to gauge the level of interest in this ensure that the carrier will be able to delivery service to: Technical program, and to allow CDC to plan the guarantee delivery of the application by Information Management—PA 04075, application review. Your LOI must be the closing date and time. If CDC CDC Procurement and Grants Office, written in the following format: receives your application after closing 2920 Brandywine Road, Atlanta, GA • Maximum number of pages: Two. due to: (1) Carrier error, when the 30341. • Font size: 12-point unreduced. carrier accepted the package with a Applications may not be submitted • Double spaced. guarantee for delivery by the closing electronically at this time. • Paper size: 8.5 by 11 inches. date and time, or (2) significant weather V. Application Review Criteria • Page margin size: One inch. delays or natural disasters, you will be • Printed only on one side of page. given the opportunity to submit V.1. Criteria • Written in plain language, avoid documentation of the carriers guarantee. You are required to provide measures jargon. If the documentation verifies a carrier of effectiveness that will demonstrate

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the accomplishment of the various 5. Budget and Justification (Not Scored) • AR–8 Public Health System identified objectives of the grant. Itemized budget and justification for Reporting Requirements • AR–9 Paperwork Reduction Act Measures of effectiveness must relate to the estimated costs of the contract; Requirements the performance goals stated in the specify the period of performance, and ‘‘ • AR–10 Smoke-Free Workplace Purpose’’ section of this method of selection. announcement. Measures must be Requirements A detailed budget and narrative • objective and quantitative, and must AR–11 Healthy People 2010 justification consistent with the stated • measure the intended outcome. These AR–12 Lobbying Restrictions objectives and planned program • measures of effectiveness must be AR–13 Prohibition on Use of CDC activities should be included. CDC may submitted with the application and will Funds for Certain Gun Control not approve or fund all proposed be an element of evaluation. Activities activities. The applicant should be • AR–14 Accounting System 1. Background and Need (40 Percent) precise about the program purpose of Requirements each budget item. Proposed contracts • AR–15 Proof of Non-Profit Status Applicant should describe the should identify the name of the • AR–21 Small, Minority, and background and need for a contractor, if known; describe the Women-Owned Business comprehensive trauma information services to be performed; provide an • AR–22 Research Integrity • program including; development, itemized budget and justification for the AR–23 States and Faith-Based current challenges in organizing and estimated costs of the contract; specify Organizations delivering trauma care, challenges of the period of performance, and method Additional information on these developing and maintaining trauma of selection. requirements can be found on the CDC systems, implementation and evaluation Web site at the following Internet of a plan to periodically update a V.2. Review and Selection Process address: http://www.cdc.gov/od/pgo/ detailed description of trauma centers in Application will be reviewed for funding/ARs.htm. the United States, development of a completeness by the Procurement and VI.3. Reporting Requirements plan to exchange information and link Grants Office (PGO) staff, and for resources of trauma centers and a plan responsiveness by the NCIPC. You must provide CDC with an for a uniform surveillance program. Incomplete applications and original, plus two hard copies of the applications that are non-responsive to following reports: 2. Methods (30 Percent) the eligibility criteria will not advance 1. Interim progress report, no less than 90 days before the end of the Applicant should provide a detailed through the review process. Applicants budget period. The progress report will description of all proposed activities will be notified that their application serve as your non-competing required to implement a comprehensive did not meet submission requirements. continuation application, and must trauma information and exchange An objective review panel will evaluate complete and responsive contain the following elements: program including letters of support and a. Current Budget Period Activities collaboration needed to achieve each applications according to the criteria listed in the ‘‘Review Criteria’’ section Objectives. objective and the overall program b. Current Budget Period Financial above. goal(s). Applicants should provide a Progress. reasonable, logically sequenced and V.3. Anticipated Announcement and c. New Budget Period Program complete schedule for implementing all Award Dates Proposed Activity Objectives. activities. Applicant should include d. Budget. position descriptions, lines of Anticipated award date: September 1, e. Additional Requested Information. command, and collaborations as 2004. f. Measures of Effectiveness. appropriate to accomplishing the VI. Award Administration Information 2. Financial status report and annual program goal(s) and objectives. progress report, no more than 90 days Applicant should describe a plan and VI.1. Award Notices after the end of the budget period. implementation dissemination of Successful applicants will receive a 3. Final financial and performance available trauma information. Notice of Grant Award (NGA) from the reports, no more than 90 days after the end of the project period. 3. Staff and Resources (20 Percent) CDC Procurement and Grants Office. The NGA shall be the only binding, These reports must be mailed to the Grants Management or Contract Can applicant provide adequate authorizing document between the Specialist listed in the ‘‘Agency facilities, staff and/or collaborators, recipient and CDC. The NGA will be Contacts’’ section of this announcement. including a full-time coordinator and signed by an authorized Grants resources to accomplish the proposed Management Officer, and mailed to the VII. Agency Contacts recipient fiscal officer identified in the goal(s)and objectives during the project For program technical assistance, application. period? Applicant should demonstrate contact: Phyllis C. McGuire, Project staff and/or collaborator availability, VI.2. Administrative and National Officer, Centers for Disease Control and expertise, previous experience, and Policy Requirements Prevention, National Center for Injury capacity to perform the undertaking Prevention and Control, 4770 Buford 45 CFR Part 74 and Part 92 successfully. Highway NE., Mailstop F41, Atlanta, GA 4. Evaluation (10 Percent) For more information on the Code of 30341–3724, Telephone: 770–488–1275, Federal Regulations, see the National E-mail address: [email protected]. The proposed evaluation plan should Archives and Records Administration For budget assistance, contact: Angie be detailed and capable of documenting at the following Internet address: http:/ Tuttle, Grants Management Specialist, program process and outcome measures. /www.access.gpo.gov/nara/cfr/cfr-table- CDC Procurement and Grants Office, Applicant should demonstrate staff and/ search.html. 2920 Brandywine Road, Atlanta, GA or collaborator availability, expertise, The following additional 30341, Telephone: 770.488.2719, E- and capacity to perform the evaluation. requirements apply to this project: mail: [email protected].

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Dated: April 7, 2004. genetic testing). This program addresses • Provide information on numbers William P. Nichols, the ‘‘Healthy People 2010’’ focus area(s) and types of laboratories and numbers Acting Director, Procurement and Grants of ‘‘Access to Quality Health Services’’ and types of waived tests. Office, Centers for Disease Control and and ‘‘Public Health Infrastructure’’. • Provide consultation and technical Prevention. Measurable outcomes of the program assistance related to scientific [FR Doc. 04–8293 Filed 4–12–04; 8:45 am] will be in alignment with the following information on errors in laboratory BILLING CODE 4163–18–P performance goal for the Public Health medicine. Practice Program Office (PHPPO): To • Provide information on CLIA assure that public health infrastructure regulations and their impact on DEPARTMENT OF HEALTH AND at the Federal, state, and local levels has laboratory testing. HUMAN SERVICES the capacity to provide essential public • Provide information from the CDC- health services to the citizens of the sponsored Institute for Quality in Centers for Disease Control and nation to respond to bioterrorism, other Laboratory Medicine. Prevention infectious disease outbreaks, other II. Award Information Assessment of Best Practices for public health threats, emergencies and Type of Award: Cooperative Standardized Quality Assurance prepare frontline state and local health Agreement. Activities in Pathology and Laboratory departments and laboratories to respond CDC involvement in this program is Medicine to current and emerging public health threats.’’ listed in the Activities Section above. Announcement Type: New. Fiscal Year Funds: 2004. Funding Opportunity Number: 04140. Activities Approximate Total Funding: Catalog of Federal Domestic Awardee activities for this program $100,000. Assistance Number: 93.064. are as follows: Approximate Number of Awards: Key Dates: • Evaluate quality assurance methods One. Letter of Intent Deadline: May 13, that have been standardized and Approximate Average Award: 2004. implemented in multiple, diverse $100,000. Application Deadline: June 14, 2004. laboratory settings for common Floor of Award Range: None. Executive Summary: This program Ceiling of Award Range: $100,000 will evaluate the effectiveness of laboratory practices. • Determine best practices in quality (This ceiling is for the first 12-month standardized approaches to quality budget period.). assurance in pathology and laboratory assurance methods for addressing pre- analytic components of laboratory Anticipated Award Date: September medicine, in order to determine 1, 2004. approaches that produce measurable testing, including the test requisition. • Determine best practices in quality Budget Period Length: 12 months. and sustainable improvements against Project Period Length: Three years. established benchmarks. Areas of assurance methods for addressing post- analytic components of laboratory Throughout the project period, CDC’s primary interest are: pre-analytic commitment to continuation of awards process, including the test requisition; testing, including the test report. • Determine best practices in quality will be conditioned on the availability post-analytic processes, including the of funds, evidence of satisfactory test report; implementation of CLIA- assurance methods for addressing implementation of CLIA-waived tests in progress by the recipient (as waived tests in point of service documented in required reports), and environments; error identification and the point of service test environment. • the determination that continued reduction; and quality assurance Determine best practices in quality assurance methods in anatomic funding is in the best interest of the activities in anatomic pathology Federal Government. (autopsies, surgical pathology, pathology (autopsy, surgical pathology cytopathology and/or genetic testing). and/or cytopathology). III. Eligibility Information • Provide leadership in assessing the I. Funding Opportunity Description impact of reporting surgical pathology III.1. Eligible Applicants Authority: This program is authorized results in a template format. Applications may be submitted by under section 317 (k) (2) of the Public Health • Provide leadership in developing public and private nonprofit Service Act, 42 U.S.C. 247b (k)(2), as strategies that lead to wider use of organizations and by governments and amended. proven methods of quality assurance their agencies, such as: Purpose: The purpose of the program and error reduction. • Public nonprofit organizations. is to determine standardized approaches • Provide leadership in developing • Private nonprofit organizations. to quality assurance in pathology and strategies that lead to improved use of • Universities. laboratory medicine that can be applied CLIA-waived tests. • Research institutions. in multiple, diverse settings (e.g. • Provide leadership in developing • Community-based organizations. community hospitals, academic medical programs that evaluate and improve • Faith-based organizations. centers, and independent laboratories) laboratory practice over a specified time • State and local governments or their that demonstrate measurable and period. Bona Fide Agents (this includes the sustainable improvements over time. In a cooperative agreement, CDC staff District of Columbia, the The program focuses on specific is substantially involved in the program Commonwealth of Puerto Rico, the opportunities for error reduction, or activities, above and beyond routine Virgin Islands, the Commonwealth of process improvement in: pre-analytic grant monitoring. the Northern Mariana Islands, American processes, including test requisitions; CDC Activities for this program are as Samoa, Guam, the Federated States of post-analytic processes, including test follows: Micronesia, the Republic of the reports; implementation of CLIA-waived • Provide consultation and technical Marshall Islands, and the Republic of tests in point of service environments, assistance in the planning, Palau). and; anatomic pathology (autopsies, implementation, and evaluation of A Bona Fide Agent is an agency/ surgical pathology, and cytology and/or program activities. organization identified by the state as

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eligible to submit an application under • Page margin size: One inch. toward the narrative page limit. This the state eligibility in lieu of a state • Printed only on one side of page. additional information includes: application. If you are applying as a • Written in plain language, avoid • Examples of past work on bona fide agent of a state or local jargon. standardized quality assurance government, you must provide a letter Your LOI must contain the following measures in pathology and laboratory from the state or local government as information: medicine. documentation of your status. Place this • Description of organization. • Publications in standardized documentation behind the first page of • Goals and objectives. approaches to quality assurance in • your application form. Methods and Technical Approach. pathology and laboratory medicine. • Project Management and Staffing • Organizational charts. III.2. Cost Sharing or Matching (Expertise in standardized processes for • Letters of support. Matching funds are not required for quality assurance in laboratory You are required to have a Dun and this program. medicine and pathology). Bradstreet Data Universal Numbering • Budget—total funds to be requested. System (DUNS) number to apply for a III.3. Other Application: You must submit a grant or cooperative agreement from the CDC will accept and review project narrative with your application Federal government. The DUNS number applications with budgets greater than forms. The narrative must be submitted is a nine-digit identification number, the ceiling of the award range. in the following format: which uniquely identifies business If your application is incomplete or • Maximum number of pages: 30. If entities. Obtaining a DUNS number is non-responsive to the requirements your narrative exceeds the page limit, easy and there is no charge. To obtain listed in this section, it will not be only the first pages, which are within a DUNS number, access entered into the review process. the page limit, will be reviewed. www.dunandbradstreet.com or call 1– You will be notified that your • Font size: 12 point unreduced. 866–705–5711. • application did not meet submission Paper size: 8.5 by 11 inches. For more information, see the CDC • requirements. Page margin size: One inch. Web site at: http://www.cdc.gov/od/pgo/ • Applicants must have experience in Printed only on one side of page. funding/pubcommt.htm. • the administration and evaluation of Held together only by rubber bands If your application form does not have standardized quality assurance or metal clips; not bound in any other a DUNS number field, please write your way. DUNS number at the top of the first programs in multiple, diverse laboratory • sites (including community hospitals Double spaced. page of your application, and/or include and academic medical centers). This Your narrative should address your DUNS number in your application experience is required for an applicant activities to be conducted over the cover letter. to be able to assess the effectiveness of entire project period, and must include Additional requirements that may the following items in the order listed: require you to submit additional these quality assurance programs and to • determine best practices. Applicant’s knowledge of and documentation with your application experience with standardized are listed in section ‘‘VI.2. Note: Title 2 of the United States Code approaches to quality assurance in Administrative and National Policy section 1611 states that an organization laboratory medicine and pathology. Requirements.’’ described in section 501(c)(4) of the Internal • Applicant’s knowledge of and Revenue Code that engages in lobbying IV.3. Submission Dates and Times activities is not eligible to receive Federal experience with quality assurance funds constituting an award, grant, or loan. activities addressing pre-analytic LOI Deadline Date: May 13, 2004. processes (including test requisition), CDC requests that you send a LOI if IV. Application and Submission post-analytic processes (including test you intend to apply for this program. Information report), implementation of CLIA-waived Although the LOI is not required, not tests in point of service environments, binding, and does not enter into the IV.1. Address to Request Application error identification and reduction; review of your subsequent application, Package anatomic pathology and/or genetic the LOI will be used to gauge the level To apply for this funding opportunity testing. of interest in this program, and to allow use application form PHS 5161. • Applicant’s proposal (including CDC to plan the application review. Application forms and instructions are plan, methods, objectives, timeline, and Application Deadline Date: June 14, available on the CDC Web site, at the staff) to evaluate the effectiveness of 2004. following Internet address: standardized approaches to quality Explanation of Deadlines: www.cdc.gov/od/pgo/forminfo.htm. assurance activities in pre-analytic Applications must be received in the If you do not have access to the processes (including test requisition), CDC Procurement and Grants Office by Internet, or if you have difficulty post-analytic processes (including test 4:00 p.m. Eastern Time on the deadline accessing the forms on-line, you may report), implementation of CLIA-waived date. If you send your application by the contact the CDC Procurement and tests in point of service environments, United States Postal Service or Grants Office Technical Information error identification and reduction; commercial delivery service, you must Management Section (PGO-TIM) staff at: anatomic pathology and/or genetic ensure that the carrier will be able to 770-488–2700. Application forms can be testing. guarantee delivery of the application by mailed to you. • Applicant’s proposed performance the closing date and time. If CDC measures. receives your application after closing IV.2. Content and Form of Submission • Applicant’s proposed budget and due to: (1) Carrier error, when the Letter of Intent (LOI): Your LOI must budget justification (which will not be carrier accepted the package with a be written in the following format: counted toward the page limit for the guarantee for delivery by the closing • Maximum number of pages: two. narrative). date and time, or (2) significant weather • Font size: 12-point unreduced. Additional information may be delays or natural disasters, you will be • Single spaced. included in the application appendices. given the opportunity to submit • Paper size: 8.5 by 11 inches. The appendices will not be counted documentation of the carriers guarantee.

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If the documentation verifies a carrier Applications may not be submitted applications according to the criteria problem, CDC will consider the electronically at this time. listed in the ‘‘V.1. Criteria’’ section application as having been received by above. V. Application Review Information the deadline. VI. Award Administration Information This announcement is the definitive V.1. Criteria guide on application submission You are required to provide measures VI.1. Award Notices address and deadline. It supersedes of effectiveness that will demonstrate Successful applicants will receive a information provided in the application the accomplishment of the various Notice of Grant Award (NGA) from the instructions. If your application does identified objectives of the cooperative CDC Procurement and Grants Office. not meet the deadline above, it will not agreement. Measures of effectiveness The NGA shall be the only binding, be eligible for review, and will be must relate to the performance goals authorizing document between the discarded. You will be notified that stated in the ‘‘Purpose’’ section of this recipient and CDC. The NGA will be your application did not meet the announcement. Measures must be signed by an authorized Grants submission requirements. objective and quantitative, and must Management Officer, and mailed to the CDC will not notify you upon receipt measure the intended outcome. These recipient fiscal officer identified in the of your application. If you have a measures of effectiveness must be application. question about the receipt of your submitted with the application and will Unsuccessful applicants will receive application, first contact your courier. If be an element of evaluation. notification of the results of the you still have a question, contact the Your application will be evaluated application review by mail. PGO-TIM staff at: 770–488–2700. Before against the following criteria: calling, please wait two to three days VI.2. Administrative and National after the application deadline. This will 1. Methods and Technical Approach (30 Policy Requirements allow time for applications to be Points) 45 CFR Part 74 and Part 92 processed and logged. a. Are the proposed methods feasible? For more information on the Code of b. Will the proposed methods achieve IV.4. Intergovernmental Review of Federal Regulations, see the National the program goals and objectives? Archives and Records Administration at Applications c. Do the proposed methods address the following Internet address: http:// Executive Order 12372 does apply to pre-analytic processes? www.access.gpo.gov/nara/cfr/cfr-table- this program. d. Do the proposed methods address post-analytic processes? search.html. The following additional IV.5. Funding Restrictions e. Do the proposed methods address requirements apply to this project: Restrictions, which must be taken into implementation of waived tests in the • AR–10 Smoke-Free Workplace account while writing your budget, are point of service environment? Requirements. as follows: f. Do the proposed methods address • AR–11 Healthy People 2010. • None. anatomic pathology? • AR–12 Lobbying Restrictions. • If you are requesting indirect costs in 2. Project Management and Staffing (30 AR–15 Proof of Non-Profit Status. your budget, you must include a copy Points) Additional information on these of your indirect cost rate agreement. If requirements can be found on the CDC your indirect cost rate is a provisional a. Does the applicant have the staff, Web site at the following Internet rate, the agreement should be less than knowledge, and expertise required to address: http://www.cdc.gov/od/pgo/ 12 months of age. perform the responsibilities associated funding/ARs.htm. with the project? Awards will not allow reimbursement VI.3. Reporting Requirements of pre-award costs. b. Are adequate qualified personnel committed to the project? Guidance for completing your budget You must provide CDC with an can be found on the CDC Web site, at 3. Program Goals and Objectives (20 original, plus two hard copies of the the following Internet address: http:// Points) following reports: 1. Interim progress report, no less www.cdc.gov/od/pgo/funding/ Does the proposal address the budgetguide.htm. than 90 days before the end of the program goals and objectives? budget period. The progress report will IV.6. Other Submission Requirements 4. Evaluation Plan (20 Points) serve as your non-competing continuation application, and must LOI Submission Address: Submit your Does the applicant describe a feasible LOI by express mail, delivery service, contain the following elements: schedule for accomplishing the a. Current Budget Period Activities fax, or E-mail to: Tracy L. Carter, activities related to this project and a M.P.H., Centers for Disease Control and Objectives. plan for evaluating their progress? b. Current Budget Period Financial Prevention, Division of Laboratory Progress. Systems, Public Health Practice Program V.2. Review and Selection Process c. New Budget Period Program Office, 4770 Buford Highway NE, MS– Applications will be reviewed for Proposed Activity Objectives. G25, Atlanta, GA 30341, Telephone: 770 completeness by the Procurement and d. Budget. 488–2523, Fax: 770–488–8282, E-mail: Grants Office (PGO) staff, and for e. Additional Requested Information. [email protected]. responsiveness by PHPPO. Incomplete f. Measures of Effectiveness. Application Submission Address: applications and applications that are 2. Financial status report, no more Submit the original and two hard copies non-responsive to the eligibility criteria than 90 days after the end of the budget of your application by mail or express will not advance through the review period. delivery service to: Technical process. Applicants will be notified that 3. Final financial and performance Information Management—PA# 04140, their application did not meet reports, no more than 90 days after the CDC Procurement and Grants Office, submission requirements. end of the project period. 2920 Brandywine Road, Atlanta, GA An objective review panel will These reports must be mailed to the 30341. evaluate complete and responsive Grants Management or Contract

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Specialist listed in the ‘‘Agency Dated: April 7, 2004. (the Act), to be eligible to receive Title Contacts’’ section of this announcement. William P. Nichols, IV–E Federal financial assistance payments, states must develop a case VII. Agency Contacts Acting Director, Procurement and Grants Office, Centers for Disease Control and plan (as defined in section 475(1)) for For general questions about this Prevention. each child receiving foster care announcement, contact: Technical [FR Doc. 04–8292 Filed 4–12–04; 8:45 am] maintenance payments. Section 471(a) Information Management Section, CDC BILLING CODE 4163–18–P (16) states that in order for a state to be Procurement and Grants Office, 2920 eligible for payments under this part, Brandywine Road, Atlanta, GA 30341, there must be a state plan, approved by Telephone: 770–488–2700. DEPARTMENT OF HEALTH AND the Secretary of the U.S. Department of For program technical assistance, HUMAN SERVICES Health and Human Services, which contact: Toby L. Merlin, MD, Project provides for the development of a case Officer, Centers for Disease Control and Administration for Children and plan for each child receiving foster care Prevention, Division of Laboratory Families assistance under the state plan and provides for a case review system which Systems, Public Health Practice Program Proposed Information Collection meets the requirements described in Office, 4770 Buford Highway NE, MS– Activity; Comment Request G25, Telephone: 770–488–8256, E-mail: section 475(5)(B) with respect to each [email protected]. Proposed Projects: Reporting and child. Through these requirements, For financial, grants management, or Recordkeeping. states also comply, in part, with Title budget assistance, contact: Sharon Title: Case Plan Requirement, Section IV–B, section 422(b)(10) of the Act, Robertson, Grants Management 422, 471(a)(16) and 475(5)(A)(B) of the which assures certain protections for Specialist, CDC Procurement and Grants Social Security Act. children in foster care. Office, 2920 Brandywine Road, Atlanta, OMB No. 0980–0140. Respondents: State Title IV–B and GA 30341, Telephone: 770–488–2748, Description: Under section 471(a) of Title IV–E Agencies E-mail: [email protected]. Title IV–E of the Social Security Act Annual Burden Estimates

Number of re- Average bur- Instrument Number of re- sponses per den hours per Total burden spondents respondent response hours

Case Plan ...... 701,461 1 2.60 1,823,799

Estimated Total Annual Burden other forms of information technology. 1703 (2002), 42 U.S.C. 15421–15425, Hours: 1,823,799. Consideration will be given to 15461–15462, and as amended, In compliance with the requirements comments and suggestions submitted hereafter. of section 3506(c)(2)(A) of the within 60 days of this publication. (B) Effect on Existing Delegations. Paperwork Reduction Act of 1995, the Dated: April 7, 2004. Administration for Children and None Robert Sargis, Families is soliciting public comment (A) Limitations. on the specific aspects of the Reports Clearance Officer. 1. This delegation shall be exercised information collection described above. [FR Doc. 04–8338 Filed 4–12–04; 8:45 am] under the Department’s existing Copies of the proposed collection of BILLING CODE 4184–01–M delegation and policy on regulations. information can be obtained and 2. This delegation shall be exercised comments may be forwarded by writing under financial and administrative to the Administration for Children and DEPARTMENT OF HEALTH AND requirements applicable to all Families, Office of Administration, HUMAN SERVICES Administration for Children and Office of Information Services, 370 Administration for Children and Families authorities. L’Enfant Promenade, SW., Washington, Families 3. I hereby affirm and ratify any DC 20447, Attn: ACF Reports Clearance actions taken by the Commissioner, Officer. E-mail address: Statement of Organization, Functions Administration on Developmental [email protected]. All requests and Delegations of Authority Disabilities, or any other Administration should be identified by the title of the on Developmental Disabilities officials, information collection. Notice is hereby given that I delegate which, in effect, involved the exercise of The Department specifically requests to the Commissioner, Administration on this authority prior to the effective date comments on: (a) Whether the proposed Developmental Disabilities, with of this delegation. collection of information is necessary authority to further redelegate, the 4. Any redelegation shall be in writing for the proper performance of the following authority vested in the and prompt notifications must be functions of the agency, including Assistant Secretary for Children and provided to all affected managers, whether the information shall have Families by the Secretary under Title II, supervisors, and other personnel. practical utility; (b) the accuracy of the Subtitle D, Parts 2 and 5 of the Help (D) Effective Date. agency’s estimate of the burden of the America Vote Act of 2002, Pub. L. 107– This delegation is effective proposed collection of information; (c) 252, 116 Stat 1666, 1698–1699, 1702– immediately. the quality, utility, and clarity of the 1703 (2002), 42 U.S.C. 15421–15425, Dated: April 2, 2004. information to be collected; and (d) 15461–15462. ways to minimize the burden of the (A) Authority to administer the Title Wade F. Horn, collection of information on II, Subtitle D, Parts 2 and 5 of the Help Assistant Secretary for Children and Families. respondents, including through the use America Vote Act of 2002, Pub. L. 107– [FR Doc. 04–8335 Filed 4–12–04; 8:45 am] of automated collection techniques or 252, 116 Stat 1666, 1698–1699, 1702– BILLING CODE 4184–01–P

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DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND ACTION: Notice. HUMAN SERVICES HUMAN SERVICES SUMMARY: The Food and Drug Administration for Children and Food and Drug Administration Administration (FDA) is announcing Families Statement of Organization, that a collection of information entitled [Docket No. 2003N–0482] Functions and Delegations of ‘‘Substantial Evidence of Effectiveness of Authority Agency Information Collection New Animal Drugs’’, has been approved Activities; Announcement of Office of by the Office of Management and Notice is hereby given that I delegate Management and Budget Approval; Budget (OMB) under provisions of the to the Commissioner, Administration on Mammography Facilities, Standards, Paperwork Reduction Act of 1995 (the Developmental Disabilities, with and Lay Summaries for Patients PRA). authority to further redelegate, the FOR FURTHER INFORMATION CONTACT: following authority vested in the AGENCY: Food and Drug Administration, Denver Presley, Office of Management Assistant Secretary for Children and HHS. Programs (HFA–250), Food and Drug Families by the Secretary under the ACTION: Notice. Administration, 5600 Fishers Lane, Developmental Disabilities Assistance Rockville, MD 20857, 301–827–1472 and Bill of Rights Act of 2000, Pub.L. SUMMARY: The Food and Drug SUPPLEMENTARY INFORMATION: In the 106–402, 114 Stat. 1677 (2000), 42 Administration (FDA) is announcing Federal Register of January 7, 2004 (69 U.S.C. 15001 et seq. that a collection of information entitled FR 923), the agency announced that the ‘‘Mammography Facilities, Standards, (a) Authority Delegated proposed information collection had and Lay Summaries for Patients’’ has been submitted to OMB for review and Authority to administer the been approved by the Office of clearance under section 3507 of the PRA Developmental Disabilities Assistance Management and Budget (OMB) under (44 U.S.C. 3507). An agency may not and Bill of Rights Act of 2000, (The the Paperwork Reduction Act of 1995. conduct or sponsor, and a person is not Act), Pub. L. 106–402, 114 Stat. 1677 FOR FURTHER INFORMATION CONTACT: (2000), 42 U.S.C. 15001 et seq., and as required to respond to, a collection of Peggy Robbins, Office of Management information unless it displays a amended, hereafter, including authority Programs (HFA–250), Food and Drug to make the initial decision regarding currently valid OMB control number. Administration, 5600 Fishers Lane, OMB has now approved the information withholding of funds from States Rockville, MD 20857, 301–827–1223. pursuant to section 127 of the Act (42 collection and has assigned OMB SUPPLEMENTARY INFORMATION: In the U.S.C. 15027). control number 0910–0356. The Federal Register of February 9, 2004 (69 approval expires on March 31, 2007. (b) Effect on Existing Delegations FR 5991), the agency announced that Dated: April 6, 2004. the proposed information collection had Replaces. Jeffrey Shuren, been submitted to OMB for review and (c) Limitations clearance under 44 U.S.C. 3507. An Assistant Commissioner for Policy. [FR Doc. 04–8252 Filed 4–12–04; 8:45 am] 1. This delegation shall be exercised agency may not conduct or sponsor, and under the Department’s existing a person is not required to respond to, BILLING CODE 4160–01–S delegation and policy on regulations. a collection of information unless it 2. This delegation does not include displays a currently valid OMB control number. OMB has now approved the DEPARTMENT OF HEALTH AND authority to hear appeals under 45 CFR HUMAN SERVICES 1386, subpart D, 45 CFR 1386.20(e), or information collection and has assigned 45 CFR 1386.34(d). OMB control number 0910–0309. The Food and Drug Administration 3. This delegation shall be exercised approval expires on March 31, 2007. A under financial and administrative copy of the supporting statement for this [Docket No. 2003N–0397] information collection is available on requirements applicable to all Agency Information Collection Administration for Children and the Internet at http://www.fda.gov/ ohrms/dockets. Activities; Announcement of Office of Families authorities. Management and Budget Approval; 4. I hereby affirm and ratify any Dated: April 2, 2004. Threshold of Regulation for actions taken by the Commissioner, Jeffrey Shuren, Substances Used in Food-Contact Administration on Developmental Assistant Commissioner for Policy. Articles Disabilities, or any other Administration [FR Doc. 04–8250 Filed 4–12–04; 8:45 am] AGENCY: Food and Drug Administration, on Developmental Disabilities officials, BILLING CODE 4160–01–S which, in effect, involved the exercise of HHS. this authority prior to the effective date ACTION: Notice. of this delegation. DEPARTMENT OF HEALTH AND SUMMARY: The Food and Drug 5. Any redelegation shall be in writing HUMAN SERVICES and prompt notifications must be Administration (FDA) is announcing provided to all affected managers, Food and Drug Administration that a collection of information entitled ‘‘Threshold of Regulation for Substances supervisors, and other personnel. [Docket No. 2003N–0424] (d) Effective Date Used in Food-Contact Articles’’ has been approved by the Office of This delegation is effective Agency Information Collection Management and Budget (OMB) under immediately. Activities; Announcement of Office of the Paperwork Reduction Act of 1995. Management and Budget Approval; Dated: April 2, 2004. FOR FURTHER INFORMATION CONTACT: Wade F. Horn, Substantial Evidence of Effectiveness of New Animal Drugs Peggy Robbins, Office of Management Assistant Secretary for Children and Families. Programs (HFA–250), Food and Drug [FR Doc. 04–8336 Filed 4–12–04; 8:45 am] AGENCY: Food and Drug Administration, Administration, 5600 Fishers Lane, BILLING CODE 4184–01–P HHS. Rockville, MD 20857, 301–827–1223.

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SUPPLEMENTARY INFORMATION: In the www.fda.gov/dockets/ecomments. industry.1 These categories of devices Federal Register of January 23, 2004 (69 Identify comments with the docket are defined as follows: FR 3372), the agency announced that number found in brackets in the 1. A critical reprocessed SUD is the proposed information collection had heading of this document. intended to contact normally sterile been submitted to OMB for review and tissue or body spaces during use. FOR FURTHER INFORMATION CONTACT: clearance under 44 U.S.C. 3507. An Barbara A. Zimmerman, Center for 2. A semicritical reprocessed SUD is agency may not conduct or sponsor, and Devices and Radiological Health (HFZ– intended to contact intact mucous a person is not required to respond to, 410), Food and Drug Administration, membranes and not penetrate normally a collection of information unless it 9200 Corporate Blvd., Rockville, MD sterile areas of the body. displays a currently valid OMB control 20850, 301–594–2036. 3. A noncritical reprocessed SUD is number. OMB has now approved the intended to make topical contact and information collection and has assigned SUPPLEMENTARY INFORMATION: not penetrate intact skin. OMB control number 0910–0298. The I. Background In the Federal Register of April 30, approval expires on March 31, 2007. A 2003 (68 FR 23139), FDA explained its copy of the supporting statement for this On October 26, 2002, MDUFMA methodology and criteria for information collection is available on (Public Law 107–250) amended the determining which device types should the Internet at http://www.fda.gov/ Federal Food, Drug, and Cosmetic Act no longer be exempt from premarket ohrms/dockets. (the act) by adding section 510(o) (21 submission requirements in accordance Dated: April 6, 2004. U.S.C. 360(o)), which provided new with MDUFMA. As described in the Jeffrey Shuren, regulatory requirements for reprocessed April 2003 Federal Register notice, in Assistant Commissioner for Policy. SUDs. According to this new provision, the first step of this process, the agency 510(k)s for certain reprocessed SUDs categorized all known types of SUDs [FR Doc. 04–8305 Filed 4–12–04; 8:45 am] identified by FDA must include that were being reprocessed as critical, BILLING CODE 4160–01–S validation data to ensure that the semicritical, or noncritical using the reprocessed SUDs are substantially previously listed definitions. Next, FDA DEPARTMENT OF HEALTH AND equivalent to predicate devices. The evaluated the overall risk (high, HUMAN SERVICES required validation data include moderate, or low) associated with the cleaning and sterilization data, and reprocessed SUDs using the review Food and Drug Administration functional performance data prioritization scheme (RPS) that had demonstrating that each SUD will been previously described in a draft [Docket No. 2004N–0154] remain substantially equivalent to its guidance document.2 In the RPS Medical Devices; Semicritical predicate device after the maximum guidance, FDA set forth factors that Reprocessed Single-Use Devices; number of times the device is could be used to evaluate the risk Termination of Exemptions From reprocessed as intended by the person associated with reprocessed SUDs and Premarket Notification; Requirement submitting the premarket notification. assign an overall risk to each SUD based for Submission of Validation Data Before the enactment of the new law, on the risk of the following: (1) Infection the agency required a manufacturer of a and (2) inadequate performance AGENCY: Food and Drug Administration, reprocessed SUD to obtain premarket following reprocessing. The designation HHS. approval or premarket clearance for the of ‘‘high risk’’ was assigned to those ACTION: Notice. device, unless the device was exempt devices that posed the greatest risk of from premarket submission infection and inadequate performance SUMMARY: The Food and Drug requirements. Under MDUFMA, some after reprocessing. Administration (FDA) is publishing a previously exempt critical and In addition to the previously listed list of semicritical reprocessed single- semicritical reprocessed SUDs will no steps, FDA also identified all use devices (SUDs) whose exemption longer be exempt from premarket reprocessed SUDs intended to come in from premarket submission is being notification requirements. contact with tissue at high risk of being terminated and for which validation Manufacturers of these identified infected with the causative agents of data, as specified under the Medical devices will need to submit 510(k)s that Creutzfeldt-Jakob Disease (CJD). As Device User Fee and Modernization Act include validation data as specified by stated in the April 2003 Federal of 2002 (MDUFMA), are necessary in a FDA. Register notice, these are generally premarket notification (510(k)). FDA is devices intended for use in requiring submission of these data to Under section 302(b) of MDUFMA, a reprocessed SUD is defined as an neurosurgery and ophthalmology. This ensure that these reprocessed SUDs are criterion was used in FDA’s evaluation substantially equivalent to predicate ‘‘original device that has previously been used on a patient and has been subjected to because insufficient scientific devices in accordance with MDUFMA. additional processing and manufacturing for information exists at this time to DATES: These actions are effective April the purpose of an additional single use on a establish standard methods to eliminate 13, 2004. Manufacturers of reprocessed patient. The subsequent processing and CJD infectious agents. SUDs identified in the list whose manufacture of a reprocessed single-use exemptions are being terminated must device shall result in a device that is 1 Spaulding, E. H., ‘‘The Role of Chemical submit 510(k)s for these devices by July reprocessed within the meaning of this Disinfection in the Prevention of Nosocomial 13, 2005, or these devices may no longer definition.’’ Infections,’’ P. S. Brachman and T. C. Eickof (ed), be legally marketed. Reprocessed SUDs are divided into Proceedings of International Conference on Nosocomial Infections, 1970, American Hospital ADDRESSES: Submit written comments the following three categories: (1) Association, Chicago, 1971:254–274. to the Division of Dockets Management Critical, (2) semicritical, and (3) 2 The draft guidance entitled ‘‘Reprocessing and (HFA–305), Food and Drug noncritical. The first two categories Reuse of Single-Use Devices: Review Prioritization reflect definitions contained in Scheme’’ (appendix 2 superseded) is available on Administration, 5630 Fishers Lane, rm. the Center for Devices and Radiological Health’s 1061, Rockville, MD 20852. Submit MDUFMA, and all three reflect a (CDRH) Web site at http://www.fda.gov/cdrh/reuse/ electronic comments to http:// classification scheme recognized in the 1156.pdf.

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Using this process and criteria, FDA previously, or intended to come in developing the list of critical developed a reference list (attachment 1 contact with tissue at high risk of being reprocessed SUDs, the agency of the April 2003 Federal Register infected with the causative agents of determined which semicritical notice). This list identifies the entire CJD (see list I of the April 2003 Federal reprocessed SUDs should be subject to group of reprocessed SUDs, and the Register notice). FDA also published a premarket submission requirements. All levels of risk associated with the revised version of this list in the Federal devices identified in the attached list devices, that FDA considered when Register of June 26, 2003 (68 FR 38071). have been determined to be high risk implementing the new statutory III. Requirements for 510(k) Exempt semicritical reprocessed SUDs. It should requirements in section 510(o) of the Semicritical Reprocessed SUDs be noted that not all exempt semicritical act. (For more detailed information on devices have been listed. Semicritical the process FDA used to identify these As discussed previously, MDUFMA reprocessed SUDs that are not listed at SUDs and assign risk categorizations, also requires FDA to review the see 68 FR 23139.) semicritical reprocessed SUDs that are this time may be added to future currently exempt from premarket updates of the list. II. Requirements for 510(k) Exempt notification requirements and determine As required by MDUFMA, Critical Reprocessed SUDs which of these devices will require manufacturers of the devices identified In the April 2003 Federal Register 510(k)s with validation data in order to in the attached list must submit 510(k)s notice, as required by MDUFMA, FDA ensure their substantial equivalence to that include validation data regarding published a list of critical reprocessed predicate devices. FDA is required to cleaning, sterilization, and functional SUDs whose exemptions from identify these devices in a notice performance, in addition to all the other premarket submission were being published in the Federal Register by required elements of 510(k)s identified terminated and for which validation April 26, 2004. The attached list of in 21 CFR 807.87, within 15 months of data in 510(k) submissions would be semicritical reprocessed SUDs publication of this notice or they may necessary. In the notice, FDA identified implements this MDUFMA requirement. those critical reprocessed SUDs that Using the methodology and criteria no longer legally market these devices were either ‘‘high’’ risk, as described described in this document for after that date.

LIST 1.—SEMICRITICAL REPROCESSED SINGLE-USE DEVICES PREVIOUSLY EXEMPT FROM PREMARKET NOTIFICATION REQUIREMENTS THAT WILL NOW REQUIRE 510(K)S WITH VALIDATION DATA

Product Code for Non- Product Code for Product Code Name for 21 CFR Section Classification Name reprocessed Device Reprocessed Device Reprocessed Device

872.5410 Orthodontic appliance and EJF NQS Orthodontic metal bracket accessories 876.4680 Ureteral stone dislodger FGO, FFL NQT, NQU Flexible and basket stone dislodger 868.6810 Tracheobronchial suction BSY NQV Tracheobronchial suction catheter catheter

IV. Requirements for 510(k) Exempt the exempt status of reprocessed SUDs categorize reprocessed SUDs, Congress Noncritical Reprocessed SUDs remains appropriate. also authorized the agency to apply MDUFMA does not require FDA to As stated in the April 30, 2003 additional criteria in determining the take any action under section 510(o) of Federal Register notice, the agency devices for which 510(k) exemptions the act for noncritical reprocessed SUDs continues to believe that the RPS is an should be terminated. that are exempt from premarket appropriate risk-based tool for The agency also received a comment submission requirements. identifying those devices that are likely that identified specific reprocessed to raise concerns about both infection V. Stakeholder Input SUDs whose exemption from the 510(k) transmission and inadequate requirements should be terminated. The In the Federal Register of February 4, performance following reprocessing. agency considered these 2003 (68 FR 5643), FDA invited FDA believes that the flowchart that is recommendations while finalizing this interested persons to provide part of the RPS provides an objective, document. Although this list of information and share views on the science-based assessment of these risks semicritical reprocessed SUDs does not implementation of MDUFMA. Since for each type of reprocessed device. In include all of those devices that were that time, the agency has received addition, while MDUFMA defines the recommended in the comment, the ‘‘ comments on various MDUFMA terms critical reprocessed single-use agency believes that 510(k)s with device’’ and ‘‘semi-critical reprocessed provisions, including several on its validation data should be required in implementation of section 510(o) of the single-use device’’ in new section accordance with MDUFMA for the act. One comment expressed concern 201(mm)(1) and (mm)(2) of the act, new devices identified on the list due to about the agency’s reliance on the section 510(o)(2)(A) states that ‘‘[t]he Review Prioritization Scheme (RPS). Secretary shall identify such devices or concerns about infection transmission According to the comment, the RPS is types of devices for which such and performance. As stated in the April a subjective and incomplete method for exemptions should be terminated in 2003 Federal Register notice, the agency accurately assessing the risk associated order to provide a reasonable assurance recognizes that the lists of critical and with reprocessing. The comment further of the safety and effectiveness of the semicritical devices may need to be stated that Congress’s intent was for the devices.’’ Given this statutory language, reevaluated and updated over time. Spaulding criteria to be the primary FDA believes that while Congress used Therefore, FDA will consider comments mechanism used to determine whether the Spaulding definitions to initially from the public on additional devices

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that should be included on the lists at DEPARTMENT OF HEALTH AND responsible for subsequent changes to any time. HUMAN SERVICES the Web site after this document Finally, FDA would like to take this publishes in the Federal Register.) Food and Drug Administration If you need special accommodations opportunity to remind entities that due to a disability, please contact reprocess SUDs of the guidance Fifth Joint Project Management Camela Pastorius (see Contact Person) ‘‘ document entitled Medical Device User Workshop on Improving Agency/ by May 4, 2004. Fee and Modernization Act of 2002, Industry Communication Throughout SUPPLEMENTARY INFORMATION: FDA (the Validation Data in Premarket the Drug Development Process; Public Center for Biologics Evaluation and Notification Submissions [510(k)s] for Workshop Research and the Center for Drug Reprocessed Single-Use Medical Evaluation and Research) and DIA are Devices.’’ FDA announced the AGENCY: Food and Drug Administration, HHS. cosponsoring a public workshop as part availability of this guidance in the of a continuing effort to develop higher ACTION: Notice of public workshop. Federal Register of July 8, 2003 (68 FR levels of teamwork, communication, 40679). This guidance document The Food and Drug Administration and procedural knowledge to facilitate provides FDA’s recommendations for (FDA) in cosponsorship with the Drug drug development and review in the manufacturers of reprocessed SUDs to Information Association (DIA) is United States. The workshop’s target assist them in complying with announcing a public workshop entitled audience is project directors, leaders, MDUFMA’s validation data submission ‘‘The Fifth Joint Project Management managers, and regulatory affairs requirement and should be helpful to Workshop: Improve Agency/Industry representatives from industry; and FDA manufacturers of those semicritical Communication Throughout the Drug reviewers, regulatory project managers, reprocessed SUDs listed below in Development Process.’’ The workshop and consumer safety officers. At the preparing their 510(k)s. This guidance will focus on facilitating the drug conclusion of the workshop, the may be found on CDRH’s Web site at development and drug review processes participants should be able to do the http://www.fda.gov/cdrh/guidance/ through interactions between industry following: (1) Identify FDA/industry html. and FDA to effectively manage risk to cultural differences that influence expedite products of public benefit to interactions between the two groups, (2) VI. Paperwork Reduction Act of 1995 market. effectively manage constructive interactions in a changing environment, This document contains information Date and Time: The public workshop and (3) manage communication collection provisions that are subject to will be held on May 11, 2004, from 8:30 strategies for facilitating drug approvals. review by the Office of Management and a.m. to 5 p.m., May 12, 2004, from 8:30 a.m. to 5 p.m., and May 13, 2004, from Budget (OMB) under the Paperwork Dated: April 6, 2004. 8:30 a.m. to 12:30 p.m. Reduction Act of 1995 (44 U.S.C. 3501– Jeffrey Shuren, Location: The public workshop will 3520). The collection of information Assistant Commissioner for Policy. be at the Hyatt Regency Bethesda, 1 [FR Doc. 04–8251 Filed 4–12–04; 8:45 am] described in this document were Bethesda Metro Center, Bethesda, MD. approved under OMB control number Contact Person: Julieann Dubeau, BILLING CODE 4160–01–S 0910–0514. Center for Drug Evaluation and Research VII. Comments (HFD–180), Food and Drug DEPARTMENT OF HEALTH AND Administration, 5600 Fishers Lane, HUMAN SERVICES Interested persons may submit to the Rockville, MD, 301–827–7310, FAX: Division of Dockets Management (see 301–827–1305, e-mail: Food and Drug Administration ADDRESSES) written or electronic [email protected], or Gail Sherman, [Docket No. 1999D–2335] comments regarding this document at Center for Biologics Evaluation and any time. Submit a single copy of Research (HFM–42), Food and Drug Guidance for Industry and Food and electronic comments or two paper Administration, 1401 Rockville Pike, Drug Administration Staff; Premarket copies of any mailed comments, except Rockville, MD 20852, 301–827–2000, Approval Applications for Absorbable that individuals may submit one paper FAX: 301–827–3079, e-mail: Powder for Lubricating a Surgeon’s copy. Comments are to be identified [email protected], or Camela Glove; Availability with the docket number found in Pastorius, Drug Information Association, AGENCY: brackets in the heading of this 800 Enterprise Rd., suite 200, Horsham, Food and Drug Administration, HHS. document. Received comments may be PA 19044, 215–442–6196, FAX: 215– seen in the Division of Dockets 442–6103, e-mail: ACTION: Notice. [email protected]. Management between 9 a.m. and 4 p.m., Registration: Mail or fax your SUMMARY: The Food and Drug Monday through Friday. registration information and registration Administration (FDA) is announcing the Dated: April 5, 2004. fee to Drug Information Association availability of the guidance entitled Jeffrey Shuren, (DIA), P.O. Box 827192, Philadelphia, ‘‘Premarket Approval Applications (PMA) for Absorbable Powder for Assistant Commissioner for Policy. PA 19182–7192. You may obtain Lubricating a Surgeon’s Glove.’’ This [FR Doc. 04–8307 Filed 4–12–04; 8:45 am] registration forms from DIA (see Contact Person) or from FDA at http:// guidance describes the information FDA BILLING CODE 4160–01–S www.fda.gov/cber/meetings.htm. recommends that you provide in a PMA Additional information regarding for absorbable powder for lubricating a registration fees and online registration surgeon’s glove. can be found at http:// DATES: Submit written or electronic www.diahome.org/docs/events/ comments on this guidance at any time. eventslsearchldetail.cfm. (FDA has ADDRESSES: Submit written requests for verified the Web site, but we are not single copies on a 3.5″ diskette of the

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guidance document entitled ‘‘Premarket absorbable powder for lubricating a V. Comments Approval Applications (PMA) for surgeon’s glove. It does not create or Interested persons may submit to the Absorbable Powder for Lubricating a confer any rights for or on any person Division of Dockets Management (see Surgeon’s Glove’’ to the Division of and does not operate to bind FDA or the ADDRESSES), written or electronic Small Manufacturers, International, and public. An alternative approach may be comments regarding the guidance at any Consumer Assistance (HFZ–220), Center used if such approach satisfies the time. Submit a single copy of electronic for Devices and Radiological Health, requirements of the applicable statute comments to http://www.fda.gov/ Food and Drug Administration, 1350 and regulations. dockets/ecomments. Submit two paper Piccard Dr., Rockville, MD 20850. Send III. Electronic Access copies of any mailed comments, except one self-addressed adhesive label to that individuals may submit one paper assist that office in processing your To receive ‘‘Premarket Approval copy. Comments are to be identified request, or fax your request to 301–443– Applications (PMA) for Absorbable with the docket number found in 8818. See the SUPPLEMENTARY Powder for Lubricating a Surgeon’s brackets in the heading of this INFORMATION section for information on Glove’’ by fax machine, call the Center document. Comments received may be electronic access to the guidance. for Devices and Radiological Health seen in the Division of Dockets Submit written comments concerning (CDRH) Facts-On-Demand system at Management between 9 a.m. and 4 p.m., this guidance to the Division of Dockets 800–899–0381, or 301–827–0111 from a Monday through Friday. Management (HFA–305), Food and Drug touch-tone telephone. Press 1 to enter Dated: March 30, 2004. Administration, 5630 Fishers Lane, rm. the system. At the second voice prompt, Beverly Chernaik Rothstein, 1061, Rockville, MD 20852. Submit press 1 to order a document. Enter the electronic comments to http:// document number (1230) followed by Acting Deputy Director for Policy and Regulations, Center for Devices and www.fda.gov/dockets/ecomments. the pound sign (#). Follow the Radiological Health. Identify comments with the docket remaining voice prompts to complete [FR Doc. 04–8306 Filed 4–12–04; 8:45 am] number found in brackets in the your request. BILLING CODE 4160–01–S heading of this document. Persons interested in obtaining a copy FOR FURTHER INFORMATION CONTACT: of the guidance may also do so by using Chiu S. Lin, Center for Devices and the Internet. CDRH maintains an entry DEPARTMENT OF HEALTH AND Radiological Health (HFZ–480), Food on the Internet for easy access to HUMAN SERVICES and Drug Administration, 9200 information including text, graphics, Corporate Blvd., Rockville, MD 20850, and files that may be downloaded to a National Institutes of Health 301–443–8913. personal computer with Internet access. Proposed Data Collection; Comment SUPPLEMENTARY INFORMATION: Updated on a regular basis, the CDRH home page includes device safety alerts, Request Health Information National I. Background Federal Register reprints, information Trends Survey (HINTS) II In the Federal Register of July 30, on premarket submissions (including SUMMARY: In compliance with the 1999 (64 FR 41744), FDA announced the lists of approved applications and requirements of Section 3506(c)(2)(A) of availability of a draft guidance for manufacturers’ addresses), small the Paperwork Reduction Act of 1995 comment entitled ‘‘Medical Glove manufacturer’s assistance, information for opportunity for public comment on Guidance Manual.’’ (See http:// on video conferencing and electronic proposed data collection projects, the www.fda.gov/cdrh/dsma/135.html for submissions, Mammography Matters, National Cancer Institute (NCI), the draft guidance.) Elsewhere in the and other device-oriented information. National Institutes of Health (NIH) will same issue of the Federal Register (64 The CDRH Web site may be accessed at publish periodic summaries of proposed FR 41710), FDA proposed that the 1999 http://www.fda.gov/cdrh. A search projects to be submitted to the Office of draft guidance serve as a special control capability for all CDRH guidance Management and Budget (OMB) for for class II gloves. However, chapter 4 documents is available at http:// review and approval. of the 1999 draft guidance contained a www.fda.gov/cdrh/guidance.html. Proposed Collection: Title: Health section that discussed PMAs for Guidance documents are also available Information National Trends Survey absorbable powder for lubricating on the Division of Dockets Management (HINTS) II. Type of Information surgeon’s gloves. Because the section Internet site at http://www.fda.gov/ Collection Request: New. Need and Use discussing PMAs for absorbable powder ohrms/dockets. of Information Collection: The Health Information National Trends Survey is not relevant to class II gloves, FDA is IV. Paperwork Reduction Act of 1995 removing this section and issuing it as (HINTS) is a biennial survey designed to a separate guidance document. FDA did This guidance contains information provide nationally representative, not receive any comments on this collection provisions that are subject to population-based data on health section of the 1999 draft guidance. review by the Office of Management and information for the United States. The Because the recommendations in this Budget (OMB) under the Paperwork NCI funded HINTS to assist in its effort section were available in draft form for Reduction Act of 1995 (the PRA) (44 to (1) encourage programmatic and comment, FDA is issuing this guidance USC 3501–3520). The collections of interdisciplinary approaches to cancer as a final document. As with any information addressed in the guidance communication research, and (2) guidance, however, you may submit document have been approved by OMB accelerate development of innovative comments at any time. in accordance with the PRA under the health communication models, theories, regulations governing premarket and research strategies in cancer II. Significance of Guidance approval applications (21 CFR part 814, prevention, control, and care. HINTS II. This guidance is being issued OMB control number 0910–0231). The scheduled to commence in early 2005, consistent with FDA’s good guidance labeling provisions addressed in the will preserve the methodological practices regulation (21 CFR 10.115). guidance have been approved by OMB integrity of the first cycle of HINTS by The guidance represents the agency’s under the PRA, OMB control number using the telephone as the primary current thinking on PMAs for 0910–0485. mode of data collection as well as

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retaining approximately 50% of the about cancer prevention, detection, 10,389; Estimated Number of Responses questionnaire content. In addition, diagnosis, treatment, and survivorship; per Respondent: 1; Average Burden HINTS II will experiment with and (4) to identify research gaps and Hours per Response: .37; and Estimated alternative modes of data collection (i.e., guide decisions about NCI’s research Total Annual Burden Hours Requested: the Internet). Data will be used (1) to efforts in health promotion and health 3,836. The annualized cost to understand individuals’ sources of and communication. Frequency of response: respondents is estimated at $38,360. access to cancer-related information; (2) One-time. Affected public: Individuals. There are no Capital Costs to report. to measure progress in improving cancer Type of Respondents: U.S. Adults, Pilot There are no Operating or Maintenance knowledge and communication to the Survey, Screeners and Interview. The Costs to report. general public; (3) to develop annual reporting burden is as follows: appropriate messages for the public Estimated Number of Respondents:

Estimated num- Type of respondent ber of respond- Frequency of Average hours Annual hour ents response per response burden

Pilot Survey ...... 150 1 .4167 63 HINTS II Screener ...... 10,239 1 .0833 854 HINTS II Interview* ...... 7,004 1 .4167 2,919

Totals ...... 3,836 *HINTS II interview respondents are a subset of the screener respondents (N = 10,389).

Request For Comments: Written DEPARTMENT OF HEALTH AND PHS seeks a commercial developer for comments and/or suggestions from the HUMAN SERVICES the following software database query public and affected agencies are invited tool: A data-mining tool (software based on one or more of the following points: National Institutes of Health query generator) that provides a script (1) Whether the proposed collection of that identifies an isolated protein by information is necessary for the Government-Owned Inventions; using physical properties of the protein proposed performance of the functions Availability for Licensing and submitting the query into a protein of the agency, including whether the AGENCY: National Institutes of Health, database (e.g., SWISS–PROT). The information shall have practical utility; Public Health Service, DHHS. inventors identified that by combining (2) The accuracy of the estimate of the an accurate determination of the ratio of ACTION: Notice. burden of the proposed collection of at least one amino acid per molecule information including the validity of the SUMMARY: The inventions listed below and at least one physical parameter of methodology and assumptions used; (3) are owned by an agency of the U.S. the protein; an accurate and unique Ways to enhance the quality, utility, and Government and are available for match can be made by the query results. clarity of the information to be licensing in the U.S. in accordance with Parameters include the ratios of amino collected; and (4) Ways to minimize the 35 U.S.C. 207 to achieve expeditious acids to others (e.g., C/F, W/C, C/Y etc.), burden of the collection of information commercialization of results of the molecular weight, the ratio of on those who are to respond, including federally-funded research and positively to negatively charged the use of appropriate automated, development. Foreign patent moieties, and/or the isoelectric point. electronic, mechanical, or other applications are filed on selected technological collection techniques or Bromotyrosine-Derived Inhibitors of inventions to extend market coverage Mycothiol-S-Conjugate Amidase other forms of information technology. for companies and may also be available FOR FURTHER INFORMATION CONTACT: To for licensing. Carole A. Bewley et al. (NIDDK) request more information on the ADDRESSES: Licensing information and proposed project or to obtain a copy of U.S. Provisional Application No. 60/ copies of the U.S. patent applications 395,219 filed 10 Jul 2002 (DHHS the data collection plans and listed below may be obtained by writing instruments, contact Bradford W. Hesse, Reference No. E–196–2002/0–US– to the indicated licensing contact at the 01); PCT Application No. PCT/ Ph.D., Project Officer, National Cancer Office of Technology Transfer, National Institute, NIH, EPN 4068, 6130 US03/21456 filed 09 Jul 2003, Institutes of Health, 6011 Executive which published as WO 04/004659 Executive Boulevard MSC 7365, Boulevard, Suite 325, Rockville, Bethesda, Maryland 20892–7365, or call on 15 Jan 2004 (DHHS Reference Maryland 20852–3804; telephone: 301/ No. E–196–2002/0–PCT–02) non-toll-free number (301) 594–9904, or 496–7057; fax: 301/402–0220. A signed FAX your request to (301) 480–2198, or Confidential Disclosure Agreement will Licensing Contact: Michael Ambrose; E-mail your request, including your be required to receive copies of the 301/594–6565; [email protected]. address, to [email protected]. patent applications. Mycobacterium tuberculosis has Comments Due Date: Comments reemerged as a leading cause of death by regarding this information collection are Query Tool for Accurate Protein an infectious agent, especially among best assured of having their full effect if Identification populations that are received within 30–days of this notice. Rodney L. Levine (NHLBI) immunocompromised. With this Dated: April 1, 2004. U.S. Patent Application No. 10/446,865 increase in the rate of infection there Rachelle Ragland-Greene, filed 29 May 2003 (DHHS Reference has also been an increase in the number OMB Clearance Liaison, National Cancel No. E–306–2002/0–US–01) of drug resistant strains, making Institute, National Institutes of health. Licensing Contact: Michael treatment of such infections more [FR Doc. 04–8270 Filed 4–12–04; 8:45 am] Shmilovich; 301/435–5019; difficult. As such, the development of BILLING CODE 4140–01–M [email protected]. new antituberculars with novel modes

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of action is paramount in the fight The invention is a device for (ACD) working group report from the Blue against such infections. occluding the lumen of a hollow organ, Ribbon Panel on Conflict of Interest. The current invention uses the vessel or aneurysm by delivering radio Place: National Institutes of Health, finding of two mycothiol-related Building 31, Conference Room 6, 9000 frequency energy to its inner wall. The Rockville Pike, Bethesda, MD 20892. amidases that are unique to apparatus uses specialized electrodes Contact Person: Shelly Pollard, ACD actinomycetes and thus share no that contact the walls of the organ to Coordinator, National Institutes of Health, homology to eukaryotic enzymes thus substantially conform to the inner 9000 Rockville Pike, Building, 2 Room BE15, reducing potential side effects for new surface. RF energy is then applied to the Bethesda, MD 20892, (301) 496–0959. therapeutics. These amidases are novel electrode at any of a broad range of Any interested person may file written targets for new therapeutics and classes desired frequencies for selected times at comments with the committee by forwarding of antimycobacterials. This invention power levels of from 20 to 200 watts. the statement to the Contact Person listed in describes a series of synthetic this notice. The statement should include the Delivery of RF energy may be regulated name, address, telephone number and when bromotyrosine-containing analogs that by monitoring temperature, tissue applicable, the business or professional exhibit amidase inhibition and thus impedance or other parameters at or affiliation of the interested person. have potential for therapeutic near the site of the electrode. A development. In the interest of security, NIH has temperature sensor located near the instituted stringent procedures for This research has been described, in electrode allows microprocessor-based part, in: GM Nicholas et al., Bioorg. entrance into the building by non- control of the power delivered to the government employees. Persons without Med. Chem. Lett. (2002) 12:2487–2490; electrode site as a function of tissue B Fetterolf and CA Bewley, Bioorg. Med. a government I.D. will need to show a temperature. The device has photo I.D. and sign-in at the security Chem. Lett. (Submitted, March 26, applications in therapeutic thrombosis 2004). desk upon entering the building. of an aneurysm, stopping blood flow to Information is also available on the Radio Frequency Cauterization Biopsy a tumor or bleeding vessel, or reducing Institute’s/Center’s home page: http:// stricture or stenosis in, for example, a Bradford J. Wood and Christan www.nih.gov/about/director/acd.htm, Pavlovich (CC) bronchus, esophagus, intestine segment where an agenda and any additional U.S. Patent Application No. 10/ or a blood vessel. The invention also information for the meeting will be 274,074 filed 17 Oct 2002 (DHHS may be useful in reducing stenosis in a posted when available. coronary artery or to reduce a restenotic Reference No. E–207–2001/1–US– (Catalogue of Federal Domestic Assistance 02) lesion from intimal hyperplasia that Program Nos. 93.14, Intramural Research may occur after angioplasty. Licensing Contact: Michael Training Award; 93.22, Clinical Research Shmilovich; 301/435–5019; Dated: April 4, 2004. Loan Repayment Program for Individuals [email protected]. Steven M. Ferguson, from Disadvantaged Backgrounds; 93.232, The invention is a method and Loan Repayment Program for Research Director, Division of Technology Development Generally; 93.39, Academic Research apparatus for using radio frequency (RF) and Transfer, Office of Technology Transfer, Enhancement Award; 93.936, NIH Acquired energy to cauterize the needle track after National Institutes of Health. Immunodeficiency Syndrome Research Loan percutaneous image-guided needle [FR Doc. 04–8268 Filed 4–12–04; 8:45 am] Repayment Program; 93.187, Undergraduate biopsy. The invention is designed to BILLING CODE 4140–01–P Scholarship Program for Individuals from limit the risks of bleeding and needle Disadvantaged Backgrounds, National track seeding that are inherent risks of Institutes of Health, HHS.) any needle biopsy. The device uses a DEPARTMENT OF HEALTH AND Dated: April 6, 2004. coaxial biopsy arrangement with the HUMAN SERVICES LaVerne Y. Stringfield, outer needle coated with a non- Director, Office of Federal Advisory conducting polymer that insulates the National Institutes of Health Committee Policy. needle shaft and the tissue immediately [FR Doc. 04–8276 Filed 4–12–04; 8:45 am] Office of the Director, National in contact with the shaft. As the needle BILLING CODE 4140–01–M Institutes of Health; Notice of Meeting is pulled back from the organ or tumor target, RF energy is applied to an Pursuant to section 10(a) of the exposed end portion of the probe, Federal Advisory Committee Act, as DEPARTMENT OF HEALTH AND causing cauterization and coagulation of amended (5 U.S.C. Appendix 2), notice HUMAN SERVICES the tissue immediately adjacent to the is hereby given of a meeting of the National Institutes of Health needle track. Modular insertions could Advisory Committee to the Director, plug the needle into any cauterization or NIH. Office of the Director, National radiofrequency generator. A variation on The meeting will be open to the Institutes of Health; Notice of Meeting the device could be used to limit public, with attendance limited to space bleeding after catheter placement into available. Individuals who plan to Pursuant to section 10(a) of the organs, such as for nephrostomy, biliary attend and need special assistance, such Federal Advisory Committee Act, as drainage, or transhepatic islet cell as sign language interpretation or other amended (5 U.S.C. Appendix 2), notice transplantation. reasonable accommodations, should is hereby given of a meeting of the Director’s Council of Public Endoluminal Radiofrequency notify the Contact Person listed below in advance of the meeting. Representatives. Cauterization System The meeting will be open to the Bradford J. Wood (CC) Name of Committee: Advisory Committee public, with attendance limited to space U.S. Patent 6,676,657 issued 13 Jan to the Director, NIH. available. Individuals who plan to 2004 (DHHS Reference No.E–244– Date: May 6, 2004. Time: 8:30 a.m. to 5 p.m. attend and need special assistance, such 2000/1–US–01) Agenda: Topics proposed for discussion as sign language interpretation or other Licensing Contact: Michael include Office of the Director updates, reasonable accommodations, should Shmilovich; 301/435–5019; Institute and Center Director presentations, notify the Contact Person listed below [email protected]. and an Advisory Committee to the Director in advance of the meeting.

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Name of Committee: Director’s Council of DEPARTMENT OF HEALTH AND is hereby given of the following Public Representatives. HUMAN SERVICES meeting. Date: April 29, 2004. The meeting will be closed to the Time: 8:30 a.m. to adjournment. National Institutes of Health public in accordance with the Agenda: Among the topics proposed for discussion are: (1) The role of public trust in provisions set forth in sections National Cancer Institute; Notice of 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., building communities of research; (2) COPR Closed Meeting public trust efforts; (3) NIH public trust as amended. The grant applications and initiative; (4) Presentation of COPR Report on Pursuant to section 10(d) of the the discussions could disclose Enhancing Public Input and Transparency in Federal Advisory Committee Act, as confidential trade secrets or commercial the Research Priority Setting Process at the amended (5 U.S.C. Appendix 2), notice property such as patentable material, NIH; and (5) Public comment. is hereby given of the following and personal information concerning Place: National Institutes of Health, individuals associated with the grant Building 31, Conference Room 6, 9000 meeting. Rockville Pike, Bethesda, MD 20852. The meeting will be closed to the applications, the disclosure of which Contact Person: Jennifer E. Gorman Vetter, public in accordance with the would constitute a clearly unwarranted NIH Public Liaison/COPR Coordinator, Office provisions set forth in sections invasion of personal privacy. of Communications and Public Liaison, 552b(c)(4) and 552b(c)(6), title 5 U.S.C., Name of Committee: National Center for Office of the Director, National Institutes of as amended. The contract proposals and Research Resources Special Emphasis Panel Health, 9000 Rockville Pike, Building 1, the discussions could disclose Clinical Research. Room 344, Bethesda, MD 20892. (301) 435– confidential trade secrets or commercial Date: May 3, 2004. 4448; [email protected]. property such as patentable material, Time: 8 a.m. to Adjournment. Any member of the public interested in Agenda: To review and evaluate grant presenting oral comments to the committee and personal information concerning individuals associated with the contract applications. may notify the Contact Person listed on this Place: Office of Review, One Democracy notice at least 10 days in advance of the proposals, the disclosure of which Plaza, 6701 Democracy Blvd., Bethesda, MD meeting. Interested individuals and would constitute a clearly unwarranted 20892, (Telephone Conference Call). representatives of organizations may submit invasion of personal privacy. Contact Person: Mohan Viswanathan, PhD, a letter of intent, a brief description of the Deputy Director, Office of Review, NCRR, organization represented, and a short Name of Committee: National Cancer Institute Special Emphasis Panel, Novel National Institutes of Health, 6701 description of the oral presentation. Only one Democracy Blvd., Room 1084, MSC 4874, 1 representative of an organization may be Technologies for in Vivo Imaging (SBIR/ STTR). Democracy Plaza, Bethesda, MD 20892–4874, allowed to present oral comments and if (301) 435–0829, [email protected]. accepted by the committee, presentations Date: April 29–30, 2004. may be limited to five minutes. Both printed Time: 8 a.m. to 6 p.m. (Catalogue of Federal Domestic Assistance and electronic copies are requested for the Agenda: To review and evaluate grant Program Nos. 93.306, Comparative Medicine; applications. record. In addition, any interested person 93.333, Clinical Research; 93.371, Biomedical Place: Holiday Inn Select Bethesda, 8120 may file written comments with the Technology; 93.389, Research Infrastructure, Wisconsin Ave, Bethesda, MD 20814. committee by forwarding their statement to 93.306, 93.333, National Institutes of Health, Contact Person: Joyce C. Pegues, PhD, the Contact Person listed on this notice. The HHS) Scientific Review Administrator, Special statement should include the name, address, Review and Resources Branch, Division of Dated: April 6, 2004. telephone number and when applicable, the Extramural Activities, National Cancer business or professional affiliation of the LaVerne Y. Stringfield, Institute, 6116 Executive Boulevard, Room interested persons. Director, Office of Federal Advisory 7149, Bethesda, MD 20892. 301/594–1286; Committee Policy. In the interest of security, NIH has [email protected]. instituted stringent procedures for entrance [FR Doc. 04–8274 Filed 4–12–04; 8:45 am] (Catalogue of Federal Domestic Assistance into the building by non-government BILLING CODE 4140–01–M employees. Persons without a government Program Nos. 93.392, Cancer Construction; I.D. will need to show a photo I.D. and sign- 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and in at the security desk upon entering the DEPARTMENT OF HEALTH AND building. Diagnosis Research; 93.395, Cancer Information is also available on the Treatment Research; 93.396, Cancer Biology HUMAN SERVICES Institute’s/Center’s home page: www.nih.gov/ Research; 93.397, Cancer Centers Support; about/publicliaison/index.html, where an 93.398, Cancer Research Manpower; 93.399, National Institutes of Health agenda and any additional information for Cancer Control, National Institutes of Health, the meeting will be posted when available. HHS.) National Institute of Allergy and Infectious Diseases; Notice of Closed Dated: April 6, 2004. (Catalogue of Federal Domestic Assistance Meeting Program Nos. 93.14, Intramural Research LaVerne Y. Stringfield, Training Award; 93.22, Clinical Research Director, Office of Federal Advisory Pursuant to section 10(a) of the Loan Repayment Program for Individuals Committee Policy. Federal Advisory Committee Act, as from Disadvantaged Backgrounds; 93.232, [FR Doc. 04–8280 Filed 4–12–04; 8:45 am] amended (5 U.S.C. Appendix 2), notice Loan Repayment Program for Research Generally; 93.39, Academic Research BILLING CODE 4140–01–M is hereby given of a meeting of the AIDS Enhancement Award; 93.936, NIH Acquired Research Advisory Committee, NIAID. Immunodeficiency Syndrome Research Loan The meeting will be open to the Repayment Program; 93.187, Undergraduate DEPARTMENT OF HEALTH AND public, with attendance limited to space Scholarship Program for Individuals from HUMAN SERVICES available. Individuals who plan to Disadvantaged Backgrounds, National attend and need special assistance, such Institutes of Health, HHS.) National Institutes of Health as sign language interpretation or other Dated: April 6, 2004. reasonable accommodations, should National Center for Research LaVerne Y. Stringfield, notify the Contact Person listed below Resources; Notice of Closed Meeting Director, Office of Federal Advisory in advance of the meeting. Committee Policy. Pursuant to section 10(d) of the Name of Committee: AIDS Research [FR Doc. 04–8281 Filed 4–12–04; 8:45 am] Federal Advisory Committee Act, as Advisory Committee, NIAID. BILLING CODE 4140–01–M amended (5 U.S.C. Appendix 2), notice Date: May 24, 2004.

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Time: 1 p.m. to 8 p.m. property such as patentable material, Rockledge Drive, MSC 7610, Rockville, Agenda: Director’s Report and and personal information concerning MD 20892–7610, 301–496–7291. Restructuring of the DAIDS Clinical Research individuals associated with the grant Networks. Name of Committee: National Place: National Institutes of Health, applications, the disclosure of which Advisory Allergy and Infectious Natcher Building, 45 Center Drive, would constitute a clearly unwarranted Diseases Council. Conference Room E1/E2, Bethesda, MD invasion of personal privacy. Date: May 24, 2004. 20892. Name of Committee: National Advisory Open: 10:30 a.m. to 11:40 a.m. Contact Person: Rona L. Siskind, Executive Allergy and Infectious Diseases Council Agenda: A report from the Institute Secretary, AIDS Research Advisory Acquired Immunodeficiency Syndrome Director and the Director of the Vaccine Committee, Division of AIDS, NIAID/NIH, Subcommittee. Research Center. Room 4139, 6700–B Rockledge Drive, MSC Date: May 24, 2004. Place: National Institutes of Health, 7610, Bethesda, MD 20892–7601, 301–435– Closed: 8:30 a.m. to 10:15 a.m. 3732. Natcher Building, 45 Center Drive, E1/ Agenda: To review and evaluate grant E2, Bethesda, MD 20892. Any interested person may file written applications and/or proposals. comments with the committee by forwarding Place: National Institutes of Health, Closed: 11:40 a.m. to 12 p.m. the statement to the Contact Person listed on Natcher Building, 45 Center Drive, Agenda: To review and evaluate grant this notice. The statement should include the Conference Room A, Bethesda, MD 20892. applications. name, address, telephone number and when Open: 1 p.m. to Adjournment. Place: National Institutes of Health, applicable, the business or professional Agenda: Program advisory discussions and Natcher Building, 45 Center Drive, E1/ affiliation of the interested person. presentations. E2, Bethesda, MD 20892. In the interest of security, NIH has Place: National Institutes of Health, Contact Person: John J McGowan, instituted stringent procedures for entrance Natcher Building, 45 Center Drive, into the building by non-government PhD, Director, Division of Extramural Conference Room E/1E2, Bethesda, MD Activities, NIAID, Room 2142, 6700-B employees. Persons without a government 20892. I.D. will need to show a photo I.D. and sign- Contact Person: John J McGowan, PhD, Rockledge Drive, MSC 7610, Rockville, in at the security desk upon entering the Director, Division of Extramural Activities, MD 20892–7610, 301–496–7291. building. NIAID, Room 2142, 6700–B Rockledge Drive, Any interested person may file MSC 7610, Rockville, MD 20892–7610, 301– written comments with the committee (Catalogue of Federal Domestic Assistance 496–7291. by forwarding the statement to the Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Name of Committee: National Advisory Contact Person listed on this notice. The Microbiology and Infectious Diseases Allergy and Infectious Diseases Council statement should include the name, Research, National Institutes of Health, HHS) Microbiology and Infectious Diseases address, telephone number and when Subcommittee. Dated: April 6, 2004. applicable, the business or professional Date: May 24, 2004. affiliation of the interested person. LaVerne Y. Stringfield, Closed: 8:30 a.m. to 10:15 a.m. In the interest of security, NIH has Director, Office of Federal Advisory Agenda: To review and evaluate grant Committee Policy. applications and/or proposals. instituted stringent procedures for entrance into the building by [FR Doc. 04–8271 Filed 4–12–04; 8:45 am] Place: National Institutes of Health, Natcher Building, 45 Center Drive, nongovernmental employees. Persons BILLING CODE 4140–01–M Conference Room F1/F2, Bethesda, MD without a government I.D. will need to 20892. show a photo I.D. and sign-in at the Open: 1 p.m. to adjournment. DEPARTMENT OF HEALTH AND security desk upon entering the Agenda: Program advisory discussions and building. Information is also available HUMAN SERVICES presentations. Place: National Institutes of Health, on the Institute’s/Center’s home page: National Institutes of Health Natcher Building, 45 Center Drive, http://www.niaid.nih.gov/facts.htm, Conference Room F1/F2, Bethesda, MD where an agenda and any additional National Institute of Allergy and 20892. information for the meting will be Infectious Diseases; Notice of Contact Person: John J McGowan, PhD, posted when available. Director, Division of Extramural Activities, Meetings (Catalogue of Federal Domestic Assistance NIAID, Room 2142, 6700–B Rockledge Drive, Program Nos. 93.855, Allergy, Immunology, Pursuant to section 10(d) of the MSC 7610, Rockville, MD 20892–7610, 301– and Transplantation Research; 93.856, Federal Advisory Committee Act, as 496–7291. amended (5 U.S.C. Appendix 2), notice Microbiology and Infectious Diseases Name of Committee: National Advisory Research, National Institutes of Health, HHS) is hereby given of meetings of the Allergy and Infectious Diseases Council Dated: April 6, 2004. National Advisory Allergy and Allergy, Immunology and Transplantation Infectious Diseases Council. Subcommittee. LaVerne Y. Stringfield, The meetings will be open to the Date: May 24, 2004. Director, Office of Federal Advisory public as indicated below, with Closed: 8:30 a.m. to 10:15 a.m. Committee Policy. attendance limited to space available. Agenda: To review and evaluate grant [FR Doc. 04–8272 Filed 4–12–04; 8:45 am] applications. Individuals who plan to attend and BILLING CODE 4140–01–M Place: National Institutes of Health, need special assistance, such as sign Natcher Building, 45 Center Drive, language interpretation or other Conference Room D, Bethesda, MD 20892. DEPARTMENT OF HEALTH AND reasonable accommodations, should Open: 1 p.m. to adjournment. notify the Contact Person listed below Agenda: Program advisory discussion HUMAN SERVICES in advance of the meeting. and presentations. National Institutes of Health The meetings will be closed to the Place: National Institutes of Health, public in accordance with the Natcher Building, 45 Center Drive, National Institute of Allergy and provisions set forth in sections Conference Room D, Bethesda, MD Infectious Diseases; Notice of Closed 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 20892. Meetings as amended. The grant applications and Contact Person: John J McGowan, the discussions could disclose PhD, Director, Division of Extramural Pursuant to section 10(d) of the confidential trade secrets or commercial Activities, NIAID, Room 2142, 6700-B Federal Advisory Committee Act, as

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amended (5 U.S.C. Appendix 2), notice DEPARTMENT OF HEALTH AND a government I.D. will need to show a is hereby given of the following HUMAN SERVICES photo I.D. and sign-in at the security meetings. desk upon entering the building. National Institutes of Health Information is also available on the The meetings will be closed to the Institute’s/Center’s home page; public in accordance with the National Institute on Deafness and www.nidcd.nih.gov/about/councils/ provisions set forth in sections Other Communication Disorders; ndcdac/ndcdac.htm, where an agenda 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Notice of Meeting and any additional information for the as amended. The contract proposals and meeting will be posted when available. the discussions could disclose Pursuant to section 10(d) of the confidential trade secrets or commercial Federal Advisory Committee Act, as (Catalogue of Federal Domestic Assistance amended (5 U.S.C. Appendix 2), notice Program Nos. 93.173, Biological Research property such as patentable material, Related to Deafness and Communicative and personal information concerning is hereby given of a meeting of the National Deafness and Other Disorders, National Institutes of Health, individuals associated with the contract HHS.) Communication Disorders Advisory proposals, the disclosure of which Dated: April 6, 2004. Council. would constitute a clearly unwarranted The meeting will be open to the LaVerne Y. Stringfield, invasion of personal privacy. public as indicated below, with Director, Office of Federal Advisory Committee Policy. Name of Committee: National Institute of attendance limited to space available. Allergy and Infectious Diseases Special Individuals who plan to attend and [FR Doc. 04–8277 Filed 4–12–04; 8:45 am] Emphasis Panel Clinical Products need special assistance, such as sign BILLING CODE 4146–01–M Distribution Center. language interpretation or other Date: May 4, 2004. reasonable accommodations, should DEPARTMENT OF HEALTH AND Time: 8:30 a.m. to 11:30 a.m. notify the Contact Person listed below HUMAN SERVICES Agenda: To review and evaluate contract in advance of the meeting. proposals. The meetings will be closed to the National Institutes of Health Place: Holiday Inn Chevy Chase, 5520 public in accordance with the Wisconsin Avenue, Terrace Room, Bethesda, provisions set forth in sections National Institute on Deafness and MD 20815. 552b(c)(4) and 552b(c)(6), title 5 U.S.C., Other Communication Disorders; Contact Person: Tracy A. Shahan, PhD, as amended. The grant applications and Notice of Closed Meeting Scientific Review Administrator, Scientific the discussions could disclose Review Program, Division of Extramural confidential trade secrets or commercial Pursuant to section 10(d) of the Activities, National Institutes of Health/ property such as patentable material, Federal Advisory Committee Act, as NIAID, 6700B Rockledge Drive, MSC 7616, and personal information concerning amended (5 U.S.C. Appendix 2), notice Bethesda, MD 20892–7616, 301–451–2606, individuals associated with the grant is hereby given of the following [email protected]. applications, the disclosure of which meeting. Name of Committee: National Institute of would constitute a clearly unwarranted The meeting will be closed to the Allergy and Infectious Diseases Special invasion of personal privacy. public in accordance with the Emphasis Panel Immune Tolerance Network- provisions set forth in sections Name of Committee: National Deafness and Clinical Site Monitoring Group. 552b(c)(4) and 552b(c)(6), title 5 U.S.C., Other Communication Disorders Advisory Date: May 4, 2004. as amended. The grant applications and Council. the discussions could disclose Time: 11:30 a.m. to 4 p.m. Date: May 21, 2004. Agenda: To review and evaluate contract Open: 8:30 a.m. to 11:30 a.m. confidential trade secrets or commercial proposals. Agenda: Staff reports on divisional, property such as patentable material, Place: Holiday Inn Chevy Chase, 5520 programmatic and special activities. and personal information concerning Wisconsin Avenue, Terrace Room, Bethesda, Place: National Institutes of Health, individuals associated with the grant MD 20815. Building 31, 31 Center Drive, Conference applications, the disclosure of which Contract Person: Tracy A. Shahan, PhD, Room 6, Bethesda, MD 20892. would constitute a clearly unwarranted Scientific Review Administrator, Scientific Closed: 11:30 a.m. to adjournment. invasion of personal privacy. Review Program, Division of Extramural Agenda: To review and evaluate grant applications. Name of Committee: National Institute on Activities, National Institutes of Health/ Place: National Institutes of Health, Deafness and Other Communications NIAID, 6700B Rockledge Drive, MSC 7616, Building 31, 31 Center Drive, Conference Disorders Special Emphasis Panel, Health Bethesda, MD 20892–7616, 301–451–2606, Room 6, Bethesda, MD 20892. Communication. [email protected]. Contact Person: Craig A. Jordan, PhD, Date: May 19, 2004. Director, Division of Extramural Activities, Time: 1 p.m. to 4 p.m. (Catalogue of Federal Domestic Assistance Agenda: To review and evaluate grant Program Nos. 93.855, Allergy, Immunology, NIDCD, NIH, Executive Plaza South, Room 400C, 6120 Executive Blvd., Bethesda, MD applications. and Transplantation Research; 93.856, 20892–7180. 301–496–8693, Place: National Institutes of Health, 6120 Microbiology and Infectious Diseases [email protected]. Executive Blvd., Rockville, MD 20852. Research, National Institutes of Health, HHS) Any interested person may file written (Telephone conference call.) Contact Person: Sheo Singh, PhD, Dated: April 6, 2004. comments with the committee by forwarding Scientific Review Administrator, Scientific the statement to the Contact Person listed on LaVerne Y. Stringfield, Review Branch, Division of Extramural this notice. The statement should include the Activities, Executive Plaza South, Room Director, Office of Federal Advisory name, address, telephone number and when 400C, 6120 Executive Blvd., Bethesda, MD Committee Policy. applicable, the business or professional 20892. 301–496–8683. [FR Doc. 04–8273 Filed 4–12–04; 8:45 am] affiliation of the interested person. BILLING CODE 4140–01–M (Catalogue of Federal Domestic Assistance In the interest of security, NIH has Program Nos. 93.173, Biological Research instituted stringent procedures for Related to Deafness and Communicative entrance into the building by non- Disorders, National Institutes of Health, government employees. Persons without HHS.)

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Dated: April 6, 2004. DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND LaVerne Y. Stringfield, HUMAN SERVICES HUMAN SERVICES Director, Office of Federal Advisory Committee Policy. National Institutes of Health National Institutes of Health [FR Doc. 04–8279 Filed 4–12–04; 8:45 am] National Institute of Environmental Center for Scientific Review; Notice of BILLING CODE 4140–01–M Health Sciences; Notice of Closed Meeting Meeting Pursuant to section 10(a) of the DEPARTMENT OF HEALTH AND Pursuant to section 10(d) of the Federal Advisory Committee Act, as HUMAN SERVICES Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice National Institutes of Health amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the is hereby given of the following Center for Scientific Review Advisory National Institutes of Neurological meeting. Committee. Disorders and Stroke; Notice of Closed The meeting will be closed to the The meeting will be open to the Meeting. public in accordance with the public, with attendance limited to space provisions set forth in sections available. Individuals who plan to Pursuant to section 10(d) of the 552b(c)(4) and 552b(c)(6), Title 5, as attend and need special assistance, such Federal Advisory Committee Act, as amended. The contract proposals and as sign language interpretation or other amended (5 U.S.C. Appendix 2), notice the discussions could disclose reasonable accommodations, should is hereby given of the following confidential trade secrets or commercial notify the Contact Person listed below meeting. property such as patentable material, in advance of the meeting. The meeting will be closed to the and personal information concerning Name of Committee: Center for Scientific public in accordance with the individuals associated with the contract Review Advisory Committee Workgroup. provisions set forth in sections proposals, the disclosure of which Date: May 17, 2004. 552b(c)(4) and 552b(c)(6), title 5 U.S.C., would constitute a clearly unwarranted Time: 8:30 a.m. to 5 p.m. as amended. The grant applications and invasion of personal privacy. Agenda: Discussion of activities to evaluate the discussions could disclose Name of Committee: National Institute of organization and function of the Center for confidential trade secrets or commercial Environmental Health Sciences Special Scientific Review Process. property such as patentable material, Emphasis Panel, Resequencing the Genome Place: Bethesda Marriott, 5151 Pooks Hill and personal information concerning Mouse Strains. Road, Bethesda, MD 20814. individuals associated with the grant Date: May 20, 2004. Contact Person: Mark Malik, PhD, applications, the disclosure of which Time: 9:30 a.m. to 3 p.m. Executive Secretary, Center for Scientific would constitute a clearly unwarranted Agenda: To review and evaluate contract Review, National Institutes of Health, 6701 invasion of personal privacy. proposals. Rockledge Drive, Room 3110, MSC 7776, Place: NIEHS/National Institutes of Health, Bethesda, MD 20892, (301) 594–6806, Name of Committee: National Institute of Building 4401, East Campus, 79 T.W. [email protected]. Neurological Disorders and Stroke Special Alexander Drive, 3446, Research Triangle Emphasis Panel, SNRP Review. Any interested person may file Park, NC 27709 (Telephone Conference Call). Date: April 12–16, 2004. written comments with the committee Contact Person: RoseAnne M. McGee, Time: 8 a.m. to 5 p.m. Associate Scientific Review Administrator, by forwarding the statement to the Agenda: To review and evaluate grant Scientific Review Branch, Office of Program Contact Person listed on this notice. The applications. Operations, Division of Extramural Research statement should include the name, Place: The Kaimana Beach Hotel, 2863 and Training, Nat. Inst. of Environmental address, telephone number and when Kalakaua Avenue, Honolulu, HI 96815. Health Sciences, P.O. Box 12233, MD EC–30, applicable, the business or professional Contact Person: Phillip F. Wiethorn, Research Triangle Park, NC 27709, 919/541– affiliation of the interested person. Scientific review Administrator, DHHS/NIH/ 0752. NINDS/DER/SRB, 6001 Executive Boulevard; Information is also available on the MSC 9529, Neuroscience Center; Room 3203, (Catalogue of Federal Domestic Assistance Institute’s/Center’s home page: http:// Bethesda, MD 20892–9529. (301) 496–5388; Program Nos. 93.115, Biometry and Risk www.csr.nih.gov/drgac.htm, where an [email protected]. Estimation—Health Risks from agenda and any additional information This notice is being published less than 15 Environmental Exposures; 93.142, NIEHS for the meeting will be posted when days prior to the meeting due to the timing Hazardous Waste Worker Health and Safety available. limitations imposed by the review and Training; 93.143, NIEHS Superfund (Catalogue of Federal Domestic Assistance funding cycle. Hazardous Substances—Basic Research and Program Nos. 93.306, Comparative Medicine; Education; 93.894, Resources and Manpower (Catalogue of Federal Domestic Assistance 93.333, Clinical Research, 93.306, 93.333, Development in the Environmental Health Program Nos. 93.853, Clinical Research 93.337, 93.393–93.396, 93.837–93.844, Sciences; 93.113, Biological Response to Related to Neurological Disorders; 93.854, 93.846–93.878, 93.892, 93.893, National Environmental Health Hazards; 93.114, Biological Basis Research in the Institutes of Health, HHS) Applied Toxicological Research and Testing, Neurosciences, National Institutes of Health, National Institutes of Health, HHS) Dated: April 6, 2004. HHS.) Dated: April 6, 2004. LaVerne Y. Stringfield, Dated: April 6, 2004. LaVerne Y. Stringfield, Director, Office of Federal Advisory LaVerne Y. Stringfield, Director, Office of Federal Advisory Committee Policy. Director, Office of Federal Advisory Committee Policy. [FR Doc. 04–8275 Filed 4–12–04; 8:45 am] Committee Policy. [FR Doc. 04–8284 Filed 4–12–04; 8:45 am] BILLING CODE 4140–01–M [FR Doc. 04–8282 Filed 4–12–04; 8:45 am] BILLING CODE 4140–01–M BILLING CODE 4140–01–M

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DEPARTMENT OF HEALTH AND Place: National Institutes of Health, 6701 Name of Committee: Center for Scientific HUMAN SERVICES Rockledge Drive, Bethesda, MD 20892. Review Special Emphasis Panel, (Telephone conference call.) Cardiovascular Signaling and Transportation. National Institutes of Health Contact Person: Cathleen L. Cooper, PhD, Date: April 8, 2004. Scientific Review Administrator, Center for Time: 1:30 p.m. to 3 p.m. Center for Scientific Review; Notice of Scientific Review, National Institutes of Agenda: To review and evaluate grant Closed Meetings Health, Department of Health and Human applications. Services, 6701 Rockledge Drive, Room 4208, Place: National Institutes of Health, 6701 Pursuant to section 10(d) of the MSC 7812, Bethesda, MD 20892. 301–435– Rockledge Drive, Bethesda, MD 20892 Federal Advisory Committee Act, as 3566; [email protected]. (Telephone Conference Call). amended (5 U.S.C. Appendix 2), notice This notice is being published less than 15 Contact Person: Larry Pinkus, PhD, days prior to the meeting due to the timing Scientific Review Administrator, Center for is hereby given of the following Scientific Review, National Institutes of meetings. limitations imposed by the review and funding cycle. Health, 6701 Rockledge Drive, Room 4132, The meetings will be closed to the MSC 7802, Bethesda, MD 20892, (301) 435– public in accordance with the Name of Committee: Center for Scientific 1214, [email protected]. provisions set forth in sections Review Special Emphasis Panel, Fluorescent This notice is being published less than 15 552b(c)(4) and 552b(c)(6), title 5 U.S.C., Molecular Rotor for Blood Plasma days prior to the meeting due to the timing Viscometry. as amended. The grant applications and limitations imposed by the review and Date: April 23, 2004. funding cycle. the discussions could disclose Time: 10 a.m. to 11 a.m. Name of Committee: Center for Scientific confidential trade secrets or commercial Agenda: To review and evaluate grant Review Special Emphasis Panel, ZRG 1 property such as patentable material, applications. BBHP–H (28) Minority/Disability Predoctoral Place: National Institutes of Health, 6701 and personal information concerning Fellowship Reviews. individuals associated with the grant Rockledge Drive, Bethesda, MD 20892. Date: April 9, 2004. applications, the disclosure of which (Telephone conference call.) Time: 11 a.m. to 1 p.m. would constitute a clearly unwarranted Contact Person: Robert T. Su, PhD, Agenda: To review and evaluate grant invasion of personal privacy. Scientific Review Administrator, Center for applications. Scientific Review, National Institutes of Place: National Institutes of Health, 6701 Name of Committee: Center for Scientific Health, 6701 Rockledge Drive, Room 4134, Rockledge Drive, Bethesda, MD 20892 Review Special Emphasis Panel, Visual MSC 7802, Bethesda, MD 20892. 301 435– (Telephone Conference Call). Systems SBIR. 1195. Contact Person: Mary Sue Krause, MED, Date: April 6, 2004. Scientific Review Administrator, Center for Time: 4 p.m. to 5 p.m. (Catalogue of Federal Domestic Assistance Scientific Review, National Institutes of Agenda: To review and evaluate grant Program Nos. 93.306, Comparative Medicine; Health, 6701 Rockledge Drive, Room 3182, applications. 93.333, Clinical Research, 93.306, 93.333, MSC 7848, Bethesda, MD 20892, (301) 435– Place: National Institutes of Health, 6701 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National 0902, [email protected]. Rockledge Drive, Bethesda, MD 20892. This notice is being published less than 15 (Telephone conference call.) Institutes of Health, HHS.) Dated: April 6, 2004. days prior to the meeting due to the timing Contact Person: Jerome R. Wujek, PhD, limitations imposed by the review and Scientific Review Administrator, Center for LaVerne Y. Stringfield, funding cycle. Scientific Review, National Institutes of Director, Office of Federal Advisory Name of Committee: Center for Scientific Health, 6701 Rockledge Drive, Room 5194, Committee Policy. MSC 7846, Bethesda, MD 20892. (301) 435– Review Special Emphasis Panel, [FR Doc. 04–8278 Filed 4–12–04; 8:45 am] 2507; [email protected]. Neurogenetics Special Emphasis Panel. This notice is being published less than 15 BILLING CODE 4140–01–M Date: April 20, 2004. days prior to the meeting due to the timing Time: 1 p.m. to 3 p.m. Agenda: To review and evaluate grant limitations imposed by the review and applications. funding cycle. DEPARTMENT OF HEALTH AND HUMAN SERVICES Place: National Institutes of Health, 6701 Name of Committee: Center for Scientific Rockledge Drive, Bethesda, MD 20892 Review Special Emphasis Panel, Cognitive National Institutes of Health (Telephone Conference Call). Neuroscience in Clinical Populations. Contact Person: Carole L. Jelsema, PhD, Date: April 7, 2004. Center for Scientific Review; Notice of Chief and Scientific Review Administrator, Time: 11 a.m. to 1 p.m. MDCN Scientific Review Group, Center for Agenda: To review and evaluate grant Closed Meetings Scientific Review Group, Center for Scientific applications. Review, National Institutes of Health, 6701 Place: National Institutes of Health, 6701 Pursuant to section 10(d) of the Rockledge Drive, Room 4146, MSC 7850, Rockledge Drive, Bethesda, MD 20892. Federal Advisory Committee Act, as Bethesda, MD 20892, (301) 435–1248, (Telephone conference call.) amended (5 U.S.C. Appendix 2), notice [email protected]. Contact Person: Michael A. Steinmetz, is hereby given of the following This notice is being published less than 15 PhD, Scientific Review Administrator, Center meetings. days prior to the meeting due to the timing for Scientific Review, National Institutes of limitations imposed by the review and Health, 6701 Rockledge Drive, Room 5172, The meetings will be closed to the funding cycle. MSC 7844, Bethesda, MD 20892. 301–435– public in accordance with the Name of Committee: Center for Scientific 1247; [email protected]. provisions set forth in sections Review Special Emphasis Panel, High This notice is being published less than 15 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Resolution Electron Microscopy. days prior to the meeting due to the timing as amended. The grant applications and Date: April 21–23, 2004. limitations imposed by the review and the discussions could disclose Time: 8 p.m. to 10 a.m. funding cycle. confidential trade secrets or commercial Agenda: To review and evaluate grant Name of Committee: Center for Scientific property such as patentable material, applications. Review Special Emphasis Panel, T Cell and personal information concerning Place: Swissotel Washington, The Biology. Watergate, 2650 Virginia Avenue, NW, Date: April 14, 2004. individuals associated with the grant Washington, DC 20037. Time: 12 p.m. to 2 p.m. applications, the disclosure of which Contact Person: Richard D. Rodewald, Agenda: To review and evaluate grant would constitute a clearly unwarranted PhD, Scientific Review Administrator, Center applications. invasion of personal privacy. for Scientific Review, National Institutes of

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Health, 6701 Rockledge Drive, Room 5142, relevant areas of science. The CERHR for maternal breast milk or cow’s milk. MSC 7840, Bethesda, MD 20892, (301) 435– invites the submission of public CERHR selected these substances for 1024, [email protected]. comments on any of these substances expert panel evaluation because of: (1) This notice is being published less than 15 and the nomination of scientists to serve The availability of numerous days prior to the meeting due to the timing limitations imposed by the review and on the expert panels for their evaluation reproductive and developmental studies funding cycle. (see below). These meetings are in laboratory animals and humans, (2) Name of Committee: Center for Scientific tentatively scheduled for 2004 and 2005 exposure information in infants and Review Special Emphasis Panel, Leukemia. although the exact dates and locations women of reproductive age, and (3) Date: April 22 2004. are not yet established. As plans are public concern for effects on infant or Time: 1 p.m. to 2:30 p.m. finalized, they will be announced in the child development. Agenda: To review and evaluate grant Federal Register and posted on the NTP Request for Public Comment on applications. Web site (http://ntp- Substances To Be Evaluated Place: National Institutes of Health, 6701 server.niehs.nih.gov). These expert Rockledge Drive, Bethesda, MD 20892 panel meetings will be open to the The CERHR invites input from the (Telephone Conference Call). public and other interested parties on Contact Person: Marcia Litwack, PhD, public with time scheduled for oral Scientific Review Administrator, Center for public comment. these substances, including toxicology Scientific Review, National Institutes of information from completed and Evaluation of Methylphenidate and ongoing studies, information on Health, 6701 Rockledge Drive, Room 6206,  MSC 7840, Bethesda, MD 20892, (301) 435– Adderall planned studies, and information about 1719, [email protected]. Methylphenidate (Ritalin , CAS RN: current production levels, human This notice is being published less than 15 113–45–1) and Adderall  exposure, use patterns, and days prior to the meeting due to the timing (amphetamine, CASRN: 300–62–9 and environmental occurrence. Information limitations imposed by the review and dextraamphetamine, CASRN: 51–64–9) and comments should be forwarded to funding cycle. are stimulants used to treat attention the CERHR at P.O. Box 12233, MD EC– (Catalogue of Federal Domestic Assistance deficit disorder with hyperactivity and 32, Research Triangle Park, NC 27709 Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, narcolepsy in children and adults. (mail), (919) 541–3455 (phone), (919) 93.337, 93.393–93.396, 93.837–93.844, Methylphenidate is also used off-label 316–4511 (fax), or [email protected] 93.846–93.878, 93.892, 93.893, National to treat depression. CERHR selected (e-mail). Information and comments Institutes of Health, HHS) these chemicals for expert panel received by 60 days from the evaluation because of: (1) The publication date of this notice will be Dated: April 6, 2004. increasing use of these drugs in made available to the CERHR staff and LaVerne Y. Stringfield, children, (2) public concern for long- the appropriate expert panel for Director, Office of Federal Advisory term effects of these drugs on child consideration in the evaluation and Committee Policy. development and behavior, (3) the posted on the CERHR Web site. [FR Doc. 04–8283 Filed 4–12–04; 8:45 am] availability of human exposure data, Request for the Nomination of BILLING CODE 4140–01–M and (4) findings from developmental Scientists for the Expert Panels studies in humans and experimental animals. The CERHR invites nominations of DEPARTMENT OF HEALTH AND qualified scientists to serve on the HUMAN SERVICES Evaluation of Magnesium Sulfate individual expert panels for: (1) Magnesium sulfate (CASRN: 7487– Methylphenidate and Adderall , (2) Public Health Service 88–9) is the most common magnesium magnesium sulfate, and (3) genistein and soy formula. Panelists are primarily National Toxicology Program salt used for seizure prophylaxis in preeclampsia or seizure control in drawn from the CERHR Expert Registry The National Toxicology Program eclampsia, and for inhibition of uterine and/or the nomination of other (NTP) Center for the Evaluation of Risks contractions during preterm labor. scientists who meet the criteria for to Human Reproduction (CERHR) CERHR selected this chemical for expert listing in that registry that include: announces plans for future evaluations panel evaluation because of: (1) The formal academic training and of Methylphenidate and Adderall , existence of an adequate exposure experience in a relevant scientific field, Magnesium Sulfate, and Genistein and database, (2) concern for the survival publications in peer-reviewed journals, Soy Formula; Requests public and development of the infant after membership in relevant professional comments on these substances; and maternal treatment, and (3) the societies, certification by an appropriate solicits the nominations of scientists availability of developmental toxicity scientific board or other entities, and qualified to serve on expert panels data. participation in similar committee evaluating these compounds. activities. Evaluation of Genistein and Soy All panel members serve as Summary Formula individual experts in their specific areas The CERHR plans to convene 3 expert Genistein (CASRN: 446–72–0) is of expertise and not as representatives panels to evaluate potential found in some legumes, such as of their employers or other reproductive and developmental soybeans and clover, or in products organizations. Scientists on the expert toxicities of (1) methylphenidate obtained from animals ingesting panel will be selected to represent a (Ritalin ) and Adderall , (2) genistein-containing feed. Genistein is a wide range of expertise, including, but magnesium sulfate, and (3) genistein phytoestrogen, defined as a non- not limited to, developmental and soy formula. For each evaluation, steroidal, estrogenic, naturally occurring toxicology, reproductive toxicology, the expert panel will consist of plant product. It is found in food, in neonatology and child development, approximately 12 scientists, selected for over-the-counter dietary supplements, epidemiology, general toxicology, their scientific expertise in various and is the primary phytoestrogen in soy pharmacokinetics, exposure assessment, aspects of reproductive and formula. Soy formula is administered to and biostatistics. Nominations received developmental toxicology and other infants as a supplement or replacement by 60 days from the publication date of

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this notice will be considered for these projects. To request more information Client outcomes will be measured panels and for inclusion in the CERHR on the proposed projects or to obtain a using a series of structured instruments Expert Registry. Nominations, including copy of the information collection administered by evaluation personnel contact information and a current plans, call the SAMHSA Reports employed and funded by the local VA curriculum vitae (if possible) should be Clearance Officer on (301) 443–7978. medical center or outpatient clinic forwarded to the CERHR at the address Comments are invited on: (a) Whether involved at each Initiative site who will given above. the proposed collections of information work closely with central NEPEC staff. are necessary for the proper Assessments will be conducted through Background Information About the face-to-face interviews and, when CERHR performance of the functions of the agency, including whether the needed, telephone interviews. The NTP established the CERHR in information shall have practical utility; Interviews (approximately one hour in June 1998 [Federal Register, December (b) the accuracy of the agency’s estimate length) will be conducted at baseline, 14, 1998: Volume 63, Number 239, page of the burden of the proposed collection defined as the date of entry into the 68782]. The CERHR is a publicly of information; (c) ways to enhance the clinical treatment program leading to accessible resource for information quality, utility, and clarity of the placement into permanent housing, and about adverse reproductive and/or information to be collected; and (d) quarterly (every 3 months) thereafter for developmental health effects associated ways to minimize the burden of the up to three years. Discharge data will be with exposure to environmental and/or collection of information on collected from program staff at the time occupational exposures. Expert panels respondents, including through the use of official discharge from the program, conduct scientific evaluations of agents of automated collection techniques or or when the client has not had any selected by the CERHR in public other forms of information technology. clinical contact from members of the forums. Proposed Project: National Outcomes program staff for at least 6 months. In Information about CERHR and its Performance Assessment of the addition to client interviews, key process for nominating agents for review Collaborative Initiative to Help End informant interviews with program or scientists for its expert registry can be Chronic Homelessness—(OMB No. managers at each site will be conducted obtained from its homepage (http:// 0930–0247; Extension, no change)— annually. cerhr.niehs.nih.gov) or by contacting Dr. This Initiative is coordinated by the U.S. At most Initiative sites, it is expected Shelby (contact information provided Interagency Council on the Homeless that more people will be screened and or evaluated for participation in the above). The CERHR selects chemicals and involves the participation of three program than receive the full range of for evaluation based upon several Council members: the Department of core housing and treatment services. factors, including production volume, Housing and Urban Development Entry into the Initiative is extent of human exposure, public (HUD), the Department of Health and conceptualized as a two-phase process concern, and published evidence of Human Services (HHS), and the involving an Outreach/Screening/ reproductive or developmental toxicity. Department of Veterans Affairs (VA). Assessment Phase (Phase I), and an CERHR follows a formal, multi-step Within HHS, SAMHSA’s Center for Active Housing Placement/Treatment process for review and evaluation of Mental Health Services is the lead Phase (Phase II) that is expected to lead selected chemicals. The formal agency. evaluation process was published in the to exit from homelessness; in some This project will monitor the Federal Register (July 16, 2001: Volume programs these two phases may be implementation and effectiveness of the 66, Number 136, pages 37047–37048) described as the Outreach and Case Initiative. A national assessment of and is available on the CERHR Web site Management Phases. It will be client outcomes is needed to assure a under ‘‘About CERHR’’ or in printed important to have at least some minimal high level of accountability and to copy from the CERHR. information on all clients so as to be identify which models work best for able to compare those who enter Dated: April 1, 2004. which people, using the same methods Housing/Treatment with those who do Kenneth Olden, for all sites. To this end, this project will not. Director, National Institute of Environmental provide a site-by-site description of Client-level data at the time of first Health Sciences. program implementation, as well as contact with the program (i.e., before the [FR Doc. 04–8269 Filed 4–12–04; 8:45 am] descriptive information on clients client receives more intensive treatment BILLING CODE 4140–01–P served; services received; housing or housing services) will be collected quality, stability, and satisfaction; and, using a screener form. The screener client outcomes in health and functional form will be completed by a member of DEPARTMENT OF HEALTH AND domains. The VA Northeast Program the clinical staff when prospective HUMAN SERVICES Evaluation Center (NEPEC), based at the clients are first told about the program, VA Connecticut Healthcare System in and express interest in participating in Substance Abuse and Mental Health West Haven, Connecticut, is responsible the program (i.e. when they enter Phase Services Administration for conducting this project. I). The purpose of this form is to Agency Information Collection Data collection will be conducted identify the sampling frame of the Activities: Proposed Collection; over a 36-month period. At each site, a evaluation at each site, or the pool of Comment Request series of measures will be used to assess potential clients from which clients are (1) program implementation (e.g., then selected. Program implementation In compliance with Section number and types of housing units will be measured using a series of 3506(c)(2)(A) of the Paperwork produced and intensity and types of progress summaries. Reduction Act of 1995 concerning treatment and supportive services Initiative sites will be responsible for opportunity for public comment on provided), (2) client descriptive screening potential participants, proposed collections of information, the information (e.g., demographic and assessing homeless and disabling Substance Abuse and Mental Health clinical characteristics, and housing and condition eligibility criteria for the Services Administration will publish treatment services received) and, (3) program, and documenting eligibility as periodic summaries of proposed client outcomes. part of the national performance

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assessment. Each site will identify a evaluation. VA evaluation staff, clinical obtaining written informed consent to limited number of portals of entry into program staff, and NEPEC will work participate in the national performance the program in a relatively small together to establish systematic assessment, and other evaluation geographic area, so that the evaluator procedures for assessing eligibility, activities. can practically and systematically enrolling clients into the Housing/ The estimated response burden to contact clients about participating in the Treatment Activity of the Initiative, collect this information is as follows:

Responses Respondents form name No. of per Hours per Total hour respondents respondent response burden

Clients: Baseline assessment ...... 1,500 1 1.50 2,250 Follow-up assessment ...... 1,500 81 1.25 15,000

Sub-total ...... 17,250 Clinicians: Screening ...... 302 100 0.25 750 Discharge ...... 303 13 0.40 156

Sub-total ...... 906 Administrators: Network definition ...... 60 1 0.25 15 Network participation ...... 105 4 0.75 315

Sub-total ...... 330

Total ...... 18,486.

3-yr. Annual Avg...... 6,162. 1 Assumes average follow-up period of 2 yrs. due to delayed recruitment at some sites & 20% attrition overall. 2 Assumes an average of 2 screening clinicians per site, and twice the number of persons screened as enrolled. 3 Assumes an average of 2 discharge clinicians per site, and discharge rate of 25%.

Send comments to Nancy Pearce, Local Law Enforcement Training, dedicated group. The Committee does SAMHSA Reports Clearance Officer, Federal Law Enforcement Training not duplicate functions being performed Room 16–105, Parklawn Building, 5600 Center, Glynco, GA 31524, 912–267– within Department of Homeland Fishers Lane, Rockville, MD 20857. 2343. Security or elsewhere in the Federal Written comments should be received SUPPLEMENTARY INFORMATION: Pursuant Government. by June 14, 2004. to the Federal Advisory Committee Act Dated: March 29, 2004. Dated: April 6, 2004. of October 6, 1972, (Pub. L. 92–463, as Stanley Moran, Anna Marsh, amended), and with the approval of the Director, National Center for State and Local Executive Officer, SAMHSA. Secretary of the Department of Law Enforcement Training. [FR Doc. 04–8294 Filed 4–12–04; 8:45 am] Homeland Security and the concurrence [FR Doc. 04–8043 Filed 4–12–04; 8:45 am] of the Office of Management and BILLING CODE 4162–20–P BILLING CODE 4810–32–P Budget, the Federal Law Enforcement Training Center announces the renewal of the Advisory Committee to the DEPARTMENT OF HOMELAND DEPARTMENT OF HOMELAND National Center for State and Local Law SECURITY SECURITY Enforcement Training (the Federal Law Coast Guard Federal Law Enforcement Training Enforcement Training Center was Center transferred from the Department of the Treasury to the Department of [USCG–2004–17511] Charter Renewal, Notice Homeland Security pursuant to section Collection of Information Under 403 of Public Law 107–296). The Review by Office of Management and AGENCY: Federal Law Enforcement primary purpose of the Advisory Budget (OMB): OMB Control Numbers: Training Center, Department of Committee is to provide a forum for Homeland Security. 1625–0025 [Formerly 2115–0100], discussion and interchange between a 1625–0030 [Formerly 2115–0120], ACTION: Notice. broad cross-section of representatives 1625–0072 [Formerly 2115–0613], for the law enforcement community and SUMMARY: The Charter for the Advisory 1625–0078 [Formerly 2115–0623] and related training institutions on training 1625–0082 [Formerly 2115–0628]. Committee to the National Center for issues and needs. Although FLETC State and Local Law Enforcement representatives participate in the AGENCY: Coast Guard, DHS. Training at the Federal Law training committee activities of the ACTION: Request for comments. Enforcement Training Center was major police membership associations, renewed for a 2-year period beginning no forum exists which provides the SUMMARY: In compliance with the January 14, 2004. broad representation required to meet Paperwork Reduction Act of 1995, the FOR FURTHER INFORMATION CONTACT: the needs of the National Center. The Coast Guard intends to seek the Reba Fischer, Designated Federal uniqueness of the program requires an approval of OMB for the renewal of five Officer, National Center for State and appropriately selected and specifically Information Collection Requests (ICRs).

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The ICRs comprise (1) 1625–0025, FOR FURTHER INFORMATION CONTACT: Mr. Privacy Act Statement of DOT in the Carriage of Bulk Solids Requiring Arthur Requina, Office of Information Federal Register published on April 11, Special Handling—46 CFR Part 148; (2) Management, 202–267–2326, for 2000 [65 FR 19477], or you may visit 1625–0030, Oil and Hazardous questions on these documents; or Ms. http://dms.dot.gov. Materials Transfer Procedures; (3) 1625– Andrea M. Jenkins, Program Manager, Information Collection Requests 0072, Waste Management Plans, Refuse U.S. DOT, 202–366–0271, for questions Discharge Logs, and Letters of on the docket. 1. Title: Carriage of Bulk Solids Instruction for Certain Persons-in- SUPPLEMENTARY INFORMATION: Requiring Special Handling—46 CFR Charge (PIC); (4) 1625–0078, Licensing Part 148. Public Participation and Request for and Manning Requirements for Officers OMB Control Number: 1625–0025 Comments of Towing Vessels; and (5) 1625–0082, [Formerly 2115–0100]. Navigation Safety Equipment and We encourage you to participate in Summary: The information in the Emergency Instructions for Certain this request for comment by submitting application for a special permit allows Towing Vessels. Before submitting the comments and related materials. We the Coast Guard to: (1) Determine the ICRs to OMB, the Coast Guard is will post all comments received, severity of the hazard posed by the inviting comments on them as described without change, to http://dms.dot.gov, material; (2) set specific guidelines for below. and they will include any personal safe carriage; or, (3) if the material presents too great a hazard, deny DATES: Comments must reach the Coast information you have provided. We Guard on or before June 14, 2004. have an agreement with DOT to use the permission for shipping the material. Docket Management Facility. Please see Need: The Coast Guard administers ADDRESSES: To make sure that your the paragraph on DOT’s ‘‘Privacy Act’’ and enforces statutes and rules for the comments and related material do not below. safe transport and stowage of hazardous enter the docket [USCG–2004–17511] Submitting comments: If you submit a materials, including bulk solids. Under more than once, please submit them by comment, please include your name and 46 CFR part 148, the Coast Guard may only one of the following means: address, identify the docket number for issue special permits for the carriage of (1) By mail to the Docket Management this request for comment [USCG–2004– bulk solids requiring special handling. Facility, U.S. Department of 17511], indicate the specific section of Respondents: Owners and operators Transportation (DOT), room PL–401, this document to which each comment of vessels that carry certain bulk solids. 400 Seventh Street SW., Washington, applies, and give the reason for each Frequency: On occasion. DC 20590–0001. Caution: Because of comment. You may submit your Burden Estimates: The estimated recent delays in the delivery of mail, comments and material by electronic burden is 1,130 hours a year. your comments may reach the Facility means, mail, fax, or delivery to the 2. Title: Oil and Hazardous Materials more quickly if you choose one of the Docket Management Facility at the Transfer Procedures. other means described below. address under ADDRESSES: but please OMB Control Number: 1625–0030 (2) By delivery to room PL–401 on the submit them by only one means. If you [Formerly 2115–0120]. Plaza level of the Nassif Building, 400 submit them by mail or delivery, submit Summary: The collection of Seventh Street SW., Washington, DC, them in an unbound format, no larger information requires vessels with a between 9 a.m. and 5 p.m., Monday than 81⁄2 by 11 inches, suitable for cargo capacity of 250 barrels or more of through Friday, except Federal holidays. copying and electronic filing. If you oil or hazardous materials to develop The telephone number is 202–366– submit them by mail and would like to and maintain transfer procedures. 9329. know that they reached the Facility, Transfer procedures provide basic safety (3) By fax to the Docket Management please enclose a stamped, self-addressed information for operating transfer Facility at 202–493–2251. postcard or envelope. We will consider systems with the goal of pollution (4) Electronically through the Web all comments and material received prevention. Site for the Docket Management System during the comment period. We may Need: Title 33 U.S.C. 1231 authorizes at http://dms.dot.gov. change the documents supporting this the Coast Guard to prescribe regulations The Docket Management Facility collection of information or even the related to the prevention of pollution. maintains the public docket for this underlying requirements in view of Title 33 CFR part 155 prescribe notice. Comments and material received them. pollution prevention regulations from the public, as well as documents Viewing comments and documents: including those related to transfer mentioned in this notice as being To view comments, as well as procedures. available in the docket, will become part documents mentioned in this notice as Respondents: Owners and operators of this docket and will be available for being available in the docket, go to of vessels. inspection or copying at room PL–401 http://dms.dot.gov at any time and Frequency: On occasion. on the Plaza level of the Nassif Building, conduct a simple search using the Burden Estimate: The estimated 400 Seventh Street SW., Washington, docket number. You may also visit the burden is 89 hours a year. DC, between 9 a.m. and 5 p.m., Monday Docket Management Facility in room 3. Title: Waste Management Plans, through Friday, except Federal holidays. PL–401 on the Plaza level of the Nassif Refuse Discharge Logs, and Letters of You may also find this docket on the Building, 400 Seventh Street, SW., Instruction for Certain Persons-in- Internet at http://dms.dot.gov. Washington, DC, between 9 a.m. and 5 Charge (PIC). Copies of the complete ICR are p.m., Monday through Friday, except OMB Control Number: 1625–0072 available through this docket on the Federal holidays. [Formerly 2115–0613]. Internet at http://dms.dot.gov, and also Privacy Act: Anyone can search the Summary: This information is needed from Commandant (CG–611), U.S. Coast electronic form of all comments to ensure that: (1) certain U.S. Guard Headquarters, room 6106 (Attn: received in dockets by the name of the oceangoing vessels develop and Mr. Arthur Requina), 2100 Second individual submitting the comment (or maintain a waste management plan; (2) Street SW., Washington, DC 20593– signing the comment, if submitted on certain U.S. oceangoing vessels 0001. The telephone number is 202– behalf of an association, business, labor maintain refuse discharge records; and 267–2326. union, etc.). You may review the (3) certain individuals that act as

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person-in-charge of the transfer of fuel Dated: April 8 2004. telephone (202) 708–2374. This is not a receive a letter of instruction, for Nathaniel S. Heiner, toll-free number. Copies of available prevention of pollution. Acting, Assistant Commandant for C4 and documents submitted to OMB may be Need: This collection of information Information Technology. obtained from Mr. Eddins. is needed as part of the Coast Guard’s [FR Doc. 04–8351 Filed 4–12–04; 8:45 am] SUPPLEMENTARY INFORMATION: This pollution prevention compliance BILLING CODE 4910–15–P program. notice informs the public that the U.S. Respondents: Owners, operators, Department of Housing and Urban masters, and persons-in-charge of Development (HUD) has submitted to DEPARTMENT OF HOUSING AND vessels. OMB, for emergency processing, a Frequency: On occasion. URBAN DEVELOPMENT survey instrument to obtain information Burden Estimate: The estimated [Docket No. FR–4903–N–29] from faith based and community burden is 55,484 hours a year. organizations on their likelihood and 4. Title: Licensing and Manning Notice of Submission of Proposed success at applying for various funding Requirements for Officers of Towing Information Collection to OMB; programs. This Notice is soliciting Vessels. Description of Materials comments from members of the public OMB Control Number: 1625–0078 and affecting agencies concerning the [Formerly 2115–0623]. AGENCY: Office of the Chief Information proposed collection of information to: Summary: Licensing and manning Officer. (1) Evaluate whether the proposed requirements ensure that towing vessels ACTION: Notice. collection of information is necessary operating on the navigable waters of the for the proper performance of the U.S. are under the control of licensed SUMMARY: The proposed information functions of the agency, including officers who meet certain qualification collection requirement described below whether the information will have and training standards. has been submitted to the Office of practical utility; (2) evaluate the Need: Title 46 CFR part 10 prescribe Management and Budget (OMB) for accuracy of the agency’s estimate of the regulations for the licensing of maritime review, as required by the Paperwork burden of the proposed collection of personnel. This information collection Reduction Act. The Department is information; (3) enhance the quality, is necessary to ensure that a mariner’s soliciting public comments on the utility, and clarity of the information to training information is available to subject proposal. be collected; and (4) minimize the assist in determining his or her overall HUD is requesting renewal of the burden of the collection of information qualifications to hold certain licenses. approval to collect this information. on those who are to respond; including Respondents: Owners and operators This collection provides information on through the use of appropriate towing vessels. the materials used and assembly automated collection techniques or Frequency: On occasion. required for new single-family home other forms of information technology, Burden Estimates: The estimated construction and improvements. HUD/ burden is 17,159 hours a year. e.g., permitting electronic submission of FHA uses this information to estimate responses. 5. Title: Navigation Safety Equipment the value of the homes and compute the This notice also lists the following and Emergency Instructions for Certain maximum mortgage amount for FHA information: Towing Vessels. insurance. OMB Control Number: 1625–0082 Title of Proposal: Description of [Formerly 2115–0628]. DATES: Comments Due Date: May 13, Materials. Summary: Navigation safety 2004. OMB Approval Number: 2502–0192. regulations help assure that the mariner ADDRESSES: Interested persons are Form Numbers: HUD–92005. piloting a towing vessel has adequate invited to submit comments regarding equipment, charts, maps, and other this proposal. Comments should refer to Description of the Need for the publications. For inspected towing the proposal by name and/or OMB Information and its Proposed Use: This vessels, a muster list and emergency approval Number (2502–0192) and collection provides information on the instructions provide effective plans and should be sent to: HUD Desk Officer, materials used and assembly required references for crew to follow in an Office of Management and Budget, New for new single family home construction emergency situation. and improvements. HUD/FHA uses this Need: The purpose of the regulations Executive Office Building, Washington, DC 20503; fax: 202–395–6974. information to estimate the value of the is to improve the safety of towing homes and compute the maximum FOR FURTHER INFORMATION CONTACT: vessels and the crews that operate them. mortgage amount for FHA insurance. Respondents: Owners, operators and Wayne Eddins, Reports Management masters of vessels. Officer, AYO, Department of Housing Respondents: Business or other for- Frequency: On occasion and Urban Development, 451 Seventh profit. Burden Estimates: The estimated Street, SW., Washington, DC 20410; e- Frequency of Submission: On burden is 367,701 hours a year. mail [email protected]; occasion.

Number of Annual re- × Hours per respondents sponses response = Burden hours

Reporting burden: ...... 2,500 0.5 2 25,000

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Total Estimated Burden Hours: states in 1999 (64 FR 58932). If the under active review. This notice 25,000. present classification of this species is announces our active review of the bull Status: Extension of a currently not consistent with the best scientific trout. approved collection. and commercial information available, What Information Is Considered in the Authority: Section 3507 of the the Service will recommend whether or Paperwork Reduction Act of 1995, 44 not a change is warranted in the Federal Review? U.S.C. 35, as amended. classification of bull trout. Any change The 5-year review considers all new Dated: April 7, 2004. in Federal classification would require a information available at the time of the Wayne Eddins, separate final rule-making process. review. This review will consider the Departmental PRA Compliance Officer, Office DATES: Information submitted for our best scientific and commercial data that of the Chief Information Officer. consideration must be received on or has become available since the current [FR Doc. 04–8342 Filed 4–12–04; 8:45 am] before July 1, 2004. listing determination or most recent BILLING CODE 4210–72–P ADDRESSES: Information submitted status review, such as: should be sent to the U.S. Fish and A. Species biology including, but not Wildlife Service, Bull Trout limited to, population trends, DEPARTMENT OF THE INTERIOR Coordinator, Attention: Bull Trout 5- distribution, abundance, demographics, year Review, 911 NE. 11th Avenue, and genetics; Fish and Wildlife Service Portland, Oregon, 97232. Information B. Habitat conditions including, but received in response to this notice and not limited to, amount, distribution, and Endangered and Threatened Wildlife review will be available for public suitability; and Plants; 5-Year Review of the Bull inspection by appointment, during Trout normal business hours, at the above C. Conservation measures that have address. New information regarding the been implemented that benefit the AGENCY: Fish and Wildlife Service, bull trout may also be sent species; Interior. electronically to D. Threat status and trends (see five ACTION: Notice of review. [email protected]. factors under heading ‘‘How do we determine whether a species is SUMMARY: The U.S. Fish and Wildlife FOR FURTHER INFORMATION CONTACT: John Service (Service), announces a 5-year Young at the above address, or at 503/ endangered or threatened?’’); and review of the bull trout (Salvelinus 231–2767. E. Other new information, data, or confluentus) under section 4(c)(2)(A) of SUPPLEMENTARY INFORMATION: corrections including, but not limited the Endangered Species Act of 1973 to, taxonomic or nomenclatural changes, (Act) (16 U.S.C. 1531 et seq.). The Why Is a 5-Year Review Conducted? identification of erroneous information purpose of reviews conducted under Section 4(c)(2)(A) of the Act requires contained in the List, and improved this section of the Act is to ensure that that we conduct a review of listed analytical methods. the classification of species as species at least once every 5 years. We How Is the Bull Trout Currently Listed? threatened or endangered on the List of are then, under section 4(c)(2)(B) and Endangered and Threatened Wildlife the provisions of subsections (a) and (b), The List is found in 50 CFR 17.11 and Plants (List) is accurate. to determine, on the basis of such a (wildlife) and 17.12 (plants). The 5-year review is an assessment of review, whether or not any species Amendments to the List through final the best scientific and commercial data should be removed from the List rules are published in the Federal available at the time of the review. (delisted), or reclassified from Register. The List is also available on Therefore, we are requesting submission endangered to threatened, or threatened our Internet site at http:// of any new information (best scientific to endangered. Our regulations at 50 endangered.fws.gov/ and commercial data) on the bull trout CFR 424.21 require that we publish a wildlife.html#Species. In Table 1 below, since its original listing as a threatened notice in the Federal Register we provide a summary of the listing species conterminously in the lower 48 announcing those species currently information for the bull trout.

TABLE 1.—SUMMARY OF THE LISTING INFORMATION FOR THE BULL TROUT

Common name Scientific name Status Where listed Final listing rule

bull trout ...... Salvelinus confluentus ...... Threatened ...... U.S.A., conterminous 64 FR 58932(01–NOV– (lower 48 states). 99).

Definitions Related to This Notice C. Threatened means any species that A. The present or threatened The following definitions are is likely to become an endangered destruction, modification, or provided to assist those persons who species within the foreseeable future curtailment of its habitat or range; contemplate submitting information throughout all or a significant portion of B. Overutilization for commercial, regarding the species being reviewed: its range. recreational, scientific, or educational A. Species includes any species or purposes; How Do We Determine Whether a C. Disease or predation; subspecies of fish, wildlife, or plant, Species is Endangered or Threatened? and any distinct population segment of D. The inadequacy of existing any species of vertebrate, which Section 4(a)(1) of the Act establishes regulatory mechanisms; or interbreeds when mature. that we determine whether a species is E. Other natural or manmade factors B. Endangered means any species that endangered or threatened based on one affecting its continued existence. is in danger of extinction throughout all or more of the five following factors: Section 4(a)(1) of the Act requires that or a significant portion of its range. our determination be made on the basis

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of the best scientific and commercial at the Holiday Inn Select, 2200 I–70 Dr. 2. May 27, 2004, 8 a.m. to 5 p.m., data available. SW, Columbia, Missouri 65203. Phone Rhame, ND. (573) 445–8531. Minutes of the meeting 3. May 28, 2004, 8 a.m. to noon, What Could Happen as a Result of This will be maintained in the office of Chief, Dickinson, ND. Review? Division of Environmental Quality, U.S. ADDRESSES: The meeting will be held at If we find that there is new Fish and Wildlife Service, Suite 322, Badlands Best Western Inn, 71 Museum information concerning the bull trout 4401 North Fairfax Drive, Arlington, Drive, Dickinson, ND 58601. indicating a change in classification Virginia 22203–1622. FOR FURTHER INFORMATION CONTACT: may be warranted, we may propose a FOR FURTHER INFORMATION CONTACT: Douglas Burger, Field Office Manager, new rule that could do one of the Everett Wilson, Acting Executive North Dakota Field Office, 2933 3rd following: (a) Reclassify the species Secretary, Aquatic Nuisance Species Ave. W, Dickinson, North Dakota. from threatened to endangered; or (b) Task Force, at (703) 358–2148. Telephone 701.227.7700. remove the species from the List. If we SUPPLEMENTARY INFORMATION: Pursuant Public Comment Procedures: The determine that a change in classification to section 10(a)(2) of the Federal meeting is open to the public and a is not warranted, the bull trout will Advisory Committee Act (5 U.S.C. App. public comment period is set for 8 a.m. remain on the List under its current I), this notice announces meetings of the on May 28, 2004. The public may make status. Aquatic Nuisance Species Task Force. oral statements before the Council or file Public Solicitation of New Information The Task Force was established by the written statements for the Council to consider. Depending on the number of We request any new information Nonindigenous Aquatic Nuisance persons wishing to make an oral concerning the status of the bull trout, Prevention and Control Act of 1990. statement, a per-person time limit may see ‘‘What information is considered in Topics to be covered during the ANS be established. the review?’’ heading for specific Task Force meeting include: criteria. Information submitted should introduction of new members; an SUPPLEMENTARY INFORMATION: The 15- be supported by documentation such as update of activities from each of the member Council advises the Secretary maps, bibliographic references, methods Task Force’s regional panels; status of the Interior, through the Bureau of used to gather and analyze the data, reports from several Task Force Land Management, on a variety of and/or copies of any pertinent committees and working groups, planning and management issues publications, reports, or letters by including the Prevention and Outreach associated with public land knowledgeable sources. Committees, the New Zealand mudsnail management in the Dakotas. Summary working group, and the Caulerpa minutes of the meeting will be available Authority working group; presentations by the for public inspection and copying. This document is published under the Mississippi River Basin Panel; an Participants will go on a field tour authority of the Endangered Species Act update on ballast water management Thursday, May 27 to tour the Gascoyne (16 U.S.C. 1531 et seq.). activities; an update on the activities of Mine which is a contender for becoming the National Invasive Species Council; a new mine/powerplant operation in Dated: March 4, 2004. and other topics. ND, from there we will proceed to David J. Wesley, Dated: March 16, 2004. Muddy Buttes south of Rhame to see Acting Regional Director, Region 1, Fish and Mamie A. Parker, Paleontological resources and discuss Wildlife Service. the significance of that site. [FR Doc. 04–8295 Filed 4–12–04; 8:45 am] Co-Chair, Aquatic Nuisance Species Task Force, Assistant Director—Fisheries & Habitat Dated: April 6, 2004. BILLING CODE 4310–55–P Conservation. Michael A. Nash, [FR Doc. 04–8309 Filed 4–12–04; 8:45 am] Assistant Field Manager, Minerals. DEPARTMENT OF THE INTERIOR BILLING CODE 4310–55–P [FR Doc. 04–8327 Filed 4–12–04; 8:45 am] BILLING CODE 4310–$$–P Fish and Wildlife Service DEPARTMENT OF THE INTERIOR Aquatic Nuisance Species Task Force Meeting Bureau of Land Management DEPARTMENT OF LABOR AGENCY: Fish and Wildlife Service, [MT030–1020–04–PH] Employment and Training Interior. Administration North Dakota: Dakotas Advisory ACTION: Notice of meeting. Council Meeting Proposed Information Collection Request Submitted for Public SUMMARY: This notice announces a AGENCY: Bureau of Land Management, Comment and Recommendations; meeting of the Aquatic Nuisance North Dakota Field Office, Interior. Species (ANS) Task Force. The meeting Workforce Investment Act (WIA) ACTION: Announcement of meeting for topics are identified in the Financial Reporting Requirements for Dakotas Resource Advisory Council. SUPPLEMENTARY INFORMATION section. Formula Funded Grants DATES: The Aquatic Nuisance Species SUMMARY: The Dakotas Advisory ACTION: Notice. Task Force will meet from 8 a.m. to 5 Council will meet in Dickinson, ND to p.m. on Wednesday, May 26, 2004, and discuss Paleontological and coal SUMMARY: The Department of Labor, as 8 a.m. to 12 p.m. on Thursday, May 27, resources and review the sage grouse part of its continuing effort to reduce 2004. Minutes of the meeting will be program. The agenda includes a day trip paperwork and respondent burden, available for public inspection during to the Gascoyne mine area. The meeting conducts a preclearance consultation regular business hours, Monday through will be open to the public. program to provide the general public Friday. DATES: The meeting dates are: and Federal agencies with an ADDRESSES: The Aquatic Nuisance 1. May 26, 2004, 1 p.m. to 5 p.m., opportunity to comment on proposed Species Task Force meeting will be held Dickinson, ND. and/or continuing collections of

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information in accordance with the States in ETA Training and Employment including the validity of the Paperwork Reduction Act of 1995 Guidance Letter No. 16–99, dated June methodology and assumptions used; (PRA95) (44 U.S.C. 3506(c)(2)(A)). This 23, 2000. This data collection was • Enhance the quality, utility, and program helps to ensure that requested granted an extension by OMB in Notice clarity of the information to be data can be provided in the desired of Action Number 1205–0408, dated collected; and format, reporting burden (time and February 12, 2001. The collection of • Minimize the burden of the financial resources) is minimized, information pursuant to that notice collection of information on those who collection instruments are clearly expired on February 29, 2004; however, are to respond, including through the understood, and the impact of collection OMB granted an extension through May use of appropriate automated, requirements on respondents can be 2004. The financial reporting electronic, mechanical, or other properly assessed. requirements for the WIA formula technological collection techniques or DATES: Submit comments on or before funded grants are set forth in Public other forms of information technology, June 14, 2004. Law 105–220, dated August 7, 1998, and e.g., permitting electronic submissions WIA Final Rule, 20 CFR part 652, et al., of responses. ADDRESSES: Send comments to Isabel dated August 11, 2000. Data collected A copy of the proposed ICR can be Danley, Office of Grants and Contract are utilized by the Department to obtained by contacting the office listed Management, Employment and Training evaluate the performance and above in the ADDRESSES section of this Administration, United States expenditure levels of the States and notice. Department of Labor, 200 Constitution local areas in carrying out the statutory III. Current Actions Avenue, NW., Room N–4720, intent of the WIA appropriated funds. Washington, DC 20210, 202–693–3047 This is the Department’s exclusive Type of Review: Extension/ (this is not a toll-free number), collection of financial data for WIA Reinstatement (without change). [email protected], and/or fax 202– formula funded grants, all of which is Agency: Employment and Training 693–3362. collected electronically. Administration. FOR FURTHER INFORMATION CONTACT: Title: WIA Financial Reporting Isabel Danley, Office of Grants and II. Desired Focus of Comments Requirements for Formula Funded Contract Management, Employment and Currently, the Department is soliciting Grants. Training Administration, United States comments concerning the proposed OMB Number: 1205–0408. Department of Labor, 200 Constitution extension/reinstatement of the WIA Agency Number: ETA 9076 A–F. Avenue, NW., Washington, DC 20210, Financial Reporting Requirements for Affected Public: States, local 202–693–3047 (this is not a toll-free Formula Funded Grants to: governments, Private Industry Councils number), [email protected], and/or • Evaluate whether the proposed and/or other for profit and non-profit fax 202–693–3362. collection of information is necessary organizations. SUPPLEMENTARY INFORMATION: for the proper performance of the Total Respondents: 56. functions of the agency, including Frequency: Quarterly. I. Background whether the information will have Total Responses: 12 per respondent This proposed information collection practical utility; per year (3 each quarter, one for each notice is requesting an extension of • Evaluate the accuracy of the year of appropriated funds available for authority to collect WIA financial data agency’s estimate of the burden of the expenditure). contained on formats provided to the proposed collection of information, Average Time per Response: 1 hour.

Total Total Annual bur- PY 2003 yr. of responses respondents Frequency responses Average Time per response den hours

PY 2001 ...... 56 Quarterly ...... 224 1 hour ...... 224 PY 2002 ...... 56 Quarterly ...... 224 1 hour ...... 224 PY 2003 ...... 56 Quarterly ...... 224 1 hour ...... 224

Totals ...... 672 ...... 672

Comments submitted in response to DEPARTMENT OF LABOR 7658 concerning the availability up to this notice will be summarized and/or $5.5 million for grants to eligible included in the request for Office of Employment and Training Workforce Investment Boards (WIBs) Management and Budget approval of the Administration that have demonstrated successfully the information collection request; they will ability to form working partnerships [SGA/DFA 04–103] also become a matter of public record. with grassroots faith-based and Solicitation for Grant Applications community organizations (FBCOs). The Dated: April 6, 2004. document contained incorrect page Emily Stover DeRocco, (SGA); Grants for Workforce Investment Boards; Correction limitation. Assistant Secretary for Employment and FOR FURTHER INFORMATION CONTACT: Training. AGENCY: Employment and Training [FR Doc. 04–8302 Filed 4–12–04; 8:45 am] Administration (ETA), Labor. James W. Stockton, Grants Officer, Division of Federal Assistance, Fax BILLING CODE 4510–30–P ACTION: Notice; correction. (202) 693–2879. SUMMARY: The Employment and Corrections Training Administration published a document in the Federal Register of In the Federal Register of April 6, April 6, 2004, at 69 FR 18126, Doc. 04– 2004, in FR Doc. 04–7658, on page

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18128, in the first column, is corrected FOR FURTHER INFORMATION CONTACT: change only applies to the number of to read: Amy A. Hobby, BLS Clearance Officer, establishments data item. Submission of Applications: The telephone number 202–691–7628. (See The BLS proposes to publish the Statement of Work must be limited to 10 ADDRESSES section). number of establishments for every pages. SUPPLEMENTARY INFORMATION: industry by geography grouping, Signed at Washington, DC, this 8th day of regardless of the size of the grouping. I. Background April, 2004. Currently, the number, or frequency, of James W. Stockton, The ARS forms are used to verify and establishments may be suppressed from Grant Officer. update existing 2002 North American publication when a grouping is very [FR Doc. 04–8322 Filed 4–12–04; 8:45 am] Industry Classification System (NAICS) small—usually one, two, or three BILLING CODE 4510–30–M codes. They also are used to update establishments. This prevents the employers’ business names and possible indirect disclosure of addresses and other geographical respondent identifying information DEPARTMENT OF LABOR information. In addition, the forms through the use of information from provide a source of multiple worksite another source. However, Statistical Bureau of Labor Statistics information, which is critical to the Policy Working Paper 22 from the Office development of the BLS Business of Management and Budget (OMB), Proposed Collection; Comment Establishment List (BEL). The BEL states, ‘‘Frequency data for Request serves as a sampling frame and a establishments are generally not ACTION: Notice. benchmark for many BLS surveys. considered sensitive because so much II. Desired Focus of Comments information about an establishment is SUMMARY: The Department of Labor, as publicly available.’’ Further, because the part of its continuing effort to reduce The Bureau of Labor Statistics is QCEW is constructed to cover virtually paperwork and respondent burden, particularly interested in comments all non-agricultural employers and conducts a pre-clearance consultation that: employment, the BLS cannot protect program to provide the general public • Evaluate whether the proposed that an establishment exists and is and Federal agencies with an collection of information is necessary included in the QCEW file. Therefore, opportunity to comment on proposed for the proper performance of the the BLS does not consider publishing and/or continuing collections of functions of the agency, including the number of establishments in an information in accordance with the whether the information will have industry-by-geography grouping, even if Paperwork Reduction Act of 1995 practical utility; one, to be a disclosure of confidential (PRA95) (44 U.S.C. 3506(c)(2)(A)). This • Evaluate the accuracy of the information even though it may be program helps to ensure that requested agency’s estimate of the burden of the possible to infer the identity of a data can be provided in the desired proposed collection of information, business establishment in that grouping. format, reporting burden (time and including the validity of the All other information on establishments financial resources) is minimized, methodology and assumptions used; maintained by the BLS in its QCEW file collection instruments are clearly • Enhance the quality, utility, and is confidential and will be used by the understood, and the impact of collection clarity of the information to be BLS for exclusively statistical purposes. requirements on respondents can be collected; The BLS believes that by following properly assessed. The Bureau of Labor • Minimize the burden of the allowable OMB disclosure policies, the Statistics (BLS) is soliciting comments collection of information on those who usefulness of one of the nation’s most concerning the proposed revision of the are to respond, including through the comprehensive economic statistical data Annual Refiling Survey (ARS) forms use of appropriate automated, sources will be vastly improved. and a change in its publication practices electronic, mechanical, or other The BLS uses the Annual Refiling in the Quarterly Census of Employment technological collection techniques or Survey (ARS) forms to gather industrial and Wages (QCEW) program. other forms of information technology, and geographical data on business A copy of the proposed information e.g., permitting electronic submissions establishments. The revised ARS forms collection request (ICR) can be obtained of responses; and are designed to verify and update by contacting the individual listed • Evaluate the change in the agency’s NAICS codes, geographical information, below in the ADDRESSES section of this publication practices in the QCEW and multiple worksite information. notice. program. DATES: Written comments must be Type of Review: Revision of a submitted to the office listed in the III. Current Action currently approved collection. ADDRESSES section below on or before The QCEW program publishes Agency: Bureau of Labor Statistics. June 14, 2004. employment and wage data for Title: Annual Refiling Survey. ADDRESSES: Send comments to Amy A. groupings defined by industry and OMB Number: 1220–0032. Hobby, BLS Clearance Officer, Division geography. The ARS is used to verify of Management Systems, Bureau of the industry code and location of Affected Public: Individuals or Labor Statistics, Room 3255, 2 businesses. For each grouping, there are households; business or other for-profit; Massachusetts Avenue, NE., three data items produced and not-for-profit institutions; farms; Federal Washington, DC 20212, telephone published: the number of government; State, local, or tribal number 202–691–7628 (this is not a toll establishments, employment, and government. free number). wages. The proposed publication Frequency: Annually.

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Average Total respond- Total time per Estimated Form ents Frequency responses response total burden (hours) hours

3023–NVS ...... 2,286,757 Once ...... 2,286,757 .083 189,800 3023–NVM ...... 35,951 Once ...... 35,951 .25 8,988 3023–NCA ...... 165,397 Once ...... 165,397 .167 27,621

Totals ...... 2,488,105 ...... 2,488,105 ...... 226,409

Total Burden Cost (Capital/Startup): Secretary of Labor to conduct, directly Under this solicitation covering Fiscal $0. or through grant or contract, such Year (FY) 2004, VETS anticipates that Total Burden Cost (Operating/ programs as the Secretary determines up to $1,500,000 will be available for Maintenance): $0. appropriate to expedite the reintegration grant awards up to a maximum of Comments submitted in response to of homeless veterans into the labor $250,000 each. This notice contains all this notice will be summarized and/or force. of the necessary information and forms included in the request for Office of The Homeless Veterans’ Reintegration to apply for grant funding. The period Management and Budget approval of the Program (HVRP) is making grants in of performance for these Program Year information collection request; they also three (3) categories: urban, non-urban, 2004 grants will be July 1, 2004 through will become a matter of public record. and a new category being introduced June 30, 2005. Two (2) optional years of Signed in Washington, DC, this 5th day of this year— ‘‘intermediaries.’’ Separate funding may be available, depending April, 2004. Solicitations for Grant Applications upon Congressional funding Cathy Kazanowski, (SGAs) are being issued for each grant appropriations, the agency’s decision to exercise the optional year(s) of funding, Chief, Division of Management Systems, category. This is the solicitation for Bureau of Labor Statistics. HVRP grants for ‘‘Intermediaries.’’ The and satisfactory grantee performance. [FR Doc. 04–8303 Filed 4–12–04; 8:45 am] results of these three (3) separately I. Funding Opportunity Description BILLING CODE 4510–24–P competed grant categories will provide valuable information on approaches and The U.S. Department of Labor techniques that work in the different (USDOL), Veterans’ Employment and Training Service (VETS), announces a DEPARTMENT OF LABOR environments. Grants to Intermediaries are intended grant competition that complies with Veterans’ Employment and Training to address two overall objectives: (1) To the requirements of 38 U.S.C. 2021, as Service coordinate efforts in order to added by section 5 of Public Law 107– collectively provide services to assist in 95, the Homeless Veterans Comprehensive Assistance Act of 2001 Homeless Veterans’ Reintegration reintegrating homeless veterans into (HVCAA). Section 2021 requires the Program (HVRP) Grants to meaningful employment within the Secretary of Labor to conduct, directly Intermediaries for Program Year 2004 labor force, and (2) to stimulate the or through grant or contract, such development of effective service Federal Agency: U.S. Department of programs as the Secretary determines delivery systems that will address the Labor, Veterans’ Employment and appropriate to expedite the reintegration complex problems facing homeless Training Service. of homeless veterans into the labor veterans. In achieving the HVRP grant Funding Opportunity: Homeless force. Veterans’ Reintegration Program (HVRP) objectives, the intermediary is expected Grants to Intermediaries for Program to sub-award a substantial portion of its 1. Program Concept and Emphasis Year 2004. grant award to eligible local grass-roots This Solicitation for Grant Announcement Type: Initial organizations. Applicants and their sub- Applications (SGA) seeks to make grants Solicitation for Grant Applications awardees/contractors will coordinate to ‘‘intermediary’’ organizations with (SGA). efforts in order to design programs that established connections to and working Funding Opportunity Number: SGA assist homeless veterans by collectively relationships with grassroots faith-based 04–05. ensuring that they receive job placement and community organizations and that Catalogue of Federal Domestic services, job training, counseling, have the ability to connect those smaller Assistance #: 17–805. supportive services, and other organizations and the people they serve Dates: Applications are due on May assistance to expedite the reintegration to the local employment service 13, 2004. of homeless veterans into the labor delivery system. HVRP grants to Period of Performance is Program force. It is anticipated that intermediaries are intended to address Year (PY) 2004, July 1, 2004, through ‘‘intermediaries’’ with established two overall objectives: (a) To coordinate June 30, 2005. connections and working relationships efforts in order to collectively provide Executive Summary (Applicants For to grassroots faith-based and community services to assist in reintegrating Grant Funds Should Read This Notice organizations will connect those smaller homeless veterans into meaningful In Its Entirety): The U.S. Department of organizations and the people they serve employment within the labor force, and Labor (USDOL), Veterans’ Employment to the local employment service (b) to stimulate the development of and Training Service (VETS), announces delivery system for some of these effective service delivery systems that a grant competition that complies with services. These programs are to be will address the complex problems the requirements of 38 U.S.C. 2021, as designed to be flexible in addressing the facing homeless veterans. added by section 5 of Public Law 107– universal as well as the local or regional In achieving the HVRP grant overall 95, the Homeless Veterans problems that have had a negative objectives, the intermediary is expected Comprehensive Assistance Act of 2001 impact on homeless veterans reentering to provide a substantial portion of its (HVCAA). Section 2021 requires the the workforce. award to eligible local grass-roots

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organizations through sub-awards/ design programs that assist homeless B. Federal, State, and local contracts. In their collaboration, the veterans by collectively ensuring the entitlement and social service agencies intermediaries will achieve the provision of job placement services, job such as the Social Security following objectives: training, counseling, supportive Administration (SSA), Department of • Organize collaboration between services, and other assistance to Veterans Affairs (DVA), State Workforce local grass-roots organizations and the expedite the reintegration of homeless Agencies (SWAs) and their local One- local employment service delivery veterans into the labor force. Successful Stop Centers (which integrate Workforce system to assist homeless veterans in applicants will also design programs Investment Act (WIA), labor exchange, reentering the workforce by leveraging that are flexible in addressing the and other employment and social the resources of both faith-based and universal as well as the local or regional services), mental health services, and community organizations and the local problems that have had a negative healthcare detoxification facilities: to employment service delivery system. impact on homeless veterans reentering familiarize them with the nature and • Expand the access of faith-based the workforce. The HVRP in FY 2004 needs of homeless veterans. and community organization clients and will seek to continue to strengthen C. Civic and private sector groups, in customers to the training, employment development of effective delivery particular Veterans’ Service opportunities, and employment services systems, to provide comprehensive Organizations, support groups, job offered by the local employment service services through a case management training and employment services, and delivery system. approach that addresses complex • community-based organizations Thoroughly document the impact problems facing homeless veterans including faith-based organizations: to and outcomes of these grant investments trying to transition into gainful provide information on homeless through quarterly, annual, and follow- employment, and to improve strategies veterans and their needs. up reporting. for employment and retention in The grantee and/or sub-awardees/ Under this Program Year 2004 HVRP employment. competition, eligible ‘‘intermediaries’’ contractors collectively will also be ‘‘ are defined as State and Local 2. Community Awareness Activities responsible for participating in Stand Down’’ events. A ‘‘Stand Down’’ is an Workforce Investment Boards, local In order to promote networking public agencies, for-profit/commercial event held in a locality, usually for three between the HVRP funded program and (3) days, where services are provided to entities, and non-profit organizations local service providers (and thereby including faith-based and community homeless veterans along with shelter, eliminate gaps or duplication in services meals, clothing, employment services, organizations. For the purposes of this and enhance the provision of assistance announcement, the eligible local and medical attention. This type of to participants), the grantee and/or sub- event is mostly a volunteer effort, which grassroots organizations to which sub- awardees/contractors collectively must awards/contracts must be made must be is organized within a community and provide project orientation workshops brings service providers together such as non-profit organizations that: and program awareness activities that it • Have social services as a major part the Department of Veterans Affairs determines are the most feasible for the of their mission; and (DVA), Disabled Veterans’ Outreach • Are headquartered in the local types of providers listed below. Program Specialists (DVOPs) and Local community to which they provide these Grantees are encouraged to demonstrate Veterans’ Employment Representatives services; and strategies for incorporating small faith- (LVERs) from the State Workforce • Have a total annual operating based and community organizations Agencies, Veteran Service budget of $300,000 or less or have seven (defined as organizations with social Organizations, military personnel, civic (7) or fewer full-time equivalent services budgets of approximately leaders, and a variety of other interested employees. $300,000 or seven (7) or fewer full-time persons, groups, and organizations. The intermediary will assist the sub- employees) into their outreach plans. Many services are provided on-site with awardees/contractors, as appropriate, in Project orientation workshops referrals also made for continued administrative tasks so that maximum conducted by grantees have been an assistance after the Stand Down event. efforts can be focused on providing effective means of sharing information These events can often be the catalyst supportive services and employment and informing the community of the that enables homeless veterans to get assistance to homeless veterans. VETS’ availability of other services; they are back into mainstream society. The encourages and expects the encouraged but not mandatory. Rather, Department of Labor has supported intermediary’s staff to provide grantees and/or sub-awardees/ replication of these events and many mentoring and technical assistance to contractors will have the flexibility to have been held throughout the nation. build the smaller organizations’ capacity attend service provider meetings, In areas where an HVRP is operating, to be a permanent contributor to the seminars, and conferences, to outstation grantees and/or sub-awardees/ local employment service delivery staff, and to develop individual service contractors collectively are encouraged system. contracts as well as to involve other and expected to participate fully and For this Fiscal Year (FY) 2004 grant agencies in program planning. offer their services for all locally solicitation, VETS seeks applicants that The grantee and/or sub-awardees/ planned Stand Down event(s). Toward will collectively provide direct services contractors collectively will be this end, up to $5,000 of the currently through a case management approach responsible for providing project requested HVRP grant funds may be that networks with Federal, State, and awareness, program information, and used to supplement the Stand Down local resources for veteran support orientation activities to the following: efforts, where funds are not otherwise programs. Successful applicants will A. Direct providers of services to available, and may be requested in the have clear strategies for employment homeless veterans including shelter and budget and explained in the budget and retention of employment for soup kitchen operators: to make them narrative. homeless veterans. Successful aware of the services available to 3. Scope of Program Design applicants’ and their grass-roots homeless veterans to make them job- organization sub-awardees/contractors ready and to aid their placement into The overall project design must will collaborate efforts in order to jobs. include the following services:

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A. Outreach, intake, assessment, peer including, but not limited to: alcohol of each individual’s abilities, interests, counseling to the degree practical, and drug rehabilitation, therapeutic needs, and barriers to employment. In employment services, and follow-up services, Post Traumatic Stress Disorder some cases, participants may require support services to enhance retention in (PTSD) services, mental health services referrals to services such as employment. Program staff providing as well as coordination with McKinney rehabilitation, drug or alcohol outreach services should have Homeless Assistance Act (MHAA) Title treatment, or a temporary shelter before experience in dealing with, and an VI programs for health care for the they can be enrolled into HVRP. Once understanding of the needs of homeless homeless, and health care programs the eligible homeless veteran is veterans. under the Homeless Veterans ‘‘stabilized,’’ the assessment must B. Provision of or referral to Comprehensive Assistance Act of 2001. concentrate on the employability of the employment services such as: job search H. Referral to housing assistance, as individual and whether the individual workshops, job counseling, assessment appropriate, provided by: local shelters, is to be enrolled into the HVRP program. of skills, resume writing techniques, Federal Emergency Management A determination should be made as to interviewing skills, subsidized trial Administration (FEMA) food and shelter whether the individual would benefit employment (work experience), job programs, transitional housing programs from pre-employment preparation such development services, job placement and single room occupancy housing as resume writing, job search into unsubsidized employment, job programs funded under MHAA Title IV workshops, employment related placement follow-up services to (and under HVCAA), and permanent counseling, and case management, or enhance retention in employment. housing programs for disabled homeless possibly an initial entry into the job C. Provision of or referral to training persons funded under MHAA Title IV market through temporary jobs. services such as: basic skills instruction, (and under HVCAA). Additionally, sheltered work remedial education activities, life skills 4. Results-Oriented Model environments, classroom training, and/ and money management training, on- or on-the-job training must be evaluated. the-job training, classroom training, No specific model is mandatory, but Such services should be noted in an vocational training, specialized and/or the applicant and/or sub-awardees/ Employability Development Plan to licensing training programs, and other contractors must collectively design a facilitate the staff’s successful formal training programs as deemed program that is responsive to the needs monitoring of the plan. Entry into full- appropriate to benefit the participant. At of the local community and achieves the time employment or a specific job- least 80% of the enrolled HVRP overall objectives of the HVRP program. training program should follow, in participants must participate in training The HVRP objectives are to successfully keeping with the ultimate objective of activities. reintegrate homeless veterans into the HVRP, to bring the participant closer to D. Grantees and/or sub-awardees/ workforce and to stimulate the self-sufficiency. Supportive services contractors will perform a preliminary development of effective service may assist the HVRP enrolled assessment of each participant’s delivery systems that will address the participant at this point or even sooner. eligibility for Department of Veterans complex problems facing homeless Job development, a crucial part of the Affairs (DVA) service-connected veterans. employability process, is usually when disability, compensation, and/or Under the Government Performance there are no competitive job openings pension benefits. As appropriate, and Results Act (GPRA), Congress and that the HVRP enrolled participant is grantees and/or sub-awardees/ the public are looking for program qualified to apply for, therefore, a job contractors will work with the Veterans results rather than program processes. opportunity is created or developed Service Organizations (VSOs) or refer The outcome measurement established specifically for that HVRP enrolled the participants to DVA in order to file for HVRP grants is for grantees and/or participant with an employer. HVRP a claim for compensation or pension. sub-awardees/contractors to collectively enrolled participants who are ready to Grantees and/or sub-awardees/ meet a minimum entered employment enter employment and/or who are in contractors will track progress of claims rate of 58%, determined by dividing the need of intensive case management and report outcomes in case number of entered employments by the services are to be referred to the DVOP management records. number of HVRP enrollments. (Actual and LVER staff at a local One-Stop E. Coordination with veterans’ performance outcomes will be reported Office. DVOP and LVER staff are able to services programs, including: Disabled quarterly in spreadsheet format to be provide HVRP enrolled participants the Veterans’ Outreach Program Specialists provided to grantees at the post award following services: job development, (DVOPs) and Local Veterans’ conference.) While the percentage of employment services, case management Employment Representatives (LVERs) in HVRP enrollments that entered and career counseling. Most DVOP and the local employment service delivery employment is an important outcome, it LVER staff received training in case system, as well as Veterans’ Workforce is also necessary to evaluate and management at the National Veterans’ Investment Programs (VWIPs), DVA measure the program’s long-term Training Institute. All DVOP and LVER services, including its Health Care for results, through the 90-day and 180-day staff provide employment related Homeless Veterans, Domiciliary Care, follow-up period, to determine the services to veterans who are most at a Regional Benefits Assistance Program, quality and success of the program. disadvantage in the labor market. VETS’ and Transitional Housing under The applicants and/or sub-awardees/ urges working hand-in-hand with Homeless Provider Grant and per diem contractors program should be based on DVOP/LVER staff to achieve economies programs. a results-oriented model. The first phase of resources. F. Networking with Veterans’ Service of activity should consist of the level of The applicant and/or sub-awardees/ Organizations such as: The American outreach necessary to introduce the contractors program must include Legion, Disabled American Veterans, program to eligible homeless veterans. tracking of program participants. Veterans of Foreign Wars, Vietnam Outreach also includes establishing Tracking should begin with the referral Veterans of America, the American contact with other agencies that to employment and continue through Veterans (AMVETS). encounter homeless veterans. Once the the 90-day and 180-day follow-up G. Referral as necessary to health care, eligible homeless veterans have been periods after entering employment to counseling, and rehabilitative services identified, an assessment must be made determine whether the veteran is in the

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same or similar job. It is important that B. The grantee and sub-awardees/ not currently receiving HVRP funds may the grantee and/or sub-awardees/ contractors must be in compliance with receive priority funding over applicants in contractors maintain contact with all terms identified in the Solicitation those States that are currently receiving veterans after placement to ensure that for Grant Application (SGA) and grant HVRP funds: Alaska, Arkansas, Delaware, Georgia, Idaho, Kansas, Mississippi, employment-related problems that may award document; and Montana, Nebraska, New Hampshire, North arise are addressed. The 90-day and C. All program and fiscal reports must Dakota, Rhode Island, South Dakota, Utah, 180-day follow-ups are fundamental to have been submitted by the established Vermont, Virginia, West Virginia, and assessing the results of the program due date and must be verifiable for Wyoming. success. Grantee and/or sub-awardees/ accuracy. 2. Cost Sharing: Cost sharing and/or contractors need to budget for 90-day III. Eligibility Information matching funds are not required. and 180-day follow-up activity so that it However, we do encourage the use of can be performed for those enrolled 1. Eligible Applicants: Applications leveraging and/or matching funds. participants placed at or near the end of for funds will be accepted from State and local Workforce Investment Boards, 3. Other Eligibility Criteria: the grant performance period. All A. This SGA is for Intermediaries grantees and/or sub-awardees/ local public agencies, for-profit/ commercial entities, and nonprofit HVRP grants. Separate SGAs for urban contractors, prior to the end of the grant and non-urban HVRP grants have been performance period, must obligate organizations, including faith-based and community organizations. Applicants simultaneously issued. sufficient funds to ensure that follow-up B. The proposal must include an activities are completed. Such results and their sub-awardees/contractors must have a familiarity with the area outreach component that uses either will be reported in the final technical DVOP/LVER staff or a trained outreach performance report. and population to be served and the ability to administer an effective and cadre. Programs must be ‘‘employment II. Award Information timely program. Applicants must also focused.’’ The services provided must be directed toward: (1) Increasing the 1. Type of Funding Instrument: One have established connections to and working relationships with grassroots employability of homeless veterans (1) year grant. through training or arranging for the 2. Funding Levels: The total funding faith-based and community organizations, and have the ability to provision of services that will enable available for this Intermediaries HVRP them to work; and (2) matching solicitation is up to $1,500,000. Awards connect those smaller organizations and the people they serve to the local homeless veterans with potential are expected to range from $100,000 to employers. a maximum of $250,000. The employment service delivery system. Eligible applicants will generally fall C. Applicants are encouraged to Department of Labor reserves the right utilize, through partnerships or sub- to negotiate the amounts to be awarded into one of the following categories: • State and local Workforce awards/contracts, experienced public under this competition. Please be Investment Boards (WIBs), established agencies, private nonprofit advised that requests exceeding under sections 111 and 117 of the organizations, private businesses, faith- $250,000 will be considered non- Workforce Investment Act. based and community organizations, responsive. • Public agencies, meaning any and colleges and universities (especially 3. Period of Performance: The period public agency of a State or of a general those with traditionally high of performance will be for twelve (12) purpose political subdivision of a State enrollments of minorities) that have an months from date of award unless that has the power to levy taxes and understanding of unemployment and modified by the Grant Officer. It is spend funds, as well as general the barriers to employment unique to expected that successful applicants and/ corporate and police powers. (This homeless veterans, a familiarity with the or sub-awardees/contractors will begin typically refers to cities and counties.) A area to be served, and the capability to program operations under this State agency may propose in its effectively provide the necessary solicitation on July 1, 2004. All program application to serve one or more of the services. funds must be obligated by June 30, potential jurisdictions located in its D. To be eligible for enrollment under 2005; a limited amount of funds may be State. This does not preclude a city or this grant an individual must be obligated and reserved for follow-up county agency from submitting an homeless and a veteran defined as activities and closeout. application to serve its own jurisdiction. follows: 4. Optional Year(s) Funding: Should • For-profit/commercial entities. • The term ‘‘homeless or homeless Congress appropriate additional funds • Nonprofit organizations. If claiming individual’’ includes persons who lack for this purpose, VETS may consider 501(c)(3) status, the Internal Revenue a fixed, regular, and adequate nighttime two (2) optional years of funding. The Service statement indicating 501(c)(3) residence. It also includes persons Government does not, however, status approval must be submitted. whose primary nighttime residence is guarantee optional year(s) funding for To be eligible for a sub-award/ either a supervised public or private any grantee (or sub-awardees/ contract from an Intermediary Grantee, shelter designed to provide temporary contractors). In deciding whether to an organization must be a local, living accommodations; an institution exercise any optional year funding, grassroots non-profit entity that: that provides a temporary residence for VETS will consider grantee (including • Have social services as a major part individuals intended to be sub-awardees/contractors) overall of their mission; and institutionalized; or a public or private performance during the previous period • Are headquartered in the local place not designed for, or ordinarily of operations as follows: community to which they provide these used as, a regular sleeping A. The grantee and/or sub-awardees/ services; and accommodation for human beings. [42 contractors collectively must meet, at • Have a total annual operating U.S.C. 11302(a)]. minimum, 85% of the planned goals for budget of $300,000 or less or have seven • The term ‘‘veteran’’ means a person Federal expenditures, enrollments, and (7) or fewer full-time equivalent who served in the active military, naval, placements in each quarter and/or at employees. or air service, and who was discharged least 85% of planned cumulative goals Note: Qualifying applications from or released under conditions other than by the end of the third quarter; and grantees in the below listed States that are dishonorable. [38 U.S.C. 101(2)]

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IV. Application and Submission executive summary does not count Approach or strategy to increase Information against the 15-page limit. The executive employment and job retention: 1. Address To Request an Application summary should include: Applicants must be responsive to the • The proposed area to be served and Amendments: Application Rating Criteria contained in Section V(1) through the activities of this grant. announcements or forms will not be and address all of the rating factors as • Years of grantee’s service to the thoroughly as possible in the narrative. mailed. The Federal Register may be residents in the proposed area to be obtained from your nearest government The applicant must: served. • Describe the specific supportive office or library. Additional application • Projects and activities that will employment and training services to be packages may be obtained from the expedite the reintegration of homeless provided under this grant and the VETS Web site at http://www.dol.gov/ veterans into the workforce. sequence or flow of such services; vets and at http://www.fedgrants.gov/. • Summary of outcomes, benefits, • Indicate the type(s) of training that The application forms and their and value added by the project. will be provided and how it relates to instructions, and other pertinent B. Section 2—Technical Proposal the jobs that are in demand, length of materials are included in the consists of a narrative proposal that training, training curriculum, and how Appendices. If copies of the standard demonstrates the need for this particular the training will improve the eligible forms are needed, they can also be grant program, the services and veterans’ employment opportunities downloaded from: http:// activities proposed to obtain successful within that geographical area; www.whitehouse.gov/omb/grants/ outcomes for the homeless veterans to • Provide a follow-up plan that _ grants forms.html. be served; and the applicants’ and/or addresses retention after 90 and 180 To receive amendments to this sub-awardees’/contractors’ ability to days with participants who have Solicitation, all applicants must register collectively accomplish the expected entered employment; their name and address in writing with outcomes of the proposed project • Include the completed Planned the Grant Officer at the following design. Quarterly Technical Performance Goals address: U.S. Department of Labor, The technical proposal narrative must (and planned expenditures) form listed Procurement Services Center, Attn: not exceed fifteen (15) pages double- in Appendix D. Cassandra Mitchell, Reference SGA 04– spaced, font size no less than 11 pt., and Linkages with facilities that serve 05, 200 Constitution Avenue, NW., typewritten on one (1) side of the paper homeless veterans: Describe program Room N–5416, Washington, DC 20210, only. Note: Resumes, charts, standard and resource linkages with other Phone Number: (202) 693–4570 (not a forms, transmittal letters, facilities that will be involved in toll free number). Memorandums of Understanding, identifying potential clients for this 2. Content and Form of Application: agreements, lists of contracts and grants, program. Describe any networks with The grant application must consist of letters of support are not included in the other related resources and/or other three (3) separate and distinct sections: page count. If provided, include these programs that serve homeless veterans. the Executive Summary, the Technical documents as attachments to the Indicate how the program will be Proposal, and the Cost Proposal. The technical proposal. coordinated with any efforts that are information provided in these three (3) Required Content: There are program conducted by public and private sections is essential to gain an activities that all applications must agencies in the community. If a understanding of the programmatic and contain to be found technically Memorandum of Understanding (MOU) fiscal contents of the grant proposal. acceptable under this SGA. Programs or other service agreement with service A complete grant application package must be ‘‘employment focused’’ and providers exists, copies should be must include: must be responsive to the rating criteria provided. • An original blue ink-signed and two in Section V(1). The required activities Linkages with other providers of (2) copies of the cover letter. are: outreach, pre-enrollment employment and training services to • An original and two (2) copies of assessments, employment development homeless veterans: Describe the the Executive Summary (see below). plans for all clients, case management, networks the program will have with • An original and two (2) copies of job placement and job retention follow- other providers of services to homeless the Technical Proposal (see below) that up (at 90 and 180 days) after individual veterans; include a description of the includes a completed Technical enters employment, utilization/ relationship with other employment and Performance Goals Form (Appendix D). coordination of services with DVOP and training programs such as Disabled • An original and two (2) copies of LVER staff, and community linkages Veterans’ Outreach Program (DVOP), the the Cost Proposal (see below) that with other programs and services that Local Veterans’ Employment includes an original blue ink-signed provide support to homeless veterans. Representative (LVER) program, and Application for Federal Assistance, SF– The following format for the technical programs under the Workforce 424 (Appendix A), a Budget Narrative, proposal is recommended: Investment Act such as the Veterans’ Budget Information Sheet SF–424A Need for the program: The applicant Workforce Investment Program (VWIP); (Appendix B), an original blue ink- must identify the geographical area to be and list the type of services that will be signed and Assurances and served and provide an estimate of the provided by each. Note the type of Certifications Signature Page (Appendix number of homeless veterans in the agreement in place, if applicable. C), and Direct Cost Description for designated geographical area. Include Linkages with the workforce Applicants and Sub-applicants poverty and unemployment rates in the development system must be (Appendix E), and a completed Survey area and identify the disparities in the delineated. Describe any networks with on Ensuring Equal Opportunity for local community infrastructure that any other resources and/or other Applicants (Appendix F). exacerbate the employment barriers programs for homeless veterans. A. Section 1—Executive Summary: A faced by the targeted veterans. Include Indicate how the program will be one to two page ‘‘Executive Summary’’ labor market information and job coordinated with any efforts for the reflecting the grantees overall strategy, opportunities in the employment fields homeless that are conducted by agencies timeline, and outcomes to be achieved and industries that are in demand in the in the community. Indicate how the in their grant proposal is required. This geographical area to be served. applicant and/or sub-awardees/

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contractors will coordinate with any blue-ink) (Appendix A) must be any. Tangible, non-expendable, personal ‘‘continuum of care’’ efforts for the completed; property having a useful life of more homeless among agencies in the The Catalog of Federal Domestic than one year and a unit acquisition cost community. If a Memorandum of Assistance number for this program is of $5,000 or more per unit must be Understanding (MOU) or other service 17.805 and it must be entered on the specifically identified; and agreements with other service providers SF–424, in Block 10. • Identification of all sources of exists, copies should be provided. The organizational unit section of leveraged or matching funds and an Linkages with other Federal agencies: Block 5 of the SF–424 must contain the explanation of the derivation of the Describe program and resource linkages Dun and Bradstreet Number (DUNS) of value of matching/in-kind services. If with the Department of Housing and the applicant. Beginning October 1, resources/matching funds and/or the Urban Development (HUD), Department 2003, all applicants for Federal grant value of in-kind contributions are made of Health and Human Services (HHS), funding opportunities are required to available, please show in Section B of and Department of Veterans Affairs include a DUNS number with their the Budget Information Sheet. (DVA) including the Compensated Work application. See OMB Notice of Final (4) A completed Assurance and Therapy (CWT) and per diem programs. Policy Issuance, 68 Federal Register Certification signature page (Appendix If a Memorandum of Understanding 38402 (June 27, 2003). Applicants’ C) must be submitted; (MOU) or other service agreements with DUNS number should be entered into (5) All applicants must submit other service providers exists, copies Block 5 of SF–424. The DUNS number evidence of satisfactory financial should be provided. is a nine-digit identification number management capability, which must Proposed supportive service strategy that uniquely identifies business include recent (within the last 18 for veterans: Describe how supportive entities. There is no charge for obtaining months) financial and/or audit service resources for veterans will be a DUNS number. To obtain a DUNS statements. Grantees and sub-awardees/ obtained and used. If resources are number call 1–866–705–5711 or access contractors are required to utilize provided by other sources or linkages, the following Web site: http:// Generally Accepted Accounting such as Federal, State, local, faith-based www.dunandbradstreet.com/. Requests Practices (GAAP), maintain a separate and community organization programs for exemption from the DUNS number accounting for these grant funds, and or colleges and universities, including requirement must be made to the Office have a checking account; those with traditionally high of Management and Budget. (6) All applicants must include, as a enrollments of minorities, the applicant (2) A completed Standard Form SF– separate appendix, a list of all must fully explain the use of these 424A ‘‘Budget Information Sheet’’ employment and training government resources and how they will be applied. (Appendix B) must be included; grants and contracts that it has had in If a Memorandum of Understanding (3) As an attachment to SF–424A, the the past three (3) years, including grant/ (MOU) or other service agreements with applicant must provide a detailed cost contract officer contact information. other service providers exists, copies breakout of each line item on the Budget should be provided. VETS reserves the right to have a DOL Information Sheet. Please label this page representative review and verify this Organizational capability to provide or pages the ‘‘Budget Narrative’’ and required program activities: The data; ensure that costs reported on the SF– (7) A completed Survey on Ensuring applicant’s relevant current or prior 424A correspond accurately with the experience in operating employment Equal Opportunity for Applicants Budget Narrative; (Appendix F) must be provided. and training programs should be clearly The Budget Narrative must include, at 3. Submission Dates and Times described. A summary narrative of a minimum: program experience and employment • Breakout of all personnel costs by (Acceptable Methods of Submission): and training performance outcomes is position, title, salary rates, and percent The grant application package must be required. The applicant should provide of time of each position to be devoted received at the designated place by the information showing outcomes of all to the proposed project (including sub- date and time specified or it will not be past employment and training programs awardees/contractors) by completing the considered. Any application received at in terms of enrollments and placements. ‘‘Direct Cost Descriptions for Applicants the Office of Procurement Services after An applicant that had operated a HVRP, and Sub-Applicants’’ form (Appendix 4:45 p.m. e.t., May 13, 2004, will not be other Homeless Employment and E); considered unless it is received before Training program, or VWIP program • Explanation and breakout of the award is made and: • must include the final or most recent extraordinary fringe benefit rates and It is determined by the Government technical performance reports. The associated charges (i.e., rates exceeding that the late receipt was due solely to applicant must also provide evidence of 35% of salaries and wages); mishandling by the Government after key staff capability. It is preferred that • Explanation of the purpose and receipt at the U.S. Department of Labor grantee be well established and not in composition of, and method used to at the address indicated; or the start-up phase or process. derive the costs of, each of the • It was sent by registered or certified Proposed housing strategy for following: travel, equipment, supplies, mail not later than the fifth calendar day homeless veterans: Describe how sub-awards/contracts, and any other before May 13, 2004; or housing resources for eligible homeless costs. The applicant must include costs • It was sent by U.S. Postal Service veterans will be obtained or accessed. of any required travel described in this Express Mail Next Day Service-Post These resources must be from linkages Solicitation. Mileage charges may not Office to Addressee, not later than 5:00 or sources other than the HVRP grant exceed 37.5 cents per mile or the p.m. at the place of mailing two (2) such as HUD, HHS, community housing current Federal rate; working days, excluding weekends and resources, DVA leasing, or other • All associated costs for retaining Federal holidays, prior to May 13, 2004. programs. participant information pertinent to the 4. Intergovernmental Review: Not C. Section 3—The Cost Proposal must follow-up survey, 180 days after the Applicable. contain the following: (1) Standard Form program performance period ends; 5. Funding Restrictions: SF–424, ‘‘Application for Federal • Description/specification of, and A. Proposals exceeding $250,000 will Assistance,’’ (with the original signed in justification for, equipment purchases, if be considered non-responsive.

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B. There is a limit of one (1) government (also known as application sent by U.S. Postal Service application per submitting organization ‘‘discretionary’’ funding), as opposed to Express Mail Next Day Service-Post and location. If two (2) applications funding that it receives from a State or Office to Addressee is the date entered from the same organization for the same local government (also known as by the Post Office clerk on the ‘‘Express location are submitted, the application ‘‘indirect’’ or ‘‘block grant’’ funding). In Mail Next Day Service-Post Office to with the later date will be considered this SGA, the term ‘‘direct’’ has the Addressee’’ label and the postmark on non-responsive. former meaning. the envelope or wrapper and on the C. Due to the limited availability of G. Limitations on Administrative and original receipt from the U.S. Postal funding, if an organization was awarded Indirect Costs: Service. ‘‘Postmark’’ has the same • Fiscal Year 2003 HVRP funds for a Administrative costs, which consist meaning as defined above. Therefore, specific location and will be receiving of all direct and indirect costs applicants should request that the postal second and possible third year funding, associated with the supervision and clerk place a legible hand cancellation that organization at that specific management of the program, are limited ‘‘bull’s-eye’’ postmark on both the location will be considered ineligible to to and will not exceed 20% of the total receipt and the envelope or wrapper. compete for FY 2004 HVRP funds. grant award. • The only acceptable evidence to D. There will not be reimbursement of Indirect costs claimed by the establish the time of receipt at the U.S. pre-award costs unless specifically applicant must be based on a Federally Department of Labor is the date/time agreed upon in writing by the approved rate. A copy of the negotiated stamp of the Procurement Services Department of Labor. approved and signed indirect cost Center on the application wrapper or E. Entities described in section negotiation agreement must be other documentary evidence or receipt 501(c)(4) of the Internal Revenue Code submitted with the application. maintained by that office. Applications that engage in lobbying activities are not Furthermore, indirect costs are sent by other delivery services, such as eligible to receive funds under this considered a part of administrative costs Federal Express, UPS, etc., will also be announcement because section 18 of the for HVRP purposes and, therefore, may accepted. Lobbying Disclosure Act of 1995, Public not exceed 20% of the total grant award. All applicants are advised that U.S. Law 104–65, 109 Stat. 691, prohibits the • If the applicant does not presently mail delivery in the Washington, DC, award of Federal funds to these entities. have an approved indirect cost rate, a area has been erratic due to security and F. The government is prohibited from proposed rate with justification may be directly funding religious activity.* submitted. Successful applicants will be anthrax concerns. All applicants must HVRP grants may not be used for required to negotiate an acceptable and take this into consideration when religious instruction, worship, prayer, allowable rate within 90 days of grant preparing to meet the application proselytizing or other inherently award with the appropriate DOL deadline, as you assume the risk for religious practices. Neutral, secular Regional Office of Cost Determination or ensuring a timely submission, that is, if, criteria that neither favor nor disfavor with the applicant’s cognizant agency because of these mail problems, the religion must be employed in the for indirect cost rates (See Office of Department does not receive an selection of grant and sub-awardees/ Management and Budget Web site at application or receives it too late to give contractors grant recipients. In addition, http://www.whitehouse.gov/omb/grants/ proper consideration, even if it was under the Workforce Investment Act atttach.html). timely mailed, the Department is not (WIA) and Department of Labor • Indirect cost rates traceable and required to consider the application. regulations implementing the WIA, a trackable through the State Workforce V. Application Review Information recipient may not train a participant in Agency’s Cost Accounting System religious activities, or permit represent an acceptable means of 1. Application Evaluation Criteria participants to construct, operate, or allocating costs to DOL and, therefore, Applications will receive up to 100 maintain any part of a facility that is can be approved for use in grants to total points based on the following primarily used or devoted to religious State Workforce Agencies. criteria: instruction or worship. Under WIA, ‘‘no 6. Other Submission Requirements: individual shall be excluded from The only acceptable evidence to A. Need for the Project: 10 Points participation in, denied the benefits of, establish the date of mailing of a late The applicant will document the need subjected to discrimination under, or application sent by registered or for this project, as demonstrated by: (i) denied employment in the certified mail is the U.S. Postal Service The potential number or concentration administration of or in connection with, postmark on the envelope or wrapper of homeless individuals and homeless any such program or activity because of and on the original receipt from the U.S. veterans in the proposed project area race, color, religion, sex (except as Postal Service. If the postmark is not relative to other similar areas of otherwise permitted under Title IX of legible, an application received after the jurisdiction, (ii) the rates of poverty the Education Amendments of 1972), above closing time and date shall be and/or unemployment in the proposed national origin, age, disability, or processed as if mailed late. ‘‘Postmark’’ project area as determined by the census political affiliation or belief.’’ means a printed, stamped or otherwise or other surveys; and (iii) the extent of * The term ‘‘direct’’ funding is used to placed impression (not a postage meter the gaps in the local infrastructure to describe funds that are provided machine impression) that is readily effectively address the employment ‘‘directly’’ by a governmental entity or identifiable without further action as barriers that characterize the target an intermediate organization with the having been applied and affixed by an population. same duties as the government entity, as employee of the U.S. Postal Service on B. Overall Strategy To Increase opposed to funds that an organization the date of mailing. Therefore applicants Employment and Retention in receives as the result of the genuine and should request that the postal clerk Employment: 35 Points independent private choice of a place a legible hand cancellation ‘‘bull’s- beneficiary. In other contexts, the term eye’’ postmark on both the receipt and The application must include a ‘‘direct’’ funding may be used to refer to the envelope or wrapper. description of the approach to providing those funds that an organization The only acceptable evidence to comprehensive employment and receives directly from the Federal establish the date of mailing of a late training services, including job training,

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job development, obtaining employer employment and training programs and review panel will screen all applicant commitments to hire, placement and providing services to participants cost proposals to ensure expenses are post-placement follow-up services. similar to those that are proposed under allocable, allowable, and reasonable. If Applications must address how they this solicitation. Specific outcomes the review panel concludes that the cost will target occupations in emerging previously achieved by the applicant proposal contains an expense(s) that is industries. Supportive services provided and/or sub-awardees/contractors must not allocable, allowable, and/or as part of the strategy of promoting job be described, such as job placements, reasonable, the application may be readiness and job retention must be benefits secured, network coalitions, considered ineligible for funding. indicated. The applicant must identify etc. The applicant and/or sub-awardees/ Further, VETS and the Grant Officer the local services and sources of training contractors must also address its will consider applicant information to be used for participants. At least 80% capacity for timely startup of the concerning the proposed cost per of enrolled participants must participate program, programmatic reporting, and placement, percentage of participants in training services. A description of the participant tracking. The applicant and/ placed into unsubsidized employment, relationship, if any, with other or sub-awardees/contractors should average wage at placement, and 180-day employment and training programs such describe its staff experience and ability retention in employment percentage. as State Workforce Agencies (including to manage the administrative, The national average cost per placement DVOP and LVER Programs), One-Stops, programmatic and financial aspects of a for HVRP for last year was $2,100. VWIP, other WIA programs, and grant program. Include a recent (within The Government reserves the right to Workforce Investment or Development the last 18 months) financial statement ask for clarification on any aspect of a Boards or entities where in place, must or audit. Final or most recent technical grant application. The Government also be specified. Applications must indicate reports for other relevant employment reserves the right to discuss any how the activities will be tailored or and training programs must be potential grantee concerns amongst responsive to the needs of homeless submitted, if applicable. Because prior Department of Labor staff. The veterans. A participant flow chart may HVRP grant experience is not a Government further reserves the right to be used to show the sequence and mix requirement for this grant, some select applicants out of rank order if of services. applicants may not have any technical such a selection would, in its opinion, Note: The applicant must complete performance reports to submit. result in the most effective and Appendix D, the Technical Performance E. Quality of Overall Housing Strategy: appropriate combination of funding, Goals Form, with proposed programmatic 10 Points program, and administrative costs, e.g., outcomes, including participants served, cost per enrollment and placement, placement/entered employments and job The application must demonstrate demonstration models, and geographic retention. Of the 35 points possible in the how the applicant and/or sub-awardees/ strategy to increase employment and service areas. The Grant Officer’s contractors propose to obtain or access determination for award under SGA 04– retention, 5 points will be awarded to grant housing resources for veterans in the proposals that demonstrate the ability to 05 is the final agency action. The maintain a six-month employment retention program and entering the labor force. submission of the same proposal from rate of 50 percent or greater. Applicants This discussion should specify the any prior year HVRP competition does whose applications persuasively propose to provisions made to access temporary, not guarantee an award under this use peer counselors who are themselves transitional, and permanent housing for Solicitation. veterans will be awarded five (5) of the participants through community available points in the scoring criteria. resources, HUD, DVA lease, or other VI. Award Administration Information means. HVRP funds may not be used for 1. Award Notices C. Quality and Extent of Linkages With housing or vehicles. Other Providers of Services to the A. The Notice of Award signed by the Homeless and to Veterans: 20 Points 2. Review and Selection Process Grant Officer is the authorizing The application must provide Applications will initially be screened document and will be provided through information on the quality and extent of to ensure timeliness, completeness, and postal mail and/or by electronic means the linkages this program will have with responsiveness to the SGA to the authorized representative as listed other providers of services to homeless requirements. Applications that satisfy on the SF-424 Grant Application. Notice veterans in the local community this initial screening will receive further that an organization has been selected as including faith-based and community review as explained below. a grant recipient does not constitute organizations. For each service, the Technical proposals will be reviewed approval of the grant application as applicant must specify who the provider by a Department of Labor review panel submitted. Before the actual grant is, the source of funding (if known), and using the point scoring system specified award, the Grant Officer may enter into the type of linkages/referral system above in Section V(1). The review panel negotiations concerning such items as established or proposed. Describe, to the will assign scores after careful program components, funding levels, extent possible, how the project would evaluation by each panel member and and administrative systems. If the be incorporated into the community’s rank applications based on this score. negotiations do not result in an continuum of care approach to respond The ranking will be the primary basis to acceptable submittal, the Grant Officer to homelessness and show any linkages identify applicants as potential grantees. reserves the right to terminate the to HUD, HHS or DVA programs that will The review panel may establish a negotiation and decline to fund the be advantageous to the proposed competitive range and/or a minimum proposal. program. qualifying score, based upon the B. A post-award conference will be proposal evaluation, for the purpose of held for those grantees awarded FY D. Demonstrated Capability in Providing selecting qualified applicants. The 2004 HVRP funds through this Required Program Services, Including review panel’s conclusions are advisory competition. The post-award conference Programmatic Reporting and Participant in nature and not binding on the Grant is expected to be held in July or August Tracking: 25 Points Officer. 2004. Up to two (2) representatives must The applicant must describe its Cost proposals will be considered in be present; a financial and a program relevant prior experience in operating two (2) ways. The Department of Labor representative are recommended. The

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site of the post-award conference has Labor, Effectuation of Title VI of the (including sub-awardees/contractors not yet been determined, however, for Civil Rights Act of 1964; information) showing the results and planning and budgeting purposes, Nondiscrimination on the Basis of performance as of the 180th day after please allot five (5) days and use Handicap in Programs and Activities; the grant period, and containing the Washington, DC, as the conference site. and Nondiscrimination on the Basis of following: The post-award conference will focus Sex in Education Programs Receiving or (1) Final Financial Status Report SF– on providing information and assistance Benefiting from Federal Financial 269A Short Form (if not previously on reporting, record keeping, grant Assistance. submitted); and requirements, and also include best (2) Final Narrative Report identifying: 3. Reporting practices from past projects. Costs (a) The total combined (directed/ associated with attending this The grantee will submit the reports assisted) number of veterans placed into conference for up to two grantee and documents listed below: employment during the entire grant period; representatives will be allowed as long A. Quarterly Financial Reports as they were incurred in accordance (b) The number of veterans still with Federal travel regulations. Such No later than 30 days after the end of employed after the 180 day follow-up costs must be charged as administrative each Federal fiscal quarter, the grantee period; costs and reflected in the proposed must report outlays, program income, (c) If the veterans are still employed budget. and other financial information at the same or similar job, if not, what (including sub-awardees/contractors are the reason(s); 2. Administrative and National Policy information) on a federal fiscal quarterly (d) Whether training received was Requirements basis using SF–269A, Financial Status applicable to jobs held; Unless specifically provided in the Report, Short Form and submit a copy (e) Wages at placement and during grant agreement, DOL’s acceptance of a of the HHS/PMS 272 drawdown report. follow-up period; proposal and an award of Federal funds These reports must cite the assigned (f) An explanation regarding why to sponsor any program(s) does not grant number and be submitted to the those veterans placed during the grant, provide a waiver of any grant appropriate State Director for Veterans’ but not employed at the end of the requirements and/or procedures. For Employment and Training (DVET). follow-up period, are not so employed; example, the OMB circulars require that and B. Quarterly Program Reports an entity’s procurement procedures (g) Any recommendations to improve must provide all procurement No later than 30 days after the end of the program. transactions will be conducted, as the Federal fiscal quarter, grantees also VII. Agency Contact practical, to provide open and free must submit a Quarterly Technical Questions and applications are to be competition. If a proposal identifies a Performance Report (including sub- forwarded to: U.S. Department of Labor, specific entity to provide the services, awardees/contractors information) to Procurement Services Center, Attn: the DOL award does not provide the the DVET that contains the following: Cassandra Mitchell, Reference SGA 04– justification or basis to sole-source the (1) A comparison of actual 05, 200 Constitution Avenue, NW., procurement, i.e., avoid competition. accomplishments to planned goals for Room N–5416, Washington, DC 20210, All grants will be subject to the the reporting period in spreadsheet Phone Number: (202) 693–4570 (this is following administrative standards and format (to be provided after grant award) not a toll free number). provisions, as applicable to the and any findings related to monitoring Resources for the Applicant: particular grantee and/or sub-awardees/ efforts; Applicants may review ‘‘VETS’ Guide to contractors: (2) An explanation for variances of • 29 CFR part 93—Lobbying. plus or minus 15% of planned program Competitive and Discretionary Grants’’ • and/or expenditure goals, to include: located at http://www.dol.gov/vets/ 29 CFR part 95—Uniform _ _ Administrative Requirements for Grants Identification of a corrective action that grants/Final VETS Guide-linked.pdf. and Agreements with Institutions of will be taken to meet the planned goals, Applicants may also find these Higher Education, Hospitals, and other if required; and a timetable for resources useful: America’s Service Nonprofit Organizations, and with accomplishment of the corrective Locator http://www.servicelocator.org/ Commercial Organizations. action. provides a directory of our nation’s One- • 29 CFR part 96—Federal Standards Stop Career Centers; the National C. 90-Day Follow-Up Report for Audit of Federally Funded Grants, Association of Workforce Boards Contracts and Agreements. No later than 120 days after the grant maintains an Internet site (http:// • 29 CFR part 97—Uniform performance period expiration date, the www.nawb.org/asp/wibdir.asp) that Administrative Requirements for Grants grantee must submit a follow-up report contains contact information for the and Cooperative Agreements to State (including sub-awardees/contractors State and local Workforce Investment and Local Governments. information) showing results and Boards; and the homepage for the • 29 CFR part 98—Federal Standards performance as of the 90th day after the Department of Labor, Center for Faith- for Government-wide Debarment and grant period, and containing the Based & Community Initiatives (http:// Suspension (Non procurement) and following: www.dol.gov/cfbci). Government-wide Requirements for (1) Final Financial Status Report SF– Comments: Comments are to be Drug-Free Workplace (Grants). 269A Short Form (that zeros out all submitted to the Veterans’ Employment • 29 CFR part 99—Audit of States, unliquidated obligations); and and Training Service (VETS), U.S. Local Governments, and Nonprofit (2) Technical Performance Report Department of Labor, Room S–1312, 200 Organization. including updated goals chart. Constitution Avenue, NW., Washington, • 29 CFR parts 30, 31, 32, 33 and 36— DC 20210, telephone (202) 693–4701 Equal Employment Opportunity in D. 180-Day Follow-Up Report (this is not a toll free number). Written Apprenticeship and Training; No later than 210 days after the grant comments are limited to ten (10) pages Nondiscrimination in Federally performance expiration date, the grantee or fewer and may be transmitted by Assisted Programs of the Department of must submit a follow-up report facsimile to (202) 693–4755. Receipt of

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submissions, whether by U.S. mail, e- Signed at Washington, DC, this 6th day of Signature Page mail, or facsimile transmittal, will not April, 2004. Appendix D: Quarterly Technical be automatically acknowledged; Lisa Harvey, Performance Goals Form however, the sender may request Acting Grant Officer. Appendix E: Direct Cost Descriptions for Applicants and Sub-Applicants confirmation that a submission has been Appendices Appendix F: Survey on Ensuring Equal received, by telephoning VETS at (202) Appendix A: Application for Federal 693–4701 or (202) 693–4753 (TTY/ Opportunity for Applicants Assistance SF–424 Appendix G: The Glossary of Terms TDD). Appendix B: Budget Information Sheet SF– Appendix H: List of Common Acronyms 424A Appendix C: Assurances and Certifications BILLING CODE 4510–79–P

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[FR Doc. 04–8187 Filed 4–12–04; 8:45 am] address the complex problems facing strategies for employment and retention BILLING CODE 4510–79–C homeless veterans. Successful of employment for homeless veterans. applicants will design programs that Successful applicants will design assist eligible veterans by providing job programs that assist eligible veterans by DEPARTMENT OF LABOR placement services, job training, providing job placement services, job counseling, supportive services, and training, counseling, supportive Veterans Employment and Training other assistance to expedite the services, and other assistance to Service reintegration of homeless veterans into expedite the reintegration of homeless the labor force. Successful programs veterans into the labor force. Successful Non-Urban Homeless Veterans’ will also be designed to be flexible in applicants will also design programs Reintegration Program (HVRP) Grants addressing the universal as well as the that are flexible in addressing the for Program Year (PY) 2004 local or regional problems that have had universal as well as the local or regional Funding Opportunity: Non-Urban a negative impact on homeless veterans problems that have had a negative Homeless Veterans’ Reintegration reentering the workforce. impact on homeless veterans reentering Program (HVRP) Grants for Program Under this solicitation covering Fiscal the workforce. The HVRP in PY 2004 Year (PY) 2004. Year (FY) 2004, VETS anticipates that will seek to continue to strengthen Announcement Type: Initial up to $1,600,000 will be available for development of effective service Solicitation for Grant Applications grant awards up to a maximum of delivery systems, to provide (SGA). $200,000 for each grant award. VETS comprehensive services through a case Funding Opportunity Number: SGA expects to award approximately eight management approach that address 04–04. (8) grants. This notice contains all of the complex problems facing eligible Catalogue of Federal Domestic necessary information and forms to veterans trying to transition into gainful Assistance #: 17–805. apply for grant funding. The period of employment, and to improve strategies Date(s): Applications are due on May performance for these PY 2004 grants for employment and retention in 13, 2004. Period of Performance is PY will be July 1, 2004 through June 30, employment. 2004, July 1, 2004 through June 30, 2005. Two (2) optional years of funding The only jurisdictions eligible to be 2005. may be available, depending upon served through this Non-Urban HVRP Executive Summary (Applicants For Congressional funding appropriations, competition in PY 2004 are the Grant Funds Should Read This Notice the agency’s decision to exercise the metropolitan areas outside of the 75 In Its Entirety): The U.S. Department of optional year(s) of funding, and U.S. cities largest in population and the Labor (USDOL), Veterans’ Employment satisfactory grantee performance. city of San Juan, Puerto Rico (See and Training Service (VETS), announces Appendix I). a grant competition that complies with I. Funding Opportunity Description the requirements of 38 U.S.C. 2021, as The U.S. Department of Labor 2. Community Awareness Activities added by section 5 of Public Law 107– (USDOL), Veterans’ Employment and In order to promote networking 95, the Homeless Veterans Training Service (VETS), announces a between the HVRP funded program and Comprehensive Assistance Act of 2001 grant competition that complies with local service providers (and thereby (HVCAA). Section 2021 requires the the requirements of 38 U.S.C. 2021, as eliminate gaps or duplication in services Secretary of Labor to conduct, directly added by section 5 of Public Law 107– and enhance the provision of assistance or through grant or contract, such 95, the Homeless Veterans to participants), the grantee must programs as the Secretary determines Comprehensive Assistance Act of 2001 provide project orientation workshops appropriate to expedite the reintegration (HVCAA). Section 2021 requires the and/or program awareness activities that of homeless veterans into the labor Secretary of Labor to conduct, directly it determines are the most feasible for force. or through grant or contract, such the types of providers listed below. The Homeless Veterans’ Reintegration programs as the Secretary determines Grantees are encouraged to demonstrate Program (HVRP) grants are designated appropriate to provide job training, strategies for incorporating small faith- in three (3) award categories: urban, counseling, and placement services based and community organizations non-urban, and intermediaries. Separate (including job readiness, literacy (defined as organizations with social Solicitations for Grant Applications training, and skills training) to expedite services budgets of approximately (SGAs) are being issued for each grant the reintegration of homeless veterans $300,000 or seven (7) or fewer full-time category. This is the solicitation for into the labor force. employees) into their outreach plans. ‘‘Non-Urban HVRP grants.’’ Previous Project orientation workshops HVRP grants have provided valuable 1. Program Concept and Emphasis conducted by grantees have been an information on approaches and HVRP grants are intended to address effective means of sharing information techniques that work in the different two objectives: (a) to provide services to and informing the community of the environments. The only jurisdictions assist in reintegrating homeless veterans availability of other services; they are that are eligible to be served through into meaningful employment within the encouraged but not mandatory. Rather, this non-urban competition for HVRPs labor force, and (b) to stimulate the grantees will have the flexibility to are the metropolitan areas outside of the development of effective service attend service provider meetings, 75 U.S. cities largest in population and delivery systems that will address the seminars, and conferences, to outstation the city of San Juan, Puerto Rico (see complex problems facing homeless staff, and to develop individual service Appendix I). veterans. contracts as well as to involve other HVRP grants are intended to address For this Fiscal Year (FY) 2004 grant agencies in program planning. two objectives: (1) To provide services solicitation, VETS seeks applicants that The grantee will be responsible for to assist in reintegrating homeless will provide direct services through a providing project awareness, program veterans into meaningful employment case management approach that information, and orientation activities within the labor force, and (2) to networks with Federal, State, and local to the following: stimulate the development of effective resources for veteran support programs. A. Direct providers of services to service delivery systems that will Successful applicants will have clear homeless veterans including shelter and

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soup kitchen operators: to make them 3. Scope of Program Design Veterans of America, the American aware of the services available to Veterans (AMVETS). The project design must include the homeless veterans to make them job- G. Referral as necessary to health care, following services: ready and to aid their placement into counseling, and rehabilitative services jobs. A. Outreach, intake, assessment, peer including, but not limited to: alcohol counseling to the degree practical, and drug rehabilitation, therapeutic B. Federal, State, and local employment services, and follow-up services, Post Traumatic Stress Disorder entitlement and social service agencies support services to enhance retention in (PTSD) services, mental health services, such as the Social Security employment. Program staff providing as well as coordination with McKinney Administration (SSA), Department of outreach services should have Homeless Assistance Act (MHAA) Title Veterans Affairs (DVA), State Workforce experience in dealing with, and an VI programs for health care for the Agencies (SWAs) and their local One- understanding of the needs of, homeless homeless, and health care programs Stop Centers (which integrate Workforce veterans. under the Homeless Veterans Investment Act, labor exchange, and B. Provision of or referral to Comprehensive Assistance Act of 2001. other employment and social services), employment services such as: job search H. Referral to housing assistance, as mental health services, and healthcare workshops, job counseling, assessment appropriate, provided by: local shelters, detoxification facilities: to familiarize of skills, resume writing techniques, Federal Emergency Management them with the nature and needs of interviewing skills, subsidized trial Administration (FEMA) food and shelter homeless veterans. employment (work experience), job programs, transitional housing programs C. Civic and private sector groups, in development services, job placement and single room occupancy housing particular Veterans’ Service into unsubsidized employment, job programs funded under MHAA Title IV Organizations, support groups, job placement follow-up services to (and under HVCAA), and permanent training and employment services, and enhance retention in employment. housing programs for disabled homeless community-based organizations C. Provision of or referral to training persons funded under MHAA Title IV (including faith-based organizations): to services such as: basic skills instruction, (and under HVCAA). remedial education activities, life skills 4. Results-Oriented Model: No specific provide information on homeless model is mandatory, but the applicant veterans and their needs. and money management training, on- the-job training, classroom training, must design a program that is The grantee will also be responsible vocational training, specialized and/or responsive to the needs of the local ‘‘ for participating in Stand Down’’ licensing training programs, and other community and achieves the HVRP ‘‘ events. A Stand Down’’ is an event formal training programs as deemed objectives. The HVRP objectives are to held in a locality, usually for three (3) appropriate to benefit the participant. At successfully reintegrate homeless days, where services are provided to least 80% of the enrolled HVRP veterans into the workforce and to homeless veterans along with shelter, participants must participate in training stimulate the development of effective meals, clothing, employment services, activities. service delivery systems that will address the complex problems facing and medical attention. This type of D. Grantees will perform a event is mostly a volunteer effort, which homeless veterans. preliminary assessment of each Under the Government Performance is organized within a community and participant’s eligibility for Department brings service providers together such as and Results Act (GPRA), Congress and of Veterans Affairs (DVA) service- the public are looking for program the Department of Veterans Affairs connected disability, compensation, (DVA), Disabled Veterans’ Outreach results rather than program processes. and/or pension benefits. As appropriate, The outcome measurement established Program Specialists (DVOPs) and Local grantees will work with the Veterans Veterans’ Employment Representatives for HVRP grants is for grantees to meet Service Organizations or refer the a minimum entered employment rate of (LVERs) from the State Workforce participants to DVA in order to file a Agencies, Veteran Service 58%, determined by dividing the claim for compensation or pension. number of entered employments by the Organizations, military personnel, civic Grantees will track progress of claims leaders, and a variety of other interested number of HVRP enrollments. (Actual and report outcomes in case performance outcomes will be reported persons, groups, and organizations. management records. Many services are provided on-site with quarterly in spreadsheet format to be E. Coordination with veterans’ provided to grantees at the post award referrals also made for continued services programs, including: Disabled assistance after the Stand Down event. conference.) While the percentage of Veterans’ Outreach Program Specialists HVRP enrollments that entered These events can often be the catalyst (DVOPs), Local Veterans’ Employment employment is an important outcome, it that enables homeless veterans to get Representatives (LVERs) in the State is also necessary to evaluate and back into mainstream society. The Workforce Agencies (SWAs) or in the measure the program long-term results, Department of Labor has supported workforce development system’s One- through the 90-day and 180-day follow- replication of these events and many Stop Centers, as well as Veterans’ up period, to determine the quality and have been held throughout the nation. Workforce Investment Programs success of the program. In areas where an HVRP is operating, (VWIPs), Department of Veterans Affairs The applicant’s program should be grantees are expected and encouraged (DVA) services, including its Health based on a results-oriented model. The to participate fully and offer their Care for Homeless Veterans, Domiciliary first phase of activity should consist of services for all locally planned Stand Care, Regional Benefits Assistance the level of outreach necessary to Down event(s). Toward this end, up to Program, and Transitional Housing introduce the program to eligible $5,000 of the currently requested HVRP under Homeless Provider Grant and per homeless veterans. Outreach also grant funds may be used to supplement diem programs. includes establishing contact with other the Stand Down efforts, where funds are F. Networking with Veterans’ Service agencies that encounter homeless not otherwise available, and may be Organizations such as: The American veterans. Once the eligible homeless requested in the budget and explained Legion, Disabled American Veterans, veterans have been identified, an in the budget narrative. Veterans of Foreign Wars, Vietnam assessment must be made of each

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individual’s abilities, interests, needs, veterans after placement to ensure that due dates and must be verifiable for and barriers to employment. In some employment-related problems are accuracy. cases, homeless veterans may require addressed. The 90-day and 180-day III. Eligibility Information referrals to services such as follow-ups are fundamental to assessing rehabilitation, drug or alcohol program results. Grantees need to 1. Eligible Applicants: Applications treatment, or a temporary shelter before budget for 90-day and 180-day follow- for funds will be accepted from State they can be enrolled into HVRP. Once up activity so that it can be performed and local Workforce Investment Boards, the eligible homeless veteran is for those HVRP enrolled participants local public agencies, for-profit/ ‘‘stabilized,’’ the assessment must placed at or near the end of the grant commercial entities, and nonprofit concentrate on the employability of the performance period. All grantees, prior organizations, including faith-based and individual and whether the individual to the end of the grant performance community organizations. Applicants is to be enrolled into the HVRP program. period, must obligate sufficient funds to must have a familiarity with the area A determination should be made as to ensure that follow-up activities are and population to be served and the whether the individual would benefit completed. Such results will be reported ability to administer an effective and from pre-employment preparation such in the final technical performance timely program. as resume writing, job search report. Eligible applicants will generally fall workshops, related counseling, and case into one of the following categories: II. Award Information management, or possibly an initial entry • State and local Workforce into the job market through temporary 1. Type of Funding Instrument: One Investment Boards (WIBs), established jobs. Additionally, sheltered work (1) year grant. under sections 111 and 117 of the environments, classroom training and/ 2. Funding Levels: The total funding Workforce Investment Act. or on-the-job training must be evaluated. available for this Non-Urban HVRP • Public agencies, meaning any Such services should be noted in an solicitation is up to $1,600,000. It is public agency of a State or of a general Employability Development Plan to anticipated that approximately eight (8) purpose political subdivision of a State facilitate the staff’s successful awards will be made under this that has the power to levy taxes and monitoring of the plan. Entry into full- solicitation. Awards are expected to spend funds, as well as general time employment or a specific job- range from $100,000 to a maximum of corporate and police powers. (This training program should follow, in $200,000. The Department of Labor typically refers to cities and counties.) A keeping with the overall objective of reserves the right to negotiate the State agency may propose in its HVRP, to bring the participant closer to amounts to be awarded under this application to serve one or more of the self-sufficiency. Supportive services competition. Please be advised that potential jurisdictions located in its may assist the HVRP enrolled requests exceeding $200,000 will be State. This does not preclude a city or participant at this point or even earlier. considered non-responsive. county agency from submitting an Job development, a crucial part of the 3. Period of Performance: The period application to serve its own jurisdiction. employability process, is usually when of performance will be for twelve (12) • For-profit/commercial entities. there are no competitive job openings months from date of award unless • Nonprofit organizations. If claiming that the HVRP enrolled participant is modified by the Grant Officer. It is 501(c)(3) status, the Internal Revenue qualified to apply for, therefore, a job expected that successful applicants will Service statement indicating 501(c)(3) opportunity is created or developed begin program operations under this status approval must be submitted. specifically for that HVRP enrolled solicitation on July 1, 2004. All program participant with an employer. HVRP Note: Qualifying applications from funds must be obligated by June 30, enrolled participants who are ready to grantees in the below listed States that are 2005; a limited amount of funds may be enter employment and/or who are in not currently receiving HVRP funds (and are obligated and reserved for follow-up need of intensive case management not listed on Appendix I) may receive activities and closeout. priority funding over applicants in those services are to be referred to the DVOP States that are currently receiving HVRP and LVER staff at a One-Stop Center. 4. Optional Year Funding: Should Congress appropriate additional funds funds: Alaska, Idaho, Montana, North Dakota, DVOP and LVER staff are able to South Dakota, Vermont, and Wyoming. provide HVRP enrolled participants the for this purpose, VETS may consider an following services: job development, optional two (2) years of funding. The 2. Cost Sharing: Cost sharing and/or employment services, case management Government does not, however, matching funds are not required. and career counseling. Most DVOP and guarantee optional year funding for any However, we do encourage the use of LVER staff received training in case grantee. In deciding whether to exercise sharing and/or matching funds. management at the National Veterans’ any optional year(s) of funding, VETS 3. Other Eligibility Criteria: Training Institute. All DVOP and LVER will consider grantee performance A. This SGA is for Non-Urban HVRP staff provide employment related during the previous period of operations grants. Separate SGAs for urban and services to veterans who are most at a as follows: intermediaries HVRP grants have been disadvantage in the labor market. VETS’ A. The grantee must meet, at simultaneously issued. urges working hand-in-hand with minimum, 85% of planned goals for B. The proposal must include an DVOP/LVER staff to achieve economies Federal expenditures, enrollments, and outreach component that uses either of resources. placements into employment in each DVOP/LVER staff or a trained outreach The applicant’s program must include quarter and/or at least 85% of planned cadre. Programs must be ‘‘employment tracking of program participants. cumulative goals by the end of the third focused.’’ The services provided must Tracking should begin with the referral quarter; and be directed toward: (1) Increasing the to employment and continue through B. The grantee must be in compliance employability of homeless veterans the 90-day and 180-day follow-up with all terms identified in the through training or arranging for the periods after entering employment to Solicitation for Grant Application (SGA) provision of services that will enable determine whether the veteran is in the and grant award document; and them to work; and (2) matching same or similar job. It is important that C. All program and fiscal reports must homeless veterans with potential the grantee maintain contact with have been submitted by the established employers.

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C. Applicants are encouraged to Phone Number: (202) 693–4570 (not a Understanding, agreements, lists of contracts utilize, through partnerships or sub- toll free number). and grants, and letters of support are not awards, experienced public agencies, 2. Content and Form of Application: included in the page count. If provided, private nonprofit organizations, private The grant application must consist of include these documents as attachments to the technical proposal. businesses, faith-based and community three (3) separate and distinct sections: organizations, and colleges and The Executive Summary, the Technical Required Content: There are program universities (especially those with Proposal, and the Cost Proposal. The activities that all applications must traditionally high enrollments of information provided in these three (3) contain to be found technically minorities) that have an understanding sections is essential to gain an acceptable under this SGA. Programs of unemployment and the barriers to understanding of the programmatic and must be ‘‘employment focused’’ and employment unique to homeless fiscal contents of the grant proposal. must be responsive to the rating criteria veterans, a familiarity with the area to A complete grant application package in Section V(1). The required activities be served, and the capability to must include: are: outreach, pre-enrollment • effectively provide the necessary An original blue ink-signed and two assessments, employment development services. (2) copies of the cover letter. plans for all clients, case management, • D. To be eligible for participation An original and two (2) copies of job placement and job retention follow- under this grant an individual must be the Executive Summary (see below). up (at 90 and 180 days) after individual • An original and two (2) copies of homeless and a veteran defined as enters employment, utilization/ the Technical Proposal (see below) that follows: coordination of services with DVOP and includes a completed Technical • The term ‘‘homeless or homeless LVER staff, and community linkages Performance Goals Form (Appendix D). with other programs and services that individual’’ includes persons who 1ack • An original and two (2) copies of a fixed, regular, and adequate nighttime provide support to homeless veterans. the Cost Proposal (see below) that The following format for the technical residence. It also includes persons includes an original blue ink-signed whose primary nighttime residence is proposal is recommended: Application for Federal Assistance, SF– Need for the program: The applicant either a supervised public or private 424 (Appendix A), a Budget Narrative, must identify the geographical area to be shelter designed to provide temporary Budget Information Sheet SF–424A served and provide an estimate of the living accommodations; an institution (Appendix B), an original blue ink- number of homeless veterans in the that provides a temporary residence for signed and Assurances and designated geographical area. Include individuals intended to be Certifications Signature Page (Appendix poverty and unemployment rates in the institutionalized; or a public or private C), Direct Cost Description for area and identify the disparities in the place not designed for, or ordinarily Applicants and Sub-applicants local community infrastructure that used as, a regular sleeping (Appendix E), and a completed Survey exacerbate the employment barriers accommodation for human beings. (42 on Ensuring Equal Opportunity for faced by the targeted veterans. Include U.S.C. 11302 (a)). Applicants (Appendix F). labor market information and job • The term ‘‘veteran’’ means a person A. Section 1—Executive Summary: A opportunities in the employment fields who served in the active military, naval, one to two page ‘‘Executive Summary’’ and industries that are in demand in the or air service, and who was discharged reflecting the grantees overall strategy, geographical area to be served. or released under conditions other than timeline, and outcomes to be achieved Approach or strategy to increase dishonorable. (38 U.S.C. 101(2)) in their grant proposal is required. This employment and job retention: IV. Application and Submission executive summary does not count Applicants must be responsive to the Information against the 15-page limit. The executive Rating Criteria contained in Section V(1) summary should include: and address all of the rating factors as 1. Address to Request an Application • The proposed area to be served thoroughly as possible in the narrative. and Amendments: Application through the activities of this grant. The applicant must: announcements or forms will not be • Years of grantee’s service to the • Describe the specific supportive mailed. The Federal Register may be residents in the proposed area to be employment and training services to be obtained from your nearest government served. provided under this grant and the • office or library. Additional application Projects and activities that will sequence or flow of such services; packages may be obtained from the expedite the reintegration of homeless • Indicate the type(s) of training that VETS Web site at http://www.dol.gov/ veterans into the workforce. will be provided and how it relates to • vets and at http://www.fedgrants.gov/. Summary of outcomes, benefits, the jobs that are in demand, length of The application forms and their and value added by the project. training, training curriculum, and how instructions, and other pertinent B. Section 2—The Technical Proposal the training will improve the eligible materials are included in the consists of a narrative proposal that veterans’ employment opportunities Appendices. If copies of the standard demonstrates the need for this particular within that geographical area; forms are needed, they can also be grant program, the services and • Provide a follow-up plan that downloaded from http:// activities proposed to obtain successful addresses retention after 90 and 180 www.whitehouse.gov/omb/grants/ outcomes for the homeless veterans to days with participants who have grants_forms.html. be served; and the applicant’s ability to entered employment; To receive amendments to this accomplish the expected outcomes of • Include the completed Planned Solicitation, all applicants must register the proposed project design. Quarterly Technical Performance Goals their name and address in writing with The technical proposal narrative must (and planned expenditures) form listed the Grant Officer at the following not exceed fifteen (15) pages double- in Appendix D. address: U.S. Department of Labor, spaced, font size no less than 11 pt., and Linkages with facilities that serve Procurement Services Center, Attn: typewritten on one (1) side of the paper homeless veterans: Describe program Cassandra Mitchell, Reference SGA 04– only. and resource linkages with other 04, 200 Constitution Avenue, NW., Note: Resumes, charts, standard forms, facilities that will be involved in Room N–5416, Washington, DC 20210, transmittal letters, Memorandums of identifying potential clients for this

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program. Describe any networks with Organizational capability to provide or pages the ‘‘Budget Narrative’’ and other related resources and/or other required program activities: The ensure that costs reported on the SF– programs that serve homeless veterans. applicant’s relevant current or prior 424A correspond accurately with the Indicate how the program will be experience in operating employment Budget Narrative; coordinated with any efforts that are and training programs should be clearly The Budget Narrative must include, at conducted by public and private described. A summary narrative of a minimum: agencies in the community. If a program experience and employment • Breakout of all personnel costs by Memorandum of Understanding (MOU) and training performance outcomes is position, title, salary rates, and percent or other service agreement with service required. The applicant should provide of time of each position to be devoted providers exists, copies should be information showing outcomes of all to the proposed project (including sub- provided. past employment and training programs awardees/contractors) by completing the Linkages with other providers of in terms of enrollments and placements. ‘‘Direct Cost Descriptions for Applicants employment and training services to An applicant that has operated a HVRP, and Sub-Applicants’’ form (Appendix homeless veterans: Describe the other Homeless Employment and E); networks the program will have with Training program, or VWIP program • Explanation and breakout of other providers of services to homeless must include the final or most recent extraordinary fringe benefit rates and veterans; include a description of the technical performance reports. The associated charges (i.e., rates exceeding relationship with other employment and applicant must also provide evidence of 35% of salaries and wages); training programs such as Disabled key staff capability. It is preferred that • Explanation of the purpose and Veterans’ Outreach Program (DVOP), the the grantee be well established and not composition of, and method used to Local Veterans’ Employment in the start-up phase or process. derive the costs of, each of the Representative (LVER) program, and Proposed housing strategy for following: Travel, equipment, supplies, programs under the Workforce homeless veterans: Describe how sub-awards/contracts, and any other Investment Act such as the Veterans’ housing resources for eligible homeless costs. The applicant must include costs Workforce Investment Program (VWIP); veterans will be obtained or accessed. of any required travel described in this and list the type of services that will be These resources must be from linkages Solicitation. Mileage charges may not provided by each. Note the type of or sources other than the HVRP grant exceed 37.5 cents per mile, or the agreement in place, if applicable. such as HUD, HHS, community housing current Federal rate; Linkages with the workforce resources, DVA leasing, or other • All associated costs for retaining development system must be programs. participant information pertinent to the delineated. Describe any networks with C. Section 3—The Cost Proposal must follow-up survey, 180 days after the any other resources and/or other contain the following: program performance period ends; programs for homeless veterans. (1) Standard Form SF–424, • Description/specification of, and Indicate how the program will be ‘‘Application for Federal Assistance’’ justification for, equipment purchases, if coordinated with any efforts for the (with the original signed in blue-ink) any. Tangible, non-expendable, personal homeless that are conducted by agencies (Appendix A) must be completed; property having a useful life of more in the community. Indicate how the The Catalog of Federal Domestic than one year and a unit acquisition cost applicant will coordinate with any Assistance number for this program is of $5,000 or more per unit must be ‘‘continuum of care’’ efforts for the 17.805 and it must be entered on the specifically identified; and homeless among agencies in the SF–424, in Block 10. • Identification of all sources of community. If a Memorandum of The organizational unit section of leveraged or matching funds and an Understanding (MOU) or other service Block 5 of the SF–424 must contain the explanation of the derivation of the agreements with other service providers Dun and Bradstreet Number (DUNS) of value of matching/in-kind services. If exists, copies should be provided. the applicant. Beginning October 1, resources/matching funds and/or the Linkages with other Federal agencies: 2003, all applicants for Federal grant value of in-kind contributions are made Describe program and resource linkages funding opportunities are required to available, please show in Section B of with the Department of Housing and include a DUNS number with their the Budget Information Sheet. Urban Development (HUD), Department application. See OMB Notice of Final (4) A completed Assurance and of Health and Human Services (HHS), Policy Issuance, 68 FR 38402 (June 27, Certification signature page (Appendix and Department of Veterans Affairs 2003). Applicants’ DUNS number C) must be submitted; (DVA) including the Compensated Work should be entered into Block 5 of SF– (5) All applicants must submit Therapy (CWT) and per diem programs. 424. The DUNS number is a nine-digit evidence of satisfactory financial If a Memorandum of Understanding identification number that uniquely management capability, which must (MOU) or other service agreements with identifies business entities. There is no include recent (within 18 months) other service providers exists, copies charge for obtaining a DUNS number. financial and/or audit statements. should be provided. To obtain a DUNS number call 1–866– Grantees are required to utilize Proposed supportive service strategy 705–5711 or access the following Web Generally Accepted Accounting for veterans: Describe how supportive site: http://www.dunandbradstreet.com. Practices (GAAP), maintain a separate service resources for veterans will be Requests for exemption from the accounting for these grant funds, and obtained and used. If resources are DUNS number requirement must be have a checking account; provided by other sources or linkages, made to the Office of Management and (6) All applicants must include, as a such as Federal, State, local, or faith- Budget. separate appendix, a list of all based and community programs, the (2) Standard Form SF–424A ‘‘Budget employment and training government applicant must fully explain the use of Information Sheet’’ (Appendix B) must grants and contracts that it has had in these resources and how they will be be included; the past three (3) years, including grant/ applied. If a Memorandum of (3) As an attachment to SF–424A, the contract officer contact information. Understanding (MOU) or other service applicant must provide a detailed cost VETS reserves the right to have a DOL agreements with other service providers breakout of each line item on the Budget representative review and verify this exists, copies should be provided. Information Sheet. Please label this page data;

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(7) A completed Survey on Ensuring G. The government is prohibited from with the applicant’s cognizant agency Equal Opportunity for Applicants directly funding religious activity.1 for indirect cost rates (See Office of (Appendix F) must be provided. These grants may not be used for Management and Budget Web site at 3. Submission Dates and Times religious instruction, worship, prayer, http://www.whitehouse.gov/omb/grants/ (Acceptable Methods of Submission): proselytizing or other inherently attach.html). The grant application package must be religious practices. Neutral, secular • Indirect cost rates traceable and received at the designated place by the criteria that neither favor nor disfavor trackable through the State Workforce date and time specified or it will not be religion must be employed in the Agency’s Cost Accounting System considered. Any application received at selection of grant and sub-grant represent an acceptable means of the Office of Procurement Services after recipients. In addition, under the allocating costs to DOL and, therefore, 4:45 p.m. ET, May 13, 2004, will not be Workforce Investment Act (WIA) and can be approved for use in grants to considered unless it is received before Department of Labor regulations State Workforce Agencies. the award is made and: implementing the WIA, a recipient may 6. Other Submission Requirements: The only acceptable evidence to • It is determined by the Government not train a participant in religious establish the date of mailing of a late that the late receipt was due solely to activities, or permit participants to application sent by registered or mishandling by the Government after construct, operate, or maintain any part certified mail is the U.S. Postal Service receipt at the U.S. Department of Labor of a facility that is primarily used or postmark on the envelope or wrapper at the address indicated; or devoted to religious instruction or • worship. Under WIA, ‘‘no individual and on the original receipt from the U.S. It was sent by registered or certified Postal Service. If the postmark is not mail not later than the fifth calendar day shall be excluded from participation in, denied the benefits of, subjected to legible, an application received after the before May 13, 2004; or above closing time and date shall be • discrimination under, or denied It was sent by U.S. Postal Service processed as if mailed late. ‘‘Postmark’’ Express Mail Next Day Service-Post employment in the administration of or in connection with, any such program means a printed, stamped or otherwise Office to Addressee, not later than 5:00 placed impression (not a postage meter p.m. at the place of mailing two (2) or activity because of race, color, religion, sex (except as otherwise machine impression) that is readily working days, excluding weekends and identifiable without further action as Federal holidays, prior to May 13, 2004. permitted under Title IX of the Education Amendments of 1972), having been applied and affixed by an 4. Intergovernmental Review: Not employee of the U.S. Postal Service on Applicable. national origin, age, disability, or political affiliation or belief.’’ the date of mailing. Therefore applicants 5. Funding Restrictions: H. Limitations on Administrative and should request that the postal clerk ‘‘ A. Proposals exceeding $200,000 will Indirect Costs: place a legible hand cancellation bull’s- be considered non-responsive. • Administrative costs, which consist eye’’ postmark on both the receipt and B. There is a limit of one (1) of all direct and indirect costs the envelope or wrapper. The only acceptable evidence to application per submitting organization associated with the supervision and establish the date of mailing of a late and location. If two (2) applications management of the program, are limited application sent by U.S. Postal Service from the same organization for the same to and will not exceed 20% of the total Express Mail Next Day Service-Post location are submitted, the application grant award. Office to Addressee is the date entered with the later date will be considered • Indirect costs claimed by the by the Post Office clerk on the ‘‘Express non-responsive. applicant must be based on a Federally Mail Next Day Service-Post Office to C. Due to the limited availability of approved rate. A copy of the negotiated Addressee’’ label and the postmark on funding, if an organization was awarded approved and signed indirect cost the envelope or wrapper and on the Fiscal Year 2003 HVRP funds for a negotiation agreement must be original receipt from the U.S. Postal specific location and will be receiving submitted with the application. Service. ‘‘Postmark’’ has the same second and possible third year funding, Furthermore, indirect costs are meaning as defined above. Therefore, that organization at that specific considered a part of administrative costs applicants should request that the postal location will be considered ineligible to for HVRP purposes and, therefore, may clerk place a legible hand cancellation compete for FY 2004 HVRP funds. not exceed 20% of the total grant award. ‘‘bull’s-eye’’ postmark on both the D. There will not be reimbursement of • If the applicant does not presently receipt and the envelope or wrapper. pre-award costs unless specifically have an approved indirect cost rate, a The only acceptable evidence to agreed upon in writing by the proposed rate with justification may be establish the time of receipt at the U.S. Department of Labor. submitted. Successful applicants will be Department of Labor is the date/time E. The only potential jurisdictions required to negotiate an acceptable and stamp of the Procurement Services that will be served through this non- allowable rate within 90 days of grant Center on the application wrapper or urban competition for HVRPs in FY award with the appropriate DOL other documentary evidence or receipt 2004 are the metropolitan areas outside Regional Office of Cost Determination or maintained by that office. Applications of the 75 U.S. cities largest in sent by other delivery services, such as 1 ‘‘ population and the city of San Juan, The term direct’’ funding is used to describe Federal Express, UPS, etc., will also be Puerto Rico (see Appendix I). funds that are provided ‘‘directly’’ by a governmental entity or an intermediate organization accepted. F. Entities described in section with the same duties as the government entity, as All applicants are advised that U.S. 501(c)(4) of the Internal Revenue Code opposed to funds that an organization receives as mail delivery in the Washington, DC that engage in lobbying activities are not the result of the genuine and independent private choice of a beneficiary. In other contexts, the term area has been erratic due to security and eligible to receive funds under this ‘‘direct’’ funding may be used to refer to those funds anthrax concerns. All applicants must announcement because section 18 of the that an organization receives directly from the take this into consideration when Lobbying Disclosure Act of 1995, Public Federal government (also known as ‘‘discretionary’’ preparing to meet the application Law No. 104–65, 109 Stat. 691, prohibits funding), as opposed to funding that it receives from a State or local government (also known as deadline, as you assume the risk for the award of Federal funds to these ‘‘indirect’’ or ‘‘block grant’’ funding). In this SGA, ensuring a timely submission, that is, if, entities. the term ‘‘direct’’ has the former meaning. because of these mail problems, the

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Department does not receive an maintain a 180 day employment retention housing for participants through application or receives it too late to give rate of fifty (50) percent or greater. community resources, HUD, DVA lease, proper consideration, even if it was Applicants whose applications persuasively or other means. HVRP funds may not be timely mailed, the Department is not propose to use peer counselors who are used for housing or vehicles. themselves veterans will be awarded five (5) required to consider the application. of the available points in the scoring criteria. 2. Review and Selection Process V. Application Review Information Applications will initially be screened C. Quality and Extent of Linkages With to ensure timeliness, completeness, and 1. Application Evaluation Criteria Other Providers of Services to the responsiveness to the SGA Applications will receive up to 100 Homeless and to Veterans: 20 points requirements. Applications that satisfy total points based on the following The application must provide this initial screening will receive further criteria: information on the quality and extent of review as explained below. A. Need for the Project: 10 points the linkages this program will have with Technical proposals will be reviewed other providers of services to homeless by a Department of Labor review panel The applicant will document the need veterans in the local community using the point scoring system specified for this project, as demonstrated by: (i) including faith-based and community above in Section V(1). The review panel The potential number or concentration organizations. For each service, the will assign scores after careful of homeless individuals and homeless applicant must specify who the provider evaluation by each panel member and veterans in the proposed project area is, the source of funding (if known), and rank applications based on this score. relative to other similar areas; (ii) the the type of linkages/referral system The ranking will be the primary basis to rates of poverty and/or unemployment established or proposed. Describe, to the identify applicants as potential grantees. in the proposed project area as extent possible, how the project would The review panel may establish a determined by the census or other be incorporated into the community’s competitive range and/or minimum surveys; and (iii) the extent of the gaps continuum of care approach to respond qualifying score, based upon the in the local infrastructure to effectively to homelessness and show any linkages proposal evaluation, for the purpose of address the employment barriers that to HUD, HHS or DVA programs that will selecting qualified applicants. The characterize the target population. be advantageous to the proposed review panel’s conclusions are advisory B. Overall Strategy To Increase program. in nature and not binding to the Grant Employment and Retention in Officer. D. Demonstrated Capability in Providing Employment: 35 points Cost proposals will be considered in Required Program Services, Including two (2) ways. The Department of Labor The application must include a Programmatic Reporting and Participant review panel will screen all applicant description of the approach to providing Tracking: 25 points cost proposals to ensure expenses are comprehensive employment and The applicant must describe its allocable, allowable, and reasonable. If training services, including job training, relevant prior experience in operating the review panel concludes that the cost job development, obtaining employer employment and training programs and proposal contains an expense(s) that is commitments to hire, placement, and providing services to participants not allocable, allowable, and/or post-placement follow-up services. similar to those that are proposed under reasonable, the application may be Applicants must address how they will this solicitation. Specific outcomes considered ineligible for funding. target occupations in emerging previously achieved by the applicant Further, VETS and the Grant Officer industries. Supportive services provided must be described, such as job will consider applicant information as part of the strategy of promoting job placements, benefits secured, network concerning the proposed cost per readiness and job retention must be coalitions, etc. The applicant must also placement, percentage of participants indicated. The applicant must identify address its capacity for timely startup of placed into unsubsidized employment, the local services and sources of training the program, programmatic reporting, average wage at placement, and 180 day to be used for participants. At least 80% and participant tracking. The applicant retention in employment percentage. of enrolled participants must participate should describe its staff experience and The national average cost per placement in training services. A description of the ability to manage the administrative, for HVRP for last year was $2,100. relationship, if any, with other programmatic and financial aspects of a The Government reserves the right to employment and training programs such grant program. Include a recent (within ask for clarification on any aspect of a as State Workforce Agencies (including the last 18 months) financial statement grant application. The Government also DVOP and LVER Programs), One-Stops, or audit. Final or most recent technical reserves the right to discuss any VWIP, other WIA programs, and reports for other relevant employment potential grantee concerns amongst Workforce Investment or Development and training programs must be Department of Labor staff. The Boards or entities where in place, must submitted, if applicable. Because prior Government further reserves the right to be specified. Applicant must indicate HVRP grant experience is not a select applicants out of rank order if how the activities will be tailored or requirement for this grant, some such a selection would, in its opinion, responsive to the needs of homeless applicants may not have any technical result in the most effective and veterans. A participant flow chart may performance reports to submit. appropriate combination of funding, be used to show the sequence and mix program, and administrative costs, e.g., of services. E. Quality of Overall Housing Strategy: cost per enrollment and placement, Note: The applicant must complete 10 points demonstration models, and geographic Appendix D, the Technical Performance The application must demonstrate service areas. The Grant Officer’s Goals Form, with proposed programmatic how the applicant proposes to obtain or determination for award under SGA 04– outcomes including participants served, access housing resources for veterans in 04 is the final agency action. The placement/entered employments and job retention. Of the 35 points possible in the the program and entering the labor submission of the same proposal from strategy to increase employment and force. This discussion should specify any prior year HVRP competition does retention, 5 points will be awarded to grant the provisions made to access not guarantee an award under this proposals that demonstrate the ability to temporary, transitional, and permanent Solicitation.

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VI. Award Administration Information provisions, as applicable to the identification of corrective action that particular grantee: will be taken to meet the planned goals, 1. Award Notices • 29 CFR part 93—Lobbying. if required; and a timetable for A. The Notice of Award signed by the • 29 CFR part 95—Uniform accomplishment of the corrective Grant Officer is the authorizing Administrative Requirements for Grants action. document and will be provided through and Agreements with Institutions of C. 90-Day Follow-Up Report: postal mail and/or by electronic means Higher Education, Hospitals, and other No later than 120 days after the grant to the authorized representative listed Nonprofit Organizations, and with performance expiration date, the grantee on the SF–424 Grant Application. Commercial Organizations. must submit a follow-up report showing Notice that an organization has been • 29 CFR part 96—Federal Standards results and performance as of the 90th selected as a grant recipient does not for Audit of Federally Funded Grants, day after the grant period, and constitute approval of the grant Contracts and Agreements. containing the following: • application as submitted. Before the 29 CFR part 97—Uniform (1) Final Financial Status Report SF– actual grant award, the Grant Officer Administrative Requirements for Grants 269A, Short Form (that zeros out all may enter into negotiations concerning and Cooperative Agreements to State unliquidated obligations); and such items as program components, and Local Governments. (2) Technical Performance Report • funding levels, and administrative 29 CFR part 98—Federal Standards including updated goals chart. systems. If the negotiations do not result for Government-wide Debarment and D. 180-Day Follow-Up Report: in an acceptable submittal, the Grant Suspension (Non procurement) and No later than 210 days after the grant Officer reserves the right to terminate Government-wide Requirements for performance expiration date, the grantee Drug-Free Workplace (Grants). must submit a follow-up report showing the negotiation and decline to fund the • proposal. 29 CFR part 99—Audit of States, the results and performance as of the Local Governments, and Nonprofit B. A post-award conference will be 180th day after the grant period, and Organization. held for those grantees awarded FY containing the following: • 29 CFR parts 30, 31, 32, 33 and 36— (1) Final Financial Status Report SF– 2004 HVRP funds through this Equal Employment Opportunity in 269A, Short Form (if not previously competition. The post-award conference Apprenticeship and Training; submitted); and is expected to be held in July or August Nondiscrimination in Federally (2) Final Narrative Report identifying: 2004. Up to two (2) representatives must Assisted Programs of the Department of (a) The total combined (directed/ be present; a financial and a program Labor, Effectuation of Title VI of the assisted) number of veterans placed into representative are recommended. The Civil Rights Act of 1964; employment during the entire grant site of the post-award conference has Nondiscrimination on the Basis of period; not yet been determined, however, for Handicap in Programs and Activities; (b) The number of veterans still planning and budgeting purposes, and Nondiscrimination on the Basis of employed after the 180 day follow-up please allot five (5) days and use Sex in Education Programs Receiving or period; Washington, DC as the conference site. Benefiting from Federal Financial (c) If the veterans are still employed The post-award conference will focus Assistance. at the same or similar job and, if not, on providing information and assistance what are the reason(s); on reporting, record keeping, grant 3. Reporting (d) Whether training received was requirements, and also include best The grantee will submit the reports applicable to jobs held; practices from past projects. Costs and documents listed below: (e) Wages at placement and during associated with attending this A. Quarterly Financial Reports: follow-up period; conference for up to two grantee No later than 30 days after the end of (f) An explanation regarding why representatives will be allowed as long each Federal fiscal quarter, the grantee those veterans placed during the grant, as they are incurred in accordance with must report outlays, program income, but not employed at the end of the Federal travel regulations. Such costs and other financial information on a follow-up period, are not so employed; must be charged as administrative costs Federal fiscal quarterly basis using SF– and and reflected in the proposed budget. 269A, Financial Status Report, Short (g) Any recommendations to improve 2. Administrative and National Policy Form, and submit a copy of the HHS/ the program. PMS 272 draw down report. These Requirements VII. Agency Contact reports must cite the assigned grant Unless specifically provided in the number and be submitted to the Questions and applications are to be grant agreement, DOL’s acceptance of a appropriate State Director for Veterans’ forwarded to: U.S. Department of Labor, proposal and an award of Federal funds Employment and Training (DVET). Procurement Services Center, Attention: to sponsor any program(s) does not B. Quarterly Program Reports: Cassandra Mitchell, Reference SGA 04– provide a waiver of any grant No later than 30 days after the end of 04, 200 Constitution Avenue NW., requirements and/or procedures. For each Federal fiscal quarter, grantees also Room N–5416, Washington, DC 20210, example, the OMB circulars require that must submit a Quarterly Technical Phone Number: (202) 693–4570 (this is an entity’s procurement procedures Performance Report to the DVET that not a toll free number). must provide all procurement contains the following: Resources for the Applicant: transactions will be conducted, as (1) A comparison of actual Applicants may review ‘‘VETS’ Guide to practical, to provide open and free accomplishments to planned goals for Competitive and Discretionary Grants’’ competition. If a proposal identifies a the reporting period in spreadsheet located at http://www.dol.gov/vets/ specific entity to provide the services, format (to be provided after grant award) grants/Final_VETS_Guide-linked.pdf. the DOL award does not provide the and any findings related to monitoring Applicants may also find these justification or basis to sole-source the efforts; resources useful: America’s Service procurement, i.e., avoid competition. (2) An explanation for variances of Locator http://www.servicelocator.org/ All grants will be subject to the plus or minus 15% of planned program provides a directory of our nation’s One- following administrative standards and and/or expenditure goals, to include: Stop Career Centers; the National

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Association of Workforce Boards transmitted by facsimile to (202) 693– Appendix B: Budget Information Sheet SF– maintains an Internet site (http:// 4755. Receipt of submissions, whether 424A www.nawb.org/asp/wibdir.asp) that by U.S. mail, e-mail, or facsimile Appendix C: Assurances and Certifications contains contact information for the transmittal, will not be automatically Signature Page State and local Workforce Investment acknowledged; however, the sender may Appendix D: Quarterly Technical Boards; and the homepage for the request confirmation that a submission Performance Goals Form Department of Labor, Center for Faith- has been received, by telephoning VETS Appendix E: Direct Cost Descriptions for Based & Community Initiatives (http:// at (202) 693–4701 or (202) 693–4753 Applicants and Sub-Applicants www.dol.gov/cfbci). (TTY/TDD). Appendix F: Survey on Ensuring Equal Opportunity for Applicants Comments: Comments are to be Signed at Washington, DC this 6th day of submitted to the Veterans’ Employment April, 2004. Appendix G: The Glossary of Terms Appendix H: List of Common Acronyms and Training Service (VETS), U.S. Lisa Harvey, Appendix I: List of 75 Largest Cities Department of Labor, Room S–1312, 200 Acting Grant Officer. Constitution Avenue, NW., Washington, Nationwide DC 20210, telephone (202) 693-4701. Appendices BILLING CODE 4510–79–P Written comments are limited to ten Appendix A: Application for Federal (10) pages or fewer and may be Assistance SF–424

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[FR Doc. 04–8193 Filed 4–12–04; 8:45 am] the requirements of 38 U.S.C. Section HVRPs are those areas listed in BILLING CODE 4510–79–C 2021, as added by Section 5 of Public Appendix I. Law 107–95, the Homeless Veterans HVRP grants are intended to address Comprehensive Assistance Act of 2001 two objectives: (1) To provide services DEPARTMENT OF LABOR (HVCAA). Section 2021 requires the to assist in reintegrating homeless Secretary of Labor to conduct, directly veterans into meaningful employment Veterans’ Employment and Training within the labor force, and (2) to Service or through grant or contract, such programs as the Secretary determines stimulate the development of effective Urban Homeless Veterans’ appropriate to expedite the reintegration service delivery systems that will Reintegration Program (HVRP) Grants of homeless veterans into the labor address the complex problems facing for Program Year (PY) 2004; Funding force. homeless veterans. Successful Opportunity applicants will design programs that The Homeless Veterans’ Reintegration assist eligible veterans by providing job Announcement Type: Initial Program (HVRP) grants are designated placement services, job training, Solicitation for Grant Applications in three (3) award categories: urban, counseling, supportive services, and (SGA). non-urban, and intermediaries. Separate other assistance to expedite the Funding Opportunity Number: SGA Solicitations for Grant Applications reintegration of homeless veterans into 04–03. (SGAs) are being issued for each grant the labor force. Successful programs Catalogue of Federal Domestic category. This is the solicitation for will also be designed to be flexible in Assistance Number: 17–805. ‘‘Urban HVRP grants.’’ Previous HVRP addressing the universal as well as the Dates: Applications are due on May grants have provided valuable local or regional problems that have had 13, 2004. information on approaches and a negative impact on homeless veterans Period of Performance is PY 2004, techniques that work in the different reentering the workforce. July 1, 2004 through June 30, 2005. environments. Due to limited funding Under this solicitation covering Fiscal Executive Summary (Applicants for and the high concentration of homeless Year (FY) 2004, VETS anticipates that Grant Funds Should Read This Notice veterans in the metropolitan areas of the up to $3,600,000 will be available for In Its Entirety): The U.S. Department of 75 U.S. cities largest in population and grant awards up to a maximum of Labor (USDOL), Veterans’ Employment the city of San Juan, Puerto Rico, the $300,000 for each grant award. VETS and Training Service (VETS), announces only jurisdictions eligible to be served expects to award approximately twelve a grant competition that complies with through this urban competition for (12) grants. This notice contains all of

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the necessary information and forms to employment, and to improve strategies training and employment services, and apply for grant funding. The period of for employment and retention in community-based organizations performance for these PY 2004 grants employment. (including faith-based organizations): to will be July 1, 2004 through June 30, Due to the limited amount of funding provide information on homeless 2005. Two (2) optional years of funding and the high concentration of homeless veterans and their needs. may be available, depending upon veterans in the metropolitan areas of the The grantee will also be responsible Congressional funding appropriations, 75 U.S. cities largest in population and for participating in ‘‘Stand Down’’ the agency’s decision to exercise the the city of San Juan, Puerto Rico, the events. A ‘‘Stand Down’’ is an event optional year(s) of funding, and only jurisdictions eligible to be served held in a locality, usually for three (3) satisfactory grantee performance. through this urban competition for days, where services are provided to HVRP are those areas listed in homeless veterans along with shelter, I. Funding Opportunity Description Appendix I. meals, clothing, employment services, The U.S. Department of Labor 2. Community Awareness Activities: and medical attention. This type of (USDOL), Veterans’ Employment and In order to promote networking between event is mostly a volunteer effort, which Training Service (VETS), announces a the HVRP funded program and local is organized within a community and grant competition that complies with service providers (and thereby eliminate brings service providers together such as the requirements of 38 U.S.C. Section gaps or duplication in services and the Department of Veterans Affairs, 2021, as added by Section 5 of Public enhance the provision of assistance to Disabled Veterans’ Outreach Program Law 107–95, the Homeless Veterans participants), the grantee must provide Specialists and Local Veterans’ Comprehensive Assistance Act of 2001 project orientation workshops and/or Employment Representatives from the (HVCAA). Section 2021 requires the program awareness activities that it State Workforce Agencies, Veteran Secretary of Labor to conduct, directly determines are the most feasible for the Service Organizations, military or through grant or contract, such types of providers listed below. personnel, civic leaders, and a variety of programs as the Secretary determines Grantees are encouraged to demonstrate other interested persons, groups, and appropriate to provide job training, strategies for incorporating small faith- organizations. Many services are counseling, and placement services based and community organizations provided on-site with referrals also (including job readiness, literacy (defined as organizations with social made for continued assistance after the training, and skills training) to expedite services budgets of approximately Stand Down event. These events can the reintegration of homeless veterans $300,000 or seven (7) or fewer full-time often be the catalyst that enables into the labor force. employees) into their outreach plans. homeless veterans to get back into 1. Program Concept and Emphasis: Project orientation workshops mainstream society. The Department of HVRP grants are intended to address conducted by grantees have been an Labor has supported replication of these two objectives: (a) To provide services effective means of sharing information events and many have been held to assist in reintegrating homeless and informing the community of the throughout the nation. veterans into meaningful employment availability of other services; they are In areas where an HVRP is operating, within the labor force, and (b) to encouraged but not mandatory. Rather, grantees are expected and encouraged stimulate the development of effective grantees will have the flexibility to to participate fully and offer their service delivery systems that will attend service provider meetings, services for all locally planned Stand address the complex problems facing seminars, and conferences, to outstation Down event(s). Toward this end, up to homeless veterans. staff, and to develop individual service $5,000 of the currently requested HVRP For this Fiscal Year (FY) 2004 grant contracts as well as to involve other grant funds may be used to supplement solicitation, VETS seeks applicants that agencies in program planning. the Stand Down efforts, where funds are will provide direct services through a The grantee will be responsible for not otherwise available, and may be case management approach that providing project awareness, program requested in the budget and explained networks with Federal, State, and local information, and orientation activities in the budget narrative. resources for veteran support programs. to the following: 3. Scope of Program Design: The Successful applicants will have clear A. Direct providers of services to project design must include the strategies for employment and retention homeless veterans including shelter and following services: of employment for homeless veterans. soup kitchen operators: to make them A. Outreach, intake, assessment, peer Successful applicants will design aware of the services available to counseling to the degree practical, programs that assist eligible veterans by homeless veterans to make them job- employment services, and follow-up providing job placement services, job ready and to aid their placement into support services to enhance retention in training, counseling, supportive jobs. employment. Program staff providing services, and other assistance to B. Federal, State, and local outreach services should have expedite the reintegration of homeless entitlement and social service agencies experience in dealing with, and an veterans into the labor force. Successful such as the Social Security understanding of the needs of, homeless applicants will also design programs Administration (SSA), Department of veterans. that are flexible in addressing the Veterans Affairs (DVA), State Workforce B. Provision of or referral to universal as well as the local or regional Agencies (SWAs) and their local One- employment services such as: job search problems that have had a negative Stop Centers (which integrate Workforce workshops, job counseling, assessment impact on homeless veterans reentering Investment Act (WIA), labor exchange, of skills, resume writing techniques, the workforce. The HVRP in PY 2004 and other employment and social interviewing skills, subsidized trial will seek to continue to strengthen services), mental health services, and employment (work experience), job development of effective service healthcare detoxification facilities: to development services, job placement delivery systems, to provide familiarize them with the nature and into unsubsidized employment, job comprehensive services through a case needs of homeless veterans. placement follow-up services to management approach that address C. Civic and private sector groups, in enhance retention in employment. complex problems facing eligible particular Veterans’ Service C. Provision of or referral to training veterans trying to transition into gainful Organizations, support groups, job services such as: basic skills instruction,

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remedial education activities, life skills 4. Results-Oriented Model: No specific facilitate the staff’s successful and money management training, on- model is mandatory, but successful monitoring of the plan. Entry into full- the-job training, classroom training, applicants will design a program that is time employment or a specific job- vocational training, specialized and/or responsive to the needs of the local training program should follow, in licensing training programs, and other community and achieves the HVRP keeping with the overall objective of formal training programs as deemed objectives. The HVRP objectives are to HVRP, to bring the participant closer to appropriate to benefit the participant. At successfully reintegrate homeless self-sufficiency. Supportive services least 80% of the enrolled HVRP veterans into the workforce and to may assist the HVRP enrolled participants must participate in training stimulate the development of effective participant at this point or even earlier. activities. service delivery systems that will Job development, a crucial part of the D. Grantees will perform a address the complex problems facing employability process, is usually when preliminary assessment of each homeless veterans. there are no competitive job openings participant’s eligibility for Department Under the Government Performance that the HVRP enrolled participant is of Veterans Affairs (DVA) service- and Results Act (GPRA), Congress and qualified to apply for, therefore, a job connected disability, compensation, the public are looking for program opportunity is created or developed and/or pension benefits. As appropriate, results rather than program processes. specifically for that HVRP enrolled grantees will work with the Veterans The outcome measurement established participant with an employer. HVRP Service Organizations or refer the for HVRP grants is for grantees to meet enrolled participants who are ready to participants to DVA in order to file a a minimum entered employment rate of enter employment and/or who are in claim for compensation or pension. 58%, determined by dividing the need of intensive case management Grantees will track progress of claims number of entered employments by the services are to be referred to the DVOP and report outcomes in case number of HVRP enrollments. (Actual and LVER staff at a One-Stop Center. management records. performance outcomes will be reported DVOP and LVER staff are able to E. Coordination with veterans’ quarterly in spreadsheet format to be provide HVRP enrolled participants the services programs, including: Disabled provided to grantees at the post award following services: job development, Veterans’ Outreach Program Specialists conference.) While the percentage of employment services, case management (DVOPs), Local Veterans’ Employment HVRP enrollments that enter and career counseling. Most DVOP and Representatives (LVERs) in the State employment is an important outcome, it LVER staff received training in case Workforce Agencies (SWAs) or in the is also necessary to evaluate and management at the National Veterans’ workforce development system’s One- measure the program’s long-term Training Institute. All DVOP and LVER results, through the 90-day and 180-day staff provide employment related Stop Centers, as well as Veterans’ follow-up period, to determine the services to veterans who are most at a Workforce Investment Programs quality and success of the program. disadvantage in the labor market. VETS’ (VWIPs), Department of Veterans Affairs The applicant’s program should be urges working hand-in-hand with (DVA) services, including its Health based on a results-oriented model. The DVOP/LVER staff to achieve economies Care for Homeless Veterans, Domiciliary first phase of activity should consist of of resources. Care, Regional Benefits Assistance the level of outreach necessary to The applicant’s program must include Program, and Transitional Housing introduce the program to eligible tracking of program participants. under Homeless Provider Grant and per homeless veterans. Outreach also Tracking should begin with the referral diem programs. includes establishing contact with other to employment and continue through F. Networking with Veterans’ Service agencies that encounter homeless the 90-day and 180-day follow-up Organizations such as: The American veterans. Once the eligible homeless periods after entering employment to Legion, Disabled American Veterans, veterans have been identified, an determine whether the veteran is in the Veterans of Foreign Wars, Vietnam assessment must be made of each same or similar job. It is important that Veterans of America, the American individual’s abilities, interests, needs, the grantee maintain contact with Veterans (AMVETS). and barriers to employment. In some veterans after placement to ensure that G. Referral as necessary to health care, cases, participants may require referrals employment-related problems are counseling, and rehabilitative services to services such as rehabilitation, drug addressed. The 90-day and 180-day including, but not limited to: Alcohol or alcohol treatment, or a temporary follow-ups are fundamental to assessing and drug rehabilitation, therapeutic shelter before they can be enrolled into program results. Grantees need to services, Post Traumatic Stress Disorder the HVRP program. Once the eligible budget for 90-day and 180-day follow- (PTSD) services, and mental health homeless veteran is ‘‘stabilized,’’ the up activity so that it can be performed services as well as coordination with assessment must concentrate on the for those participants placed at or near McKinney Homeless Assistance Act employability of the individual and the end of the grant performance period. (MHAA) Title VI programs for health whether the individual is to be enrolled All grantees, prior to the end of the care for the homeless, and health care into the HVRP program. grant performance period, must obligate programs under the Homeless Veterans A determination should be made as to sufficient funds to ensure that follow-up Comprehensive Assistance Act of 2001. whether the HVRP enrolled participant activities are completed. Such results H. Referral to housing assistance, as would benefit from pre-employment will be reported in the final technical appropriate, provided by: Local shelters, preparation such as resume writing, job performance report. Federal Emergency Management search workshops, related employment Administration (FEMA) food and shelter counseling, and case management, or II. Award Information programs, transitional housing programs possibly an initial entry into the job 1. Type of Funding Instrument: One and single room occupancy housing market through temporary jobs. (1) year grant. programs funded under MHAA Title IV Additionally, sheltered work 2. Funding Levels: The total funding (and under HVCAA), and permanent environments, classroom training and/ available for this Urban HVRP housing programs for disabled homeless or on-the-job training must be evaluated. solicitation is up to $3,600,000. It is persons funded under MHAA Title IV Such services should be noted in an anticipated that approximately twelve (and under HVCAA). Employability Development Plan to (12) awards will be made under this

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solicitation. Awards are expected to typically refers to cities and counties.) A living accommodations; an institution range from $200,000 to a maximum of State agency may propose in its that provides a temporary residence for $300,000. The Department of Labor application to serve one or more of the individuals intended to be reserves the right to negotiate the potential jurisdictions located in its institutionalized; or a public or private amounts to be awarded under this State. This does not preclude a city or place not designed for, or ordinarily competition. Please be advised that county agency from submitting an used as, a regular sleeping requests exceeding $300,000 will be application to serve its own jurisdiction. accommodation for human beings. [42 considered non-responsive. • For-profit/commercial entities. U.S.C. 11302 (a)]. 3. Period of Performance: The period • Nonprofit organizations. If claiming • The term ‘‘veteran’’ means a person of performance will be for twelve (12) 501(c)(3) status, the Internal Revenue who served in the active military, naval, months from date of award unless Service statement indicating 501(c)(3) or air service, and who was discharged modified by the Grant Officer. It is status approval must be submitted. or released under conditions other than expected that successful applicants will Note: Qualifying applications from dishonorable. [38 U.S.C. 101(2)] begin program operations under this grantees in the below listed States that are IV. Application and Submission solicitation on July 1, 2004. All program not currently receiving HVRP funds (and are Information funds must be obligated by June 30, included on Appendix I) may receive priority 2005; a limited amount of funds may be funding over applicants in those States that 1. Address to Request an Application obligated and reserved for follow-up are currently receiving HVRP funds: and Amendments: Application activities and closeout. Arkansas, Delaware, Georgia, Kansas, announcements or forms will not be 4. Optional Year Funding: Should Mississippi, Nebraska, New Hampshire, mailed. The Federal Register may be Rhode Island, Utah, Virginia, and West obtained from your nearest government Congress appropriate additional funds Virginia. for this purpose, VETS may consider an office or library. Additional application optional two (2) years of funding. The 2. Cost Sharing: Cost sharing and/or packages may be obtained from the Government does not, however, matching funds are not required. VETS Web site at http://www.dol.gov/ guarantee optional year funding for any However, we do encourage the use of vets and at http://www.fedgrants.gov/. grantee. In deciding whether to exercise sharing and/or matching funds. The application forms and their any optional year(s) of funding, VETS 3. Other Eligibility Criteria: instructions, and other pertinent will consider grantee performance A. This SGA is for Urban HVRP materials are included in the during the previous period of operations grants. Separate SGAs for non-urban Appendices. If copies of the standard as follows: and intermediaries HVRP grants have forms are needed, they can also be A. The grantee must meet, at been simultaneously issued. downloaded from: http:// minimum, 85% of planned goals for B. The proposal must include an www.whitehouse.gov/omb/grants/ Federal expenditures, enrollments, and outreach component that uses either grants_forms.html. placements in each quarter and/or at DVOP/LVER staff or a trained outreach To receive amendments to this least 85% of planned cumulative goals cadre. Programs must be ‘‘employment Solicitation, all applicants must register by the end of the third quarter; and focused.’’ The services provided must their name and address in writing with B. The grantee must be in compliance be directed toward: (1) Increasing the the Grant Officer at the following with all terms identified in the employability of homeless veterans address: U.S. Department of Labor, Solicitation for Grant Application (SGA) through training or arranging for the Procurement Services Center, Attn: and grant award document; and provision of services that will enable Cassandra Mitchell, Reference SGA 04– C. All program and fiscal reports must them to work; and (2) matching 03, 200 Constitution Avenue, NW., have been submitted by the established homeless veterans with potential Room N–5416, Washington, DC 20210, due dates and must be verifiable for employers. Phone Number: (202) 693–4570 (not a accuracy. C. Applicants are encouraged to toll free number). utilize, through partnerships or sub- 2. Content and Form of Application: III. Eligibility Information awards, experienced public agencies, The grant application must consist of 1. Eligible Applicants: Applications private nonprofit organizations, private three (3) separate and distinct sections: for funds will be accepted from State businesses, faith-based and community the Executive Summary, the Technical and local Workforce Investment Boards, organizations, and colleges and Proposal, and the Cost Proposal. The local public agencies, for-profit/ universities (especially those with information provided in these three (3) commercial entities, and nonprofit traditionally high enrollments of sections is essential to gain an organizations, including faith-based and minorities) that have an understanding understanding of the programmatic and community organizations. Applicants of unemployment and the barriers to fiscal contents of the grant proposal. must have a familiarity with the area employment unique to homeless A complete grant application package and population to be served and the veterans, a familiarity with the area to must include: ability to administer an effective and be served, and the capability to • An original blue ink-signed and two timely program. effectively provide the necessary (2) copies of the cover letter. Eligible applicants will generally fall services. • An original and two (2) copies of into one of the following categories: D. To be eligible for enrollment under the Executive Summary (see below). • State and local Workforce this HVRP grant an individual must be • An original and two (2) copies of Investment Boards (WIBs), established homeless and a veteran defined as the Technical Proposal (see below) that under Sections 111 and 117 of the follows: includes a completed Technical Workforce Investment Act. • The term ‘‘homeless or homeless Performance Goals Form (Appendix D). • Public agencies, meaning any individual’’ includes persons who lack • An original and two (2) copies of public agency of a State or of a general a fixed, regular, and adequate nighttime the Cost Proposal (see below) that purpose political subdivision of a State residence. It also includes persons includes an original blue ink-signed that has the power to levy taxes and whose primary nighttime residence is Application for Federal Assistance, SF– spend funds, as well as general either a supervised public or private 424 (Appendix A), a Budget Narrative, corporate and police powers. (This shelter designed to provide temporary Budget Information Sheet SF–424A

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(Appendix B), an original blue ink- provide an estimate of the number of programs under the Workforce signed and Assurances and homeless veterans in the designated Investment Act such as the Veterans’ Certifications Signature Page (Appendix geographical area. Include poverty and Workforce Investment Program (VWIP); C), a Direct Cost Description for unemployment rates in the area and and list the type of services that will be Applicants and Sub-applicants identify the disparities in the local provided by each. Note the type of (Appendix E), and a completed Survey community infrastructure that agreement in place, if applicable. on Ensuring Equal Opportunity for exacerbate the employment barriers Linkages with the workforce Applicants (Appendix F). faced by the targeted veterans. Include development system must be A. Section 1—Executive Summary: A labor market information and job delineated. Describe any networks with one to two page ‘‘Executive Summary’’ opportunities in the employment fields any other resources and/or other reflecting the grantees’ overall strategy, and industries that are in demand in the programs for homeless veterans. If a timeline, and outcomes to be achieved geographical area to be served. Memorandum of Understanding (MOU) in their grant proposal is required. This Approach or strategy to increase or other service agreements with other executive summary does not count employment and job retention: service providers exists, copies should against the 15-page limit. The executive Applicants must be responsive to the be provided. summary should include: Rating Criteria contained in Section V(1) Linkages with other Federal agencies: • The proposed area to be served and address all of the rating factors as Describe program and resource linkages through the activities of this grant. thoroughly as possible in the narrative. with the Department of Housing and • Years of grantee’s service to the The applicant must: • Urban Development (HUD), Department residents in the proposed area to be Describe the specific supportive of Health and Human Services (HHS), served. employment and training services to be • and Department of Veterans Affairs Projects and activities that will provided under this grant and the (DVA), to include the Compensated expedite the reintegration of homeless sequence or flow of such services; Work Therapy (CWT) and per diem • Indicate the type(s) of training that veterans into the workforce. programs. If a Memorandum of • Summary of outcomes, benefits, will be provided under the grant and Understanding (MOU) or other service and value added by the project. how it relates to the jobs that are in agreements with other service providers B. Section 2—Technical Proposal demand, length of training, training exists, copies should be provided. consists of a narrative proposal that curriculum, and how the training will demonstrates the need for this particular improve the eligible veterans’ Proposed supportive service strategy grant program, the services and employment opportunities within that for veterans: Describe how supportive activities proposed to obtain successful geographical area; service resources for veterans will be outcomes for the homeless veterans to • Provide a follow-up plan that obtained and used. If resources are be served; and the applicant’s ability to addresses retention after 90 and 180 provided by other sources or linkages, accomplish the expected outcomes of days with participants who have such as Federal, State, local, or faith- the proposed project design. entered employment; based and community programs, the The technical proposal narrative must • Include the completed Planned applicant must fully explain the use of not exceed fifteen (15) pages double- Quarterly Technical Performance Goals these resources and how they will be spaced, font size no less than 11 pt., and (and planned expenditures) form listed applied. If a Memorandum of typewritten on one (1) side of the paper in Appendix D. Understanding (MOU) or other service only. Note: Resumes, charts, standard Linkages with facilities that serve agreements with other service providers forms, transmittal letters, homeless veterans: Describe program exist, copies should be provided. Memorandums of Understanding, and resource linkages with other Organizational capability to provide agreements, lists of contracts and grants, facilities that will be involved in required program activities: The and letters of support are not included identifying potential clients for this applicant’s relevant current or prior in the page count. If provided, include program. Describe any networks with experience in operating employment these documents as attachments to the other related resources and/or other and training programs should be clearly technical proposal. programs that serve homeless veterans. described. A summary narrative of Required Content: There are program Indicate how the program will be program experience and employment activities that all applications must coordinated with any efforts that are and training performance outcomes is contain to be found technically conducted by public and private required. The applicant should provide acceptable under this SGA. Programs agencies in the community. Indicate information showing outcomes of all must be ‘‘employment focused’’ and how the applicant will coordinate with past employment and training programs must be responsive to the rating criteria any ‘‘continuum of care’’ efforts for the in terms of enrollments and placements. in Section V(1). The required program homeless among agencies in the An applicant that has operated a HVRP, activities are: Outreach, pre-enrollment community. If a Memorandum of other Homeless Employment and assessments, employment development Understanding (MOU) or other service Training program, or VWIP program plans for each enrolled participant, case agreement with service providers exists, must include the final or most recent management, job placement, job copies should be provided. technical performance reports. The retention follow-up (at 90 and 180 days) Linkages with other providers of applicant must also provide evidence of after individual enters employment, employment and training services to key staff capability. It is preferred that utilization/coordination of services with homeless veterans: Describe the the grantee be well established and not DVOP and LVER staff, and community networks the program will have with in the start-up phase or process. linkages with other programs and other providers of services to homeless Proposed housing strategy for services that provide support to veterans; include a description of the homeless veterans: Describe how homeless veterans. relationship with other employment and housing resources for eligible homeless The following format for the technical training programs such as Disabled veterans will be obtained or accessed. proposal is recommended: Need for the Veterans’ Outreach Program (DVOP), the These resources must be from linkages program: The applicant must identify Local Veterans’ Employment or sources other than the HVRP grant the geographical area to be served and Representative (LVER) program, and such as HUD, HHS, community housing

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resources, DVA leasing, or other exceed 37.5 cents per mile, or the working days, excluding weekends and programs. current Federal rate; Federal holidays, prior to May 13, 2004. C. Section 3—The Cost Proposal must • All associated costs for retaining 4. Intergovernmental Review: Not contain the following: Applicants can participant information pertinent to the Applicable. expect that the cost proposal will be follow-up survey, 180 days after the 5. Funding Restrictions: reviewed for allocability, allowability, program performance period ends; A. Proposals exceeding $300,000 will and reasonableness. • Description/specification of, and be considered non-responsive. (1) Standard Form SF–424, justification for, equipment purchases, if B. There is a limit of one (1) ‘‘Application for Federal Assistance’’ any. Tangible, non-expendable, personal application per submitting organization (with the original signed in blue-ink) property having a useful life of more and location. If two (2) applications (Appendix A) must be completed; than one year and a unit acquisition cost from the same organization for the same The Catalog of Federal Domestic of $5,000 or more per unit must be location are submitted, the application Assistance number for this program is specifically identified; and with the later date will be considered • 17.805 and it must be entered on the Identification of all sources of non-responsive. SF–424, in Block 10. leveraged or matching funds and an C. Due to the limited availability of The organizational unit section of explanation of the derivation of the funding, if an organization was awarded Block 5 of the SF–424 must contain the value of matching/in-kind services. If Fiscal Year 2003 HVRP funds for a Dun and Bradstreet Number (DUNS) of resources/matching funds and/or the specific location and will be receiving the applicant. Beginning October 1, value of in-kind contributions are made second and possible third year funding, 2003, all applicants for Federal grant available, please show in Section B of that organization at that specific funding opportunities are required to the Budget Information Sheet. location will be considered ineligible to include a DUNS number with their (4) A completed Assurance and compete for FY 2004 HVRP funds. application. See OMB Notice of Final Certification signature page (Appendix D. There will not be reimbursement of Policy Issuance, 68 FR 38402 (June 27, C) (signed in blue ink) must be pre-award costs unless specifically 2003). Applicants’ DUNS number is to submitted; agreed upon in writing by the (5) All applicants must submit be entered into Block 5 of SF–424. The Department of Labor. evidence of satisfactory financial DUNS number is a nine-digit E. Entities described in Section management capability, which must identification number that uniquely 501(c)(4) of the Internal Revenue Code include recent (within the last 18 identifies business entities. There is no that engage in lobbying activities are not months) financial and/or audit charge for obtaining a DUNS number. eligible to receive funds under this statements. Grantees are required to To obtain a DUNS number call 1–866– announcement because Section 18 of utilize Generally Accepted Accounting 705–5711 or access the following Web the Lobbying Disclosure Act of 1995, Practices (GAAP), maintain a separate site: http://www.dunandbradstreet.com/ Public Law No. 104–65, 109 Stat. 691, accounting for these grant funds, and . Requests for exemption from the DUNS prohibits the award of Federal funds to have a checking account; number requirement must be made to these entities. (6) All applicants must include, as a the Office of Management and Budget. F. The only potential areas that will separate appendix, a list of all ‘‘ be served through this urban (2) Standard Form SF–424A Budget employment and training government Information Sheet’’ (Appendix B) must competition for HVRPs in FY 2004 are grants and contracts that it has had in the metropolitan areas of the 75 U.S. be included; the past three (3) years, including grant/ (3) As an attachment to SF–424A, the cities largest in population and the city contract officer contact information. of San Juan, Puerto Rico (see Appendix applicant must provide a detailed cost VETS reserves the right to have a DOL breakout of each line item on the Budget I). representative review and verify this G. The government is prohibited from Information Sheet. Please label this page data; or pages the ‘‘Budget Narrative’’ and directly funding religious activity.* (7) A completed Survey on Ensuring HVRP grants may not be used for ensure that costs reported on the SF– Equal Opportunity for Applicants 424A correspond accurately with the religious instruction, worship, prayer, (Appendix F) must be provided. proselytizing or other inherently Budget Narrative; 3. Submission Dates and Times The Budget Narrative must include, at religious practices. Neutral, secular (Acceptable Methods of Submission): criteria that neither favor nor disfavor a minimum: The grant application package must be • religion must be employed in the Breakout of all personnel costs by received at the designated place by the position, title, salary rates, and percent selection of grant and sub-grant date and time specified or it will not be recipients. In addition, under the of time of each position to be devoted considered. Any application received at to the proposed project (including sub- Workforce Investment Act (WIA) and the Office of Procurement Services after Department of Labor regulations grantees) by completing the ‘‘Direct Cost 4:45 p.m. ET, May 13, 2004, will not be Descriptions for Applicants and Sub- implementing the WIA, a recipient may considered unless it is received before not train a participant in religious Applicants’’ form (Appendix E); the award is made and: • Explanation and breakout of • It is determined by the Government * extraordinary fringe benefit rates and The term ‘‘direct’’ funding is used to describe that the late receipt was due solely to funds that are provided ‘‘directly’’ by a associated charges (i.e., rates exceeding mishandling by the Government after governmental entity or an intermediate organization 35% of salaries and wages); receipt at the U.S. Department of Labor with the same duties as the government entity, as • Explanation of the purpose and at the address indicated; or opposed to funds that an organization receives as • the result of the genuine and independent private composition of, and method used to It was sent by registered or certified choice of a beneficiary. In other contexts, the term derive the costs of, each of the mail not later than the fifth calendar day ‘‘direct’’ funding may be used to refer to those funds following: travel, equipment, supplies, before May 13, 2004; or that an organization receives directly from the sub-awards/contracts, and any other • It was sent by U.S. Postal Service Federal government (also known as ‘‘discretionary’’ funding), as opposed to funding that it receives costs. The applicant must include costs Express Mail Next Day Service-Post from a State or local government (also known as of any required travel described in this Office to Addressee, not later than 5 ‘‘indirect’’ or ‘‘block grant’’ funding). In this SGA, Solicitation. Mileage charges may not p.m. at the place of mailing two (2) the term ‘‘direct’’ has the former meaning.

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activities, or permit participants to identifiable without further action as B. Overall Strategy To Increase construct, operate, or maintain any part having been applied and affixed by an Employment and Retention in of a facility that is primarily used or employee of the U.S. Postal Service on Employment: 35 Points devoted to religious instruction or the date of mailing. Therefore applicants The application must include a worship. Under WIA, ‘‘no individual should request that the postal clerk description of the approach to providing shall be excluded from participation in, place a legible hand cancellation ‘‘bull’s- comprehensive employment and denied the benefits of, subjected to eye’’ postmark on both the receipt and training services, including job training, discrimination under, or denied the envelope or wrapper. job development, obtaining employer employment in the administration of or The only acceptable evidence to commitments to hire, placement, and in connection with, any such program establish the date of mailing of a late post-placement follow-up services. or activity because of race, color, application sent by U.S. Postal Service Applicants must address how they will religion, sex (except as otherwise Express Mail Next Day Service-Post target occupations in emerging permitted under Title IX of the Office to Addressee is the date entered industries. Supportive services provided Education Amendments of 1972), by the Post Office clerk on the ‘‘Express as part of the strategy of promoting job national origin, age, disability, or Mail Next Day Service-Post Office to readiness and job retention must be political affiliation or belief.’’ Addressee’’ label and the postmark on indicated. The applicant must identify H. Limitations on Administrative and the envelope or wrapper and on the the local services and sources of training Indirect Costs original receipt from the U.S. Postal to be used for participants. At least 80% Service. ‘‘Postmark’’ has the same • Administrative costs, which consist of enrolled participants must participate meaning as defined above. Therefore, in training. A description of the of all direct and indirect costs applicants should request that the postal associated with the supervision and relationship, if any, with other clerk place a legible hand cancellation management of the program, are limited employment and training programs such ‘‘bull’s-eye’’ postmark on both the to and will not exceed 20% of the total as State Workforce Agencies (including receipt and the envelope or wrapper. grant award. DVOP and LVER Programs), One-Stops, • Indirect costs claimed by the The only acceptable evidence to VWIP, other WIA programs, and applicant must be based on a Federally establish the time of receipt at the U.S. Workforce Investment or Development approved rate. A copy of the negotiated Department of Labor is the date/time Boards or entities where in place, must approved and signed indirect cost stamp of the Procurement Services be specified. Applicant must indicate negotiation agreement must be Center on the application wrapper or how the activities will be tailored or submitted with the application. other documentary evidence or receipt responsive to the needs of homeless Furthermore, indirect costs are maintained by that office. Applications veterans. A participant flow chart may considered a part of administrative costs sent by other delivery services, such as be used to show the sequence and mix for HVRP purposes and, therefore, may Federal Express, UPS, etc., will also be of services. accepted. not exceed 20% of the total grant award. Note: The applicant must complete • If the applicant does not presently All applicants are advised that U.S. Appendix D, the Technical Performance have an approved indirect cost rate, a mail delivery in the Washington, DC Goals Form, with proposed programmatic proposed rate with justification may be area has been erratic due to security and outcomes, including participants served, submitted. Successful applicants will be anthrax concerns. All applicants must placement/entered employments and job required to negotiate an acceptable and take this into consideration when retention. Of the 35 points possible in the preparing to meet the application strategy to increase employment and allowable rate within 90 days of grant retention, 5 points will be awarded to grant award with the appropriate DOL deadline, as you assume the risk for proposals that demonstrate the ability to Regional Office of Cost Determination or ensuring a timely submission, that is, if, maintain a 180 day employment retention with the applicant’s cognizant agency because of these mail problems, the rate of 50 percent or greater. Applicants for indirect cost rates (See Office of Department does not receive an whose applications persuasively propose to Management and Budget Web site at application or receives it too late to give use peer counselors who are themselves http://www.whitehouse.gov/omb/grants/ proper consideration, even if it was veterans will be awarded five (5) of the attach.html). timely mailed, the Department is not available points in the scoring criteria. • Indirect cost rates traceable and required to consider the application. C. Quality and Extent of Linkages trackable through the State Workforce With Other Providers of Services to the V. Application Review Information Agency’s Cost Accounting System Homeless and to Veterans: 20 Points represent an acceptable means of 1. Application Evaluation Criteria: The application must provide allocating costs to DOL and, therefore, Applications will receive up to 100 total information on the quality and extent of can be approved for use in grants to points based on the following criteria: the linkages this program will have with other providers of services to homeless State Workforce Agencies. A. Need for the Project: 10 Points 6. Other Submission Requirements: veterans in the local community The only acceptable evidence to The applicant will document the need including faith-based and community establish the date of mailing of a late for this project, as demonstrated by: (i) organizations. For each service, the application sent by registered or The potential number or concentration applicant must specify who the provider certified mail is the U.S. Postal Service of homeless individuals and homeless is, the source of funding (if known), and postmark on the envelope or wrapper veterans in the proposed project area the type of linkages/referral system and on the original receipt from the U.S. relative to other similar areas; (ii) the established or proposed. Describe, to the Postal Service. If the postmark is not rates of poverty and/or unemployment extent possible, how the project would legible, an application received after the in the proposed project area as be incorporated into the community’s above closing time and date shall be determined by the census or other continuum of care approach to respond processed as if mailed late. ‘‘Postmark’’ surveys; and (iii) the extent of the gaps to homelessness and show any linkages means a printed, stamped or otherwise in the local infrastructure to effectively to HUD, HHS or DVA programs that will placed impression (not a postage meter address the employment barriers that be advantageous to the proposed machine impression) that is readily characterize the target population. program.

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D. Demonstrated Capability in Providing Cost proposals will be considered in representative are recommended. The Required Program Services, Including two (2) ways. The Department of Labor site of the post-award conference has Programmatic Reporting and review panel will screen all applicant not yet been determined, however, for Participant Tracking: 25 Points cost proposals to ensure expenses are planning and budgeting purposes, allocable, allowable, and reasonable. If please allot five (5) days and use The applicant must describe its the review panel concludes that the cost Washington, DC. as the conference site. relevant prior experience in operating proposal contains an expense(s) that is The post-award conference will focus employment and training programs and not allocable, allowable, and/or on providing information and assistance providing services to participants reasonable, the application may be on reporting, record keeping, grant similar to those that are proposed under considered ineligible for funding requirements, and also include best this solicitation. Specific outcomes Further, VETS and the Grant Officer practices from past projects. Costs previously achieved by the applicant will consider applicant information associated with attending this must be described, such as job concerning the proposed cost per conference for up to two grantee placements, benefits secured, network placement, percentage of participants representatives will be allowed as long coalitions, etc. The applicant must also placed into unsubsidized employment, as they are incurred in accordance with address its capacity for timely startup of average wage at placement, and 180-day Federal travel regulations. Such costs the program, programmatic reporting, retention in employment percentage. must be charged as administrative costs and participant tracking. The applicant The national average cost per placement and reflected in the proposed budget. should describe its staff experience and for HVRP for last year was $2,100. 2. Administrative and National Policy ability to manage the administrative, The Government reserves the right to Requirements: Unless specifically programmatic and financial aspects of a ask for clarification on any aspect of a provided in the grant agreement, DOL’s grant program. Include a recent (within grant application. The Government also acceptance of a proposal and an award the last 18 months) financial statement reserves the right to discuss any of Federal funds to sponsor any or audit. Final or most recent technical potential grantee concerns amongst program(s) does not provide a waiver of reports for other relevant programs must Department of Labor staff. The any grant requirements and/or be submitted, if applicable. Because Government further reserves the right to procedures. For example, the OMB prior HVRP grant experience is not a select applicants out of rank order if circulars require that an entity’s requirement for this grant, some such a selection would, in its opinion, procurement procedures must provide applicants may not have any technical result in the most effective and all procurement transactions will be performance reports to submit. appropriate combination of funding, conducted, as practical, to provide open program, and administrative costs, e.g., E. Quality of Overall Housing Strategy: and free competition. If a proposal cost per enrollment and placement, 10 Points identifies a specific entity to provide the demonstration models, and geographic services, the DOL award does not The application must demonstrate service areas. The Grant Officer’s provide the justification or basis to sole- how the applicant proposes to obtain or determination for award under SGA 04– source the procurement, i.e., avoid access housing resources for veterans in 03 is the final agency action. The competition. All grants will be subject the program and entering the labor submission of the same proposal from to the following administrative force. This discussion should specify any prior year HVRP competition does standards and provisions, as applicable the provisions made to access not guarantee an award under this to the particular grantee: temporary, transitional, and permanent Solicitation. • 29 CFR part 93—Lobbying. • housing for participants through VI. Award Administration Information 29 CFR part 95—Uniform community resources, HUD, DVA lease, Administrative Requirements for Grants or other means. HVRP funds may not be 1. Award Notices: and Agreements with Institutions of A. The Notice of Award signed by the used for housing or vehicles. Higher Education, Hospitals, and other Grant Officer is the authorizing Nonprofit Organizations, and with 2. Review and Selection Process: document and will be provided through Applications will initially be screened Commercial Organizations. postal mail and/or by electronic means • 29 CFR part 96—Federal Standards to ensure timeliness, completeness, and to the authorized representative listed for Audit of Federally Funded Grants, compliance with the SGA requirements. on the SF–424 Grant Application. Contracts and Agreements. Applications that satisfy this initial Notice that an organization has been • 29 CFR part 97—Uniform screening will receive further review as selected as a grant recipient does not Administrative Requirements for Grants explained below. constitute approval of the grant and Cooperative Agreements to State Technical proposals will be reviewed application as submitted. Before the and Local Governments. by a Department of Labor review panel actual grant award, The Grant Officer • 29 CFR part 98—Federal Standards using the point scoring system specified may enter into negotiations concerning for Government-wide Debarment and above in Section V(1). The review panel such items as program components, Suspension (Non procurement) and will assign scores after careful funding levels, and administrative Government-wide Requirements for evaluation by each panel member and systems. If the negotiations do not result Drug-Free Workplace (Grants). rank applications based on this score. in an acceptable submittal, the Grant • 29 CFR part 99—Audit of States, The ranking will be the primary basis to Officer reserves the right to terminate Local Governments, and Nonprofit identify applicants as potential grantees. the negotiation and decline to fund the Organization. The review panel may establish a proposal. • 29 CFR parts 30, 31, 32, 33 and 36— competitive range and/or a minimum B. A post-award conference will be Equal Employment Opportunity in qualifying score, based upon the held for those grantees awarded FY Apprenticeship and Training; proposal evaluation, for the purpose of 2004 HVRP funds through this Nondiscrimination in Federally selecting qualified applicants. The competition. The post-award conference Assisted Programs of the Department of review panel’s conclusions are advisory is expected to be held in July or August Labor, Effectuation of Title VI of the in nature and not binding on the Grant 2004. Up to two (2) representatives must Civil Rights Act of 1964; Officer. be present; a financial and a program Nondiscrimination on the Basis of

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Handicap in Programs and Activities; (2) Technical Performance Report Locator http://www.servicelocator.org/ and Nondiscrimination on the Basis of including updated goals chart. provides a directory of our nation’s One- Sex in Education Programs Receiving or D. 180–Day Follow-Up Report: No Stop Career Centers; the National Benefiting from Federal Financial later than 210 days after the grant Association of Workforce Boards Assistance. performance expiration date, the grantee maintains an Internet site (http:// 3. Reporting: The grantee will submit must submit a follow-up report showing www.nawb.org/asp/wibdir.asp) that the reports and documents listed below: results and performance as of the 180th contains contact information for the A. Quarterly Financial Reports: No day after the grant period, and State and local Workforce Investment later than 30 days after the end of each containing the following: Boards; and the homepage for the Federal fiscal quarter, the grantee must (1) Final Financial Status Report SF– Department of Labor, Center for Faith- report outlays, program income, and 269A Short Form (if not previously Based & Community Initiatives (http:// other financial information on a federal submitted); and www.dol.gov/cfbci). fiscal quarterly basis using SF–269A, (2) Final Narrative Report identifying: Comments: Comments are to be Financial Status Report, Short Form, (a) The total combined (directed/ submitted to the Veterans’ Employment and submit a copy of the HHS/PMS 272 assisted) number of veterans placed into and Training Service (VETS), U.S. draw down report. These reports must employment during the entire grant Department of Labor, Room S–1312, 200 cite the assigned grant number and be period; Constitution Avenue, NW., Washington, submitted to the appropriate State (b) The number of veterans still DC 20210, telephone (202) 693-4701. Director for Veterans’ Employment and employed after the 180 day follow-up Written comments are limited to ten Training (DVET). period; (10) pages or fewer and may be B. Quarterly Program Reports: No (c) If the veterans are still employed transmitted by facsimile to (202) 693– later than 30 days after the end of each at the same or similar job, and if not, 4755. Receipt of submissions, whether Federal fiscal quarter, grantees also what are the reason(s); by U.S. mail, e-mail, or facsimile must submit a Quarterly Technical (d) Whether training received was transmittal, will not be automatically Performance Report to the DVET that applicable to jobs held; acknowledged; however, the sender may contains the following: (e) Wages at placement and during request confirmation that a submission follow-up period; has been received, by telephoning VETS (1) A comparison of actual (f) An explanation regarding why at (202) 693–4701 or (202) 693–4753 accomplishments to planned goals for those veterans placed during the grant, (TTY/TDD). the reporting period in spreadsheet but not employed at the end of the Signed at Washington, DC this 6th day of format (to be provided to grantees after follow-up period, are not so employed; grant award) and any findings related to April, 2004. and Lisa Harvey, monitoring efforts; (g) Any recommendations to improve Acting Grant Officer. (2) An explanation for variances of the program. plus or minus 15% of planned program Appendices and/or expenditure goals, to include: VII. Agency Contact Appendix A: Application for Federal identification of corrective action that Questions and applications are to be Assistance SF–424 will be taken to meet the planned goals, forwarded to: Department of Labor, Appendix B: Budget Information Sheet SF– if required; and a timetable for Procurement Services Center, Attention: 424A accomplishment of the corrective Cassandra Mitchell, Reference SGA 04– Appendix C: Assurances and Certifications action. 03, 200 Constitution Avenue NW., Signature Page C. 90–Day Follow-Up Report: No later Room N–5416, Washington, DC 20210, Appendix D: Quarterly Technical than 120 days after the grant Performance Goals Form Phone Number: (202) 693–4570 (this is Appendix E: Direct Cost Descriptions for performance expiration date, the grantee not a toll free number). Applicants and Sub-Applicants must submit a follow-up report showing Resources for the Applicant: Appendix F: Survey on Ensuring Equal results and performance as of the 90th Applicants may review ‘‘VETS’ Guide to Opportunity for Applicants day after the grant period, and Competitive and Discretionary Grants’’ Appendix G: The Glossary of Terms containing the following: located at http://www.dol.gov/vets/ Appendix H: List of Common Acronyms (1) Final Financial Status Report SF– grants/Final_VETS_Guide-linked.pdf. Appendix I: List of 75 Largest Cities 269A Short Form (that zeros out all Applicants may also find these Nationwide unliquidated obligations); and resources useful: America’s Service BILLING CODE 4510–79–P

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[FR Doc. 04–8190 Filed 4–12–04; 8:45 am] population. The Commission will also NATIONAL ARCHIVES AND RECORDS BILLING CODE 4510–79–C discuss congressionally mandated ADMINISTRATION reports on specialty hospitals, the usefulness of the IRS Form 990 in Advisory Committee on Preservation; MEDICARE PAYMENT ADVISORY reporting on hospitals’ access to capital, Meeting COMMISSION and an assessment of the strengths and AGENCY: National Archives and Records weaknesses of available data to judge Administration. Commission Meeting total financial circumstances of ACTION: Notice of meeting. AGENCY: Medicare Payment Advisory hospitals and other providers of SUMMARY: Commission. Medicare services. In accordance with the Federal Advisory Committee Act (5 ACTION: Notice of meeting. Agendas will be e-mailed U.S.C. App. 2) and implementing approximately one week prior to the regulation 41 CFR 101.6, the National SUMMARY: The Commission will hold its meeting. The final agenda will be next public meeting on Thursday, April Archives and Records Administration available on the Commission’s Web site (NARA) announces a meeting of the 22, 2004, and Friday, April 23, 2004, at (http://www.MedPAC.gov). the Ronald Reagan Building, Advisory Committee on Preservation. International Trade Center, 1300 ADDRESSES: MedPAC’s address is: 601 NARA uses the Committee’s Pennsylvania Avenue, NW., New Jersey Avenue, NW., Suite 9000, recommendations on NARA’s Washington, DC. The meeting is Washington, DC 20001. The telephone implementation of strategies for tentatively scheduled to begin at 10 a.m. number is (202) 220–3700. preserving the permanently valuable on April 22, and at 10 a.m. on April 23. records of the Federal Government. Topics for discussion include: long- FOR FURTHER INFORMATION CONTACT: DATES: June 15, 2004, from 9 a.m. to 4 term care hospitals; the Medicare Diane Ellison, Office Manager, (202) p.m. hospice program; chronic care 220–3700. ADDRESSES: National Archives and improvement for chronic kidney Mark E. Miller. Records Administration, 8601 Adelphi disease; beneficiaries’ financial Road, lecture rooms C & D, College Park, Executive Director. resources; private insurers’ strategies for MD 20740–6001. [FR Doc. 04–8334 Filed 4–12–04; 8:45 am] purchasing imaging and other services; FOR FURTHER INFORMATION CONTACT: prescription drug implementation BILLING CODE 6820–BW–M Alan Calmes, Preservation Officer, 301– issues; and the Medicare dual eligible 837–1567.

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SUPPLEMENTARY INFORMATION: UNITED STATES NUCLEAR (the Act), and the Commission’s rules The agenda for the meeting will be REGULATORY COMMISSION and regulations. In accordance with 10 CFR 54.29, the NRC will issue a Options for the Preservation and [Docket Nos. 50–266 and 50–301] Duplication of the November 22, 1963, renewed license on the basis of its review if it finds that actions have been Dallas Police Dictation Belts. Nuclear Management Company, LLC, Point Beach Nuclear Plant, Units 1 and identified and have been or will be 1. Background 2; Notice of Acceptance for Docketing taken with respect to: (1) Managing the 2. Preservation of the original dictation of the Application and Notice of effects of aging during the period of belts Opportunity for Hearing Regarding extended operation on the functionality of structures and components that have 3. Reproduction of the dictation belts for Renewal of Facility Operating License Nos. DPR–24 and DPR–27 for an been identified as requiring aging preservation and access Additional 20-Year Period management review, and (2) time- 4. Recommendations limited aging analyses that have been The U.S. Nuclear Regulatory identified as requiring review, such that This meeting will be open to the Commission (NRC or the Commission) there is reasonable assurance that the public, but seating may be limited. is considering application for the activities authorized by the renewed Dated: April 6, 2004. renewal of Operating License Nos. DPR– licenses will continue to be conducted Mary Ann Hadyka, 24 and DPR–27, which authorize the in accordance with the current licensing Nuclear Management Company, LLC, to basis (CLB), and that any changes made Committee Management Officer. operate the Point Beach Nuclear Plant, to the plant’s CLB comply with the Act [FR Doc. 04–8253 Filed 4–12–04; 8:45 am] Units 1 and 2 at 1540 megawatts and the Commission’s regulations. BILLING CODE 7515–01–P thermal for each unit. The renewed Additionally, in accordance with 10 licenses would authorize the applicant CFR 51.95(c), the NRC will prepare an to operate the Point Beach Nuclear environmental impact statement that is Plant, Units 1 and 2, for an additional a supplement to the Commission’s NATIONAL SCIENCE FOUNDATION 20 years beyond the period specified in NUREG–1437, ‘‘Generic Environmental the current licenses. The current Impact Statement for License Renewal Sunshine Act Meeting operating license for the Point Beach of Nuclear Power Plants,’’ dated May Nuclear Plant, Unit 1 expires on October 1996. Pursuant to 10 CFR 51.26, and as AGENCY HOLDING MEETING: National 5, 2010, and the current operating part of the environmental scoping Science Foundation, National Science license for the Point Beach Nuclear process, the staff intends to hold a Board, Committee on Nominations. Plant, Unit 2 expires on March 8, 2013. public scoping meeting. Detailed On February 26, 2004, the information regarding this meeting will DATE AND TIME: April 12, 11:30 a.m. to Commission’s staff received an be the subject of a separate Federal 12:30 p.m. application from Nuclear Management Register notice. PLACE: National Science Foundation, Company, LLC filed pursuant to 10 CFR Within 60 days after the date of Room 1220, 4201 Wilson Boulevard, Part 54, to renew the Operating License publication of this Federal Register Arlington, VA 22230. Nos. DPR–24 and DPR–27 for Point Notice, the requestor/petitioner may file Beach Nuclear Plant, Units 1 and 2, a request for a hearing, and any person STATUS: This meeting will be closed to respectively. A Notice of Receipt and whose interest may be affected by this the public. Availability of the license renewal proceeding and who wishes to application, ‘‘Nuclear Management participate as a party in the proceeding MATTERS TO BE CONSIDERED: Monday, Company, LLC; Notice of Receipt and must file a written request for a hearing April 12, 2004. Closed Session (11:30 Availability of Application for Renewal and a petition for leave to intervene a.m. to 12:30 p.m.) of Point Beach Nuclear Plant, Units 1 with respect to the renewal of the Selection of committee chairman; and 2, Facility Operating License Nos. licenses. Requests for a hearing and a Discussion of candidates for NSB DPR–24 and DPR–27 for Additional 20- petition for leave to intervene shall be Chairman and Vice Chairman; Year Period,’’ was published in the filed in accordance with the Discussion of candidates for two Federal Register on March 8, 2004 (69 Commission’s ‘‘Rules of Practice for vacancies on the NSB Executive FR 10765). Domestic Licensing Proceedings’’ in 10 Committee. The Commission’s staff has CFR Part 2. Interested persons should determined that Nuclear Management consult a current copy of 10 CFR 2.309, FOR INFORMATION CONTACT: Michael P. Company, LLC has submitted sufficient which is available at the Commission’s Crosby, Ph.D., Director, National information in accordance with 10 CFR Public Document Room (PDR), located Science Board Office and Executive 54.19, 54.21, 54.22, 54.23, and 51.53(c) at One White Flint North, 11555 Officer, (703) 292–7000, www.nsf.gov/ that is acceptable for docketing. The Rockville Pike (first floor), Rockville, nsb. current Docket Nos. 50–266 and 50–301 Maryland 20852 and is accessible from for Operating License Nos. DPR–24 and the Agencywide Documents Access and Michael P. Crosby, DPR–27, respectively, will be retained. Management System’s (ADAMS) Public Director, National Science Board Office and The docketing of the renewal Electronic Reading Room on the Internet Executive Officer. application does not preclude at http://www.nrc.gov/reading-rm/ [FR Doc. 04–8449 Filed 4–9–04; 12:20 pm] requesting additional information as the adams.html. Persons who do not have BILLING CODE 7555–01–M review proceeds, nor does it predict access to ADAMS or who encounter whether the Commission will grant or problems in accessing the documents deny the application. located in ADAMS should contact the Before issuance of each requested NRC’s PDR reference staff at 1–800– renewed license, the NRC will have 397–4209, or by email at [email protected]. If made the findings required by the a request for a hearing or a petition for Atomic Energy Act of 1954, as amended leave to intervene is filed within the 60-

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day period, the Commission or a entitle the requestor/petitioner to relief. Counsel, U.S. Nuclear Regulatory presiding officer designated by the A requestor/petitioner who fails to Commission, Washington, DC 20555– Commission or by the Chief satisfy these requirements with respect 0001, and it is requested that copies be Administrative Judge of the Atomic to at least one contention will not be transmitted either by means of facsimile Safety and Licensing Board Panel will permitted to participate as a party. transmission to 301–415–3725 or by rule on the request and/or petition; and Each contention shall be given a email to [email protected]. A the Secretary or the Chief separate numeric or alpha designation copy of the request for hearing and Administrative Judge of the Atomic within one of the following groups and petition for leave to intervene should all like subject-matters shall be grouped Safety and Licensing Board will issue a also be sent to the attorney for the together: notice of a hearing or an appropriate licensee. Attorney for the Applicant: order. In the event that no request for a 1. Technical—primarily concerns David R. Lewis, Esq., Shaw Pittman, hearing or petition for leave to intervene issues relating to technical and/or is filed within the 60-day period, the health and safety matters discussed or 2300 N Street, NW., Washington, DC NRC may, upon completion of its referenced in the Point Beach Nuclear 20037. evaluations and upon making the Plant, Units 1 and 2 safety analysis for Nontimely requests and/or petitions findings required under 10 CFR parts 51 the application (including issues related and contentions will not be entertained and 54, renew the licenses without to emergency planning and physical absent a determination by the further notice. security to the extent that such matters Commission, the presiding officer, or As required by 10 CFR 2.309, a are discussed or referenced in the the Atomic Safety and Licensing Board petition for leave to intervene shall set application). that the petition, request and/or forth with particularity the interest of 2. Environmental—primarily concerns contentions should be granted based on issues relating to matters discussed or the petitioner in the proceeding, and a balancing of the factors specified in 10 referenced in the Environmental Report how that interest may be affected by the CFR 2.309(a)(1)(i)–(viii). results of the proceeding, taking into for the license renewal application consideration the limited scope of 3. Miscellaneous—does not fall into Detailed information about the license matters that may be considered one of the categories outlined above. renewal process can be found under the pursuant to 10 CFR parts 51 and 54. The As specified in 10 CFR 2.309, if two Nuclear Reactors icon at http:// petition must specifically explain the or more requestors/petitioners seek to www.nrc.gov/reactors/operating/ reasons why intervention should be co-sponsor a contention or propose licensing/renewal.html on the NRC’s permitted with particular reference to substantially the same contention, the Web page. Copies of the application to the following factors: (1) The nature of requestors/petitioners will be required renew the operating licenses for the the requestor’s/petitioner’s right under to jointly designate a representative who Point Beach Nuclear Plant, Units 1 and Act to be made a party to the shall have the authority to act for the 2, are available for public inspection at requestors/petitioners with respect to proceeding; (2) the nature and extent of the Commission’s PDR, located at One that contention within ten (10) days the requestor’s/petitioner’s property, White Flint North, 11555 Rockville Pike after advised of such contention. financial, or other interest in the (first floor), Rockville, Maryland, proceeding; and (3) the possible effect of Those permitted to intervene become parties to the proceeding, subject to any 20855–2738, and at http://www.nrc.gov/ any decision or order which may be reactors/operating/licensing/renewal/ entered in the proceeding on the limitations in the order granting leave to applications/point-beach.html the requestor’s/petitioner’s interest. The intervene, and have the opportunity to NRC’s Web page while the application petition must also set forth the specific participate fully in the conduct of the contentions which the petitioner/ hearing, including the opportunity to is under review. The NRC maintains an requestor seeks to have litigated at the participate fully in the conduct of the Agencywide Documents Access and proceeding. hearing. A request for a hearing or a Management System (ADAMS), which Each contention must consist of a petition for leave to intervene must be provides text and image files of NRC’s specific statement of the issue of law or filed by: (1) First class mail addressed public documents. These documents fact to be raised or controverted. In to the Office of the Secretary of the may be accessed through the NRC’s addition, the requestor/petitioner shall Commission, U.S. Nuclear Regulatory Public Electronic Reading Room on the provide a brief explanation of the bases Commission, Washington, DC 20555– Internet at http://www.nrc.gov/reading- of each contention and a concise 0001, Attention: Rulemaking and rm/adams.html under ADAMS statement of the alleged facts or the Adjudications Staff; (2) courier, express accession number ML040580020. expert opinion that supports the mail, and expedited delivery services: Persons who do not have access to contention on which the requestor/ Office of the Secretary, Sixteenth Floor, ADAMS or who encounter problems in petitioner intends to rely in proving the One White Flint North, 11555 Rockville accessing the documents located in contention at the hearing. The Pike, Rockville, Maryland, 20852, ADAMS, may contact the NRC Public requestor/petitioner must also provide Attention: Rulemaking and Document Room (PDR) Reference staff Adjudications Staff; (3) Email addressed references to those specific sources and at 1–800–397–4209, 301–415–4737, or to the Office of the Secretary, U.S. documents of which the requestor/ by e-mail to [email protected]. petitioner is aware and on which the Nuclear Regulatory Commission, requestor/petitioner intends to rely to [email protected]; or (4) The staff has verified that a copy of establish those facts or expert opinion. facsimile transmission addressed to the the license renewal application is also The requestor/petitioner must provide Office of the Secretary, U.S. Nuclear available to local residents near the sufficient information to show that a Regulatory Commission, Washington, Point Beach Nuclear Plant at the Lester genuine dispute exists with the DC, Attention: Rulemakings and Public Library, at 1001 Adams Street, applicant on a material issue of law or Adjudications Staff at 301–415–1101, Two Rivers, Wisconsin 54241. 1 fact. Contentions shall be limited to verification number is 301–415–1966. A Dated at Rockville, Maryland, this the 7th matters within the scope of the action copy of the request for hearing and day of April 2004 under consideration. The contention petition for leave to intervene must also must be one that, if proven, would be sent to the Office of the General

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For the Nuclear Regulatory Commission. This meeting will be webcast live at less than one week’s notice to the Pao-Tsin Kuo, the Web address—http://www.nrc.gov. public. Program Director, License Renewal and Week of April 19, 2004—Tentative * * * * * Environmental Impacts, Division of The NRC Commission Meeting Regulatory Improvement Programs, Office of Therea re no meetings scheduled for Schedule can be found on the Internet Nuclear Reactor Regulation. the Week of April 19, 2004. at http://www.nrc.gov/what-we-do/ [FR Doc. 04–8286 Filed 4–12–04; 8:45 am] Week of April 26, 2004—Tentative policy-making/schedule.html. BILLING CODE 7590–01–U * * * * * Wednesday, April 28, 2004 This notice is distributed by mail to several hundred subscribers; if you no NUCLEAR REGULATORY 9:30 a.m. Discussion of Security Issues (Closed—Ex. 1) longer wish to receive it, or would like COMMISSION to be added to the distribution, please Week of May 3, 2004—Tentative Advisory Committee on Nuclear contact the Office of the Secretary, Waste; Revised Tuesday, May 4, 2004 Washington, DC 20555 (301–415–1969). In addition, distribution of this meeting The agenda for the 149th meeting of 9:30 a.m. Briefing on Results of the notice over the Internet system is the Advisory Committee on Nuclear Agency Action Review Meeting available. If you are interested in Waste (ACNW) scheduled for April 20– (Public Meeting) (Contact: Bob receiving this Commission meeting 22, 2004, 11545 Rockville Pike, Pascarelli, 301–415–1245). schedule electronically, please send an Rockville, Maryland, has been revised to This meeting will be webcast live at electronic message to [email protected]. include a presentation on the Scientific the Web address—http://www.nrc.gov. Dated: April 8, 2004. and Technical Priorities at Yucca Dave Gamberoni, Mountain on Wednesday, April 21, Thursday, May 6, 2004 Office of the Secretary. 2004, as follows: 1:30 p.m. Meeting with Advisory 4 p.m.–5 p.m.: Scientific and Committee on Reactor Safeguards [FR Doc. 04–8419 Filed 4–9–04; 9:24 am] Technical Priorities at Yucca Mountain (ACRS) (Public Meeting) (Contact: BILLING CODE 7590–01–M (Open)—The Committee will hear John Larkins, 301–415–7360). presentations by and hold discussions This meeting will be webcast live at NUCLEAR REGULATORY with representatives of the Electric the Web address—http://www.nrc.gov. COMMISSION Power Research Institute regarding their Week of May 10, 2004—Tentative December 2003 report on scientific and Biweekly Notice; Applications and technical priorities at Yucca Mountain. Monday, May 10, 2004 Amendments to Facility Operating All other items pertaining to this Licenses Involving No Significant 1:30 p.m. Briefing on Grid Stability meeting remain the same as previously Hazards Considerations published in the Federal Register on and Offsite Power Issues (Public Thursday, April 1, 2004 (69 FR 17243). Meeting) (Contact: Cornelius I. Background For further information, contact Mr. Holden, 301–415–3036). Pursuant to section 189a. (2) of the Howard J. Larson, Special Assistant, This meeting will be webcast live at Atomic Energy Act of 1954, as amended ACNW, (Telephone: 301–415–6805), the Web address—http://www.nrc.gov. (the Act), the U.S. Nuclear Regulatory between 7:30 a.m. and 4:15 p.m., ET. Tuesday, May 11, 2004 Commission (the Commission or NRC Dated: April 7, 2004. staff) is publishing this regular biweekly J. Samuel Walker, 9:30 a.m. Briefing on Status of Office notice. The Act requires the Acting Secretary of the Commission. of International Programs (OIP) Commission publish notice of any Programs, Performance, and Plans [FR Doc. 04–8285 Filed 4–12–04; 8:45 am] amendments issued, or proposed to be (Public Meeting) (Contact: Ed Baker, BILLING CODE 7590–01–P issued and grants the Commission the 301–415–2344). authority to issue and make This meeting will be webcast live at immediately effective any amendment NUCLEAR REGULATORY the Web address—http://www.nrc.gov. to an operating license upon a COMMISSION 1:30 p.m. Briefing on Threat determination by the Commission that Environment Assessment (Closed— such amendment involves no significant Sunshine Act Meeting Ex. 1). hazards consideration, notwithstanding the pendency before the Commission of DATES: Weeks of April 12, 19, 26, May Week of May 17, 2004—Tentative a request for a hearing from any person. 3, 10, 17, 2004. This biweekly notice includes all There are no meetings scheduled for PLACE notices of amendments issued, or : Commissioners’ Conference the Week of May 17, 2004. Room, 11555 Rockville Pike, Rockville, proposed to be issued from, March 19 * The scheduled for Commission Maryland. through April 1, 2004. The last biweekly meetings is subject to change on short notice was published on March 30, 2004 STATUS: Public and closed. notice. To verify the status of meetings (69 FR 16615). MATTERS TO BE CONSIDERED: call (recording)—(301) 415–1292. Week of April 12, 2004 Contact person for more information: Notice of Consideration of Issuance of Dave Gamberoni, (301) 415–1651. Amendments to Facility Operating Tuesday, April 13, 2004 SUPPLEMENTARY INFORMATION: By a vote Licenses, Proposed No Significant 9:30 a.m. Briefing on Status of Office of 3–0 on April 1, the Commission Hazards Consideration Determination, of Nuclear Regulatory Research determined pursuant to U.S.C. 552b(e) and Opportunity for a Hearing (RES) Programs, Performance, and and § 9.107(a) of the Commission’s rules The Commission has made a Plans (Public Meeting) (Contact: that ‘‘Discussion of Security Issues proposed determination that the Alan Levin, 301–415–6656). (Closed—Ex. 1)’’ be held April 7, and on following amendment requests involve

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no significant hazards consideration. also be delivered to Room 6D22, Two the proceeding; and (4) the possible Under the Commission’s regulations in White Flint North, 11545 Rockville effect of any decision or order which 10 CFR 50.92, this means that operation Pike, Rockville, Maryland, from 7:30 may be entered in the proceeding on the of the facility in accordance with the a.m. to 4:15 p.m. Federal workdays. requestor’s/petitioner’s interest. The proposed amendment would not (1) Copies of written comments received petition must also set forth the specific Involve a significant increase in the may be examined at the Commission’s contentions which the petitioner/ probability or consequences of an Public Document Room (PDR), located requestor seeks to have litigated at the accident previously evaluated; or (2) at One White Flint North, Public File proceeding. create the possibility of a new or Area O1F21, 11555 Rockville Pike (first Each contention must consist of a different kind of accident from any floor), Rockville, Maryland. The filing of specific statement of the issue of law or accident previously evaluated; or (3) requests for a hearing and petitions for fact to be raised or controverted. In involve a significant reduction in a leave to intervene is discussed below. addition, the petitioner/requestor shall margin of safety. The basis for this Within 60 days after the date of provide a brief explanation of the bases proposed determination for each publication of this notice, the licensee for the contention and a concise amendment request is shown below. may file a request for a hearing with statement of the alleged facts or expert The Commission is seeking public respect to issuance of the amendment to opinion which support the contention comments on this proposed the subject facility operating license and and on which the petitioner/requestor determination. Any comments received any person whose interest may be intends to rely in proving the contention within 30 days after the date of affected by this proceeding and who at the hearing. The petitioner/requestor publication of this notice will be wishes to participate as a party in the must also provide references to those considered in making any final proceeding must file a written request specific sources and documents of determination. Within 60 days after the for a hearing and a petition for leave to which the petitioner is aware and on date of publication of this notice, the intervene. Requests for a hearing and a which the petitioner/requestor intends licensee may file a request for a hearing petition for leave to intervene shall be to rely to establish those facts or expert with respect to issuance of the filed in accordance with the opinion. The petition must include amendment to the subject facility Commission’s ‘‘Rules of Practice for sufficient information to show that a operating license and any person whose Domestic Licensing Proceedings’’ in 10 genuine dispute exists with the interest may be affected by this CFR Part 2. Interested persons should applicant on a material issue of law or proceeding and who wishes to consult a current copy of 10 CFR 2.309, fact. Contentions shall be limited to participate as a party in the proceeding which is available at the Commission’s matters within the scope of the must file a written request for a hearing PDR, located at One White Flint North, amendment under consideration. The and a petition for leave to intervene. Public File Area 01F21, 11555 Rockville contention must be one which, if Normally, the Commission will not Pike (first floor), Rockville, Maryland. proven, would entitle the petitioner/ issue the amendment until the Publicly available records will be requestor to relief. A petitioner/ expiration of 60 days after the date of accessible from the Agencywide requestor who fails to satisfy these publication of this notice. The Documents Access and Management requirements with respect to at least one Commission may issue the license System’s (ADAMS) Public Electronic contention will not be permitted to amendment before expiration of the 60- Reading Room on the Internet at the participate as a party. day period provided that its final NRC Web site, http://www.nrc.gov/ Those permitted to intervene become determination is that the amendment reading-rm/doc-collections/cfr/. If a parties to the proceeding, subject to any involves no significant hazards request for a hearing or petition for limitations in the order granting leave to consideration. In addition, the leave to intervene is filed within 60 intervene, and have the opportunity to Commission may issue the amendment days, the Commission or a presiding participate fully in the conduct of the prior to the expiration of the 30-day officer designated by the Commission or hearing. comment period should circumstances by the Chief Administrative Judge of the If a hearing is requested, and the change during the 30-day comment Atomic Safety and Licensing Board Commission has not made a final period such that failure to act in a Panel, will rule on the request and/or determination on the issue of no timely way would result, for example in petition; and the Secretary or the Chief significant hazards consideration, the derating or shutdown of the facility. Administrative Judge of the Atomic Commission will make a final Should the Commission take action Safety and Licensing Board will issue a determination on the issue of no prior to the expiration of either the notice of a hearing or an appropriate significant hazards consideration. The comment period or the notice period, it order. final determination will serve to decide will publish in the Federal Register a As required by 10 CFR 2.309, a when the hearing is held. If the final notice of issuance. Should the petition for leave to intervene shall set determination is that the amendment Commission make a final No Significant forth with particularity the interest of request involves no significant hazards Hazards Consideration Determination, the petitioner in the proceeding, and consideration, the Commission may any hearing will take place after how that interest may be affected by the issue the amendment and make it issuance. The Commission expects that results of the proceeding. The petition immediately effective, notwithstanding the need to take this action will occur should specifically explain the reasons the request for a hearing. Any hearing very infrequently. why intervention should be permitted held would take place after issuance of Written comments may be submitted with particular reference to the the amendment. If the final by mail to the Chief, Rules and following general requirements: (1) The determination is that the amendment Directives Branch, Division of name, address and telephone number of request involves a significant hazards Administrative Services, Office of the requestor or petitioner; (2) the consideration, any hearing held would Administration, U.S. Nuclear Regulatory nature of the requestor’s/petitioner’s take place before the issuance of any Commission, Washington, DC 20555– right under the Act to be made a party amendment. 0001, and should cite the publication to the proceeding; (3) the nature and A request for a hearing or a petition date and page number of this Federal extent of the requestor’s/petitioner’s for leave to intervene must be filed by: Register notice. Written comments may property, financial, or other interest in (1) First class mail addressed to the

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Office of the Secretary of the Description of amendment request: new accident precursors and do not involve Commission, U.S. Nuclear Regulatory The licensee proposed to relocate the any alterations to plant configurations which Commission, Washington, DC 20555– average power range monitor (APRM)- could initiate a new or different kind of accident. The proposed changes do not affect 0001, Attention: Rulemaking and based stability protection settings for the intended function of the APRM system Adjudications Staff; (2) courier, express Option II stability solution to the Core nor do they affect the operation of the system mail, and expedited delivery services: Operating Limits Report (COLR). The in a way which would create a new or Office of the Secretary, Sixteenth Floor, Option II solution demonstrates that different kind of accident. One White Flint North, 11555 Rockville existing quadrant-based APRM trip Therefore, the proposed changes do not Pike, Rockville, Maryland, 20852, systems will initiate a reactor scram for create the possibility of a new or different Attention: Rulemaking and postulated reactor instability and avoid kind of accident from any accident Adjudications Staff; (3) E-mail violating the minimum critical power previously evaluated. 3. Does the proposed change involve a addressed to the Office of the Secretary, ratio safety limit. Use of Option II was significant reduction in a margin of safety? U.S. Nuclear Regulatory Commission, previously approved by the Nuclear Response: No. [email protected]; or (4) facsimile Regulatory Commission staff thru The proposed change will relocate the transmission addressed to the Office of Amendment No. 235, dated October 18, APRM based stability protection settings for the Secretary, U.S. Nuclear Regulatory 2002. the Option II stability solution from the TS Commission, Washington, DC, Basis for proposed no significant to the COLR. The APRM based stability Attention: Rulemakings and hazards consideration determination: protection settings for protection against Adjudications Staff at (301) 415–1101, As required by 10 CFR 50.91(a), the reactor instability assure anticipated coupled licensee provided its analysis of the neutronic/thermal-hydraulic instabilities will verification number is (301) 415–1966. not compromise established fuel safety A copy of the request for hearing and issue of no significant hazards limits. No fuel thermal limits or other design petition for leave to intervene should consideration, which is presented and licensing basis acceptance criteria are also be sent to the Office of the General below: adversely affected. No other events are Counsel, U.S. Nuclear Regulatory 1. Does the proposed change involve a adversely affected. The margin of safety, as Commission, Washington, DC 20555– significant increase in the probability or defined in the TS, for all events is 0001, and it is requested that copies be consequences of an accident previously maintained. transmitted either by means of facsimile evaluated? Therefore, the proposed change does not Response: No. involve a significant reduction in a margin of transmission to 301–415–3725 or by e- safety. mail to [email protected]. A copy The proposed changes will relocate the of the request for hearing and petition Average Power Range Monitor (APRM) based The NRC staff has reviewed the stability protection settings for the Option II for leave to intervene should also be licensee’s analysis and, based on this stability solution from the Technical review, it appears that the three sent to the attorney for the licensee. Specifications (TS) to the Core Operating Nontimely requests and/or petitions Limits Report (COLR). The APRM based standards of 10 CFR 50.92(c) are and contentions will not be entertained stability protection settings are not an satisfied. Therefore, the NRC staff absent a determination by the initiator or a precursor to an accident. proposes to determine that the Commission or the presiding officer of Furthermore, changes to the stability requested amendment involves no the Atomic Safety and Licensing Board protection settings do not physically modify significant hazards consideration. or change the function, or system interfaces, Attorney for licensee: Kevin P. Gallen, that the petition, request and/or the of the APRM Neutron Flux Scram and Morgan, Lewis & Bockius, LLP, 1800 M contentions should be granted based on Neutron Flux Control Rod Block systems or Street, NW., Washington, DC 20036– a balancing of the factors specified in 10 components. The APRM based stability 5869. CFR 2.309(a)(1)(i)–(viii). protection settings provide automatic NRC Section Chief: Richard J. Laufer. For further details with respect to this protection to assure that anticipated coupled action, see the application for neutronic/thermal-hydraulic instabilities will AmerGen Energy Company, LLC, et al., amendment which is available for not compromise established fuel safety Docket No. 50–219, Oyster Creek public inspection at the Commission’s limits. The proposed TS changes cannot Nuclear Generating Station, Ocean increase the consequences of a previously County, New Jersey PDR, located at One White Flint North, evaluated accident because the changes do Public File Area 01F21, 11555 Rockville not alter any Limiting Safety System Setting, Date of amendment request: March 8, Pike (first floor), Rockville, Maryland. but only relocate the applicable stability 2004. Publicly available records will be protection settings to the COLR. The Description of amendment request: accessible from the Agencywide applicable stability protection settings will The proposed amendment would delete Documents Access and Management continue to be determined by an NRC Operating License Condition 2.C.(6) System’s (ADAMS) Public Electronic approved methodology. ‘‘Long Range Planning Program.’’ The Reading Room on the Internet at the Therefore, the proposed changes do not original objective of this requirement NRC Web site, http://www.nrc.gov/ involve a significant increase in the probability or consequences of an accident was to enable the licensee to better reading-rm/adams.html. If you do not previously evaluated. control and manage resources regarding have access to ADAMS or if there are 2. Does the proposed change create the major activities. The license condition problems in accessing the documents possibility of a new or different kind of does not have any direct effect on plant located in ADAMS, contact the NRC accident from any accident previously design or operation. Since imposition of PDR Reference staff at 1–800–397–4209, evaluated? this requirement on May 27, 1988, the 301–415–4737 or by e-mail to Response: No. licensee has developed internal [email protected]. The proposed changes will relocate the processes to control and manage work APRM based stability protection settings for activities, thus leading the licensee to AmerGen Energy Company, LLC, et al., the Option II stability solution from the TS determine that this license condition is Docket No. 50–219, Oyster Creek to the COLR. The APRM based stability Nuclear Generating Station, Ocean protection settings for the Option II stability no longer needed. Basis for proposed no significant County, New Jersey solution assure anticipated coupled neutronic/thermal-hydraulic instabilities will hazards consideration determination: Date of amendment request: February not compromise established fuel safety As required by 10 CFR 50.91(a), the 27, 2004. limits. These changes do not introduce any licensee has provided its analysis of the

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issue of no significant hazards Based on the NRC staff’s analysis, it of an accident previously evaluated, and consideration. The NRC staff has appears that the three standards of 10 no increase in the probability of an reviewed the licensee’s analysis against CFR 50.92(c) are satisfied. Therefore, the accident previously evaluated. the three standards of 10 CFR 50.92(c). NRC staff proposes to determine that the The second standard requires that The NRC staff’s analysis is presented amendment request involves no operation of the unit in accordance with below: significant hazards consideration. the proposed amendment will not create The first standard requires that Attorney for licensee: Kevin P. Gallen, the possibility of a new or different kind operation of the unit in accordance with Morgan, Lewis & Bockius, LLP, 1800 M of accident from any accident the proposed amendment will not Street, NW., Washington, DC 20036– previously evaluated. The proposed involve a significant increase in the 5869. amendment is not the result of a probability or consequences of an NRC Section Chief: Richard J. Laufer. hardware design change, nor does it accident previously evaluated. The AmerGen Energy Company, LLC, lead to the need for a hardware design subject license condition was not a Docket No. 50–289, Three Mile Island change. There is no change in the factor in the scenario of any previously Nuclear Station, Unit 1 (TMI–1), methods the unit is operated. As a analyzed postulated design-basis Dauphin County, Pennsylvania result, all SSCs will continue to perform accident or anticipated operational as previously analyzed by the licensee, Date of amendment request: March 8, transient. No hardware design change is and previously evaluated and accepted 2004. by the NRC staff. Therefore, the involved with the proposed Description of amendment request: amendment. Thus, the proposed proposed amendment will not create the The proposed amendment would delete possibility of a new or different kind of deletion of the license condition would Operating License Condition 2.C.(9) create no adverse effect on the accident from any previously evaluated. ‘‘Long Range Planning Program.’’ The The third standard requires that functional performance of any plant original objective of this requirement structure, system, or component (SSC). operation of the unit in accordance with was to enable the licensee to better the proposed amendment will not All SSCs will continue to perform their control and manage resources regarding design functions with no decrease in involve a significant reduction in a major activities. The license condition margin of safety. Since the proposed their capabilities to mitigate the does not have any direct effect on plant previously analyzed consequences of deletion of the license condition will design or operation. Since imposition of not lead the licensee to exceed or alter postulated accidents and anticipated this requirement on May 27, 1988, the operational transients. Accordingly, the a design basis or safety limit, and will licensee has developed internal not result in operating any component deletion of the license condition will processes to control and manage work lead to no increase in the consequences in a less conservative manner, the activities, thus leading the licensee to proposed amendment will not affect in of an accident previously evaluated, and determine that this license condition is no increase in the probability of an any way the performance characteristics no longer needed. and intended functions of any SSC. accident previously evaluated. Basis for proposed no significant The second standard requires that Therefore, the proposed amendment hazards consideration determination: does not involve a significant reduction operation of the unit in accordance with As required by 10 CFR 50.91(a), the the proposed amendment will not create in a margin of safety. licensee has provided its analysis of the Based on the NRC staff’s analysis, it the possibility of a new or different kind issue of no significant hazards appears that the three standards of 10 of accident from any accident consideration. The NRC staff has CFR 50.92(c) are satisfied. Therefore, the previously evaluated. The proposed reviewed the licensee’s analysis against NRC staff proposes to determine that the amendment is not the result of a the three standards of 10 CFR 50.92(c). amendment request involves no hardware design change, nor does it The NRC staff’s analysis is presented significant hazards consideration. lead to the need for a hardware design below: Attorney for licensee: Edward J. change. There is no change in the The first standard requires that Cullen, Jr., Esquire, Vice President, methods the unit is operated. As a operation of the unit in accordance with General Counsel and Secretary, Exelon result, all SSCs will continue to perform the proposed amendment will not Generation Company, LLC, 300 Exelon as previously analyzed by the licensee, involve a significant increase in the Way, Kennett Square, PA 19348. and previously evaluated and accepted probability or consequences of an NRC Section Chief: Richard J. Laufer. by the NRC staff. Therefore, the accident previously evaluated. The proposed amendment will not create the subject license condition was not a Calvert Cliffs Nuclear Power Plant, Inc., possibility of a new or different kind of factor in the scenario of any previously Docket Nos. 50–317 and 50–318, Calvert accident from any previously evaluated. analyzed postulated design-basis Cliffs Nuclear Power Plant, Unit Nos. 1 The third standard requires that accident or anticipated operational and 2, Calvert County, Maryland operation of the unit in accordance with transient. No hardware design change is Date of amendments request: the proposed amendment will not involved with the proposed December 12, 2003. involve a significant reduction in a amendment. Thus, the proposed Description of amendments request: margin of safety. Since the proposed deletion of the license condition would The proposed amendment would delete deletion of the license condition will create no adverse effect on the Technical Specification (TS) Section not lead the licensee to exceed or alter functional performance of any plant 5.5.3, ‘‘Post-Accident Sampling,’’ a design basis or safety limit, and will structure, system, or component (SSC). requirements to maintain a Post- not result in operating any component All SSCs will continue to perform their Accident Sampling System (PASS). in a less conservative manner, the design functions with no decrease in Licensees were generally required to proposed amendment will not affect in their capabilities to mitigate the implement PASS upgrades as a result of any way the performance characteristics previously analyzed consequences of NUREG–0737, ‘‘Clarification of TMI and intended functions of any SSC. postulated accidents and anticipated [Three Mile Island] Action Plan Therefore, the proposed amendment operational transients. Accordingly, the Requirements,’’ and Regulatory Guide does not involve a significant reduction deletion of the license condition will 1.97, Revision 3, ‘‘Instrumentation for in a margin of safety. lead to no increase in the consequences Light-Water-Cooled Nuclear Power

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Plants to Access Plant and Environs mitigation. Past experience has indicated that the event in order to mitigate the Conditions During and Following an there exists in-plant instrumentation and consequences of the accident. The use of a Accident.’’ Implementation of these methodologies available in lieu of a PASS for PASS is redundant and does not provide upgrades was an outcome of the NRC’s collecting and assimilating information quick recognition of core events or rapid needed to assess core damage following an response to events in progress. The intent of lessons learned from the accident that accident. Furthermore, the implementation of the requirements established as a result of the occurred at TMI Unit 2. Requirements Severe Accident Management Guidance TMI–2 accident can be adequately met related to PASS were imposed by Order (SAMG) emphasizes accident management without reliance on a PASS. for many facilities and were added to or strategies based on in-plant instruments. Therefore, this change does not involve a included in the TS for nuclear power These strategies provide guidance to the significant reduction in [a] margin of safety. reactors currently licensed to operate. plant staff for mitigation and recovery from Based upon the reasoning presented above Lessons learned and improvements a severe accident. Based on current severe and the previous discussion of the implemented over the last 20 years have accident management strategies and amendment request, the requested change shown that the information obtained guidelines, it is determined that the PASS does not involve a significant hazards provides little benefit to the plant staff in consideration. from PASS can be readily obtained coping with an accident. The NRC staff proposes to determine through other means or is of little use The regulatory requirements for the PASS in the assessment and mitigation of can be eliminated without degrading the that the amendment request involves no accident conditions. plant emergency response. The emergency significant hazards consideration. The NRC staff issued a notice of response, in this sense, refers to the Attorney for licensee: James M. Petro, opportunity for comment in the Federal methodologies used in ascertaining the Jr., Esquire, Counsel, Constellation Register on August 11, 2000 (65 FR condition of the reactor core, mitigating the Energy Group, Inc., 750 East Pratt Street, 49271) on possible amendments to consequences of an accident, assessing and 5th floor, Baltimore, MD 21202. eliminate PASS, including a model projecting offsite releases of radioactivity, NRC Section Chief: Richard J. Laufer. safety evaluation and model no and establishing protective action recommendations to be communicated to Duke Energy Corporation, Docket Nos. significant hazards consideration offsite authorities. The elimination of the 50–369 and 50–370, McGuire Nuclear (NSHC) determination, using the PASS will not prevent an accident Station, Units 1 and 2, Mecklenburg consolidated line item improvement management strategy that meets the initial County, North Carolina process. The NRC staff subsequently intent of the post-TMI–2 accident guidance Date of amendment request: June 25, issued a notice of availability of the through the use of the SAMGs, the emergency plan (EP), the emergency 2003. models for referencing in a license Description of amendment request: amendment application in the Federal operating procedures (EOP), and site survey monitoring that support modification of The proposed amendments would Register on October 31, 2000 (65 FR correct two inadvertent editorial 65018). The licensee affirmed the emergency plan protective action recommendations (PARs). changes made by Duke during the applicability of the following NSHC Therefore, the elimination of PASS submittal of Technical Specification determination in its application dated requirements from Technical Specifications (TS) Amendment 194/175 which December 12, 2003. (TS) (and other elements of the licensing revised TS 3.3.1 (Reactor Trip System Basis for proposed no significant bases) does not involve a significant increase Instrumentation) and TS Amendment hazards consideration determination: in the consequences of any accident 197/178 which revised TS 4.2.1 (Design As required by 10 CFR 50.91(a), an previously evaluated. Features, Fuel Assemblies). analysis of the issue of no significant Criterion 2—The Proposed Change Does Not Basis for proposed no significant hazards consideration is presented Create the Possibility of a New or Different hazards consideration determination: below: Kind of Accident From Any Previously As required by 10 CFR 50.91(a), the Evaluated Criterion 1—The Proposed Change Does Not licensee has provided its analysis of the The elimination of PASS related issue of no significant hazards Involve a Significant Increase in the requirements will not result in any failure Probability or Consequences of an Accident consideration, which is presented mode not previously analyzed. The PASS below: Previously Evaluated was intended to allow for verification of the The PASS was originally designed to extent of reactor core damage and also to 1. Does this LAR [License Amendment perform many sampling and analysis provide an input to offsite dose projection Request] involve a significant increase in the functions. These functions were designed calculations. The PASS is not considered an probability or consequences of an accident and intended to be used in post accident accident precursor, nor does its existence or previously evaluated? situations and were put into place as a result elimination have any adverse impact on the No. Approval and implementation of this of the TMI–2 accident. The specific intent of pre-accident state of the reactor core or post LAR will have no affect on accident the PASS was to provide a system that has accident confinement of radionuclides probabilities or consequences since the the capability to obtain and analyze samples within the containment building. proposed changes are editorial in nature and of plant fluids containing potentially high Therefore, this change does not create the were previously reviewed and approved by levels of radioactivity, without exceeding possibility of a new or different kind of the NRC [Nuclear Regulatory Commission]. plant personnel radiation exposure limits. accident from any previously evaluated. 2. Does this LAR create the possibility of Analytical results of these samples would be a new or different kind of accident from any used largely for verification purposes in Criterion 3—The Proposed Change Does Not accident previously evaluated? aiding the plant staff in assessing the extent Involve a Significant Reduction in [a] No. This LAR does not involve any of core damage and subsequent offsite Margin of Safety physical changes to the plant. Therefore, no radiological dose projections. The system The elimination of the PASS, in light of new accident causal mechanisms will be was not intended to and does not serve a existing plant equipment, instrumentation, generated. The proposed changes are function for preventing accidents and its procedures, and programs that provide editorial in nature and were previously elimination would not affect the probability effective mitigation of and recovery from reviewed and approved by the NRC. of accidents previously evaluated. reactor accidents, results in a neutral impact Consequently, plant accident analyses will In the 20 years since the TMI–2 accident to the margin of safety. Methodologies that not be affected by these changes. and the consequential promulgation of post are not reliant on PASS are designed to 3. Does this LAR involve a significant accident sampling requirements, operating provide rapid assessment of current reactor reduction in a margin of safety? experience has demonstrated that a PASS core conditions and the direction of No. Margin of safety is related to the provides little actual benefit to post accident degradation while effectively responding to confidence in the ability of the fission

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product barriers to perform their design (2) Create the possibility of a new or using the consolidated line-item functions during and following accident different kind of accident from any kind of improvement process. The NRC staff conditions. These barriers include the fuel accident previously evaluated[.] subsequently issued a notice of cladding, the reactor coolant system, and the The proposed LAR modifies the Technical availability of the models for referencing containment system. The performance of Specifications to incorporate new TS these barriers will not be affected by the requirements associated with the new CRD/ in license amendment applications in proposed changes since they are editorial in RTB configuration. The systems affected by the Federal Register on October 22, nature and have been previously reviewed implementing the proposed changes to the 2003 (68 FR 60422). The licensee and approved by the NRC. TS are not assumed to initiate design basis affirmed the applicability of the model accidents. Rather, the systems affected by the NSHC determination in its application The NRC staff has reviewed the changes are used to mitigate the dated March 3, 2004. licensee’s analysis and, based on this consequences of an accident that has already review, it appears that the three occurred. The proposed TS changes do not Basis for proposed no significant standards of 10 CFR 50.92(c) are affect the mitigating function of these hazards consideration determination: satisfied. Therefore, the NRC staff systems. The reliability of the mitigating As required by 10 CFR 50.91(a), an proposes to determine that the systems will be improved by implementation analysis of the issue of no significant amendment request involves no of the RTB Upgrade. Consequently, these hazards consideration is presented significant hazards consideration. changes do not alter the nature of events below: Attorney for licensee: Ms. Lisa F. postulated in the Safety Analysis Report nor do they introduce any unique precursor Criterion 1—The Proposed Change Does Not Vaughn, Duke Energy Corporation, 422 mechanisms. Therefore, the proposed South Church Street, Charlotte, North Involve a Significant Increase in the amendment will not create the possibility of Probability or Consequences of an Accident Carolina 28201–1006. a new or different kind of accident from any Previously Evaluated NRC Section Chief: John A. Nakoski. previously evaluated. (3) Involve a significant reduction in a The proposed change to the RCP flywheel Duke Energy Corporation, Docket Nos. margin of safety. examination frequency does not change the 50–269, 50–270, and 50–287, Oconee The proposed TS changes do not response of the plant to any accidents. The Nuclear Station, Units 1, 2, and 3, unfavorably affect any plant safety limits, set RCP will remain highly reliable and the Oconee County, South Carolina points, or design parameters. The changes proposed change will not result in a significant increase in the risk of plant Date of amendment request: January also do not unfavorably affect the fuel, fuel cladding, RCS [reactor coolant system], or operation. Given the extremely low failure 15, 2004, as supplemented by letter containment integrity. Therefore, the probabilities for the RCP motor flywheel dated March 15, 2004. proposed TS change, which adds TS during normal and accident conditions, the Description of amendment request: requirements associated with the CRD/RTB extremely low probability of a loss-of-coolant The proposed amendments would upgrade, do not involve a significant accident (LOCA) with loss of offsite power revise the Technical Specifications reduction in the margin of safety. (LOOP), and assuming a conditional core associated with the control rod drive The NRC staff has reviewed the damage probability (CCDP) of 1.0 (complete (CRD) trip devices. These amendments licensee’s analysis and, based on this failure of safety systems), the core damage are needed to support implementation review, it appears that the three frequency (CDF) and change in risk would of the reactor trip breaker (RTB) standards of 10 CFR 50.92(c) are still not exceed the NRC’s acceptance replacement. guidelines contained in Regulatory Guide satisfied. Therefore, the NRC staff (RG) 1.174 (<1.0E–6 per year). Moreover, Basis for proposed no significant proposes to determine that the hazards consideration determination: considering the uncertainties involved in this amendment request involves no evaluation, the risk associated with the As required by 10 CFR 50.91(a), the significant hazards consideration. licensee has provided its analysis of the postulated failure of an RCP motor flywheel Attorney for licensee: Anne W. is significantly low. Even if all four RCP issue of no significant hazards Cottington, Winston and Strawn, 1200 motor flywheels are considered in the consideration, which is presented 17th Street, NW., Washington, DC bounding plant configuration case, the risk is below: 20005. still acceptably low. (1) Involve a significant increase in the NRC Section Chief: John A. Nakoski. The proposed change does not adversely probability or consequences of an accident Entergy Nuclear Operations, Docket affect accident initiators or precursors, nor previously evaluated[.] alter the design assumptions, conditions, or The proposed LAR [license amendment Nos. 50–247 and 50–286, Indian Point configuration of the facility, or the manner in request] modifies the Technical Nuclear Generating Unit Nos. 2 and 3, which the plant is operated and maintained; Specifications [TS] to incorporate new TS Westchester County, New York alter or prevent the ability of structures, requirements associated with the new Date of amendment request: March 3, systems, components (SSCs) from performing Control Rod Drive (CRD)/Reactor Trip 2004. their intended function to mitigate the Breaker (RTB) configuration. The proposed Description of amendment request: consequences of an initiating event within LAR will continue to ensure that the CRD the assumed acceptance limits; or affect the trip devices will be operable to ensure that The proposed amendments would revise the administrative Technical source term, containment isolation, or the reactor remains capable of being tripped radiological release assumptions used in at any time it is critical. Reliable CRD reactor Specifications (TSs) for the Reactor evaluating the radiological consequences of trip circuit breakers and associated support Coolant Pump Flywheel Inspection an accident previously evaluated. Further, circuitry provides assurance that a reactor Program to extend the allowable the proposed change does not increase the trip will occur when initiated. The new RTBs inspection interval to 20 years. will have the same seismic and quality group The NRC staff issued a notice of type or amount of radioactive effluent that may be released offsite, nor significantly qualifications as the existing components in opportunity for comment in the the CRDCS [CRD control system] system [sic]. increase individual or cumulative Federal Register on June 24, 2003 (68 occupational/public radiation exposure. The The new RTBs will enhance the reliability of FR 37590), on possible amendments to the system by resolving age-related proposed change is consistent with the safety degradation issues and replacing obsolete extend the inspection interval for analysis assumptions and resultant equipment. Therefore, the proposed LAR reactor coolant pump (RCP) flywheels, consequences. Therefore, the proposed does not involve a significant increase in the including a model safety evaluation and change does not involve a significant probability or consequences of an accident model no significant hazards increase in the probability or consequences previously evaluated. consideration (NSHC) determination, of an accident previously evaluated.

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Criterion 2—The Proposed Change Does Not accumulator pressure. Condition B of Specific, Risk-Informed Decisionmaking: Create the Possibility of a New or Different TS 3.5.1 specifies a CT to restore an Technical Specifications,’’ for all cases Kind of Accident From Any Accident accumulator to operable status when it except those that are based on design basis Previously Evaluated has been declared inoperable for a success criteria. As indicated in WCAP– The proposed change in flywheel reason other than the boron 15049–A, design basis accumulator success criteria are not considered necessary to inspection frequency does not involve any concentration of the water in the change in the design or operation of the RCP. mitigate large break loss-of-coolant accident accumulator not being within the (LOCA) events, and were only included in Nor does the change to examination required range. This change was frequency affect any existing accident the WCAP–15049–A evaluation as a worst scenarios, or create any new or different proposed by the Westinghouse Owners case data point. In addition, WCAP–15049– accident scenarios. Further, the change does Group participants in the TS Task Force A states that the NRC has indicated that an not involve a physical alteration of the plant (TSTF) and is designated TSTF–370. incremental conditional core damage (i.e., no new or different type of equipment TSTF–370 is supported by NRC- frequency (ICCDP) greater than 5E–07 does will be installed) or alter the methods approved Topical Report WCAP–15049– not necessarily mean the change is governing normal plant operation. In A, ‘‘Risk-Informed Evaluation of an unacceptable. addition, the change does not impose any Extension to Accumulator Completion The proposed technical specification change does not involve any hardware new or different requirements or eliminate Times,’’ submitted on May 18, 1999. any existing requirements, and does not alter changes nor does it affect the probability of The NRC staff issued a notice of any event initiators. There will be no change any assumptions made in the safety analysis. opportunity for comment in the Federal The proposed change is consistent with the to normal plant operating parameters, safety analysis assumptions and current plant Register on July 15, 2002 (67 FR 46542), engineered safety feature (ESF) actuation operating practice. Therefore, the proposed on possible amendments concerning setpoints, accident mitigation capabilities, change does not create the possibility of a TSTF–370, including a model safety accident analysis assumptions or inputs. new or different kind of accident from any evaluation and model no significant Therefore, this change does not involve a accident previously evaluated. hazards consideration (NSHC) significant increase in the probability or determination, using the consolidated consequences of an accident previously Criterion 3—The Proposed Change Does Not evaluated. Involve a Significant Reduction in a Margin line item improvement process. The of Safety NRC staff subsequently issued a notice Criterion 2—The Proposed Change Does Not Create the Possibility of a New or Different The proposed change does not alter the of availability of the models for referencing in license amendment Kind of Accident From any Previously manner in which safety limits, limiting safety Evaluated system settings, or limiting conditions for applications in the Federal Register on operation are determined. The safety analysis March 12, 2003 (68 FR 11880). The No new accident scenarios, transient acceptance criteria are not impacted by this licensee affirmed the applicability of the precursors, failure mechanisms, or limiting change. The proposed change will not result following NSHC determination in its single failures are introduced as a result of the proposed change. As described in Section in plant operation in a configuration outside application dated March 9, 2004. of the design basis. The calculated impact on 9.1 of the WCAP–15049–A evaluation, the Basis for proposed no significant plant design will not be changed with this risk is insignificant and meets the acceptance hazards consideration determination: criteria contained in RG 1.174. There are no proposed technical specification CT increase. significant mechanisms for inservice As required by 10 CFR 50.91(a), an All safety systems still function in the same degradation of the RCP flywheel. Therefore, analysis of the issue of no significant manner and there is no additional reliance on the proposed change does not involve a hazards consideration is presented additional systems or procedures. The significant reduction in a margin of safety. below: proposed accumulator CT increase has a very small impact on core damage frequency. The The NRC staff proposes to determine Criterion 1—The Proposed Change Does Not WCAP–15049–A evaluation demonstrates that the amendment request involves no Involve a Significant Increase in the that the small increase in risk due to significant hazards consideration. Probability or Consequences of an Accident increasing the CT for an inoperable Attorney for licensee: Mr. John Fulton, Previously Evaluated accumulator is within the acceptance criteria provided in RGs 1.174 and 1.177. No new Assistant General Counsel, Entergy The basis for the accumulator limiting accidents or transients can be introduced Nuclear Operations, Inc., 440 Hamilton condition for operation (LCO), as discussed in Bases Section 3.5.1.1, is to ensure that a with the requested change and the likelihood Avenue, White Plains, NY 10601. of an accident or transient is not impacted. NRC Section Chief: Richard J. Laufer. sufficient volume of borated water will be immediately forced into the core through The malfunction of safety related Entergy Nuclear Operations, Inc., each of the cold legs in the event the RCS equipment, assumed to be operable in the Docket No. 50–286, Indian Point pressure falls below the pressure of the accident analyses, would not be caused as a accumulators, thereby providing the initial result of the proposed technical specification Nuclear Generating Unit No. 3, change. No new failure mode has been Westchester County, New York cooling mechanism during large RCS pipe ruptures. As described in Section 9.2 of created and no new equipment performance Date of amendment request: March 9, WCAP–15049–A, the proposed change will burdens are imposed. 2004. allow plant operation with an inoperable Therefore, this change does not create the Description of amendment request: accumulator for up to 24 hours, instead of 1 possibility of a new or different kind of hour, before the plant would be required to accident from any accident previously The proposed amendment would extend evaluated. the completion time (CT) from 1 hour to begin shutting down. The impact of the increase in the accumulator CT on core 24 hours for Condition B of Technical Criterion 3—The Proposed Change Does Not damage frequency for all the cases evaluated Involve a Significant Reduction in a Margin Specification (TS) 3.5.1, in WCAP–15049–A is within the acceptance of Safety ‘‘Accumulators.’’ The accumulators are limit of 1.0E–06/yr for a total plant core part of the emergency core cooling damage frequency (CDF) less than 1.0E–03/ The proposed change does not involve a system and consist of tanks partially yr. The incremental conditional core damage significant reduction in a margin of safety. filled with borated water and probabilities calculated in WCAP–15049–A There will be no change to the departure from nucleate boiling ratio (DNBR) pressurized with nitrogen gas. The for the accumulator CT increase meet the criterion of 5E–07 in Regulatory Guides (RG) correlation limit, the design DNBR limits, or contents of the tank are discharged to 1.174, ‘‘An Approach for using Probabilistic the safety analysis DNBR limits. the reactor coolant system (RCS) if, as Risk Assessment in Risk-Informed Decisions The basis for the accumulator LCO, as during a loss-of-coolant accident, the On Plant-Specific Changes to the Licensing discussed in Bases Section 3.5.1.1, is to coolant pressure decreases to below the Basis,’’ and 1.177, ‘‘An Approach for Plant- ensure that a sufficient volume of borated

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water will be immediately forced into the As required by 10 CFR 50.91(a), an consequences of any accident previously core through each of the cold legs in the analysis of the issue of no significant evaluated. event the RCS pressure falls below the hazards consideration is presented pressure of the accumulators, thereby Criterion 2—The Proposed Change Does Not providing the initial cooling mechanism below: Create the Possibility of a New or Different during large RCS pipe ruptures. As described Kind of Accident From any Previously in Section 9.2 of WCAP–15049–A, the Criterion 1—The Proposed Change Does Not Evaluated. proposed change will allow plant operation Involve a Significant Increase in the The elimination of the hydrogen with an inoperable accumulator for up to 24 Probability or Consequences of an Accident recombiner requirements and relaxation of hours, instead of 1 hour, before the plant Previously Evaluated the hydrogen monitor requirements, would be required to begin shutting down. The revised 10 CFR 50.44 no longer defines including removal of these requirements The impact of this on plant risk was a design-basis loss-of-coolant accident from TS, will not result in any failure mode evaluated and found to be very small. That (LOCA) hydrogen release, and eliminates not previously analyzed. The hydrogen is, increasing the time the accumulators will requirements for hydrogen control systems to recombiner and hydrogen monitor equipment be unavailable to respond to a large LOCA mitigate such a release. The installation of was intended to mitigate a design-basis event, assuming accumulators are needed to hydrogen recombiners and/or vent and purge hydrogen release. The hydrogen recombiner mitigate the design basis event, has a very systems required by 10 CFR 50.44(b)(3) was and hydrogen monitor equipment are not small impact on plant risk. intended to address the limited quantity and considered accident precursors, nor does Since the frequency of a design basis large rate of hydrogen generation that was their existence or elimination have any LOCA (a large LOCA with loss of offsite postulated from a design-basis LOCA. The adverse impact on the pre-accident state of power) would be significantly lower than the Commission has found that this hydrogen the reactor core or post accident confinement large LOCA frequency of the WCAP–15049– release is not risk-significant because the of radionuclides within the containment A evaluation, the impact of increasing the design-basis LOCA hydrogen release does not building. accumulator CT from 1 hour to 24 hours on contribute to the conditional probability of a Therefore, this change does not create the plant risk due to a design basis large LOCA large release up to approximately 24 hours possibility of a new or different kind of would be significantly less than the plant risk after the onset of core damage. In addition, accident from any previously evaluated. increase presented in the WCAP–15049–A these systems were ineffective at mitigating Criterion 3—The Proposed Change Does Not evaluation. hydrogen releases from risk-significant Therefore, this change does not involve a Involve a Significant Reduction in the accident sequences that could threaten Margin of Safety. significant reduction in a margin of safety. containment integrity. The elimination of the hydrogen With the elimination of the design-basis The NRC staff proposes to determine recombiner requirements and relaxation of LOCA hydrogen release, hydrogen monitors that the amendment request involves no the hydrogen monitor requirements, significant hazards consideration. are no longer required to mitigate design- including removal of these requirements Attorney for licensee: Mr. John Fulton, basis accidents and, therefore, the hydrogen from TS, in light of existing plant equipment, Assistant General Counsel, Entergy monitors do not meet the definition of a instrumentation, procedures, and programs Nuclear Operations, Inc., 440 Hamilton safety-related component as defined in 10 that provide effective mitigation of and CFR 50.2. RG [Regulatory Guide] 1.97 recovery from reactor accidents, results in a Avenue, White Plains, NY 10601. Category 1, is intended for key variables that NRC Section Chief: Richard J. Laufer. neutral impact to the margin of safety. most directly indicate the accomplishment of The installation of hydrogen recombiners Entergy Nuclear Operations, Inc., a safety function for design-basis accident and/or vent and purge systems required by Docket No. 50–293, Pilgrim Nuclear events. The hydrogen monitors no longer 10 CFR 50.44(b)(3) was intended to address Power Station, Plymouth County, meet the definition of Category 1 in RG 1.97. the limited quantity and rate of hydrogen As part of the rulemaking to revise 10 CFR Massachusetts generation that was postulated from a design- 50.44, the Commission found that Category 3, basis LOCA. The Commission has found that Date of amendment request: as defined in RG 1.97, is an appropriate this hydrogen release is not risk-significant December 24, 2003. categorization for the hydrogen monitors because the design-basis LOCA hydrogen Description of amendment request: because the monitors are required to release does not contribute to the conditional The proposed amendment would delete diagnose the course of beyond design-basis probability of a large release up to requirements in the Pilgrim Nuclear accidents. approximately 24 hours after the onset of The regulatory requirements for the Power Station Technical Specifications core damage. hydrogen monitors can be relaxed without Category 3 hydrogen monitors are adequate (TSs) 3.7.A.7.c and 4.7.A.7.c, associated degrading the plant emergency response. The to provide rapid assessment of current with hydrogen analyzers. The NRC staff emergency response, in this sense, refers to reactor core conditions and the direction of issued a notice of opportunity for the methodologies used in ascertaining the degradation while effectively responding to comment in the Federal Register on condition of the reactor core, mitigating the the event in order to mitigate the August 2, 2002 (67 FR 50374), on consequences of an accident, assessing and consequences of the accident. The intent of possible amendments to eliminate the projecting offsite releases of radioactivity, the requirements established as a result of the hydrogen analyzers from TSs, including and establishing protective action TMI, Unit 2 accident can be adequately met without reliance on safety-related hydrogen a model safety evaluation and model no recommendations to be communicated to offsite authorities. Classification of the monitors. significant hazards consideration hydrogen monitors as Category 3, and Therefore, this change does not involve a (NSHC) determination, using the removal of the hydrogen monitors from TS significant reduction in the margin of safety. Consolidated Line Item Improvement will not prevent an accident management Removal of hydrogen monitoring from TS Process (CLIIP). The NRC staff strategy through the use of the SAMGs will not result in a significant reduction in subsequently issued a notice of [Severe Accident Management Guidelines], their functionality, reliability, and availability of the models for referencing the emergency plan (EP), the emergency availability. in license amendment applications in operating procedures (EOP), and site survey Based upon the reasoning presented the Federal Register on September 25, monitoring that support modification of above, the requested change does not 2003 (68 FR 55416). The licensee emergency plan protective action involve a significant hazards recommendations (PARs). affirmed the applicability of the relevant Therefore, the elimination of the hydrogen consideration. Therefore, the NRC staff portions of the model NSHC recombiner requirements and relaxation of proposes to determine that the determination in its application dated the hydrogen monitor requirements, amendment request involves no December 24, 2003. including removal of these requirements significant hazards consideration. Basis for proposed no significant from TS, does not involve a significant Attorney for licensee: J.M. Fulton, hazards consideration determination: increase in the probability or the Esquire, Assistant General Counsel,

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Pilgrim Nuclear Power Station, 600 subsection IWB–3600 requirements. The of surveillance tests other than RTTs to Rocky Hill Road, Plymouth, Waterford 3 FSAR has analyzed the assure that response time requirements Massachusetts 02360–5599. conditions that would result from a thermal were met for sensors in those loops. NRC Section Chief: Darrell J. Roberts, or pressurization transient on the Waterford Supplement 1 to NEDO–32291–A was 3 pressurizer. The proposed deletion of the Acting. pressurizer heatup and cooldown rates and prepared to document an analysis to extend the conclusions of the original Entergy Operations Inc., Docket No. 50– relocation of the limits to the TRM does not study to cover the logic components in 382, Waterford Steam Electric Station, change the way that the pressurizer is designed or operated. selected instrumentation loops that have Unit 3, St. Charles Parish, Louisiana Therefore, the proposed change does not intermediate length response time Date of amendment request: March create the possibility of a new or different requirements. The intent was to 15, 2004. kind of accident from any previously demonstrate that elimination of the RTT Description of amendment request: evaluated. requirements for the logic portions of 3. Does the proposed change involve a The amendment proposes to move the those loops is of no safety significance. Waterford Steam Electric Station, Unit 3 significant reduction in a margin of safety? Response: No. Supplement 1 concludes, for instrument (Waterford 3) Technical Specification The margin of safety is established by the loops meeting the application criteria of (TS) 3.4.8.2, pressurizer heatup and rules contained in the ASME Section III the Licensing Topical Report, that cooldown limits to the Technical Code. Any future changes to the cooldown or performance of ongoing TS required Requirements Manual (TRM), which is heatup rates will be evaluated using 10 CFR surveillance tests other than RTTs (i.e., reviewed in accordance with Section 50.59 and are required to meet the ASME calibration tests, functional tests, and 50.59 of Title 10 of the Code of Federal Code margins. logic system functional tests) provides Regulations (10 CFR), ‘‘Changes, tests, Therefore, the proposed change does not adequate assurance that those and experiments.’’ The associated action involve a significant reduction in a margin of safety. instrument loops will meet their statement, surveillance requirement, respective response time requirements. and bases are also proposed for The NRC staff has reviewed the Basis for proposed no significant relocation. licensee’s analysis and, based on this hazards consideration determination: Basis for proposed no significant review, it appears that the three As required by 10 CFR 50.91(a), the hazards consideration determination: standards of 10 CFR 50.92(c) are licensee has provided its analysis of the As required by 10 CFR 50.91(a), the satisfied. Therefore, the NRC staff issue of no significant hazards licensee has provided its analysis of the proposes to determine that the consideration, which is presented issue of no significant hazards amendment request involves no below: consideration, which is presented significant hazards consideration. 1. The proposed change does not involve below: Attorney for licensee: N.S. Reynolds, Esquire, Winston & Strawn 1400 L a significant increase in probability or 1. Does the proposed change involve a consequences of an accident previously significant increase in the probability or Street NW., Washington, DC 20005– evaluated. consequences of an accident previously 3502. The proposed amendment to the TS evaluated? NRC Section Chief: Robert A. Gramm. eliminates selected RTT requirements in Response: No. Exelon Generation Company, LLC, accordance with the NRC approved BWROG The probability of an accident is Docket Nos. 50–373 and 50–374, LTR. Elimination of RTT for selected unchanged as a result of the proposed change instrumentation in the Reactor Protection to delete the Waterford 3 pressurizer heatup LaSalle County Station, Units 1 and 2, System and Primary Containment Isolation and cooldown rates and associated action, LaSalle County, Illinois Instrumentation does not result in the surveillance requirement, and bases from the Date of amendment request: March alteration of the design, material, or TS. The cooldown and heatup rates are not 12, 2004. construction standards that were applicable initiators to any accidents or pressurizer Description of amendment request: prior to the proposed change. The response transients discussed in the Waterford 3 Final The proposed amendments would time assumptions used in the accident Safety Analysis Report (FSAR). Therefore, analyses remain unchanged. Only the the probability of an accident is not changed. modify the Technical Specifications methodology used for response time The purpose of the pressurizer heatup and (TS) to eliminate selected response time verification is changed. All component cooldown limits is to ensure that given testing (RTT) requirements associated models used in the affected trip channels transient events will not negatively affect the with Reactor Protection System were analyzed for a bounding response time. pressurizer structural integrity beyond Code instrumentation and Primary As documented in the BWROG LTR and allowables. These limits will be maintained Containment Isolation instrumentation supplement, a degraded response time will within ASME [American Society of for Main Steam Line Isolation functions. be detected by other TS required tests. The Mechanical Engineers] Code allowables in The proposed changes are consistent bounding response time of the relays the TRM in accordance with 10 CFR 50.59. with the Boiling Water Reactor Owners discussed in the supplement to the LTR can Therefore, the consequences of an accident be used in place of actual measured response are not increased. Group (BWROG) Licensing Topical times to ensure that the instrumentation Therefore, the proposed change does not Report ‘‘System Analyses for the systems will meet the response time involve a significant increase in the Elimination of Selected Response Time requirements of the accident analysis. probability or consequences of an accident Testing Requirements,’’ NEDO– The proposed change will not result in the previously evaluated. 32291√A, Supplement 1, dated October modification of any system interface that 2. Does the proposed change create the 1999, as approved by the NRC on June would increase the likelihood of an accident possibility of a new or different kind of 11, 1999. since these events are independent of the accident from any accident previously The original Licensing Topical Report proposed change. In addition, the proposed evaluated? (LTR) NEDO–32291–A, dated October amendment will not change, degrade, or Response: No. 1995, established a generic basis for prevent actions, or alter any assumptions The limitations imposed on the pressurizer previously made in evaluating the heatup and cooldown rates are provided to elimination of many RTTs for radiological consequences of an accident. assure that the pressurizer is operated within instrument loops that had good Therefore, the proposed change does not the design criteria assumed for the flaw performance histories and longer involve a significant increase in the evaluation and fatigue analysis performed in response time requirements. The probability or consequences of an accident accordance with the ASME Code Section XI, justification was based on the adequacy previously evaluated.

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2. The proposed change does not create the assumptions of the safety analyses, and event. This potential increase in probability possibility of a new or different kind of therefore, the margin of safety is not affected. is acceptable because the OPRM function accident from any accident previously This is based on the ability to detect a will automatically detect the condition and evaluated. degraded response time of an instrument or initiate a reactor scram before the Minimum The proposed action does not involve relay by the other required TS tests, Critical Power Ratio (MCPR) Safety Limit is physical alteration of the station. No new component reliability, and redundancy and reached. Consequences of the potential equipment is being introduced, and installed diversity of the affected functions, as justified instability event are reduced because of the equipment is not being operated in a new or in the reviewed and approved LTR and more reliable automatic detection and different manner. There is no change being Supplement. suppression of an instability event, and the made to the parameters within which LaSalle Therefore, the proposed change does not elimination of dependence on the manual is operated. There are no setpoints at which involve a significant reduction in a margin of operator actions. protective or mitigative actions are initiated safety. Therefore, the proposed changes do not that are affected by this proposed action. All involve a significant increase in the Reactor Protection System and Primary The NRC staff has reviewed the probability or consequences of an accident Containment Isolation Instrumentation licensee’s analysis and, based on this previously evaluated. channels affected by the proposed change review, it appears that the three 2. Does the proposed change create the will continue to have an initial response time standards of 10 CFR 50.92(c) are possibility of a new or different kind of verified by test before initially placing the satisfied. Therefore, the NRC staff accident from any accident previously channel in service and after any maintenance proposes to determine that the evaluated? that could affect response time. Response: No. The modification replaces requested amendments involve no procedural actions that were established to The proposed change does not alter significant hazards consideration. assumptions made in the safety analysis. A avoid operating conditions where reactor review of the failure modes of the affected Attorney for licensee: Mr. Edward J. instabilities might occur with an NRC sensors and relays indicates that a sluggish Cullen, Deputy General Counsel, Exelon approved automatic detect and suppress response of the instruments can be detected BSC—Legal, 2301 Market Street, function. by other TS surveillances. Changing the Philadelphia, PA 19101. Potential failures in the OPRM Upscale method of periodically verifying instrument NRC Section Chief: Anthony J. function could result in either failure to take response for the selected instrument Mendiola. the required mitigating action or an channels will not create any new accident unintended reactor scram. These are the initiators or scenarios. Periodic surveillance Exelon Generation Company, LLC, and same potential effects of failure of the operator to take the correct appropriate of these instruments will detect significant PSEG Nuclear LLC, Dockets Nos. 50– action under the current procedural actions. degradation in the channel characteristic. 277 and 50–278, Peach Bottom Atomic The net effect of the modification changes the This proposed action will not alter the Power Station, Units 2 and 3, York and method by which an instability event is manner in which equipment operation is Lancaster Counties, Pennsylvania detected and by which mitigating action is initiated, nor will the function demands on Date of application for amendments: initiated, but does not change the type of credited equipment be changed. No change is stability event that could occur. The effects being made to procedures relied upon to February 27, 2004. Description of amendment request: of failure of the OPRM equipment are limited respond to an off-normal event. As such, no to reduced or failed mitigation, but such new failure modes are being introduced. The proposed change to the Technical failure cannot cause an instability event or The sensors and relays in the affected Specifications (TSs) supports the other type of accident. channels will be able to meet the bounding activation of the trip outputs of the Therefore, since no radiological barrier will response times as defined and presented in previously-installed Oscillation Power be challenged as a result of activating the the LTR Supplement. It has been found Range Monitor (OPRM) portion of the OPRM trip function, it is concluded that this acceptable to use component bounding Power Range Neutron Monitoring proposed activity does not create the response times in place of actual measured (PRNM) system. Specifically, this possibility of a new or different kind of response times to ensure that accident from any accident previously instrumentation systems will meet response proposed change will revise TS Sections 3.3.1.1, ‘‘Reactor Protection System evaluated. time requirements of the accident analyses. 3. Does the proposed change involve a In addition, [Exelon Generation Company, Instrumentation,’’ and 3.4.1, significant reduction in a margin of safety? LLC] EGC’s adherence to the conditions ‘‘Recirculation Loops Operating Response: No. The current safety analyses listed in the NRC Safety Evaluations for the Reporting Requirements,’’ and their assume that the existing procedural actions LTR and Supplement provides additional associated TS Bases, and TS Section are adequate to prevent an instability event. assurance that the instrumentation systems 5.6.5, ‘‘Core Operating Limits Report As a result, there is currently no quantitative will meet the response time requirements of (COLR).’’ In addition, the proposed or qualitative assessment of an instability the accident analyses. event with respect to its impact on MCPR. Therefore, the proposed change does not change deletes the Interim Corrective Action requirements from the The OPRM trip function is being create the possibility of a new or different implemented to automate the detection (via kind of accident from any previously Recirculation Loops Operating TSs. direct measurement of neutron flux) and evaluated. Basis for proposed no significant subsequent suppression (via scram) of an 3. The proposed change does not involve hazards consideration determination: instability event prior to exceeding the MCPR a significant reduction in a margin of safety. As required by 10 CFR 50.91(a), the Safety Limit. The OPRM trip provides a trip Implementation of the BWROG LTR licensee has provided its analysis of the output of the same type as currently used for methodologies for eliminating selected issue of no significant hazards the Average Power Range Monitor (APRM). response time testing requirements does not consideration, which is presented Its failure modes and types are identical to involve a significant reduction in the margin below: those for the present APRM output. of safety. The current response time limits Currently, the MCPR Safety Limit is not are based on the maximum values assumed 1. Does the proposed change involve a impacted by an instability event since the in the plant safety analyses. The analyses significant increase in the probability or event is ‘‘mitigated’’ by manual means via the conservatively establish the margin of safety. consequences of an accident previously procedural actions, which prevent plant The elimination of the selected response time evaluated? operating conditions where an instability testing does not affect the capability of the Response: No. This modification has no event is possible. In both methods of associated systems to perform their intended impact on any of the previously installed mitigation (manual and automated), the function within the allowed response time PRNM functions. Plant operation in portions margin of safety associated with the MCPR used as the basis for plant safety analyses. of the former restricted region may Safety Limit is maintained. Plant and system response to an initiating potentially cause a marginal increase in the Therefore, since the MCPR Safety Limit event will remain in compliance within the probability of occurrence of an instability will not be exceeded as a result of an

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instability event following implementation of Register on May 13, 2003 (68 FR 25664). emergency plan protective action the OPRM trip function, it is concluded that The licensee affirmed the applicability recommendations (PARs). the proposed change does not involve a of the following NSHC determination in Therefore, the elimination of PASS significant reduction in a margin of safety. its application dated February 27, 2004. requirements from Technical Specifications The NRC staff has reviewed the (TS) (and other elements of the licensing Basis for proposed no significant bases) does not involve a significant increase licensee’s analysis and, based on this hazards consideration determination: in the consequences of any accident review, it appears that the three As required by 10 CFR 50.91(a), an previously evaluated. standards of 10 CFR 50.92(c) are analysis of the issue of no significant satisfied. Therefore, the NRC staff Criterion 2—The Proposed Change Does Not hazards consideration is presented proposes to determine that the Create the Possibility of a New or Different below: Kind of Accident From any Previously amendment request involves no Evaluated significant hazards consideration. Criterion 1—The Proposed Change Does Not Attorney for Licensee: Mr. Edward The elimination of PASS related Involve a Significant Increase in the requirements will not result in any failure Cullen, Vice President and General Probability or Consequences of an Accident mode not previously analyzed. The PASS Counsel, Exelon Generation Company, Previously Evaluated was intended to allow for verification of the LLC, 2301 Market Street, S23–1, The PASS was originally designed to extent of reactor core damage and also to Philadelphia, PA 19101. perform many sampling and analysis provide an input to offsite dose projection NRC Section Chief: Darrell Roberts, functions. These functions were designed calculations. The PASS is not considered an Acting. and intended to be used in post accident accident precursor, nor does its existence or elimination have any adverse impact on the Florida Power Corporation, et al., situations and were put into place as a result of the TMI–2 accident. The specific intent of pre-accident state of the reactor core or post Docket No. 50–302, Crystal River Unit the PASS was to provide a system that has accident confinement of radioisotopes within No. 3 Nuclear Generating Plant, Citrus the capability to obtain and analyze samples the containment building. County, Florida of plant fluids containing potentially high Therefore, this change does not create the levels of radioactivity, without exceeding possibility of a new or different kind of Date of amendment request: February accident from any previously evaluated. 27, 2004. plant personnel radiation exposure limits. Description of amendment request: Analytical results of these samples would be Criterion 3—The Proposed Change Does Not used largely for verification purposes in The proposed amendment would delete Involve a Significant Reduction in the aiding the plant staff in assessing the extent Margin of Safety Technical Specification (TS) Section of core damage and subsequent offsite The elimination of the PASS, in light of 5.6.2.6, ‘‘Post Accident Sampling,’’ radiological dose projections. The system requirements to maintain a Post existing plant equipment, instrumentation, was not intended to and does not serve a procedures, and programs that provide Accident Sampling System (PASS). function for preventing accidents and its effective mitigation of and recovery from Licensees were generally required to elimination would not affect the probability reactor accidents, results in a neutral impact implement PASS upgrades as described of accidents previously evaluated. to the margin of safety. Methodologies that in NUREG–0737, ‘‘Clarification of TMI In the 20 years since the TMI–2 accident are not reliant on PASS are designed to [Three Mile Island] Action Plan and the consequential promulgation of post provide rapid assessment of current reactor accident sampling requirements, operating Requirements,’’ and Regulatory Guide core conditions and the direction of experience has demonstrated that a PASS degradation while effectively responding to 1.97, Revision 3, ‘‘Instrumentation for provides little actual benefit to post accident Light-Water-Cooled Nuclear Power the event in order to mitigate the mitigation. Past experience has indicated that consequences of the accident. The use of a Plants to Access Plant and Environs there exists in-plant instrumentation and PASS is redundant and does not provide Conditions During and Following an methodologies available in lieu of a PASS for quick recognition of core events or rapid Accident.’’ Implementation of these collecting and assimilating information response to events in progress. The intent of upgrades was an outcome of the NRC’s needed to assess core damage following an the requirements established as a result of the lessons learned from the accident that accident. Furthermore, the implementation of TMI–2 accident can be adequately met occurred at TMI Unit 2. Requirements Severe Accident Management Guidance without reliance on a PASS. (SAMG) emphasizes accident management Therefore, this change does not involve a related to PASS were imposed by Order strategies based on in-plant instruments. for many facilities and were added to or significant reduction in the margin of safety. These strategies provide guidance to the Based upon the reasoning presented above included in the TS for nuclear power plant staff for mitigation and recovery from and the previous discussion of the reactors currently licensed to operate. a severe accident. Based on current severe amendment request, the requested change Lessons learned and improvements accident management strategies and does not involve a significant hazards implemented over the last 20 years have guidelines, it is determined that the PASS consideration. shown that the information obtained provides little benefit to the plant staff in coping with an accident. The NRC staff proposes to determine from PASS can be readily obtained that the amendment request involves no through other means or is of little use The regulatory requirements for the PASS can be eliminated without degrading the significant hazards consideration. in the assessment and mitigation of plant emergency response. The emergency Attorney for licensee: Steven R. Carr, accident conditions. response, in this sense, refers to the Associate General Counsel—Legal The NRC staff issued a notice of methodologies used in ascertaining the Department, Progress Energy Service opportunity for comment in the Federal condition of the reactor core, mitigating the Company, LLC, Post Office Box 1551, Register on March 3, 2003 (68 FR consequences of an accident, assessing and Raleigh, North Carolina 27602–1551. 10052) on possible amendments to projecting offsite releases of radioactivity, NRC Section Chief: William F. Burton, eliminate PASS, including a model and establishing protective action Acting. safety evaluation and model no recommendations to be communicated to significant hazards consideration offsite authorities. The elimination of the Nuclear Management Company, LLC, (NSHC) determination, using the PASS will not prevent an accident Docket No. 50–331, Duane Arnold management strategy that meets the initial Energy Center, Linn County, Iowa consolidated line item improvement intent of the post-TMI–2 accident guidance process. The NRC staff subsequently through the use of the SAMGs, the Date of amendment request: January issued a notice of availability of the emergency plan (EP), the emergency 28, 2004. models for referencing in a license operating procedures (EOP), and site survey Description of amendment request: amendment application in the Federal monitoring that support modification of Duane Arnold Energy Center

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implemented improved technical change is administrative in nature. Therefore, systems, and components are maintained specifications in 1998 via Amendment the proposed change does not involve a consistent with the safety analyses and 223 using NUREG 1433, ‘‘Standard significant reduction in a margin of safety. licensing basis. Therefore, this change does Technical Specifications—General not involve a significant increase in the Adoption of TSTF–264, Revision 0 probability or consequences of an accident Electric Plants BWR/4,’’ Revision 1, as 1. Does the change involve a significant previously evaluated. a model. The proposed amendment increase in the probability or consequences 2. Does the change create the possibility of would revise Technical Specification of an accident previously evaluated? a new or different kind of accident from any Sections 5.5.11, 1.4, 3.3.1.1, and 5.5.2 to Response: No. accident previously evaluated? adopt the following selected NRC The proposed change deletes Surveillance Response: No. approved generic changes to the Requirements. Surveillances are not initiators The proposed change does not involve a improved technical specification to any accident previously evaluated. physical alteration of the plant (no new or NUREG. Consequently, the probability of an accident different type of equipment will be installed) previously evaluated is not significantly • Technical Specification Task Force or changes in methods governing normal increased. The equipment being tested is still plant operation. The proposed change does (TSTF)–273, Revision 2, Safety Function required to be Operable and capable of impose different requirements. However, Determination Program Clarifications. performing the accident mitigation functions • these changes are consistent with the TSTF–284, Revision 3, Add ‘‘Met’’ assumed in the accident analysis. As a result, assumptions in the safety analyses and versus ‘‘Perform’’ to Specification 1.4, the consequences of any accident previously licensing basis. Thus, this change does not Frequency. evaluated are not significantly affected. create the possibility of a new or different • TSTF–264, Deletion of Flux Therefore, the proposed change does not kind of accident from any accident Monitors Specific Overlap Surveillance involve a significant increase in the previously evaluated. Requirements. probability or consequences of an accident 3. Does this change involve a significant • TSTF–299, Administrative Controls previously evaluated. reduction in a margin of safety? 2. Does the change create the possibility of Program 5.5.2.b Test Interval Defined Response: No. a new or different kind of accident from any The proposed change provides additional and Allowance for 25 Percent Extension accident previously evaluated? restrictions which enhance plant safety. This of Frequency. Response: No. change maintains requirements within the Basis for proposed no significant The proposed change does not involve a safety analyses and licensing basis. hazards consideration determination: physical alteration of the plant (no new or Therefore, this change does not involve a As required by 10 CFR 50.91(a), the different type of equipment will be installed) significant reduction in a margin of safety. licensee has provided its analysis of the or a change in the methods governing normal plant operation. The remaining Surveillance The NRC staff has reviewed the issue of no significant hazards licensee’s analysis and, based on this consideration, which is presented Requirements are Consistent with industry practice and are considered to be sufficient review, it appears that the three below: to prevent the removal of the subject standards of 10 CFR 50.92(c) are Surveillances from creating a new or satisfied. Therefore, the NRC staff Adoption of TSTF–273, Revision 2, and different type of accident. Therefore, the TSTF–284, Revision 3 proposes to determine that the proposed change does not create the amendment request involves no 1. Does the change involve a significant possibility of a new or different kind of significant hazards consideration. increase in the probability or consequences accident from any accident previously Attorney for licensee: Jonathan Rogoff, of an accident previously evaluated? evaluated. Morgan Lewis, 1111 Pennsylvania Response: No. 3. Does this change involve a significant The proposed change involves reduction in a margin of safety? Avenue NW., Washington, DC 20004. reformatting, renumbering, and rewording Response: No. NRC Section Chief: L. Raghavan. the existing Technical Specifications. The The deleted Surveillance Requirements do Nuclear Management Company, LLC, reformatting, renumbering, and rewording not result in a significant reduction in the Docket No. 50–331, Duane Arnold process involves no technical changes to the margin of safety. As provided in the Energy Center, Linn County, Iowa existing Technical Specifications. As such, justification, the change has been evaluated this change is administrative in nature and to ensure that the deleted Surveillance Date of amendment request: February does not affect initiators of analyzed events Requirements are not necessary for 27, 2004. or assumed mitigation of accident or verification that the equipment used to meet Description of amendment request: transient events. Therefore, the proposed the LCO [limiting condition for operation] The proposed amendment would changes do not involve a significant increase can perform its required functions. Thus, remove license condition 2.C.(2)(b) to in the probability or consequences of an appropriate equipment continues to be tested perform large transient testing as part of accident previously evaluated. in a manner and at a frequency necessary to 2. Does the change create the possibility of give confidence that the equipment can the extended power uprate (EPU) power a new or different kind of accident from any perform its assumed safety function. ascension testing program at the Duane accident previously evaluated? Therefore, the proposed change does not Arnold Energy Center (DAEC). Response: No. involve a significant reduction in a margin of Basis for proposed no significant The proposed change does not involve a safety. hazards consideration determination: physical alteration of the plant (no new or As required by 10 CFR 50.91(a), the Adoption of TSTF–299, Revision 0 different type of equipment will be installed) licensee has provided its analysis of the or changes in methods governing normal 1. Does the change involve a significant issue of no significant hazards plant operation. The proposed change will increase in the probability or consequences consideration, which is presented not impose any new or eliminate any old of an accident previously evaluated? requirements. Therefore, the proposed Response: No. below: change does not create the possibility of a The proposed change provides more (1) The proposed amendment will not new or different kind of accident from any stringent requirements for operation of the involve a significant increase in the accident previously evaluated. facility. These more stringent requirements probability or consequences of an accident 3. Does this change involve a significant do not result in operation that will increase previously evaluated. reduction in a margin of safety? the probability of initiating an analyzed event The requested licensing action would Response: No. and do not alter assumptions relative to remove the current requirement to perform The proposed change will not reduce a mitigation of an accident or transient event. specific large transient tests as part of the margin of safety because it has no effect on The more restrictive requirements continue DAEC EPU power ascension testing program. any safety analyses’ assumptions. This to ensure process variables, structures, No other changes are proposed. Therefore,

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the probability of an accident previously the pressure suppression chamber- no new or different type of equipment will evaluated is not significantly increased. reactor building vacuum breakers be installed. The proposed changes do not The proposed action will not affect any instrumentation, (4) clarify the introduce new accident initiators. System, Structure, or Component designed operating force requirements for the Consequently, the changes cannot create the for the mitigation of previously analyzed possibility of a new or different kind of events. The proposed change does not affect pressure suppression chamber—drywell accident from any accident previously the source term, containment isolation, or vacuum breakers surveillance test, and evaluated. radiological release assumptions used in (5) make corrections resulting from Therefore, the proposed amendment will evaluating the radiological consequences of License Amendments (LAs) 130 and not create the possibility of a new or different any accident previously evaluated. Thus, the 132. kind of accident from any accident proposed change will not increase the Basis for proposed no significant previously analyzed. consequences of any previously evaluated hazards consideration determination: 3. Does the proposed amendment involve accident. As required by 10 CFR 50.91(a), the a significant reduction in the margin of (2) The proposed amendment will not licensee has provided its analysis of the safety? create the possibility of a new or different The SRM Detector-not-fully-inserted rod kind of accident from any accident issue of no significant hazards block bypass set point, the Pressure previously evaluated. consideration, which is presented Suppression Chamber—Reactor Building The requested licensing action would below: Vacuum Breakers actuation instrumentation remove the current requirement to perform 1. Does the proposed amendment involve set point requirement and the Pressure specific large transient tests as part of the a significant increase in the probability or Suppression Chamber—Drywell Vacuum DAEC EPU power ascension testing program. consequences of an accident previously Breakers surveillance test requirements are No other changes are proposed. Therefore, evaluated? being clarified in the MNGP TS to ensure the proposed change does not create the Response: No. these functions will adequately support safe possibility of a new or different kind of The SRM Detector-not-fully-inserted rod operation of the facility. Typographical errors accident from any previously evaluated. block bypass set point, the Pressure are being corrected along with corrections (3) The proposed amendment will not Suppression Chamber—Reactor Building resulting from omissions and an oversight involve a significant reduction in a margin of Vacuum Breakers actuation instrumentation from previous LAs. These changes do not safety. set point requirement and the Pressure exceed or alter a design basis or a safety limit Performance of these specific large Suppression Chamber—Drywell Vacuum for a parameter established in the MNGP transient tests is not necessary to ensure Breakers surveillance test requirements are Updated Safety Analysis Report (USAR) or acceptable plant operation at the higher being clarified in the MNGP TS to ensure the MNGP facility license. Consequently, the thermal power level. Simple, integrated these functions will adequately support safe changes do not result in a significant systems tests are performed in lieu of the operation of the facility. Typographical errors reduction in the margin of safety. complex, challenging large transient tests. are being corrected along with corrections Therefore, the proposed amendment does Other required testing of the specific SSCs resulting from omissions and an oversight not involve a significant reduction in the that have been modified for EPU ensures that from previous LAs. The proposed TS changes margin of safety. the plant will respond as expected during do not introduce new equipment or new The NRC staff has reviewed the any abnormal operating event, including equipment operating modes, nor do the these specific transients. Thus, the proposed proposed changes alter existing system licensee’s analysis and, based on this elimination of the large transient tests will relationships. The changes do not affect plant review, it appears that the three not significantly reduce any margin of safety operation, design function or any analysis standards of 10 CFR 50.92(c) are from that previously approved for EPU that verifies the capability of a SSC satisfied. Therefore, the NRC staff operation at the DAEC. [structure, system or component] to perform proposes to determine that the The NRC staff has reviewed the a design function. Further, the proposed amendment request involves no licensee’s analysis and, based on this changes do not increase the likelihood of the significant hazards consideration. review, it appears that the three malfunction of any structure, system or Attorney for licensee: Jonathan Rogoff, component (SSC) or impact any analyzed Esquire, Vice President, Counsel & standards of 10 CFR 50.92(c) are accident. Consequently, the probability of an satisfied. Therefore, the NRC staff accident previously evaluated is not affected. Secretary, Nuclear Management proposes to determine that the Therefore, the proposed amendment does Company, LLC, 700 First Street, amendment request involves no not involve a significant increase in the Hudson, WI 54016. significant hazards consideration. probability or consequences of an accident NRC Section Chief: L. Raghavan. Attorney for licensee: Jonathan Rogoff, previously evaluated. Nuclear Management Company, LLC, Morgan Lewis, 1111 Pennsylvania 2. Does the proposed amendment create the possibility of a new or different kind of Docket Nos. 50–266 and 50–301, Point Avenue, NW., Washington, DC 20004. Beach Nuclear Plant, Units 1 and 2, NRC Section Chief: L. Raghavan. accident from any accident previously evaluated? Town of Two Creeks, Manitowoc Nuclear Management Company, LLC, Response: No. County, Wisconsin Docket No. 50–263, Monticello Nuclear The SRM Detector-not-fully-inserted rod Date of amendment request: February block bypass set point, the Pressure Generating Plant, Wright County, 10, 2004. Minnesota Suppression Chamber—Reactor Building Vacuum Breakers actuation instrumentation Description of amendment request: Date of amendment request: January set point requirement and the Pressure The proposed change involves the 30, 2004. Suppression Chamber—Drywell Vacuum extension from 1 hour to 24 hours of the Description of amendment request: Breakers surveillance test requirements are completion time (CT) for Action (a) of The proposed amendment would revise being clarified in the MNGP TS to ensure Technical Specification (TS) 3.5.1.1, Monticello Nuclear Generating Plant these functions will adequately support safe which defines requirements for (MNGP) Technical Specifications (TS) operation of the facility. Typographical errors accumulators. Accumulators are part of to (1) clarify the permissive set point for are being corrected along with corrections the emergency core cooling system and the source range monitor (SRM) detector resulting from omissions and an oversight consist of tanks partially filled with from previous LAs. The changes do not not-fully-inserted rod block bypass, (2) create the possibility of new credible failure borated water and pressurized with correct a typographical error in the mechanisms, or malfunctions. These changes nitrogen gas. The contents of the tank surveillance requirement for do not modify the design function or are discharged to the reactor coolant suppression pool temperature operation of any SSC. Further the changes do system (RCS) if, as during a loss-of- monitoring, (3) clarify the set point for not involve physical alterations of the plant; coolant accident, the coolant pressure

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decreases to below the accumulator criterion of 5E–07 in Regulatory Guides (RG) correlation limit, the design DNBR limits, or pressure. Action (a) of TS 3.5.1.1 1.174, ‘‘An Approach for using Probabilistic the safety analysis DNBR limits. specifies a CT to restore an accumulator Risk Assessment in Risk-Informed Decisions The basis for the accumulator LCO, as to operable status when it has been On Plant-Specific Changes to the Licensing discussed in Basis Section 3.5.1.1, is to Basis,’’ and 1.177, ‘‘An Approach for Plant- ensure that a sufficient volume of borated declared inoperable for a reason other Specific, Risk-Informed Decisionmaking: water will be immediately forced into the than the boron concentration of the Technical Specifications,’’ for all cases core through each of the cold legs in the water in the accumulator not being except those that are based on design basis event the RCS pressure falls below the within the required range. This change success criteria. As indicated in WCAP– pressure of the accumulators, thereby was proposed by the Westinghouse 15049–A, design basis accumulator success providing the initial cooling mechanism Owners Group participants in the TS criteria are not considered necessary to during large RCS pipe ruptures. As described Task Force (TSTF) and is designated mitigate large break loss-of-coolant accident in Section 9.2 of WCAP–15049–A, the proposed change will allow plant operation TSTF–370. TSTF–370 is supported by (LOCA) events, and were only included in the WCAP–15049–A evaluation as a worst with an inoperable accumulator for up to 24 NRC-approved topical report WCAP– hours, instead of 1 hour, before the plant ‘‘ case data point. In addition, WCAP–15049– 15049–A, Risk-Informed Evaluation of A states that the NRC has indicated that an would be required to begin shutting down. an Extension to Accumulator incremental conditional core damage The impact of this on plant risk was Completion Times,’’ submitted on May frequency (ICCDP) greater than 5E–07 does evaluated and found to be very small. That 18, 1999. The NRC staff issued a notice not necessarily mean the change is is, increasing the time the accumulators will of opportunity for comment in the unacceptable. be unavailable to respond to a large LOCA The proposed technical specification event, assuming accumulators are needed to Federal Register on July 15, 2002 (67 FR mitigate the design basis event, has a very change does not involve any hardware 46542), on possible amendments small impact on plant risk. changes nor does it affect the probability of concerning TSTF–370, including a Since the frequency of a design basis large any event initiators. There will be no change model safety evaluation and model no LOCA (a large LOCA with loss of offsite to normal plant operating parameters, significant hazards consideration power) would be significantly lower than the engineered safety feature (ESF) actuation large LOCA frequency of the WCAP–15049– (NSHC) determination, using the setpoints, accident mitigation capabilities, consolidated line item improvement A evaluation, the impact of increasing the accident analysis assumptions or inputs. accumulator CT from 1 hour to 24 hours on process. The NRC staff subsequently Therefore, this change does not involve a plant risk due to a design basis large LOCA issued a notice of availability of the significant increase in the probability or would be significantly less than the plant risk models for referencing in license consequences of an accident previously increase presented in the WCAP–15049–A amendment applications in the Federal evaluated. evaluation. Register on March 12, 2003 (68 FR Criterion 2—The Proposed Change Does Not Therefore, this change does not involve a 11880). The licensee included in its Create the Possibility of a New or Different significant reduction in a margin of safety. application several minor changes to Kind of Accident From Any Previously The NRC staff proposes to determine make the plant specific TS more Evaluated that the amendment request involves no consistent with the STS and TSTF–370. No new accident scenarios, transient significant hazards consideration. The licensee affirmed the applicability precursors, failure mechanisms, or limiting Attorney for licensee: Jonathan Rogoff, of the following NSHC determination in single failures are introduced as a result of Esquire, Vice President, Counsel & its application dated February 10, 2004. the proposed change. As described in Section Secretary, Nuclear Management Basis for proposed no significant 9.1 of the WCAP–15049–A evaluation, the Company, LLC, 700 First Street, hazards consideration determination: plant design will not be changed with this Hudson, WI 54016. As required by 10 CFR 50.91(a), an proposed technical specification CT increase. NRC Section Chief: L. Raghavan. All safety systems still function in the same analysis of the issue of no significant manner and there is no additional reliance on Southern Nuclear Operating Company, hazards consideration is presented additional systems or procedures. The Inc., et al., Docket Nos. 50–424 and 50– below: proposed accumulator CT increase has a very 425, Vogtle Electric Generating Plant, small impact on core damage frequency. The Units 1 and 2, Burke County, Georgia Criterion 1—The Proposed Change Does Not WCAP–15049–A evaluation demonstrates Involve a Significant Increase in the that the small increase in risk due to Date of amendment request: February Probability or Consequences of an Accident increasing the CT for an inoperable 20, 2004. Previously Evaluated accumulator is within the acceptance criteria Description of amendment request: The basis for the accumulator limiting provided in RGs 1.174 and 1.177. No new The proposed amendments would condition for operation (LCO), as discussed accidents or transients can be introduced revise Vogtle Electric Generating Plant, in Basis Section 3.5.1.1, is to ensure that a with the requested change and the likelihood Units 1 and 2 Administrative Controls sufficient volume of borated water will be of an accident or transient is not impacted. Section 5.2.2.g of Technical The malfunction of safety related immediately forced into the core through Specification to limit the requirement of each of the cold legs in the event the RCS equipment, assumed to be operable in the pressure falls below the pressure of the accident analyses, would not be caused as a the Shift Technical Advisor function to accumulators, thereby providing the initial result of the proposed technical specification Modes 1–4 in accordance with NUREG cooling mechanism during large RCS pipe change. No new failure mode has been 0737. ruptures. As described in Section 9.2 of created and no new equipment performance Basis for proposed no significant WCAP–15049–A, the proposed change will burdens are imposed. hazards consideration determination: allow plant operation with an inoperable Therefore, this change does not create the As required by 10 CFR 50.91(a), the accumulator for up to 24 hours, instead of 1 possibility of a new or different kind of licensee has provided its analysis of the hour, before the plant would be required to accident from any accident previously issue of no significant hazards begin shutting down. The impact of the evaluated. consideration, which is presented increase in the accumulator CT on core damage frequency for all the cases evaluated Criterion 3—The Proposed Change Does Not below: in WCAP–15049–A is within the acceptance Involve a Significant Reduction in the 1. Does the proposed change involve a limit of 1.0E–06/yr for a total plant core Margin of Safety significant increase in the probability or damage frequency (CDF) less than 1.0E–03/ The proposed change does not involve a consequences of an accident previously yr. The incremental conditional core damage significant reduction in a margin of safety. evaluated? probabilities calculated in WCAP–15049–A There will be no change to the departure The proposed change to TS [Technical for the accumulator CT increase meet the from nucleate boiling ratio (DNBR) Specification] 5.2.2.g does not significantly

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increase the probability or consequences of Temperature limits and Cold Attorney for licensee: Mr. Arthur H. an accident previously evaluated in the Overpressure Protection System Domby, Troutman Sanders, FSAR [Final Safety Analysis Report]. This setpoints and the methodology used to NationsBank Plaza, Suite 5200, 600 revision does not have any effect on the justify eliminating the reactor vessel Peachtree Street, NE., Atlanta, Georgia probability of any accident initiators. The consequences of accidents previously closure head/vessel flange requirements. 30308–2216. evaluated in the FSAR are not adversely The proposed amendment would also NRC Section Chief: John A. Nakoski. affected by this proposed change because the revise TS 3.4.12, ‘‘Cold Overpressure Tennessee Valley Authority, Docket No. STA [Shift Technical Advisor] is not credited Protection System (COPS)’’, to change 50–259, Browns Ferry Nuclear Plant for mitigation of any accidents. The proposed the Reactor Coolant System vent size. (BFN), Unit 1, Limestone County, change which requires the STA function to Basis for proposed no significant Alabama be available while in Modes 1–4 is in hazards consideration determination: accordance with the requirements of NUREG As required by 10 CFR 50.91(a), the Date of amendments request: March 0737, Item I.A.1.1. Consequently, the licensee has provided its analysis of the 9, 2004 (TS 434). probability or consequences of an accident issue of no significant hazards Description of amendments request: previously evaluated are not significantly The proposed amendment would lower increased. consideration, which is presented 2. Does the proposed change create the below: the current Reactor Vessel Water possibility of a new or different kind of 1. Do the proposed changes involve a Level—Low, Level 3 Allowable Value in accident from any previously evaluated? significant increase in the probability or the Unit 1 Technical Specifications for The proposed change to TS 5.2.2.g does not consequences of an accident previously several instrument functions to reduce create the possibility of a new or different evaluated? the likelihood of unnecessary reactor kind of accident from any previously No. The proposed changes to the Technical scrams and the resultant engineered evaluated. No new accident scenarios, failure Specifications [TS] and PTLRs [Pressure and safety feature actuations by increasing mechanism, or limiting single failures are Temperature Limits Reports] do not affect any plant equipment, test methods, or plant the operating range between the normal introduced as a result of the proposed reactor vessel water level and Level 3 change. The proposed Technical operation, and are not initiators of any Specifications change does not challenge the analyzed accident sequence. Operation in trip functions. performance or integrity of any safety-related accordance with the proposed TS will ensure Basis for proposed no significant systems. The proposed change to TS 5.2.2.g that all analyzed accidents will continue to hazards consideration determination: is in accordance with NUREG 0737. be mitigated by the SSCs [systems, structures As required by 10 CFR 50.91(a), the 3. Does the proposed change involve a and components] as previously analyzed. licensee has provided its analysis of the significant reduction in a margin of safety? 2. Do the proposed changes create the issue of no significant hazards The proposed change to TS 5.2.2.g will not possibility of a new or different kind of consideration, which is presented accident from any previously evaluated? reduce a margin of safety because it has no below: direct effect on any safety analyses No. The proposed changes do not assumptions. The STA function is to evaluate introduce any new equipment, create new 1. Does the proposed amendment involve plant conditions and provide advice to the failure modes for existing equipment, or a significant increase in the probability or shift supervisor during plant transients and create any new limiting single failures. The consequences of an accident previously accidents. The proposed change limits the changes to the P-T [pressure-temperature] evaluated? requirements for the STA function to Modes limits and COPS [Cold Overpressure No. The Reactor Vessel Water Level—Low, 1–4 in accordance with NUREG 0737. The Protection Systems] setpoints will ensure Level 3 functions are in response to water STA function is not credited for the that appropriate fracture toughness margins level transients and are not involved in the initiation of accidents or transients. mitigation of any accidents previously are maintained to protect against reactor Therefore, reducing the BFN, Unit 1, Level 3 evaluated. vessel failure during both normal and low temperature operation. The changes to the Allowable Value does not increase the The NRC staff has reviewed the P-T limits and COPS setpoints are consistent probability of an accident previously licensee’s analysis and, based on this with the methodology approved by the NRC evaluated. review, it appears that the three [Nuclear Regulatory Commission] in WCAP– Additionally, the results of the safety standards of 10 CFR 50.92(c) are 14040, Rev. 4. Plant operation will not be evaluation associated with the lowering of altered, and all safety functions will continue the Level 3 Allowable Value concludes that satisfied. Therefore, the NRC staff the previously evaluated transient and proposes to determine that the to perform as previously assumed in accident analyses. accident consequences are not significantly amendment request involves no affected by the change. Therefore, the significant hazards consideration. 3. Do the proposed changes involve a significant reduction in a margin of safety? proposed amendment does not involve a Attorney for licensee: Mr. Arthur H. significant increase in the probability of No. The proposed changes will not consequences or an accident previously Domby, Troutman Sanders, adversely affect the operation of plant evaluated. NationsBank Plaza, Suite 5200, 600 equipment or the function of any equipment 2. Does the proposed amendment create Peachtree Street, NE., Atlanta, Georgia assumed in the accident analysis. The the possibility of a new or different kind of 30308–2216. utilization of ASME [American Society of accident from any accident previously NRC Section Chief: John A. Nakoski. Mechanical Engineers] Code Case N–640 evaluated? maintains the relative margin of safety Southern Nuclear Operating Company, No. The proposed amendment to lower the commensurate with that which existed at the BFN, Unit 1, Reactor Vessel Water Level— Inc., et al., Docket Nos. 50–424 and 50– time that ASME B&PV [Boiler and Pressure 425, Vogtle Electric Generating Plant, Low, Level 3 Allowable Value does not Vessel] Code, Section XI, Appendix G was involve a hardware change and the purpose Units 1 and 2, Burke County, Georgia approved in 1974 and will ensure an of the Level 3 function is not affected. The Date of amendment request: February acceptable margin of safety. Level 3 functions will continue to fulfill their 26, 2004. The NRC staff has reviewed the design objective. The proposed changes do Description of amendment request: licensee’s analysis and, based on this not create the possibility of any new failure The proposed amendments would review, it appears that the three mechanisms. No new external threats or revise Technical Specification (TS) standards of 10 CFR 50.92(c) are release pathways are created. Therefore, reduction of the Allowable Value does not 5.6.6, ‘‘Reactor Coolant System (RCS) satisfied. Therefore, the NRC staff result in the possibility of a new or different Pressure and Temperature Limits Report proposes to determine that the kind of accident. (PTLR)’’, to reference the NRC-approved amendment request involves no 3. Does the proposed amendment involve methodology for developing Pressure- significant hazards consideration. a significant reduction in a margin of safety?

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No. The results of the safety evaluation proposes to determine that the must be considered. First the PHYSICS associated with the reducing the BFN, Unit amendment request involves no TESTS are performed in accordance with the 1, Reactor Vessel Water Level—Low, Level 3 significant hazards consideration. TSs in Mode 2. Therefore, the power level of Allowable Value concluded that transient Attorney for licensee: General the reactor is limited to 5 percent or less. and accident consequences remain within Along with this, the reactor trip function of the required acceptance criteria. Therefore, Counsel, Tennessee Valley Authority, the Intermediate Range detectors will be the margin of safety is not reduced for any 400 West Summit Hill Drive, ET 11A, unaffected by the proposed amendment and event evaluated. Knoxville, Tennessee 37902. therefore, will be available to mitigate a NRC Section Chief: William F. Burton, reactivity transient at low power. Further, the The NRC staff has reviewed the Acting. trip setpoint for the Power Range monitors licensee’s analysis and, based on this are decreased during startup. This setpoint review, it appears that the three Tennessee Valley Authority, Docket reduction provides an additional measure to standards of 10 CFR 50.92(c) are Nos. 50–327 and 50–328, Sequoyah limit a reactivity excursion. Therefore, the satisfied. Therefore, the NRC staff Nuclear Plant, Units 1 and 2, Hamilton proposed change does not involve a proposes to determine that the County, Tennessee significant increase in the probability or consequences of an accident previously amendment request involves no Date of amendment request: March 5, significant hazards consideration. evaluated. 2004. 2. Does the proposed change create the Attorney for licensee: General Description of amendment request: possibility of a new or different kind of Counsel, Tennessee Valley Authority, The proposed amendments would accident from any accident previously 400 West Summit Hill Drive, ET 11A, delete surveillance requirement (SR) evaluated? Knoxville, Tennessee 37902. 4.9.2.c and SRs 4.10.3.2 and 4.10.4.2 No. The proposed changes permit the NRC Section Chief: William F. Burton, from the Technical Specifications (TSs). conduct of normal operating evolutions Acting. during limited periods when additional SR 4.9.2.c requires channel functional controls over reactivity margin are imposed Tennessee Valley Authority (TVA), tests for each Source Range neutron flux by the TSs. The proposed change does not Docket Nos. 50–327 and 50–328, monitor within 8 hours prior to initial introduce any new equipment into the plant Sequoyah Nuclear Plant (SQN), Units 1 core alterations. SRs 4.10.3.2 and or significantly alter the manner in which and 2, Hamilton County, Tennessee 4.10.4.2 require channel functional tests existing equipment will be operated. The for each Power Range and Intermediate proposed changes are not based on a change Date of amendment request: March 5, Range neutron flux monitor within 12 in the design or configuration of the plant. 2004. hours prior to the initiation of a physics The changes to operating allowances are Description of amendment request: test. In addition, the proposed changes minor and are only applicable during certain conditions. The operating allowances are The proposed amendments would include revisions to the associated TS delete Technical Specifications (TSs) consistent with those acceptable at other bases (3/4.9.2, 3/4.10.3, and 3/4.10.4). times. The proposed changes delete the 3.6.4.1, ‘‘Hydrogen Monitors,’’ and Basis for proposed no significant 3.6.4.2, ‘‘Electric Hydrogen requirements for the performance of a CFT hazards consideration determination: for the Source Range, Intermediate Range, Recombiners-W.’’ The proposed changes As required by Title 10, Code of Federal and Power Range instrumentation within 8 support Title 10, Code of Federal Regulations, Part 50, Section 91(a) (10 hours of initiating CORE ALTERATIONS for Regulations, Part 50, Section 44 (10 CFR CFR 50.91(a)), the licensee has provided the Source Range monitors and within 12 50.44), ‘‘Standards for Combustible Gas its analysis of the issue of no significant hours of starting a PHYSICS TEST for the Control system in Light-Water-Cooled hazards consideration, which is Intermediate Range and Power Range instrumentation. Since the proposed changes Power Reactors’’ and are consistent with presented below: the Industry/Technical Specification only allow activities that are presently Task Force (TSTF) Standard TS Change 1. Does the proposed change involve a approved and routinely conducted, no Traveler, TSTF–447, ‘‘Elimination of significant increase in the probability or possibility exists for a new or different kind consequences of an accident previously of accident from those previously evaluated. Hydrogen Recombiners and change to evaluated? Therefore, the proposed change does not Hydrogen and Oxygen Monitors.’’ No. The proposed amendment removes the create the possibility of a new or different Basis for proposed no significant requirement to perform an additional kind of accident from any previously hazards consideration determination: CHANNEL FUNCTIONAL TEST (CFT) on the evaluated. As required by 10 CFR 50.91(a), the Intermediate and Power Range functions 3. Does the proposed change involve a licensee has provided its analysis of the within 12 hours of performing a PHYSICS significant reduction in a margin of safety? issue of no significant hazards TEST. The Intermediate and Power Range No. As stated previously, the proposed consideration, which is presented instrumentation is determined to be change deletes the requirement to perform an below: OPERABLE by periodic SRs which must be additional CFT for the Source Range, confirmed to be within frequency prior to Intermediate Range, and Power Range TVA has reviewed the proposed no making the reactor critical. The proposed instrumentation within 8 hours of initiating significant hazards consideration amendment also removes the requirement to CORE ALTERATIONS for the Source Range determination published on September 25, perform an additional CFT on the Source monitors and within 12 hours of starting a 2003, (68 FR 55416) as part of the Range monitors. The Source Range PHYSICS TEST for the Intermediate Range consolidated line item improvement process instrumentation is determined to be and Power Range instrumentation. The (CLIIP). TVA has concluded that the OPERABLE by periodic SRs, which must be Source Range, Intermediate Range, and proposed determination presented in the confirmed to be within frequency prior to Power Range instrumentation channels are notice is applicable to SQN, and the Mode 6, prior to CORE ALTERATIONS, and determined to be OPERABLE by meeting the determination is hereby incorporated by must remain OPERABLE. A CFT for the requirements of the periodic surveillance. reference to satisfy the requirements of 10 Source Range, Intermediate Range, or Power These SRs are not affected by the proposed CFR 50.91(a). Range instrumentation is not a precursor to, amendment. The proposed changes do not The United States Nuclear Regulatory or assumed to be an initiator of any analyzed involve a significant reduction in a margin of accident. Therefore, this change does not safety because the ability to monitor the Commission (NRC) staff has reviewed involve a significant increase in the reactor during the applicable operating the licensee’s analysis and, based on probability of an accident previously conditions and modes of operation will be this review, it appears that the three evaluated. maintained. The proposed changes do not standards of 10 CFR 50.92(c) are Regarding a significant increase in the affect these operating restrictions and the satisfied. Therefore, the NRC staff consequences of an accident, several factors margin of safety which assures the ability to

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monitor the reactor is not affected. Therefore, 400 West Summit Hill Drive, ET 11A, be reduced by the implementation of the the proposed change does not involve a Knoxville, Tennessee 37902. changes. significant reduction in a margin of safety. NRC Section Chief: William F. Burton, The NRC staff has reviewed the The United States Nuclear Regulatory Acting. licensee’s analysis and, based on this Commission (NRC) staff has reviewed Virginia Electric and Power Company, review, it appears that the three the licensee’s analysis and, based on Docket Nos. 50–338 and 50–339, North standards of 50.92(c) are satisfied. this review, it appears that the three Anna Power Station, Unit Nos. 1 and 2, Therefore, the NRC staff proposes to standards of 10 CFR 50.92(c) are Louisa County, Virginia determine that the amendment request satisfied. Therefore, the NRC staff involves no significant hazards Date of amendment request: March 4, proposes to determine that the consideration. amendment request involves no 2004. significant hazards consideration. Description of amendment request: Attorney for licensee: Ms. Lillian M. Attorney for licensee: General The proposed amendments would Cuoco, Esq., Senior Counsel, Dominion Counsel, Tennessee Valley Authority, delete the note in Improved Technical Resources Services, Inc., Millstone 400 West Summit Hill Drive, ET 11A, Specification Surveillance Requirement Power Station, Building 475, 5th Floor, Knoxville, Tennessee 37902. 3.4.12.7 that permitted the performance Rope Ferry Road, Rt. 156, Waterford, NRC Section Chief: William F. Burton, of the Channel Operational Test within Connecticut 06385. Acting. 12 hours of entering a mode in which NRC Section Chief: John A. Nakoski. Tennessee Valley Authority (TVA), the power-operated relief valves Previously Published Notices of Docket Nos. 50–327 and 50–328, (PORVs) are required to be operable for Consideration of Issuance of Sequoyah Nuclear Plant (SQN), Units 1 low temperature overpressure Amendments to Facility Operating and 2, Hamilton County, Tennessee protection (LTOP). Licenses, Proposed No Significant Basis for proposed no significant Date of amendment request: March 5, Hazards Consideration Determination, hazards consideration determination: and Opportunity for a Hearing 2004. As required by 10 CFR 50.91(a), the Description of amendment request: licensee has provided its analysis of the The following notices were previously The proposed amendments would issue of no significant hazards published as separate individual change Technical Specification (TS) consideration, which is presented notices. The notice content was the 4.0.5.c. Specifically, the proposed below: same as above. They were published as change would extend the examination individual notices either because time frequency for the reactor coolant pump 1. Do changes involve a significant increase did not allow the Commission to wait (RCP) motor flywheel from a 10-year in the probability or consequences of an for this biweekly notice or because the interval to an interval not to exceed 20 accident previously evaluated? The proposed changes to perform a action involved exigent circumstances. years. This proposed change is Channel Operational Test on each required They are repeated here because the consistent with the Industry/Technical PORV at least 31 days prior to entering the biweekly notice lists all amendments Specification Task Force (TSTF) LTOP Mode will continue to ensure issued or proposed to be issued Standard Technical Specification verification and adjustment, if required, of its involving no significant hazards Change Traveler, TSTF–421, ‘‘Revision lift setpoint. Changes will not affect the consideration. to RCP Flywheel Inspection Program probability of occurrence of any accident (WCAP–15666).’’ previously analyzed: nor alter the design For details, see the individual notice Basis for proposed no significant assumptions, conditions, and configuration in the Federal Register on the day and hazards consideration determination: of the facility or the manner in which the page cited. This notice does not extend As required by Title 10, Code of Federal plant is operated and maintained. Therefore, the notice period of the original notice. the proposed changes do not involve a Regulations, Part 50, Section 91(a) (10 significant increase in the consequences of Calvert Cliffs Nuclear Power Plant, Inc., CFR 50.91(a)), the licensee has provided any previously analyzed accident. Docket Nos. 50–317 and 50–318, Calvert its analysis of the issue of no significant 2. Do changes create the possibility of a Cliffs Nuclear Power Plant, Unit Nos. 1 hazards consideration, which is new or different kind of accident from any and 2, Calvert County, Maryland presented below: accident previously evaluated? The proposed changes to perform a TVA has reviewed the proposed no Date of application for amendment: Channel Operational Test on each required significant hazards consideration February 25, 2004. PORV at least 31 days prior to entering the determination published on June 24, 2003 LTOP Mode will not create any new accident Brief description of amendments: The (68 FR 37590), as part of the consolidated or event initiators. No systems, structures, or amendment would extend the line item improvement process (CLIIP). TVA components are being physically modified implementation date for Amendment has concluded that the proposed such that the design function is being altered. Nos. 261 and 238 for Calvert Cliffs Units determination presented in the notice is The proposed changes do not impose any applicable to SQN, and the determination is 1 and 2, respectively, to July 1, 2004. new or different requirements for the hereby incorporated by reference to satisfy The changes to the reactor pressure performance of the Channel Operational Test. the requirements of 10 CFR 50.91(a). vessel pressure-temperature limits Therefore, the proposed changes do not cooldown rates that were approved by The United States Nuclear Regulatory create the possibility of a new or different Amendment Nos. 261 and 238 are more Commission (NRC) staff has reviewed kind of accident from those previously analyzed. conservative than the plants existing the licensee’s analysis and, based on rates and result in a longer cooldown this review, it appears that the three 3. Do changes involve a significant reduction in a margin of safety? period. The existing cooldown rates are standards of 10 CFR 50.92(c) are acceptable through the end of 2004. satisfied. Therefore, the NRC staff The proposed changes do not involve any change to the safety analysis limits. The level Date of publication of individual proposes to determine that the of safety of facility operation is unaffected by amendment request involves no notice in Federal Register: March 5, the proposed changes since there is no 2004 (69 FR 10487). significant hazards consideration. change in the intent for the performance of Attorney for licensee: General the Channel Operational Test. Therefore, it is Expiration date of individual notice: Counsel, Tennessee Valley Authority, concluded that the margin of safety will not May 5, 2004.

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Notice of Issuance of Amendments to AmerGen Energy Company, LLC, et al., Date of issuance: March 19, 2004. Facility Operating Licenses Docket No. 50–219, Oyster Creek Effective date: March 19, 2004, and Nuclear Generating Station, Ocean shall be implemented within 90 days of During the period since publication of County, New Jersey the date of issuance. the last biweekly notice, the Date of application for amendment: Amendment Nos.: Unit 1–151, Unit Commission has issued the following December 23, 2003, as supplemented by 2—151, Unit 3—151. amendments. The Commission has letter dated January 30, 2004. Facility Operating License Nos. NPF– determined for each of these Brief description of amendment: The 41, NPF–51, and NPF–74: The amendments that the application amendment modified Technical amendments revised the Technical complies with the standards and Specification (TS) requirements for Specifications. requirements of the Atomic Energy Act mode change limitations to adopt the TS Date of initial notice in Federal of 1954, as amended (the Act), and the Task Force (TSTF) change TSTF–359, Register: December 9, 2003 (68 FR Commission’s rules and regulations. ‘‘Increase Flexibility in Mode 68659) The December 18, 2003, The Commission has made appropriate Restraints.’’ supplemental letter provided revised findings as required by the Act and the Date of issuance: March 29, 2004. technical specification pages to reflect Commission’s rules and regulations in Effective date: As of the date of changes that were approved in 10 CFR Chapter I, which are set forth in issuance to be implemented within 60 Amendment No. 149, did not expand the license amendment. days. the scope of the application as originally Amendment No.: 241. Notice of Consideration of Issuance of Facility Operating License No. NPF– noticed, and did not change the NRC Amendment to Facility Operating 69: Amendment revised the Technical staff’s original proposed no significant License, Proposed No Significant Specifications. hazards consideration determination. Hazards Consideration Determination, Date of initial notice in Federal The Commission’s related evaluation and Opportunity for A Hearing in Register: January 20, 2004 (69 FR of the amendment is contained in a connection with these actions was 2738). Safety Evaluation dated March 19, 2004. published in the Federal Register as The January 30, 2004, letter provided No significant hazards consideration indicated. clarifying information within the scope comments received: No. of the original application and did not Arizona Public Service Company, et al., Unless otherwise indicated, the change the staff’s initial proposed no Docket Nos. STN 50–528, STN 50–529, Commission has determined that these significant hazards consideration and STN 50–530, Palo Verde Nuclear amendments satisfy the criteria for determination. The staff’s related Generating Station, Units Nos. 1, 2, and categorical exclusion in accordance evaluation of the amendment is 3, Maricopa County, Arizona with 10 CFR 51.22. Therefore, pursuant contained in a Safety Evaluation dated to 10 CFR 51.22(b), no environmental March 29, 2004. Date of application for amendments: impact statement or environmental No significant hazards consideration September 17, 2003 as supplemented by assessment need be prepared for these comments received: No. letter dated February 20, 2004. amendments. If the Commission has Arizona Public Service Company, et al., Brief description of amendments: The prepared an environmental assessment Docket Nos. STN 50–528, STN 50–529, amendments revise the technical under the special circumstances and STN 50–530, Palo Verde Nuclear specifications to support the provision in 10 CFR 51.12(b) and has Generating Station, Units Nos. 1, 2, and replacement of part-length control made a determination based on that 3, Maricopa County, Arizona element assemblies (CEAs) with a new assessment, it is so indicated. design, referred to as part-strength Date of application for amendments: CEAs. The two designs are For further details with respect to the October 7, 2003, and its supplement action see (1) the applications for geometrically very similar and contain dated December 18, 2003. essentially the same amount and type of amendment, (2) the amendment, and (3) Brief description of amendments: The neutron absorber in the lower half of the the Commission’s related letter, Safety amendments revise Technical assemblies, which is the region of the Evaluation and/or Environmental Specification (TS) Section 5.5.6, CEAs inserted into the reactor core ‘‘Containment Tendon Surveillance Assessment as indicated. All of these during normal operations. items are available for public inspection Program,’’ for consistency with the Date of issuance: March 23, 2004. at the Commission’s Public Document requirements of 10 CFR 50.55a(g)(4) for Effective date: March 23, 2004, and Room, located at One White Flint North, components classified as Code Class CC. shall be implemented within 60 days of Public File Area 01F21, 11555 Rockville The amendments also delete the the date of issuance. Pike (first floor), Rockville, Maryland. provisions of Surveillance Requirement Amendment Nos.: Unit 1—152, Unit Publicly available records will be (SR) 3.0.2 from this TS. In addition, the 2—152, Unit 3—152. accessible from the Agencywide amendments revise TS 5.5.16, Facility Operating License Nos. NPF– Documents Access and Management ‘‘Containment Leakage Rate Testing 41, NPF–51, and NPF–74: The Systems (ADAMS) Public Electronic Program,’’ to add exceptions to Regulatory Guide 1.163, ‘‘Performance- amendments revised the Technical Reading Room on the internet at the Based Containment Leak-Testing Specifications. NRC Web site, http://www.nrc.gov/ Program.’’ Also, the paragraphs in Date of initial notice in Federal reading-rm/adams.html. If you do not Section 5.5.16 have been sequenced to Register: December 9, 2003 (68 FR have access to ADAMS or if there are more clearly separate the requirements 68657). The February 20, 2004, problems in accessing the documents of the program. This is considered an supplemental letter provided additional located in ADAMS, contact the NRC administrative change and is consistent clarifying information, did not expand Public Document Room (PDR) Reference with the guidance in NUREG–1432, the scope of the application as originally staff at 1–800–397–4209, 301–415–4737 ‘‘Standard Technical Specifications noticed, and did not change the NRC or by e-mail to [email protected]. Combustion Engineering Plants,’’ staff’s original proposed no significant Revision 2. hazards consideration determination.

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The Commission’s related evaluation 12948). The November 10 and December and in accordance with Title 10 of the of the amendment is contained in a 10, 2003, and January 30, 2004, Code of Federal Regulations, Section Safety Evaluation dated March 23, 2004. supplements provided clarifying 50.67. Specifically, the amendment No significant hazards consideration information that did not change the revised: TS 3.7.8, ‘‘Plant Systems, comments received: No. scope of the proposed amendment as Control Room Envelope Pressurization described in the original notice of System;’’ TS 3.9.4, ‘‘Refueling Carolina Power & Light Company, proposed action published in the Operations, Containment Building Docket No. 50–325, Brunswick Steam Federal Register and did not change the Penetrations;’’ TS 3.9.9, ‘‘Refueling Electric Plant, Unit 1, Brunswick initial proposed no significant hazards Operations, Containment Purge and County, North Carolina consideration determination. Exhaust Isolation System,’’ and TS Date of application for amendment: The Commission’s related evaluation 3.9.12, ‘‘Refueling Operations, Fuel October 31, 2003, as supplemented of the amendment is contained in a Building Exhaust Filter System.’’ March 4, March 12, and March 19, 2004. Safety Evaluation dated March 26, 2004. Date of issuance: March 17, 2004. Brief description of amendment: The No significant hazards consideration Effective date: As of the date of amendment revised the Minimum comments received: No. issuance and shall be implemented Critical Power Ratio Safety Limit within 90 days from the date of contained in Technical Specification Consumers Energy Company, Docket issuance. 2.1.1.2. No. 50–155, Big Rock Point Nuclear Amendment No.: 219. Date of issuance: March 26, 2004. Plant, Charlevoix County, Michigan Facility Operating License No. NPF– Effective date: Effective as of the date Date of application for amendment: 49: The amendment revised the TSs. of issuance and shall be implemented November 20, 2002, and August 6, 2003, Date of initial notice in Federal prior to startup for Unit 1, Cycle 15, as supplemented by letters dated Register: March 4, 2003 (68 FR 40711). operation. December 1, 2003, and February 20, The May 13 and September 18, 2003, Amendment No.: 231. 2004. and February 12 and March 10, 2004, Facility Operating License Nos. DPR– Brief description of amendment: The supplements contained clarifying 71: Amendment changes the Technical amendment revises the Big Rock Point information and did not change the Specifications. License and Defueled Technical staff’s initial proposed finding of no Date of initial notice in Federal Specifications to remove reactor significant hazards consideration. Register: January 6, 2004 (69 FR 693). operational and administrative The Commission’s related evaluation The March 4, March 12, and March 19, requirements that are no longer of the amendment is contained in a 2004, supplemental letters provided applicable due to the transfer of all Safety Evaluation dated March 17, 2004. No significant hazards consideration clarifying information that did not spent fuel from the spent fuel pool into comments received: No. change the scope of the proposed dry cask storage at the Big Rock Point amendment as described in the original Independent Spent Fuel Storage Entergy Nuclear Vermont Yankee, LLC notice of proposed action published in Installation. and Entergy Nuclear Operations, Inc., the Federal Register and did not change Date of issuance: March 19, 2004. Docket No. 50271, Vermont Yankee the initial proposed no significant Effective date: As of the date of Nuclear Power Station, Vernon, hazards consideration determination. issuance and shall be implemented Vermont The Commission’s related evaluation within 45 days. Date of application for amendment: of the amendment is contained in a Amendment No.: 125. December 5, 2003, as supplemented on Safety Evaluation dated March 26, 2004. Facility Operating License No. DPR–6: February 9, 2004. No significant hazards consideration Amendment revises the Defueled Brief description of amendment: The comments received: No. Technical Specifications. amendment revised the Safety Limit Date of initial notice in Federal Minimum Critical Power Ratio values in Carolina Power & Light Company, et Register: January 21, 2003 (68 FR al., Docket No. 50–400, Shearon Harris Technical Specification 1.1.A.1 to 2800), and November 25, 2003 (68 FR incorporate the results of the cycle- Nuclear Power Plant, Unit 1, Wake and 66133). The Commission’s related Chatham Counties, North Carolina specific core reload analysis for evaluation of the amendment is Vermont Yankee Nuclear Power Station Date of application for amendment: contained in a Safety Evaluation dated Cycle 24 operation. February 14, 2003, as supplemented by March 19, 2004. Date of Issuance: March 22, 2004. letters dated November 10 and No significant hazards consideration Effective date: As of the date of December 10, 2003, and January 30, comments received: No. issuance, and shall be implemented 2004. Dominion Nuclear Connecticut, Inc., within 60 days. Brief description of amendment: This Docket No. 50–423, Millstone Power Amendment No.: 217. amendment revises Technical Facility Operating License No. DPR– Station, Unit No. 3, New London Specification (TS) 5.6.3.d to allow an 28: The amendment revised the TSs. County, Connecticut increase in the decay heat load from 1.0 Date of initial notice in Federal MBTU/hr to 7.0 MBTU/hr for fuel Date of application for amendment: Register: January 20, 2004 (69 FR stored in Spent Fuel Pools C and D at March 4, 2003, as supplemented May 13 2741). The supplement dated February Shearon Harris Nuclear Power Plant, and September 18, 2003, and February 9, 2004, provided additional Unit 1. 12 and March 10, 2004. information that clarified the Date of issuance: March 26, 2004. Brief description of amendment: The application, did not expand the scope of Effective date: March 26, 2004. amendment revised selected sections of the application as originally noticed, Amendment No.: 115. the Technical Specifications (TSs) based and did not change the staff’s original Facility Operating License No. NPF– upon a re-analysis of fuel handling proposed no significant hazards 63. Amendment revises the Technical accidents (FHAs). The revised analysis consideration determination. Specifications. is based upon selective implementation The Commission’s related evaluation Date of initial notice in Federal of the alternative source term of this amendment is contained in a Register: March 18, 2003 (68 FR methodology of Regulatory Guide 1.183, Safety Evaluation dated March 22, 2004.

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No significant hazards consideration restore a unit specific essential service Amendment No.: 96. comments received: No. water train to operable status. Facility Operating License No. NPF– Date of issuance: March 18, 2004. 86: The amendment revises the TS. Entergy Nuclear Vermont Yankee, LLC Effective date: As of the date of Date of initial notice in Federal and Entergy Nuclear Operations, Inc., issuance and shall be implemented Register: May 28, 2002 (67 FR 36931). Docket No. 50–271, Vermont Yankee within 30 days. The January 14, 2004, letter provided Nuclear Power Station, Vernon, Amendment Nos.: 136/136, 130/130. clarifying information that did not Vermont Facility Operating License Nos. NPF– change the initial proposed no Date of application for amendment: 37, NPF–66, NPF–72 and NPF–77: The significant hazards consideration March 26, 2003, as supplemented on amendments revised the Technical determination or expand the July 24, 2003. Specifications. amendment beyond the scope of the Brief description of amendment: The Date of initial notice in Federal initial notice. amendment revised the Technical Register: September 30, 2003. The Commission’s related evaluation Specifications (TSs) regarding reactor The Commission’s related evaluation of the amendment is contained in a pressure vessel (RPV) fracture toughness of the amendments is contained in a Safety Evaluation dated March 23, 2004. and material surveillance requirements Safety Evaluation dated March 18, 2004. No significant hazards consideration (SRs). Specifically, the amendment No significant hazards consideration comments received: No. comments received: No. revised the pressure-temperature limits Nebraska Public Power District, Docket for the RPV as specified in TS Figures Exelon Generation Company, LLC, No. 50–298, Cooper Nuclear Station, 3.6.1, 3.6.2, and 3.6.3. In addition, the Docket Nos. 50–352 and 50–353, Nemaha County, Nebraska amendment deleted TS 4.6.A.5, which Limerick Generating Station, Units 1 specifies plant-specific RPV material Date of amendment request: August and 2, Montgomery County, 25, 2003. SRs. These plant-specific SRs are being Pennsylvania replaced by implementing the Boiling Brief description of amendment: The Water Reactor Vessel and Internals Date of application for amendments: amendment revises the Technical Project (BWRVIP) RPV integrated September 8, 2003. Specification (TS) for Limiting surveillance program (ISP). The details Brief description of amendments: The Condition for Operation requirement of the BWRVIP ISP will be added to the amendments modified Technical 3.5.1 to incorporate TS Task Force Vermont Yankee Nuclear Power Station Specifications requirements to adopt the Traveler 318 to allow one low pressure Updated Final Safety Analysis Report. provisions of Industry/Technical coolant injection pump inoperable in Date of Issuance: March 29, 2004. Specification Task Force (TSTF) change each of the two emergency core cooling Effective date: As of the date of 359, ‘‘Increase Flexibility in Mode system divisions. issuance, and shall be implemented Restraints.’’ Date of issuance: March 31, 2004. within 60 days. Date of issuance: March 12, 2004. Effective date: As of the date of Amendment No.: 218. Effective date: As of date of issuance issuance and shall be implemented Facility Operating License No. DPR– and shall be implemented within 60 within 60 days of issuance. 28: Amendment revised the TSs. days. Amendment No.: 203. Date of initial notice in Federal Amendment Nos.: 169 and 132. Facility Operating License No. DPR– Register: April 29, 2003 (68 FR 22747). Facility Operating License Nos. NPF– 46: Amendment revised the Technical The supplement dated July 24, 2003, 39 and NPF–85: The amendments Specifications. Federal provided additional information that revised the Technical Specifications. Date of initial notice in Federal Register: clarified the application, did not expand Date of initial notice in October 14, 2003 (68 FR Register: the scope of the application as originally December 9, 2003 (68 FR 59218). The Commission’s related evaluation noticed, and did not change the staff’s 68668). The Commission’s related evaluation of the amendment is contained in a original proposed no significant hazards of the amendments is contained in a Safety Evaluation dated March 31, 2004. consideration determination. Safety Evaluation dated March 12, 2004. No significant hazards consideration The Commission’s related evaluation No significant hazards consideration comments received: No. of this amendment is contained in a comments received: No. Safety Evaluation dated March 29, 2004. Nuclear Management Company, LLC, No significant hazards consideration FPL Energy Seabrook, LLC, Docket No. Docket Nos. 50–266 and 50–301, Point comments received: No. 50–443, Seabrook Station, Unit No. 1, Beach Nuclear Plant, Units 1 and 2, Rockingham County, New Hampshire Town of Two Creeks, Manitowoc Exelon Generation Company, LLC, County, Wisconsin Docket Nos. STN 50–454 and STN 50– Date of amendment request: April 15, 455, Byron Station, Unit Nos. 1 and 2, 2002, as supplemented by letter dated Date of application for amendments: Ogle County, Illinois January 14, 2004. March 27, 2003, as supplemented on Description of amendment request: November 3, 2003, and January 28, Docket Nos. STN 50–456 and STN 50– The amendment revises the Technical 2004. 457, Braidwood Station, Unit Nos. 1 Specifications (TSs) to relocate the Brief description of amendments: The and 2, Will County, Illinois boron concentration limits and ‘‘Safety amendment revises Technical Date of application for amendments: Limits’’ figures to the Core Operating Specification Surveillance Requirement June 11, 2003, as supplemented on Limits Report. Some limiting conditions 3.2.4.2, ‘‘Rod Group Alignment Limits.’’ December 5, December 30, 2003, and and actions are revised to be consistent The revision expands the alignment February 18, 2004. with the Improved Standard Technical limits on allowable rod cluster control Brief description of amendments: The Specifications. assembly, or rod, deviation from amendments revise technical Date of issuance: March 23, 2004. demanded position. The change applies specification 3.7.8 to permit a one-time Effective date: As of its date of in Mode 1, when operating at greater extension from 72 hours to 144 hours issuance, and shall be implemented than 85 percent of rated thermal power. for the completion time required to within 90 days. Date of issuance: March 29, 2004.

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Effective date: As of the date of Facility Operating License No. DPR– Brief description of amendments: The issuance and shall be implemented 52 and DPR–68: Amendments revised Amendment revises the Technical within 45 days. the TSs. Specification 5.5.9, ‘‘Steam Generator Amendment Nos.: 212 and 217. Date of initial notice in Federal (SG) Tube Surveillance Program,’’ to Facility Operating License Nos. DPR– Register: October 28, 2003 (68 FR allow the use of Westinghouse 24 and DPR–27: Amendments revised 61480). The December 8, 2003, and (Westinghouse Electric Station LLC) the Technical Specifications. February 24, 2004, letters provided leak limiting Alloy 800 sleeves for Date of initial notice in Federal clarifying information that did not repair of degraded SG tubes. Register: April 29, 2003 (68 FR 22749). change the scope of the original request Date of issuance: March 24, 2004. The supplemental letters contained or the initial proposed no significant Effective date: As of the date of clarifying information and did not hazards consideration determination. issuance and shall be implemented change the initial no significant hazards The Commission’s related evaluation within 30 days from the date of consideration determination and did not of the amendment is contained in a issuance. expand the scope of the original Federal Safety Evaluation dated March 10, 2004. Amendment Nos.: 112. No significant hazards consideration Register notice. Facility Operating License No. NPF– comments received: No. The Commission’s related evaluation 87: The amendments revised the of the amendments is contained in a Tennessee Valley Authority, Docket No. Technical Specifications. Safety Evaluation dated March 29, 2004. 50–390, Watts Bar Nuclear Plant, Unit Date of initial notice in Federal No significant hazards consideration 1, Rhea County, Tennessee Register: July 21, 2003. Supplemental comments received: No. Date of application for amendment: letters dated January 8, January 21, and Pacific Gas and Electric Company, March 24, 2003, as supplemented March 8, 2004 provided clarifying Docket Nos. 50–275 and 50–323, Diablo December 4, 2003, and February 12, information that did not change the Canyon Nuclear Power Plant, Unit Nos. 2004. scope of the original Federal Register 1 and 2, San Luis Obispo County, Brief description of amendment: The notice or the original no significant California amendment revises the design and hazards consideration determination. The Commission’s related evaluation Date of application for amendments: licensing basis failure modes and effects of the amendments is contained in a June 11, 2003. analysis for specific valves in the Safety Evaluation dated March 24, 2004. Brief description of amendments: The essential raw cooling water system, No significant hazards consideration amendments revise the technical component cooling water system, and comments received: No. specifications to allow use of the power control air system to address a condition distribution monitoring system (PDMS) in which containment integrity, Union Electric Company, Docket No. for power distribution measurements as accident flood levels, and sump boron 50–483, Callaway Plant, Unit 1, described in Topical Report WCAP– concentrations subsequent to a high- Callaway County, Missouri 12462–P–A, ‘‘BEACON: Core Monitoring energy line break could not be Date of application for amendment: and Support System.’’ automatically ensured, and, therefore, December 8, 2003. Date of issuance: March 31, 2004. manual actions are required. Date of issuance: March 29, 2004. Brief description of amendment: The Effective date: March 31, 2004, and Effective date: As of the date of amendment revises Technical shall be implemented within 180 days issuance and shall be implemented in Specification (TS) Section 5.5.6, from the date of issuance. conjunction with the next update to the ‘‘Containment Tendon Surveillance Amendment Nos.: Unit 1—164; Unit Updated Final Safety Analysis Report Program,’’ for consistency with the 2—166. required by 10 CFR 50.71(e). requirements of 10 CFR 50.55a(g)(4) for Facility Operating License Nos. DPR– Amendment No.: 51. components classified as Code Class CC. 80 and DPR–82: The amendments Facility Operating License No. NPF– The amendment also deletes the revised the Technical Specifications. 90: Amendment revises the Updated provisions of Surveillance Requirement Date of initial notice in Federal Final Safety Analysis Report. (SR) 3.0.2 from this TS. In addition, the Register: July 8, 2003 (68 FR 40717). Date of initial notice in Federal amendment revises TS 5.5.16, The Commission’s related evaluation Register: April 15, 2003 (68 FR 18287). ‘‘Containment Leakage Rate Testing of the amendments is contained in a The supplemental letters provided Program,’’ to add exceptions to Safety Evaluation dated March 31, 2004. clarifying information that was within Regulatory Guide 1.163, ‘‘Performance- No significant hazards consideration the scope of the initial notice and did Based Containment Leak-Testing comments received: No. not change the initial proposed no Program.’’ Tennessee Valley Authority, Docket significant hazards consideration Date of issuance: March 17, 2004. Nos. 50–260 and 50–296, Browns Ferry determination. Effective date: March 17, 2004, and Nuclear Plant, Units 2 and 3, Limestone The Commission’s related evaluation shall be implemented within 90 days County, Alabama of the amendment is contained in a from the date of issuance. Safety Evaluation dated March 29, 2004. Amendment No.: 160. Date of application for amendments: No significant hazards consideration September 18, 2003, as supplemented comments received: No. Facility Operating License No. NPF– December 8, 2003, and February 24, 30: The amendment revised the 2004. TXU Generation Company LP, Docket Technical Specifications. Description of amendment request: No. 50–445, Comanche Peak Steam Date of initial notice in Federal The amendments revised the pressure- Electric Station, Unit No. 1, Somervell Register: January 6, 2004 (69 FR 700). temperature limit curves in Technical County, Texas The Commission’s related evaluation Specification (TS) 3.4.9. Date of amendment request: July 21, of the amendment is contained in a Date of issuance: March 10, 2004. 2003, as supplemented by letters dated Safety Evaluation dated March 17, 2004. Effective date: March 10, 2004. January 8, January 21, and March 8, No significant hazards consideration Amendment Nos.: 288 & 247. 2004. comments received: No.

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Wolf Creek Nuclear Operating Errata sheets have been issued for SECURITIES AND EXCHANGE Corporation, Docket No. 50–482, Wolf Regulatory Guide 1.184, COMMISSION Creek Generating Station, Coffey ‘‘ Decommissioning of Nuclear Power [File No. 1–31703] County, Kansas Reactors,’’ and Regulatory Guide 1.185, Date of amendment request: October ‘‘Standard Format and Content for Post- Issuer Delisting; Notice of Application 17, 2003. Shutdown Decommissioning Activities of Essex Corporation, To Withdraw Its Brief description of amendment: The Report.’’ These errata sheets update Common Stock, No Par Value, From amendment revises Technical Reference 1 in both guides to Listing and Registration on the Specification (TS) Section 5.5.6, Supplement 1, ‘‘Generic Environmental American Stock Exchange LLC ‘‘Containment Tendon Surveillance Impact Statement on Decommissioning April 7, 2004. Program,’’ for consistency with the of Nuclear Facilities’’ (Volumes 1 and 2) requirements of 10 CFR 50.55a(g)(4) for Essex Corporation, a Virginia to NUREG–0586 (November 2002), corporation (‘‘Issuer’’), has filed an components classified as Code Class CC. which supersedes the previous version application with the Securities and The amendment also deletes the of NUREG–0586, issued in August 1988. Exchange Commission (‘‘Commission’’), provisions of Surveillance Requirement Comments and suggestions in pursuant to Section 12(d) of the (SR) 3.0.2 from this TS. In addition, the Securities Exchange Act of 1934 amendment revises TS 5.5.16, connection with items for inclusion in (‘‘Act’’) 1 and Rule 12d2–2(d) ‘‘Containment Leakage Rate Testing guides currently being developed or thereunder,2 to withdraw its Common Program,’’ to add exceptions to improvements in all published guides Stock, no par value (‘‘Security’’), from Regulatory Guide 1.163, ‘‘Performance- are encouraged at any time. Written listing and registration on the American Based Containment Leak-Testing comments may be submitted to the Stock Exchange LLC (‘‘Amex’’ or Program.’’ Rules and Directives Branch, Division of Administrative Services, Office of ‘‘Exchange’’). Date of issuance: March 17, 2004. The Board of Directors (‘‘Board’’) of Effective date: March 17, 2004, and Administration, U.S. Nuclear Regulatory the Issuer approved a resolution on shall be implemented within 90 days Commission, Washington, DC 20555. March 15, 2004 to withdraw the Issuer’s from the date of issuance. Questions on the content of this guide Security from listing on the Amex and Amendment No.: 152. may be directed to Mr. T. Smith, (301) to list the Security on Nasdaq National Facility Operating License No. NPF– 415–6721; e-mail [email protected]. Market System (‘‘Nasdaq NMS’’). The 42: The amendment revised the Regulatory guides are available for Board states that the reasons it is taking Technical Specifications. inspection or downloading at the NRC’s such action are to offer shareholders a Date of initial notice in Federal broader market, including liquidity and Register: November 12, 2003 (68 FR Web site at http://www.nrc.gov under increased visibility. The Issuer expects 64140). NRC Documents and in NRC’s ADAMS The Commission’s related evaluation System at the same site. Single copies of to trade the Security on the Nasdaq of the amendment is contained in a regulatory guides may be obtained free NMS on March 31, 2004. The Issuer stated in its application Safety Evaluation dated March 17, 2004. of charge by writing the Reproduction and Distribution Services Section, U.S. that it has met the requirements of No significant hazards consideration Amex Rule l8 by complying with all comments received: No. Nuclear Regulatory Commission, Washington, DC 20555–0001, or by fax applicable laws in the State of Virginia, Dated at Rockville, Maryland, this 5th day to (301) 415–2289, or by e-mail to in which it is incorporated, and with the of April 2004. Amex’s rules governing an issuer’s [email protected]. Issued guides may voluntary withdrawal of a security from For the Nuclear Regulatory Commission. also be purchased from the National Ledyard B. Marsh, listing and registration. Technical Information Service (NTIS) The Issuer’s application relates solely Director, Division of Licensing Project on a standing order basis. Details on this to the withdrawal of the Securities from Management, Office of Nuclear Reactor service may be obtained by writing Regulation. listing on the Amex and from NTIS at 5285 Port Royal Road, [FR Doc. 04–8047 Filed 4–12–04; 8:45 am] registration under section 12(b) of the Springfield, VA 22161; telephone 1– Act 3 and shall not affect its obligation BILLING CODE 7590–01–P 800–553–6847; http://www.ntis.gov/. to be registered under section 12(g) of Regulatory guides are not copyrighted, the Act.4 Any interested person may, on NUCLEAR REGULATORY and Commission approval is not or before April 30, 2004, submit by COMMISSION required to reproduce them. letter to the Secretary of the Securities and Exchange Commission, 450 Fifth —(5 U.S.C. 552(a)) Regulatory Guide; Issuance, Street, NW., Washington, DC 20549– Availability Dated at Rockville, MD, this 31st day of 0609, facts bearing upon whether the March 2004. application has been made in The Nuclear Regulatory Commission For the Nuclear Regulatory Commission. accordance with the rules of the Amex (NRC) has issued errata sheets for two Ashok C. Thadani, and what terms, if any, should be guides in its Regulatory Guide Series. Director, Office of Nuclear Regulatory imposed by the Commission for the This series has been developed to protection of investors. All comment describe and make available to the Research. [FR Doc. 04–8287 Filed 4–12–04; 8:45 am] letters should refer to File No. 1–31703. public such information as methods Comments may also be submitted acceptable to the NRC staff for BILLING CODE 7590–01–P electronically at the following e-mail implementing specific parts of the address: [email protected]. The NRC’s regulations, techniques used by the staff in its review of applications for 1 15 U.S.C. 78l(d). permits and licenses, and data needed 2 17 CFR 240.12d2–2(d). by the NRC staff in its review of 3 15 U.S.C. 781(b). applications for permits and licenses. 4 15 U.S.C. 781(g).

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Commission, based on the information SECURITIES AND EXCHANGE must have completed the Exchange submitted to it, will issue an order COMMISSION requirements for registration. granting the application after the date The office may begin operating as a mentioned above, unless the [Release No. 34–49529; File No. SR–CHX– branch on receipt of written approval Commission determines to order a 2004–04] from the Exchange. hearing on the matter. Self-Regulatory Organizations; Notice (3) Firms that are also members of the For the Commission, by the Division of of Filing of Proposed Rule by the New York Stock Exchange are not Market Regulation, pursuant to delegated Chicago Stock Exchange, subject to these requirements. However, authority.5 Incorporated, To Revise Its Article VI, New York Stock Exchange members will Jonathan G. Katz, Rule 5 To Correct a Reference to the be required to notify the Exchange in writing of any openings and closings of Secretary. Form Used for the Registration of New Branch Offices a branch office, along with the name of [FR Doc. 04–8323 Filed 4–12–04; 8:45 am] the office manager. BILLING CODE 8010–01–P April 6, 2004. * * * * * Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 II. Self-Regulatory Organization’s SECURITIES AND EXCHANGE (’’Act’’),1 and Rule 19b–4 thereunder,2 Statement of the Purpose of, and COMMISSION notice is hereby given that on January 7, Statutory Basis for, the Proposed Rule 2004, the Chicago Stock Exchange, Change [File No. 500–1] Incorporated (‘‘CHX’’ or ‘‘Exchange’’), In its filing with the Commission, the filed with the Securities and Exchange CHX included statements concerning Whispering Oaks International, Inc., D/ Commission (‘‘Commission’’) the the purpose of and basis for the b/a BioCurex, Inc.; Order of proposed rule change as described in proposed rule change and discussed any Suspension of Trading Items I, II, and III below, which Items comments it received regarding the have been prepared by the Exchange. proposed rule change. The text of these April 8, 2004. The Commission is publishing this statements may be examined at the It appears to the Securities and notice to solicit comments on the places specified in Item IV below. The Exchange Commission that there is a proposed rule change from interested CHX has prepared summaries, set forth lack of current and accurate information persons. in Sections A, B, and C below, of the concerning the securities of Whispering I. Self-Regulatory Organization’s most significant aspects of such Oaks International, d/b/a BioCurex, Inc. Statement of the Terms of Substance of statements. ‘‘ ( BioCurex’’), because of questions the Proposed Rule Change A. Self-Regulatory Organization’s regarding the accuracy of assertions by Statement of the Purpose of, and BioCurex and by others, in press This proposal would update the reference to a form used by certain CHX Statutory Basis for, the Proposed Rule releases and e-mails to investors member firms for the registration of new Change concerning, among other things, (1) a branch offices. The text of the proposed study confirming the effectiveness of its 1. Purpose rule change is set forth below. Proposed primary product and (2) approval of its new language is in italics; proposed Under the Exchange’s rules, a member main product by the Food and Drug deletions are in [brackets]. firm for which the Exchange is the Administration. * * * * * designated examining authority must The Commission is of the opinion that notify the Exchange before opening a the public interest and the protection of Chicago Stock Exchange Rules Article new branch office.3 The Exchange’s investors require a suspension of trading VI Restrictions and Requirements rules currently require that a firm in the securities of the above listed * * * * * provide this notice by completing and company. submitting a MW–B form. Supervision of Members and Member The Exchange represents, however, Therefore, it is ordered, pursuant to Organizations and Their Branch and that it currently asks its member firms section 12(k) of the Securities Exchange Resident Offices to submit Schedule E to Form BD for Act of 1934, that trading in the above * * * * * that purpose. The proposed rule would listed company is suspended for the Rule 5. No change to text. correct the reference to the form in its period from 3 p.m. EDT on April 8, 2004 Article VI, Rule 5 and would make other through 11:59 p.m. EDT on April 22, * * * Interpretations and Policies non-substantive changes to the text. 2004. .01 Registration of new branch 2. Statutory Basis By the Commission. offices.— J. Lynn Taylor, Outlined below are the steps to be The CHX believes that the proposed taken when registering new branch rule change is consistent with Section Assistant Secretary. offices. 6(b) of the Act,4 in general, and furthers [FR Doc. 04–8407 Filed 4–8–04; 8:45 am] (1) Each member organization must the objectives of Section 6(b)(5) of the BILLING CODE 8010–01–P forward a[A] completed Schedule E to Act,5 in particular, in that it is designed Form BD [MW–B form will be to promote just and equitable principles forwarded] to the Exchange. of trade, to remove impediments to and (2) Before approval of the branch perfect the mechanism of a free and office is granted, the office manager or open market and a national market the registered representative in charge 3 See CHX Rule 5 of Article VI. 1 15 U.S.C. 78s(b)(1). 4 15 U.S.C. 78f(b). 5 17 CFR 200.30–3(a)(1). 2 17 CFR 240.19b–4. 5 15 U.S.C. 78f(b)(5).

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system, and, in general, to protect available for inspection and copying in to start at 3:30 p.m. e.s.t., rather than investors and the public interest. the Commission’s Public Reference 9:30 a.m., and (2) amend Rule 4709(b) Room. Copies of such filing will also be to change the frequency with which B. Self-Regulatory Organization’s available for inspection and copying at Nasdaq would disseminate the Nasdaq Statement on Burden on Competition the principal office of the Exchange. All Order Imbalance Indicator (‘‘NOII’’). The Exchange does not believe that submissions should refer to File No. The text of the proposed rule change the proposed rule change will impose SR–CHX–2004–04 and should be is set forth below. Proposed new any inappropriate burden on submitted by May 4, 2004. language is in italics; proposed competition. For the Commission, by the Division of deletions are in [brackets]. C. Self-Regulatory Organization’s Market Regulation, pursuant to delegated * * * * * authority.6 Statement on Comments on the 4709. Nasdaq Closing Cross Proposed Rule Change Received From Margaret H. McFarland, (a) Definitions. For the purposes of Members, Participants or Others Deputy Secretary. this rule the term: [FR Doc. 04–8326 Filed 4–12–04; 8:45 am] No written comments were either (1) No Change. solicited or received. BILLING CODE 8010–01–P (2) ‘‘Imbalance Only Order’’ or ‘‘IO’’ shall mean an order to buy or sell at a III. Date of Effectiveness of the specified price or better that may be Proposed Rule Change and Timing for SECURITIES AND EXCHANGE executed only during the Nasdaq Commission Action COMMISSION Closing Cross and only against MOC or Within 35 days of the date of [Release No. 34–49534; File No. SR–NASD– LOC orders. IO orders can be entered publication of this notice in the Federal 2004–060] between [9:30:01 a.m.] 3:30 p.m. and Register or within such longer period (i) 3:59:59 p.m., but they cannot be Self-Regulatory Organizations; Notice as the Commission may designate up to cancelled or modified after 3:50:00 of Filing and Immediate Effectiveness 90 days of such date if it finds such except to increase the number of shares of Proposed Rule Change by the longer period to be appropriate and or to increase (decrease) the buy (sell) National Association of Securities publishes its reasons for so finding or limit price. IO sell (buy) orders will only Dealers, Inc., Regarding the Nasdaq (ii) as to which the self-regulatory execute at or above (below) the 4:00:00 organization consents, the Commission Closing Cross SuperMontage offer (bid). All IO will: April 7, 2004. orders must be available for automatic A. By order approve such proposed Pursuant to Section 19(b)(1) of the execution. rule change, as amended, or Securities Exchange Act of 1934 (3) ‘‘Limit On Close Order’’ or ‘‘LOC’’ B. Institute proceedings to determine (‘‘Act’’),1 and Rule 19b–4 thereunder,2 shall mean an order to buy or sell at a whether the proposed rule change, as notice is hereby given that on April 5, specified price or better that is to be amended, should be disapproved. 2004, the National Association of executed only during the Nasdaq IV. Solicitation of Comments Securities Dealers, Inc. (‘‘NASD’’), Closing Cross. LOC orders can be entered, cancelled, and corrected Interested persons are invited to through its subsidiary, The Nasdaq Stock Market, Inc. (‘‘Nasdaq’’), filed with between 9:30:01 a.m. and 3:50:00 p.m. submit written data, views, and [and] LOC Orders will execute only at arguments concerning the foregoing, the Securities and Exchange Commission (‘‘Commission’’) the the price determined by the Nasdaq including whether the proposed rule Closing Cross. All LOC orders must be change is consistent with the Act. proposed rule change as described in Items I and II below, which Items have available for automatic execution. Persons making written submissions (4) ‘‘Market on Close Order’’ shall should file six copies thereof with the been prepared by Nasdaq. Nasdaq has designated the proposed rule change as mean an order to buy or sell at the Secretary, Securities and Exchange market that is to be executed only Commission, 450 Fifth Street, NW., ‘‘non-controversial’’ under Section 3 during the Nasdaq Closing Cross. MOC Washington, DC 20549–0609. 19(b)(3)(A) of the Act and Rule 19b– 4 orders can be entered, cancelled, and Comments may also be submitted 4(f)(6) thereunder, which renders the proposed rule change effective upon corrected between 9:30:01 a.m. and electronically at the following e-mail 3:50:00 p.m. [and] MOC orders will address: [email protected]. All filing with the Commission. The Commission is publishing this notice to execute only at the price determined by comment letters should refer to File No. the Nasdaq Closing Cross. All MOC SR–CHX–2004–04. This file number solicit comments on the proposed rule change from interested persons. orders must be available for automatic should be included on the subject line execution. if e-mail is used. To help the I. Self-Regulatory Organization’s (5) No Change. Commission process and review your Statement of the Terms of Substance of (6) No Change. comments more efficiently, comments the Proposed Rule Change (b) Order Imbalance Indicator. should be sent in hardcopy or by e-mail Beginning at 3:50 p.m., Nasdaq shall The proposed rule change would but not by both methods. Copies of the disseminate by electronic means an make two amendments to NASD Rule submission, all subsequent Order Imbalance Indicator every 30 4709 governing the Nasdaq Closing amendments, all written statements seconds until 3:55, and then beginning Cross. Specifically, the proposed rule with respect to the proposed rule at 3:55, every 15 seconds until [3:58] change would: (1) Change Rule change that are filed with the 3:59, and then beginning at 3:59, every 4709(a)(2) to change the order entry Commission, and all written 5 seconds until [3:59, and then every time for Imbalance Only Orders (‘‘IOs’’) communications relating to the second until] market close. The Order Imbalance Indicator shall contain the proposed rule change between the 6 17 CFR 200.30–3(a)(12). Commission and any person, other than 1 15 U.S.C. 78s(b)(1). following real time information: those that may be withheld from the 2 17 CFR 240.19b–4. (1)–(4) No Change. public in accordance with the 3 15 U.S.C. 78s(b)(3)(A). (c) No Change. provisions of 5 U.S.C. 552, will be 4 17 CFR 240.19b–4(f)(6). * * * * *

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II. Self-Regulatory Organization’s the Act,6 in particular, in that Section Act 8 and Rule 19b–4(f)(6) thereunder.9 Statement of the Purpose of, and 15A(b)(6) requires, among other things, At any time within 60 days of the filing Statutory Basis for, the Proposed Rule that a national securities association’s of the proposed rule change, the Change rules be designed to protect investors Commission may summarily abrogate In its filing with the Commission, and the public interest. Nasdaq believes such rule change if it appears to the Nasdaq included statements concerning that the proposed rule change is Commission that such action is the purpose of and basis for the consistent with the obligations under necessary or appropriate in the public proposed rule change and discussed any these provisions of the Act because it interest, for the protection of investors, comments it received on the proposed would result in the public or otherwise in furtherance of the rule change. The text of these statements dissemination of information that more purposes of the Act. may be examined at the places specified accurately reflects the trading in a Nasdaq has requested that the in Item IV below. Nasdaq has prepared particular security at the close. Commission waive the 30-day operative summaries, set forth in Sections A, B, Furthermore, to the extent a security is delay. The Commission believes that and C below, of the most significant a component of an index, Nasdaq waiving the 30-day operative delay is consistent with the protection of aspects of such statements. believes the index would more accurately reflect the value of the investors and the public interest A. Self-Regulatory Organization’s market, or segment of the market, the because it will allow Nasdaq to effect Statement of the Purpose of, and index is designed to measure. Nasdaq the proposed amendments to the Statutory Basis for, the Proposed Rule believes the corresponding result should Nasdaq Closing Cross prior to the Change be trades, or other actions, executed at launch of the Nasdaq Closing Cross scheduled for Wednesday, April 7, 1. Purpose prices more reflective of the current market when the price of an execution, 2004.10 For these reasons, the Nasdaq is proposing two amendments or other action, is based on the last sale, Commission designates the proposal to to NASD Rule 4709 governing the the high price or low price of a security, be effective and operative upon filing Nasdaq Closing Cross. Specifically, 11 or the value of an index. with the Commission. Nasdaq proposes to modify subsection (a)(2) which defines an IO and currently B. Self-Regulatory Organization’s IV. Solicitation of Comments permits market participants to enter Statement on Burden on Competition Interested persons are invited to such orders beginning at 9:30:01 a.m. submit written data, views, and E.S.T. Nasdaq has determined that it is Nasdaq does not believe that the arguments concerning the foregoing, inefficient to accept and retain such proposed rule change will result in any including whether the proposed rule orders early in the trading day because burden on competition that is not change is consistent with the Act. IOs do not impact the market or the necessary or appropriate in furtherance Persons making written submissions Closing Cross until 3:50 p.m. and of the purposes of the Act. should file six copies thereof with the market participants derive little benefit C. Self-Regulatory Organization’s Secretary, Securities and Exchange from entering them that early. Statement on Comments on the Commission, 450 Fifth Street, NW., Accordingly, Nasdaq proposes to change Proposed Rule Change Received From Washington, DC 20549–0609. the order entry time for IOs to start at Members, Participants or Others Comments may also be submitted 3:30 p.m. E.S.T. in order to better electronically at the following e-mail allocate order processing resources. Written comments were neither address: [email protected]. All Nasdaq is also proposing to amend solicited nor received. comment letters should refer to File No. subsection (b) of Rule 4709 to change SR–NASD–2004–060. This file number the frequency with which Nasdaq will III. Date of Effectiveness of the should be included on the subject line disseminate the NOII. Currently, the Proposed Rule Change and Timing for if e-mail is used. To help the rule provides for the following Commission Action Commission process and review your dissemination: beginning at 3:50 p.m., Because the foregoing proposed rule comments more efficiently, comments Nasdaq will disseminate the NOII every change does not: should be sent in hardcopy or by e-mail 30 seconds until 3:55, and then every 15 but not by both methods. Copies of the seconds until 3:58, and then every 5 (i) Significantly affect the protection submission, all subsequent seconds until 3:59, and then every of investors or the public interest; amendments, all written statements second until market close. Nasdaq has (ii) Impose any significant burden on with respect to the proposed rule determined that this dissemination competition; and change that are filed with the would be an unnecessary drain on (iii) Become operative for 30 days system resources. Nasdaq proposes to from the date on which it was filed, or 8 15 U.S.C. 78s(b)(3)(A). 9 change that dissemination to the such shorter time as the Commission 17 CFR 240.19b–4(f)(6). The Commission notes following: beginning at 3:50 p.m., that Nasdaq provided written notice of its intent to may designate, if consistent with the file the proposed rule change, along with a brief Nasdaq would disseminate the NOII protection of investors and the public description and text of the proposed rule change at every 30 seconds until 3:55, then interest,7 it has become effective least five business days prior to the date of filing beginning at 3:55 every 15 seconds until pursuant to Section 19(b)(3)(A) of the of the proposed rule change. 3:59, and then beginning at 3:59 every 10 The Commission revised this sentence to 5 seconds until market close. clarify that the launch date of the Nasdaq Closing 6 15 U.S.C. 78o–3(b)(6). Cross is Wednesday, April 7, 2004. Telephone 2. Statutory Basis 7 The Commission revised this section to reflect conversation between Jeffrey S. Davis, Associate that the proposed rule change does not become Vice President and Associate General Counsel, Nasdaq believes that the proposed operative for 30 days from the date on which it was Nasdaq, and Ann E. Leddy, Special Counsel, rule change is consistent with the filed, or such shorter time as the Commission may Division, Commission (April 6, 2004). provisions of Section 15A of the Act,5 in designate. Telephone conversation between Jeffrey 11 For purposes only of waiving the 30-day S. Davis, Associate Vice President and Associate operative delay of the proposed rule change, the general, and with Section 15A(b)(6) of General Counsel, Nasdaq, and Ann E. Leddy, Commission considered the proposed rule’s impact Special Counsel, Division of Market Regulation on efficiency, competition, and capital formation. 5 15 U.S.C. 78o–3. (‘‘Division’’), Commission (April 6, 2004). 15 U.S.C. 78c(f).

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Commission, and all written the Original Notices.4 Thereafter, NASD the Second Notices.9 The Commission communications relating to the and NYSE submitted amendments to published notice of these amendments proposed rule change between the their respective proposals, which on September 26, 2003 (‘‘Third Commission and any person, other than contained their responses to the Notices’’).10 The Commission received those that may be withheld from the comment letters.5 The Commission 14 comments in response to the Third public in accordance with the published notice of the amended Notices.11 On February 10, 2004, NASD provisions of 5 U.S.C. 552, will be proposals in the Federal Register submitted a sixth amendment, which available for inspection and copying in (‘‘Second Notices’’).6 The Commission responded to the issues raised by the the Commission’s Public Reference received four comment letters in commenters in response to the Third Room. Copies of such filing will also be response to the Second Notices.7 Notice.12 NASD submitted its seventh available for inspection and copying at Subsequently, NYSE submitted a fourth and eight amendments on March 23, the principal office of the NASD. All amendment 8 and NASD submitted its 2004, and April 5, 2004, respectively, submissions should refer to File No. fourth and fifth amendments, which which made minor changes to its SR–NASD–2004–060 and should be amended the proposals as published in proposal.13 Finally, on March 24, 2004, submitted by May 4, 2004. the Second Notices and responded to 9 For the Commission, by the Division of the comments received in response to See letters from Brian J. Woldow, Office of General Counsel, NASD, to Katherine A. England, Market Regulation, pursuant to delegated Division, SEC, dated September 3, 2003 (’’NASD 12 authority. 4 One commenter submitted a single letter that Amendment No. 4’’) and September 16, 2003 Margaret H. McFarland, addressed both Original Notices. See letter from (‘‘NASD Amendment No. 5’’). Deputy Secretary. Melvyn Musson, Business Continuity Planning 10 See Securities Exchange Act Release Nos. Manager, Edward D. Jones & Co., to Jonathan G. 48502 (September 17, 2003), 68 FR 55691 (NYSE); [FR Doc. 04–8266 Filed 4–12–04; 8:45 am] Katz, Secretary, SEC, dated September 30, 2002 and 48503 (September 17, 2003), 68 FR 55686 BILLING CODE 8010–01–P (‘‘Edward Jones 1’’). A second commenter submitted (NASD). two letters that addressed each proposal separately. 11 One comment letter addressed the Third See letters from Jerry W. Klawitter, Securities Notices of both the NASD and the NYSE. See letter Industry Association (‘‘SIA’’) Business Continuity from Jerry W. Klawitter, SIA Business Continuity SECURITIES AND EXCHANGE Planning Committee and Bond Market Association Committee, to Jonathan G. Katz, Secretary, SEC, COMMISSION (‘‘BMA’’) Business Continuity Management Council, dated October 16, 2003 (‘‘SIA 3’’). Eight comment to Margaret H. McFarland, Deputy Secretary, SEC, letters were nearly identical and addressed only the [Release No. 34–49537; File Nos. SR– dated September 30, 2002 (collectively, ‘‘SIA/BMA NASD Third Notice. See letters from Jack R. Handy, NASD–2002–108 and SR–NYSE–2002–35] 1’’). A third commenter submitted a letter that Jr., President & CEO, Financial Network Investment addressed only the NASD Original Notice. See letter Corporation, dated October 14, 2003; Patrick H. Self-Regulatory Organizations; from Frances M.. Stadler, Deputy Senior Counsel, McEvoy, President/CEO, IFG Network Securities, National Association of Securities Investment Company Institute, to Jonathan G. Katz, Inc., undated but received by the Commission on Dealers, Inc. and New York Stock Secretary, SEC, dated September 30, 2002 (‘‘ICI’’). October 15, 2003; Patrick H. McEvoy, President/ 5 CEO, Multi-Financial Securities Corporation, Exchange, Inc.; Order Approving See letters from Brian J. Woldow, Office of General Counsel, NASD, to Katherine A. England, undated but received by the Commission on Proposed Rule Changes Relating to Division of Market Regulation (‘‘Division’’), SEC, October 15, 2003; Patrick H. McEvoy, President/ Business Continuity Planning of dated December 11, 2002 (‘‘NASD Amendment No. CEO, Vestax Securities Corporation, undated but 1’’); January 8, 2003 (‘‘NASD Amendment No. 2’’); received by the Commission on October 15, 2003; Members and Notice of Filing and Ronald R. Barhorst, President, ING Financial Order Granting Accelerated Approval and February 19, 2003 (‘‘NASD Amendment No. 3’’). See also letters from Darla C. Stuckey, Advisers, LLC, undated but received by the of NASD Amendment Nos. 6, 7, and 8 Corporate Secretary, NYSE, to Nancy Sanow, Commission on October 16, 2003; Karl Lindberg, Division, SEC, dated January 10, 2003 (‘‘NYSE President, Locust Street Securities Inc., undated but April 7, 2004. Amendment No. 1’’); March 6, 2003 (‘‘NYSE received by the Commission on October 16, 2003; Amendment No. 2’’); and March 26, 2003 (‘‘NYSE Kevin P. Maas, Chief Compliance Officer, PrimeVest Financial Services, undated but received I. Introduction Amendment No. 3’’). NYSE Amendment No. 3 by the Commission on October 15, 2003; Barbara incorporated and superceded NYSE Amendments Pursuant to Section 19(b)(1) of the Stewart, President, Washington Square Securities, No. 1 and 2. Securities Exchange Act of 1934 Inc., undated but received by the Commission on 6 1 2 See Securities Exchange Act Release Nos. 47441 October 15, 2003, to Secretary, SEC (collectively, (’’Act’’) and Rule 19b–4 thereunder, (March 4, 2003), 68 FR 11432 (March 10, 2003) the National Association of Securities ‘‘Joint Commenters’’). Three additional comment (noticing Amendments No. 1, 2, and 3 of NASD letters addressed only the NASD Third Notice. See Dealers, Inc. (‘‘NASD’’) on August 7, proposal); and 48502 (March 27, 2003), 68 FR 16334 letters from Henry H. Hopkins, Vice President and 2002, and the New York Stock (April 3, 2003) (noticing Amendment No. 3 of NYSE Chief Legal Counsel, and John R. Gilner, Vice ‘‘ proposal). President & Associate Legal Counsel, T. Rowe Price Exchange, Inc. ( NYSE’’) on August 16, 7 2002, filed with the Securities and Two commenters addressed only the NASD Investment Services, Inc., to Jonathan G. Katz, Second Notice. See letters from Melvyn Musson, Secretary, SEC, dated October 16, 2003 (‘‘T. Rowe Exchange Commission (‘‘SEC’’ or Business Continuity Planning Manager, Edward D. Price’’); Joseph H. Moglia, CEO, Ameritrade Holding ‘‘Commission’’) proposed rule changes Jones & Co., to Jonathan G. Katz, Secretary, SEC, Corporation, to Margaret H. McFarland, Deputy that would require every member to dated March 28, 2003 (‘‘Edward Jones 2’’); Thomas Secretary, SEC, dated October 17, 2003 establish and maintain a business K. Heard, Associate Vice President & Director of (‘‘Ameritrade’’); W. Thomas Boulter, Vice President Contingency Planning, A.G. Edwards & Sons, Inc., & Chief Compliance Officer, Jefferson Pilot continuity plan (‘‘BCP’’) and to provide to Jonathan G. Katz, Secretary, SEC, dated March Securities Corporation, to Jonathan G. Katz, either NASD or NYSE, as appropriate, 31, 2003 (‘‘A.G. Edwards’’). One commenter Secretary, SEC, dated October 17, 2003 (‘‘Jefferson with certain emergency contact submitted separate letters to each of the NASD and Pilot’’). One commenter submitted separate but information. On September 9, 2002, the NYSE Second Notices. See letters from Jerry W. nearly identical letters to both the NASD Third Klawitter, SIA Business Continuity Planning Notice and the NYSE Third Notice. See letters from Commission published notice of both Committee and BMA Business Continuity Barry S. Augenbraun, Senior Vice President and proposals in the Federal Register Management Council, to Jonathan G. Katz, Corporate Secretary, Raymond James Financial, (‘‘Original Notices’’).3 The Commission Secretary, SEC, dated March 31, 2003 (responding Inc., to Jonathan G. Katz, Secretary, SEC, dated received four comments in response to to NASD Second Notice); Jerry W. Klawitter, SIA October 16, 2003 (collectively, ‘‘Raymond James’’). Business Continuity Planning Committee and BMA 12 See letter from Brian J. Woldow, Office of Business Continuity Management Council, to General Counsel, NASD, to Katherine A. England, 12 17 CFR 200.30–3(a)(12). Jonathan G. Katz, Secretary, SEC, dated April 24, Division, SEC, dated February 10, 2004 (’’NASD 1 15 U.S.C. 78s(b)(1). 2003 (responding to NYSE Second Notice) Amendment No. 6’’). 2 17 CFR 240.19b–4. (collectively, ‘‘SIA/BMA 2’’). 13 See letters from Shirley H. Weiss, Associate 3 See Securities Exchange Act Release Nos. 46443 8 See letter from Darla C. Stuckey, Corporate General Counsel, NASD, to Katherine A. England, (August 30, 2002), 67 FR 57264 (File No. SR– Secretary, NYSE, to Katherine A. England, Division, Division, SEC, dated March 23, 2004 (‘‘NASD NYSE–2002–35); and 46444 (August 30, 2002), 67 SEC, dated September 11, 2003 (‘‘NYSE Amendment No. 7’’), and April 5, 2004 (‘‘NASD FR 57257 (File No. SR–NASD–2002–108). Amendment No. 4’’). Amendment No. 8’’).

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NYSE submitted a letter responding to Specifically, each BCP must address of significant business disruptions and the issues raised by the commenters in data back-up and recovery (hard copy generally how the member planned to response to the Third Notice.14 and electronic); mission critical respond. This order approves the NASD and systems; 18 financial and operational Proposed NASD Rule 3520(a) requires NYSE proposals, as amended, and assessments; 19 alternate each member to report to NASD approves NASD Amendment Nos. 6, 7, communications between customers emergency contact information, which and 8 on an accelerated basis. In and the member; alternate includes the designation of two addition, the Commission solicits communications between the member emergency contact persons.22 The comment from interested persons on and its employees; alternate physical emergency contact persons must be NASD Amendment Nos. 6, 7, and 8. location of employees; 20 critical members of senior management and II. Description of the Proposals business constituent, bank, and registered principals. Proposed NASD counterparty impact; regulatory Rule 3520(b) requires members to Proposed NASD Rule 3510(a) and reporting; communications with promptly update emergency contact proposed NYSE Rule 446(a) set forth a regulators; and how the member will information in the event of a material basic requirement for NASD and NYSE assure customers’ prompt access to their change and requires the member’s members and member organizations to funds and securities in the event that Executive Representative, or his or her create, maintain, review, and update a the member determines that it is unable designee, to review and update such written BCP that identifies procedures to continue its business. Finally, if a emergency contact information within relating to an emergency or significant member relies on another entity for any 17 days after the end of each calendar business disruption. Under the of the required elements, the BCP must quarter. proposed rules, members’ BCPs ‘‘must address the relationship with the third Proposed NYSE Rule 446(g) requires a be reasonably designed to enable the party.21 member or member organization to member to meet its existing obligations Proposed NASD Rule 3510(e) and designate one or more emergency to customers’’ and address members’ proposed NYSE Rule 446(d) each contact persons who must be senior existing relationships with other broker- require a member to disclose to its officers of the firm; to provide the name, dealers and counter-parties. A member customers how its BCP addresses the title, mailing address, e-mail address, of NASD or NYSE is required to make possibility of a future significant telephone number, and fax number of its BCP available to its respective self- business disruption and how the such person(s); and to notify NYSE regulatory organization (‘‘SRO’’) upon member plans to respond to events of promptly of any change in such 15 request. varying scope. Such disclosure, at a designations. Proposed NASD Rule 3510(b) and minimum, must be made in writing to NASD proposes that the effectiveness proposed NYSE Rule 446(b) require customers at account opening, posted of its new rules be calculated from the each member to update its BCP in the on the member’s Web site (if the date of publication of the Commission’s event of any material change to the member maintains a Web site), and approval order, with different effective member’s operations, structure, mailed to customers upon request. As dates for clearing firms and introducing business, or location. In addition, the proposed, an NASD or NYSE member firms. Each NASD-member clearing firm proposed rules require every member to would not be required to disclose its must establish a BCP, as required under conduct, at a minimum, an annual actual plan. Instead, the member would proposed NASD Rule 3510, within 120 review of its BCP to determine whether be required to disclose only a summary days of the publication of the any modifications are necessary in light of how its BCP addressed the possibility Commission’s approval order. An of changes to the member’s operations, NASD-member introducing firm must 18 structure, business, or location. NASD and NYSE proposed substantively the establish a BCP, as required under same definition for ‘‘mission critical system.’’ The Both proposed rules require that a proposed NASD Rule 3510, within 150 BCP be approved by the member. proposed rules define ‘‘mission critical system’’ as any system that is necessary, depending on the days of the publication of the Proposed NASD Rule 3510(d) requires a nature of a member’s business, to ensure prompt Commission’s approval order. All NASD member of senior management, who and accurate processing of securities transactions, members (both clearing and introducing including, but not limited to, order taking, order must be a registered principal, to firms) must designate their emergency approve a BCP and be responsible for entry, execution, comparison, allocation, clearance and settlement of securities transactions, the contact persons, as required in proposed conducting the annual review. Proposed maintenance of customer accounts, access to NASD Rule 3520, within 60 days of NYSE Rule 446(g) requires a senior customer accounts and the delivery of funds and publication of the Commission’s securities. See proposed NASD Rule 3510(f)(1) and officer, as defined in NYSE Rule 351(e), approval order. NYSE proposes that its to approve and review the BCP on an proposed NYSE Rule 446(e). 19 rule will take effect 120 days after annual basis. NASD and NYSE proposed substantively the same definition for ‘‘financial and operation Commission approval. The proposed rules set forth the assessment.’’ As defined, a ‘‘financial and Finally, NASD proposes to offer an elements that a BCP must address, if operational assessment’’ means a set of written optional repository service for its applicable,16 which shall be tailored to procedures that allows a member to identify members’ BCPs. In its Amendment No. the size and needs of the member.17 changes in its operational, financial, and credit risk exposure. See proposed NASD Rule 3510(f)(2) and 8, however, NASD stated that this proposed NYSE Rule 446(f). online repository service would be 14 See letter from Darla C. Stuckey, Corporate 20 NASD’s added this element in its Amendment operated through an outside vendor and Secretary, NYSE, to Katherine A. England, Division, No. 8. Therefore, under the final proposals, NASD SEC, dated March 23, 2004 (‘‘NYSE Response and NYSE will require their members to address the that any NASD members wishing to use Letter’’). exact same aspects of business continuity. 15 See proposed NASD Rule 3510(a) and proposed 21 NASD and NYSE stated that this provision 22 NASD originally proposed to require certain NYSE Rule 446(a). would permit a member that is a subsidiary of additional emergency information, such as location 16 The proposed rules provide that if an element another entity to satisfy its obligations under the of books and records (including back-up locations), is not applicable to a member the BCP must contain rules by participation in a corporate-wide BCP of clearance and settlement information, identification the rationale as to why such element is not the parent, even if the parent were not itself a of key banking relationships, and alternative included in the BCP. See proposed NASD Rule member. However, the parent company’s BCP communication plans for investors. In its 3510(c) and proposed NYSE Rule 446(b). would be required to comply with the requirements Amendment No. 8, NASD withdrew this portion of 17 See proposed NASD Rule 3510(c) and proposed of the BCP rule and would have to be available to the proposal and deleted the words ‘‘Among other NYSE Rule 446(c). NASD and/or NYSE (as appropriate) upon request. things’’ from proposed NASD Rule 3520(a).

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this service would pay a monthly fee NASD and NYSE, in response, NASD, however, did state that it would directly to the repository. declined to amend their proposals as consider, based on its experience with suggested. In explaining their decision the rule following its adoption, whether III. Summary of Comments not to amend this provision of the to enumerate specific relationships that In total, the Commission received 22 proposed rules, NASD and NYSE noted it views critical to all members. In comment letters on the proposed rule the following statement made by the addition, NASD amended its proposal to changes.23 Generally, the commenters Commission: read ‘‘critical business constituent, bank, supported the proposed new rules.24 As The decision by a broker-dealer to risk and counter-party impact’’ so that it is noted above, NASD and NYSE generally capital or provide brokerage services on identical to the NYSE proposal. an ongoing basis is, in essence, a matter addressed the issues raised in the 2. Customer Access to Funds and of business judgment. Given the comment letters received in response to Securities the Original Notices and the Second competitive nature of the securities Notices in subsequent amendments.25 business, however, the Commission As noted above, proposed NASD Rule These amendments, including NASD’s expects there to be incentives for broker- 3510(c)(9) and proposed NYSE and NYSE’s responses to the comment dealers to be prepared to participate in 446(c)(10) requires a member’s BCP to letters, were published by the the markets following a wide-scale address ‘‘[h]ow the member will assure Commission in the Federal Register.26 disruption as soon as the markets’ customers’’ prompt access to their funds In response to the Third Notices, the trading facilities become available.30 and securities in the event that the Commission received 14 comment In its Amendment No. 4, NASD stated member determines that it is unable to letters.27 NASD and NYSE submitted that it did not intend members to continue its business.’’ This new responses to the issues raised in the interpret its rule to require them to language was published in the Third comments letters the Commission continue their business in the event of Notices. NASD and NYSE stated that received in response to the Third a significant business disruption. NYSE this new category should help to ensure Notices.28 The issues raised by the stated that it believed that further that, if a member is unable to continue commenters in response to the Third amendment was not warranted because its business following a significant Notices and NASD and NYSE responses its position that members are not business disruption, customers could are summarized below. required to continue its business is clear access their funds or securities held and that this position is consistent with through the member. A. Meeting Existing Obligations to the Commission’s Policy Statement. In response to the Third Notices, one Customers commenter argued that the obligations B. Plan Elements placed on a firm under the proposed In the Third Notices, NASD and rules might conflict with the obligations NYSE amended their respective 1. Critical Business Constituent, Banks, and Counter-Party Impact of the firm imposed by the Securities proposals to provide that the procedures Investor Protection Corporation In responding to the Third Notices, set forth in a BCP should be reasonably (‘‘SIPC’’).35 NASD and NYSE stated that one commenter commended the designed to enable a member to meet its they did not believe that the provisions revision to limit the scope of this existing obligations to customers and conflict with SIPC rules and did not provision to ‘‘critical’’ counter-parties.31 address existing relationships with intend for the proposed rule change to other broker-dealers and counter- However, the commenter requested that 29 have any effect on a member’s parties. A majority of commenters NASD and NYSE communicate any obligations under such rules. The new advocated returning to the language criteria that they develop to define such provisions require a member only to published in the Second Notices, which critical relationships at the earliest address how it would assure such stated that each member’s plan must be opportunity. Another commenter argued access. NASD and NYSE continued that, ‘‘ reasonably designed to enable the that the proposal appeared to impose on if a member believed that SIPC rules ‘‘ member to continue its business.’’ members the impossible requirement’’ might affect a member’s response to this Specifically, the Joint Commenters of addressing how they would remedy subsection, the member should address ‘‘ argued that the phrase meet its existing the possible failure of industry-wide SIPC rules in its BCP. Finally, NASD obligation to customers’’ was vague and systems on which all parties must rely, and NYSE noted that a member could did not adequately clarify that a member such as the Depository Trust 32 not rely on SIPC membership, by itself, would not be required to continue its Company. Several commenters argued to satisfy its obligations under the business. They also argued that the that because the terms are not defined proposed rules, because SIPC phrase ‘‘address their existing the intent of the rule language was 33 involvement in the liquidation of a relationships with other broker-dealers vague and ambiguous. Finally, one broker-dealer is limited to SIPC’s and counter-parties’’ did not stipulate commenter recommended that NASD authority under the Securities Investor what level of detail would be required and NYSE should use the same rule Protection Act of 1970. in the BCP and appeared to add new language to avoid confusion.34 requirements to the BCP rather than In its Amendment No. 6, NASD C. Disclosure clarifying that a member would not be responded that it believed that members In the Third Notices, NASD and required to stay in business. should be responsible for identifying NYSE proposed that members disclose those relationships that it deems critical to their customers how their BCPs 23 See supra notes 4, 7 and 11. for purposes of complying with the rule. address a future significant business 24 See Ameritrade, Edward Jones 1, ICI, Jefferson disruption. Several commenters argued Pilot, Joint Commenters, Raymond James, and SIA/ 30 Business Continuity Planning for Trading that the disclosure provision would be BMA 1. Markets, Securities Exchange Act Release No. 48545 36 25 See supra notes 5, 8, and 9 and accompanying (September 25, 2003), 68 FR 56656, 56658 (October burdensome and costly. The Joint text. 1, 2003) (‘‘Policy Statement’’). Commenters, for example, maintained 26 See supra notes 6 and 10. 31 See SIA 3. 27 See supra note 11. 32 See Raymond James. 35 See id. 28 See supra notes 12 and 14. 33 See Joint Commenters. 36 See Jefferson Pilot, Joint Commenters, and 29 See Ameritrade and Joint Commenters. 34 See SIA 3. Raymond James.

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that the cost of delivering the summary the parties with whom the member has this comparison is appropriate. The BCP to customers at account opening back-up arrangements. Policy Statement sets forth the outweighed any benefits. The Joint In order to make the disclosure Commission’s view that self regulatory Commenters also noted that a customer meaningful, NASD and NYSE stated organizations (‘‘SROs’’) that operate receives large amounts of information at that, when addressing events of varying trading markets and electronic account opening and, ‘‘as more scope, a member should: (1) Provide communications networks (‘‘ECNs’’) information is added, the import of the specific scenarios of varying severity should, among other things, plan to information becomes lost and the (e.g., a firm-only business disruption, a resume trading operations by the next customer becomes increasingly disruption to a single building, a business day in response to a wide-scale frustrated with the account opening disruption to a business district, a city- business disruption. The current process.’’ Another commenter echoed wide disruption and a regional proposals require a member only to that ‘‘providing a summary that is not disruption); (2) state whether it plans to create and maintain a BCP that is easily understood will lead to customer continue business during that scenario reasonably designed to meet the confusion.’’ 37 This commenter argued and, if so, its planned recovery time; member’s obligations to its customers that ‘‘deficient business continuity plans and (3) provide general information on and that addresses certain enumerated by member firms can be detected and its intended response. Furthermore, areas. NYSE also noted that many firms, deterred sufficiently through the NASD and NYSE stated that the as a matter of best practices, have regulatory audit process’’ rather than disclosure requirement was necessary to already established BCPs. Therefore, through public disclosure. In the enable customers to make educated NASD and NYSE declined to amend the alternative, the commenter decisions about whether to place their effective dates. recommended that it would be funds and securities at a specific firm. IV. Discussion sufficient for a firm to post its summary Finally, in response to the liability BCP on its Web site and provide it on concern, NASD and NYSE stated that a One of the critical ‘‘lessons learned’’ demand rather than to provide it to member could include in its BCP from the events of September 11, 2001, every customer at account opening.38 cautionary language to the effect that the is the need for more rigorous business Another commenter—noting that it had plan was subject to modification, that an continuity planning in the financial identified over 200 mission critical updated plan would be promptly posted services industry. Since September 11, functions in its various departments and on the member’s website, and that the resilience of the U.S. securities developed a response plan for each of customers also could obtain an updated markets has been a matter of principal these functions—argued that it would be plan by requesting a written copy by concern to the Commission and to other impossible to summarize these plans in mail. Plans also can be flexible enough regulators. In April 2003, for example, any meaningful way.39 to provide for individualized responses the Commission—together with the Two comments raised concerns about to various events. Office of the Comptroller of the disclosing potentially confidential and Currency and the Board of Governors of proprietary information.40 One D. Emergency Contact Information the Federal Reserve System—issued an commenter also argued that a firm might In response to the NASD Third Interagency Paper on Sound Practices to be subject to liability for breach of Notice, one commenter asserted that Strengthen the Resilience of the U.S. contract or misrepresentation if it NASD’s discussion in its Amendment Financial System,45 which noted that, determined to vary a course of action No. 4 suggests that the Executive ‘‘because of the interdependent nature of from what was disclosed in its summary Representative should have the the U.S. financial markets, all financial BCP in order to react more appropriately authority to make potentially time firms have a role in improving the in a recovery situation.41 sensitive decisions on behalf of the firm, overall resilience of the financial In their responses, NASD and NYSE which may conflict with the governing system. It therefore is appropriate for all stated that they continued to believe charter of many member firms.42 In its financial firms to review their business that this requirement was necessary to Amendment No. 6, however, NASD continuity plans * * * ’’.46 enable customers to make educated stated it ‘‘in no way sought to alter the Subsequently, the Commission issued decisions about whether to place their scope of authority of a member’s the Policy Statement,47 which set forth funds and securities at a specific broker- Executive Representative to make these the Commission’s view that SROs that dealer. NASD and NYSE also stated that types of decisions.’’ operate trading markets and ECNs they believe that these provisions would should apply certain basic principles in E. Implementation encourage members to create adequate their business continuity planning contingency plans. In response to one In response to the Second Notices, within a specified timeframe. commenter’s concern about disclosing one commenter recommended that the Specifically, the Commission stated that confidential and proprietary proposed rules should become effective it expected each SRO market and ECN, information, NYSE stated that a member 360 days from the publication of the among other things, to have a BCP that would be required only to summarize final rules in the Federal Register.43 anticipates the resumption of trading no the manner in which its BCP addresses After the Third Notices, this commenter later than the next business day the possibility of significant business reiterated its view that the proposed following a wide-scale business disruptions. NASD and NYSE reiterated implementation schedule was too disruption, and that this generally that members would not be required to aggressive, suggesting instead that requires geographic diversity between disclose the specific location of any NASD and NYSE should follow the primary and back-up sites. In the Policy back-up facilities, any proprietary Commission’s implementation dates for information contained in the plan, or trading markets set forth in the Policy 45 Securities Exchange Act Release No. 47638 Statement.44 NASD and NYSE both (April 7, 2003), 68 FR 17809 (April 11, 2003) (‘‘Interagency Paper’’). 37 responded that they do not believe that See Jefferson Pilot. 46 The Interagency Paper sets forth sound 38 See id. practices for business continuity planning for the 39 See Raymond James. 42 See SIA 3. clearance and settlement systems of the U.S. 40 See Ameritrade and Joint Commenters. 43 See SIA/BMA 2. financial markets. 41 See Ameritrade. 44 See SIA 3. 47 See supra note .

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Statement, the Commission declined to system, and in general to protect their funds and securities. While the establish new regulatory requirements investors and the public interest. new rules establish few minimum for non-ECN broker-dealers but did The proposed rules will require standards that the BCP of every NASD state: member firms to establish written plans or NYSE member must meet, a customer that address general areas of business The establishment of a next-business will be in a much better position to continuity. Requiring every NASD and day resumption goal for the SRO evaluate whether a particular firm’s NYSE member to address how it would Markets and ECNs should serve as a emergency preparedness meets his or handle business disruptions of varying her expectations. useful resumption benchmark for scope is an important first step in The summary of the member’s BCP securities firms as well. The decision by reducing the impact of any such that is disclosed to customers should a broker-dealer to risk capital or provide disruptions. Although no plan can include a discussion of how the broker- brokerage services on an ongoing basis reasonably be expected to mitigate the dealer intends to respond to events of is, in essence, a matter of business effects of every crisis, a firm that has a varying scope (e.g., a firm-only judgment. Given the competitive nature BCP meeting the requirements of the disruption, a disruption to a single of the securities business, however, the proposed rules should be in a much building, a disruption to a business Commission expects there to be better position to respond to a district, a city-wide disruption, and a incentives for broker-dealers to be significant event. Furthermore, regional disruption); whether the prepared to participate in the markets implementation of the proposed rules broker-dealer intends to continue its following a wide-scale disruption as by all NASD and NYSE members business during each scenario and, if so, soon as the markets’ trading facilities collectively should reduce the adverse the planned recovery time; and how the become available.48 systemic consequences of a disruption broker-dealer intends to respond to each With their respective proposals, that affects multiple firms in a particular scenario. This requirement should give NASD and NYSE are taking an area. Therefore, the Commission the summary BCP a basic framework important step in setting forth business believes that the new rules should against which it can readily be continuity planning requirements for enhance the resilience of the U.S. compared to other BCPs. The broker-dealers that allow for flexibility financial markets generally. Commission believes that it is important and the exercise of business judgment, The Commission agrees with the for customers to understand the yet at the same time assure that approach taken by the SROs to allow capabilities and plans of the NASD or investors have sufficient information to each member the flexibility to tailor its NYSE member with which they choose evaluate the level of a firm’s BCP and, BCP to the nature, type, and scope of its to do business, and this disclosure in any event, that all customers have business. The new rules require each should provide investors with such prompt access to their funds and member’s BCP, at a minimum, to information. securities. For the reasons discussed address various aspects of business Although the new NASD and NYSE below, the Commission finds that the continuity planning. Thus, the new rules are fundamentally process-based, proposed rule changes, as amended, are rules envisage a planning process but do every member is required to include one element in its BCP: A discussion of how consistent with the requirements of the not—except with respect to customer access to funds and securities, described the member will assure its customers’ Act and the regulations thereunder.49 In below—dictate the content of the plans prompt access to their funds and particular, the Commission believes that that result from that process. For securities in the event that the member NASD’s proposal is consistent with example, although a member firm is unable to operate. A broker-dealer Section 15A(b)(6) of the Act 50 which would be required in its plan to address that holds funds and securities on requires, among other things, that the its mission critical systems and the behalf of its customers is acting as the rules of a national securities association back-up for such systems, the rules do customers’ agent. The Commission be designed to prevent fraudulent and not require a member to take specific believes that it is reasonable and manipulative acts and practices, to actions such as establishing a back-up consistent with the Act for NASD and promote just and equitable principles of facility or obtaining a specified amount NYSE to require that a member address trade, to remove impediments to and of redundant telecommunications how it will assure customers’ access to perfect the mechanism of a free and capacity. their funds and securities even if the open market and a national market The Commission believes that NASD member cannot operate or determines system, and in general to protect and NYSE have identified important that it is not economically feasible to investors and the public interest. The elements that must be addressed in each continue its business during or after a Commission also believes that NYSE’s member’s BCP. While the new rules are significant business disruption. The proposal is consistent with Section primarily procedures-based rather than Commission expects that a discussion of 51 6(b)(5) of the Act which requires, standards-based, they include an this subject will appear on the summary among other things, that the rules of a important provision to encourage NASD BCP, as a likely concern of any customer national securities exchange be and NYSE members to develop is how to recover funds and securities designed to prevent fraudulent and thoughtful and robust plans: An if the broker-dealer is incapacitated. manipulative acts and practices, to obligation to disclose a summary of The Commission believes that it is promote just and equitable principles of their BCPs to their customers. This reasonable and consistent with the Act trade, to remove impediments to and obligation should harness market forces for NASD and NYSE to require each perfect the mechanism of a free and to improve the emergency preparedness member to designate emergency contact open market and a national market of particular firms as well as the persons and to provide NASD and securities industry as a whole. The NYSE (as appropriate) with emergency 48 Policy Statement, 68 FR at 56658. information contained in these public contact information for such persons. 49 In approving these proposals, the Commission disclosures will allow individual This information should facilitate efforts considered the proposed rules’ impact on efficiency, competition, and capital formation. See customers (and potential customers) to to coordinate efforts between NASD or 15 U.S.C. 78c(f). compare the emergency preparedness of NYSE and its members to resume 50 15 U.S.C. 78o–3(b)(6). a broker-dealer to that of its competitors operations after a significant business 51 15 U.S.C. 78f(b)(5). and help them to decide where to place disruption. The Commission also

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believes that it is reasonable and SR–NASD–2002–108. The file number 19b–4 2 thereunder, a proposal to amend consistent with the Act for NASD and should be included on the subject line the procedures for the review of Nasdaq NYSE to require each member to review if e-mail is used. To help the listing determinations. On February 20, and update its BCPs and its emergency Commission process and review your 2004, Nasdaq submitted Amendment contact information in the manner and comments more efficiently, comments No. 1 to the proposal,3 which replaced at the times specified in the new rules. should be sent in hardcopy or by e-mail the original proposal in its entirety. On The Commission believes that the but not by both methods. Copies of the March 1, 2004, the Commission implementation timeframes proposed by submission, all subsequent published the proposed rule change, as NASD and NYSE are reasonable and amendments, all written statements amended, in the Federal Register.4 The consistent with the Act. In particular, with respect to the proposed rule Commission received no comments on the Commission believes that it is change that are filed with the the proposal. This order approves the reasonable for NASD to grant its NASD- Commission, and all written amended proposal. member introducing firms 30 days more communications relating to the The Commission believes that the than NASD-member clearing firms, as proposed rule change between the proposed rule change is consistent with introducing firms may need to Commission and any person, other than the Act and the rules and regulations incorporate the business recovery those that may be withheld from the thereunder applicable to a national strategies of their clearing firms into public in accordance with the securities association.5 In particular, the their own plans. provisions of 5 U.S.C. 552, will be Commission believes that the proposal The Commission believes that it is available for inspection and copying in is consistent with Section 15A(b)(6) of reasonable for NASD to arrange with an the Commission’s Public Reference the Act 6 which requires, among other outside vendor to serve as a repository Room. Copies of such filing will also be things, that the rules of an association for its members’ BCPs. Use of this available for inspection and copying at be designed to promote just and service would be voluntary and subject the principal office of NASD. All equitable principles of trade and to to a monthly fee payable by a member submissions should refer to the File No. protect investors and the public interest. directly to the repository. The SR–NASD–2002–108 and should be NASD Rule 4830 provides that all Commission believes that this service submitted by May 4, 2004. hearings before the Nasdaq Listing may be beneficial to members during Qualifications Panel be conducted by at emergency situations. Specifically, it VI. Conclusion least two persons designated by the will enable a member to get a copy of It is therefore ordered, pursuant to Nasdaq board of directors. Nasdaq’s its BCP even if its offices are not Section 19(b)(2) of the Act,53 that the practice is to conduct such hearings accessible. proposed rule changes (SR–NASD– before panels composed of two Pursuant to Section 19(b)(2) of the members. Currently, NASD Rule 4830 52 2002–108 and SR–NYSE–2002–35), as Act, the Commission finds good cause amended, are approved. does not make provision for a deadlock for approving NASD Amendment Nos. between the two members of the panel. 6, 7, and 8 prior to the thirtieth day after For the Commission, by the Division of Under new paragraph (d) of NASD Rule the date of publication of notice thereof Market Regulation, pursuant to delegated authority.54 4830, in the event of a deadlock, the in the Federal Register. These issuer would be afforded the amendments make only minor revisions Margaret H. McFarland, opportunity for a new hearing before a to the rule text that clarify the NASD Deputy Secretary. new Listing Qualifications Panel proposal and do not alter its substance. [FR Doc. 04–8324 Filed 4–12–04; 8:45 am] comprised of three members. The issuer In addition, the Commission believes BILLING CODE 8010–01–P and Nasdaq staff would be afforded the that NASD’s proposal should be opportunity to supplement the record approved, as amended by Amendments on review, including any information Nos. 6, 7, and 8, at the same time as the SECURITIES AND EXCHANGE that was not available at the time of the NYSE proposal to provide consistent COMMISSION first hearing before the Listing regulation among NASD and NYSE [Release No. 34–49535; File No. SR–NASD– Qualifications Panel. There would be no members. Accordingly, the Commission 2004–018] fee for the second hearing. believes that good cause exists to Among other things, the rule change approve Amendment Nos. 6, 7, and 8 on Self-Regulatory Organizations; Order also: (1) Allows the Listing an accelerated basis. Approving Proposed Rule Change and Qualifications Panel or the Nasdaq Amendment No. 1 Thereto by the Listing Council to reconsider its V. Solicitation of Comments on NASD decision, but only if there were a Amendment Nos. 6, 7, and 8 National Association of Securities Dealers, Inc. To Amend the Procedures mistake of material fact in the decision; Interested persons are invited to for the Review of Nasdaq Listing (2) clarifies when the Nasdaq Listing submit written data, views, and Determinations Council may assert jurisdiction over a arguments concerning the foregoing, decision or permit the Listing including whether NASD Amendment April 7, 2004. Qualifications Panel to proceed with the Nos. 6, 7, and 8 are consistent with the On January 28, 2004, the National Act. Persons making written Association of Securities Dealers, Inc. 2 17 CFR 240.19b–4. submissions should file six copies (‘‘NASD’’), through its subsidiary, the 3 See letter from Mary M. Dunbar, Vice President thereof with the Secretary, Securities Nasdaq Stock Market, Inc. (‘‘Nasdaq’’), and Deputy General Counsel, Nasdaq, to Katherine A. England, Division of Market Regulation, and Exchange Commission, 450 Fifth filed with the Securities and Exchange Commission, dated February 20, 2004 Street NW., Washington, DC 20549– Commission (‘‘Commission’’), pursuant (‘‘Amendment No. 1’’). 0609. Comments may also be submitted to Section 19(b)(1) of the Securities 4 See Securities Exchange Act Release No. 49306 electronically at the following e-mail Exchange Act of 1934 (‘‘Act’’) 1 and Rule (February 23, 2004), 69 FR 9662 (March 1, 2004). address: [email protected]. All 5 In approving the proposed rule change, the Commission has considered the proposed rule’s comment letters should refer to File No. 53 Id. impact on efficiency, competition, and capital 54 17 CFR 200.30–3(a)(12). formation. See 15 U.S.C. 78c(f). 52 15 U.S.C. 78s(b)(2). 1 15 U.S.C. 78s(b)(1). 6 15 U.S.C. 78o–3(b)(6).

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reconsideration; and (3) allows pursuant to Section 19(b)(3)(A) of the LCM Section 802.01B with respect to documents required by the NASD Rule Act 4 and Rule 19b–4(f)(6) thereunder,5 applicable continued listing standards. 4800 process to be delivered by e-mail, which renders the proposal effective Additionally, the Exchange is if the issuer consents to such method of upon filing.6 The Commission is proposing an addition to LCM Section delivery. publishing this notice to solicit 202.05 to specify publication The Commission believes that these comments on the proposed rule change, requirements regarding any change in proposals will improve the efficiency as amended, from interested persons. the terms of a listed unit, such as and fairness of the process by which changes to the terms and conditions of I. Self-Regulatory Organization’s Nasdaq makes listing determinations any of the components or to the ratio of Statement of the Terms of Substance of and, therefore, are reasonable and the components within the unit, and to the Proposed Rule Change consistent with the Act. specify that the issuer must provide It is therefore ordered, pursuant to The Exchange is proposing to amend current information in this regard on its Section 19(b)(2) of the Act,7 that the the Listed Company Manual (‘‘LCM’’) website, or if it does not maintain a proposed rule change (SR–NASD–2004– Sections 102.01C, 202.05 and 802.01B to website, in its annual report to unit 018), as amended, is approved. clarify that income deposit securities holders. Changes that should be For the Commission, by the Division of intended to be traded as a unit will, as publicized would include those Market Regulation, pursuant to delegated a general matter, be listed if each of the resulting from a stock split or an authority.8 component parts of the unit meets the automatic exchange of one or more Margaret H. McFarland, applicable requirements for listing. components of the unit (e.g., as a result Deputy Secretary. of a secondary offering of units). The II. Self-Regulatory Organization’s issuer would be expected to provide [FR Doc. 04–8325 Filed 4–12–04; 8:45 am] Statement of the Purpose of, and BILLING CODE 8010–01–P public disclosure as soon as practicable Statutory Basis for, the Proposed Rule regarding the nature and effective date Change of the change. For example, changes SECURITIES AND EXCHANGE In its filing with the Commission, the resulting from a stock split should be COMMISSION NYSE included statements concerning subject to prior disclosure, while changes with respect to original issue [Release No. 34–49515; File No. SR–NYSE– the purpose of and basis for the 2004–17] proposed rule change, and discussed discount should be disclosed as soon as any comments it received on the such information is available. Self-Regulatory Organizations; Notice proposed rule change. The text of these Disclosure of this nature is appropriate of Filing and Immediate Effectiveness statements may be examined at the to ensure that sufficient information of Proposed Rule Change and places specified in Item IV below. The regarding the attributes of IDS units is Amendment No. 1 Thereto by the New Exchange has prepared summaries, set publicly available and readily accessible York Stock Exchange, Inc. Relating to forth in Sections A, B, and C below, of on a timely basis.7 the Listing of Income Deposit the most significant aspects of such 2. Statutory Basis Securities (Sections 102.01C, 202.05 statements. and 802.01B of the Listed Company The Exchange believes that the A. Self-Regulatory Organization’s Manual) proposal is consistent with Section 6(b) Statement of the Purpose of, and of the Act,8 in general, and Section April 1, 2004. Statutory Basis for, the Proposed Rule 6(b)(5) of the Act,9 in particular, in that Pursuant to Section 19(b)(1) of the Change it will promote just and equitable Securities Exchange Act of 1934 1. Purpose principles of trade; facilitate (’’Act’’) 1 and Rule 19b–4 thereunder,2 transactions in securities, remove notice is hereby given that on March 17, The Exchange is considering the impediments to and perfect the 2004, the New York Stock Exchange, listing of units comprised of common mechanisms of a free and open market Inc. (‘‘NYSE’’ or ‘‘Exchange’’) filed with stock and a debt security, sometimes and a national market system; and the Securities and Exchange referred to as income deposit securities protect investors and the public interest. Commission (‘‘Commission’’) the (‘‘IDS’’). In contrast to a typical unit, an proposed rule change as described in IDS unit can be expected to trade as a B. Self-Regulatory Organization’s Items I and II below, which Items have unit for an extended period of time, Statement on Burden on Competition been prepared by the Exchange. On although holders can have certain rights The Exchange does not believe that March 29, 2004, the Exchange amended to separate the IDS unit into its the proposed rule change will impose the proposed rule change.3 The component parts (or to combine the any burden on competition that is not Exchange filed the proposed rule change components into an IDS). necessary or appropriate in furtherance In order to provide clarity and of the purposes of the Act. 7 15 U.S.C. 78s(b)(2). transparency with respect to the listing C. Self-Regulatory Organization’s 8 17 CFR 200.30–3(a)(12). standards applicable to IDS units, the 1 Statement on Comments on the 15 U.S.C. 78s(b)(1). Exchange is proposing to amend LCM 2 Proposed Rule Change Received from 17 CFR 240.19b–4. Section 102.01C to clarify that each 3 See Letter from Darla C. Stuckey, Corporate Members, Participants or Others Secretary, NYSE, to Nancy J. Sanow, Assistant component of a unit must meet the Director, Division of Market Regulation, applicable listing standards. A Written comments on the proposed Commission, dated March 26, 2004 (‘‘Amendment comparable amendment is proposed to rule change were neither solicited nor No. 1’’). In Amendment No. 1, the Exchange made received. certain changes to Section 7 of the form 19b–4 and Section III of Exhibit 1 of the proposed rule change 4 15 U.S.C. 78s(b)(1). and confirmed that the original and continuing 5 17 CFR 240.19b–4. 7 The Commission notes that Amendment No. 1 equity distribution standards set out in the Listed 6 The NYSE asked the Commission to waive the also set forth the standards applicable to the units Company Manual Sections 102.01A and 802.01A five-day pre-filing notice requirement and the 30- as a whole. See supra at footnote 3. will be applied to units listed as income deposit day operative delay. See Rule 19b–4(f)(6)(iii). 17 8 15 U.S.C. 78f(b). securities. CFR 240.19b–4(f)(6)(iii). 9 15 U.S.C. 78f(b)(5).

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III. Date of Effectiveness of the submissions should file six copies through its wholly owned subsidiary Proposed Rule Change and Timing for thereof with the Secretary, Securities PCX Equities, Inc. (‘‘PCXE’’), filed with Commission Action and Exchange Commission, 450 Fifth the Securities Exchange Commission Because the foregoing proposed rule Street, NW., Washington, DC 20549– (‘‘Commission’’ or ‘‘SEC’’) the proposed change does not: 0609. Comments may also be submitted rule change as described in Items I and (i) Significantly affect the protection electronically at the following e-mail II below, which Items have been of investors or the public interest; address: [email protected]. All prepared by the Exchange. On March 3, (ii) impose any significant burden on comment letters should refer to File No. 2004, the Exchange submitted competition; and SR–NYSE–2004–17. This file number Amendment No. 1 to the proposed rule (iii) become operative for 30 days should be included on the subject line change.3 On March 22, 2004, the from the date on which it was filed, or if e-mail is used. To help the Exchange submitted Amendment No. 2 such shorter time as the Commission Commission process and review to the proposed rule change.4 The may designate, it has become effective comments more efficiently, comments Commission is publishing this notice to pursuant to Section 19(b)(3)(A) of the should be sent in hardcopy or by e-mail solicit comments on the proposed rule Act 10 and Rule 19b–4(f)(6) but not by both methods. Copies of the change from interested persons and to thereunder.11 submission, all subsequent grant accelerated approval to the The NYSE has asked the Commission amendments, all written statements proposed rule change. with respect to the proposed rule to waive the five-day pre-filing notice I. Self-Regulatory Organization’s change that are filed with the requirement and the 30-day operative Statement of the Terms of Substance of Commission, and all written delay. The Commission believes the Proposed Rule Change waiving the five-day pre-filing notice communications relating to the requirement and the 30-day operative proposed rule change between the The Exchange proposes to amend its delay is consistent with the protection Commission and any person, other than rules governing the Archipelago of investors and the public interest. The those that may be withheld from the Exchange (‘‘ArcaEx’’), the equities Commission notes that it recently public in accordance with the trading facility of PCXE. The Exchange approved a similar proposal by the provisions of 5 U.S.C. 552, will be proposed to adopt listing standards for American Stock Exchange LLC available for inspection and copying in index-linked exchangeable notes. With (’’Amex’’), which the NYSE’s proposal the Commission’s Public Reference this filing, PCX proposes to add PCXE is based upon.12 The Amex proposal Room. Copies of such filing will also be Rule 5.2(j)(4) to permit for listing or was published for comment and the available for inspection and copying at pursuant to unlisted trading privileges Commission received no comments on the principal office of the NYSE. All (‘‘UTPs’’), index-linked exchangeable it.13 Finally, the Commission does not submissions should refer to refer to File notes. The text of the proposed rule believe the NYSE’s proposal raises any No. SR–NYSE–2004–17, and should be change appears below. Proposed new new regulatory issues. For these submitted by May 4, 2004. language is in italics. reasons, the Commission designates the For the Commission, by the Division of * * * * * proposal to be effective and operative Market Regulation, pursuant to delegated Rule 5.2(a)–(i)—No change. (j)(1)– upon filing of the amended proposal authority.16 (3)—No change. with the Commission.14 Margaret H. McFarland, Index-Linked Exchangeable Notes At any time within 60 days of the Deputy Secretary. filing of the amended proposed rule (4) Index-linked exchangeable notes [FR Doc. 04–8263 Filed 4–12–04; 8:45 am] which are exchangeable debt securities change, the Commission may summarily BILLING CODE 8010–01–P abrogate such rule change if it appears that are exchangeable at the option of to the Commission that such action is the holder (subject to the requirement that the holder in most circumstances necessary or appropriate in the public SECURITIES AND EXCHANGE exchange a specified minimum amount interest, for the protection of investors, COMMISSION or otherwise in furtherance of the of notes), on call by the issuer or at [Release No. 34–49532; File No. SR–PCX– ‘‘ purposes of the Act.15 maturity for a cash amount (the Cash 2004–01] Value Amount’’) based on the reported IV. Solicitation of Comments market prices of the Underlying Stocks Self-Regulatory Organizations; Notice Interested persons are invited to of an Underlying Index will be of Filing and Order Granting considered for listing and trading by the submit written data, views and Accelerated Approval of a Proposed arguments concerning the foregoing, Rule Change and Amendment Nos. 1 including whether the proposed rule 3 On March 3, 2004, the Exchange filed a Form and 2 Thereto by the Pacific Exchange, 19b–4, which replaced the original filing in its change, as amended, is consistent with Inc. To Trade, Either By Listing or entirety (‘‘Amendment No. 1’’). the Act. Persons making written Pursuant to Unlisted Trading 4 See letter to Nancy J. Sanow, Assistant Director, Privileges, Index-Linked Exchangeable Division of Market Regulation, Commission, from 10 15 U.S.C. 78s(b)(3)(A). Tania J.C. Blanford, Staff Attorney, Regulatory Notes ‘‘ 11 17 CFR 240.19b–4(f)(6). Policy, PCX, dated March 19, 2004 ( Amendment No. 2’’). In Amendment No. 2, the Exchange made 12 See Securities Exchange Act Release No. 48666 April 7, 2004. a change to the proposed rule text to the conform (October 21, 2003); 68 FR 61239 (October 27, 2003) Pursuant to section 19(b)(1) of the it to those previously approved by both the (SR-Amex-2003–83). American Stock Exchange LLC (‘‘Amex’’), 13 See id. Securities Exchange Commission Act of 1 Philadelphia Stock Exchange, Inc. (’’Phlx’’), and the 14 For purposes only of accelerating the operative 1934 (‘‘Act’’), and Rule 19b–4 Chicago Board Options Exchange, Inc. (‘‘CBOE’’). date of this proposal, the Commission has thereunder,2 notice is hereby given that See Securities Exchange Act Release Nos. 46370 considered the proposed rule’s impact on on February 6, 2004, the Pacific (August 16, 2002), 67 FR 54509 (August 22, 2002) efficiency, competition, and capital formation. 15 Exchange, Inc. (‘‘PCX’’ or ‘‘Exchange’’), (Order granting accelerated approval to SR–CBOE– U.S.C. 78c(f). 2002–29); 45082 (November 19, 2001), 66 FR 59282 15 Because the proposed rule change became (November 27, 2001) (Order granting accelerated effective on March 29, 2004, the date on which 16 17 CFR 200.30–3(a)(12). approval to SR–Phlx–2001–92); and 44621 (July 30, Amendment No. 1 was filed, the 60-day abrogation 1 15 U.S.C. 78s(b)(1). 2001), 66 FR 41064 (August 6, 2001) (Order granting period began on March 29, 2004. 2 CFR 240.19b–4. accelerated approval to SR–Amex–2001–29).

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Corporation pursuant to Rule 19b–4(e) Corporation will consider the 19(b)(2) of the Act,5 and the rules under the Securities Exchange Act of suspension of trading in or removal thereunder, or by the Exchange under 1934, provided: from listing of that series of index- rules adopted pursuant to Rule 19b–4(e) (a) Both the issue and the issuer of linked exchangeable notes under any of of the Act; 6 or such security meet the criteria set forth the following circumstances: • An index which the issuer has above in ‘‘Other Securities’’ (PCXE Rule (i) If the series has fewer than 50,000 created and for which an Exchange will 5.2(j)(1)), except that the minimum notes issued and outstanding; have obtained approval from the public distribution shall be 150,000 (ii) If the market value of all index- Commission pursuant to Section notes with a minimum of 400 public linked exchangeable notes of that series 19(b)(2) of the Act 7 and the rules note-holders, except, if traded in issued and outstanding is less than thereunder, or from the Exchange under thousand dollar denominations, then no $1,000,000; or rules adopted pursuant to Rule 19b–4(e) minimum number of holders. (iii) If such other event shall occur or of the Act 8 (each, an ‘‘Issuer Index’’). (b) The issue has a minimum term of such other condition exists which in the In addition, each Underlying Stock one year. opinion of the Corporation makes will meet the following criteria: (c) The issuer will be expected to have further dealings on the Corporation • Each issuer of an Underlying Stock a minimum tangible net worth in excess inadvisable. shall be an Exchange Act reporting of $250,000,000, and to otherwise * * * * * company that is listed on a national substantially exceed the earnings securities exchange or is traded through requirements set forth in PCXE Rule II. Self-Regulatory Organization’s the facilities of a national securities 5.2(j)(1). In the alternative, the issuer Statement of the Purpose of, and association and is subject to last sale will be expected: (i) to have a minimum Statutory Basis for, the Proposed Rule reporting; tangible net worth of $150,000,000 and Change • Each Underlying Stock of a Third- to otherwise substantially exceed the In its filing with the Commission, the Party Index will meet the standards set earnings requirements set forth in PCXE Exchange included statements forth in the Commission’s Section Rule 5.2(j)(1); and (ii) not to have issued concerning the purpose of and basis for 19(b)(2) of the Act order approving the index-linked exchangeable notes where the proposed rule change and discussed index, or the Exchange rules under the original issue price of all the issuer’s any comments it had on the proposed which it was approved, as the case may other index-linked exchangeable note rule change. The text of these statements be; and offerings (combined with other index- may be examined at the places specified • Each Underlying Stock of an Issuer linked exchangeable note offerings of in Item III below. The Exchange has Index will meet (with minor the issuer’s affiliates) listed on a prepared summaries, set forth in modifications set forth below) the national securities exchange or traded Sections A, B and C below, of the most criteria in PCX Rule 7.3(b)–(c); or (with through the facilities of Nasdaq exceeds significant aspects of such statements. minor modifications set forth below) the 25% of the issuer’s net worth. criteria for underlying securities in (d) The index to which an A. Self-Regulatory Organization’s PCXE Rule 5.2(j)(1) and the index exchangeable-note is linked shall either Statement of the Purpose of, and concentration limits in PCX Rule be (i) indices that have been created by Statutory Basis for, the Proposed Rule 7.3(b)(6) and PCX Rule 7.3(b)(12) in so a third party and been reviewed and Change far as it relates to PCX Rule 7.3(b)(6). have been approved for the trading of 1. Purpose options or other derivatives securities Description of Index-Linked (each, a ‘‘Third-Party Index’’) either by The purpose of this proposed rule Exchangeable Notes the Commission under Section 19(b)(2) change is to enact listing standards for Index-linked exchangeable notes are of the Securities Exchange Act of 1934, index-linked exchangeable notes. Under exchangeable debt securities that are as amended (the ‘‘Exchange Act’’) and PCXE Rule 5.2(j)(1), the Exchange may exchangeable at the option of the holder rules thereunder or by the Corporation approve for listing and trading, (subject to the requirement that the under rules adopted pursuant to Rule securities which cannot be readily holder in most circumstances exchange 19b–4(e); or (ii) indices which the issuer categorized under the listing criteria for a specified minimum amount of notes), has created and for which the common and preferred stocks, bonds, on call by the issuer, or at maturity for Corporation will have obtained approval debentures, or warrants. The Exchange a cash amount (the Cash Value from either the Commission pursuant to now proposes to list for trading, Amount’’) based on the reported market Section 19(b)(2) and rules thereunder or whether by listing or pursuant to UTPs, prices of the Underlying Stocks of an from the Corporation under rules under new PCXE Rule 5.2(j)(4), index- Underlying Index. Each index-linked adopted pursuant to Rule 19b–4(e) linked exchangeable notes that are exchangeable note is intended to (each an ‘‘Issuer Index’’). The Issuer intended to allow investors to hold a provide investors with an instrument Indices and their underlying securities single, exchange-listed note that closely tracks the Underlying Index. must meet one of the following: exchangeable for the cash value of the Notwithstanding that the notes are (i) The procedures and criteria set underlying stocks (‘‘Underlying Stocks’’) linked to an index, they will trade as a forth PCX Rule 7.3(b)–(c); or of an index (’’Underlying Index,’’ single security. The linkage is on a 1-to- (ii) The criteria set forth in subsection ‘‘Index,’’ ‘‘Underlying Indices,’’ or 1 basis so that a holder of notes is fully (C) and (D) of PCXE Rule 5.2(j)(2), the ‘‘Indices’’), and thereby acquire—in a exposed to depreciation and index concentration limits set forth in single security and single trade— appreciation of the Underlying Stocks. PCX Rule 7.3(b)(6), and PCX Rule exposure to a specific index of equity The Exchange will disseminate, on a 7.3(b)(12) in so far as it relates to PCX securities. real time basis for each series of index- Rule 7.3(b)(6). Each Underlying Index must be: linked exchangeable notes, an estimate, (e) Index-linked Exchangeable Notes • An index that has been created by will be treated as equity instruments; a third party and approved for the 5 15 U.S.C. 78s(b)(2). (f) Beginning twelve months after the trading of options or other derivative 6 17 CFR 240.19b–4(e). initial issuance of a series of index- securities (each, a ‘‘Third-Party Index’’) 7 15 U.S.C. 78s(b)(2). linked exchangeable notes, the by the Commission under Section 8 17 CFR 240.19b–4(e).

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updated every 15 seconds, of the value specified thresholds or the occurrence denominations, then no minimum of a note of that series.9 This will be of other specified events. number of holders. based, for example, upon current Index-linked exchangeable notes may (C) Principal Amount/Aggregate information regarding the value of the be subject to call by the issuer on Market Value—Not less than $4 million. Underlying Index. The value for any specified dates or during specified (D) Tangible Net Worth—The issuer newly created index shall be periods, upon at least 30, but not more will be expected to have a minimum disseminated by the Exchange on a real- than 60, days notice to holders. The call tangible net worth in excess of $250 time basis and updated every 15 price would be equal to the Cash Value million, and to otherwise substantially seconds. Amount, plus any accrued but unpaid exceed the earnings requirements set Index-linked exchangeable notes are quarterly interest coupons. forth in PCXE Rule 5.2(j)(1)(C). In the expected to trade at a lower cost than At maturity, the holder of an index- alternative, the issuer will be expected: the cost of trading each of the linked exchangeable note will receive (i) to have a minimum tangible net Underlying Stocks separately (because cash amount equal to the Cash Value worth of $150 million, and to otherwise of reduced commission and custody Amount, plus any accumulated but substantially exceed the earnings costs) and also give investors the ability unpaid quarterly and annual requirements set forth in PCXE Rule to maintain index exposure without any supplemental interest coupons. 5.2(j)(1)(C); and (ii) not to have issued management or administrative fees and Although a specific maturity date will index-linked exchangeable notes where ongoing expenses. The initial offering not be established until the time of the the original issue price of all the issuer’s price for an index-linked exchangeable initial offering of a series of index- other index-linked exchangeable note note will be established on the date the linked exchangeable notes, the index- offerings (combined with other index- note is priced for sale to the public. In linked exchangeable notes will provide linked exchangeable note offerings of addition, index-linked exchangeable for maturity within a period of not less the issuer’s affiliates) listed on a notes will not include embedded than one nor more than thirty years national securities exchange or traded options or leverage. Because index- from the date of issue. through the facilities of Nasdaq exceeds linked exchangeable notes are debt In connection with the initial listing 25% of the issuer’s net worth. securities, holders will not be of each series of index-linked recognized by issuers of the Underlying exchangeable notes, the Exchange has Description of the Underlying Indices Stocks as the owner of those stocks and established that a minimum of 150,000 Underlying Indices will either be: (i) will have no rights as a stockholder with notes held by at least 400 holders be Indices that have been created by a third respect to those stocks. required to be outstanding when trading party and have been reviewed and Additional issuances of a series of begins. Beginning twelve months after approved for the trading of options or index-linked exchangeable notes may be the initial issuance of a series of index- other derivative securities (each, a made subsequent to the initial issuance linked exchangeable notes, the ‘‘Third-Party Index’’) either by the of that series (and prior to the maturity Exchange will consider the suspension Commission under Section 19(b)(2) of of that series) for purposes of providing of trading in or removal from listing of the Act,10 and the rules thereunder, or market liquidity. Each series of index- that series of index-linked exchangeable by the Exchange under rules adopted linked exchangeable notes may or may notes under any of the following pursuant to Rule 19b–4(e) 11; or (ii) not provide for quarterly interest circumstances: (i) If the series has fewer indices which the issuer has created and coupons based on dividends or other than 50,000 notes issued and for which an Exchange will have cash distributions paid on the outstanding; (ii) if the market value of obtained approval either from the Underlying Stocks during a prescribed all index-linked exchangeable notes of Commission pursuant to section 19(b)(2) period and an annual supplemental that series issued and outstanding is less of the Act 12 and rules thereunder or coupon based on the value of the than $1 million; or (iii) if such other from the Exchange under rules adopted Underlying Index during a prescribed event shall occur or such other pursuant to Rule 19b–4(e) 13 (each, an period. Index-linked exchangeable notes condition exists which in the opinion of ‘‘Issuer Index’’). will generally be acquired, held, or the Exchange makes further dealings on All changes to an Underlying Index, transferred only in round-lot amounts the Exchange inadvisable. including the deletion and addition of (or round-lot multiples) of 100 notes, Eligibility Standards for Issuers Underlying Stocks, index rebalancing, although odd-lot orders are permissible. and changes to the calculation of the Beginning on a specified date and up The following standards shall apply index, will be made in accordance with to a specified date prior to the maturity to each issuer of index-linked the Commission’s section 19(b)(2) of the date or any call date, the holder of an exchangeable notes: Act 14 order or the Exchange rules under index-linked exchangeable note may (A) Assets/Equity—The issuer shall which that index was approved, as the exchange some or all of its index-linked have assets in excess of $100 million case may be. exchangeable notes for their Cash Value and stockholders’ equity of at least $10 The Underlying Index will be Amount, plus any accrued but unpaid million. In the case of an issuer that is calculated based on either the market quarterly interest coupons. Holders will unable to satisfy the earnings criteria set capitalization, modified market generally be required to exchange a forth in PCXE Rule 5.2(j)(1)(C), the capitalization, price, equal-dollar, or certain specified minimum amount of Exchange generally will require the modified equal-dollar weighting index-linked exchangeable notes, issuer to have the following: (i) Assets methodology. If the issuer or a broker- although this minimum requirement in excess of $200 million and dealer is responsible for maintaining (or may be waived following a downgrade stockholders’ equity of at least $10 has a role in maintaining) the in the issuer’s credit rating below million; or (ii) assets in excess of $100 Underlying Index, it would be required million and stockholders’ equity of at 9 In cases where the issuer of the index-linked least $20 million. 10 15 U.S.C. 78s(b). exchangeable note disseminates the estimate of the (B) Distribution—Minimum public 11 note through another exchange, the PCX will ensure 17 CFR 240.19b–4(e). that such value is being disseminated by such other distribution of 150,000 notes with a 12 15 U.S.C. 78s(b)(2). exchange on a real-time basis and updated every 15 minimum of 400 public noteholders, 13 17 CFR 240.19b–4(e). seconds. except, if traded in thousand dollar 14 15 U.S.C. 78s(b)(2).

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to erect and maintain a ‘‘Fire Wall,’’ in (d) 90% of the index’s numerical (2) In the alternative, each Underlying a form satisfactory to the Exchange, to index value and at least 80% of the total Stock of an Issuer Index shall meet each prevent the flow of information number of Underlying Stocks will meet of the following criteria: regarding the Underlying Index from the the then current criteria for (a)(i) A minimum market index production personnel to the sales standardized option trading set forth in capitalization of $3 billion and during and trading personnel, and the index PCX Rule 3.6; the 12 months preceding listing is must be calculated by a third party who (e) American Depositary Receipts shown to have traded at least 2.5 is not a broker-dealer.15 (‘‘ADRs’’) that are not subject to million shares; (ii) a minimum market comprehensive surveillance agreements capitalization of $1.5 billion and during Eligibility Standards for Underlying do not in the aggregate represent more the 12 months preceding listing is Stocks than 20% of the weight of the index; shown to have traded at least 10 million The following standards shall apply (f) All component stocks or ADRs will shares; or (iii) a minimum market to each Underlying Stock: either be listed on the Amex or the New capitalization of $500 million and (A) General Criteria—Each issuer of York Stock Exchange, Inc. (‘‘NYSE’’) or during the 12 months preceding listing an Underlying Stock shall be an traded through the facilities of the is shown to have traded at least 15 Exchange Act reporting company that is National Association of Securities million shares; listed on a national securities exchange Dealers Automated Quotation System (b) No Underlying Stock will or is traded through the facilities of a (‘‘Nasdaq’’) and reported National represent more than 25% of the weight national securities association and is Market System securities; and of the index, and the five highest subject to last sale reporting. (g) No Underlying Stock will weighted component securities in the (B) Criteria Applicable to Underlying represent more than 25% of the weight index do not in the aggregate account Stocks of Third-Party Indices—In of the index, and the five highest for more than 50% of the weight of the ‘‘ addition to meeting the General weighted Underlying Stocks in the index (60% for an index consisting of fewer than 25 component securities), Criteria’’ set forth under clause (A) index will not in the aggregate account except that for capitalization-weighted above, each Underlying Stock of a for more than 50% of the weight of the and price-weighted indices these Third-Party Index shall also meet the index (60% for an index consisting of standards need be satisfied only as of criteria specified for Underlying Stocks fewer than 25 Underlying Stocks). of that index in the Commission’s the first day of January and July in each The standards set forth in clauses (a) Section 19(b)(2) order approving that year; to (g) above must be continuously index or the Exchange rules under (c) If any Underlying Stock is the maintained, except that: which it was approved. stock of a non-U.S. company that is (C) Criteria Applicable to Underlying (a) The criteria that no single traded in the U.S. market as sponsored Stocks of Issuer Indices—In addition to Underlying Stock represent more than American Depositary Shares (‘‘ADS’’) or meeting the ‘‘General Criteria’’ set forth 25% of the weight of the index and the ADRs then for each such security the under clause (A) above, each five highest weighted Underlying Stocks Exchange shall either: Underlying Stock of an Issuer Index in the index cannot represent more than (i) Have in place a comprehensive shall also meet the criteria specified in 50% (or 60% of indices with less than surveillance sharing agreement with the (1) or (2) below: 25 Underlying Stocks) of the weight of primary exchange on which each (1) Each Underlying Stock of an Issuer the index, need only be satisfied for security underlying the ADS or ADR is Index shall meet each of the following capitalization-weighted and price- traded; criteria: weighted indices as of the first day of (ii) The combined trading volume of (a) A minimum market value of at January and July in each year; each non-U.S. security and other related least $75 million, except that for each of (b) The total number of Underlying non-U.S. securities occurring in the U.S. the lowest weighted Underlying Stocks Stocks in the index may not increase or market or in markets with which the in the index that in aggregate account decrease by more than 331⁄3% from the Exchange has in place a comprehensive for no more than 10% of the weight of number of Underlying Stocks in the surveillance sharing agreement the index, the market value can be at index at the time of its initial listing, represents (on a share equivalent basis least $50 million; and in no event may be fewer than nine for any ADSs) at least 50% of the (b) Trading volume in each of the last Underlying Stocks; combined worldwide trading volume in six months of not less than 1 million (c) The trading volume of each each non-U.S. security, other related shares, except that for each of the lowest Underlying Stock in the index must be non-U.S. securities, and other classes of weighted Underlying Stocks in the at least 500,000 shares for each of the common stock related to each non-U.S. index that in the aggregate account for last six months, except that for each of security over the six-month period no more than 10% of the weight of the the lowest weighted Underlying Stocks preceding the date of listing of the index, the trading volume shall be at in the index that in the aggregate related index-linked exchangeable note; least 500,000 shares in each of the last account for no more than 10% of the or six months; weight of the index trading volume (iii) (A) the combined trading volume (c) In a capitalization-weighted index, must be at least 400,000 shares for each of each non-U.S. security and other the lesser of the five highest weighted of the last six months; and related non-U.S. securities occurring in Underlying Stocks in the index or the (d) In a capitalization-weighted index, the U.S. market represents (on a share highest weighted Underlying Stocks in the lesser of the five highest weighted equivalent basis) at least 20% of the the index that in the aggregate represent Underlying Stocks in the index or the combined world-wide trading volume in at least 30% of the total number of highest weighted Underlying Stocks in each non-U.S. security and in other Underlying Stocks in the index, each the index that in the aggregate represent related non-U.S. securities over the six- have an average monthly trading at least 30% of the total number of month period preceding the date of volume of at least 2 million shares over stocks in the index have had an average listing of the related index-linked the previous six months; monthly trading volume of at least 1 exchangeable note; (B) the average daily million shares over the previous six trading volume for each non-U.S. 15 See PCX Rule 7.3(b)(12). months. security in the U.S. markets over the six

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months preceding the date of listing of subject to all Exchange rules governing 2. Statutory Basis 16 the related index-linked exchangeable the trading of equity securities, The proposed rule change, as note is 100,000 or more shares; and (C) including provisions of PCXE Rule 7.56 amended, is consistent with section 6(b) the trading volume is at least 60,000 (trade-through rule), which prohibits of the Act,21 in general, and furthers the shares per day in the U.S. markets on a ETP Holders and Sponsored objectives of section 6(b)(5),22 in majority of the trading days for the six Participants (hereinafter ‘‘Users’’) from particular, in that it is designed to months preceding the date of listing of initiating trade-throughs for ITS prevent fraudulent and manipulative the related index-linked exchangeable securities, as well as Exchange rules acts and practices, to promote just and note. governing priority, parity and equitable principles of trade, and to (d) An Underlying Stock may not precedence of orders, market volatility remove impediments to and perfect the exceed 5% of the total outstanding related trading halt provisions, and mechanism of a free and open market common shares of the issuer of that responsibilities of Market Makers.17 and a national market system, and, in Underlying Stock, however, if any Exchange equity margin rules and the general, to protect investors and the Underlying Stock is a non-U.S. security three trading sessions 18 of the Exchange public interest. represented by ADSs, common shares, will apply to trading in index-linked B. Self-Regulatory Organization’s or otherwise, then for each such index- exchangeable notes. linked exchangeable note the Statement on Burden on Competition Prior to the commencement of trading instrument may not exceed: The Exchange does not believe that in index-linked exchangeable notes, the (i) 2% of the total shares outstanding the proposed rule change will impose Exchange will distribute a circular to its worldwide provided at least 20% of the any burden on competition. worldwide trading volume in each non- Users highlighting the characteristics of U.S. security and related non-U.S. index-linked exchangeable notes, C. Self-Regulatory Organization’s security during the six month period including, but no limited to: that the Statement on Comments on the preceding the date of listing occurs in notes are subject to call by the issuer; Proposed Rule Change Received From the U.S. market; that Users must adhere to the Members, Participants or Others (ii) 3% of the total worldwide shares procedures established under PCXE Written comments on the proposed outstanding provided at least 50% of the Rules 9.2(a) and 9.2(b); that the rule change were neither solicited nor worldwide trading volume in each non- Exchange may consider factors such as received. U.S. security and related non-U.S. those set forth in PCX Rule 7.10(b) in III. Solicitation of Comments security during the six-month period exercising its discretion to halt or preceding the date of listing occurs in suspend trading; and that trading will Interested persons are invited to the U.S. market; and be halted in the event that market submit written data, views and (iii) 5% of the total shares outstanding volatility parameters set forth in PCXE arguments concerning the foregoing, worldwide provided at least 70% of the Rule 7.12 have been reached. including whether the proposal is consistent with the Act. Persons making worldwide trading volume in each non- In addition, pursuant to Rule 10A–3 written submissions should file six U.S. security and related non-U.S. of the Act 19 and section 3 of the copies thereof with the Secretary, security during the six-month period Sarbanes-Oxley Act of 2002,20 the Securities and Exchange Commission, preceding the date of listing occurs in Exchange will prohibit the initial or 450 Fifth Street NW., Washington, DC the U.S. market. continued listing of any security of an (e) If any non-U.S. security and 20549–0609. Comments may also be issuer that is not in compliance with the submitted electronically at the following related securities have less than 20% of requirements set forth therein. the worldwide trading volume occurring e-mail address: [email protected]. in the U.S. market during the six-month Lastly, the Exchange’s surveillance All comment letters should refer to File period preceding the date of listing, procedures for index-linked No. SR–PCX–2004–01. The file number then the instrument may not be linked exchangeable notes will be similar to should be included on the subject line to that non-U.S. security. the procedures used for equity-linked if e-mail is used. To help the If an issuer proposes to list an index- term notes, index portfolio receipts trust Commission process and review your linked exchangeable note that relates to issued receipts, and other equity non- comments more efficiently, comments more than the allowable percentages set option products traded on the Exchange should be sent in hardcopy or by e-mail forth above, the Exchange, with the and will incorporate and rely upon but not by both methods. Copies of the concurrence of the staff of the Market existing Exchange surveillance systems. submission, all subsequent Regulation Division (‘‘Division’’), will The Exchange will closely monitor amendments, all written statements evaluate the maximum percentage of activity in index-linked exchangeable with respect to the proposed rule index-linked exchangeable note that notes to identify and deter any potential change that are filed with the may be issued on a case-by-case basis. improper trading activity in the index- Commission, and all written If an Underlying Stock to which an linked exchangeable notes. communications relating to the index-linked exchangeable note is to be proposed rule change between the linked is the stock of a non-U.S. 16 See PCXE Rule 7 et seq. for a discussion of the Commission and any person, other than company which is traded in the U.S. rules governing equity trading. those that may be withheld from the market as a sponsored ADS, ordinary 17 However, the Exchange represents that if Index- public in accordance with the linked exchangeable notes are traded only in round shares or otherwise, then the minimum lots (or round-lot multiples), the Exchange rules provisions of 5 U.S.C. 552, will be number of holders of such Underlying relating to odd-lot executions will not apply. available for inspection and copying in Stock shall be 2,000. 18 The Exchange operates three trading sessions the Commission’s Public Reference each day it is open. The three trading sessions are Room. Copies of such filing will also be Exchange Rules Applicable to Index- (1) the Opening Session; (2) the Core Trading available for inspection and copying at Linked Exchangeable Notes Session; and (3) the Late Trading Session. See PCXE Rule 7.34(a). the principal office of the Exchange. All Index-linked exchangeable notes will 19 17 CFR 240.10A–3. be treated as equity instruments. Index- 20 See Section 3 of Pub. L. 107–204, 116 Stat. 745 21 15 U.S.C. 78f(b). linked exchangeable notes will be (2002). 22 15 U.S.C. 78f(b)(5).

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submissions should refer to the File No. Furthermore, the Commission has exchangeable notes will be regulated as SR–PCX–2004–01 and should be approved the trading of identical equity instruments and will be subject submitted by May 4, 2004. products on the Amex, Phlx, and to all of the Exchange’s rules governing CBOE.27 the trading of equity securities. IV. Commission’s Findings and Order The Commission notes that the initial Nevertheless, the Commission believes Granting Accelerated Approval of offering price of an index-linked that the unique nature of index-linked Proposed Rule Change exchangeable note will be determined exchangeable notes, related to, among The Commission finds that the on the date that the note is priced for other things, the exchangeability proposed rule change, as amended, is sale to the public. The Commission feature,29 raise certain product design, consistent with the requirements of believes that index-linked exchangeable disclosure, trading, and other issues that section 6(b)(5) of the Act 23 and the rules notes will be attractive to investors must be addressed. and regulations thereunder applicable to because they are expected to trade at a national securities exchange. In lower cost than the cost of trading each A. Index-Linked Exchangeable Notes particular, the Commission believes the of the Underlying Stocks separately. The Generally Exchange’s proposal to list to trade, Commission also notes that the The Commission believes that the whether by listing or unlisted trading Exchange will disseminate an estimate proposed index-linked exchangeable privileges,24 index-linked exchangeable of the value of a note for each series of notes are reasonably designed to notes will provide an instrument for index-linked exchangeable notes, on a provide investors with an investment investors to achieve desired investment real time basis, every 15 seconds. The vehicle that substantially reflects the objectives through the purchase of debt value of any Underlying Index will also value of the Underlying Stocks of an securities—index-linked exchangeable be publicly available to investors on a Underlying Index. Index-linked notes—exchangeable for the cash value real time basis. The Exchange, for exchangeable notes will be treated as of the Underlying Stocks of an example, has stated that to the extent equity instruments subject to Exchange Underlying Index.25 Accordingly, the there is an existing Index, it will ensure rules governing the trading of equity Commission finds that the Exchange’s its value is publicly available, and if it securities. As such, the Commission proposal will facilitate transactions in is a new Index, that the Exchange would finds that adequate rules and securities, remove impediments to and publish the value itself on a real time procedures exist to govern the trading of perfect the mechanism of a free and basis. This will ensure investors receive index-linked exchangeable notes. In this open market and a national system, and, up-to-date information on the value of regard, the Commission notes that the in general, protect investors and the the note and the Underlying Index. Exchange will impose specific criteria public interest, and is not designed to Accordingly, index-linked exchangeable in the selection of issuers, the permit unfair discrimination between notes should allow investors to: (i) Underlying Stocks, and the Underlying customers, issuers, brokers, or dealers.26 Respond quickly to market changes Indices. through intra-day trading opportunities; As noted above, the Exchange rules 23 15 U.S.C. 78f(b)(5). In approving this rule, the (ii) engage in hedging strategies not for index-linked exchangeable notes Commission notes that it has considered the currently available to retail investors; contain specific criteria for issuers. For proposed rule’s impact on efficiency, competition, example, the issuer must have a and capital formation. 15 U.S.C. 78c(f). and (iii) reduce transaction costs for 24 The Commission notes that, pursuant to Rule trading a group or index of securities. minimum tangible net worth in excess 12f–5 under the Act, prior to trading a particular Although the value of index-linked of $250 million and substantially exceed class or type of security pursuant to unlisted trading exchangeable notes will be based on the the earnings requirements in PCXE Rule privileges, the Exchange must have listing value of the Underlying Stocks in an 5.2(j)(1)(C); or a minimum tangible standards comparable to those of the primary market on which the security is listed. 17 CFR Underlying Index, index-linked value of $150 million, substantially 240.15f–5. The Commission finds that adequate exchangeable notes are not leveraged exceed the earnings requirements in rules and procedures exist to govern the trading of instruments.28 In essence, index-linked PCXE Rule 5.2(j)(1)(C), and not to have index-linked exchangeable notes on the Exchange, issued index-linked exchangeable notes pursuant to unlisted trading privileges. exchangeable notes are debt securities 25 Index-linked exchangeable notes will generally based on the Underlying Stocks of an where the original issue price of all the be acquired, held or transferred only in round-lot Underlying Index; the holders of such issuer’s other index-linked amounts (or round-lot multiples) of 100 notes notes will not be considered owners of exchangeable note offerings (combined although odd-lot orders are permissible. Although the Underlying Stocks and will not have with other index-linked exchangeable these notes will have features similar to other index related products, they differ from other products the rights of a stockholder in those note offerings of the issuer’s affiliates) with respect to their exchangeability feature. The stocks. However, index-linked listed on a national securities exchange Commission notes that the holder of the note may or traded through the facilities of exchange the notes at his or her option, on call by integrity of the markets, and other valid regulatory Nasdaq exceeds 25% of the issuer’s net the issuer, or at maturity for the cash value based concerns. upon the reported market prices of the Underlying worth. These criteria are in part 27 See Securities Exchange Act Release Nos. intended to ensure that the issuer has Stocks of an Underlying Index. Holders, however, 46370 (August 16, 2002), 67 FR 54509 (August 22, will generally be required to exchange a certain 2002) (Order granting accelerated approval to SR– enough assets to meet its obligations specified minimum amount of index-linked CBOE–2002–29); 45082 (November 19, 2001), 66 FR under the terms of the note and should exchangeable notes, although this minimum 59282 (November 27, 2001) (Order granting help to reduce systematic risk. requirement may be waived following a downgrade accelerated approval to SR–Phlx–2001–92); and in the issuer’s credit rating below specified 44621 (July 30, 2001), 66 FR 41064 (August 6, 2001) The minimum issue requirements for thresholds or the occurrence of other specified (Order granting accelerated approval to SR–Amex– the issue of index-linked exchangeable events. 2001–29). notes should also serve to establish a 26 Pursuant to Section 6(b)(5) of the Act, the 28 In contrast, proposals to list exchange-trade minimum level of liquidity for the Commission must predicate approval of exchange derivative products that contain a built-in leverage product. These issues requirements trading for new products upon a finding that the feature or component raise additional regulatory introduction of the product is in the public interest. issues, including heightened concerns regarding include: (i) A minimum public Such a finding would be difficult with respect to manipulation, market impact, and customer distribution of 150,000 notes with a a product that served no investment, hedging or suitability. See, e.g., Securities Exchange Act minimum of 400 public noteholders (no other economic functions, because any benefits that Release No. 36165 (August 29, 1995), 65 FR 46653 might be derived by market participants would (September 7, 1995) (relating to the establishment minimum number of holders if traded in likely be outweighed by the potential for of uniform listing and trading guidelines for stock manipulation, diminished pubic confidence in the index, currency, and currency index warrants). 29 See supra note 25.

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one thousand dollar denominations), 9.2 generally requires that members be the Act,34 provide adequate safeguards and (ii) market value of $4 million. personally informed of the essential to protect investors and the public The Exchange rules applicable to the facts of each customer prior to giving interest. While the index-linked index-linked exchangeable notes also the required written approval for the exchangeable notes have certain call contain minimum requirements for the opening of that customer account.32 and redemption features that make them Indices the note can be linked to and the C. Trading of Index-Linked different from other products, the underlying components of those Exchangeable Notes Exchange has addressed any concerns Indices. For example, because all by adopting the existing criteria used in components of an Underlying Index The Commission finds that adequate other index related products. In must be a U.S. reporting company, there rules and procedures exist to govern the addition, the Exchange will highlight will be information of available Index trading of index-linked exchangeable these different features in the circular to component stocks. Further, the notes. Index-linked exchangeable notes members. Exchange’s proposed rules for the will be treated as equity instruments Indices underlying index-linked subject to all Exchange rules governing D. Dissemination of Information exchangeable notes are linked to other the trading of equity securities. These The Commission believes that the approved criteria for index related rules include: rules governing priority, value of index-linked exchangeable products. Accordingly, any Underlying parity and precedence of orders, market notes that the Exchange proposes to Index would have to follow the criteria volatility related trading halt provisions disseminate will provide investors with adopted by the Commission for that pursuant to PCXE Rule 7.12, timely and useful information Index, including the criteria for Responsibilities of Specialists, Users concerning the value of the index-linked component stocks already in Exchange’s dealing for their own accounts, exchangeable notes based on current rules. These requirements will generally specialists, odd-lot brokers, and information regarding the value of the contain, among other things, minimum registered traders, and handling of Underlying Index. The value of the market capitalization, trading volume, orders and reports. In addition, the Underlying Index will also be publicly and concentration requirements that are Exchange’s equity margin rules and the disseminated. This information will be three trading sessions 33 of the Exchange designed to reduce manipulation disseminated and updated every 15 will apply to transactions in index- concerns and ensure a minimum level seconds during regular New York linked exchangeable notes. of liquidity for component securities. trading hours of 9:30 a.m. to 4 p.m. In summary, the rules for selecting The Commission is satisfied with the components of Indices are intended to Exchange’s development of specific E. Surveillance listing and delisting criteria for index- make the Underlying Stocks and the The Commission believes that the Underlying Indices representative of the linked exchangeable notes. For example, in connection with the initial listing of surveillance procedures developed by market they are intended to reflect as each series of index-linked the Exchange for index-linked well as to reduce manipulation concerns exchangeable notes, the Exchange has exchangeable notes should be adequate by setting forth minimum liquidity established that a minimum of 150,000 to address concerns associated with the standards for Underlying Stocks. notes held by at least 400 holders be listing and trading of index-linked such Accordingly, the Commission believes required to be outstanding when trading notes. In this regard, the Exchange has that these criteria should serve to ensure begins. These criteria should help developed procedures to monitor that the Underlying Stocks of ensure that a minimum level of liquidity activity in index-linked exchangeable Underlying Indices are well capitalized will exist in each series of index-linked notes to identify and deter improper and actively traded. exchangeable notes to allow for trading activity. B. Disclosure maintenance of fair and orderly markets. The Commission also notes that The delisting criteria also allows the concerns are raised when a broker- The Commission believes that the dealer is involved in the development Exchange’s proposal should ensure that Exchange to consider suspension of trading and the delisting of a series of and maintenance of an Underlying investors have information that will Index upon which a product, such as allow them to be adequately apprised of index-linked exchangeable notes if an event were to occur that made further index-linked exchangeable notes is the terms, characteristics, and risks of dealings in such series inadvisable. This based, in that case, the broker-dealer trading index-linked exchangeable will give the Exchange flexibility to and its affiliate should have procedures notes. The Commission notes that upon delist index-linked exchangeable notes designed specifically to address the the initial listing of any class of index- if circumstances warrant such action. improper sharing of information. The linked exchangeable notes, the Further, Exchange rules have specific Commission notes that the Exchange Exchange will issue a circular to its criteria that allow them to delist if there requires the implementation of Users explaining the unique is fewer than 50,000 notes issued and procedures that are satisfactory to the characteristics and risks of this type of outstanding, or if the market value of Exchange to prevent the misuse of security.30 The circular will also note the index-exchangeable notes is less material, non-public information Exchange User’s responsibilities under than $100,000. This should ensure a regarding changes to Underlying Stocks PCXE Rules 9.2(a) and 9.2(b) regarding minimum level of liquidity for these of an Underlying Index in a particular transactions in index-linked products. Accordingly, the Commission series of index-linked exchangeable exchangeable notes. PCXE Rule 9.2(a) believes that the rules governing the notes. In addition, the Commission generally requires that Users use due trading of index-linked exchangeable notes that if a broker-dealer is involved diligence to learn the essential facts notes, consistent with section 6(b)(5) of in developing or maintaining an relative to every customer, every order Underlying Index, the Index must be or account accepted.31 Exchange Rule 32 Id. See also PCXE Rule 9.2(b). calculated by a third party who is not 33 The Exchange operates three trading sessions a broker-dealer.35 The Commission 30 The Exchange represents that it will highlight each day it is open. The three trading sessions are the exchangeability feature of index-linked (1) the Opening Session; (2) the Core Trading exchangeable notes in its circular to Users. Session; and (3) the Late Trading Session. See PCXE 34 15 U.S.C. 78(f)(6)(5). 31 See PCXE Rule 9.2(a). Rule 7.34(a). 35 See PCX Rule 7.3(b)(12).

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believes that such information barrier and 19(b) of the Act,41 to approve the provided by the originating firm from its procedures will address the proposed rule change, as amended, on own proprietary account (‘‘facilitation unauthorized transfer and misuse of an accelerated basis. order’’). Under certain conditions, Rule material, non-public information. 1064 provides ‘‘participation IV. Conclusion Lastly, the Exchange has represented guarantees’’ in such crossing or pursuant to Rule 10A–3 of the Act 36 It is therefore ordered, pursuant to facilitation transactions, entitling the and Section 3 of the Sarbanes-Oxley Act section 19(b)(2) of the Act,42 that the floor broker to cross a certain percentage of 2002,37 that it will prohibit the initial proposed rule change, as amended, (SR– of the original order with the other order or continued listing of any security of an PCX–2004–01) is hereby approved on an or orders ahead of members of the issuer that is not in compliance with the accelerated basis. trading crowd.5 These participation requirements set forth therein. For the Commission, by the Division of guarantees currently apply to F. Scope of the Commission’s Order Market Regulation, pursuant to delegated transactions in equity options only. The authority.43 Exchange proposes to amend Rule 1064 The Commission is approving the Margaret H. McFarland, to provide a participation guarantee for Exchange’s proposed listing and trading Deputy Secretary. trading in index options, and to set the standards for the index-linked [FR Doc. 04–8265 Filed 4–12–04; 8:45 am] guaranteed percentage in such options exchangeable notes as discussed herein. BILLING CODE 8010–01–P at 20%.6 Index-linked exchangeable notes addressed in this order can be listed The Commission finds that the 38 proposed rule change is consistent with pursuant to Rule 19b–4(e) if they meet SECURITIES AND EXCHANGE the requirements of the Act and the the standards discussed above in the COMMISSION Exchange rules. The Commission notes rules and regulations thereunder that with respect to any future rules [Release No. 34–49523; File No. SR–Phlx– applicable to a national securities adopted by the Exchange pursuant to 2003–71] exchange,7 and, in particular, the Rule 19b–4(e),39 the Exchange has requirements of section 6(b)(5) of the Self-Regulatory Organizations; Act.8 The Exchange believes that indicated that in its Section 19(b)(2) Philadelphia Stock Exchange, Inc.; filings to adopt such new rules, it will establishing a participation guarantee of Order Granting Approval to Proposed 20% for crossing and facilitation state and discuss whether or not it Rule Change Relating to Participation proposes to apply the new rule transactions in index options would Guarantees for Floor Brokers make the Exchange more competitive by standards to index-linked exchangeable Representing Crossing and Facilitation notes. providing an incentive to index options Orders in Index Options order flow providers to bring order flow G. Accelerated Approval April 2, 2004. to the Exchange. The Commission The Commission finds good cause for On October 20, 2003, the Philadelphia believes that participation guarantees approving the proposal, as amended, Stock Exchange, Inc. (‘‘Phlx’’ or are reasonable and within the business prior to the thirtieth day after the date ‘‘Exchange’’) filed with the Securities judgment of the Exchange, as long as of publication of notice of filing thereof and Exchange Commission they do not restrict competition and do in the Federal Register. The proposal (’’Commission’’), pursuant to Section not harm investors.9 The Commission establishes listing and trading standards 19(b)(1) of the Securities Exchange Act has found, with respect to participation for a new product, index-linked of 1934 (‘‘Act’’) 1 and Rule 19b–4 guarantees in other contexts, that exchangeable notes. Granting thereunder,2 a proposed rule change to guarantees of as much as 40% of an accelerated approval will allow the amend Phlx Rule 1064, Crossing, order in options trading are not Exchange to immediately begin listing Facilitation and Solicited Orders, with inconsistent with statutory standards of and trading series of index-linked respect to index options. On January 9, exchangeable notes under these new 2004, Phlx filed Amendment No. 1 to 5 The percentage of the order that a floor broker standards. While the structure of the the proposed rule change.3 The is entitled to cross after all public customer orders product is different from those have been satisfied is: (1) 20% of the remaining proposed rule change, as amended, was contracts in the order if the order is traded at the previously reviewed by the published for comment in the Federal best bid or offer given by the crowd in response to Commission, the Exchange proposes to Register on February 18, 2004.4 The the floor broker’s initial request for a market; and apply existing criteria used for other Commission received no comments on (2) 40% of the remaining contracts in the order if index related products. In addition, the the order is traded between the best bid or offer the proposal. given by the crowd in response to the floor broker’s Commission has approved the trading of Phlx Rule 1064 sets forth, among initial request for a market. These guarantees apply identical products on the Amex, Phlx, other things, the procedures by which a when the original order is of an eligible size as and CBOE.40 Accordingly, the floor broker holding an option order determined by the Phlx Options Committee on an Commission believes that there is good option-by-option basis, but in no case less than 500 (‘‘original order’’) may cross it with contracts. See Phlx Rule 1064, Commentary .02(ii)– cause, consistent with Sections 6(b)(5) another order or orders he or she is (iii). holding, or, in the case of a public 6 The 20% guarantee would apply whether the 36 17 CFR 240.10A–3. customer order, with a contra side order order is traded at or between the best bid or offer 37 See Section 3 of Pub. L. 107–204, 116 Stat. 745 given by the crowd in response to the floor broker’s (2002). initial request for a market. All other provisions in 41 15 U.S.C. 78f(b)(5) and 78s(b). 38 17 CFR 240.19b–4(e). Rule 1064 concerning participation guarantees in 42 15 U.S.C. 78s(b)(2). 39 Id. equity options would apply to index options in the 43 17 CFR 200.30–3(a)(12). 40 See Securities Exchange Act Release Nos. same manner as they apply to equity options. See 1 46370 (August 16, 2002), 67 FR 54509 (August 22, 15 U.S.C. 78s(b)(1). Notice. 2002) (Order granting accelerated approval to SR– 2 17 CFR 240.19b–4. 7 In approving this proposed rule change, the CBOE–2002–29); 45082 (November 19, 2001), 66 FR 3 See letter from Richard S. Rudolph, Director and Commission notes that it has considered the 59282 (November 27, 2001) (Order granting Counsel, Phlx, to Ira Brandriss, Special Counsel, proposed rule’s impact on efficiency, competition, accelerated approval to SR–Phlx–2001–92); and Division of Market Regulation, Commission, dated and capital formation. 15 U.S.C. 78c(f). 44621 (July 30, 2001), 66 FR 41064 (August 6, 2001) January 8, 2004. 8 15 U.S.C. 78f(b)(5). (Order granting accelerated approval to SR-Amex- 4 See Securities Exchange Act Release No. 49215 9 See, e.g., Securities Exchange Act Release No. 2001–29). (February 9, 2004), 69 FR 7662 (‘‘Notice’’). 47729 (April 24, 2003), 68 FR 23344 (May 1, 2003).

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competition and free and open Title: ‘‘BusinessLINC Program.’’ • Fax: 1–202–493–2251. markets.10 Description of Respondents: Small • Mail: Docket Management Facility; The Commission notes that, pursuant Business Owners. U.S. Department of Transportation, 400 to Phlx Rule 1064, Commentary .02(vi), Form No: N/A. Seventh Street, SW., Nassif Building, if a crossing or facilitation trade takes Annual Responses: 81. Room PL–401, Washington, DC 20590– place in a situation in which the Annual Burden: 4,200. 001. specialist is entitled to an Enhanced ADDRESSES: Send all comments • Hand Delivery: Room PL–401 on Specialist Participation (specialist regarding whether this information the plaza level of the Nassif Building, guarantee), the percentage received by collection is necessary for the proper 400 Seventh Street, SW., Washington the specialist, combined with the performance of the function of the DC, between 9 a.m. and 5 p.m., Monday percentage crossed by the floor broker, agency, whether the burden estimates through Friday, except on Federal may be no more than 40% of the are accurate, and if there are ways to holidays. original order (after public customer minimize the estimated burden and • Federal eRulemaking Portal: Go to orders have been satisfied). enhance the quality of the collection, to http://www.regulations.gov. Follow the It is therefore ordered, pursuant to Radwan Saade, Economist, Office of online instructions for submitting section 19(b)(2) of the Act,11 that the Advocacy, Small Business comments. proposed rule change (File No. SR– Administration, 409 3rd Street, SW., Instructions: All submissions must Phlx–2003–71) be, and it hereby is, Suite 7800, Washington, DC 20416. include the agency name and docket approved. FOR FURTHER INFORMATION CONTACT: number for this notice. For detailed For the Commission, by the Division of Radwan Saade, Economist, 202–205– instructions on submitting comments Market Regulation, pursuant to delegated 6878 or Curtis B. Rich, Management and additional information on the authority.12 Analyst, 202–205–7030. rulemaking process, see the Public Participation heading of the Margaret H. McFarland, SUPPLEMENTARY INFORMATION: SUPPLEMENTARY INFORMATION section of Deputy Secretary. Title: ‘‘Evaluation of State Efforts to this document. Note that all comments [FR Doc. 04–8264 Filed 4–12–04; 8:45 am] Review and Alleviate State Regulatory received will be posted without change BILLING CODE 8010–01–P Burdens on Small Businesses.’’ to http://dms.dot.gov including any Description of Respondents: The personal information provided. Office of Advocacy is surveying states to Please see the Privacy Act heading SMALL BUSINESS ADMINISTRATION gain a better understanding of what under Regulatory Notes. states are doing to help small businesses Data Collection Available for Public Docket: For access to the docket to overcome state regulatory burdens. read background documents or Comments and Recommendations Form No: 2196. comments received, go to http:// Annual Responses: 130. dms.dot.gov at any time or to Room PL– ACTION: Notice and request for Annual Burden: 120. comments. 401 on the plaza level of the Nassif Jacqueline White, Building, 400 Seventh Street, SW., SUMMARY: In accordance with the Chief, Administrative Information Branch. Washington, DC, between 9 a.m. and 5 Paperwork Reduction Act of 1995, this [FR Doc. 04–8380 Filed 4–12–04; 8:45 am] p.m., Monday through Friday, except notice announces the Small Business BILLING CODE 8025–01–P Federal holidays. Administration’s intentions to request FOR FURTHER INFORMATION CONTACT: approval on a new and/or currently Ladd Hakes, Business Policy Division, approved information collection. DEPARTMENT OF TRANSPORTATION M–61, Office of the Senior Procurement DATES: Submit comments on or before Executive, Office of the Secretary, (202) June 14, 2004. Office of the Secretary 366–4268. Refer to OMB Control ADDRESSES: Send all comments Number 2105–0520. [Docket No, OST–04–17391] regarding whether this information SUPPLEMENTARY INFORMATION: collection is necessary for the proper Notice of Request for Renewal of a Title: Uniform Administrative performance of the function of the Previously Approved Collection Requirements For Grants and agency, whether the burden estimates Cooperative Agreements to State and are accurate, and if there are ways to AGENCY: Office of the Secretary. Local Governments. minimize the estimated burden and ACTION: Notice. OMB Control Number: 2105–0520. enhance the quality of the collection, to Type of Request: Extension without Veronica Johnson, Program Analyst, SUMMARY: In accordance with the change, of a previously approved Office of Business Development, Small Paperwork reduction Act of 1995, this collection. Business Administration, 409 3rd Street, notice announces the U.S. Department Abstract: The requested extension of SW., Suite 8800, Washington, DC 20416. of Transportation’s (DOT) intention to the approved control number covers the FOR FURTHER INFORMATION CONTACT: request extension of a previously information and collection requirements Veronica Johnson, Program Analyst, approved information collection. imposed by Office of Management and 202–619–0472 or Curtis B. Rich, DATES: Comments on this notice must be Budget (OMB) Circular A–102, Grants Management Analyst, 202–205–7030. received by June 14, 2004. and Cooperative Agreements with State SUPPLEMENTARY INFORMATION: ADDRESSES: You may submit comments and Local Governments, which the (identified by DOT DMS Docket Number Department of Transportation codified 10 See, e.g., Securities Exchange Act Release Nos. OST–04–17391) by any of the following at 49 CFR part 18. The information 42455 (February 24, 2000), 65 FR 11388 (March 2, methods: collected, retained and provided by the 2000) at 11398; and 43100 (July 31, 2000), 65 FR • 48778 (August 9, 2000) at notes 96–99 and Web site: http://dms.dot.gov. State and local government grantees is accompanying text. Follow the instructions for submitting required to ensure grantee eligibility 11 15 U.S.C. 78s(b)(2). comments on the DOT electronic docket and their conformance with Federally 12 17 CFR 200.30–3(a)(12). site. mandated reporting requirements. OMB

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provides management and oversight of • Fax: 1–202–493–2251. and provided by the nonprofit grantees the circular. OMB also provides for a • Mail: Docket Management Facility; is required to ensure grantee eligibility standard figure of 70 burden hours per U.S. Department of Transportation, 400 and their conformance with Federally grantee for completion of required Seventh Street, SW., Nassif Building, mandated reporting requirements. OMB forms. This collection covers only those Room PL–401, Washington, DC 20590– provides management and oversight of DOT programs that utilize the standard 001. the circular. OMB also provides for a OMB forms SF 269, SF 270, SF 271, SF • Hand Delivery: Room PL–401 on standard figure of 70 burden hours per 272 and SF 424. the plaza level of the Nassif Building, grantee annually for completion of Respondents: State and local 400 Seventh Street, SW., Washington required forms. This collection covers governments receiving Federal financial DC, between 9 a.m. and 5 p.m., Monday only those DOT programs that utilize assistance from the Department of through Friday, except on Federal the standard OMB forms SF 269, SF Transportation (DOT). holidays. 270, SF 271, SF 272 and SF 424. Estimated Number of Respondents: • Federal eRulemaking Portal: Go to Respondents: Individuals or 1,795. http://www.regulations.gov. Follow the households and business or others for Estimated Total Burden on online instructions for submitting profit organizations. Respondents: 125,650 hours. comments. Estimated Number of Respondents: Comments are invited on: (a) Whether Instructions: All submissions must 150. the proposed collection of information include the agency name and docket Estimated Total Burden on is necessary for the proper performance number for this notice. For detailed Respondents: 10,500 hours. of the functions of the Department, instructions on submitting comments Comments are invited on: (a) Whether including whether the information will and additional information on the the proposed collection of information have practical utility; (b) the accuracy of rulemaking process, see the Public is necessary for the proper performance the Department’s estimate of the burden Participation heading of the of the functions of the Department, of the proposed information collection; SUPPLEMENTARY INFORMATION section of including whether the information will (c) ways to enhance the quality, utility this document. Note that all comments have practical utility; (b) the accuracy of and clarity of the information collection; received will be posted without change the Department’s estimate of the burden and (d) ways to minimize the burden of to http://dms.dot.gov including any of the proposed information collection; the collection of information on personal information provided. Please (c) ways to enhance the quality, utility respondents, including the use of see the Privacy Act heading under and clarity of the information collection; automated collection techniques or Regulatory Notes. and (d) ways to minimize the burden of other forms of information technology. Docket: For access to the docket to the collection of information on All responses to this notice will be respondents, including the use of summarized and included in the request read background documents or comments received, go to http:// automated collection techniques or for OMB approval. All comments will other forms of information technology. also become a matter of public record. dms.dot.gov at any time or to Room PL– 401 on the plaza level of the Nassif All responses to this notice will be Issued in Washington, DC on April 6, 2004. Building, 400 Seventh Street, SW., summarized and included in the request David J. Litman, Washington, DC, between 9 a.m. and 5 for OMB approval. All comments will Senior Procurement Executive. p.m., Monday through Friday, except also become a matter of public record. [FR Doc. 04–8347 Filed 4–12–04; 8:45 am] Federal holidays. Issued in Washington, DC on April 6, 2004. BILLING CODE 4910–62–P FOR FURTHER INFORMATION CONTACT: David J. Litman, Ladd Hakes, Business Policy Division, Senior Procurement Executive. M–61, Office of the Senior Procurement [FR Doc. 04–8348 Filed 4–12–04; 8:45 am] DEPARTMENT OF TRANSPORTATION Executive, Office of the Secretary, (202) BILLING CODE 4910–62–P Office of the Secretary 366–4272. Refer to OMB Control Number 2105–0531. [Docket No. OST–04–17390] SUPPLEMENTARY INFORMATION: DEPARTMENT OF TRANSPORTATION Title: Uniform Administrative Notice of Request for Renewal of a Requirements for Grants and Office of the Secretary Previously Approved Collection Cooperative Agreements With Notice of Applications for Certificates AGENCY: Office of the Secretary. Institutions of Higher Education, of Public Convenience and Necessity ACTION: Notice. Hospitals, and Other Nonprofit and Foreign Air Carrier Permits Filed Organizations. SUMMARY: In accordance with the Under Subpart B (Formerly Subpart Q) OMB Control Number: 2105–0531. During the Week Ending April 2, 2004 Paperwork reduction Act of 1995, this Type of Request: Extension without notice announces the U.S. Department change, of a previously approved The following Applications for of Transportation’s (DOT) intention to collection. Certificates of Public Convenience and request extension of a previously Abstract: The requested extension of Necessity and Foreign Air Carrier approved information collection. the approved control number covers the Permits were filed under subpart B DATES: Comments on this notice must be information and collection requirements (formerly subpart Q) of the Department received by June 14, 2004. imposed by the Office of Management of Transportation’s procedural ADDRESSES: You may submit comments and Budget (OMB) Circular A–110, regulations (see 14 CFR 301.201 et seq.). (identified by DOT DMS Docket Number Uniform Administrative Requirements The due date for answers, conforming OST–04–7390) by any of the following for Grants and Agreements with applications, or motions to modify methods: Institutions of Higher Education, scope are set forth below for each • Web site: http://dms.dot.gov. Hospitals, and Other Non-Profit application. Following the Answer Follow the instructions for submitting Organizations, which the Department of period DOT may process the application comments on the DOT electronic docket Transportation codified at 49 CFR part by expedited procedures. Such site. 19. The information collected, retained procedures may consist of the adoption

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of a show-cause order, a tentative order, FOR FURTHER INFORMATION CONTACT: Issued in Renton, Washington, on March or in appropriate cases a final order Stephen Slotte, Airplane and Flightcrew 25, 2004. without further proceedings. Interface Branch ANM–111, Transport Kalene C. Yanamura, Docket Number: OST–2004–17451. Airplane Directorate, Aircraft Acting Manager, Transport Airplane Date Filed: March 29, 2004. Certification Service, FAA, 1601 Lind Directorate, Aircraft Certification Service. Due Date for Answers, Conforming Avenue SW., Renton, Washington [FR Doc. 04–8368 Filed 4–12–04; 8:45 am] Applications, or Motion to Modify 98055–4056; telephone (425) 227–2315; BILLING CODE 4910–13–M Scope: April 19, 2004. fax (425) 227–1320; e-mail Description: Application of Clay Lacy [email protected]. Aviations, Inc., requesting a certificate DEPARTMENT OF TRANSPORTATION of public convenience and necessity to SUPPLEMENTARY INFORMATION: engage in foreign charter air Federal Aviation Administration transportation of persons, property and Availability of AC mail. Advisory Circular 25.1353–1, Electrical The AC can be found and Equipment and Installations Docket Number: OST–2004–17452. downloaded from the AC from the Date Filed: March 29, 2004. Internet at the link titled http:// AGENCY: Federal Aviation Due Date for Answers, Conforming Administration (FAA), DOT. Applications, or Motion to Modify www.airweb.faa.gov/rgl. A paper copy may be obtained by contacting the ACTION: Notice of availability of Scope: April 19, 2004. Advisory Circular (AC) 25.1353–1. Description: Application of Clay Lacy person named above under the caption FOR FURTHER INFORMATION CONTACT. Aviation, Inc., requesting a certificate of SUMMARY: This AC provides methods public convenience and necessity Discussion acceptable to the Administrator for authorizing it to engage in interstate showing compliance with the revised charter air transportation of persons, Advisory Circular 25.869–1 has been airworthiness standards for electrical property and mail. prepared to provide guidance on one equipment and installation on transport Docket Number: OST–2004–17461. means of demonstrating compliance category airplanes. The guidance Date Filed: March 31, 2004. with the requirements of § 25.869, provided in the AC supplements the Due Date for Answers, Conforming ‘‘Electrical System Fire and Smoke engineering and operational judgment Applications, or Motion to Modify Protection,’’ of Title 14, Code of Federal that must form the basis of any Scope: April 21, 2004. Regulations (CFR). Part 25 contains the compliance findings relative to Description: Application of Air airworthiness standards applicable to electrical installation and nickel Tahoma, Inc., requesting a certificate of transport category airplanes. cadmium installation to minimize the public convenience and necessity to hazards to an airplane. engage in interstate charter air The means of compliance described EFFECTIVE DATE: March 25, 2004. transportation. in AC 25.869–1 is intended to provide guidance to supplement the engineering FOR FURTHER INFORMATION CONTACT: Maria Gulczewski, and operational judgment that must for Stephen Slotte, Airplane and Flightcrew Supervisory Dockets Officer, Docket the basis of any compliance findings Branch, Transport Airplane Directorate, Operations, Alternate Federal Register relative to paragraph 25.869(a). This FAA, Aircraft Certification Service, Liaison. 1601 Lind Avenue SW., Renton, paragraph concerns the protection of [FR Doc. 04–8349 Filed 4–12–04; 8:45 am] Washington 98055–4056; telephone electrical systems from fire and smoke. BILLING CODE 4910–62–P (425) 227–2315; fax (425) 227–1320; e- Harmonization of Standards and mail [email protected]. Guidance SUPPLEMENTARY INFORMATION: DEPARTMENT OF TRANSPORTATION The AC is based on recommendations Availability of AC Federal Aviation Administration submitted to the FAA by the Aviation The AC can be found and Rulemaking Advisory Committee Advisory Circular 25.869–1, Electrical downloaded from the Internet at the System Fire and Smoke Protection (ARAC). We initiated this action under link titled http://www.airweb.faa.gov/ the ‘‘Fast Track Harmonization rgl. A paper copy of the AC may be AGENCY: Federal Aviation Program’’ (64 FR 66522, November 26, obtained by contacting the person Administration (FAA), DOT. 1999). The goal of ‘‘harmonization named above under the caption FOR ACTION: Notice of availability of tasks,’’ such as this, is to ensure that: FURTHER INFORMATION CONTACT. Advisory Circular (AC) 25.869–1. • Where possible, standards and Discussion SUMMARY: The AC provides methods guidance do not require domestic and Advisory circular 25.1353–1, acceptable to the Administrator for foreign parties to manufacture or ‘‘Electrical Equipment and showing compliance with revised operate to different standards for each Installations,’’ has been prepared to airworthiness standards for fire country involved; and provide guidance on one means of protection of electrical system • The standards and guidance demonstrating compliance with the components on transport category adopted are mutually acceptable to the requirements of § 25.1353, ‘‘Electrical airplanes. The guidance provided in the FAA and the foreign aviation Equipment and Installations,’’ of Title AC supplements the engineering and authorities. 14, Code of Federal Regulations (CFR) operational judgment that must form the The guidance contained in the AC has part 25. Part 25 contains the basis of any compliance findings airworthiness standards applicable to been harmonized with that of the JAA, relative to electrical system fire and transport category airplanes. and provides a method of compliance smoke protection to minimize the The means of compliance described hazards to an airplane. that has been found acceptable to both in AC 25.1353–1 is intended to provide EFFECTIVE DATES: March 25, 2004. the FAA and JAA. guidance to supplement the engineering

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and operational judgment that must to the East, Runway 7–25 to the south, airport. The property is currently form the basis of any compliance and Runway 12–30 to the West. The vacant. The property would remain findings relative to paragraph property is currently designated as airport property under the ownership of §§ 25.1353(a) and 25.1353(c)(6). These future aeronautical use on the currently the sponsor and leased for the purposes paragraphs concern electrical approved Airport Layout Plan. The of revenue generation. equipment, nickel cadmium battery Sponsor proposes changing the land-use Matthew J. Thys, installations, and nickel cadmium to non-aeronautical/commercial Acting Manager, Orlando Airports District battery storage. development for the purposes of Office, Southern Region. generating revenue to cover operational Harmonization of Standards and [FR Doc. 04–8367 Filed 4–12–04; 8:45 am] and capital expenses of the airport. The Guidance BILLING CODE 4910–13–M property would remain airport property The AC is based on recommendations under the ownership of the sponsor. submitted to the FAA by the Aviation Documents reflecting the sponsor’s DEPARTMENT OF TRANSPORTATION Rulemaking Advisory Committee request are available, by appointment (ARAC). The FAA tasked ARAC (63 FR only, for inspection at the Airport Federal Aviation Administration 50954, September 23, 1998) to provide Manager’s office and the FAA Airports advice and recommendations on District Office. Commercial Space Transportation; ‘‘harmonizing’’ certain sections of part DATES: Comments must be received on Waiver of Public Notice Requirement 25 with the counterpart standards or before May 13, 2004. for Suborbital Rocket Launch contained in Joint Aviation ADDRESSES: Documents are available for Requirements (JAR) 25. The goal of AGENCY: Federal Aviation review at the Airport Manager’s office, Administration (FAA), DOT. ‘‘harmonization tasks,’’ such as this, is to Martin County Airport/Witham Field, ACTION: Notice of waiver. ensure that: 1805 SE Airport Road, Stuart, FL 34996 • Where possible, standards and and the FAA Airports District Office, SUMMARY: The FAA has determined to guidance do not require domestic and 5950 Hazeltine National Drive, Suite waive the public notice requirement of foreign parties to manufacture or 400, Orlando, FL 32822. Written 14 CFR part 431 for Reusable Launch operate to different standards for each comments on the sponsor’s request must Vehicle (RLV) missions to be conducted country involved; and be delivered or mailed to: Matthew J. • by Scaled Composites, LLC, under The standards and guidance Thys, Assistant Manager, Orlando License No. LRLS 04–067, issued by the adopted are mutually acceptable to the Airports District Office, 5950 Hazeltine FAA on April 1, 2004. The FAA finds FAA and the foreign aviation National Drive, Suite 400, Orlando, FL that waiving the public notice authorities. 32822–5024. requirement is in the public interest and The guidance contained in the AC has FOR FURTHER INFORMATION CONTACT: will not jeopardize public health and been harmonized with that of the JAA, Matthew J. Thys, Assistant Manager, safety, safety of property, and national and provides a method of compliance Orlando Airports District Office, 5950 security and foreign policy interests of that has been found acceptable to both Hazeltine National Drive, Suite 400, the United States. the FAA and JAA. Orlando, FL 32822–5024. FOR FURTHER INFORMATION CONTACT: Issued in Renton, Washington, on March SUPPLEMENTARY INFORMATION: Section George Nield, Deputy Associate 25, 2004. 125 of The Wendell H. Ford Aviation Administrator for Commercial Space Kalene C. Yanamura, investment and Reform Act for the 21st Transportation and Acting Manager, Acting Manager, Transport Airplane Century (AIR–21) requires the FAA to Licensing and Safety Division, Office of Directorate, Aircraft Certification Service. provide an opportunity for public notice the Associate Administrator for [FR Doc. 04–8369 Filed 4–12–04; 8:45 am] and comment prior to the ‘‘waiver’’ or Commercial Space Transportation, BILLING CODE 4910–13–M ‘‘modification’’ of a sponsor’s Federal Federal Aviation Administration, U.S. obligation to use certain airport land for Department of Transportation, 800 non-aeronautical purposes. Independence Avenue SW., DEPARTMENT OF TRANSPORTATION The property is located on the west Washington, DC 20591, (202) 267–9222. side of the airport and is bordered by SUPPLEMENTARY INFORMATION: Federal Aviation Administration Monterey Road to the North, Taxiway D Background Public Notice for a Change in Use of to the East, Runway 7–25 to the South, Aeronautical Property at Martin County and Runway 12–30 to the West. The Federal Aviation Administration Airport/Witham Field in Stuart, FL The property was owned by Martin (FAA) licenses the launch of a launch County and leased to the Federal vehicle, reentry of a reentry vehicle and AGENCY: Federal Aviation Government on May 27, 1943. The the operation of a launch or reentry site Administration (FAA), DOT. Federal Government transferred the under authority granted to the Secretary ACTION: Request for public comment. property back to the Martin County of Transportation in the Commercial Board of County Commissioners Space Launch Act of 1984, as amended SUMMARY: The Federal Aviation through a Surplus Property Agreement (CSLA), codified in 49 U.S.C. Subtitle Administration is requesting public under Regulation 16-War Asset IX, chapter 701, and delegated to the comment on the Martin County Board of Administration, dated July 1, 1949. FAA Administrator. Licensing authority County Commissioners (Sponsor) The property is currently designated under the CSLA is carried out by the request to change approximately 30 as future aeronautical use on the Associate Administrator for Commercial acres of airport property from currently approved Airport Layout Plan. Space Transportation. aeronautical use to non-aeronautical The Sponsor proposes changing the The CSLA allows the FAA to waive a use. land-use to non-aeronautical/ requirement for an individual license The property is located on the west commercial development for the applicant if the Administrator decides side of the airport and is bordered by purposes of generating revenue to cover that the waiver is in the public interest Monterey Road to the North, Taxiway D operational and capital expenses of the and will not jeopardize public health

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and safety, safety of property, and response plan that contains procedures by Scaled Composites of RLV missions national security and foreign policy for informing the affected public of a authorized by License No. LRLS 04–067. interests of the United States. 49 U.S.C. planned RLV mission. 14 CFR 431.45(a). Issued in Washington DC, on April 8, 2004. 70105(b)(3). The FAA has determined to waive the Patricia Grace Smith, On April 1st, the FAA issued the first public notice requirement for commercial Reusable Launch Vehicle Associate Administrator for Commercial SpaceShipOne flights, relieving Scaled Space Transportation. (RLV) mission license authorizing Composites of the requirement to issue [FR Doc. 04–8308 Filed 4–12–04; 8:45 am] Scaled Composites, LLC, to conduct local notice of planned launch events. manned suborbital RLV missions. The While risk to public safety from BILLING CODE 4910–13–P license, issued in accordance with SpaceShipOne launches is within licensing requirements under 14 CFR allowable limits under 14 CFR part 431, DEPARTMENT OF TRANSPORTATION part 431, is valid for up to one year or and is expected to be highly remote, the until the authorized missions are FAA is concerned that public notice Federal Aviation Administration completed, whichever occurs first. may have the unintended effect of Scaled Composites, LLC (Scaled drawing spectators to the launch area Notice of Public Hearing and Composites) plans to conduct piloted thereby increasing risk to public safety Availability of a Draft Environmental RLV missions using its SpaceShipOne and the safety of property. Accordingly, Assessment (EA) for Installation of vehicle, an RLV that is operated at all the FAA has determined that waiver of Category II/III Approaches at O’Hare times under an Experimental the public notice requirement is in the International Airport at Chicago, IL Airworthiness Certificate (EAC). public interest. SpaceShipOne is an air-launched, Waiving the public notice AGENCY: Federal Aviation winged, hybrid rocket-powered, requirement will not jeopardize public Administration (FAA), DOT. horizontal landing vehicle that is a health and safety or the safety of ACTION: Notice to hold a public hearing suborbital rocket as defined by the FAA. property, and is consistent with U.S. and of availability of a draft See Federal Register Notice, 68 FR national interests. Public notice is Environmental Assessment for 59977–59980, issued October 20, 2003, intended to alert the public in the Installation of Category II/III approaches as corrected. It is carried aloft using a vicinity of an RLV mission that a launch at Chicago O’Hare International Airport. carrier aircraft, known as the White event will be occurring that includes SUMMARY: Knight. The White Knight is operated ascent and descent flight. Without The Federal Aviation under an EAC. At the designated notice, the public may be alarmed at the Administration (FAA) has prepared and altitude, the SpaceShipOne is released sight of a launch vehicle and believe it is making available the Draft from the White Knight, and after a brief to be unauthorized activity. Concerned Environmental Assessment (DEA) for glide for vehicle separation, the pilot persons may wish to seek shelter. the following proposed action at O’Hare ignites its rocket motor. Licensed However, for SpaceShipOne launches, International Airport: the upgrade of activity commences upon rocket motor the FAA has determined that because Runways 27LK and 27R from a category ignition. the most hazardous operations will I approach to a Category II/III approach, Scaled Composites plans to conduct occur in remote, unpopulated area, the installation of an Approach Lighting flight activities commencing upon take- there should be little opportunity for the System with Sequenced Flashing Lights off of the White Knight carrier aircraft public to be alarmed at the sight of the (ALSF–2) system to Runways 27L and from Mojave Airport, East Kern Airport vehicle. During glide flight, when the 27R, the construction of localizer District (EKAD). Licensed launch vehicle will briefly pass over populated buildings and associated equipment activity will commence, under the terms area, the vehicle will be in a safe, non- including removal of the existing and conditions of the RLV mission explosive configuration and should not buildings, installation of 1,000-gallon license, in R–2515 airspace within the pose unusual risk to the local underground storage tanks at the shared use areas of the R–2508 complex population. Moreover, Scaled localizer buildings, the replacement or around and above Edwards Air Force Composites has conducted limited test potential relocation of the localizer Base, and will conclude, for nominal flights using the SpaceShipOne vehicle, antennae on Runway 27R, the flight, upon landing at Mojave Airport. up to 15-second rocket motor burn-time, installation of an Inner Marker and Far As specified in the license, rocket- and has performed return glide flight to Field Monitor on Runways 27L and 27R, powered ballistic flight will occur over Mojave Airport. On all occasions, return the removal of existing Medium unpopulated area east of Mojave glide flight of the SpaceShipOne vehicle Intensity Approach Lighting System Airport. Ballistic flight resembles a to Mojave Airport has been uneventful with Runway Alignment Indicator parabolic arc with steep ascent, from a public safety perspective and has Lights (MALSR) systems from Runway followed by a coast period during which not been hazardous to public health and 27L and 27R, the removal of the weightlessness occurs, and then safety or the safety of property. Runways 27L and 27R Middle Marker, atmospheric entry. Following In accordance with RLV mission shelter, and antenna, the replacement of atmospheric entry, SpaceShipOne will licensing requirements under 14 CFR the glide slope antenna and equipment circle down in a glide phase part 431, proposed SpaceShipOne for Runway 27R, the installation of containment area, defined in the launch missions have undergone an taxiway centerline lights in the apron license, and must avoid identified interagency policy review. The review north of Gates B–17 through B–22, the population centers. In a nominal identified no concerns relating to installation of Runway Guard Lights situation, the SpaceShipOne operates as national security or foreign policy (RGLs) at connecting taxiways to a glider after its ballistic flight profile is considerations. The FAA has Runways 27L and 27R, the expansion of concluded, having used up its fuel determined that waiving the public lease areas, by the FAA, from the City8 supply. It will fly back to Mojave notice requirement will not jeopardize of Chicago on airport property, the Airport, where it will land on the U.S. national security or foreign policy. development of Category II/III designated Mojave Airport runway. For the foregoing reasons, the FAA instrument approach procedures for Under 14 CFR part 431, a licensee is has waived the public notice Runways 27L and27R, and the issuance required to maintain an emergency requirement with respect to the conduct of National Airspace System (NAS)

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Change Proposal (NCP) waivers ADDRESSES: Written comments are (f) This meeting is designed for associated with design and installation encouraged from persons or interested listening carefully to public statements. of the preceding. parties unable to attend the public As such, there will be no rebuttal from The Draft EA is being prepared in hearing or who do not wish to make persons facilitating the meeting. accordance with the National public statements. Written comments Issued in Des Plaines, Illinois April 7, Environmental Policy Act (NEPA) of concerning the Draft EA will be 2004. 1969, as amended, FAA Order 1050.1D, accepted until 5 p.m. CST, Tuesdy, June Vincent Bridgeworth, ‘‘Policies and Procedures for 1, 2004. Written comments may be sent Manager, Chicago NAS Implementation Considering Environmental Impacts,’’ to: Ms. Virginia Marcks, ANI–430, Center, ANI–400, Great Lakes Region. and FAA Order 5050.4A, ‘‘Airport Federal Aviation Administration, 2300 [FR Doc. 04–8372 Filed 4–12–04; 8:45 am] Environmental Handbook.’’ The East Devon Avenue, Des Plaines, IL BILLING CODE 4910–13–M proposed development action is 60018. consistent with the National Airspace FOR FURTHER INFORMATION CONTACT: Ms. System Plan prepared by the U.S. Virginia Marcks, Environmental DEPARTMENT OF TRANSPORTATION Department of Transportation, Federal Engineer, ANI–430, Federal Aviation Aviation Administration (FAA). Administration, 2300 East Devon Federal Aviation Administration A Draft Environmental Assessment Avenue, Des Plaines, Illinois 60018. will be available for public review 30 [Summary Notice No. PE–2004–25] Telephone number: 847–294–7494. days prior to the Public Hearing during SUPPLEMENTARY INFORMATION: Petitions for Exemption; Dispositions normal business hours at the following of Petitions Issued locations: Background Arlington Heights Memorial Library, O’Hare, the world’s busiest airport in AGENCY: Federal Aviation 500 N. Dunton Ave., Arlington terms of aircraft operations in 2003, Administration (FAA), DOT. Heights, IL 60004 functions as both a gateway for ACTION: Notice of dispositions of prior Bensenville Public Library, 200 S. petitions. Church Rd., Bensenville, IL 60106 international passengers and as a key Chicago Department of Aviation Office, component in the domestic network of SUMMARY: Pursuant to FAA’s rulemaking Terminal 2 E/F Concourse, Mezzanine the national air transportation system. provisions governing the application, Level Chicago O’Hare International In its domestic role, O’Hare is unique in processing, and disposition of petitions Airport 60016 that it serves as the nation’s only dual for exemption part 11 of Title 14, Code Des Plaines Public Library, 1501 major airline hub (for both United and of Federal Regulations (14 CFR), this Ellinwood St., Dews Plaines, IL 60016 American Airlines) and, due to its notice contains the dispositions of Eisenhower Public Library, 4652 N. geographic location, serves as a logical certain petitions previously received. Olcott Ave., Harwood Heights, IL connecting point for significant The purpose of this notice is to improve 60706 passenger flows across the United the public’s awareness of, and Elk Grove Village Public Library, 1001 States. However, increasing traffic has participation in, this aspect of FAA’s Wellington Ave., Elk Grove Village, IL resulted in record level delays at regulatory activities. Neither publication 60007 O’Hare, particularly during IFR or of this notice nor the inclusion or Elmhurst Public Library, 211 Prospect inclement weather conditions, placing omission of information in the summary Ave., Elmhurst, IL 60126 O’Hare last in on-time performance is intended to affect the legal status of Franklin Park Public Library, 10311 among the 31 busiest U.S. airports. any petition or its final disposition. Grand Ave., Franklin Park, IL 60131 Since the mid-70’s, the installation of FOR FURTHER INFORMATION CONTACT: John Harold Washington Library, 400 South Category II/III capability has been Linsenmeyer, Office of Rulemaking State St., 5th Floor, Chicago, IL 60605 examined for the potential to benefit Norridge Village Hall, Office of the arrival and departure capabilities during (ARM–1), Federal Aviation Village Clerk, 4000 N. Olcott Ave., poor weather conditions. The FAA’s Administration, 800 Independence Norridge, IL 60706 Proposed Action will allow existing Avenue, SW., Washington, DC 20591. Northlake Public Library, 231 N. Wolf scheduled operations to occur during Tel. (202) 267–5174. This notice is published pursuant to Rd., Northlake, IL 60164 IFR weather conditions, thereby 14 CFR §§ 11.85 and 11.91. Oakton Community College Library, Des reducing cancellations and delays Plaines, IL 60016 benefiting the entire National Airspace Issued in Washington, DC, on April 8, Park Ridge Public Library, 20 S. System. 2004. Prospect Ave., Park Ridge, IL 60068 Donald P. Byrne, Rosemont village Hall, Office of the Meeting Procedures Assistant Chief Counsel for Regulations. Village Clerk, 9501 Devon Avenue, (a) Persons wishing to speak at the Rosemont, IL 60018 meeting are asked to limit their Dispositions of Petitions Schiller Park Public Library, 4200 Old comments to five minutes. This could Docket No.: FAA–2004–17072. River Rd., Schiller Park, IL 60176 be extended depending on the number Petitioner: Cessna Aircraft Company. Wood Dale Public Library, 520 N. Wood of person wishing to speak. Section of 14 CFR Affected: 14 CFR Dale Rd., Wood Dale, IL 60191 (b) Persons wishing to make oral 25.161(d). Northeast Illinois Planning Commission presentations will be required to Description of Relief Sought/ (NIPC), 222 South Riverside Plaza, identify themselves for the record. Disposition: To grant relief concerning Suite 1800, Chicago, Illinois 60606 (c) Proceedings of the meeting will be the engine-out lateral/directional trim Dates, Times and Place: Oral or documented and recorded. requirements for Cessna Model 680 written comments may also be given at (d) Any person who wishes to submit airplanes. a Public Hearing that will be held on a position paper or other written Grant of Exemption, 03/24/2004, Tuesday, May 18, 2004, 2 p.m. to 7 p.m. comments for the record may do so. Exemption No. 8280 at the Fountain Blue Banquets and (e) The sessions may be adjourned at Conference Center, 2300 Mannheim any time if persons present have had an [FR Doc. 04–8365 Filed 4–12–04; 8:45 am] Road, Des Plaines, IL 60018. opportunity to speak. BILLING CODE 4910–13–P

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DEPARTMENT OF TRANSPORTATION 113), Federal Aviation Administration, (202) 267–8937 or 1601 Lind Ave SW., Renton, WA [email protected]. Federal Aviation Administration 98055–4056; or John Linsenmeyer (202– Members of the public may present a [Summary Notice No. PE–2004–17474] 267–5174), Office of Rulemaking (ARM– written statement to the Committee at 1), Federal Aviation Administration, any time. Petitions for Exemption; Summary of 800 Independence Avenue, SW., Issued in Washington, DC on April 7, 2004. Petitions Received Washington, DC 20591. Joan Bauerlein, This notice is published pursuant to AGENCY: Federal Aviation 14 CFR 11.85 and 11.91. Director of Operations Planning Research & Administration (FAA), DOT. Development. Issued in Washington, DC, on April 8, [FR Doc. 04–8370 Filed 4–12–04; 8:45 am] ACTION: Notice of petition for exemption 2004. BILLING CODE 4910–13–M received. Donald P. Byrne, SUMMARY: Pursuant to FAA’s rulemaking Assistant Chief Counsel for Regulations. DEPARTMENT OF TRANSPORTATION provisions governing the application, Petitions for Exemption processing, and disposition of petitions for exemption, part 11 of Title 14, Code Docket No.: FAA–2004–17474. Federal Aviation Administration Petitioner: Zero Gravity Corporation. of Federal Regulations (14 CFR), this Sections of 14 CFR Affected: 14 CFR Notice of Passenger Facility Charge notice contains a summary of a certain 25.785 and 25.1447(c)(1). (PFC) Approvals and Disapprovals petition seeking relief from specified Description of Relief Sought: To allow AGENCY: requirements of 14 CFR. The purpose of an interior configuration which includes Federal Aviation this notice is to improve the public’s a ‘‘floating area’’ where persons can Administration (FAA), DOT. awareness of, and participation in, this experience weightless flight on a ACTION: Monthly Notice of PFC aspect of FAA’s regulatory activities. specially modified Boeing Model 727 Approvals and Disapprovals. In Neither publication of this notice nor airplane. February 2004, there were 11 the inclusion or omission of information applications approved. This notice also in the summary is intended to affect the [FR Doc. 04–8366 Filed 4–12–04; 8:45 am] includes information on two legal status of any petition or its final BILLING CODE 4910–13–P applications, one approved in disposition. November 2002, and the other approved in October 2003, inadvertently left off DATES: Comments on petitions received DEPARTMENT OF TRANSPORTATION must identify the petition docket the November 2002 and October 2003 number involved and must be received Federal Aviation Administration notices, respectively. Additionally, on or before April 27, 2004. three approved amendments to ADDRESSES: You may submit comments Research, Engineering and previously approved applications are identified by DOT DMS Docket Number Development Advisory Committee listed. FAA–2004–17474 by any of the Pursuant to section 10(A)(2) of the SUMMARY: The FAA publishes a monthly following methods: • Federal Advisory Committee Act (Public notice, as appropriate, of PFC approvals Web site: http://dms.dot.gov. Law 92–463; 5 U.S.C. App. 2), notice is and disapprovals under the provisions Follow the instructions for submitting hereby given of a meeting of the FAA of the Aviation Safety and Capacity comments on the DOT electronic docket Research, Engineering and Development Expansion Act of 1990 (Title IX of the site. (R,E&D) Advisory Committee. Omnibus Bus Reconciliation Act of • Fax: 1–202–493–2251. AGENCY: Federal Aviation 1990) (Pub. L. 101–508) and Part 158 of • Mail: Docket Management Facility; Administration. the Federal Aviation Regulations (14 U.S. Department of Transportation, 400 ACTION: Notice of meeting. CFR Part 158). This notice is published Seventh Street, SW., Nassif Building, pursuant to paragraph d of § 158.29. Room PL–401, Washington, DC 20590– Name: Research, Engineering & 0001. PFC Applications Approved • Development Advisory Committee. Hand Delivery: Room PL–401 on Time and Date: May 4, 2004–8:30 Public Agency: City of Portland, the plaza level of the Nassif Building, a.m. to 4:30 p.m. Maine. 400 Seventh Street, SW., Washington, Place: Federal Aviation Application Number: 02–03–C–00– DC, between 9 am and 5 pm, Monday Administration, 800 Independence PWM. through Friday, except Federal holidays. Avenue, SW—Bessie Coleman Room, Application Type: Impose and use a • Federal eRulemaking Portal: Go to Washington, DC 20591. PFC. http://www.regulations.gov. Follow the Purpose: On May 4 from 8:30 a.m. to PFC Level: $3.00. online instructions for submitting 4:30 p.m. the meeting agenda will Total PFC Revenue Approved in this comments. include receiving from the Committee Decision: $14,214,483. Docket: For access to the docket to guidance for FAA’s research and Earliest Charge Effective Date: read background documents or development investments in the areas of February 1, 2004. comments received, go to http:// air traffic services, airports, aircraft Estimated Charge Expiration Date: dms.dot.gov at any time or to Room PL– safety, human factors and environment December 1, 2010. 401 on the plaza level of the Nassif and energy. Class of Air Carriers Not Required to Building, 400 Seventh Street, SW., Attendance is open to the interested Collect PFC’s: Air taxi/commercial Washington, DC, between 9 am and 5 public but seating is limited. Persons operators. pm, Monday through Friday, except wishing to attend the meeting or obtain Determination: Approved. Based on Federal holidays. information should contact Gloria information contained in the public FOR FURTHER INFORMATION CONTACT: Dunderman at the Federal Aviation agency’s application, the FAA has Susan Boylon (425–227–1152), Administration, 800 Independence determined that the approved class Transport Airplane Directorate (ANM– Avenue, SW., Washington, DC 20591 accounts for less than 1 percent of the

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total annual enplanements at Portland Earliest Charge Effective Date: August FOR FURTHER INFORMATION CONTACT: International Jetport. 1, 2004. Nicoletta S. Oliver, Central Region Brief Description of Projects Approved Estimated Charge Expiration Date: Airports Division, (816) 329–2642. for Collection and Use: December 1, 2011. Public Agency: Jackson Hole Airport Terminal canopy completion. Class of Air Carriers Not Required to Board, Jackson, Wyoming. Passenger boarding bridge acquisition. Collect PFC’S: None. Application Number: 04–09–C–00– Passenger boarding bridge—regional Brief Description of Projects Approved JAC. jet modifications. for Collection and Use: Application Type: Impose and use a Runway 11/29 upgrade/relocation. Runway safety area design and PFC. Taxiway improvements. construction. PFC Level: $4.50. Terminal roadway system expansion. Construct northwest apron. Total PFC Revenue Approved in this Snow removal equipment acquisition. Master plan. Decision: $1,814,693. PFC application preparation and Parking expansion. Earliest Charge Effective Date: program administration. Security improvements. November 1, 2004. Brief Description of Projects Approved Acquire security equipment. Estimated Charge Expiration Date: for Collection: Baggage claim expansion Rehabilitation of west side apron November 1, 2008. and improvements. including associated taxiway. Class of Air Carriers Not Required to Decision Date: November 29, 2002. Decision Date: February 2, 2004. Collect PFC’s: None. FOR FURTHER INFORMATION CONTACT: FOR FURTHER INFORMATION CONTACT: Brief Description of Projects Approved Priscilla Scott, New England Region Suzanne Lee-Pang, Seattle Airports for Collection and Use: Airports Division, (718) 238–7614. District Office, (425) 227–2654. Terminal building expansion. Public Agency: Broome County Public Agency: Cedar Rapids Airport Landside improvements. Department of Aviation, Binghamton, Commission, Cedar Rapids, Iowa. Noise monitoring system and Part 150 New York. Application Number: 04–03–C–00– update. Application Number: 03–06–C–00– CID. Runway threshold lighting. BGM. Application Type: Impose and use a Security improvements. Application Type: Impose and use a PFC. Decision Date: February 9, 2004. PFC. PFC Level: $4.50. FOR FURTHER INFORMATION CONTACT: PFC Level: $4.50. Total PFC Revenue Approved in this Christopher Schaffer, Denver Airports Total PFC Revenue Approved in this Decision: $4,182,615. District Office, (303) 342–1258. Decision: $7,996. Earliest Charge Effective Date: May 1, Public Agency: County of Mercer, Earliest Charge Effective Date: 2004. West Trenton, New Jersey. February 1, 2005. Estimated Charge Expiration Date: Application Number: 04–02–C–00– Estimated Charge Expiration Date: July 1, 2006. TTN. March 1, 2005. Class of Air Carriers Not Required to Application Type: Impose and use a Class of Air Carriers Not Required to Collect PFC’S: Part 135 air taxi/ PFC. Collect PFC’s. Part 135 (air taxi) commercial operators. PFC Level: $4.50. operators. Determination: Approved. Based on Total PFC Revenue Approved in this Determination: Approved. Based on information contained in the public Decision: $1,061,436. information contained in the public agency’s application, the FAA has Earliest Charge Effective Date: May 1, agency’s application, the FAA has determined that the approved class 2004. determined that the approved class accounts for less than 1 percent of the Estimated Charge Expiration Date: accounts for less than 1 percent of the total annual enplanements at Eastern May 1, 2011. total annual enplanements at Greater Iowa Airport. Class of Air Carriers Not Required to Binghamton Airport. Brief Description of Projects Approved Collect PFC’s: Nonscheduled/on- Brief Description of Projects Approved for Collection and Use: demand air carriers filing FAA Form for Use: Acquire two snow removal end 1800–31. Aircraft rescue and firefighting facility loaders. Determination: Approved. Based on refurbishment. Rehabilitate runway 13/31. information contained in the public Passenger boarding bridge purchase. Extend south end of runway 13/31. agency’s application, the FAA has Brief Description of Projects Approved Improve north end of runway 13/31 determined that the approved class for Collection and Use: safety area and relocate road. accounts for less than 1 percent of the Airport security access control system Extend north of runway 13/31 and total annual enplanements at Trenton- enhancement. construct taxiway F connection. Mercer Airport. Airport security fence improvements. Improve east end of runway 9/27 Brief Description of Projects Approved Decision Date: October 9, 2003. safety area. for Collection and Use: FOR FURTHER INFORMATION CONTACT: Reconstruct T-hangar taxiways and Construct taxiway E—construction Robert Levine, New York Airports general aviation aprons. only. District Office, (516) 227–3807. Construct runway and taxiways Airport planning studies. Public Agency: City of Klamath Falls, overlay. Acquire aircraft rescue and Oregon. Construct cargo ramp expansion, firefighting safety equipment. Application Number: 03–02–C–00– phase I. Install apron lighting. LMT. Construct terminal and cargo ramp Acquire airport snow sweeper. Application Type: Impose and use a expansion and rehabilitation, phase II. Install airfield guidance signage. PFC. Construct cargo apron. Construct taxiway G. PFC Level: $4.50. Rehabilitate cargo apron, phase III. Remove obstructions—runway 24 Total PFC Revenue Approved in this Rehabilitate cargo apron, phase IV. runway protection zone. Decision: $877,799. Decision Date: February 6, 2004. Improve terminal building.

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Improve runway 6/24. accounts for less than 1 percent of the Estimated Charge Expiration Date: Rehabilitate taxiways A, C and a total annual enplanements at April 1, 2010. portion of D. Springfield-Branson Regional Airport. Class of Air Carriers Not Required to Rehabilitate runway 16/34. Brief Description of Projects Approved Collect PFC’s: Air taxi/commercial Conduct environmental assessment. for Collection and Use: operators filing FAA Form 1800–31. Acquire aircraft rescue and Design midfield terminal. Determination: Approved. Based on firefighting vehicles. Purchase and install loading bridge. information contained in the public Improve runway safety areas, phase I. Modify existing loading bridges (four). agency’s application, the FAA has Security enhancements. PFC consulting fees. determined that the approved class Design snow removal building, phase Brief Description of Withdrawn accounts for less than 1 percent of the I. Projects: total annual enplanements at Buffalo PFC application services. Acquire land for midfield terminal. Niagara International Airport. Decision Date: February 10, 2004. Determination: This project was Brief Description of Projects Approved withdrawn by the public agency by FOR FURTHER INFORMATION CONTACT: Dan for Collection and Use: Vornea, New York Airports District letter dated December 3, 2003. Design and construction, extension of Construct snow removal equipment Office, (516) 227–3812. runway 14/32. building. Public Agency: Indian Wells Valley Design and construction, extension, Construct taxiway T. Airport District, Inyokern, California. widening and rehabilitation of taxiway Determination: These projects were Application Number: 04–04–C–00– D. withdrawn by the public agency by IYK. Design and construction, extension letter dated August 13, 2003. Application Type: Impose and use a and rehabilitation of runway 5/23. Decision Date: February 18, 2004. PFC. Design and construction, extension PFC Level: $3.00. FOR FURTHER INFORMATION CONTACT: and rehabilitation of taxiway A. Total PFC Revenue Approved in this Lorna Sandridge, Central Region Design and construction, overhead Decision: $36,183. Airports Division, (816) 329–2641. canopies for pedestrian walkways. Decision Date: February 23, 2004. Earliest Charge Effective Date: April 1, Public Agency: Golden Triangle 2004. Regional Airport Authority, Columbus, FOR FURTHER INFORMATION CONTACT: Estimated Charge Expiration Date: Mississippi. Philip Brito, New York Airports District October 1, 2004. Application Number: 04–03–C–00– Office, (516) 227–3800. Class of Air Carriers Not Required to GTR. Public Agency: County of Collect PFC’s: Nonscheduled/on- Application Type: Impose and use a Westchester, Mount Vernon, New York. demand air carriers filing FAA Form PFC. Application Number: 04–02–I–00– 1800–31. PFC Level: $4.50. HPN. Total PFC Revenue Approved in this Determination: Approved. Based on Application Type: Impose a PFC. Decision: $285,555. information contained in the public PFC Level: $4.50. Earliest Charge Effective Date: August Total PFC Revenue Approved in this agency’s application, the FAA has 1, 2005. Decision: $20,200,000. determined that the approved class Estimated Charge Expiration Date: Earliest Charge Effective Date: May 1, accounts for less than 1 percent of the October 1, 2007. 2004. total annual enplanements at Inyokern Class of Air Carriers Not Required to Estimated Charge Expiration Date: Airport. Collect PFC’s: None. October 1, 2014. Brief Description of Project Approved Brief Description of Projects Approved Class of Air Carriers Not Required to for Collection And Use: for Collection and Use: Collect PFC’s: Nonscheduled/on- Install security gates and rehabilitate Construction of demand air carriers filing FAA Form pavement. tower. 1800–31. Decision Date: February 12, 2004. Master plan/noise compatibility Determination: Approved. Based on FOR FURTHER INFORMATION CONTACT: study. information contained in the public David Delshad, Western Pacific Region Handicapped lift device. agency’s application, the FAA has Airports Division, (310) 725–3627. Runway overlay, grooving, and determined that the approved class Public Agency: City of Springfield marking. accounts for less than 1 percent of the Airport Board, Springfield, Missouri. Taxiway seal coat. total annual enplanements at Application Number: 03–04–C–00– Reconstruction of general aviation Westchester County Airport. SGF. ramp. Brief Description of Project Approved Application Type: Impose and use a Decision Date: February 23, 2004. for Collection: New deicing facilities. PFC. FOR FURTHER INFORMATION CONTACT: Decision Date: February 25, 2004. PFC Level: $4.50. David Shumate, Jackson Airports FOR FURTHER INFORMATION CONTACT: Dan Total PFC Revenue Approved in this District Office, (601) 664–9882. Vornea, New York Airports District Decision: $1,847,000. Public Agency: Niagara Frontier Office, (516) 227–3812. Earliest Charge Expiration Date: May Transportation Authority, Buffalo, New Public Agency: Benedum Airport 1, 2004. York. Authority, Clarksburg, West Virginia. Estimated Charge Expiration Date: Application Number: 04–05–C–00– Application Number: 04–03–C–00– August 1, 2005. BUF. CKB. Class of Air Carriers Not Required to Application Type: Impose and use a Application Type: Impose and use a Collect PFC’s: Nonscheduled Part 135 PFC. PFC. and air taxi operators. PFC Level: $3.00. PFC Level: $4.50. Determination: Approved. Based on Total PFC Revenue Approved in this Total PFC Revenue Approved in this information contained in the public Decision: $7,045,262. Decision: $2,920,641. agency’s application, the FAA has Earliest Charge Effective Date: May 1, Earliest Charge Effective Date: May 1, determined that the approved class 2009. 2004.

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Estimated Charge Expiration Date: Earliest Charge Effective Date: April 1, Runway 2C/20C extension (part B). May 1, 2054. 2007. Noise mitigation. Class of Air Carriers Not Required to Estimated Charge Expiration Date: Two elevators in terminal building. Collect PFC’s: None. May 1, 2014. Brief Description of Projects Approved Class of Air Carriers Not Required to Airfield pavement rehabilitation for Collection and Use: Collect PFC’s: Part 135 air taxis. (phases 1, 2, 3, 4, and 5) and runway Terminal modifications. Determination: Approved. Based on 2R/20L joint and crack repair. Construct de-ice containment facility. information contained in the public Acquire aircraft rescue and Construct run-up pad. agency’s application, the FAA has firefighting equipment. Install segmented circle/wind cone. determined that the approved class Acquire pavement sweeper. Runway extension (land acquisition). accounts for less than 1 percent of the Runway extension (construction). Airfield re-signing. total annual enplanements at Nashville Acquire snow removal equipment. Decision Date: February 25, 2004. International Airport. FOR FURTHER INFORMATION CONTACT: Brief Description of Projects Approved Brief Description of Disapproved Matthew DiGiulian, Beckley Airports for Collection and Use: Project: District Office, (304) 252–6216. Airfield construction. Terminal ambulance. Public Agency: Metropolitan Develop general aviation area south of Determination: The eligibility of Nashville Airport Authority, Nashville, Murfreesboro Road and east of runway emergency vehicles is limited to those Tennessee. 2C/20C. vehicles required to meet Part 139 Application Number: 04–11–C–00– Engineering study to develop land requirements. This vehicle is not a Part BNA. north of runway 13/31. 136 requirement. Application Type: Impose and use a Relocate electrical vault on west side. Decision Date: February 26, 2004. PFC. Storm water treatment facility PFC Level: $3.00 engineering study and upgrade. FOR FURTHER INFORMATION CONTACT: Total PFC Revenue Approved in this Widen taxiway fillets at taxiways L2, Cynthia K. Wills, Memphis Airports Decision: $81,518,055. K2, T3, and Lima Kilo. District Office, (901) 322–8190.

AMENDMENTS TO PFC APPROVALS

Amendment ap- Original ap- Amended ap- Original esti- Amended esti- Amendment No. proved proved net PFC proved net PFC mated charge mated charge city, state date revenue revenue exp. date exp. date

92–01–C–05–MCO Orlando, FL ...... 02/06/04 $26,441,847 $34,099,841 09/01/94 09/01/94 95–03–C–02–MCO Orlando, FL ...... 02/06/04 $21,527,408 $18,637,986 04/01/96 11/01/95 02–05–C–03–BGM Binghamton, NY ...... 02/24/04 $4,567,319 $4,567,151 03/01/05 03/01/05

Issued in Washington, DC on March 31, restricted highway routes and ECH), Federal Motor Carrier Safety 2004. restrictions or limitations affecting how Administration, U.S. Department of JoAnn Horne, motor carriers may transport certain Transportation, 400 Seventh Street, Manager, Financial Analysis and Passenger hazardous materials on the highway. SW., Washington, DC 20590. Office Facility Charge Branch. This notice is required by the hours are from 7:30 a.m. to 4:00 p.m., [FR Doc. 04–8371 Filed 4–12–04; 8:45 am] Paperwork Reduction Act. EST., Monday through Friday, except BILLING CODE 4910–13–M DATES: Please submit your comments by Federal holidays. June 14, 2004. SUPPLEMENTARY INFORMATION: Title: Transportation of Hazardous Materials; ADDRESSES: Mail or hand deliver DEPARTMENT OF TRANSPORTATION Highway Routing. comments to the U.S. Department of OMB Control Number: 2126–0014. Federal Motor Carrier Safety Transportation, Dockets Management Background: The data for the Administration Facility, Room PL–401, 400 Seventh Transportation of Hazardous Materials; Street, SW., Washington, DC 20590, or Highway Routing designations are [Docket No. FMCSA–2004–17048] submit electronically at http:// collected under authority of 49 U.S.C. dmses.dot.gov/submit. Be sure to Notice of Request for Comments on 5112 and 5125. That authority places include the docket number appearing in responsibility on the Secretary of Renewing Approval for an Information the heading of this document on your Collection: OMB Control No. 2126– Transportation (Secretary) to specify comment. All comments received will and regulate standards for establishing, 0014 (Transportation of Hazardous be available for examination and Materials, Highway Routing) maintaining, and enforcing routing copying at the above address from 9 designations. AGENCY: Federal Motor Carrier Safety a.m. to 5 p.m., e.t., Monday through Under 49 CFR 397.73, the Administration (FMCSA), DOT. Friday, except Federal holidays. If you Administrator has the authority to would like to be notified when your ACTION: Notice; request for comments. request that each State and Indian tribe, comment is received, you must include through its routing agency, provide SUMMARY: This notice announces that a self-addressed, stamped postcard or information identifying hazardous the FMCSA intends to request the Office you may print the acknowledgment materials routing designations within of Management and Budget (OMB) to page that appears after submitting their respective jurisdictions. That renew approval of the information comments electronically. information is collected and collection described below. That FOR FURTHER INFORMATION CONTACT: Mr. consolidated by the FMCSA and information collection requires States Michael Johnsen (202–366–4111), published annually in whole, or as and Indian tribes to identify designated/ Hazardous Materials Division (MC– updates, in the Federal Register.

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Respondents: The reporting burden is DEPARTMENT OF TRANSPORTATION this document. Note that all comments shared by the 50 States, the District of received will be posted without change Columbia, Puerto Rico, American Federal Motor Carrier Safety to http://dms.dot.gov, including any Samoa, Guam, Northern Marianas, and Administration personal information provided. Please the Virgin Islands. [Docket Nos. FMCSA–99–6480, FMCSA– see the Privacy Act heading under Regulatory Notices. Estimated Total Annual Burden: The 2001–11426] Docket: For access to the docket to annual reporting burden is estimated to Qualification of Drivers; Exemption read background documents or be 13 hours, calculated as follows: (53 × × Applications; Vision comments received, go to http:// respondents 1 response 15 minutes/ dms.dot.gov at any time or to Room PL– 60 minutes = 13.25 hours, rounded to 13 AGENCY: Federal Motor Carrier Safety 401 on the plaza level of the Nassif hours). Administration (FMCSA), DOT. Building, 400 Seventh Street, SW., Frequency: There is one response ACTION: Notice of renewal of exemption; Washington, DC, between 9 a.m. and 5 annually from approximately 53 request for comments. p.m., Monday through Friday, except respondents. Federal Holidays. SUMMARY: This notice publishes the FOR FURTHER INFORMATION CONTACT: Public Comments Invited: Your FMCSA decision to renew the Ms. comments are particularly invited on exemptions from the vision requirement Sandra Zywokarte, Office of Bus and whether the collection of information is in the Federal Motor Carrier Safety Truck Standards and Operations, (202) necessary for the FMCSA to meet its Regulations for 24 individuals. The 366–2987, FMCSA, Department of goal of reducing truck crashes, FMCSA has statutory authority to Transportation, 400 Seventh Street, including whether the information is exempt individuals from vision SW., Washington, DC 20590–0001. Office hours are from 7:45 a.m. to 4:15 useful to this goal; the accuracy of the standards if the exemptions granted will p.m., e.t., Monday through Friday, estimate of the burden of the not compromise safety. The agency has except Federal holidays. information collection; ways to enhance concluded that granting these SUPPLEMENTARY INFORMATION: the quality, utility and clarity of the exemptions will provide a level of safety Public Participation: The DMS is information collected; and ways to that will be equivalent to, or greater available 24 hours each day, 365 days minimize the burden of the collection of than, the level of safety maintained without the exemptions for these each year. You can get electronic information on respondents, including submission and retrieval help the use of automated collection commercial motor vehicle (CMV) drivers. guidelines under the ‘‘help’’ section of techniques or other forms of information the DMS web site. If you want us to technology. DATES: This decision is effective April notify you that we received your Electronic Access and Filing: You 23, 2004. Comments from interested comments, please include a self- may submit or retrieve comments online persons should be submitted by May 13, addressed, stamped envelope or through the Docket Management System 2004. postcard or print the acknowledgement (DMS) at http://dmses.dot.gov/submit. ADDRESSES: You may submit comments page that appears after submitting Acceptable formats include: MS Word identified by DOT DMS Docket comments on-line. (versions 95 to 97), MS Word for Mac Numbers FMCSA–99–6480 and Privacy Act: Anyone is able to search (versions 6 to 8), Rich Text File (RTF), FMCSA–2001–11426 by any of the the electronic form of all comments following methods: received into any of our dockets by the American Standard Code Information • Interchange (ASCII)(TXT), Portable Web site: http://dms.dot.gov. name of the individual submitting the Follow the instructions for submitting Document Format (PDF), and comment (or signing the comment, if comments on the DOT electronic docket WordPerfect (versions 7 to 8). The DMS submitted on behalf of an association, site. business, labor union, etc.). You may is available 24 hours each day, 365 days • Fax: 1–202–493–2251. review the Department of each year. Electronic submission and • Mail: Docket Management Facility; Transportation’s complete Privacy Act retrieval help and guidelines are U.S. Department of Transportation, 400 Statement in the Federal Register available under the help section of the Seventh Street, SW., Nassif Building, published on April 11, 2000 (Volume Web site. You may also download an Room PL–401, Washington, DC 20590– 65, Number 70; Pages 19477–78) or you electronic copy of this document from 0001. may visit http://dms.dot.gov. the DOT Docket Management System on • Hand Delivery: Room PL–401 on the Internet at http://dms.dot.gov/ the plaza level of the Nassif Building, Exemption Decision search.htm. Please include the docket 400 Seventh Street, SW., Washington, Under 49 U.S.C. 31315 and 31136(e), number appearing in the heading of this DC, between 9 am and 5 pm, Monday the FMCSA may renew an exemption document. through Friday, except Federal from the vision requirement in 49 CFR Holidays. 391.41(b)(10), which applies to drivers Authority: The Paperwork Reduction Act • of 1995, 44 U.S.C. chapter 35, as amended; Federal eRulemaking Portal: Go to of CMVs in interstate commerce, for a 2- and 49 CFR 1.73. http://www.regulations.gov. Follow the year period if it finds ‘‘such exemption on-line instructions for submitting would likely achieve a level of safety Issued: April 6, 2004. comments. that is equivalent to, or greater than, the Annette M. Sandberg, Instructions: All submissions must level that would be achieved absent Administrator. include the agency name and docket such exemption.’’ The procedures for [FR Doc. 04–8320 Filed 4–12–04; 8:45 am] numbers for this notice. For detailed requesting an exemption (including BILLING CODE 4910–EX–P instructions on submitting comments renewals) are set out in 49 CFR Part 381. and additional information on the This notice addresses 24 individuals rulemaking process, see the Public who have requested renewal of their Participation heading of the exemptions in a timely manner. The Supplementary Information section of FMCSA has evaluated these 24

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applications for renewal on their merits and decided to extend each exemption for a renewable 2-year period. They are:

Louis N. Adams Marshall L. Hood Anthony G. Parrish Guy M. Alloway Edward W. Hosier Bill L. Pearcy Lyle H. Banser Charles F. Koble Robert H. Rogers Lloyd J. Botsford Robert W. Lantis Bobby C. Spencer Joseph E. Buck, Sr. Lucio Leal Sammy D. Steinsultz Paul D. Gaither Terry W. Lytle Mark J. Stevwing David L. Grajiola Earl R. Mark Frankie A. Wilborn Walter D. Hague, Jr. Richard W. Neyens Jeffrey L. Wuollett

These exemptions are extended deficiencies over the past 2 years DEPARTMENT OF TRANSPORTATION subject to the following conditions: (1) indicates each applicant continues to That each individual have a physical meet the vision exemption standards. Federal Railroad Administration exam every year (a) by an These factors provide an adequate basis Notice of Funds Availability and ophthalmologist or optometrist who for predicting each driver’s ability to Request for Comment To Assist in the attests that the vision in the better eye continue to drive safely in interstate continues to meet the standard in 49 Development and Implementation of a commerce. Therefore, the FMCSA Procedure for Fair Competitive Bidding CFR 391.41(b)(10), and (b) by a medical concludes that extending the exemption examiner who attests that the individual by Amtrak and Non-Amtrak Operators for each renewal applicant for a period of State-Supported Intercity Passenger is otherwise physically qualified under of 2 years is likely to achieve a level of 49 CFR 391.41; (2) that each individual Rail Routes safety equal to that existing without the provide a copy of the ophthalmologist’s AGENCY: or optometrist’s report to the medical exemption. Federal Railroad Administration (FRA), Department of examiner at the time of the annual Comments medical examination; and (3) that each Transportation (DOT). individual provide a copy of the annual The FMCSA will review comments ACTION: Notice. medical certification to the employer for received at any time concerning a retention in the driver’s qualification particular driver’s safety record and SUMMARY: Under this Notice, the FRA file and retain a copy of the certification determine if the continuation of the solicits comments from interested on his/her person while driving for exemption is consistent with the parties on how the Secretary of presentation to a duly authorized requirements at 49 U.S.C. 31315 and Transportation, working with affected Federal, State, or local enforcement 31136(e). However, the FMCSA requests States, could develop and implement a official. Each exemption will be valid that interested parties with specific data procedure for fair competitive bidding for 2 years unless rescinded earlier by concerning the safety records of these by Amtrak and non-Amtrak operators the FMCSA. The exemption will be drivers submit comments by May 13, for State-supported intercity passenger rescinded if: (1) The person fails to 2004. rail routes. FRA also encourages comply with the terms and conditions interested States to submit a Statement of the exemption; (2) the exemption has In the past the FMCSA has received of Interest in receiving a grant to resulted in a lower level of safety than comments from Advocates for Highway support an initiative leading to a fair was maintained before it was granted; or and Auto Safety (Advocates) expressing and open competitive selection of an (3) continuation of the exemption would continued opposition to the FMCSA’s operator to provide passenger rail not be consistent with the goals and procedures for renewing exemptions service over a specific intercity route objectives of 49 U.S.C. 31315 and from the vision requirement in 49 CFR that receives or will receive State 31136(e). 391.41(b)(10). Specifically, Advocates financial support. Services eligible for objects to the agency’s extension of the funding under programs administered Basis for Renewing Exemptions exemptions without any opportunity for by the Federal Transit Administration Under 49 U.S.C. 31315(b)(1), an public comment prior to the decision to are not eligible for a grant under this exemption may be granted for no longer renew, and reliance on a summary notice. Responses to this notice are than 2 years from its approval date and statement of evidence to make its sought on or before May 28, 2004. may be renewed upon application for decision to extend the exemption of DATES: All submissions of Statements of additional 2-year periods. In accordance each driver. Interest and comments must be received with 49 U.S.C. 31315 and 31136(e), each in FRA’s offices by close of business of the 24 applicants has satisfied the The issues raised by Advocates were Friday, May 28, 2004. The deadline for entry conditions for obtaining an addressed at length in 66 FR 17994 the submission of applications will be exemption from the vision requirements (April 4, 2001). The FMCSA continues noted in the solicitation from FRA to (64 FR 68195, 65 FR 20251, 67 FR to find its exemption process prospective grantees as a result of the 17102, 67 FR 10471, 67 FR 19798). Each appropriate to the statutory and evaluation of the Statements of Interest. of these 24 applicants has requested regulatory requirements. ADDRESSES: timely renewal of the exemption and Issued on: April 8, 2004. Applicants must submit an has submitted evidence showing that original and six (6) copies to the Federal Pamela M. Pelcovits, the vision in the better eye continues to Railroad Administration at one of the meet the standard specified at 49 CFR Office Director, Policy, Plans, and Program following addresses: 391.41(b)(10) and that the vision Development. Postal address (note correct zip code): impairment is stable. In addition, a [FR Doc. 04–8319 Filed 4–12–04; 8:45 am] Federal Railroad Administration, review of each record of safety while BILLING CODE 4910–EX–P Attention: Alex Chavrid, Chief, driving with the respective vision Passenger Programs Division (RDV–11),

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Mail Stop #20, 1120 Vermont Ave., quality rail services at reasonable section.’’ (Note: Section 168 of Division NW., Washington, DC 20590. prices.’’ Subsequently, on June 27, 2003, H of the Consolidated Appropriations FedEx/courier address (note correct Secretary Mineta submitted to Congress Act, 2004, imposes an across-the-board zip code): Federal Railroad proposed legislation: ‘‘The Rail rescission of 0.59 percent to all Administration, Attention: Alex Passenger Reform Investment Act’’ that appropriations in the act, thereby Chavrid, Chief, Passenger Programs would take this principle and make reducing the appropriation that is Division, (RDV–11), Room #773, 1120 competitive selection of intercity available for costs associated with the Vermont Ave., NW., Washington, DC passenger rail service operators by implementation of the fair bid 20005. States the foundation for a new procedure and demonstration of Due to delays caused by enhanced approach to providing intercity competition to $2,485,250.) screening of mail delivered via the US passenger rail service in the United Section 151 provides the Secretary of Postal Service, applicants are States. Since the enactment of ARAA, Transportation with significant encouraged to use other means to assure some States have contemplated using flexibility and latitude in establishing timely receipt of materials. competitive processes to select the referenced ‘‘fair bid procedure.’’ The FOR FURTHER INFORMATION CONTACT: operators of intercity passenger rail purpose of this notice is threefold. First, Mark Yachmetz, Associate service they deem important enough to FRA seeks comment and Administrator for Railroad Development support financially. However, to date recommendations on how such a ‘‘fair (RDV–1), Federal Railroad there has not yet been a successful bid procedure’’ should be structured, Administration, 1120 Vermont Avenue process through which a fair and open what issues should be addressed in such a procedure, how they could be best NW., Washington, DC 20590. Phone: competition has resulted in the addressed, how the available funds (202) 493–6381; Fax: (202) 493–6330. selection of an operator other than should best be used and whether the SUPPLEMENTARY INFORMATION: The Amtrak. Section 151 of the General available funds are adequate for the demonstration will be supported with Provisions of the Transportation, intended purpose. Second, FRA seeks to Treasury, and Independent Agencies up to $2,485,250 of Federal funds identify the extent of interest among the Appropriations Act, 2004 (included as provided to FRA as part of the States in competitively selecting Division F of the Consolidated Transportation, Treasury, and operators of State-supported intercity Appropriations Act, 2004 (Public Law Independent Agencies Appropriations rail passenger service. Finally, FRA Act, 2004 (included as Division F of the 108–199 (January 23, 2004)) provides as wishes to identify the State or States ‘‘ Consolidated Appropriations Act, 2004 follows: For the purpose of assisting that could implement or make the most (Public Law 108–199 (January 23, State-supported intercity rail service, in progress toward implementing a ‘‘fair 2004)). FRA anticipates soliciting one or order to demonstrate whether bid procedure’’ in the most timely more grant applications and awarding competition will provide higher quality manner with the available Federal one or more grants to eligible rail passenger service at reasonable funding. participants before September 30, 2004. prices, the Secretary of Transportation, Authority: The authority for the The funds made available under this working with affected States, shall program can be found in Section 151 of program will be available for activities develop and implement a procedure for the Transportation, Treasury, and related to developing and/or fair competitive bidding by Amtrak and Independent Agencies Appropriations implementing a fair and open non-Amtrak operators for State- Act, 2004 (included as Division F of the competitive process for selecting an supported routes: Provided, That in the Consolidated Appropriations Act, 2004 operator of a State-supported intercity event a State desires to select or selects (Public Law 108–199 (January 23, passenger rail route. FRA anticipates a non-Amtrak operator for the route, the 2004)). The Secretary of that no further public notice will be State may make an agreement with Transportation’s responsibilities under made with respect to selecting Amtrak to use facilities and equipment this program have been delegated to the applicants for this demonstration. of, or have services provided by, Amtrak Federal Railroad Administration. Purpose: From the creation of Amtrak under terms agreed to by the State and Funding: The Transportation, in 1971 until the enactment of the Amtrak to enable the non-Amtrak Treasury, and Independent Agencies Amtrak Reform and Accountability Act operator to provide the State-supported Appropriations Act, 2004, provides (ARAA) in 1997, the National Railroad service: Provided further, That if the $2,485,250 for this purpose. It is Passenger Corporation, better known as parties cannot agree on terms, the anticipated that the available funding Amtrak, had the exclusive right to Secretary shall, as a condition of receipt could be used for one or more grants. If operate intercity passenger rail service of Federal grant funds, order that the two grants are awarded, FRA may over the routes where it provided facilities and equipment be made choose not to award the grants in equal service. ARAA eliminated Amtrak’s available under reasonable terms and amounts. Additional funding for this or monopoly as the exclusive intercity compensation: Provided further, That related work may be available in passenger rail service operator on these when prescribing reasonable subsequent fiscal years and may be routes. Some have argued since compensation to Amtrak, the Secretary awarded without further competition. enactment of ARAA that competition in shall consider quality of service as a Eligible Participants: Any State that the selection of intercity rail passenger major factor when determining whether, presently provides financial assistance service operators could result in and the extent to which, the amount of for an intercity passenger rail service improved service and/or lower costs. On compensation shall be greater than the operated by Amtrak or any State or June 22, 2002, Secretary of incremental costs of using the facilities group of States that is willing to provide Transportation, Norman Y. Mineta, and providing the services: Provided financial assistance for an intercity rail identified the five principles for further, That the Secretary may passenger service, the operator of which intercity passenger rail reform reprogram up to $2,500,000 from the is selected through a fair bid procedure, advocated by the U.S. Department of Amtrak operating grant funds for costs is eligible to participate in this program. Transportation. Included among these associated with the implementation of Comment and recommendations on how principles are: ‘‘Introduce carefully the fair bid procedure and such a ‘‘fair bid procedure’’ should be managed competition to provide higher demonstration of competition under this structured, what issues should be

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addressed in such a procedure, how Amtrak, including the terms and 9. Length of the demonstration period they could be best addressed, how the conditions under which this access and prospects for the service at the end available funds should best be used and would be provided. of the demonstration period. whether the available funds are 9. Describe how the State or States Issued in Washington, DC on April 7, 2004. adequate for the intended purpose are would propose that a fair bid procedure Mark E. Yachmetz, solicited from eligible participants and to be implemented by the Secretary Associate Administrator for Railroad any other interested party. should address the issue of access to rail Development. Requirements for Statements of infrastructure. [FR Doc. 04–8321 Filed 4–12–04; 8:45 am] Interest: The following points describe 10. Describe the equipment proposed the minimum content that is required in for use in providing the service, its BILLING CODE 4910–06–P Statements of Interest. current ownership, current use and any 1. Describe the service to be subject to commitment that the State might have fair bid competition, including for access to this equipment. DEPARTMENT OF THE TREASURY frequencies of service, schedules for 11. Describe how the State or States operation, any unique aspects of the would propose that a fair bid procedure Submission for OMB Review; service sought by the State, endpoints to be implemented by the Secretary Comment Request and intermediate stops and connections should address the issue of access to rail April 6, 2004. to other intercity and commuter rail and passenger equipment. transit services, and estimates of annual The Department of Treasury has 12. Describe the provisions the State submitted the following public ridership, revenue and expenses during or States would make to address the the period of operation covered by the information collection requirement(s) to liability of the operator selected under OMB for review and clearance under the fair bid competition. the fair bid competition, the owner of 2. Describe the analysis, if any, Paperwork Reduction Act of 1995, Pub. the rail infrastructure and others in the L. 104–13. Copies of the submission(s) undertaken regarding the incorporation event of an accident. of this service into State and/or regional may be obtained by calling the Treasury 13. Describe how the State or States Bureau Clearance Officer listed. transportation plans. would propose that a fair bid procedure 3. Describe the experience or analysis, Comments regarding this information to be implemented by the Secretary collection should be addressed to the if any, undertaken by the State regarding should address the issue of liability. competitive selection of passenger OMB reviewer listed and to the 14. Describe any other issues that Treasury Department Clearance Officer, service providers, by any mode of need to be addressed either by the intercity transportation, for commuter Department of the Treasury, Room Secretary or by the State or States to 11000, 1750 Pennsylvania Avenue, rail service or for local transit service. implement a fair bid competitive 4. Describe how the State or States NW., Washington, DC 20220. process for selection of an operator of an envision their role and that of the DATES: Written comments should be intercity passenger rail service. selected operator in defining the key received on or before May 13, 2004 to Format: Statements of Interest or attributes of the service to be provided. be assured of consideration. 5. Describe the history, if any, of State comments may not exceed twenty-five Internal Revenue Service (IRS) and other non-Federal financial support pages in length. for this service and the financial support Selection Criteria: The following will OMB Number: 1545–0056. the State and other non-Federal sources be considered to be positive selection Form Number: IRS Forms 1023 and propose during the period of operation factors in evaluating Statements of 872–C. resulting from the fair bid competition, Interest for this demonstration: Type of Review: Extension. clearly indicating the estimated amount 1. The contribution the proposed fair Title: and sources for the required non- bid competitive selection will make to Form 1023: Application for Federal funds required. understanding the issues that must be Recognition of Exemption Under section 6. Identify the entity that would addressed in competitive selection of 501(c)(3) of the Internal Revenue Code; conduct the fair bid competition. To the intercity rail operators. and extent this entity does not presently 2. The timeliness of the initiation of Form 872–C: Consent Fixing Period of have legal authority to undertake such the competitive bid process and Limitation upon Assessment of Tax a competition, identify the process and initiation of the competitively bid Under section 4940 of the Internal schedule under which this authority service. Revenue Code. would be provided. 3. The ability of the State or States to Description: Form 1023 is filed by 7. Describe the route over which the adequately address the challenges facing applicants seeking Federal income tax service would be operated, including a competitive selection of an operator of exemption as organizations described in the owner of the rail infrastructure, the intercity passenger rail service. section 501(c)(3). IRS uses the traffic types (including ownership of 4. Financial commitment from non- information to determine if the trains), volumes, and speeds presently Federal sources. applicant is exempt and whether the involved in operation on the track 5. Cost to the Federal Government. applicant is a private foundation. Form segment(s) over which the service 6. Past and likely future State 872–C extends the statute of limitations would operate. commitments to support the service in for assessing tax under section 4940. 8. Describe any communications question. Respondents: Not-for-profit between the State and the owner of the 7. Projected ridership, revenues, institutions. rail infrastructure over which the expenses and capital needs of the Estimated Number of Respondents/ service would operate that addresses the expected service. Recordkeepers: 29,409. issue of access for passenger service 8. Likely effects of the competitively Estimated Burden Hours Respondent/ operated by an entity other than bid service on other Amtrak services. Recordkeeper:

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Preparing and send- Form Recordkeeping Learning about the law or ing the form to the the form IRS

1023 Parts I to IV ...... 55 hr., 43 min ...... 5 hr., 00 min ...... 8 hr., 32 min. 1023 Schedule A ...... 7 hr., 10 min ...... 00 min ...... 7 min. 1023 Schedule B ...... 4 hr., 46 min ...... 30 min ...... 36 min. 1023 Schedule C ...... 5 hr., 1 min ...... 35 min ...... 42 min. 1023 Schedule D ...... 4 hr., 4 min ...... 42 min ...... 47 min. 1023 Schedule E ...... 9 hr., 19 min ...... 1 hr., 5 min ...... 1 hr., 17 min. 1023 Schedule F ...... 2 hr., 37 min ...... 2 hr., 52 min ...... 3 hr., 3 min. 1023 Schedule G ...... 2 hr., 37 min ...... 00 min ...... 2 min. 1023 Schedule H ...... 1 hr., 54 min ...... 42 min ...... 45 min. 1023 Schedule I ...... 3 hr., 35 min ...... 00 min ...... 3 min. 872–C ...... 1 hr., 25 min ...... 24 min ...... 25 min.

Frequency of response: On occasion. Description: Form 5471 and related involvement of U.S. persons with Estimated Total Reporting/ schedules are used by U.S. persons that certain foreign corporations. Recordkeeping Burden: 2,069,267 hours. have an interest in a foreign corporation. Respondents: Business or other for- OMB Number: 1545–0704. The form is used to report income from profit, Individuals or households. Form Number: IRS Form 5471 and the foreign corporation. The form and Estimated Number of Respondents/ related Schedules. schedules are used to satisfy the Recordkeepers: 43,000. Type of Review: Revision. reporting requirements of sections 6035, Title: Information Return of U.S. 6038 and 6046 and the regulations Estimated Burden Hours Respondent/ Persons with Respect to Certain Foreign thereunder pertaining to the Recordkeeper: Corporations.

Preparing and send- Form Recordkeeping Learning abouth the law or ing the form to the the form IRS

5471 ...... 82 hr., 45 min ...... 16 hr., 14 min ...... 24 hr., 17 min. Schedule J (Form 5471) ...... 3 hr., 49 min ...... 1 hr., 29 min ...... 1 hr., 37 min. Schedule M (Form 5471) ...... 26 hr., 33 min ...... 6 min ...... 32 min. Schedule N (Form 5471) ...... 8 hr., 22 min ...... 2 hr., 28 min ...... 2 hr., 43 min. Schedule O (Form 5471) ...... 10 hr., 45 min ...... 24 min ...... 35 min.

Frequency of response: Annually. Form 8038–G: Information Return for to assure that tax-exempt bonds are Estimated Total Reporting/ Tax-Exempt Governmental Obligation; issued consistent with the rules of Recordkeeping Burden: 6,700,035 hours. and Internal Revenue Code (IRC) sections Form 8038–GC: Information Return OMB Number: 1545–0720. 141–149. for Small Tax-Exempt Governmental Form Number: IRS Forms 8038, 8038– Respondents: State, local or tribal Bond Issues, Leases, and Installment government, not-for-profit institutions G, and 8038–GC. Sales Type of Review: Revision. Description: Forms 8038, 8038–G, and Estimated Number of Respondents/ Title: Form 8038: Information Return 8038–GC collect the information that Recordkeepers: 3,816. for Tax-Exempt Private Activity Bond IRS is required to collect by Code Estimated Burden Hours Respondent/ Issues; section 149(e). IRS uses the information Recordkeeper:

Copying, assembling, Form Learning about the law or Preparing the form and sending the form the form to the IRS

8038 ...... 10 hr., 35 min ...... 12 hr., 27 min ...... 16 min. 8038–G ...... 2 hr., 52 min ...... 3 hr., 15 min ...... 00 min. 8038–GC ...... 2 hr., 22 min ...... 2 hr., 34 min ...... 00 min.

Frequency of response: Quarterly, Title: Form 8282: Donee Information contribution deduction. Form 8283 is Annually, Other (8038-GC at least once Return (Sale, Exchange or Other sued to report the required information. every 5 years). Disposition of Donated Property); and Code section 6050L requires donee Estimated Total Reporting/ Form 8283: Noncash Charitable organizations to file an information Recordkeeping Burden: 293,900 hours. Contributions. return with the IRS if they dispose of Description: Internal Revenue Code the property received within two years. OMB Number: 1545–0908. section 170(a)(1) and regulation section Form 8282 is used for this purpose. Form Number: IRS Forms 8282 and 1.170A–13(c) require donors of property Respondents: Individuals or 8283. valued over $5,000 to file certain households, Business or other for-profit. Type of Review: Revision. information with their tax return in Estimated Number of Respondents/ order to receive the charitable Recordkeepers: 4,718,000.

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Estimated Burden Hours Respondent/ amount of income tax and FICA tax to Expanded section 6038B to require U.S. Recordkeeper: withhold from the tipped employee’s persons transferring property to foreign Recordkeeping ...... 3 hr., 35 min. wages. partnerships in certain transactions to Learning about the law 12 min. Respondents: Business or other for- report those transfers; (2) expanded or the form. profit, Individuals or households. section 6038 to require certain U.S. Preparing and sending 15 min. Estimated Number of Respondents/ Partners of controlled foreign the form to the IRS. Recordkeepers: 300,000. partnerships to report information about Estimated Burden Hours Respondent/ the partnerships; and (3) modified the Frequency of response: Annually. Recordkeeper: 2 hours reporting required under section 6046A Estimated Total Reporting/ Frequency of response: On occasion. with respect to acquisitions and Estimated Total Reporting/ Recordkeeping Burden: 9,485,220 hours. dispositions of foreign partnership Recordkeeping Burden: 600,000 hours. OMB Number: 1545–1603. interests. Form 8865 is used by U.S. OMB Number: 1545–1668. persons to fulfill their reporting Regulation Project Number: REG– Form Number: IRS Form 8865 and 104691–97 Final. obligations under sections 6038B, 6038, Schedules. and 6046A. Type of Review: Extension. Type of Review: Extension. Title: Electronic Tip Report. Title: Return of U.S. Persons With Respondents: Business or other for- Description: The regulations provide Respect to Certain Foreign Partnerships. profit, Individuals or households, Not- rules authorizing employers to establish Description: The Taxpayer Relief Act for-profit institutions. electronic systems for use by their of 1997 significantly modified the Estimated Number of Respondents/ tipped employees in reporting tips to information reporting requirements with Recordkeepers: 5,000. their employer. The information will be respect to foreign partnerships. The Act Estimated Burden Hours Respondent/ used by employers to determine the made the following three changes: (1) Recordkeeper:

Preparing, copying, Learning about the law or assembling and send- Form Recordkeeping the form ing the form to the IRS

8865 ...... 98 hr., 55 min ...... 22 hr., 38 min ...... 36 hr., 22 min. Schedule K–1 (Form 8865) ...... 31 hr., 4 min ...... 10 hr., 3 min ...... 18 hr., 10 min. Schedule O (Form 8865) ...... 13 hr., 9 min ...... 2 hr., 22 min ...... 2 hr., 42 min. Schedule P (Form 8865) ...... 5 hr., 15 min ...... 30 min ...... 36 min.

Frequency of response: Annually. Form Number: IRS Form 720–TO. Title: Voluntary Compliance on Alien Estimated Total Reporting/ Type of Review: Extension. Withholding Program (‘‘VCAP’’). Recordkeeping Burden: 458,510 hours. Title: Terminal Operator Report. Description:The revenue procedure OMB Number: 1545–1733. Description: Representatives of the will improve voluntary compliance of Form Number: IRS Form 720-CS. motor fuel industry, state governments, colleges and universities in connection Type of Review: Extension. and the Federal government are working with their obligations to report, Title: Carrier Summary Report. to ensure compliance with excise taxes withhold and pay taxes due on Description: Representatives of the on motor fuels. This joint effort has compensation paid to foreign students motor fuel industry, state governments, resulted in a system to track the and scholars (nonresident aliens). The and the Federal government are working movement of all products to and from revenue procedure provides an optional to ensure compliance with excise taxes terminals. Form 720–TO is an opportunity for colleges and universities on motor fuels. This joint effort has information return that will be used by which have not fully complied with resulted in a system to track the terminal operators to report their their tax obligations concerning movement of all products to and from monthly receipts and disbursements of nonresident aliens to self-audit and terminals. Form 720–CS is an products. come into compliance with applicable information return that will be used by Respondents: Business or other for- reporting and payment requirements. carriers to report their monthly profit. Respondents: Not-for-profit deliveries and receipts of products to Estimated Number of Respondents/ institutions, State, local or tribal and from terminals. Recordkeepers: 1,500. government. Respondents: Business or other for- Estimated Burden Hours Respondent/ Estimated Number of Respondents/ profit. Recordkeeper: Recordkeepers: 495. Estimated Number of Respondents/ Estimated Burden Hours Respondent/ Recordkeepers: 475. Recordkeeping ...... 19 hr., 21 min. Recordkeeper: 700 hours. Estimated Burden Hours Respondent/ Learning about the law 30 min. Recordkeeper: or the form. Frequency of response: On occasion. Preparing and sending 49 min. Estimated Total Reporting/ Recordkeeping ...... 14 hr., 21 min. the form to the IRS. Recordkeeping Burden: 346,500 hours. Learning about the law 30 min. OMB Number: 1545–1862. or the form. Frequency of response: Monthly. Preparing and sending 45 min. Form Number: IRS Form 8316. the form to the IRS. Estimated Total Reporting/ Type of Review: Extension. Recordkeeping Burden: 2,347,020 hours. Title: Information Regarding Request Frequency of response: Monthly. OMB Number: 1545–1735. for Refund of Social Security Tax Estimated Total Reporting/ Revenue Procedure Number: Revenue Erroneously Withheld on Wages Recordkeeping Burden: 183,027 hours. Procedure 2001–20. Received by a Nonresident alien on an OMB Number: 1545–1734. Type of Review: Extension. F, J, or M Type Visa.

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Description: Form 8316 is requested international boycott (within the improving customer service at the from nonresident alien taxpayers meaning of section 999(b)(3) of the Internal Revenue Service brought claiming a refund of Social Security tax Internal Revenue Code of 1986). forward by the Area and Issue erroneously withheld on wages On the basis of the best information Committees. received. currently available to the Department of DATES: The meeting will be held Friday, Respondents: Individuals or the Treasury, the following countries May 7, 2004, 8 a.m. to 5:30 p.m., and households. may require participation in, or Saturday, May 8, 2004, 8 a.m. to 12:30 Estimated Number of Respondents/ cooperation with, an international p.m. central daylight time. Recordkeepers: 22,000. boycott (within the meaning of section Estimated Burden Hours Respondent/ 999(b)(3) of the Internal Revenue Code FOR FURTHER INFORMATION CONTACT: Recordkeeper: 15 minutes. of 1986). Barbara Toy at 1–888–912–1227, or 414–297–1611. Frequency of response: On occasion. Bahrain, Estimated Total Reporting/ Kuwait, SUPPLEMENTARY INFORMATION: Notice is Recordkeeping Burden: 5,500 hours. Lebanon, hereby given pursuant to section Clearance Officer: Glenn P. Kirkland, Libya, 10(a)(2) of the Federal Advisory (202) 622–3428, Internal Revenue Oman, Committee Act, 5 U.S.C. App. (1988) Service, Room 6411–03, 1111 Qatar, that an open meeting of the Joint Constitution Avenue, NW., Washington, Saudi Arabia, Committee of the Taxpayer Advocacy DC 20224. Syria, Panel (TAP) will be held Friday, May 7, OMB Reviewer: Joseph F. Lackey, Jr., United Arab Emirates, and 2004, 8 a.m. to 5:30 p.m., and Saturday, (202) 395–7316, Office of Management Yemen, Republic of. May 8, 2004, 8 a.m. to noon, central and Budget, Room 10235, New Dated: April 7, 2004. daylight time at the Embassy Suites Executive Office Building, Washington, Hotel Chicago Downtown, 600 North Barbara Angus, DC 20503. State Street, Chicago, IL 60610. If you International Tax Counsel, (Tax Policy). Lois K. Holland, would like to have the Joint Committee [FR Doc. 04–8262 Filed 4–12–04; 8:45 am] of TAP consider a written statement, Treasury PRA Clearance Officer. BILLING CODE 4810–25–M please call 1–888–912–1227 or 414– [FR Doc. 04–8261 Filed 4–12–04; 8:45 am] 297–1611, or write Barbara Toy, TAP BILLING CODE 4830–01–P Office, MS–1006–MIL, 310 West DEPARTMENT OF THE TREASURY Wisconsin Avenue, Milwaukee, WI 53203–2221, or fax to 414–297–1623, or DEPARTMENT OF THE TREASURY Internal Revenue Service you can contact us at Office of the Secretary Open Meeting of the Joint Committee www.improveirs.org. of the Taxpayer Advocacy Panel The agenda will include the List of Countries Requiring following: Monthly committee summary Cooperation With an International AGENCY: Internal Revenue Service (IRS), report, discussion of issues brought to Boycott Treasury. the joint committee, office reports, and ACTION: Notice. discussion of next meeting. In order to comply with the mandate Dated: March 7, 2004. of section 999(a)(3) of the Internal SUMMARY: An open meeting of the Joint Revenue Code of 1986, the Department Committee of the Taxpayer Advocacy Bernard Coston, of the Treasury is publishing a current Panel will be conducted. The Taxpayer Director, Taxpayer Advocacy Panel. list of countries which may require Advocacy Panel is reviewing public [FR Doc. 04–8379 Filed 4–12–04; 8:45 am] participation in, or cooperation with, an comment, ideas, and suggestions on BILLING CODE 4830–01–P

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Corrections Federal Register Vol. 69, No. 71

Tuesday, April 13, 2004

This section of the FEDERAL REGISTER DEPARTMENT OF TRANSPORTATION Wednesday, April 7, 2004 make the contains editorial corrections of previously following correction: published Presidential, Rule, Proposed Rule, Federal Aviation Administration and Notice documents. These corrections are § 39.13 [Corrected] prepared by the Office of the Federal 14 CFR Part 39 On page 18254, in the third column, Register. Agency prepared corrections are in § 39.13, under the heading Initial issued as signed documents and appear in [Docket No. 2003–NM–47–AD; Amendment Inspection, in the first line, paragraph the appropriate document categories 39–13566; AD 2004–07–22] elsewhere in the issue. ‘‘(a)’’ should read ‘‘(d)’’. RIN 2120–AA64 [FR Doc. C4–7449 Filed 4–12–04; 8:45 am] Airworthiness Directives; Boeing BILLING CODE 1505–01–D Model 747 Series Airplanes Correction In rule document 04–7449 beginning on page 18250, in the issue of

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Part II

Department of the Interior Fish and Wildlife Service

50 CFR Part 17 Endangered and Threatened Wildlife and Plants; Proposed Designation of Critical Habitat for the California Red-legged Frog (Rana aurora draytonii); Proposed Rule

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DEPARTMENT OF THE INTERIOR Sacramento Fish and Wildlife Office, at case they would be removed from or the above address, or fax your made part of the final designation. We Fish and Wildlife Service comments to 916/414–6712. particularly seek comments concerning: 3. You may send your comments by (1) The reasons why any areas should 50 CFR Part 17 electronic mail (e-mail) to or should not be determined to be RIN–1018–AJ16 [email protected]. For directions on critical habitat as provided by section 4 how to submit electronic filing of of the Act, including whether the Endangered and Threatened Wildlife comments, see the ‘‘Public Comments benefits of designation will outweigh and Plants; Proposed Designation of Solicited’’ section below. In the event any threats to the species resulting from Critical Habitat for the California Red- that our Internet connection is not the designation; legged Frog (Rana aurora draytonii) functional, please submit comments by (2) Specific information on the the alternate methods mentioned above. amount and distribution of California AGENCY: Fish and Wildlife Service, All comments and materials received, red-legged frog and its habitat, and Interior. as well as supporting documentation which habitat or habitat components are ACTION: Proposed rule. used in preparation of this proposed essential to the conservation of this rule, will be available for public species and why; SUMMARY: We, the U.S. Fish and (3) Whether the primary constituent Wildlife Service (Service), propose to inspection, by appointment, during elements for the California red-legged designate critical habitat for the normal business hours at the above frog as defined in this proposal are California red-legged frog (Rana aurora address. biologically and scientifically accurate, draytonii) pursuant to the Endangered FOR FURTHER INFORMATION CONTACT: For specifically, Species Act of 1973, as amended (Act). general information, and for information (a) Whether aquatic habitat used for A total of approximately 1,674,582 about Alameda, Butte, Contra Costa, El breeding must have a minimum deep hectares (4,138,064 acres) in Alameda, Dorado, Fresno, Kern, Marin, Mariposa, water depth of 0.5 meters (m) (20 inches Butte, Contra Costa, El Dorado, Fresno, Merced, Napa, Plumas, San Joaquin, San (in)); Kern, Los Angeles, Marin, Mariposa, Mateo, Santa Clara, Solano, Sonoma, (b) Whether aquatic components must Merced, Monterey, Napa, Plumas, Stanislaus, Tehama, and Tuolumne consist of two or more breeding sites Riverside, San Benito, San Diego, San Counties, contact Wayne White, Field located within 2 kilometers (km) (1.25 Joaquin, San Luis Obispo, San Mateo, Supervisor, Sacramento Fish and miles (mi)) of each other; Santa Barbara, Santa Clara, Santa Cruz, Wildlife Office, U.S. Fish and Wildlife (c) Should the primary constituent Solano, Sonoma, Stanislaus, Tehama, Service, 2800 Cottage Way, Suite W. elements be more descriptive of the Tuolumne, and Ventura Counties, 2605, Sacramento, California 95825 variations in habitat preference California, is proposed for designation (telephone 916/414–6600; facsimile throughout the range of the subspecies; as critical habitat. 916/414–6712). (4) Whether the two recently This proposed designation of critical For information about Monterey, Los discovered populations of California habitat for the California red-legged frog Angeles, San Benito, San Luis Obispo, red-legged frogs in Youngs Creek, in is being published in accordance with Santa Barbara, Santa Cruz, and Ventura Calaveras County, and in artificial the November 6, 2002, consent decree Counties, contact Diane Noda, Field ponds in Nevada County are essential to that ordered us to publish a proposal by Supervisor, Ventura Fish and Wildlife the conservation of the subspecies and March 2004. In light of this deadline, we Office, U.S. Fish and Wildlife Service, should be included in designated have based this proposal solely on the 2394 Portola Road, Suite B, Ventura, critical habitat; configuration of our previously California 93003 (telephone 805/644– (5) Land use designations and current published final designation of critical 1766; facsimile 805/644–3958). or planned activities in or adjacent to habitat for the California red-legged frog For information about areas in the San the areas proposed and their possible (66 FR 14626, March 13, 2001). We Gabriel Mountains of Los Angeles impacts on proposed critical habitat; hereby solicit data and comments from County or Riverside and San Diego (6) Any foreseeable economic or other the public on all aspects of this Counties, contact Jim Bartel, Field potential impacts resulting from the proposal, incuding data on economic Supervisor, Carlsbad Fish and Wildlife proposed designation, in particular, any and other impacts of the designation. Office, U.S. Fish and Wildlife Service, impacts on small entities; We may revise this proposal prior to 2730 Loker Avenue West, Carlsbad, (7) Some of the lands we have final designation to incorporate or California 92008 (telephone 760/431– identified as essential for the address new information received 9440; facsimile 760/431–9624). conservation of the California red-legged during public comment periods or SUPPLEMENTARY INFORMATION: frog are not being proposed as critical otherwise available to us. Public Comments Solicited habitat. We specifically solicit comment DATES: We will accept comments until on the inclusion or exclusion of such June 14, 2004. Public hearing requests It is our intent that any final action areas and: must be received by May 28, 2004. resulting from this proposal will be as (a) Whether these areas are essential; ADDRESSES: If you wish to comment, accurate as possible. Therefore, we (b) Whether these areas warrant you may submit your comments and solicit comments or suggestions from exclusion; and materials concerning this proposal by the public, other concerned (c) The basis for not designating these any one of several methods: governmental agencies, the scientific areas as critical habitat (section 3(5)(A) 1. You may submit written comments community, industry, or any other or section 4(b)(2) of the Act); and information to the Field Supervisor, interested party concerning this (8) With specific reference to the Sacramento Fish and Wildlife Office, proposed rule. On the basis of public recent amendments to sections 4(a)(3) U.S. Fish and Wildlife Service, 2800 comment, during the development of and 4(b)(2) of the Act, we request Cottage Way, Suite W. 2605, the final rule we may find that areas information from the Department of Sacramento, California 95825. proposed are not essential, appropriate Defense to assist the Secretary of the 2. You may hand-deliver written for exclusion under section 4(b)(2), or Interior in excluding critical habitat on comments and information to our not appropriate for exclusion, in which lands administered by or under the

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control of the Department of Defense Preamble which now consumes nearly the entire listing program budget. This leaves the based on the benefit of an Integrated Designation of Critical Habitat Provides Service with little ability to prioritize its Natural Resources Management Plan Little Additional Protection to Species (INRMP) to the conservation of the activities to direct scarce listing species; and information regarding In 30 years of implementing the Act, resources to the listing program actions impacts to national security associated the Service has found that the with the most biologically urgent designation of statutory critical habitat with proposed designation of critical species conservation needs. provides little additional protection to habitat; and The consequence of the critical most listed species, while consuming habitat litigation activity is that limited (9) Whether our approach to significant amounts of conservation listing funds are used to defend active designating critical habitat could be resources. The Service’s present system lawsuits and to comply with the improved or modified in any way to for designating critical habitat is driven growing number of adverse court orders. provide for greater public participation by litigation rather than biology, limits As a result, the Service’s own to and understanding, or to assist us in our ability to fully evaluate the science proposals to undertake conservation accommodating public concerns and involved, consumes enormous agency actions based on biological priorities are comments. resources, and imposes huge social and significantly delayed. economic costs. The Service believes If you wish to comment, you may The accelerated schedules of court- that additional agency discretion would submit your comments and materials ordered designations have left the allow our focus to return to those concerning this proposal by any one of Service with almost no ability to actions that provide the greatest benefit provide for additional public several methods (see ADDRESSES to the species most in need of section). Please submit electronic participation beyond those minimally protection. required by the Administrative comments in ASCII file format and Procedure Act (APA), the Act, and the avoid the use of special characters or Role of Critical Habitat in Actual Service’s implementing regulations, or any form of encryption. Please also Practice of Administering and to take additional time for review of ‘‘ Implementing the Act include Attn: RIN 1018–AJ16’’ in your comments and information to ensure the e-mail subject header and your name While attention to and protection of rule has addressed all the pertinent and return address in the body of your habitat is paramount to successful issues before making decisions on message. If you do not receive a conservation actions, we have listing and critical habitat proposals, confirmation from the system that we consistently found that, in most due to the risks associated with have received your Internet message, circumstances, the designation of noncompliance with judicially imposed contact us directly by calling our critical habitat is of little additional deadlines. This in turn fosters a second Sacramento Fish and Wildlife Office at value for most listed species, yet it round of litigation in which those who phone number 916/414–6600. Please consumes large amounts of conservation will suffer adverse impacts from these ‘‘ note that the e-mail address resources. Sidle (1987) stated, Because decisions challenge them. The cycle of [email protected] will be closed out at the ESA [Act] can protect species with litigation appears endless, is very the termination of the public comment and without critical habitat designation, expensive, and in the final analysis critical habitat designation may be period. In the event that our Internet provides little additional protection to redundant to the other consultation connection is not functional, please listed species. requirements of section 7.’’ The costs resulting from the submit comments by the alternate Currently, only 445 or 36 percent of methods mentioned above. designation include legal costs, the cost the 1244 listed species in the U.S. under of preparation and publication of the Our practice is to make comments, the jurisdiction of the Service have designation, the analysis of the including names and home addresses of designated critical habitat (Service economic effects and the cost of respondents, available for public 2004). We address the habitat needs of requesting and responding to public review. Individual respondents may all 1244 listed species through comment, and in some cases the costs request that we withhold their home conservation mechanisms such as of compliance with National addresses from the rulemaking record, listing, section 7 consultations, the Environmental Policy Act (NEPA); all which we will honor to the extent Section 4 recovery planning process, the are part of the cost of critical habitat allowable by law. There also may be Section 9 protective prohibitions of designation. These costs result in circumstances in which we would unauthorized take, Section 6 funding to minimal benefits to the species that are withhold from the rulemaking record a the States, and the Section 10 incidental not already afforded by the protections respondent’s identity, as allowable by take permit process. The Service of the Act enumerated earlier, and they law. If you wish us to withhold your believes that it is these measures that directly reduce the funds available for name and/or address, you must state may make the difference between direct and tangible conservation actions. this prominently at the beginning of extinction and survival for many species. Background your comment. However, we will not consider anonymous comments. We Procedural and Resource Difficulties in Species Description will make all submissions from Designating Critical Habitat The California red-legged frog (Rana organizations or businesses, and from We have been inundated with aurora draytonii) is the largest native individuals identifying themselves as lawsuits regarding critical habitat frog in the western United States. It is representatives or officials of designation, and we face a growing endemic to California and Baja organizations or businesses, available number of lawsuits challenging critical California, Mexico. It is typically found for public inspection in their entirety. habitat determinations once they are from sea level to elevations of Comments and materials received will made. These lawsuits have subjected the approximately 1,500 meters (m) (5,000 be available for public inspection, by Service to an ever-increasing series of feet (ft)). The California red-legged frog appointment, during normal business court orders and court-approved ranges in body length from 40 to 130 hours at the above address. settlement agreements, compliance with millimeters (mm) (1.6 to 5.1 in), with

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adult females attaining a significantly tadpoles, and 30 to 40 percent for frog populations occupy naturally longer body length than males (138 mm California red-legged frog tadpoles occurring wetland environments. As (5.4 in) versus 116 mm (4.6 in)) (Hayes occurring without bullfrogs (Lawler et natural wetlands and streams were and Miyamoto 1984). The posterior al. 1999). Sexual maturity can be converted for agriculture, flood control, abdomen and hind legs of adults vary in attained at 2 years of age by males and and urban development, California red- color, but are often red or salmon pink; 3 years of age by females (Jennings and legged frogs colonized small artificial the back is characterized by small black Hayes 1985), with adults living 8 to 10 impoundments created by cattle flecks and larger irregular dark blotches years (Jennings, U.S. Geological Survey ranchers for the purpose of providing with indistinct outlines on a brown, (USGS), Biological Resources Division water for their cattle. Without these gray, olive, or reddish-brown (BRD), pers. comm. 2000). However, the impoundments, the range of California background. Dorsal spots usually have average life span is probably much red-legged frogs would be limited light centers (Stebbins 1985), and the lower (Scott, USGS, BRD, pers. comm. further in this region. dorsolateral folds (folds along the sides 2000). Several researchers have attributed of the frog) are prominent. Larvae range the decline and extirpation of California Geographic Range from 14 to 80 mm (0.6 to 3.1 in) in red-legged frogs to the introduction of length, and the background color of the The historic range of the California bullfrogs (Rana catesbeiana) and body is dark brown or olive with darker red-legged frog extended along the coast predatory fishes (Hayes and Jennings spots (Storer 1925). A line of very small, from the vicinity of Point Reyes 1986; Moyle 1973). This decline has indistinct gold-colored spots are thought National Seashore, Marin County, been attributed to both predation and to become the dorsolateral fold. The California, and inland from the vicinity competition. Twedt (1993) observed the California red-legged frog is one of two of Redding, Shasta County, California, predation of juvenile northern red- subspecies of the red-legged frog (R. southward to northwestern Baja legged frogs (R. aurora aurora) and aurora). For a detailed description of the California, Mexico (Jennings and Hayes suggested that bullfrogs may prey on two subspecies, see the Recovery Plan 1985; Hayes and Krempels 1986). subadult red-legged frogs. This is for the California Red-legged Frog California red-legged frogs have been supported by Cook (Sonoma County (Service 2002) and references identified documented in 46 counties in Water Agency, in litt. 2000) and David within the plan. California, but now remain in only 248 Cook and M. Jennings (in litt. 2000), streams or drainages in 26 counties; the who documented bull frog predation of Life History subspecies has lost approximately 70 both tadpoles and juvenile California Male California red-legged frogs percent of its former range (61 FR red-legged frogs, as well as a large adult, appear at breeding sites 2 to 4 weeks 25813, May 23, 1996). California red- by bullfrogs. In addition, bullfrogs may before females (Storer 1925). A pair in legged frogs are still locally abundant have a competitive advantage over red- amplexus (breeding position) moves to within portions of the San Francisco legged frogs. Bullfrogs are larger, have an oviposition site (the location where Bay area (including Marin County) and more generalized food habits (Bury and eggs are laid), and the eggs are fertilized the central coast. Within the remaining Whelan 1984), and have an extended while being attached to a brace. Braces distribution of the subspecies, only breeding season (Storer 1933) during include emergent vegetation such as isolated populations have been which an individual female produces as bulrushes (Scirpus sp.), cattails (Typha documented in the Sierra Nevada, many as 20,000 eggs (Emlen 1977). sp.), or roots and twigs, although northern Coast, and northern Transverse Further, bullfrog larvae are unpalatable breeding has been documented in ponds ranges. The subspecies was previously to predatory fish (Kruse and Francis without emergent vegetation (Steven believed to be extirpated (exterminated) 1977). Bullfrogs also interfere with red- Bobzien in litt. 2001). Each mass from most of its range in the southern legged frog reproduction. Both contains about 2,000 to 5,000 individual Transverse and Peninsular Ranges, but California and northern red-legged frogs eggs measuring approximately 2.0 to 2.8 two additional populations have have been observed in amplexus with mm (0.08 to 0.11 in) in diameter. Eggs recently been discovered. The species is both male and female bullfrogs (Twedt hatch in 6 to 14 days depending on still present in Baja California, Mexico 1993; Service files). water temperatures (Jennings et al., (California Natural Diversity Data Base California red-legged frogs are 1992). Larvae typically metamorphose (CNDDB) 1998; Service, in litt. 2003). currently threatened by human between July and September 3.5 to 7 activities, many of which operate Threats months after eggs are laid (Storer 1925; concurrently and cumulatively with Wright and Wright 1949). However, The California red-legged frog was each other and with natural several researchers have recently listed as a threatened subspecies on May disturbances (e.g., droughts and floods). observed larvae to overwinter in Contra 23, 1996 (61 FR 25813). Habitat loss and Current factors associated with Costa, Marin, Santa Clara, and San Luis alteration, overexploitation, and declining populations of the frog Obispo Counties (Bobzien et al. 2000), introduction of exotic predators were include degradation and loss of habitat and possibly in Ventura County (R. significant factors in the subspecies’ through urbanization, mining, improper Smith, Los Angeles Zoo, in litt. 2001), decline in the early-to-mid-1900s. management of grazing, recreation, with new metamorphs being observed Reservoir construction, expansion of invasion of nonnative plants, in March and April. introduced predators, management of impoundments, water diversions, Of the various life stages, larvae grazing in riparian areas resulting in degraded water quality, and introduced probably experience the highest loss of stream bank habitat and plunge predators. These factors have resulted in mortality rates. Survival rate from pools, and prolonged drought the isolation and fragmentation of hatching to metamorphosis (the process fragmented and eliminated many of the habitats within many watersheds, often of changing from a tadpole to a frog) has Sierra Nevada foothill populations. precluding dispersal between been estimated as less than 1 percent Only a few drainages currently support subpopulations and jeopardizing the (Jennings et al. 1992), 1.9 percent (Cook California red-legged frogs in the Sierra viability of metapopulations (broadly 1997), or less than 5 percent (Lawler et Nevada foothills, compared to more defined as multiple subpopulations that al. 1999) for California red-legged frog than 60 historical records. In Northern occasionally exchange individuals tadpoles co-occurring with bullfrog California, few California red-legged through dispersal and are capable of

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colonizing or rescuing habitat patches perennial aquatic habitat. Such and were becoming less abundant when the local subpopulations have alteration allows nonnative species such within the study area. They also found been extirpated). The fragmentation of as bullfrogs and nonnative warm water introduced generalists able to tolerate existing habitat, and the continued fish species to invade the habitat and lower quality habitat and to replace colonization of existing habitat by further adversely affect California red- native fish species within the system. nonnative species, may represent the legged frog populations. California red- This scenario has been demonstrated in most significant current threats to legged frogs are rarely found in areas Santa Clara Valley, California, where the California red-legged frogs. where a large majority of the watershed loss of California red-legged frog Numerous studies have demonstrated has been developed (H.T. Harvey and populations was attributed in part to the the impacts of fragmentation on other Associates 1997, Service files). This is invasion of bullfrogs into urbanized anuran (frog and toad) species. Urban further supported by Schueler (1994), areas (H.T. Harvey and Associates populations of common frogs (Rana who summarized research examining 1997). temporaria) were more genetically macroinvertebrate and fish diversity. Climate distinct than rural populations (Hitchins Those results illustrated the difficulty of and Beebee 1997). Based on genetic maintaining predevelopment stream California red-legged frogs are analysis, Reh and Seitz (1990) found quality when watershed development adapted to survive in a Mediterranean that highways effectively isolated R. exceeds 10–15 percent impervious climate where habitat quality varies temporaria populations. Kuhn (1987, in cover. For example, Klein (1979, in spatially and temporally. Due to this Reh and Seitz 1990) estimated that 24 to Schueler 1994) found that variability, population sizes can vary 40 cars per hour killed 50 percent of macroinvertebrate diversity consistently widely from year to year. During common toad (Bufo bufo) individuals became poor when watershed favorable years, California red-legged migrating across a road, while Heine imperviousness exceeded 10 to 15 frogs can experience extremely high (1987, in Reh and Seitz 1990) found that percent; this has been supported by rates of reproduction and produce large 26 cars per hour could reduce the Schueler and Galli (1992 in Schueler numbers of dispersing young, resulting survival rate of toads crossing roads to 1994) and Shaver et al. (1994, in in an increase in the number of zero. In addition, Fahrig et al. (1995) Schueler 1994). This loss of diversity occupied sites. In contrast, frogs may found a significant negative correlation has also been observed in fish (Klein temporarily disappear from an area between traffic density and the density 1979; Limburg and Schmidt 1990, both during periods of extended drought. of anuran populations. Thus, heavily in Schueler 1994). Therefore, it is important for the long- traveled roads are an important human- In addition to the modification of term survival and recovery of the caused landscape component, hindering hydroperiod, impacts within the species to protect those sites that appear amphibian movement through vehicle watershed can also affect water and to be unoccupied, but can be strikes and thereby fragmenting habitat quality. As watersheds are recolonized by dispersing individuals amphibian populations. developed, the area of impervious from nearby subpopulations (Semlitsch In addition to the fragmentation of surface increases, resulting in an 2000). habitat, activities that occur on upland increase of sediments containing Habitat habitats can have both direct and organic matter, pesticides and indirect significant deleterious impacts fertilizers, heavy metals, hydrocarbons, California red-legged frogs use a on California red-legged frogs. For and other debris entering streams and variety of habitat types, including example, amphibian species-richness wetlands (U.S. Environmental various aquatic, riparian, and upland (number of species in an area) is related Protection Agency (EPA) 1993). Skinner habitats. They include, but are not to land use in the watersheds of Puget et al. (1999) found developed limited to, ephemeral ponds, Sound, Washington (Richter and Azous watersheds had greater concentrations intermittent streams, seasonal wetlands, 1995, 1997); species-richness was of toxic effluents than less developed springs, seeps, permanent ponds, significantly lower in watersheds where areas with more open space. The perennial creeks, manmade aquatic more than 40 percent of the land area decrease in water quality can have features, marshes, dune ponds, lagoons, was developed. This was attributed to profound impacts on native amphibians riparian corridors, blackberry (Rubus increases in the total water level and other wetland vertebrates. Richter sp.) thickets, nonnative annual fluctuations within wetlands (e.g., both and Azous (1997) observed that grasslands, and oak savannas. Among increases in the number of fluctuations wetlands adjacent to undeveloped the variety of habitats where California of water levels within the wetland and upland areas were more likely to have red-legged frogs have been found, the increases in the magnitude of richer populations of native only common factor is association with fluctuations). Specifically, urbanization amphibians. Mensing et al. (1998) found a permanent water source. Apparently, leads to higher peak flows and volumes, that amphibian abundance was California red-legged frogs can use resulting in increases in the magnitude, negatively influenced by land use at virtually any aquatic system, provided a frequency, and duration of wetland small scales (e.g., within 0.5 to 1.0 km permanent water source, ideally free of hydroperiods and stream levels (Reinalt (0.30 to 0.60 mi). nonnative predators, is nearby. and Taylor 1997). Urbanization within Habitat fragmentation, wetland Permanent water sources can include, the range of the California red-legged conversions, and hydrological but are not limited to, ponds, perennial frog often results in similar effects on alterations cumulatively result in creeks (or permanent plunge pools wetlands. changes in wetland species within intermittent creeks), seeps, and Urbanization results in additional composition, including amphibian natural and artificial springs. California water runoff sources into wetlands and composition. Amphibian declines can red-legged frogs may complete their stream courses associated with be attributed to increasing numbers of entire life cycle in a particular area (i.e., irrigation and home use activities, nonnative competitors and predators a pond that is suitable for all life stages) especially during the summer months. capable of thriving in disturbed or utilize multiple habitat types. These This often drastically alters the conditions (Harris 1998). Onorato et al. variable life-history characteristics hydroperiod and converts intermittent (1998) found native fish species were enable California red-legged frogs to streams and seasonal wetlands to sensitive to anthropogenic disturbances change habitat use in response to

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varying conditions. During a period of burrows and moist leaf litter (Jennings variability. There is anecdotal evidence abundant rainfall, the entire landscape and Hayes 1994). Stream channels with that juvenile red-legged frogs disperse at may become suitable habitat. portions narrower and deeper than 46 least 1 km (0.6 mi) away from breeding Conversely, habitat use may be centimeters (cm) (18 in) may also habitat. These data are the result of drastically confined during periods of provide habitat (61 FR 25813). This type consulting biologists conducting prolonged drought. of dispersal and habitat use is not surveys for California tiger salamanders Populations of California red-legged observed in all California red-legged (Ambystoma californiense) in eastern frogs are most likely to persist where frogs, however, and is likely dependent Alameda (Monk and Associates 1997a multiple breeding areas are within an on the year-to-year variations in climate and 1997b) and Santa Clara Counties (B. assemblage of habitats used for dispersal and habitat suitability and varying Mori, in litt. 2000). In both locations, (N. Scott and G. Rathbun in litt. USGS, requirements of each life stage. newly metamorphosed California red- BRD, 1998), a trait typical of many frog legged frogs were found dispersing away Dispersal and toad species (Laan and Verboom from breeding habitat during rain 1990; Reh and Seitz 1990; Mann et al. At any time of the year, adult events. The ability of juveniles and 1991; Sjogren-Gulve 1994; Griffiths California red-legged frogs may move adults to disperse is important for the 1997; Marsh et al. 1999). Breeding sites from breeding sites. They can be long-term survival and recovery of the have been documented in a variety of encountered living within streams at subspecies because the dispersing aquatic habitats. Larvae, juveniles, and distances exceeding 2.9 km (1.8 mi) individuals can recolonize areas adult frogs have been observed from the breeding site and have been subjected to localized extirpation. inhabiting streams, creeks, ponds, found farther than 100 m (328 ft) from The manner in which nondispersing marshes, sag ponds, deep pools, and water in adjacent dense riparian California red-legged frogs use upland backwaters within streams and creeks, vegetation. The California red-legged habitats is not well understood. The dune ponds, lagoons, estuaries, and frog has been observed inhabiting length of time California red-legged artificial impoundments, such as stock riparian areas for up to 77 days (J. frogs spend in upland habitats, patterns ponds. Furthermore, breeding has been Bulger et al., USGS, BRD, in litt. 2000), of use, and whether juveniles, documented in these habitat types but typically remains within 60 m (200 subadults, and adults use uplands irrespective of vegetation cover. Frogs ft) of water. During periods of wet differently are under study. Preliminary successfully breed in artificial ponds weather, starting with the first rains of data from San Simeon and Pico creeks with little or no emergent vegetation (S. fall, some individuals may make in central California indicated that the Bobzien in litt. 2000), and have been overland excursions through upland number of days when California red- observed to successfully breed and habitats. Most of these overland legged frogs were found more than 2.0 inhabit stream reaches that are not movements occur at night. Evidence m (7 ft) from water ranged from 0 to 56 cloaked in riparian vegetation (Bobzien from marked adult frogs on the San days (G. Rathbun, in litt. 2000), while et al. 2000). The importance of riparian Simeon coast of San Luis Obispo the majority of California red-legged vegetation for this subspecies is not well County, California, suggests that frog frogs observed in eastern Contra Costa understood. It is believed that riparian movements of about 1.6 km (1 mi), over County spent the entire wet season plant communities provide good upland habitats, are possible over the within streamside habitat (T. Tatarian, foraging habitat due to the moisture and course of a wet season (N. Scott and G. in litt. 2000). However, several frogs camouflage that occur within the Rathbun, in litt. 1998). Frogs will make have been documented moving away community, as well as providing areas long-distance, straight-line, point-to- from the streamside habitat for varying for dispersal and supporting pools and point movements rather than using periods (T. Tatarian, pers. comm. 2001). backwater aquatic areas for breeding. corridors for moving between habitats The healthiest California red-legged However, other factors are more likely (N. Scott and G. Rathbun, in litt. 1998). frog populations persist as a collection to influence the suitability of aquatic Dispersing adult frogs in northern Santa of subpopulations that exchange genetic breeding sites, such as the general lack Cruz County traveled distances from 0.4 information through individual of introduced aquatic predators. km (0.25 mi) to more than 3.2 km (2 mi) dispersal events. These populations California red-legged frogs often without apparent regard to topography, persist and flourish where suitable disperse from their breeding habitat to vegetation type, or riparian corridors (J. breeding and nonbreeding habitats are utilize various aquatic, riparian, and Bulger, in litt. 2000). Many newly interspersed throughout the landscape upland estivation habitats in the metamorphosed juveniles tend to and are interconnected by unfragmented summer; however, it is also common for disperse short distances initially from dispersal habitat. Where this habitat individuals to remain in the breeding July through September, and then move mosaic exists, local extirpations may be area on a year-round basis. Frogs use a farther away from the breeding habitat counterbalanced by the colonization of number of habitat features, including during warm rain events (Monk 1997a; new habitat or recolonization of ponds, streams, marshes, boulders or M. Jennings in litt. 2000; N. Scott in litt. unoccupied areas of suitable habitat. rocks, organic debris such as downed 2000; Brian Mori in litt. 2000). Bobzien Studies on other frogs and toads have trees or logs, industrial debris, and et al. (2000) observed juveniles demonstrated that the probability of a agricultural features such as drains, inhabiting a wide variety of habitats habitat being occupied is positively watering troughs, or spring boxes. When while adults primarily inhabited deep correlated with the distance to the riparian habitat is present, frogs spend pools; and they postulated that juveniles nearest currently occupied habitat patch considerable time resting and feeding in might segregate themselves away from (Laan and Verboom 1990; Mann et al. the vegetation (G. Rathbun in litt. 2000). adults to escape predation and 1991; Marsh et al. 1999). Isolated When riparian habitat is absent, frogs competition. patches far removed from occupied spend considerable time resting and The dispersal capabilities of juveniles patches eventually became extirpated feeding under rocks and ledges, both in have not been studied, but are likely (Sjogren-Gulve 1994). In addition to and out of water (Trish Tatarian, dependent upon rainfall and moisture distance between habitat patches, the Sonoma State University, Sonoma levels during and immediately fragmentation of dispersal routes can County in litt. 2000). California red- following dispersal events and on also result in the isolation of legged frogs can also use small mammal habitat availability and environmental subpopulations. Studies from other

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anuran species have shown that A second population of California notice (65 FR 80409) announcing the fragmentation has resulted in problems red-legged frogs was discovered on reopening of the comment period on the associated with inbreeding (Reh and private land in Youngs Creek, Calaveras proposal to designate critical habitat for Seitz 1990; Hitchings and Beebee 1997) County, California, in 2003. The the California red-legged frog and a and an increase in unoccupied suitable population was subsequently notice of availability of the draft habitat, and can ultimately result in confirmed, but due to limited access, we economic analysis on the proposed extinction (Sjogren-Gulve 1994). have not been able to determine the determination. The comment period The long-term probability of the extent of this population. Youngs Creek was reopened until January 22, 2001. A survival and recovery of California red- is a tributary of Cosgove Creek, a final rule designating critical habitat for legged frogs is dependent upon the tributary to Calaveras River; however, the California red-legged frog was protection of existing breeding habitat, during the site visits, there was no signed on March 1, 2001, and published the movements of individuals between specific evidence visible of invasive or in the Federal Register on March 13, aquatic patches, and the ability to predatory species bullfrogs are known to 2001 (66 FR 14626). recolonize newly created or vacated occur in ponds on adjacent property. On June 8, 2001, the Home Builders habitats. Recolonization, which is vital Association of Northern California, to the recovery of this subspecies, is Previous Federal Action California Chamber of Commerce, dependent upon landscape On February 2, 1994, we published a California Building Industry characteristics including the distance proposal to list the frog as an Association, California Alliance for Jobs, between patches, the number and endangered species (59 FR 4888). Based and the Building Industry Legal Defense severity of barriers between patches, on information provided during the Fund filed a lawsuit in the U.S. District and the presence of interconnecting public comment period, we Court for the District of Columbia elements (e.g., habitat where frogs can subsequently published a final rule challenging the Service’s designation of rehydrate), and upon the dispersal listing the California red-legged frog as critical habitat for the California red- capability of California red-legged frogs threatened on May 23, 1996 (61 FR legged frog. Home Builders Ass’n of (Laan and Verboom 1990). 25813). At the time of the final listing, Northern California, et al. v. Norton, et Since the publication of our last we determined that designating critical al., Civ. No. 01–1291 (RJL) (D. D.C.). On designation of critical habitat for the habitat was not prudent due to the November 6, 2002, the court entered a California red-legged frog on March 13, potential increased degree of threat from consent decree remanding the 2001 (66 FR 14626), two new the publication of specific localities. designation to the Service to conduct an populations of the subspecies have been This specific information would make economic analysis in accordance with documented. However, due to limited the species more vulnerable to the Tenth Circuit’s decision in New access to these populations since they vandalism and also to collection for Mexico Cattle Growers Ass’n v. U.S. occur on private property and the market consumption. Consequently, we Fish and Wildlife Service, 248 F.3d 1277 limited information we have concerning did not designate critical habitat for the (10th Cir. 2001). The consent decree their status, we have not been able to subspecies. vacated the critical habitat designation make a determination at this time as to On March 24, 1999, the Earthjustice for the California red-legged frog with whether they are essential to the Legal Defense Fund, on behalf of the the exception of Units 5 and 31, Units conservation of the subspecies. We Jumping Frog Research Institute, the not known to be occupied by the frog, specifically seek information concerning Southwest Center for Biological and ordered the Service to promulgate these two new populations to assist us Diversity, and the Center for Sierra a proposed revised designation by in making that determination. If, upon Nevada Conservation, filed a lawsuit in March 2004, and a final revised rule by receipt of additional data and further the Northern District of California on November 2005. This proposed rule is analysis, we determine these our failure to designate critical habitat published in accordance with the populations to be essential to the for the California red-legged frog. November 6, 2002, consent decree. conservation of the subspecies, it would On December 15, 1999, the court be our intention to include them in final ordered us to make a prudency Critical Habitat critical habitat. determination by August 31, 2000, and Section 3(5)(A) of the Act defines The first population was discovered issue a final rule by December 29, 2001. critical habitat as—(i) the specific areas on private property in the South Fork On January 18, 2000, the court clarified within the geographic area occupied by Yuba River watershed in Nevada an error in the December 15, 1999, order a species, at the time it is listed in County, California, in 2002. This stating that the Service shall issue a accordance with the Act, on which are presence of this population was final rule by December 29, 2000. On found those physical or biological subsequently confirmed by Sacramento August 22, 2000, we submitted a features (I) essential to the conservation Fish and Wildlife staff in 2003. During declaration requesting an extension of of the species and (II) that may require the site visit, California red-legged frog the court order to March 1, 2001, citing special management considerations or tadpoles were observed suggesting the the need to extend the comment period. protection; and (ii) specific areas presence of a breeding population. On September 11, 2000, we published a outside the geographic area occupied by Further, during this site visit, there was proposed rule to designate a species at the time it is listed, upon no specific evidence visible of invasive approximately 2,175,000 ha (5,373,650 a determination that such areas are or predatory species on site. The ac) as critical habitat for the California essential for the conservation of the California red-legged frogs on this site red-legged frog (65 FR 54891) in species. ‘‘Conservation’’ means the use occur in artificial ponds, but they are California. The comment period was of all methods and procedures that are not active stock ponds. Because this open until October 11, 2000. During this necessary to bring an endangered or a population is located on private land, comment period, four public hearings threatened species to the point at which we have not had the opportunity to were held in Ventura (September 19, listing under the Act is no longer study it. Consequently, we are not able 2000), San Luis Obispo (September 21, necessary. to make any specific conclusions 2000), Dublin (September 26, 2000), and The designation of critical habitat regarding the status of this population of Sacramento (September 28, 2000). On does not affect land ownership or the subspecies at this locale. December 21, 2000, we published a establish a refuge, wilderness, reserve,

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preserve, or other conservation area. It economic, national security, and any designation will not control the does not allow government or public other relevant impact, of specifying any direction and substance of future access to private lands. Under section 7 particular area as critical habitat. We recovery plans, habitat conservation of the Act, Federal agencies must may exclude areas from critical habitat plans, or other species conservation consult with us on activities they designation when the benefits of planning efforts if new information undertake, fund, or permit that may exclusion outweigh the benefits of available to these planning efforts calls affect critical habitat and lead to its including the areas within critical for a different outcome. destruction or adverse modification. habitat, provided the exclusion will not Methods However, the Act prohibits result in extinction of the species. unauthorized take of listed species and Our Policy on Information Standards In identifying areas that are essential requires consultation for activities that Under the Endangered Species Act, to conserve the California red-legged may affect them, including habitat published in the Federal Register on frog, we used the best scientific and alterations, regardless of whether July 1, 1994 (59 FR 34271) and our U.S. commercial data available. These critical habitat has been designated. We Fish and Wildlife Service Information included data from research and survey have found that the designation of Quality Guidelines (2002) provide observations published in peer- critical habitat provides little additional criteria, establish procedures, and reviewed articles, recovery criteria and protection to most listed species. provide guidance to ensure that our strategy outlined in the Recovery Plan To be included in a critical habitat decisions represent the best scientific (Service 2002), regional Geographic designation, habitat must be either a and commercial data available. They Information System (GIS) watershed and specific area within the geographic area require our biologists, to the extent species coverages, data compiled in the occupied by the species on which are consistent with the Act and with the use California Natural Diversity Database found those physical or biological of the best scientific and commercial (CNDDB), data and analysis used to features essential to the conservation of data available, to use primary and develop regional Habitat Conservation the species (primary constituent original sources of information as the Plans (HCPs), and data collected from elements, as defined at 50 CFR basis for recommendations to designate reports submitted by biologists holding 424.12(b)) and which may require critical habitat. When determining section 10(a)(1)(A) recovery permits. In special management considerations or which areas are critical habitat, a the development of this proposal, we protections, or be specific areas outside primary source of information should be also took into consideration any of the geographic area occupied by the the listing package for the species. information provided to us during the species which are determined to be Additional information may be obtained public comment periods on our essential to the conservation of the from a recovery plan, articles in peer- previous proposed critical habitat species. Section 3(5)(C) of the Act states reviewed journals, conservation plans designation (65 FR 54891, September that not all areas that can be occupied developed by States and counties, 11, 2000) and draft economic analysis of by a species should be designated as scientific status surveys and studies, our proposed critical habitat (65 FR critical habitat unless the Secretary biological assessments, or other 80409, December 21, 2000). determines that all such areas are unpublished materials and expert Primary Constituent Elements essential to the conservation of the opinion or personal knowledge. species. Our regulations (50 CFR Section 4 of the Act requires that we In accordance with section 3(5)(A)(i) 424.12(e)) also state that, ‘‘The Secretary designate critical habitat on the basis of of the Act and regulations at 50 CFR shall designate as critical habitat areas what we know at the time of 424.12, in determining which areas to outside the geographic area presently designation. Habitat is often dynamic, designate as critical habitat, we are occupied by the species only when a and species may move from one area to required to consider those physical and designation limited to its present range another over time. Furthermore, we biological features (primary constituent would be inadequate to ensure the recognize that designation of critical elements) that are essential to the conservation of the species.’’ habitat may not include all of the conservation of the species, and that Regulations at 50 CFR 424.02(j) define habitat areas that may eventually be may require special management special management considerations or determined to be necessary for the considerations and protection. These protection to mean any methods or recovery of the species. For these include, but are not limited to, space for procedures useful in protecting the reasons, critical habitat designations do individual and population growth and physical and biological features of the not signal that habitat outside the for normal behavior; food, water, air, environment for the conservation of designation is unimportant or may not light, minerals, or other nutritional or listed species. When we designate be required for recovery. physiological requirements; cover or critical habitat, we may not have the Areas that support populations of a shelter; sites for breeding, reproduction, information necessary to identify all listed species, but are outside the rearing (or development) of offspring; areas that are essential for the designation of critical habitat for it, will and habitats that are protected conservation of the species. continue to be subject to conservation protection from disturbance or are Nevertheless, we are required to actions implemented under section representative of the historic designate those areas we consider to be 7(a)(1) of the Act and to the regulatory geographical and ecological essential, using the best information protections afforded by the section distributions of a species. available to us. Accordingly, we do not 7(a)(2) jeopardy standard, as determined Due to the complex life history and designate critical habitat in areas on the basis of the best available dispersal capabilities of the California outside the geographic area occupied by information at the time of the action. red-legged frog, and the dynamic nature the species unless the best available Federally funded or permitted projects of the environments in which they are scientific and commercial data affecting listed species outside their found, the primary constituent elements demonstrate that unoccupied areas are designated critical habitat areas may described below are found throughout essential for the conservation needs of still result in jeopardy findings in some the watersheds that are being designated the species. cases. Similarly, critical habitat as critical habitat. Special management, Section 4(b)(2) of the Act requires that designations made on the basis of the such as habitat rehabilitation efforts we take into consideration the best available information at the time of (e.g., removal of nonnative predators),

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may be necessary throughout the area habitats (J. Bulger, in litt. 2000). We the feature) and at least 90 m (300 ft) being proposed for designation. Critical believe that this is likely the upward wide. Essential dispersal habitat habitat for California red-legged frogs limit of dispersal capability and that the consists of all upland and wetland will provide for breeding and 2-km (1.25-mi) dispersal element will habitat free of barriers that connects two nonbreeding habitat and for dispersal ensure that connectivity between or more patches of essential breeding between these habitats, as well as breeding habitats will be maintained habitat within 2 km (1.25 mi) of one allowing for expansion of frog within areas designated as critical another. Dispersal barriers include populations, which is essential to the habitat. In addition, breeding sites must heavily traveled roads (an average of 30 conservation of the subspecies. be connected by essential dispersal cars per hour from 10 p.m. to 4 a.m.) Critical habitat includes: (a) Essential habitat, described below. that possess no bridges or culverts; aquatic habitat; (b) associated uplands; moderate to high density urban or Associated Upland Habitat For Forage, and (c) dispersal habitat connecting industrial developments; and large Shelter, Water Quality Maintenance essential aquatic habitat. reservoirs over 20 ha (50 ac) in size. Associated upland and riparian Breeding and Foraging Habitat Agricultural lands such as row crops, habitat is essential to maintain orchards, vineyards, and pastures do not Aquatic habitat is essential for California red-legged frog populations constitute barriers to California red- providing space, food, and cover, associated with essential aquatic legged frog dispersal. necessary to sustain all life stages of habitat. The associated uplands and In summary, the primary constituent California red-legged frogs. It consists of riparian habitat provide food and shelter elements for the California red-legged virtually all low-gradient fresh water sites for California red-legged frogs and frog consist of three components: bodies, including natural and man-made assist in maintaining the integrity of (1) Aquatic habitat with a permanent (e.g., stock) ponds, backwaters within aquatic sites by protecting them from water source with pools (i.e., water streams and creeks, marshes, lagoons, disturbance and supporting the normal bodies) having a minimum depth of 0.5 and dune ponds, except for deep functions of the aquatic habitat. The m (20 in) for breeding and which can lacustrine water habitat (e.g., deep lakes palustrine or emergent aquatic habitat is maintain water during the entire tadpole and reservoirs 20 ha (50 ac) or larger in often characterized by presence of rearing season; size) inhabited by nonnative predators. cattail (Typha spp.), bulrush (Scirpus (2) Upland areas up to 90 m (300 ft) The subspecies requires a permanent spp.), and other persistent emergent from the water’s edge associated with water source to ensure that aquatic vegetation that allows for shelter, forage, the above aquatic habitat that will habitat is available year round. and attachment of egg masses, while the provide for shelter, forage, maintenance Permanent water sources can include, associated adjacent upland habitat often of the water quality of the aquatic but are not limited to, ponds, perennial contains blackberry (Rubus sp.) and habitat, and dispersal; and creeks (or permanent plunge pools other upland perennial species that (3) Upland barrier-free dispersal within intermittent creeks), seeps, and provide for shelter from predatory habitat that is at least 90 m (300 ft) in springs. Aquatic habitat used for species and forage habitat (Service width that connect at least two (or more) breeding must have a minimum deep 2002). suitable breeding locations defined by water depth of 0.5 m (20 in) and Key conditions include the timing, the aquatic habitat above, all within 2 maintain water during the entire tadpole duration, and extent of water moving km (1.25 miles) of one another. rearing season (at least March through within the system, filtering capacity, Criteria Used To Identify Critical July). During periods of drought, or less- and maintaining the habitat to favor Habitat than-average rainfall, these breeding California red-legged frogs and sites may not hold water long enough discourage the colonization of We considered several criteria in the for individuals to complete nonnative species such as bullfrogs. selection and proposal of specific metamorphosis, but these sites would Essential upland habitat consists of all boundaries for California red-legged frog still be considered essential breeding upland areas within 90 m (300 ft) of the critical habitat. These criteria, which habitat in wetter years. Ponds that edge of the ordinary high-water mark, or follow the recovery strategy outlined in support a small population of California no further than the watershed boundary. the final Recovery Plan (Service 2002), red-legged frogs, but are not surrounded This is based, in part, on the work of J. focused on designating units (1) by suitable upland habitat, or are cut off Bulger et al. (in litt. 2000), who found Throughout the geographic and from other breeding ponds or permanent that frogs were capable of inhabiting elevational range of the subspecies; (2) water sources by impassable dispersal upland habitats within 60 m (200 feet) that would result in protecting barriers, do not have the primary of aquatic habitat for continuous populations that are geographically constituent elements for California red- durations exceeding 20 days, and G. distributed in a manner that allows for legged frog critical habitat. Rathbun (in litt. 2000), who observed the continued existence of viable and To be a primary constituent element frogs inhabiting riparian habitat for essential metapopulations despite for California red-legged frog critical durations exceeding 30 days. fluctuations in the status of habitat, the aquatic components must subpopulations; and (3) that possess consist of two or more breeding sites Dispersal Habitat large continuous blocks of occupied located within 2 km (1.25 mi) of each Essential dispersal habitat provides habitat, representing source populations other; at least one of the breeding sites connectivity among California red- and/or unique ecological characteristics, must also be a permanent water source. legged frog breeding habitat (and or areas where the re-establishment of Also, the aquatic component can consist associated upland) patches. While frogs California red-legged frogs is essential to of two or more seasonal breeding sites can pass many obstacles, and do not the recovery of the subspecies (Service with a permanent nonbreeding water require a particular type of habitat for 2002). We first determined the source located within 2 km (1.25 mi) of dispersal, the habitat connecting occupancy status of areas. Areas were each breeding site. California red-legged essential breeding locations and other considered to possess extant frogs have been documented to travel aquatic habitat must be free of barriers populations if California red-legged 3.6 km (2.25 mi) in a virtual straight-line (e.g., a physical or biological feature that frogs have been documented in that area migration from nonbreeding to breeding prevents frogs from dispersing beyond since 1985. We then selected areas that

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are inhabited by populations (source quality, breeding and nonbreeding We are also proposing to designate populations) that are capable of habitat, and dispersal habitat in a areas that are not currently known to be maintaining their current population manner consistent with the overall goal occupied by the subspecies, but which levels and capable of providing of protecting and sustaining are essential for its conservation. We individuals to recruit into metapopulations. included one area in Tuolumne County subpopulations found in adjacent areas. We selected all of the planning in the Sierra Nevada and one in the We also selected several areas that may watersheds that intersected areas of high Tujunga watershed in Los Angeles lack source populations, but which have California red-legged frog abundance, County in the Peninsular Range of other unique ecological significance, areas essential to maintain connectivity, southern California. These areas, within with the goal of maintaining the full and/or areas of unique ecological the historic range of the subspecies with range of the genetic variability and significance as identified by the core some occurrences documented as evolutionary adaptation in the areas from the final Recovery Plan recently as the mid-1980s, are strong subspecies. These include areas on the (Service 2002). In areas where planning candidate areas for re-establishment due periphery of the current range and watersheds were large and/or to preliminary positive discussions with elsewhere that represent the historic watersheds were significantly altered Federal agencies and adjacent distribution of the subspecies, and areas hydrologically, we used alternative landowners, are composed entirely of that provide connectivity among source structural, political, or topographic large blocks of Federal land, and are populations or between source boundaries (e.g., roads, county identified in the final Recovery Plan populations and unoccupied extirpated boundaries, elevation contour lines) as (Service 2002) as important areas. Of the approximate 1,674,582 ha critical habitat boundaries because in reestablishment areas essential to the (4,140,440 ac) that are proposed for these areas the benefits of using recovery of the California red-legged designation as critical habitat for the planning watersheds were limited. frog. These areas also provide important California red-legged frog, an estimated Using the planning watersheds as the connectivity among currently occupied 81,020 ha (200,212 ac) are considered minimum mapping unit of this critical areas. In order for future unoccupied habitat (Units 5 and 31). All habitat designation would not allow us reestablishment to be successful, special of this unoccupied habitat occurs on to avoid towns, other developed areas, management in these areas is needed, Federal lands, and was identified in the or other areas where the primary including habitat restoration and the core areas essential for California red- constituent elements are not found. To removal of nonnative species, such as legged frog recovery in our final address this shortcoming, we overlayed predators. However, the primary Recovery Plan (Service 2002). Both the planning watersheds with a 100-m constituent elements for California red- unoccupied and occupied areas not Universal Transverse Mercator (UTM) legged frogs are present in these areas. Without reestablishment in the Sierra included in this designation can still be North American Datum of 1983 (NAD Nevada and Southern California, it is targets for recovery actions, including 83) grid. Using information from recent reestablishing populations. probable that California red-legged frogs digital aerial photography, we then will be extirpated from these areas, The critical habitat units were removed NAD 83 grid cells that did not greatly reducing the likelihood of delineated by first creating data layers contain the primary constituent eventual recovery of the species. As a in a geographic information system elements. Although the data available to result, we have determined that re- (GIS) format of all of the core areas as us were not sufficiently detailed to establishment of California red-legged proposed in the final Recovery Plan definitively map the primary frog populations in these currently (Service 2002). We then used the constituent elements by grid cell, this unoccupied areas is essential to the California Watershed Map (CALWATER approach did allow us to remove conservation of the species. Since the version 2.2), a coverage developed by significant urban and other developed listing of California red-legged frogs as California Department of Water areas, including some agricultural lands, a threatened species in 1996, no Resources (DWR), to identify from the final designation. progress has been made improving watersheds containing core areas and We could not depend solely on habitat for this species within these delineate their boundaries in a 1:24,000 federally owned lands for critical unoccupied areas. Because California format. CALWATER is a set of habitat designation as these lands are red-legged frogs have been extirpated watershed boundaries meeting limited in geographic location, size, and from these areas, Federal agencies have standardized delineation criteria, habitat quality within the current range determined their actions will not consisting of six levels of increasing of the California red-legged frog. In adversely affect California red-legged specificity, with the primary purpose of addition to the federally owned lands, frogs and have further declined to use assigning a single, unique code to a we are designating critical habitat on their authority under section 7(a)(1) to specific watershed polygon (e.g., a non-Federal public lands and privately help recover the California red-legged planning watershed). CALWATER owned lands, including land owned by frogs in the Sierra Nevada and southern delineates the boundaries of planning the California Department of Parks and Transverse and Peninsular Ranges. watersheds 1,200 to 4,000 ha (3,000 to Recreation, the California Department of Therefore, given the lack of protection 10,000 ac) in size. We used these Fish and Game, DWR, and the for these areas, it is important to ensure planning watersheds as the minimum University of California, as well as that special management actions are mapping unit to delineate critical regional and local park lands and water implemented in unoccupied lands habitat units because watersheds district lands. All non-Federal lands within the Sierra Nevada by designating represent functional, hydrologic designated as critical habitat meet the them as critical habitat. management units that allow for definition of critical habitat under efficient evaluation of factors that affect section 3 of the Act in that they are Special Management Considerations or the quality of aquatic habitat and, thus, within the geographical area occupied Protections are extremely relevant to amphibian by the subspecies, are essential to the As we undertake the process of populations. The use of planning conservation of the subspecies, and may designating critical habitat for a species, watersheds also allowed us to delineate require special management we first evaluate lands defined by those critical habitat that protects habitat considerations or protection. physical and biological features

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essential to the conservation of the November 2003), Section 318 Military base, and has implemented conservation species for inclusion in the designation Readiness and Conservation of measures as recommended. Therefore, pursuant to section 3(5)(A) of the Act. Protected Species makes the following we have determined that Vandenberg Secondly, we then evaluate lands amendment to section 4(a)(3) of the Act: Air Force Base that the INRMP as defined by those features to assess The Secretary shall not designate as critical drafted and implemented provides a whether they may require special habitat any lands or other geographical areas conservation benefit to the California management considerations or owned or controlled by the Department of red-legged frog. As such, the lands protections. As discussed throughout Defense, or designated for its use, that are essential to the conservation of the this proposed rule, our previous final subject to an integrated natural resources California red-legged frog on designation of critical habitat for the management plan [INRMP] prepared under Vandenberg Air Force Base have been California red-legged frog (66 FR 14626, section 101 of the Sikes Act (16 U.S.C. 670a), excluded from this proposed if the Secretary determines in writing that March 13, 2001) and in our final such plan provides a benefit to the species designation of critical habitat for the recovery plan for the species (Service for which critical habitat is proposed for subspecies. 2002), the frog and its habitat are designation. The Camp Parks U.S. Army Reserve threatened by a multitude of factors Training Area completed an INRMP in We believe that bases that have including by not limited to: degradation 2003 and a biological opinion was completed and approved INRMPs that and loss of habitat through urbanization, issued in July of 2003. The INRMP does address the needs of the species mining, improper management of provide conservation measures for the generally do not meet the definition of grazing, recreation, invasion of California red-legged frog and provides critical habitat as those bases require no nonnative plants, impoundments, water management direction on conserving additional special management or diversions, degraded water quality, and listed and imperiled species and their protection. Further, the statutory introduced predators, and previous habitats on the base. In addition, Camp amendment to section 4(a)(3) the Act overexploitation. While many of these Parks actively consults with us on all provides guidance on the relationship of threats operate concurrently and actions that may affect California red- INRMPs to critical habitat. Therefore, cumulatively with each other and with legged frogs on the base, and has lands essential to the conservation of a natural disturbances (e.g., droughts and implemented conservation measures as species that are owned or managed by floods), the fragmentation of existing recommended. Therefore, we have DOD and covered by INRMPs are habitat, and the continued colonization determined that the INRMP as drafted of existing habitat by nonnative species, excluded from critical habitat and implemented provides a may represent the most significant designations if they meet the following conservation benefit to the California current threats to California red-legged three criteria: (1) A current INRMP must red-legged frog. As such, the lands frogs. As such we believe that each area be complete and provide a conservation essential to the conservation of the proposed for designation as critical benefit to the species; (2) the plan must California red-legged frog on Camp habitat may require some level of provide assurances that the Parks have been excluded from this management and/or protection to conservation management strategies will proposed designation of critical habitat address the current and future threats to be implemented; and (3) the plan must for the subspecies. Camp Parks has the California red-legged frog and provide assurances that the worked with us and developed an habitat essential to its conservation to conservation management strategies will Endangered Species Management Plan ensure the overall recovery of the be effective, by providing for periodic (ESMP) as an appendix to their INRMP. subspecies. monitoring and revisions as necessary. The ESMP was drafted specifically for If all of these criteria are met, then the California red-legged frogs and includes Relationship to Section 4(a)(3) of the lands covered under the plan would be nonnative predator control and other Act excluded from a designation of critical conservation measures that would The Sikes Act Improvements Act of habitat for the species. benefit the frog. Camp Parks has already 1997 (Sikes Act) requires each military Vandenberg Air Force Base completed implemented several portions of the installation that includes land and water an INRMP in 1997 prior to the passage ESMP and had done so even prior to the suitable for the conservation and and implementation of the Sikes Act final approval of the INRMP. management of natural resources to Improvements Act of 1997. While we complete, by November 17, 2001, an did not specifically participate in its Relationship to Section 4(b)(2) of the Integrated Natural Resources development, this older plan does Act Management Plan (INRMP). An INRMP provide conservation measures for the Section 4(b)(2) of the Act states that integrates implementation of the California red-legged frog, as well as for critical habitat shall be designated, and military mission of the installation with the management of important wetland revised, on the basis of the best stewardship of the natural resources habitats across the base. The INRMP available scientific data available after found there. Each INRMP includes an provides management direction on taking into consideration the economic assessment of the ecological needs on conserving listed and imperiled species impact, the effect on national security, the installation, including needs to and their habitats on the base. Known and any other relevant impact, of provide for the conservation of listed frog sites are protected from disturbance specifying any particular area as critical species; a statement of goals and from human activities and grazing habitat. An area may be excluded from priorities; a detailed description of through measures appropriate to the critical habitat if it is determined, management actions to be implemented given situation. Vandenberg’s INRMP following an analysis, that the benefits to provide for these ecological needs; specifies monitoring of California red- of such exclusion outweigh the benefits and a monitoring and adaptive legged frog populations on the base, and of specifying a particular area as critical management plan. We consult with the periodic surveys to provide continuous habitat, unless the failure to designate military on the development and evaluation of the subspecies’ status at such area as critical habitat will result implementation of INRMPs for known and new sites identified on the in the extinction of the species. installations with listed species. base. In addition, Vandenberg actively Consequently, we may exclude an area The 2004 National Defense consults with us on all actions that may from designated critical habitat based on Authorization Act (Pub. L. 108–136, affect California red-legged frogs on the economic impacts, the effect on national

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security, or other relevant impacts such species, in this case, the California red- habitat on the bases than a critical as preservation of conservation legged frog. habitat designation. partnerships, if we determine the (1) Benefits of Inclusion (2) Benefits of Exclusion benefits of excluding an area from critical habitat outweigh the benefits of The principal benefit of any CSLO is a training facilities managed including the area in critical habitat, designated critical habitat is that by the California Army Reserve National provided the action of excluding the activities in such habitat that may affect Guard (CA ARNG) and the U.S. Army area will not result in the extinction of critical habitat require consultation (Army), respectively. Their mission is to the species. under section 7 of the Act. Such provide a major training area for In our critical habitat designations, we consultation would ensure that National Guard and U.S. Army Reserve have used both the provisions outlined adequate protection is provided to avoid troops for overseas deployment, and to in section 4(b)(2) of the Act to evaluate adverse modification of critical habitat. protect public safety during emergency those specific areas that are proposed In the absence of designated critical disasters. During the public comment for designation as critical habitat and habitat, this consultation will not look period for the proposal for the previous those areas which are subsequently specifically at the issue of adverse designation of critical habitat for the finalized (i.e., designated). We have modification of critical habitat; California red-legged frog, CSLO applied the provisions of these sections however, it will look at the very similar concluded that the designation, if it of the Act to lands essential to the concept of jeopardy to the listed species. were to become final, would seriously conservation of the subject species to Our experience is that, under most limit their ability to conduct their evaluate and either exclude them from circumstances, consultations under the critical training activities. They final critical habitat or not include them jeopardy standard will reach the same conclude that a final designation that in proposed critical habitat. Lands result as consultations under the includes these installations would likely which we have either excluded from or adverse modification standard. result in delays in training and closure of areas to allow for reinitiation of not included in critical habitat based on Implementing regulations (50 CFR Part section 7 consultation on critical those provisions include those covered 402) define ‘‘jeopardize the continued habitat. They asserted that the by: (1) Legally operative HCPs that cover existence of’’ and ‘‘destruction or designation of critical habitat for the the species, and provide assurances that adverse modification of’’ in virtually California red-legged frog on their the conservation measures for the identical terms. Jeopardize the facilities will have a detrimental effect species will be implemented and continued existence of means to engage on the ability of the CA ARNG and effective; (2) draft HCPs that cover the in an action ‘‘that reasonably would be Army to meet their training mission and species, have undergone public review expected * * * to reduce appreciably potentially affect national security. and comment, and provide assurances the likelihood of both the survival and that the conservation measures for the Even though the lands on these bases recovery of a listed species.’’ currently meet the definition of critical species will be implemented and Destruction or adverse modification effective (i.e., pending HCPs); (3) Tribal habitat for the California red-legged frog, means an Aalteration that appreciably conservation plans that cover the we have determined that it is diminishes the value of critical habitat species and provide assurances that the appropriate to exclude CSLO from this for both the survival and recovery of a conservation measures for the species critical habitat designation under listed species.’’ Common to both will be implemented and effective; (4) section 4(b)(2) of the Act in the interest definitions is an appreciable detrimental State conservation plans that provide of national security. The primary benefit effect on both survival and recovery of assurances that the conservation of excluding CSLO is to ensure that a listed species, in the case of critical measures for the species will be their mission-critical military training habitat by reducing the value of the implemented and effective; (5) Fish and activities can continue without habitat so designated. Thus, actions Wildlife Service Comprehensive interruption while the INRMPs are Conservation Plans that provide satisfying the standard for adverse being completed. CSLO is in the process assurances that the conservation modification are nearly always found to of updating their draft INRMP. We fully measures for the species will be also jeopardize the species concerned, expect that, once the INRMP is implemented and effective. and the existence of a critical habitat completed and approved, areas of the designation does not materially affect base included in the proposed critical Exclusions of Military Lands Pursuant the outcome of consultation. Additional habitat designation will no longer meet to Section 4(b)(2) of the Act measures to protect the habitat from the definition of critical habitat, as they Although Camp San Luis Obispo adverse modification are not likely to be will require no additional special (CSLO) completed their INRMP in required. management or protection. November 2001, they are now updating We have determined that the benefits Training activities are ongoing, and it to include an additional species, and of designating critical habitat on CSLO the CA ARNG and Army believe that by we are in process of evaluating it to are small. The primary benefit of implementing specific conservation determine if it adequately covers and designation is the prohibition on measures, their training activities are provides a conservation benefit to the destruction or adverse modification of not likely to adversely affect California California red-legged frog. CSLO critical habitat under section 7 of the red-legged frogs on the bases, ensuring contains habitat essential to the Act. However, all frog habitat on CSLO compliance with section 7(d) of the Act. conservation of the California red-legged is occupied, and we believe that section In particular, CSLO considers all frog. The proposed critical habitat 7 consultation on any proposed action permanent and intermittent waterways encompasses more than 90 percent of on these bases that would result in an and riparian areas to be sensitive habitat CSLO. Subsection 4(b)(2) of the Act adverse modification conclusion would and provides buffers. Sections of Chorro allows us to exclude areas from critical also result in a jeopardy conclusion. As Creek, and several ponds, springs, and habitat designation where the benefits of noted above, we expect that, when reservoirs have been fenced to exclude exclusion outweigh the benefits of completed and adopted, the updated military training activities and cattle designation, provided the exclusion will INRMPs will provide equal or greater grazing. Although avoiding these areas not result in the extinction of the protection to California red-legged frog constrains training activities to some

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degree, the effectiveness of their overall and Wildlife Office (see ADDRESSES the species. The San Joaquin County mission is not compromised. Camp section) or on the Internet at http:// MSHCP seeks to accomplish these goals Parks has also identified essential sacramento.fws.gov/es/documents. for the California red-legged frog California red-legged frog habitat and These maps are provided to allow the through the implementation of specific has designated these areas as sensitive public the opportunity to adequately conservation objectives. The principal habitat areas. Further, Camp Parks is comment on these exclusions. benefit of designating critical habitat is currently implementing measures to that federally authorized or funded Relationship of Critical Habitat to the promote the conservation of California activities that may affect a species’ San Joaquin County Multi-Species/Open red-legged frogs by implementing critical habitat would require Space Habitat Conservation Plan (San control of non-native predators. consultation with us under section 7 of Joaquin County MSHCP) The proposed critical habitat the Act. In the case of the San Joaquin designation included about 90 percent The San Joaquin County MSHCP was County MSHCP, we must evaluate the of CSLO. If these areas are included in developed and a finalized EIR/EIS impact of the plan on the species for the final designation of critical habitat completed in November 2000. A non- which the participants are seeking for the California red-legged frog, the CA jeopardy biological opinion was issued incidental take permits, pursuant to ARNG and U.S. Army would be on the plan in May 2001. Participants in section 7 of the Act. compelled by their interpretation of the this HCP include seven cities and the Act to significantly curtail necessary County of San Joaquin. The San Joaquin Benefits of Exclusion training within the area designated as MSHCP encompasses all of San Joaquin The benefits of excluding lands critical habitat, to the detriment of County except for federally-owned within HCPs from critical habitat mission-critical training capability and lands at the Lawrence Livermore designation include relieving potentially national security, until the Laboratory and some areas landowners, communities, and counties reinitiation of consultation is encompassing projects not covered by of any additional regulatory burden that concluded. As a result, this would the San Joaquin County MSHCP (Tracy might be imposed by critical habitat. greatly restrict use of the installation, Hills, The American River Water Many HCPs, particularly large regional severely limiting CSLO’s utility as Resources Investigation Project, Folsom HCPs, take many years to develop and, training sites. South Canal Connection of the East Bay upon completion, become regional Municipal Utility District Supplemental conservation plans that are consistent Benefits of Exclusion Outweigh the Water Supply Program, and the South with the recovery objectives for listed Benefits of Inclusion County Surface Water Supply Project). species that are covered within the plan Through the development of this The San Joaquin County MSHCP is also area. Additionally, many of these HCPs proposal, we have identified lands that a subregional plan under the State’s provide conservation benefits to we believe to be essential to the NCCP and was developed in unlisted sensitive species. Imposing an conservation of the California red-legged cooperation with the California additional regulatory review after an frog. We have considered these lands in Department of Fish and Game. HCP is completed solely as a result of relation to lands owned and managed by Approximately 100,841 ac (40,808 ha) of the designation of critical habitat may DOD that are used for mission-critical covered species habitat are proposed for undermine conservation efforts and training. Based on our analysis above conservation. partnerships in many areas. In fact, it and our analysis and treatment of these We are proposing to exclude a portion could result in the loss of species’ lands in our previous designation of of Unit 15 from proposed critical habitat benefits if participants abandon the critical habitat for the California red- for the California red-legged frog voluntary HCP process because it may legged frog, we have determined that the pursuant to section 4(b)(2) of the Act result in additional regulations benefits of excluding these lands from because it is within the planning area requiring more of the participants than critical habitat pursuant to the potential boundary for the San Joaquin County other parties who have not voluntarily effects on national security as allowed MSHCP. Our analysis for excluding participated in species conservation. under section 4(b)(2) of the Act portions of Unit 15 from proposed Designation of critical habitat within the outweigh the potential benefits of critical habitat is outlined below. The boundaries of approved HCPs could be including these lands in the proposed San Joaquin County Multi-Species viewed as a disincentive to those designation. Further, we have Conservation Plan (SJMSCP) identifies entities currently developing HCPs or determined that excluding the bases the California red-legged frog as a contemplating them in the future. will not result in the extinction of the covered species and has identified areas A related benefit of excluding lands red-legged frog, as numerous frog core where growth and development are within HCPs from critical habitat areas remain within the final critical expected to occur (build-out areas). designation is the unhindered, habitat designation and sections 7(a)(2) Only one percent of the area considered continued ability to seek new and 9 of the Act still apply to the habitat for the California red-legged frog partnerships with future HCP activities affecting red-legged frogs on would be affected by development participants including States, counties, CSLO. activities. local jurisdictions, conservation Should additional information organizations, and private landowners, become available that changes our Benefits of Inclusion which together can implement analysis of the benefits of excluding any As stated previously, the benefits of conservation actions that we would be of these areas compared to the benefits designating critical habitat on lands unable to accomplish otherwise. If lands of including them in the critical habitat within the boundaries of approved within HCP plan areas are designated as designation, we may revise this final HCPs are small. Where HCPs are in critical habitat, it would likely have a designation accordingly. Maps place that include coverage for the negative effect on our ability to establish delineating essential habitat for the California red-legged frog, the HCPs and new partnerships to develop HCPs, California red-legged frog, overlaid with their IAs include management measures particularly large, regional HCPs that ‘‘mission-critical’’ training areas on and protections designed to protect, involve numerous participants and CSLO, are available for public review restore, monitor, manage, and enhance address landscape-level conservation of and comment at the Sacramento Fish the habitat to benefit the conservation of species and habitats. By preemptively

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excluding these lands, we preserve our benefits of critical habitat, including existing natural and open space areas current partnerships and encourage informing the public of areas that are that are already conserved through other additional conservation actions in the essential for the long-term survival and means (e.g., State Parks, Forest Service, future. conservation of the species are still and County Park Lands). Furthermore, an HCP or NCCP/HCP accomplished from material provided The County of Riverside and the application must itself be consulted on our website and through public participating jurisdictions have signaled upon. While this consultation will not notice and comment procedures their sustained support for the Western look specifically at the issue of adverse required to establish an HCP or NCCP/ Riverside MSHCP as evidenced by the modification to critical habitat, unless HCP. The public has also been informed November 5, 2002, passage of a local critical habitat has already been through the public participation that bond measure to fund the acquisition of designated within the proposed plan occurs in the development of many land in support of the MSHCP. On area, it will determine if the HCP regional HCPs or NCCP/HCPs. For these November 14, 2002, a Notice of jeopardizes the species in the plan area. reasons, we believe that proposing Availability of a Draft Environmental The jeopardy analysis is similar to the critical habitat has little benefit in areas Impact Report (EIS/EIR) and Receipt of analysis of adverse modification to covered by HCPs, provided that the HCP and Application for an Incidental Take critical habitat. In addition, Federal or NCCP/HCP specifically and Permit was published in the Federal actions not covered by the HCP in areas adequately covers the species for which Register. Public comment on these occupied by listed species would still critical habitat is being proposed. We do documents was accepted until January require consultation under section 7 of not believe that this exclusion would 14, 2003. Subsequently, on June 17, the Act. HCP and NCCP/HCPs typically result in the extinction of the species. 2003, the County of Riverside Board of provide for greater conservation benefits Should additional information Supervisors voted unanimously to to a covered species than section 7 become available that changes our support the completion of the Western consultations because HCPs and NCCP/ analysis of the benefits of excluding any Riverside MSHCP. HCPs assure the long-term protection of these areas compared to the benefits The Western Riverside MSHCP and management of a covered species of including them in the critical habitat indicates that conservation actions and its habitat, and funding for such designation, we may revise this final within their planning area will be management through the standards designation accordingly. Maps implemented such that the long-term found in the 5 Point Policy for HCPs (64 delineating essential habitat for the conservation of the Riverside fairy FR 35242) and the HCP ‘‘No Surprises’’ California red-legged frog, overlaid with shrimp will be addressed. Although the regulation (63 FR 8859). Such the planning area for the San Joaquin MSHCP is not yet completed and assurances are typically not provided by County MSHCP, are available for public implemented, significant progress has section 7 consultations, which, in review and comment at the Sacramento been achieved in the development of contrast to HCPs, often do not commit Fish and Wildlife Office (see ADDRESSES this HCP, including the preparation of the project proponent to long-term section) or on the Internet at http:// the EIS/EIR, the solicitation of public special management or protections. sacramento.fws.gov. These maps are review and comment, and the initiation Thus, a consultation typically does not provided to allow the public the of a consultation with us on the accord the lands it covers the extensive opportunity to adequately comment on issuance of incidental take permits for benefits a HCP or NCCP/HCP provides. these exclusions. those species identified for coverage The development and implementation within the draft plan. Relationship of Critical Habitat to the of HCPs or NCCP/HCPs provide other We are excluding a portion of Unit 30 Draft Western Riverside Multiple important conservation benefits, from proposed critical habitat for the Species Habitat Conservation Plan including the development of biological California red-legged frog pursuant to (MSHCP) information to guide the conservation section 4(b)(2) of the Act because it is efforts and assist in species The Draft Western Riverside Multiple within the planning area boundary for conservation, and the creation of Species Habitat Conservation Plan the proposed Western Riverside innovative solutions to conserve species (MSHCP) has been in development for MSHCP. Our analysis for excluding the while allowing for development. several years. Participants in this HCP portion of Unit 30 within the planning include 14 cities; the County of area boundary for the Western Riverside Benefits of Exclusion Outweigh the Riverside, including the Riverside MSHCP from proposed critical habitat is Benefits of Inclusion County Flood Control and Water outlined below. We have reviewed and evaluated Conservation Agency, Riverside County HCPs and NCCP/HCPs currently Transportation Commission, Riverside Benefits of Inclusion approved and implemented within the County Parks and Open Space District, As stated previously, the benefits of areas being proposed as critical habitat and Riverside County Waste designating critical habitat on lands for the California red-legged frog. Based Department; the California Department within the boundaries of approved on this evaluation, we find that the of Parks and Recreation; and the HCPs are small. Where HCPs are in benefits of exclusion of the lands California Department of place that include coverage for the essential to the conservation of the Transportation. The Western Riverside California red-legged frog, the HCPs and California red-legged frog in the MSHCP is also being proposed as a their IAs include management measures planning area for the San Joaquin subregional plan under the State’s NCCP and protections designed to protect, County MSHCP outweigh the benefits of and is being developed in cooperation restore, monitor, manage, and enhance proposing portions of Unit 15 as critical with the California Department of Fish the habitat to benefit the conservation of habitat. and Game. Within the 1.26 million-acre the species. The Western Riverside The exclusion of these lands from (510,000 ha) planning area of the MSHCP seeks to accomplish these goals critical habitat will help preserve the MSHCP, approximately 153,000 ac for the California red-legged frog partnerships that we have developed (62,000 ha) of diverse habitats are through the implementation of specific with the local jurisdiction and project proposed for conservation. The conservation objectives. The principal proponent in the development of the proposed conservation of 153,000 ac benefit of designating critical habitat is HCP and NCCP/HCP. The educational (62,000 ha) will complement other that federally authorized or funded

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activities that may affect a species’ look specifically at the issue of adverse required to establish a HCP or NCCP/ critical habitat would require modification to critical habitat, unless HCP. The public has also been informed consultation with us under section 7 of critical habitat has already been through the public participation that the Act. In the case of the proposed designated within the proposed plan occurs in the development of many Western Riverside MSHCP, we must area, it will determine if the HCP regional HCPs or NCCP/HCPs. For these evaluate the impact of the plan on the jeopardizes the species in the plan area. reasons, we believe that proposing species for which the participants are The jeopardy analysis is similar to the critical habitat has little benefit in areas seeking incidental take permits, analysis of adverse modification to covered by HCPs, provided that the HCP pursuant to section 7 of the Act. critical habitat. In addition, Federal or NCCP/HCP specifically and actions not covered by the HCP in areas adequately covers the species for which Benefits of Exclusion occupied by listed species would still critical habitat is being proposed. We do The benefits of excluding lands require consultation under section 7 of not believe that this exclusion would within HCPs from critical habitat the Act. HCP and NCCP/HCPs typically result in the extinction of the species. designation include relieving provide for greater conservation benefits In the event that the Western landowners, communities, and counties to a covered species than section 7 Riverside MSHCP is not found to benefit of any additional regulatory burden that consultations because HCPs and NCCP/ the California red-legged frog and the might be imposed by critical habitat. HCPs assure the long-term protection coverage for this species is not granted, Many HCPs, particularly large regional and management of a covered species we will include the areas essential to HCPs take many years to develop and, and its habitat, and funding for such the conservation of the California red- upon completion, become regional management through the standards legged frog in Unit 30 in the final conservation plans that are consistent found in the 5 Point Policy for HCPs (64 designation of Critical Habitat. with the recovery objectives for listed FR 35242) and the HCP ‘‘No Surprises’’ Maps delineating essential habitat for species that are covered within the plan regulation (63 FR 8859). Such the California red-legged frog, overlaid area. Additionally, many of these HCPs assurances are typically not provided by with the planning area for the Western provide conservation benefits to section 7 consultations that, in contrast Riverside MSHCP are available for unlisted, sensitive species. Imposing an to HCPs, often do not commit the public review and comment at the additional regulatory review after an project proponent to long-term special Sacramento Fish and Wildlife Office HCP is completed solely as a result of management or protections. Thus, a (see ADDRESSES section) or on the the designation of critical habitat may consultation typically does not accord Internet at http://sacramento.fws.gov/es/ undermine conservation efforts and the lands it covers the extensive benefits documents. These maps are provided to partnerships in many areas. In fact, it a HCP or NCCP/HCP provides. The allow the public the opportunity to could result in the loss of species’ development and implementation of adequately comment on these benefits if participants abandon the HCPs or NCCP/HCPs provide other exclusions. voluntary HCP process because it may important conservation benefits, Critical Habitat Designation result in additional regulations including the development of biological requiring more of them than other information to guide the conservation The areas we are proposing as critical parties who have not voluntarily efforts and assist in species habitat currently provide all of those participated in species conservation. conservation, and the creation of habitat components necessary to meet Designation of critical habitat within the innovative solutions to conserve species the primary biological needs of the boundaries of approved HCPs could be while allowing for development. California red-legged frog, as described viewed as a disincentive to those in the final Recovery Plan (Service entities currently developing HCPs or Benefits of Exclusion Outweigh the 2002), and defined by the primary contemplating them in the future. Benefits of Inclusion constituent elements. We did not A related benefit of excluding lands We have reviewed and evaluated include all areas currently occupied by within HCPs from critical habitat HCPs and NCCP/HCPs currently California red-legged frogs, only areas designation is the unhindered, approved and implemented within the possessing large populations, continued ability to seek new areas being proposed as critical habitat representing unique ecological partnerships with future HCP for the California red-legged frog. Based characteristics, or representing historic participants including states, counties, on this evaluation, we find that the geographic area where California red- local jurisdictions, conservation benefits of exclusion the lands essential legged frogs can be re-established. organizations, and private landowners, to the conservation of the California red- In selecting areas of critical habitat, which together can implement legged frog in the planning area for the we made an effort to avoid developed conservation actions that we would be proposed and pending Western areas, such as towns and other similar unable to accomplish otherwise. If lands Riverside MSHCP outweigh the benefits lands that are not likely to contribute to within HCP plan areas are designated as of proposing portions of Unit 30 as California red-legged frog conservation. critical habitat, it would likely have a critical habitat. However, the minimum mapping unit negative effect on our ability to establish The exclusion of these lands from that we used to approximate our new partnerships to develop HCPs, critical habitat will help preserve the delineation of critical habitat for particularly large, regional HCPs that partnerships that we have developed California red-legged frogs did not allow involve numerous participants and with the local jurisdiction and project us to exclude all developed areas such address landscape-level conservation of proponent in the development of the as roads and rural developed areas or species and habitats. By preemptively HCP and NCCP/HCP. The educational other lands. Existing features and excluding these lands, we preserve our benefits of critical habitat, including structures within the boundaries of the current partnerships and encourage informing the public of areas that are mapped units, such as buildings, roads, additional conservation actions in the essential for the long-term survival and aqueducts, railroads, other paved areas, future. conservation of the species is still lawns, and other urban landscaped Furthermore, an HCP or NCCP/HCP accomplished from material provided areas, and uplands removed from application must itself be consulted on our website and through public essential aquatic and dispersal habitat, upon. While this consultation will not notice and comment procedures are not likely to contain the primary

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constituent elements essential for the land ownership. Proposed critical Santa Clara, Santa Cruz, Solano, conservation of the California red-legged habitat for the California red-legged frog Sonoma, Stanislaus, Tehama, frog. Therefore, Federal actions limited includes approximately 1,674,582 ha Tuolumne, and Ventura Counties, to these areas would not trigger a (4,140,440 ac) in Alameda, Butte, Contra California. These total numbers also section 7 consultation, unless they affect Costa, El Dorado, Fresno, Kern, Los include the specific areas excluded as the species and/or primary constituent Angeles, Marin, Mariposa, Merced, discussed above. A brief description of elements in adjacent critical habitat. Monterey, Napa, Plumas, Riverside, San each proposed critical habitat unit is Table 1 shows the approximate area of Benito, San Diego, San Joaquin, San given below. proposed critical habitat by county and Luis Obispo, San Mateo, Santa Barbara,

TABLE 1.—APPROXIMATE AREA ENCOMPASSING PROPOSED CRITICAL HABITAT IN HECTARES (HA) (ACRES (AC)) BY COUNTY AND LAND OWNERSHIP

County Federal land Local/state land Private land Total

Plumas ...... 22,904 ha ...... NA ...... 2,458 ha ...... 25,362 ha (56,598 ac) ...... (6,074 ac) ...... (62,672 ac) Butte ...... 15,115 ha ...... 135 ha ...... 6,305 ha ...... 21,555 ha (37,350 ac) ...... (335 ac) ...... (15,582 ac) ...... (53,267 ac) El Dorado ...... 8,624 ha ...... 10 ha ...... 15,456 ha ...... 24,090 ha (21,312 ac) ...... (26 ac) ...... (38,193 ac) ...... (59,531 ac) Tuolumne ...... 49,054 ha ...... NA ...... NA ...... 49,054 ha (121,216 ac) ...... (121,216 ac) Mariposa ...... 1,262 ha ...... NA ...... NA ...... 1,262 ha (3,120 ac) ...... (3,120 ac) Tehama ...... 2,727 ha ...... NA ...... 12,771 ha ...... 15,498 ha (6,740 ac) ...... (31,560 ac) ...... (38,300 ac) Napa ...... 2,151 ha ...... 758 ha ...... 20,056 ha ...... 22,965 ha (5,317 ac) ...... (1,874 ac) ...... (49,562 ac) ...... (56,753 ac) Sonoma ...... NA ...... 819 ha ...... 7,154 ha ...... 7,973 ha ...... (2,025 ac) ...... (17,678 ac) ...... (19,703 ac) Solano ...... 826 ha ...... 67 ha ...... 9,765 ha ...... 10,658 ha (2,042 ac) ...... (168 ac) ...... (24,130 ac) ...... (26,340 ac) Marin ...... 30,247 ha ...... 4,846 ha ...... 45,649 ha ...... 80,742 ha (74,742 ac) ...... (11,976 ac) ...... (112,802 ac) ...... (199,520 ac) Alameda ...... 337 ha ...... 1,853 ha ...... 95,404 ha ...... 97,594 ha (833 ac) ...... (4,581 ac) ...... (235,750 ac) ...... (241,164 ac) Contra Costa ...... 47 ha ...... 7,618 ha ...... 47,676 ha ...... 55,341 ha (117 ac) ...... (18,826 ac) ...... (117,810 ac) ...... (136,753 ac) Santa Clara ...... 2,298 ha ...... 15,563 ha ...... 69,941 ha ...... 87,802 ha (5,678 ac) ...... (38,459 ac) ...... (172,828 ac) ...... (216,966 ac) San Joaquin ...... NA ...... 38 ha ...... 11,386 ha ...... 11,424 ha ...... (96 ac) ...... (28,136 ac) ...... (28,232 ac) Stanislaus ...... 27 ha ...... 10,809 ha ...... 5,824 ha ...... 16,660 ha (67 ac) ...... (26,711 ac) ...... (14,392 ac) ...... (41,170 ac) Merced ...... 1,010 ha ...... 2,627 ha ...... 66,880 ha ...... 70,517 ha (2,496 ac) ...... (6,493 ac) ...... (165,266 ac) ...... (174,255 ac) Fresno ...... 6,807 ha ...... NA ...... 3,058 ha ...... 9,865 ha (16,822 ac) ...... (7,557 ac) ...... (24,379 ac) San Benito ...... 11,826 ha ...... NA ...... 102,340 ha ...... 114,166 ha (29,224 ...... (252,888 ...... (282,112 ac) San Mateo ...... 418 ha ...... 9,785 ha ...... 67,711 ha ...... 77,914 ha (1,033 ac) ...... (24,180 ac) ...... (167,319 ...... (192,532 ac) Santa Cruz ...... 137 ha ...... 10,059 ha ...... 32,773 ha ...... 42,969 ha (340 ac) ...... (24,858 ac) ...... (80,985 ac) ...... (106,183 ac) Monterey ...... 18,604 ha ...... 1,487 ha ...... 135,419 ha ...... 155,510 ha (45,972 ac) ...... (3,675 ac) ...... (334,629 ac) ...... (384,276 ac) San Luis Obispo ...... 11,010 ha ...... 2,050 ha ...... 203,916 ha ...... 216,976 ha (27,208 ac) ...... (5,068 ac) ...... (503,889 ac) ...... (536,165 ac) Kern ...... 473 ha ...... NA ...... 12,148 ha ...... 12,621 ha (1,171 ac) ...... (30,021 ac) ...... (31,192 ac) Santa Barbara ...... 79,365 ha ...... 1,134 ha ...... 123,083 ha ...... 203,582 ha (196,117 ac) ...... (2,804 ac) ...... (304,147 ac) ...... (503,068 ac) Ventura ...... 104,547 ha ...... NA ...... 6,458 ha ...... 111,005 ha (258,343 ac) ...... (15,959 ac) ...... (274,302 ac) Los Angeles ...... 76,927 ha ...... 4,961 ha ...... 26,269 ha ...... 108,157 ha (190,091 ac) ...... (12,261 ac) ...... (64,914 ac) ...... (267,266 ac) Riverside ...... 11,829 ha ...... NA ...... 6,784 ha ...... 18,613 ha (29,232 ac) ...... (16,764 ac) ...... (45,996 ac) San Diego ...... 4,296 ha ...... NA ...... 410 ha ...... 4,706 ha (10,616 ac) ...... (1,015 ac) ...... (11,631 ac)

Total ...... 463,438 ha ...... 74,949 ha ...... 1,147,070 ha ...... 1,674,582 ha (1,145,211 ac) ...... (185,229 ac) ...... (2,834,503 ac) ...... (4,138,064 ac)

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Unit 1. North Fork Feather Unit Mariposa Counties. The unit Annadel State Park in Sonoma County. Unit 1 consists of drainages found encompasses approximately 50,316 ha The unit encompasses approximately within the North Fork Feather River (124,336 ac), of which 100 percent is 2,559 ha (6,326 ac), of which drainage. The unit encompasses managed by Stanislaus National Forest approximately 76 percent is privately approximately 46,917 ha (115,939 ac). or the National Park Service (NPS). owned and 24 percent is managed by The North Fork Feather unit is the Historically, California red-legged frogs the California Department of Parks and northeasternmost of the critical habitat were found in several locations in Unit Recreation (CDPR). Unit 8 is occupied units. This unit is located in Plumas and 5 and in adjacent areas, including two by one known core population of Butte Counties. Approximately 81 historical occurrences from 1984. California red-legged frogs (Cook 1997). percent of the unit consists of Federal Although this unit currently is This area represents a source population lands managed by Plumas and Lassen considered unoccupied, it contains all with potential linkage to the Sears Point National Forests, and the majority of the of the constituent elements and is in unit as well as units to the west. remaining area is privately owned. need of special management practices that include the eradication of Unit 9. Stebbins Cold Canyon Preserve California red-legged frogs have been Unit documented in the French Creek nonnative predators in suitable breeding watershed in Butte County. This habitat. This area is a candidate for Unit 9 consists of drainages found population represents one of only three reestablishment, and is within a core within and adjacent to Stebbins Cold existing populations in the Sierra recovery area as defined in the draft Canyon Preserve and the Quail Ridge Nevada. This unit is in need of special Recovery Plan and considered essential Wilderness Preserve in Napa and Solano management, including the eradication to the conservation of California red- Counties. The unit is comprised of of exotic predators in suitable breeding legged frogs in the Sierra Nevada. watersheds that form Capell Creek, habitat adjacent to documented Unit 6. Headwaters of Cottonwood including Wragg Canyon, Markley breeding habitats. Other necessary Creek Unit Canyon, Steel Canyon, and Wild Horse management may include re- Canyon watersheds. The unit Unit 6 consists of drainages found establishment of red-legged frogs within encompasses approximately 8,589 ha within the headwaters of Cottonwood the area; however, natural (21,227 ac), of which approximately 75 and Red Bank Creeks in Tehama recolonization is likely to occur if percent is privately owned and 25 County. The unit encompasses nonnative predators are removed. percent is managed by the University of approximately 15,498 ha (38,300 ac), of California Natural Reserve System, the Unit 2 which approximately 18 percent is Quail Ridge Wilderness Conservancy, within the boundaries of the Mendocino Unit 2 is an artifact of the previous and the Bureau of Land Management National Forest; the majority of the proposed designation of critical habitat (BLM). Unit 9 represents one of the remaining 82 percent is privately for the California red-legged frog. There historic occurrences of California red- owned. Unit 6 is occupied by a is no Unit 2 in this current proposal. legged frogs in this area, and represents population known from CNDDB (2000) an important link between populations Unit 3. Weber Creek/Cosumnes Unit records. No additional sightings have in Marin County and populations on the been reported from the area. This area Unit 3 consists of drainages in the east side of the Coast Range. Weber Creek and North Fork Cosumnes contains all of the constituent elements River watersheds in El Dorado County. and is essential in that it represents the Unit 10. Sears Point Unit The unit encompasses approximately northernmost population of California Unit 10 consists of Stage Gulch and 24,090 ha (59,531 ac), of which 36 red-legged frogs within the Coast Range. Lower Petaluma River watersheds, percent is within the El Dorado National This area has not been adequately tributaries to the Petaluma River. This Forest and 64 percent is privately surveyed and additional populations unit is located in and adjacent to Sears owned. California red-legged frogs have may be present. This population may be Point in Sonoma and Marin Counties been documented in the Weber Creek used as a source population to provide and encompasses approximately 4,358 watershed. This population represents natural reestablishment in the northern ha (10,771 ac), all of which is privately one of only three existing populations in portion of the Coast Range. owned. Unit 10 is occupied by several the Sierra Nevada. This unit requires Unit 7. Cleary Preserve Unit subpopulations. Essential breeding special management, including the habitat is dispersed throughout the unit, eradication of exotic predators in Unit 7 consists of drainages found and has been documented in several suitable breeding habitat adjacent to within the watersheds that form the ponds and streams. This unit provides documented breeding habitats. Other tributaries to Pope Creek in Napa linkages to the units to the north, east, necessary management may include re- County. The unit encompasses and west. establishment of red-legged frogs within approximately 13,793 ha (34,087 ac), of the area; however, natural which approximately 88 percent is Unit 11. American Canyon Unit recolonization is likely to occur if privately owned; the remaining 12 nonnative predators are removed. percent is managed by Federal or State Unit 11 consists of watersheds within agencies. Unit 7 represents one of the and adjacent to American Canyon Creek Unit 4 few documented occurrences of and Sulphur Springs Creek in Napa and Unit 4 is an artifact of the previous California red-legged frogs in this area Solano Counties. Watersheds within proposed designation of critical habitat (McGinnis 2001) and represents an this unit include Fagan Creek, a for the California red-legged frog. There important link between populations in tributary to the Napa River, the Jameson is no Unit 4 in this current proposal. Marin County and populations on the Canyon watershed, and the Sky Valley east side of the Coast Range. and Pine Lake watersheds that flow into Unit 5. Yosemite Unit Lake Herman. The unit encompasses Unit 5 consists of drainages found in Unit 8. Annadel State Park Preserve approximately 11,240 ha (27,779 ac), of the tributaries of the Tuolumne River Unit which 99 percent is privately owned. and Jordan Creek, a tributary to the Unit 8 consists of the Upper Sonoma Unit 11 is occupied by several Merced River, in Tuolumne and Creek watershed found partially within subpopulations.

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Unit 12. Point Reyes Unit with several large core subpopulations, populations to the north and Unit 12 consists of watersheds within including the population within CCWD populations in southern Monterey and adjacent to Bolinas Lagoon, Point and EBRPD lands, and essential County and northern San Luis Obispo Reyes, and Tomales Bay in Marin and breeding habitat is located throughout County. the unit. Sonoma Counties. This unit Unit 20. Estrella River/Cholame Creek encompasses approximately 81,168 ha Unit 16. Pajaro River Unit Unit (200,572 ac); 44 percent is managed by Unit 16 consists of portions of two Unit 20 consists of the drainages the NPS, CDPR, and the Marin watersheds that are part of the Pajaro comprising the Cholame Creek, Estrella Municipal Water District, and 56 percent is privately owned. Unit 12 is River Drainage, the Flint Hills River, and the Saw Tooth Ridge occupied with several populations watershed in San Benito County, and watersheds in Monterey, San Luis known primarily through research by G. the Santa Clara Valley watershed in Obispo, and Kern Counties. The unit Fellers, BRD (Service files). Essential Santa Clara and San Benito Counties. encompasses approximately 159,576 ha breeding habitat is dispersed throughout The unit encompasses approximately (394,325 ac), of which 99 percent is the unit. This unit contains one of the 19,524 ha (48,247 ac) and is all privately privately owned and the remaining 1 largest known populations of California owned. Unit 16 is occupied and is an percent is federally managed. Unit 20 is red-legged frogs. essential unit in providing connectivity occupied by a large population. The from the outer coast plain and ranges to unit contains areas in a unique Unit 13. Tiburon Peninsula Unit the inner Coast Ranges. ecological setting of springs, wetlands and vernal pools in a very dry ecological Unit 13 consists of the Belvedere Unit 17. Elkhorn Slough/Salinas River setting. This unit also provides Lagoon watershed within and adjacent Unit to the Tiburon Peninsula in Marin connectivity between inner and outer County. The unit encompasses Unit 17 consists of coastal drainages Coast Ranges and into the Transverse approximately 628 ha (1,554 ac), all of of southern Santa Cruz and northern Ranges. which is privately owned. Unit 12 is Monterey Counties. The unit is located in Santa Cruz, Monterey, and San Unit 21. San Simeon Unit/Morro Bay occupied by one known breeding Unit population known from CNDDB (2000) Benito Counties. The unit encompasses records. approximately 66,799 ha (165,067 ac), of Unit 21 consists of the coastal which 93 percent is privately owned; watersheds of San Luis Obispo County Unit 14. San Mateo/Northern Santa CDPR and the Elkhorn Slough National from Arroyo de la Cruz south to Los Cruz Unit Estuarine Research Reserve manage the Osos Creek. The unit encompasses Unit 14 consists of coastal watersheds remaining 7 percent. Unit 17 is approximately 84,757 ha (209,445 ac), of within San Mateo County and northern occupied and provides connectivity which 94 percent is privately owned; Santa Cruz County that drain into the from the coastal plain and outer coast the remaining 6 percent is managed by Pacific Ocean. The unit encompasses ranges to the inner coast ranges. The CDPR and Federal agencies. Unit 21 is approximately 96,296 ha (237,955 ac), of unit represents a unique ecological set occupied and contains several core which 83 percent is privately owned; in that it is a large estuary/freshwater populations of California red-legged the remaining 17 percent is primarily slough system not typically found on frogs. This unit also supports a unique managed by the San Francisco Public the California coast. ecological setting, representative of the Utilities Commission (SFPUC) and central coastal oak savannah grassland. Unit 18. Carmel River Unit CDPR. Unit 14 is occupied by several This unit also provides connectivity core subpopulations known from Unit 18 consists of drainages from the outer Coast Range in Monterey various sources including formal comprising the Carmel River watershed County into the Transverse Ranges in consultations with the U.S. Army Corps in Monterey County. This unit San Luis Obispo and Santa Barbara of Engineers (Corps) (Service files). encompasses approximately 62,976 ha Counties. Essential breeding habitat is dispersed (155,620 ac), of which approximately 26 Unit 22. Lopez Lake/Arroyo Grande throughout the unit; populations have percent is managed by the Los Padres been documented in ponds and National Forest and CDPR, while the Creek Unit wetlands throughout Unit 14. This area remaining 74 percent is privately Unit 22 consists of the watersheds of contains numerous areas with large owned. Unit 18 is occupied, and Arroyo Grande Creek and its tributaries populations including Pescadero Marsh, populations of California red-legged in San Luis Obispo County. The unit and watersheds to the south. frogs are found throughout the drainage encompasses approximately 34,500 ha from the headwaters to the coast. This (85,254 ac), of which 79 percent is Unit 15. East Bay/Diablo Range Unit unit provides connectivity from the privately owned and Los Padres Unit 15 consists of watersheds within Elkhorn Slough unit to the more National Forest and BLM manage the Contra Costa, Alameda, San Joaquin, southern coastal units. remaining 21 percent. Unit 22 is Santa Clara, Stanislaus, San Benito, occupied and provides habitat Unit 19. The Pinnacles Unit Merced, and Fresno Counties. The unit connectivity from the San Simeon Unit- encompasses approximately 426,480 ha Unit 19 consists of two watersheds, Morro Bay Unit down into the Sisquoc (1,053,850 ac), of which 87 percent is Gloria Lake and George Hansen Canyon, River Unit and Transverse Range. privately owned; the remaining 13 in San Benito and Monterey Counties. percent is managed, in part, by East Bay This unit encompasses approximately Unit 23. Coastal Dunes Unit Regional Park District (EBRPD), East Bay 11,051 ha (27,309 ac), of which 57 Unit 23 consists of coastal watersheds Municipal Utilities District (EBMUD), percent is managed by the NPS and comprising the coastal dune ponds from Contra Costa Water District (CCWD), BLM; the remaining 43 percent is Arroyo Grande south to San Antonio U.S. Bureau of Reclamation (BOR), U.S. privately owned. Unit 19 is occupied Creek in San Luis Obispo and Santa Department of Energy (DOE), CDPR, and is representative of the inner coast Barbara Counties. The unit encompasses SFPUC, CDFG, Santa Clara Valley Water range. The unit provides connectivity approximately 21,358 ha (52,782 ac), of District, and DWR. Unit 15 is occupied between the Pajaro River and other which 3 percent is managed by Federal,

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State, and local municipalities California. Populations in this unit may recovery unit. Unit 29 contains all of the (primarily Service and CDPR), with the play an important role in stabilizing constituent elements, in addition it remaining 97 percent in private populations in tributaries to the Santa supports a habitat mosaic of coastal sage ownership. Unit 23 is occupied and Ynez River, which is affected by scrub, coast live oak woodlands, and represents a core population occupying agriculture, water management, and grasslands that is substantially different a unique coastal dune system. This unit non-native species. from habitat contained in other units. also provides connectivity between the Unit 27. Matilija/Sespe/Piru Creek Unit Unit 30. Santa Rosa Plateau/Santa Ana Lopez Lake/Arroyo Grande Creek Unit Mountains Unit down into the Santa Ynez River Unit. This unit consists of watersheds that comprise portions of the Matilija, Sespe, This unit consists of portions of the Unit 24. Santa Ynez River Unit and Piru Creek drainages in Santa watersheds comprising the Santa Rosa Unit 24 consists of watersheds Barbara, Ventura, and Los Angeles Plateau and the Santa Ana Mountains in forming the Santa Ynez River in Santa Counties. The unit encompasses Riverside and San Diego Counties, Barbara County. The unit encompasses approximately 126,955 ha (313,716 ac), including De Luz Creek, Murrieta, and approximately 98,744 ha (244,004 ac), of of which 96 percent is managed by the San Mateo Canyon watersheds. The unit which approximately 60 percent is Los Padres National Forest and 4 encompasses approximately 23,319 ha privately owned; the BOR and Los percent is privately owned. Unit 27 is (57,627 ac), of which approximately 69 Padres National Forest manage the occupied and provides connectivity percent is managed by the U.S. Forest remaining 40 percent. Unit 24 is across the Transverse Ranges from the Service (Forest Service), and occupied and contains core populations. Santa Ynez River Unit to the San approximately 31 percent is privately Frogs are found on the Santa Ynez River Francisquito-Amargosa Creek Unit. The owned (a portion of which is owned by from the headwaters to the estuary. The Sespe Creek area, which includes The Nature Conservancy). headwaters provide connectivity to the portions of the Sespe Wilderness and The unit includes habitat essential to Sisquoc River Unit and the Matilija/ provides the primary east-west the conservation of the California red- Sespe/Piru Creek Unit. This unit connectivity, currently supports large legged frog, and is within a core provides essential connectivity from numbers of bullfrogs and predatory fish recovery area, as defined in the draft coastal dune systems, up the Santa Ynez and is in need of special management. Recovery Plan. This unit contains a River to the headwaters of the small, genetically unique population on Unit 28. San Francisquito-Amargosa Transverse Range. The Nature Conservancy’s Santa Rosa Creek Unit Plateau Ecological Reserve (Reserve). Unit 25. Sisquoc River Unit This unit consists of San Francisquito This unit is the focal point of recovery Unit 25 consists of watersheds and Amargosa Creeks and the efforts essential for the conservation of forming the drainages of the Sisquoc intervening drainages in Los Angeles the California red-legged frog and its River in Santa Barbara County. These County, including all or parts of the genetic diversity in southern California. include the Cherokee Spring, Ernest Lancaster, Rock Creek, Acton, Bouquet The Reserve and adjacent watershed Blanco Spring, Horse Canyon, La Brea Eastern, Mint Canyon, and Sierra Pelona lands contain riparian habitat with the Creek, Manzano Creek, Peach Tree watersheds. The unit encompasses primary constituent elements essential Spring, and the Lower Sisquoc River approximately 42,851 ha (105,890 ac), of to the maintenance of the California red- watersheds. The unit encompasses which 80% percent is primarily legged frog population and the re- approximately 49,284 ha (121,785 ac), of managed by the Angeles National establishment of the subspecies in which 39 percent is privately owned, Forest; the remaining 20% percent is southern California. A recovery program and 61 percent is managed by the Los privately owned. Unit 28 is occupied, is currently being implemented on the Padres National Forest. Unit 25 is supporting a substantial core population Reserve that includes habitat occupied. This unit represents a core and may be a source population for restoration, nonnative species/predator population that provides connectivity units to the south and west. This unit removal, and augmentation of the red- from Lopez Lake/Arroyo Grande Creek also supports the only known legged frog population. Preliminary Unit into the westernmost portion of the population occupying a drainage discussions have been initiated with the Transverse Ranges. It is also the only flowing into the Mojave Desert. Cleveland National Forest concerning undammed river included as critical re-establishment of California red-legged Unit 29. Malibu Coastal Unit habitat in this region; for this reason, the frogs in the San Mateo watershed. threats of nonnative fish are minimal. This unit consists of the upper coastal Additionally, The Nature Conservancy watersheds in the Santa Monica has acquired lands between the current Unit 26. Coastal Santa Barbara Unit Mountains of Ventura and Los Angeles Reserve and Cleveland National Forest, Unit 26 consists of coastal tributaries Counties that drain into the Pacific and intends to acquire additional lands including the Bear Creek watershed, Ocean near Malibu, including the West in this corridor to add to the Reserve. east to and including the Ellwood Las Virgenes Canyon, Lindero Canyon, Habitat restoration, and nonnative Canyon watershed in Santa Barbara Sherwood, Triunfo Canyon, East Las predator management activities are County. The unit encompasses Virgenes Canyon, and Monte Nido being conducted in these areas, and approximately 39,977 ha (98,791 ac), of watersheds. The unit encompasses these lands are being evaluated for which 23 percent is managed by the Los approximately 21,235 ha (52,475 ac), of possible red-legged frog re- Padres National Forest and the CDPR; which approximately 67 percent is establishment. the remaining 77 percent is privately privately owned and 33 percent is owned. Unit 26 is occupied by managed in part by the NPS, CDPR, and Unit 31. Tujunga Unit numerous small populations. It contains local municipalities. Unit 29 contains This unit consists of portions of the a unique ecological setting: numerous one occupied drainage; California red- Tujunga watersheds in Los Angeles and relatively small watersheds along a legged frogs have likely persisted in this County. It encompasses approximately south-facing coastal terrace drain drainage because of its isolation from 29,744 ha (73,500 ac), of which 100 directly into the Pacific Ocean. This the nonnative predators that are percent is managed by the Angeles type of habitat is not found elsewhere in prevalent in most drainages in this National Forest. This unit contains

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habitat essential to the conservation of the Fifth Circuit (Sierra Club v. U.S. extensive redesign or relocation of the California red-legged frogs in southern Fish and Wildlife Service et al., 245 F.3d project. Costs associated with California and is within a core recovery 434), the Court found our definition of implementing a reasonable and prudent area as defined in the draft Recovery destruction or adverse modification to alternative are similarly variable. Plan. Red-legged frogs are not known to be invalid. In response to this decision, Regulations at 50 CFR 402.16 require currently occupy this unit, but we are reviewing the regulatory Federal agencies to reinitiate numerous populations have been definition of adverse modification in consultation on previously reviewed historically documented within the relation to the conservation of the actions in instances where critical boundaries of the unit and adjacent species. habitat is subsequently designated and Forest Service lands. This unit is a focal Section 7(a)(4) requires Federal the Federal agency has retained point for reestablishment of the agencies to confer with us on any action discretionary involvement or control California red-legged frog in southern that is likely to jeopardize the continued over the action or such discretionary California. Preliminary discussions have existence of a proposed species or result involvement or control is authorized by been initiated with the Angeles National in destruction or adverse modification law. Consequently, some Federal Forest concerning the re-establishment of proposed critical habitat. Conference agencies may request reinitiation of project, in addition to nonnative species reports provide conservation consultation or conference with us on management and habitat restoration. recommendations to assist the agency in actions for which formal consultation eliminating conflicts that may be caused has been completed, if those actions Effect of Critical Habitat Designation by the proposed action. The may affect designated critical habitat or Section 7 Consultation conservation recommendations in a adversely modify or destroy proposed conference report are advisory. critical habitat. The regulatory effects of a critical We may issue a formal conference Federal activities that may affect the habitat designation under the Act are report, if requested by the Federal action California red-legged frog, occupied triggered through the provisions of agency. Formal conference reports habitat, or its critical habitat will require section 7, which applies only to include an opinion that is prepared consultation under section 7. Activities activities conducted, authorized, or according to 50 CFR 402.14, as if critical on private, State, county, or lands under funded by a Federal agency (Federal habitat were designated. We may adopt local jurisdictions requiring a permit actions). Regulations implementing this the formal conference report as the from a Federal agency, such as Federal interagency cooperation provision of the biological opinion when critical habitat Highway Administration or Federal Act are codified at 50 CFR part 402. is designated, if no substantial new Emergency Management Act funding, or Individuals, organizations, States, local information or changes in the action a permit from the Corps under section governments, and other non-Federal alter the content of the opinion (see 50 404 of the Clean Water Act, will entities are not affected by the CFR 402.10(d)). continue to be subject to the section 7 designation of critical habitat unless If a species is listed or critical habitat consultation process. Federal actions their actions occur on Federal lands, is designated, section 7(a)(2) requires not affecting listed species or critical require Federal authorization, or involve Federal agencies to ensure that activities habitat, and actions on non-Federal Federal funding. they authorize, fund, or carry out are not lands that are not federally funded, Section 7(a)(2) of the Act requires likely to jeopardize the continued authorized, or permitted do not require Federal agencies, including us, to insure existence of such a species or to destroy section 7 consultation. that their actions are not likely to or adversely modify its critical habitat. Section 4(b)(8) of the Act requires us jeopardize the continued existence of a If a Federal action may affect a listed to evaluate briefly and describe, in any listed species or result in the species or its critical habitat, the proposed or final regulation that destruction or adverse modification of responsible Federal agency (action designates critical habitat, those designated critical habitat. This agency) must enter into consultation activities involving a Federal action that requirement is met through section 7 with us. Through this consultation, the may adversely modify such habitat or consultation under the Act. Our action agency would ensure that the that may be affected by such regulations define ‘‘jeopardize the permitted actions do not destroy or designation. We note that such activities continued existence’’ as to engage in an adversely modify critical habitat. may also jeopardize the continued action that reasonably would be If we issue a biological opinion existence of the species. expected, directly or indirectly, to concluding that a project is likely to Activities that, when carried out, reduce appreciably the likelihood of result in the destruction or adverse funded, or authorized by a Federal both the survival and recovery of a modification of critical habitat, we agency may directly or indirectly listed species in the wild by reducing would also provide reasonable and destroy or adversely modify critical the reproduction, numbers, or prudent alternatives to the project, if habitat for California red-legged frog distribution of that species (50 CFR any are identifiable. Reasonable and include, but are not limited to: 402.02). ‘‘Destruction or adverse prudent alternatives are defined at 50 (1) Sale, exchange, or lease of lands modification of designated critical CFR 402.02 as alternative actions managed by the BLM, BOR, Department habitat’’ is defined as a direct or indirect identified during consultation that can of Defense (DOD), DOE, NPS, or Forest alteration that appreciably diminishes be implemented in a manner consistent Service; the value of the critical habitat for both with the intended purpose of the action, (2) Regulation of activities affecting the survival and recovery of the species that are consistent with the scope of the waters of the United States by the Army (50 CFR 402.02). Such alterations Federal agency’s legal authority and Corps under section 404 of the Clean include, but are not limited to, adverse jurisdiction, that are economically and Water Act, with the exception of changes to the physical or biological technologically feasible, and that the maintenance activities on ponds located features, i.e., the primary constituent Service’s Regional Director believes on private lands for the express elements, that were the basis for would avoid the destruction or adverse purposes of maintaining the area to determining the habitat to be critical. modification of critical habitat. water stock; However, in a March 15, 2001, decision Reasonable and prudent alternatives can (3) Regulation of water flows, water of the United States Court of Appeals for vary from slight project modifications to delivery, damming, diversion, and

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channelization by the BOR and the listed plants and wildlife and inquiries requested. Requests for public hearings Corps or other water transfers, about prohibitions and permits may be must be made in writing 45 days diversion, or impoundment, addressed to the U.S. Fish and Wildlife following the publication of the groundwater pumping, irrigation Service, Branch of Endangered Species, proposal in the Federal Register. We activity that causes barriers or deterrents 911 N.E. 11th Ave, Portland, OR 97232 will schedule public hearings on this to dispersal, inundates or drains habitat, (telephone 503/231–2063; facsimile proposal, if any are requested, and will or significantly converts habitat; 503/231–6243). announce the dates, times and locations (4) Regulation of grazing, recreation, Economic Analysis of those hearings in the Federal Register mining, or logging by the BLM, BOR, and local newspapers at least 15 days DOD, or NPS; Section 4(b)(2) of the Act requires us prior to the first hearing. (5) Funding and implementation of to designate critical habitat on the basis disaster relief projects by the FEMA and of the best scientific and commercial Clarity of the Rule the Natural Resource Conservation data available, and to consider the Executive Order 12866 requires each Service’s Emergency Watershed economic, national security, and other agency to write regulations and notices Program, including erosion control, relevant impacts of designating a that are easy to understand. We invite flood control, streambank repair to particular area as critical habitat. We your comments on how to make this reduce the risk of loss of property; may exclude areas from critical habitat proposed rule easier to understand, (6) Funding and regulation of new upon a determination that the benefits including answers to questions such as road construction or road improvements of such exclusions outweigh the benefits the following: (1) Are the requirements by the FHA; of specifying such areas as critical in the proposed rule clearly stated? (2) (7) Funding of construction or habitat. We cannot exclude such areas Does the proposed rule contain development activities by the from critical habitat when such technical jargon that interferes with the Department of Housing and Urban exclusion will result in the extinction of clarity? (3) Does the format of the Development or other agencies that the species. proposed rule (groupings and order of destroy, fragment, or degrade suitable An analysis of the economic impacts the sections, use of headings, habitat; of proposing critical habitat for paragraphing, and so forth) aid or (8) Clearing of vegetation and California red-legged frog is being reduce its clarity? (4) Is the description hydrological modifications by the DOE prepared. We will announce the of the notice in the SUPPLEMENTARY or other agencies; and availability of the draft economic INFORMATION section of the preamble (9) Promulgation of air and water analysis as soon as it is completed, at helpful in understanding the proposed quality standards under the Clean Air which time we will seek public review rule? What else could we do to make Act and the Clean Water Act and the and comment. When published, copies this proposed rule easier to understand? clean up of toxic waste and superfund of the draft economic analysis will be Send a copy of any comments on how sites under the Resource Conservation available by contacting the Sacramento we could make this proposed rule easier and Recovery Act (RCRA) and the Fish and Wildlife Office directly (see to understand to: Office of Regulatory Comprehensive Environmental ADDRESSES section) or available for Affairs, Department of the Interior, Response, Compensation, and Liability downloading from the Internet at Room 7229, 1849 C Street, NW., Act by the EPA. http://sacramento.fws.gov/es/ Washington, DC 20240. You may e-mail With the exception of the two documents. unoccupied units, all lands proposed for your comments to this address: designation as critical habitat are within Peer Review [email protected]. the geographic range of the California In accordance with our joint policy Required Determinations red-legged frog and are occupied by the published in the Federal Register on Regulatory Planning and Review subspecies, and/or are likely to be used July 1, 1994 (59 FR 34270), we will seek by the subspecies, whether for foraging, the expert opinions of at least three In accordance with Executive Order breeding, growth of larvae and appropriate and independent specialists 12866, this document is a significant juveniles, intra-specific communication, regarding this proposed rule. The rule in that it may raise novel legal and dispersal, migration, genetic exchange purpose of this review is to ensure that policy issues, but it is not anticipated to and sheltering. Federal agencies already our critical habitat designation is based have an annual effect on the economy consult with us on activities in areas on scientifically sound data, of $100 million or more or affect the currently occupied by the subspecies, or assumptions, and analyses. We will economy in a material way. As such, the if the subspecies may be affected by the send these peer reviewers copies of this Office of Management and Budget action, to ensure that their actions do proposed rule immediately following (OMB) has reviewed this rule. The not jeopardize the continued existence publication in the Federal Register. We Service is preparing a draft economic of the subspecies. Furthermore, in will invite the selected peer reviewers to analysis of this proposed action. The unoccupied habitat, we are only comment, during the public comment Service will use this analysis to meet proposing to designate federally period, on the specific assumptions and the requirement of section 4(b)(2) of the managed land as critical habitat. Thus, conclusions regarding the proposed Act to determine the economic we do not anticipate substantial designation of critical habitat. consequences of designating the specific additional regulatory protection will We will consider all comments and areas as critical habitat and excluding result from the proposed critical habitat information received during the public any area from critical habitat if it is designation. comment periods on this proposed rule determined that the benefits of such If you have questions regarding during the preparation of a final exclusion outweigh the benefits of whether specific activities may rulemaking. Accordingly, the decision specifying such areas as part of the constitute adverse modification of may differ from this proposal. critical habitat, unless failure to critical habitat in California, contact the designate such area as critical habitat Field Supervisor, Sacramento Fish and Public Hearings will lead to the extinction of the Wildlife Office (see ADDRESSES section). The Act provides for one or more California red-legged frog. This analysis Requests for copies of the regulations on public hearings on this proposal, if will also be used to determine

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compliance with Executive Order $11.5 million in annual business, and economic impacts of the proposed 12866, Regulatory Flexibility Act, Small agricultural businesses with annual regulation to approximately 2,175,000 Business Regulatory Enforcement sales less than $750,000. To determine ha (5,373,650 ac), a significantly larger Fairness Act, and Executive Order if potential economic impacts to these area than was designated as final critical 12630. small entities are significant, we habitat for the California red-legged frog. This analysis will be made available considered the types of activities that In that analysis we additionally for public review and comment. Copies might trigger regulatory impacts under evaluated the potential effect of the may be obtained from the Sacramento this proposed rule as well as types of proposed regulation on small entities. Fish and Wildlife Office’s Internet Web project modifications that may result. In We determined in that analysis that site at http://sacramento.fws.gov/es/ general, the term significant economic small business in the construction, documents, or by contacting the impact is meant to apply to a typical development, mining, ranching and Sacramento Fish and Wildlife Office small business firm’s business timber industries could potentially be directly (see ADDRESSES section) operations. affected by proposed regulation if the To determine if this proposed rule Regulatory Flexibility Act (5 U.S.C. 601 designation leads to significant project would affect a substantial number of et seq.) modifications or delays associated with small entities, we considered the those activities. The results of the Under the Regulatory Flexibility Act number of small entities affected within analysis further suggested that if the (5 U.S.C. 601 et seq., as amended by the particular types of economic activities areas proposed as critical habitat were Small Business Regulatory Enforcement (e.g., housing development, oil and gas designated, it appeared unlikely that the Fairness Act (SBREFA) of 1996), production, timber harvesting etc.). We designation would lead to a significant whenever an agency is required to considered each industry individually increased number of consultations and publish a notice of rulemaking for any to determine if certification is project modifications (i.e., significant proposed or final rule, it must prepare appropriate. In estimating the numbers additional regulatory and/or economic and make available for public comment of small entities potentially affected, we burden) because the majority of the area a regulatory flexibility analysis that also considered whether their activities designated is considered occupied by describes the effect of the rule on small have any Federal involvement; some the species. As such, this rule is not entities (i.e., small businesses, small kinds of activities are unlikely to have expected to result in any significant organizations, and small government any Federal involvement and so will not regulatory restrictions in addition to jurisdictions). However, no regulatory be affected by the designation of critical those currently in existence. flexibility analysis is required if the habitat. Designation of critical habitat Many of the activities sponsored by head of an agency certifies the rule will only affects activities conducted, Federal agencies within critical habitat not have a significant economic impact funded, permitted or authorized by areas are carried out by small entities (as on a substantial number of small Federal agencies; non-Federal activities defined by the Regulatory Flexibility entities. are not affected by the designation. Act) through contract, grant, permit, or The SBREFA amended the Regulatory If this critical habitat designation is other Federal authorization. As Flexibility Act (RFA) to require Federal made final, Federal agencies must discussed above, these actions are agencies to provide a statement of the consult with us if their activities may already currently required to comply factual basis for certifying that a rule affect designated critical habitat. with the protections of the Act, and the will not have a significant economic Consultations to avoid the destruction designation of critical habitat is not impact on a substantial number of small or adverse modification of critical anticipated to have any additional entities. However, the SBREFA does not habitat would be incorporated into the effects on these activities. The analysis explicitly define ‘‘substantial number’’ existing consultation process. In areas did, however, recognize that to the or ‘‘significant economic impact.’’ where occupancy by California red- extent that these industries constitute Consequently, to assess whether a legged frog is unknown, the designation small business entities, there may be ‘‘substantial number’’ of small entities of critical habitat could trigger some costs resulting from the regulation. are affected by this proposed additional review of Federal agencies However, we did not believe that these designation, the following analysis pursuant to section 7 of the Act and may costs would reach the threshold for considers the relative number of small result in additional requirements on being considered significant economic entities likely to be impacted in an area. Federal activities to avoid destruction or impacts to a substantial number of small The SBREFA also amended the RFA to adverse modification of critical habitat. business entities. require a certification statement. There are two units (Unit 5 and Unit 31) In the development of our final According to the Small Business in this proposed designation that are designation of critical habitat, we Administration (SBA), small entities currently not known to be occupied by significantly modified our proposal include small organizations, such as the California red-legged frog. These such that only 1,674,582 ha (4,140,440 independent nonprofit organizations, units occur entirely on Federal lands or ac) were designated, a reduction of and small governmental jurisdictions, are managed by Federal agencies, the approximately 22 percent or 488,580 ha including school boards and city and Stanislaus National Forest and the NPS (1,206,330 ac) from the proposal. Of the town governments that serve fewer than (Unit 5) and Angeles National Forest approximate 1,674,582 ha (4,140,440 ac) 50,000 residents, as well as small (Unit 31). that were finalized and which are businesses (13 CFR 121.201). Small During the development of our last currently being proposed for businesses include manufacturing and designation of critical habitat for the designation as critical habitat for the mining concerns with fewer than 500 California red-legged frog, we conducted California red-legged frog, an estimated employees, wholesale trade entities an economic analysis of our proposed 5 percent or 81,020 ha (200,212 ac) is with fewer than 100 employees, retail designation (65 FR 54892, September considered unoccupied habitat (Units 5 and service businesses with less than $5 11, 2000) and made it available to the and 31). Because the scope of the final million in annual sales, general and public for review on December 21, 2000 designation and this new proposed heavy construction businesses with less (65 FR 80409). Because the scope of this designation is significantly less than than $27.5 million in annual business, analysis was the proposed critical that originally proposed in 2000 and special trade contractors doing less than habitat, it evaluated the potential analyzed, we believe that it is unlikely

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that this proposal, if finalized, would However, as discussed above, these proposal. The designation may have result in a significant economic impact actions are currently subject to some benefit to these governments in on a substantial number of small equivalent restrictions through the that the areas essential to the entities. We will further analyze this listing protections of the subspecies, conservation of the species are more when we conduct our analysis of the and no further restrictions are clearly defined, and the primary potential economic effects of this new anticipated. constituent elements of the habitat proposed designation of critical habitat (b) This rule will not produce a necessary to the survival of the species for the California red-legged frog. Federal mandate of $100 million or are specifically identified. While Therefore, based on the analysis greater in any year, that is, it is not a making this definition and conducted for our previous designation, ‘‘significant regulatory action’’ under the identification does not alter where and we are certifying that this proposed Unfunded Mandates Reform Act. The what federally sponsored activities may designation of critical habitat is not designation of critical habitat imposes occur, it may assist these local expected to have a significant adverse no obligations on State or local governments in long-range planning, impact on a substantial number of small governments. rather than forcing/necessitating them to entities, and an initial regulatory Takings wait for case-by-case section 7 flexibility analysis is not required. consultations to occur. This assessment of economic effect In accordance with Executive Order may be modified prior to publication of 12630, this rule is not anticipated to Civil Justice Reform a final rule, based on a review of the have significant takings implications. A In accordance with Executive Order draft economic analysis currently being takings implication assessment is not 12988, the Department of the Interior’s prepared pursuant to section 4(b)(2) of required. As discussed above, the Office of the Solicitor has determined the Act, Executive Order 12866, and designation of critical habitat affects that this proposed rule does not unduly public comments received during the only Federal actions. The rule will not burden the judicial system and meets public comment period. This analysis is increase or decrease the current the requirements of sections 3(a) and for the purposes of compliance with the restrictions on private property 3(b)(2) of the Order. We are proposing Regulatory Flexibility Act and does not concerning take of the California red- to designate critical habitat in reflect our position on the type of legged frog. Due to current public accordance with the provisions of the economic analysis required by New knowledge of the subspecies’ Endangered Species Act. The rule uses Mexico Cattle Growers Assn. v. U.S. protections, the prohibition against take standard property descriptions and Fish & Wildlife Service 248 F. 3d 1277 of the subspecies both within and identifies the primary constituent (10th Cir. 2001). outside of the designated areas, and the elements within the designated areas to fact that critical habitat provides no Executive Order 13211 assist the public in understanding the substantial incremental restrictions in habitat needs of the California red- On May 18, 2001, the President issued areas occupied by the California red- legged frog. an Executive Order 13211 (E.O. 13211) legged frog, we do not anticipate that on regulations that significantly affect property values will be affected by the Paperwork Reduction Act of 1995 (44 energy supply, distribution, and use. critical habitat designation. While real U.S.C. 3501 et seq.) E.O. 13211 requires agencies to prepare estate market values may temporarily This proposed rule does not contain Statements of Energy Effects when decline following designation, due to any information collection requirements undertaking certain actions. This the perception that critical habitat that require OMB approval under the proposed rule is considered by OMB to designation may impose additional Paperwork Reduction Act. An agency be a significant regulatory action under regulatory burdens on land use, we may not conduct or sponsor, and a E.O. 12866 in that it may raise novel expect any such impacts to be short person is not required to respond to, a legal and policy issues. However, we do term. Additionally, critical habitat collection of information unless it not anticipate that the proposed designation does not preclude displays a valid OMB Control Number. designation of critical habitat for the development of HCPs and issuances of California red-legged frog will incidental take permits. Owners of areas National Environmental Policy Act significantly affect energy supplies, that are included in proposed critical We have determined that we do not distribution, or use. Therefore, we do habitat will continue to have the need to prepare an Environmental not believe that this action is a opportunity to utilize their property in Assessment or an Environmental Impact significant action and no Statement of ways consistent with the survival of the Statement as defined by the National Energy Effects is required. We will California red-legged frog. Environmental Policy Act of 1969, in connection with regulations adopted further examine any potential effect in Federalism our economic analysis of this proposal. pursuant to section 4(a) of the Act. We In accordance with Executive Order published a notice outlining our reasons Unfunded Mandates Reform Act (2 13132, the rule does not have significant for this determination in the Federal U.S.C. 1501 et seq.) Federalism effects. A Federalism Register on October 25, 1983 (48 FR In accordance with the Unfunded assessment is not required. In keeping 49244). Mandates Reform Act (2 U.S.C. 1501 et with Department of the Interior and seq.): Department of Commerce policy, we Government-to-Government (a) This rule will not ‘‘significantly or requested information from and Relationship With Tribes uniquely’’ affect small governments. A coordinated development of this critical In accordance with the President’s Small Government Agency Plan is not habitat proposal with appropriate State memorandum of April 29, 1994, required. Small governments will be resource agencies in California. The ‘‘Government-to-Government Relations affected only to the extent that any impact of the proposed designation on with Native American Tribal programs having Federal funds, permits, State and local governments and their Governments’’ (59 FR 22951); Executive or other authorized activities must activities is not believed to be Order 13175 (November 9, 2000; 65 FR ensure that their actions will not significant. We will examine this more 67249) and DOI’s manual at 512 DM 2, adversely affect the critical habitat. fully in our economic analysis of the we readily acknowledge our

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responsibility to communicate and Wildlife Offices (see ADDRESSES Stanislaus, Tehama, Tuolumne, and Ventura meaningfully with recognized Federal section). Counties, California, on the maps below. Tribes on a government-to-government 2. Within these areas, the primary List of Subjects in 50 CFR Part 17 basis. constituent elements for the California red- We are not aware of any Tribal lands Endangered and threatened species, legged frog consist of three components: essential for the conservation of the Exports, Imports, Reporting and (a) Aquatic habitat with a permanent water California red-legged frog within the recordkeeping requirements, source with pools (i.e., water bodies) having Transportation. a minimum depth of 0.5 m (20 in) for areas proposed for designation as breeding and which can maintain water critical habitat. Therefore, this proposal Proposed Regulation Promulgation during the entire tadpole rearing season; does not contain any Tribal lands or (b) Upland areas up to 90 m (300 ft) from lands that we have identified as For the reasons outlined in the the water’s edge associated with the above impacting Tribal trust resources. preamble, we propose to amend part 17, aquatic habitat that will provide for shelter, subchapter B of chapter I, title 50 of the Relationship With Mexico forage, maintenance of the water quality of Code of Federal Regulations, as follows: the aquatic habitat, and dispersal; and We are not aware of any existing (c) Upland barrier-free dispersal habitat national-level regulatory mechanism in PART 17—[AMENDED] that is at least 90 m (300 ft) in width that Mexico that would protect the 1. The authority citation for part 17 connects two or more suitable breeding California red-legged frog or its habitat. continues to read as follows: locations defined by the aquatic habitat Although new legislation for wildlife is above, all within 2 km (1.25 mi) of one pending in Mexico, and Mexico has Authority: 16 U.S.C. 1361–1407; 16 U.S.C. another. 1531–1544; 16 U.S.C. 4201–4245; Pub. L. 99– 3. Existing features and structures within laws that could provide protection for 625, 100 Stat. 3500; unless otherwise noted. rare species, there are enforcement the boundaries of the mapped units, such as buildings, roads, aqueducts, railroads, other challenges. Even if specific protections 2. Amend § 17.95(d) by revising the introductory text of the critical habitat paved areas, lawns, and other urban were available and enforceable in landscaped areas, and uplands removed from Mexico, the portion of the California designation for the California red-legged frog (Rana aurora draytonii) to read as essential aquatic and dispersal habitat, will red-legged frog’s range in Mexico alone, not contain one or more of the primary in isolation, would not be adequate to follows: constituent elements and, therefore, would ensure the long-term conservation of the § 17.95 Critical habitat—fish and wildlife. not trigger a section 7 consultation, unless subspecies. they affect the species and/or primary * * * * * constituent elements in adjacent critical References Cited (d) Amphibians. habitat. A complete list of all references cited * * * * * 4. Map 1, Index map of critical habitat units for California Red-Legged Frog, follows: in this final rule is available upon CALIFORNIA RED-LEGGED FROG (Rana request from the Sacramento Fish and aurora draytonii) * * * * * Wildlife Office (see ADDRESSES section). 1. Critical habitat units are depicted for Dated: March 30, 2004. Authors Alameda, Butte, Contra Costa, El Dorado, Paul Hoffman, Fresno, Kern, Los Angeles, Marin, Mariposa, Acting Assistant Secretary of Fish and The primary authors of this notice are Merced, Monterey, Napa, Plumas, Riverside, Wildlife and Parks. Douglas Krofta of the Arlington Fish and San Benito, San Diego, San Joaquin, San Luis Wildlife Office and staff from the Obispo, San Mateo, Santa Barbara, Santa [FR Doc. 04–7693 Filed 4–12–04; 8:45 am] Carlsbad, Ventura, and Sacramento Fish Clara, Santa Cruz, Solano, Sonoma, BILLING CODE 4310–55–P

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Part III

Department of Health and Human Services Substance Abuse and Mental Health Services Administration

Mandatory Guidelines and Proposed Revisions to Mandatory Guidelines for Federal Workplace Drug Testing Programs; Notices

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DEPARTMENT OF HEALTH AND authority of section 503 of Pub. L. 100– donor may challenge the accuracy of a HUMAN SERVICES 71, 5 U.S.C. 7301 note, and E. O. No. validity testing result, and an expansion 12564. The Mandatory Guidelines were of the existing performance testing Substance Abuse and Mental Health first published in the Federal Register program and laboratory inspection Services Administration on April 11, 1988 (53 FR 11979), and program. revised on June 9, 1994 (59 FR 29908), Mandatory Guidelines for Federal and on November 13, 1998 (63 FR Provisions of the Proposed Revisions to Workplace Drug Testing Programs 63483). the Mandatory Guidelines AGENCY: Substance Abuse and Mental The Department is revising the 1. Definitions Health Services Administration, HHS. Mandatory Guidelines here concerning the determination of the validity of The proposed revisions added ACTION: Revised mandatory guidelines. urine specimens. In another document definitions specifically associated with specimen validity testing. These include SUMMARY: The Department of Health and published along with this revision, the Department is proposing to revise the the definitions for adulterated Human Services (‘‘HHS’’ or specimen, confirmatory validity test, ‘‘Department’’) is establishing standards Mandatory Guidelines again to add alternative specimens, instrumented dilute specimen, initial validity test, for determining the validity of urine invalid result, non-negative specimen, specimens collected under the initial test facilities, and point of collection testing. oxidizing adulterant, and substituted Mandatory Guidelines for Federal specimen. Workplace Drug Testing Programs. The alternative specimen proposal These standards ensure that specimen will be subject to a 90-day comment 2. SVT Requirement period after which the Department will validity testing (SVT) and reporting The proposed revisions require each procedures are uniformly applied to all consider the comments received and issue a final revision. Until the final Federal agency to have specimen Federal agency urine specimens when a validity tests conducted on all urine validity test is conducted. revision on alternative specimens is issued, the Mandatory Guidelines as specimens collected under the DATES: Effective Date: November 1, contained in this revision govern. Mandatory Guidelines. 2004. This revision becomes effective 180 3. Split Specimen Testing Comment Date: Submit comments on days after the date of publication so that or before June 14, 2004. laboratories have an opportunity to The proposed revisions grant the ADDRESSES: You may submit comments, purchase and become familiar with donor the right to request that a split identified by (insert docket number and/ testing equipment to be used in (Bottle B) specimen be tested to confirm or RIN number), by any of the following assessing the validity of a urine an adulteration or substitution result methods: specimen. that was reported by the primary • E-mail: [email protected]. Include The revision of the Guidelines is laboratory on the primary (Bottle A) docket number and/or RIN number in subject to further comment only on the specimen. the subject line of the message. creatinine criterion that is part of the 4. SVT Reporting Criteria • Fax: 301–443–3031. requirement to report a urine specimen • Mail: 5600 Fishers Lane, Rockwall as substituted because the Department The proposed revisions add a new II, Suite 815, Rockville, Maryland has based this criterion on information section, entitled ‘‘Validity Testing,’’ to 20857. received after the comment period the Mandatory Guidelines. The new • Hand Delivery/Courier: 5515 closed on October 22, 2001. section requires a laboratory to conduct Security Lane, Suite 815, Rockville, validity testing and establishes the Maryland 20852. II. Summary of the Proposed Revised criteria that must be used by a Instructions: All submissions received Mandatory Guidelines laboratory to report a specimen as must include the agency name and On August 21, 2001, HHS published adulterated, substituted, invalid, or docket number or Regulatory a notice in the Federal Register (66 FR dilute. Information Number (RIN) for this 43876), proposing that the Mandatory rulemaking. All comments will be Guidelines be revised to include 5. Cutoff Levels available for public review at 5515 standards for determining the validity of The proposed revisions establish a pH Security Lane, Suite 815, Rockville, urine specimens collected by Federal cutoff for reporting a specimen as Maryland 20852. agencies under the Federal Workplace adulterated and establish a creatinine FOR FURTHER INFORMATION CONTACT: Drug Testing Program. These proposed cutoff and a specific gravity cutoff for Walter F. Vogl, Ph.D., Division of revisions to the Mandatory Guidelines reporting a specimen as substituted. The Workplace Programs, CSAP, 5600 establish the analytical standards for creatinine concentration cutoff is Fishers Lane, Rockwall II, Suite 815, determining the validity of urine proposed to be less than 5 mg/dL. The Rockville, Maryland 20857, telephone specimens in order to ensure that SVT specific gravity cutoff is proposed to be (301) 443–6014, fax (301) 443–3031, or and reporting procedures are uniformly less than 1.002. The pH cutoff is e-mail: [email protected]. applied to all Federal agency urine proposed to be less than 3. specimens. Set forth below is a SUPPLEMENTARY INFORMATION: 6. Retesting description of the major provisions of I. Background the proposed revision of the Mandatory The proposed revisions require a The Mandatory Guidelines for Federal Guidelines, including, among other second laboratory to conduct validity Workplace Drug Testing Programs things, definitions for certain terms tests when it is unable to reconfirm the (Mandatory Guidelines) establish the associated with SVT, a discussion of the drug or drug metabolite that was scientific and technical guidelines for specific SVT requirements and how originally reported positive in a single Federal workplace drug testing validity testing results should be specimen or primary (Bottle A) programs and standards for certification reported, clarification of the specimen. The proposed revisions also of laboratories engaged in urine drug qualifications and responsibilities of a add criteria for retesting a specimen for testing for Federal agencies, under Medical Review Officer (MRO), how a adulterants and substitution.

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7. Quality Control a few days after the formal ending date. In reviewing different specimen The proposed revisions establish That proved to be unnecessary. The validity test procedures and methods, specific quality control criteria and Department received 23 public the Department learned from mistakes other procedural and test requirements comments by October 22nd on the made by participants. The Department for performing each individual validity proposed changes from Federal corrected these mistakes as they test. agencies, individuals, organizations, occurred, including making corrections laboratories, and companies that were or canceling test results in cases where 8. MRO Qualifications and Duties then made available for public view on laboratory inspectors, contractor staff, The proposed revisions clarify the our Internet Web site and Federal program staff were not qualifications and responsibilities of the (www.drugfreeworkplace.gov). All certain about the ability of a laboratory MRO and expand the MRO’s duties to written comments were reviewed and forensically to defend a test result in review adulteration, substitution, and taken into consideration in the court. This approach is a practice the invalid test results reported by a preparation of the revised Mandatory Department will continue. laboratory. Guidelines. Set forth below is an The Department has established these overview of the various comments and final requirements for SVT to produce 9. Donor’s Right To Challenge Results recommendations received and the the most accurate, reliable, and correctly The proposed revisions provide that a Department’s responses to those interpreted test results. In a national donor has the same right to challenge concerns. Similar comments are system that has reduced the number of the accuracy of a positive, adulterated, considered together. detected adulterated and substituted or substituted result reported for a Over the past several years, there has specimens to the current levels of about single specimen collection as for a split been an increasing number of chemical three one-hundredths of one percent of specimen collection. adulterants marketed on the Internet all federally mandated workplace tests and in counter-culture, pro-drug use performed in the past year, some may 10. HHS Notification of Results magazines. These adulterants are ask if it is worth the effort to prevent The proposed revisions state that an advertised as able to prevent this very small number of individuals MRO will notify the designated laboratories from detecting drugs or from masking their personal use of regulatory office that is responsible for metabolites in physiological specimens illicit drugs. The answer is yes. The the laboratory certification program (e.g., urine, hair, oral fluid) that are purpose of the entire program has been when a second laboratory fails to collected as part of a drug testing to prevent and deter the use of illicit reconfirm a positive, adulterated, or program. These products are often toxic drugs in the Federal workplace. It has substituted result reported by a first or corrosive and are sold to be added to been vitally important to always project laboratory. a specimen in order to mask the a sure and certain standard that Federal presence of any drugs or metabolites. 11. Performance Testing and Laboratory employees will be held personally Examples of adulterants include various Inspection Programs accountable regarding employment nitrites (Klear, Whizzies), pyridinium selection or even job retention should The proposed revisions expand the chlorochromate (Urine Luck, LL481, they choose to use illicit drugs. performance testing program and the Sweet Pee’s Spoiler), surfactant (Mary The Department intends to decrease laboratory inspection program. The Jane SuperClean 13), and acid (Amber- or remove opportunities to subvert a performance testing program will 13, THC–Free). As of this time, workplace drug test through these include performance testing samples to approximately 400 different products revisions to the Mandatory Guidelines challenge each certified laboratory’s (although many contain the same and will seek to hold all individuals ability to correctly perform validity adulterant) are available for adulterating accountable for their choices. tests. The inspection program will urine specimens. include inspecting and evaluating the Even more blatant are recent increases 1. Mandatory SVT (Paragraph 2.1(a)(4)) SVT procedures used by the laboratories in openly marketed promises to conceal The Department specifically in a manner similar to that for all other current illicit drug use by substituting a requested comments from Federal laboratory operations. ‘‘clean’’ urine specimen for the drug- agencies and employees covered by E.O. user’s ‘‘dirty’’ one. Some products 12564 and Pub. L. 100–71 regarding the III. Summary of Public Comments and actually advertise a prosthetic device in proposal to require SVT as part of their HHS’s Response a range of skin tones complete with drug testing programs. Only one Federal The August 21, 2001, Federal Register waistband, fluid reservoir, agency submitted a comment on this notice proposing revisions to the thermocouple heating device, and issue. The comment submitted Mandatory Guidelines set forth a 60-day externally formulated and color-dyed concurred with the proposal to make public comment period, ending on solution marketed as synthetic urine. SVT mandatory on urine specimens October 22, 2001. During the public These devices and systems are targeted collected by all Federal agencies. comment period, the terrorist strikes of for use by individuals who want to Because there were no comments September 11 occurred, which have conceal their illicit drug use by using submitted by Federal agencies or demanded a new focus and resolve from such a system to suborn a drug test. Federal employees opposed to the our government and citizens, that The final requirements that make up proposal, the Department believes it is continue undiminished to date. the revisions to the Mandatory appropriate to require each Federal Initially, there was concern that the Guidelines are based on seven years of agency to make SVT a required part of public comment period would need to experience with SVT. These revisions its workplace drug testing program. be extended, or that some comments are the collective product of a broad might be delayed due to temporary community of medical, forensic, 2. Donor Right To Request a Retest of an disruptions in the delivery of research, and production laboratory Adulterated or Substituted Specimen documents. In light of the national testing experts who have contributed (Sections 2.2(h) and 2.6(e)) emergency, the Department determined their knowledge, determination, and One commenter suggested that the that public comments would be problem-solving skills to address those proposed requirement for the donor to considered, even if they were received who would cheat on a drug test. request a retest on a single specimen or

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a test of a split specimen within 72 recommendation. The Department and excessive foaming, among others, to hours after being notified by the MRO believes that all laboratories must have remain as abnormal physical that his or her specimen was reported the capability and actually test all characteristics that can be evaluated at positive, adulterated, or substituted was specimens for one or more oxidizing a laboratory and prompt additional insufficient. The 72-hour rule has been adulterants. This is especially critical testing as specified in paragraph in the Guidelines since 1994 and the for those specimens where a drug test 2.4(g)(5). However, a laboratory may Department is not aware of any occasion result or other evidence indicates that a choose not to test the specimen if the in which the donor was unable to specimen may be adulterated. laboratory believes that testing the request a test of a split specimen within Otherwise, many specimens adulterated specimen may damage its instruments. this time frame. Additionally, MROs with oxidants may simply be reported For example, a specimen that is have the discretion to extend the 72- as negative. This action is consistent gelatinous may possibly clog the tubing hour time frame when necessary. The with the Federal Workplace Drug used in an immunoassay analyzer, proposed revision to this section of the Testing Program goal of ensuring an thereby shutting down the instrument Mandatory Guidelines simply expands accurate and reliable result on every and requiring extensive maintenance. In the donor’s ability to request a retest specimen tested, whether the result is such a case, the laboratory may assume when a specimen is identified as positive or negative for drugs, that the urine specimen is not a valid adulterated or substituted. The donor adulterated, substituted, or invalid. urine specimen and must report an shall be allowed the same ability to One commenter suggested there is no invalid result to the MRO. This invalid request through the MRO a retest of a value in determining the pH for every result is then used by the MRO to direct single specimen that is reported either specimen because the number of the agency to have the donor drug positive, adulterated, or specimens reported with a pH that is too immediately submit another urine substituted. In cases where a split low or too high is extremely low. The specimen using a direct observed specimen was collected consistent with Department believes that the collection. See section 2.6(c). agency policy, the donor shall be elimination of this requirement would One commenter stated that allowed the same ability to request allow the use of adulterants that alter insufficient data exists to support the through the MRO a retest of the split the pH causing it to be out of the normal proposed requirement that a specimen (Bottle B) specimen when the primary physiological range, and hence interfere be reported as an ‘‘invalid result’’ if specimen is reported either drug with obtaining a valid drug test or validity testing performed on the positive, adulterated, or substituted. adulterant result. Therefore, as was specimen shows creatinine Based on our experience, the proposed, the revisions to the concentration and specific gravity Department continues to believe that 72 Mandatory Guidelines shall require that results that are considered to be hours is a sufficient period of time for a laboratory determine the pH for every inconsistent with normal human a donor to request a retest on a single specimen tested. physiology. The Department believes specimen or a test of the split specimen One commenter suggested the that the conditions given for creatinine after being notified by the MRO that his requirement that a laboratory must test concentration and specific gravity or her specimen was reported positive, a specimen for oxidizing adulterants did results that are inconsistent with normal adulterated, or substituted. not clearly state that the test(s) was to range values indicate possible The same commenter also suggested be performed on each specimen. The tampering with the specimen. The that a Federal agency should have the Department agrees that the statement of requirement to report these inconsistent authority to direct a retest of a single the requirement in the proposed values as ‘‘invalid results’’ ensures the specimen or the test of a split specimen revisions was unclear. As a result, collection of another specimen to at any time. The Department believes paragraph 2.4(g)(4) has been revised to determine if the donor did provide a that limiting the ability to request a indicate that one or more validity tests valid specimen or, in fact, did tamper retest to the donor ensures that each for oxidizing adulterants must be with the first specimen collected. donor is offered the same chance to performed on each specimen. With regard to the proposal to dispute the reported test results. One commenter recommended either establish the lower specific gravity However, the Guidelines do not to define abnormal color or odor or to cutoff as less than 1.002 for the preclude a judge from issuing a court delete any reference to abnormal substitution criteria, the Department has order to retest a specimen, an physical characteristics as a condition to reconsidered this proposal and is administrative law judge from ordering perform additional validity tests. The establishing the specific gravity cutoff as a retest of a specimen, or a Federal Department believes there are physical less than or equal to 1.0010. Note that agency from retesting a specimen as part characteristics that can be used to this cutoff is stated to four decimal of a legal or administrative proceeding identify specimens that may require places. This will retain the specific to defend a test result when the donor some additional validity tests. However, gravity cutoff that the laboratories have elected not to request a retest of a definitions cannot be developed to been using since HHS issued guidance specimen reported positive, adulterated, specifically describe all the possible for all laboratories in determining the or substituted. A new paragraph abnormal characteristics that may be validity of a specimen (Division of 2.6(e)(4) has been included to ensure observed by laboratory personnel. In Workplace Programs Memorandum that a Federal agency may conduct a response to this comment, the dated September 28, 1998, Subject: retest under this limited situation. parenthetical reference to color, odor, or Guidance for Reporting Specimen excessive foaming has been deleted in Validity Test Results, Program 3. SVT (Section 2.4(g)) the Mandatory Guidelines to avoid Document #35). At the time the Program One commenter suggested that it is limiting the possible characteristics that Guidance was issued and the proposed unnecessary for all laboratories to have may be used to trigger additional changes to the Mandatory Guidelines the capability to identify and quantitate validity tests. Because of the large were published in August 2001, the oxidizing adulterants and recommended number of adulterants being marketed to refractometers that were in use read the establishing a list of laboratories that mask the presence of or remove drugs or values to three decimal places (i.e., would specialize in adulteration testing. metabolites from a specimen, the 1.001). Since the time that the The Department does not agree with this Department fully intends for color, odor, Department published the proposed

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cutoff of less than 1.002, a new series of to 1.020 as defining a ‘‘substituted laboratory may only report an ‘‘invalid electronic refractometers have been specimen.’’ After careful consideration result’’ for a specimen rather than an made available that measure specific of the supplemental information, the adulterated result. Paragraph 2.4(h)(4) gravity to four decimal places. The use Department believes that it is clearly describes the combination of of a refractometer that measures specific appropriate to propose lowering the methods that a laboratory must use to gravity to four decimal places allows a creatinine decision point to identify a report a specimen as adulterated for a laboratory to report and display specific substituted specimen to less than 2 mg/ specific adulterant. The only exceptions gravity values that are within one ten- dL and specific gravity to less than or to this requirement pertain to the tests thousandth from the cutoff rather than equal to 1.0010 or greater than or equal used to measure the creatinine being essentially a ‘‘yes’’ or ‘‘no’’ answer to 1.0200. With regard to the proposal concentration, specific gravity, and pH. (that is, 1.000 or 1.001 for a ‘‘yes’’ in August 2001 to establish the lower To report a specimen as adulterated answer, 1.002 for a ‘‘no’’ answer when specific gravity cutoff as less than 1.002 because the pH is too low or too high, using a three decimal place for the substitution criteria, the a pH meter may be used for both the refractometer). Therefore, the Department has reconsidered this initial and confirmatory pH tests Department directs that all laboratories proposal and is requiring to establish because it is considered a reference must use refractometers that report and the specific gravity cutoff as less than or method by the scientific community, is display specific gravity to four decimal equal to 1.0010. Note that this cutoff is a highly reliable instrument, and gives places. These instruments also have now stated to four decimal places. This extremely accurate results when electronic and hard copy reporting will retain the specific gravity cutoff properly calibrated. Further, pH values peripheral device capability and thus that the laboratories have been using represent a logarithmic scale and allow machine generated since HHS issued guidance for all therefore represent very large documentation, which recent laboratories in determining the validity differences between each pH unit. Based administrative and legal proceedings of a specimen (Division of Workplace on this assessment, using a pH meter for have advocated. Programs memorandum dated both the initial and confirmatory pH After the close of the public comment September 28, 1998, Subject: Guidance tests is scientifically and forensically period, and prior to the publication of for Reporting Specimen Validity Test valid. a final notice in the Federal Register Results, Program Document #35). At the The Department believes it is that would have established the criteria time the Program Guidance was issued scientifically acceptable to use the same used to report a specimen as and the proposed changes to the creatinine test for both the initial and substituted, the Department became Mandatory Guidelines were published confirmatory creatinine tests and to use aware of supplemental information from in August 2001, the refractometers that refractometry to measure specific a Congressionally-mandated study by were in use read the values to three gravity for both the initial and the Department of Transportation (DOT) decimal places (i.e., 1.001). Since the confirmatory specific gravity tests. For Federal Aviation Administration (FAA) time that the Department published the creatinine, the most accepted method to indicating that the Department’s proposed cutoff of less than 1.002, a determine the creatinine concentration treatment of substitution should be new series of electronic refractometers is the Jaffe’ or modified Jaffe’ reconsidered. The information was have been made available that measure colorimetric procedure. In addition, any presented at a conference sponsored by specific gravity to four decimal places. endogenous substance that may the FAA in Tampa, Florida, on February Therefore, the Department is requiring interfere with the creatinine 4–6, 2003, that brought together that all laboratories must use colorimetric test is going to produce a toxicologists, nephrologists and other refractometers that report and display reading such that the creatinine physicians, MROs, technical experts in specific gravity to four decimal places. various fields, and HHS and DOT These instruments also have electronic concentration will appear to be higher officials. Attendees at the conference and hard copy reporting peripheral rather than lower than the true generally agreed that it would be device capability and thus allow creatinine concentration. In other appropriate to lower the creatinine machine generated documentation, words, interfering compounds will criterion that is part of the requirement which recent administrative and legal increase the creatinine concentration, to report a urine specimen as proceedings have advocated. raising it above 2 mg/dL, and therefore substituted. This information lead DOT the specimen will not meet the criteria to publish an interim final rule in the 4. Reporting Results (Section 2.4(h)) to report it as substituted. As of this Federal Register (68 FR 31624) on May Three commenters expressed concern time, the Department does not know of 28, 2003, that changed the way MROs that the same test could be used for both any endogenous interfering substance were expected to interpret substitution the initial and confirmatory validity that will lower the apparent reading on results reported by the laboratories. tests. The commenters believe that the the colorimetric creatinine test. This supplemental information initial validity test should use a Therefore, the Department believes it is strongly suggested that if the different analytical methodology than acceptable to use the same colorimetric Department adopted the proposed the confirmatory validity test before a creatinine test for both the initial and cutoffs as written, in rare, but very real specimen can be reported adulterated or confirmatory tests. circumstances, it might be possible to substituted. The Department agrees with With regard to using refractometry for misidentify an individual as providing a the commenters’ recommendation that both specific gravity tests, a substituted specimen, when in fact the initial and confirmatory validity tests refractometer, like a pH meter, is specimen was actually produced by the use a different analytical methodology considered a reference instrument and individual. To date, to the best of our and has revised the reporting policy for its results are scientifically acceptable. knowledge, there have not been any adulterants to require that two different Therefore, the Department believes it is Federal employees who have raised a methods are used before a specimen can acceptable to use refractometry for both challenge to the specific creatinine be reported as adulterated. If a specific gravity tests. Moreover, the decision point of less than or equal to laboratory uses the same test (e.g., the combination of specific gravity and 5 mg/dL and specific gravity less than same colorimetric test) for both the creatinine serves as two tests employing or equal to 1.001 or greater than or equal initial test and the confirmatory test, the different scientific principles.

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A valid scientific identification is recommended since the inception of a drug positive to ensure consistency based on the use of two methods used this program. between the retesting policy for drugs on two separate aliquots obtained from Our on-going review of specimen and the policy for retesting adulterants. the original urine specimen. The nature validity test results and inspection of The Department agrees with the of the analytical method is based on the laboratories has shown analysis to date recommendation and has specified chemical composition of the substance to be competent and reasonable and to using the LOD to reconfirm the presence to be tested. Further, the combination of have met satisfactory scientific criteria. of an adulterant except when retesting techniques is a function of both the Results of these specimen validity tests for pH and nitrite. However, the expected prevalence of the substance to have also been introduced and retesting for an adulterant requires the be tested and the nature of the analytical effectively been supported in legal second laboratory to use its technique. This may be illustrated by proceedings. The Department conducted confirmatory test for the adulterant that the following examples: a special review of SVT in all certified was reported present in the single or (1) For drugs, drugs are tested by laboratories. This included analysis for Bottle A specimen by the first immunoassay on the first aliquot. Each adulterants where the same test was laboratory. For example, reconfirming a immunoassay test has variable used on two different aliquots of the pH that was too low or too high requires specificity for a particular drug class. donor’s specimen. Based on program the second laboratory to test an aliquot The gas chromatography/mass experience and availability and of a single specimen or the split (Bottle spectrometry (GC/MS) confirmatory development of refined analytical B) specimen using its confirmatory pH drug test is specific for a particular drug procedures, the Department is meter test. Another example, or metabolite. The presence of drugs is establishing specific requirements for reconfirming the presence of chromium not expected in a urine specimen. While analytical procedures to identify the (VI) requires the second laboratory to the number of drugs to be identified in common adulterants. See section 2.4(h). test an aliquot of a single specimen or a urine specimen is limited to those One commenter recommended the split (Bottle B) specimen using its specified by these Guidelines, the reporting any specimen with a nitrite confirmatory test to determine the number of drugs to be excluded concentration between 200 mcg/mL and presence of chromium (VI) above the comprises a long list. 500 mcg/mL as an ‘‘invalid result.’’ The LOD. The second laboratory cannot use (2) For creatinine, creatinine is tested Department agrees with this its initial colorimetric test to reconfirm by colorimetric assays using the same recommendation and has changed the the presence of chromium (VI). assay in each of two aliquots. The Guidelines at paragraph 2.4(h)(7)(iii) to presence of creatinine in urine is include a nitrite range as one of the 6. Quality Control Requirements for expected. Its concentration is normally conditions upon which a specimen Validity Tests (Section 2.5(d)) expected to be relatively high and it is must be reported as an ‘‘invalid result.’’ One commenter suggested that the among a very small number of waste Although a 500 mcg/mL nitrite Mandatory Guidelines should specify products found in urine. concentration is established as the what the reference method is for each (3) For alcohol, although not part of concentration at or above which a type of validity test. The Department the Federal workplace drug testing specimen is reported adulterated for believes that the methods being used for program, a breath sample is initially nitrite, clinical evidence (see Urry, F.M. the various validity tests, with the tested on an approved device and, if et al., Nitrite Adulteration of Workplace exception of the pH meter, do not meet positive, a confirmatory test is Urine Drug Testing Specimens. 1. the classical definition of a reference conducted using the same approved Sources and Associated Concentrations method (i.e., a method to which other device on a second breath sample. The of Nitrite in Urine and Distinction tests are compared). The Department most common of the breath devices Between Natural Sources and views it as more important that the utilizes a fuel cell in which the alcohol Adulteration, ‘‘Journal of Analytical performance characteristics of the is consumed resulting in a proportional Toxicology’’ 22: 89–95 (1998)) indicates method used for each type of validity electronic response. Alcohol is a volatile that any nitrite concentration above 129 test can be documented by the substance and although not expected to mcg/mL is not physiologically possible laboratory prior to using the method, as be present in the breath, is among a very and is, therefore, an abnormal is the case for the drug tests used by the short list of possible substances. The concentration. The Department also laboratories. Establishing the concentration of alcohol, when present notes that since Program Documents 35 performance characteristics of a method in the body, is relatively very high. and 37 were issued in 1998 and 1999 prior to its use ensures that the method The three examples constitute valid and the proposed Changes to the can provide accurate measurements on scientific and forensic identification Mandatory Guidelines were published donor specimens which are verified by although there is variation in the in August 2001, some adulterant simultaneously obtaining results for analytical parameters and expected products now contain lower amounts of quality control samples. If the quality prevalence of the substances in nitrite mixed with other oxidant control samples results indicate a biological specimens. Program compounds in an effort to avoid possible error, then all specimens Documents 35 and 37 issued by HHS in detection. associated with those quality control 1998 and 1999 established the samples must be retested until the framework for reporting a specimen as 5. Retesting a Specimen for Adulterants quality control sample results satisfy the substituted and adulterated. This (Section 2.4(k)) acceptance criteria established by the framework included an analysis on two One commenter suggested deleting laboratory. aliquots with various qualitative and any reference to limit of quantitation One commenter suggested that the quantitative procedures. Each laboratory (LOQ) when a second laboratory is proposed number of calibrators and had the flexibility to develop the retesting a specimen for any adulterant controls is excessive for some of the specific testing requirements, to validate other than when retesting for pH or to validity tests. The Department believes the methods used, and to establish reconfirm the presence of nitrite. The that the proposed quality control quality control procedures using good commenter suggested that the retesting requirements for the validity tests are laboratory practices. This generally should use the limit of detection (LOD) appropriate and are similar to those stated scientific approach has been as is used when retesting a specimen for required for the initial and confirmatory

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drug tests. Since the results of validity point (i.e., greater than or equal to should be covered with appropriate tests can lead to the same personnel 1.0200). Therefore, the Department has calibrators and controls. actions that may occur as if the combined the controls that are required 10. Requirements for Performing specimen was reported positive for a when conducting either the initial or Oxidizing Adulterant Tests (Section drug, it is essential that every effort is confirmatory specific gravity tests 2.5(h)) made to ensure the accuracy and regardless of which decision point is reliability of every validity test result. applicable. Several commenters expressed concern with the proposed requirements 7. Requirements for Measuring 9. Requirements for Measuring pH for performing oxidizing adulterant Creatinine Concentration (Section (Section 2.5(g)) tests. There was a general request for 2.5(e)) One commenter suggested that, when more specific information and a concern One commenter suggested that determining pH levels, a control in the that these oxidizing tests fail to meet requiring calibrators at 5 mg/dL and 20 normal range should also be included. appropriate scientific standards. The mg/dL for a creatinine test requires an The Department agrees with this Department agrees that the proposed unnecessary re-validation of the test and suggestion and is requiring that either a requirement for performing oxidizing that a control in the normal range calibrator or control in the normal range adulterants was unclear. Therefore, the (greater than 20 mg/dL) is useful. The be included in each test batch when Department has revised the Department proposed using calibrators conducting either the initial or requirements described in section at 5 mg/dL and 20 mg/dL because most confirmatory pH test. 2.5(h). The Department expects each creatinine tests are calibrated at 100 mg/ laboratory to test each specimen for one One commenter noted that the dL. Since the decision points for our or more oxidizing adulterants. This can controls proposed for a colorimetric pH workplace drug testing program are so be accomplished by either using a single test are inconsistent with the controls much lower than used for most clinical test that responds to several oxidizing required for a pH meter test. The laboratory testing, it is essential that the adulterants (e.g., a general oxidant Department believes that this method be validated and calibrated at 2 colorimetric test for the initial test for inconsistency cannot be eliminated due mg/dL to ensure the highest degree of oxidizing adulterants) or one or more to the differences in the way accuracy and confidence around the initial tests that identify specific colorimetric pH tests and pH meters are decision point used to determine a oxidizing adulterants (e.g., an initial calibrated. substituted specimen. With regard to nitrite colorimetric test, an initial including a control in the normal range, Section 2.5(g) has been revised to chromium (VI) colorimetric test). the commenter overlooked the fact that require the use of three controls when Additionally, the Department is a control in the normal range was using a pH screening test (i.e., pH paper, permitting the general oxidant included in the requirements for the dipsticks, or colorimetric tests that have colorimetric test to be used with initial creatinine test. Given an initial a narrow dynamic range and do not different calibrators or controls to creatinine test result at less than the 2 support the pH cutoffs) to determine if possibly detect different adulterants. For mg/dL cutoff concentration, there is no the pH of a specimen is too low or too example, the general oxidant need to run another control in the high. This section also specifies the colorimetric test can be used to detect normal range for the confirmatory test. calibrators and controls that must be nitrite using a calibrator or control with However, controls are needed above and used if an initial colorimetric pH test or a greater than or equal to 200 mcg/mL below 2 mg/dL to ensure the highest initial pH meter test is conducted nitrite-equivalent cutoff or to detect degree of accuracy and confidence without having used a screening test to chromium (VI) using a greater than or around the cutoff. determine if the pH of a specimen may equal to 50 mcg/mL chromium (VI)- be too low or too high. Additionally, the equivalent cutoff. Since individuals 8. Requirements for Measuring Specific Department believes that when a pH attempting to subvert the drug testing Gravity (Section 2.5(f)) screening test is used and the pH of the program may use a number of different One commenter stated that the specimen is possibly too low or too oxidizing adulterants, the testing requirement for four quality control high, the initial and confirmatory pH requirement for oxidizing adulterants is samples when determining specific meter tests may use calibrators and intentionally drafted broadly to permit gravity is excessive. The commenter controls that are focused on either the the flexibility needed to combat such suggested simply including one lower or upper decision point, as tampering with the testing process. calibrator at each decision point and appropriate. This is a reasonable Although these oxidizing adulterant one control in the normal range. The approach because pH meter tests are tests are new, the Department expects Department believes that a decision manual rather than automated. the laboratories to validate each point must be bracketed whenever However, an exception exists when a oxidizing adulterant test before it is possible to ensure the accuracy of a test colorimetric pH test is used as the initial used to test donor specimens and to result rather than using the approach pH test whether a screening pH test was apply the specified quality control recommended by the commenter. Since or was not conducted. The Department requirements to ensure the proper the time the proposed policy was believes that most laboratories will use performance of each test on donor published, the Department has re- an initial colorimetric pH test to test all specimens. evaluated the control requirements for specimens received, rather than using measuring specific gravity. The screening tests, because it is an 11. Requirements for Performing Department believes that each initial automated procedure and would be ‘‘Other’’ Adulterant Tests (Section 2.5(j)) and confirmatory specific gravity test efficient and cost effective compared to One commenter suggested that the should have a calibrator and controls using pH screening tests or a ‘‘manual’’ proposed requirement for the covering the entire range rather than pH meter test. To avoid having to repeat performance of ‘‘other’’ validity tests for selecting controls based on whether the the colorimetric pH test with focused adulterants did not permit the flexibility specimen is being evaluated against the calibrators and controls only for those necessary to ensure that as new lower decision point (i.e., less than or specimens that may have a pH that is adulterants are identified, the equal to 1.0010) or the higher decision too low or too high, the entire pH range Mandatory Guidelines would permit

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laboratories to test for these new unable to reconfirm the result reported reconfirm a positive drug result reported adulterants. The Department agrees with by the original laboratory testing the for Bottle A. that comment and has revised paragraph specimen as meaning that the MRO is In section 2.4(h), the Department 2.5(j)(3) to ensure that newly identified not receiving the same notification. The included all the reporting requirements adulterants not included in paragraphs agency’s designated representative to report a specimen adulterated, 2.5(j)(1) or (2) or in any other section of always receives all results reported by substituted, diluted, or as an invalid the Mandatory Guidelines can be tested an MRO. This requirement is intended result in paragraphs (4), (5), (6), and (7). for by a laboratory. to ensure that the HHS regulatory office A new section 2.4(h)(12) was One commenter asked if a specimen is notified of such reports to permit the included to require a laboratory to containing glutaraldehyde could be initiation of an investigation to report on the Federal CCF and/or reported as adulterated based on using determine if an error was made by either computer-generated electronic report the confirmatory test procedure on two laboratory. the actual numerical value (e.g., separate aliquots. The revision to the concentration) associated with an Mandatory Guidelines requires that a 14. Additional Changes Related to the adulterated specimen (when applicable) specimen can only be reported New SVT Requirements and the confirmatory creatinine adulterated for glutaraldehyde if the In addition to the changes discussed concentration and the confirmatory initial and confirmatory glutaraldehyde above, the Department is revising other specific gravity for a substituted tests use different methodologies. For sections of the Mandatory Guidelines specimen. The Department believes that glutaraldehyde, the characteristic that are directly affected by the new this requirement will eliminate the need response on immunoassay drug tests is SVT requirements. for an MRO to generate a separate very well established and may serve as In section 1.2, the original definitions written request, thereby reducing the the initial test for determining the for an ‘‘initial test’’ and a ‘‘confirmatory paperwork associated with each presence of glutaraldehyde or by test’’ are being changed to read ‘‘initial adulterated and substituted specimen. Section 2.4(h)(15) was revised to performing a separate initial aldehyde drug test’’ and ‘‘confirmatory drug test,’’ require each laboratory to provide a test. The confirmatory test for respectively, to prevent any confusion statistical summary report every six glutaraldehyde traditionally has been with the new definitions for ‘‘initial months rather than monthly to a Federal gas chromatography/mass spectrometry. validity test’’ and ‘‘confirmatory validity agency. The format for the report was test.’’ The Department is adding the 12. MRO Qualifications and Review of also changed to include the provision word ‘‘drug’’ throughout the Mandatory Results (Section 2.6) for information on adulterated, Guidelines when referring to initial drug One commenter recommended that substituted, and invalid specimens. The tests and confirmatory drug tests. the Mandatory Guidelines be revised to Department believes reducing the require an MRO to complete formal Under section 2.2(f)(4), the collector frequency of the report to a semi-annual training and pass an examination, as must direct the donor to empty his or basis is cost effective and avoids required in the DOT Procedures for her pockets and display the items to requiring laboratories to report a Transportation Workplace Drug and ensure that no items are present that summary for several specimens as Alcohol Testing Program (49 CFR Part could be used to adulterate the opposed to a more reasonable number 40). The Department recognizes that specimen. If nothing is there that can be that would be tested over a six-month other changes to the Mandatory used to adulterate a specimen, the donor period of time. Both of these changes are Guidelines may be needed; however, places the items back into his or her consistent with the requirements in the our intent in the solicitation of comment pockets and the collection procedure DOT drug testing regulations (49 CFR was to focus only on proposing changes continues. If the donor refuses to show Part 40). associated with mandating validity the collector the items in his or her In sections 2.4(i) and 3.9, the testing on specimens collected under pockets, this is considered a refusal to requirement to retain positive the Mandatory Guidelines. cooperate in the testing process. The specimens in long-term storage is One commenter expressed concern Department believes this requirement is expanded to include specimens that an MRO may direct a laboratory to necessary because of the ease with reported as adulterated, substituted, and send a specimen to another laboratory which a donor can conceal a small invalid. Because administrative and/or before determining that the second amount of an adulterant and the legal actions may be taken that relate to laboratory has the capability to perform availability of numerous adulterants on specimens with these results, it is any additional tests. The Department the Internet and in drug culture imperative that they be retained frozen agrees that an MRO should always magazines. This change also ensures and available for possible future contact a laboratory to determine its consistency with the collection retesting. capability before having a specimen procedure specified in the DOT drug In section 2.4(j), the retesting policy transferred for additional validity testing regulations (49 CFR Part 40). The for drugs has been expanded. If a second testing. This policy applies especially to Department believes that every effort laboratory fails to reconfirm the paragraph 2.6(c)(2) when Laboratory A must be made to prevent a donor from presence of a drug when retesting a reports an invalid result and the bringing something to the collection site single specimen or testing a split (Bottle laboratory and MRO agree that further that could be used to adulterate a B) specimen, the second laboratory is testing may be useful in an attempt to specimen and, thereby, preventing it required to conduct validity tests in an be able to report a positive, adulterated, from being properly tested for drugs. attempt to determine a reason for failing or substituted result. Section 2.4(h)(2) was revised to to reconfirm the presence of the drug or ensure that each specimen is subject to metabolite. 13. Laboratory Result Not Reconfirmed validity testing to determine that it is a Sections 2.5(k)(1) and (3) have been by a Second Laboratory (Section 2.6(g)) valid urine specimen before a negative revised to require that an agency blind One commenter interpreted the result is reported. sample program includes samples that proposed requirement that the MRO Section 2.2(h)(8) was deleted because are adulterated or substituted along with notify the designated HHS regulatory it only deals with the testing of a split negative samples and drug positive office when a second laboratory was (Bottle B) specimen that failed to samples. This requirement ensures that

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a laboratory’s procedures are challenged The term ‘‘specimen chain of custody always completes the test result section with samples that are adulterated or form’’ is being replaced with the term on the Federal CCF; however, a copy of substituted. ‘‘Federal drug testing custody and the Federal CCF may or may not be sent Section 2.6, where appropriate, has control form’’ (or ‘‘Federal CCF’’) to the MRO depending on whether the been revised to describe how an MRO throughout the Mandatory Guidelines. test result is negative or non-negative. is expected to review adulterated, This is the official name given to the For a negative result, an electronic substituted, and invalid results as well form approved by the Office of report is sufficient. The Department as drug positive results. Management and Budget (OMB) to believes the reporting requirements in Sections 2.6(g)(1) through (16) give collect a urine specimen from a Federal these two sections will reduce the specific requirements on how an MRO employee. paperwork burden and is consistent reports a result to a Federal agency The definition for ‘‘chain of custody’’ with the intended use of the five-part when Laboratory B fails to reconfirm the has been revised to clarify that it refers Federal CCF. test result reported by Laboratory A. The to a ‘‘process’’ that is used to track the A new section 2.4(h)(11) was Department believes these requirements handling and storage of specimens included to require a laboratory to are necessary to ensure uniformity rather than ‘‘procedures’’ and deleted report to an MRO a quantitative value among MROs when a failed to reconfirm the sentences that reference the OMB for morphine or codeine that is greater occurs. form because the Federal CCF is defined than or equal to 15,000 ng/mL. Section Section 2.6(h) has been revised to separately. 2.6(d) was also revised regarding the describe how an MRO shall report a Section 2.2(g) was revised because the policy that an MRO must follow when final test result to a Federal agency. current Federal CCF does not allow a verifying a donor specimen as positive Section 3.4 has been revised to ensure collector to transfer the custody of a for morphine or codeine when the that each laboratory has the capability to specimen to another individual prior to concentration is at or above 15,000 ng/ test for the five required classes of drugs releasing the specimen to an express mL. The Department believes that a as well as to conduct validity tests as carrier or courier for shipment to a morphine or codeine concentration at or specified in these Mandatory laboratory. In addition, the first above 15,000 ng/mL is high enough to Guidelines. sentence requiring the collector to prevent falsely accusing an individual Section 3.5 has been revised to clarify maintain the specimen bottle within of opiate abuse who may have only that all drug and validity tests are to be sight is redundant with the requirement eaten poppy seeds or falsely accusing an conducted by a certified laboratory at in paragraph 2.2(f)(17) as revised and individual who does not exhibit any the same facility. was deleted. clinical evidence of opiate abuse and Sections 3.17, 3.18, and 3.19 have Section 2.4(b)(2) was revised to does not provide a legitimate medical been revised to clearly distinguish clearly describe the types of errors that explanation. These revisions are also between performance testing (PT) may occasionally occur on a Federal consistent with the laboratory reporting samples that contain drugs and PT CCF and/or specimen bottle label/seal and MRO verification policies in DOT samples that will challenge a that are considered to be fatal flaws. 49 CFR Part 40. laboratory’s specimen validity tests. In These errors require a laboratory to stop Section 2.4(h)(14) was revised to the proposed changes to the Mandatory the testing process and to report the clarify that a laboratory may report all Guidelines, a revision was proposed to result as rejected for testing. Paragraph test results by faxing a completed copy section 3.2 to indicate that laboratories 2.4(b)(3) was added to describe two of the Federal CCF, sending a completed would be challenged with specimen types of correctable flaws that, if not copy of the Federal CCF by courier or validity samples in the PT program and corrected, would also require the mail, electronically transmitting a inspections would include reviewing laboratory to report a specimen as legible image or copy of the completed validity testing procedures. The rejected for testing. Provisions similar to Federal CCF, and/or may forward a Department believes the specific these were originally implemented by computer-generated electronic report. performance requirements for the Program Document #9 (October 10, The Department believes that revising samples challenging a laboratory’s 1991). The Department believes this paragraph clarifies the point that specimen validity tests are comparable including these provisions in the sending a computer-generated electronic to the requirements for the performance Guidelines will ensure uniform report does not prohibit a laboratory testing with samples containing drugs or treatment by laboratories when these from also sending a completed Federal metabolites. types of errors occur. The provisions are CCF by one of the other ways described. also consistent with those contained in The section also requires that a copy of 15. Other Changes the DOT drug testing regulations (49 the completed Federal CCF must be The Department is making several CFR Part 40). transmitted by one of the ways technical changes and/or clarifications Section 2.4(f)(1) was revised to allow described for a non-negative result (i.e., to other sections of the Mandatory a laboratory to report a quantitative drug a computer-generated electronic report Guidelines. Several of these changes test result three different ways. The is not sufficient, by itself, when a reflect policies or procedures that have Department believes that a laboratory laboratory reports a non-negative result been previously implemented. The should have the option to report a to the MRO). Department believes it is appropriate to quantitative result as either ‘‘exceeds the Sections 2.5(b) and (c) were revised to include these changes in this revision of linear range of the test,’’ ‘‘greater than or modify the general quality control the Guidelines. equal to (specify the upper limit of requirements for the initial drug and The term ‘‘collection site person’’ is linearity),’’ or as an accurate confirmatory drug tests. The current being replaced with the term ‘‘collector’’ quantitative result obtained by diluting Guidelines require including ‘‘positive throughout the Mandatory Guidelines. an aliquot of the specimen before control(s) fortified with drug or The Department is making this change conducting the confirmatory drug test. metabolite’’ and ‘‘at least one positive because the use of the term ‘‘collector’’ Section 2.4(h)(13) and (14) were control with the drug or metabolite at or has become the most common way to revised to describe the different ways near the threshold (cutoff).’’ These two refer to the individual involved with results can be transmitted from a requirements can actually be satisfied collecting a specimen from a donor. laboratory to an MRO. A laboratory using a single control, which was not

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the intent of the requirements. The use laboratories have workloads that require revisions to the Mandatory Guidelines of the original phrase ‘‘at or near the more inspectors to conduct a thorough do not change the information threshold (cutoff)’’ is too vague and review of both their procedures and test collection requirements in them. allows different interpretations. The results. The Department believes this The Mandatory Guidelines establish Department believes the revised change is fair, equitable, and cost the standards for a National Laboratory requirements will ensure consistency by effective for all the laboratories. Certification Program (NLCP), which stating that each initial drug test batch Other appropriate minor editorial include requirements for a laboratory to shall include a control targeted at 25 changes are being made for clarity and become certified and to maintain percent above the cutoff and a control consistency. certification. Prior to the initial targeted at 75 percent of the cutoff. The certification process, each interested 16. List of Adulterants revised requirements in these two laboratory is required to submit an sections have been described in other In accordance with the Federal application to the NLCP contractor for NLCP program documents for several Register notice (66 FR 43876) dated review and evaluation. years and placing them in the August 21, 2001, the Department will Certified laboratories are inspected Mandatory Guidelines eliminates begin including a list of known every six months. Prior to each possible misinterpretation. adulterants in the monthly Federal maintenance inspection, the laboratory A new section 2.5(c)(4) was added to Register notice that lists the laboratories receives and completes a copy of require a laboratory to include in each that meet minimum standards to engage Sections B and C of the NLCP confirmatory drug test batch at least one in urine drug testing for Federal inspection checklist. The information calibrator or control at or below 40 agencies. The list will be revised as new submitted by the laboratory allows the percent of the cutoff. Prior Department adulterants are identified. members of the inspection team to policy required a laboratory to include become familiar with a laboratory’s Executive Order 12866: Economic such a calibrator or control only when procedures before arriving at the Impact the confirmatory drug test batch laboratory to conduct the inspection, contained an aliquot of a single In accordance with Executive Order thereby facilitating the completion of specimen or a split (Bottle B) specimen 12866, the agency has submitted the the inspection. received from a different laboratory for Guidelines for review by the Office of The Mandatory Guidelines require confirmatory drug testing. The Management and Budget. However, certified laboratories to maintain Department believes including a because the Mandatory Guidelines will information concerning quality calibrator or control at or below 40 not have an annual impact of $100 assurance and quality control, security percent of the cutoff in each million or more, and will not have a and chain of custody, documentation, to confirmatory drug test batch is material adverse effect on the economy, report test results in accordance with appropriate to ensure that the laboratory productivity, competition, jobs, the the specifications, and to participate in documents the accuracy of the environment, public health or safety, or a performance testing and inspection confirmatory drug test below the cutoff State, local or tribal governments, they program. In addition, there are for each confirmatory drug test whether are not subject to the detailed analysis procedures that are used to review the it contains or does not contain such a requirements of Section 6(a)(3)(C) of suspension or proposed revocation of a specimen received from a different Executive Order 12866. certified laboratory. laboratory. This has been clarified in The Mandatory Guidelines also Paperwork Reduction Act of 1995 other program documents and ensures require using an OMB-approved Federal that a uniform policy exists in all These guidelines contain information custody and control form (CCF) to laboratories. collection provisions which are subject document the integrity and security of Section 3.20 has been revised to to review by the Office of Management a urine specimen from the time it is provide that the number of inspectors and Budget (OMB) under the Paperwork collected until received by the on an inspection team can be two or Reduction Act of 1995 (the PRA)(44 laboratory. more rather than the three previously U.S.C. 3507(d)). The title, description Description of Respondents: specified for any inspection. In practice, and respondent description of the Individuals or Households; Business or the number of inspectors on an information collections are shown in the other for-profit; Not-for profit inspection team has varied depending following paragraphs with an estimate institutions. on the size of the laboratory. This of the annual reporting burden. Response burden estimate: We change was implemented several years Included in the estimate is the time for estimate the total annual response ago because the consolidation and reviewing instructions, searching burden imposed by the Mandatory growth of several laboratories caused a existing data sources, gathering and Guidelines to be 1,786,839 hours. This significant increase in their workloads, maintaining the data needed, and is comprised as follows: (1) A laboratory and these increases made it difficult for completing and reviewing the collection is estimated to require an average of 3 inspectors to review a sufficient number of information. hours to complete the NLCP of non-negative test results in the time Title: Mandatory Guidelines for Application form. An average of 3 allotted. By changing the number of Federal Workplace Drug Testing laboratories apply each year, resulting inspectors for different sized Programs. in an annual estimate of 9 hours of laboratories, the percentage of non- Description: The Mandatory response burden. (2) Sections B and C negative test results reviewed by the Guidelines for Federal Workplace Drug of the NLCP Inspection Checklist, which inspection teams remains somewhat Testing Programs establish the scientific average 3 hours to complete, must be comparable between the different sized and technical guidelines for Federal completed in advance of each of the 2 laboratories. Currently, there are several Workplace drug testing programs and annual inspections. Based on 50 very small laboratories, and using two standards for certification of laboratories certified laboratories undergoing 2 inspectors is clearly sufficient to engaged in urine drug testing for Federal maintenance inspections each year, the conduct a thorough review of the agencies under authority of section 503 annual estimated response burden for laboratory’s procedures and test results. of Public Law 100–71, 5 U.S.C. 7301 the NLCP Inspection Checklist is 300 Conversely, several very large and Executive Order 12564. These hours. (3) Recordkeeping, reporting and

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disclosure burden for each laboratory is hours for 50 laboratories. This estimate estimated at 250 hours per laboratory includes the following: per year, for an annual total of 12,500

Section Topic

Recordkeeping

2.3(a)(4)* ...... Responsible person at laboratory documents in-service training of personnel. 2.3(a)(5)* and 2.4(q)(1)* ...... Maintain manual of all procedures used and dates they were in effect. 2.3(a)(6)* and 2.5(a)* ...... Documentation of quality assurance program. 2.3(f)* ...... Specifies contents of laboratory personnel files. 2.4(a)(1)* ...... Requires documentation of laboratory visitor access. 2.4(a)(2)* and (b)(4)* ...... Requires use of laboratory chain of custody form by personnel conducting tests. 2.4(h)(17)* ...... Requires specimen records to be maintained for two years. 2.4(p)* ...... Requires two year retention of documentation of all aspects of testing process. 2.5(k)(6) ...... Requires documenting retesting when false positive error occurs on blind performance testing sample.

Reporting

2.2(c), 2.2(f)(8) and 2.2(f)(14) ...... Require use of Federal CCF by collector and specify things to note on it. 2.4(h); 3.17(f) ...... Specifies reporting of test results from laboratory to Medical Review Officer (MRO); specifies same reporting method for performance testing samples. 2.4(h)(15) ...... Specifies contents of periodic laboratory summary statistical report to Federal agency. 2.6(h)(1) ...... Specifies MRO reporting of final test results to Federal agency using Federal CCF. 3.17(f) ...... Specifies laboratory reporting of performance test samples. 4.4 and 4.5(a) ...... Specify contents of laboratory request for official review of suspension/proposed revocation of certification. 4.6 ...... Requires appellant notification to reviewing official at end of abeyance period. 4.7(a) ...... Specifies contents of appellant review submission. 4.9(a) and (c) ...... Specify contents of appellant expedited review file.

Disclosure

3.4 ...... Requires laboratories to notify non-regulated private-sector employers/clients when testing specimens not under Guidelines.

Note: Activities designated by an * are unless it displays a currently valid OMB 2.5 Quality Assurance and Quality Control. considered to be usual and customary control number. 2.6 Reporting and Review of Results. business practices for such laboratories and 2.7 Protection of Employee Records. no additional burden is considered to be Charles G. Curie, 2.8 Individual Access to Test and imposed by these requirements. Administrator, SAMHSA. Laboratory Certification Results. Dated: April 2, 2004. Subpart C—Certification of Laboratories (4) There are an estimated 7,096,000 Tommy G. Thompson, Engaged in Urine Drug Testing for Federal Federal CCFs completed each year, with Secretary. Agencies an average response burden of 5 The Mandatory Guidelines as revised 3.1 Introduction. minutes for the donor, 4 minutes for the are hereby adopted in accordance with 3.2 Goals and Objectives of Certification. collector, 3 minutes for the laboratory, section 503 of Public Law 100–71 and 3.3 General Certification Requirements. and 3 minutes for the Medical Review Executive Order 12564. For the public’s 3.4 Capability to Test for Five Classes of Officer. This results in 1,419,200 hours convenience, the full version of the Drugs and to Conduct Validity Tests of burden. Mandatory Guidelines as revised is 3.5 Initial and Confirmatory Capability at Same Site. Individuals and organizations may provided. It includes the new validity testing requirements as well as the 3.6 Personnel. submit comments on these burden 3.7 Quality Assurance and Quality Control. changes to the opiate cutoff estimates or any other aspect of these 3.8 Security and Chain of Custody. concentrations that became effective on information collection provisions, 3.9 One-Year Storage for Positive, December 1, 1998 (63 FR 63483). including suggestions for reducing the Adulterated, Substituted, and Invalid burden, and should direct them to: Mandatory Guidelines for Federal Specimens. Workplace Drug Testing Programs 3.10 Documentation. SAMHSA Reports Clearance Officer, 3.11 Reports. Room 16–105, Parklawn Building, 5600 Subpart A—General 3.12 Certification. Fishers Lane, Rockville, MD 20857. Sec. 3.13 Revocation. The information collection provisions 1.1 Applicability. 3.14 Suspension. 3.15 Notice. in the Mandatory Guidelines have been 1.2 Definitions. 1.3 Future Revisions. 3.16 Recertification. approved under OMB control number 3.17 Performance Testing (PT) Requirement 0930–0158. This approval expires July Subpart B—Scientific and Technical for Certification. 31, 2006. An agency may not conduct or Requirements 3.18 PT Program Samples. sponsor, and a person is not required to 2.1 The Drugs. 3.19 Evaluation of PT Sample Results. respond to, a collection of information 2.2 Specimen Collection Procedures. 3.20 Inspections. 2.3 Laboratory Personnel. 3.21 Results of Inadequate Performance. 2.4 Laboratory Analysis Procedures. 3.22 Listing of Certified Laboratories

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Subpart D—Procedures for Review of Agencies may not deviate from the include the review, interpretation, and Suspension or Proposed Revocation of a provisions of these Guidelines without reporting of test results; maintenance of Certified Laboratory the written approval of the Secretary. In chain of custody; and proper remedial 4.1 Applicability. requesting approval for a deviation, an action to be taken in response to test 4.2 Definitions. agency must petition the Secretary in systems being out of control-limits or 4.3 Limitation on Issues Subject to Review. writing and describe the specific detecting aberrant test or quality control 4.4 Specifying Who Represents the Parties. provision or provisions for which a results. 4.5 The Request for Informal Review and the Reviewing Official’s Response. deviation is sought and the rationale Chain of Custody. Refers to the 4.6 Abeyance Agreement. therefor. The Secretary may approve the process used to document the handling 4.7 Preparation of the Review File and request upon a finding of good cause as and storage of a specimen. Written Argument. determined by the Secretary. Collection Site. A place designated by 4.8 Opportunity for Oral Presentation. (f) Agencies shall purchase drug the agency where individuals present 4.9 Expedited Procedures for Review of testing services only from laboratories themselves for the purpose of providing Immediate Suspension. certified by HHS or an HHS-recognized a specimen of their urine to be analyzed 4.10 Ex parte Communications. certification program in accordance for the presence of drugs. 4.11 Transmission of Written with these Guidelines. Collector. A person who instructs and Communications by Reviewing Official assists individuals at a collection site and Calculation of Deadlines. Section 1.2 Definitions 4.12 Authority and Responsibilities of and who receives and makes an initial Reviewing Official. For purposes of these Guidelines, the examination of the urine specimen 4.13 Administrative Record. following definitions are adopted: provided by those individuals. A 4.14 Written Decision. Aliquot. A fractional part of a collector shall have successfully 4.15 Court Review of Final Administrative specimen used for testing. It is taken as completed training to carry out this Action; Exhaustion of Administrative a sample representing the whole function. Remedies. specimen. Confirmatory Drug Test. A second Authority: E.O. 12564 and sec. 503 of Pub. Adulterated Specimen. A urine analytical procedure to identify the L. 100–71. specimen containing a substance that is presence of a specific drug or metabolite Subpart A—General not a normal constituent or containing which is independent of the initial test an endogenous substance at a and which uses a different technique Section 1.1—Applicability concentration that is not a normal and chemical principle from that of the (a) These mandatory guidelines apply physiological concentration. initial test in order to ensure reliability to: Calibrator. A solution of known and accuracy. (At this time, gas (1) Executive Agencies as defined in concentration used to calibrate a chromatography/mass spectrometry 5 U.S.C. 105; measurement procedure or to compare (GC/MS) is the only authorized (2) The Uniformed Services, as the response obtained with the response confirmation method for cocaine, defined in 5 U.S.C. 2101(3) (but of a test specimen/sample. The marijuana, opiates, amphetamines, and excluding the Armed Forces as defined concentration of the analyte of interest phencyclidine.) in 5 U.S.C. 2101(2)); in the calibrator is known within limits Confirmatory Validity Test. A second (3) And any other employing unit or ascertained during its preparation. test performed on a different aliquot of authority of the Federal Government Calibrators may be used to establish a the original urine specimen to further except the United States Postal Service, calibration curve over a range of support a validity test result. the Postal Rate Commission, and interest. Control. A sample used to monitor the employing units or authorities in the Certifying Scientist. An individual status of an analysis to maintain its Judicial and Legislative Branches. with at least a bachelor’s degree in the performance within desired limits. (b) Subpart C of these Guidelines chemical or biological sciences or Dilute Specimen. A urine specimen (which establishes laboratory medical technology or equivalent who with creatinine and specific gravity certification standards) applies to any reviews all pertinent data and quality values that are lower than expected for laboratory which has or seeks control results. The individual shall human urine. Donor. The individual from whom a certification to perform urine drug have training and experience in the urine specimen is collected. testing for Federal agencies under a drug theory and practice of all methods and Federal Drug Testing Custody and testing program conducted under E.O. procedures used in the laboratory, Control Form (Federal CCF). The OMB- 12564. Only laboratories certified under including a thorough understanding of approved form used to document the these standards are authorized to chain of custody procedures, quality handling and transfer of a specimen perform urine drug testing for Federal control practices, and analytical from the time of collection until receipt agencies. procedures relevant to the results that by the laboratory and used by the (c) The Intelligence Community, as the individual certifies. Relevant certifying scientist to certify the defined by Executive Order No. 12333, training and experience shall also shall be subject to these Guidelines only laboratory results. Initial Drug Test (also known as to the extent agreed to by the head of the Transportation (DOT) does have such authority. affected agency. DOT is required by law to develop requirements for Screening Test). An immunoassay test (d) These Guidelines do not apply to its regualted industry that ‘‘incorporate the to eliminate ‘‘negative’’ urine specimens drug testing conducted under legal Department of Health and Human Services from further consideration and to scientific and technical guidelines dated April 11, identify the presumptively positive authority other than Executive Order 1988, and any amendments to those guidelines 12564, including testing of persons in ***’’ See, e.g., 49 U.S.C. 20140(c)(2). In carrying specimens that require confirmation or the criminal justice system, such as out its mandate, DOT requires by regulation that its further testing. arrestees, detainees, probationers, federally regulated employers use only HHS Initial Validity Test. The first test 1 certified laboratories in the testing of employees, 49 used to determine if a urine specimen incarcerated persons, or parolees. (e) CFR 40.39, and incorporates the scientific and technical aspects of the guidelines in its is adulterated, dilute, or substituted. 1 Although HHS has no authority to regulate the regulations. The DOT-regulated industry should Invalid Result. Refers to the result transportatiion industry, the Department of refer to the DOT regulations at 49 CFR Part 40. reported by a laboratory for a urine

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specimen that contains an unidentified Secretary. The Secretary of Health and testing in paragraph (a) of this section. adulterant, contains an unidentified Human Services or the Secretary’s Such approval shall be limited to the interfering substance, has an abnormal designee. The Secretary’s designee may use of the appropriate science and physical characteristic, or has an be a contractor or other recognized technology and shall not otherwise limit endogenous substance at an abnormal organization which acts on behalf of the agency discretion to test for any drugs concentration that prevents the Secretary in implementing these covered under Schedule I or II of the laboratory from completing testing or Guidelines. CSA. obtaining a valid drug test result. Specimen. The portion of urine that is (c) Urine specimens collected Laboratory Chain of Custody Form. collected from a donor. pursuant to Executive Order 12564, The form(s) used by the testing Standard. A reference material of Public Law 100–71, and these laboratory to document the handling known purity or a solution containing a Guidelines shall not be used for any and security of the specimen and all reference material at a known other analysis or test unless authorized aliquots of the specimens during testing concentration. by an agency’s drug-free workplace and storage by the laboratory. The form, Substituted Specimen. A urine program. which may account for an entire specimen with creatinine and specific (d) These Guidelines are not intended laboratory test batch, shall include the gravity values that are so diminished or to limit any agency which is specifically names and signatures of all individuals so divergent that they are not consistent authorized by law to include additional who handled the specimens or aliquots with normal human urine. categories of drugs in the drug testing of and the date and purpose of the access. its own employees or employees in its Limit of Detection. The lowest Section 1.3 Future Revisions regulated industries. concentration at which an analyte can In order to ensure the full reliability Section 2.2 Specimen Collection be reliably shown to be present under and accuracy of drug assays, the Procedures defined conditions. accurate reporting of test results, and Limit of Quantitation. The lowest the integrity and efficacy of Federal (a) Designation of Collection Site. An concentration at which an analyte can drug testing programs, the Secretary agency drug testing program shall have be reliably shown to be present and may make changes to these Guidelines one or more designated collection sites quantified under defined conditions. to reflect improvements in the available which have all necessary personnel, Medical Review Officer (MRO). A science and technology. These changes materials, equipment, facilities, and licensed physician responsible for will be published in final as a notice in supervision to provide for the receiving laboratory results generated by the Federal Register. collection, security, temporary storage, an agency’s drug testing program who and shipping or transportation of urine has knowledge of substance abuse Subpart B—Scientific and Technical specimens to a certified drug testing disorders and has appropriate medical Requirements laboratory. training to interpret and evaluate an Section 2.1 The Drugs (b) Security. A collection site must be individual’s test result together with his secure. If a collection site facility is or her medical history and any other (a) The President’s Executive Order dedicated solely to urine collection, it relevant biomedical information. 12564 defines ‘‘illegal drugs’’ as those shall be secure at all times. If a facility Non-Negative Specimen. A urine included in Schedule I or II of the cannot be dedicated solely to drug specimen that is reported as adulterated, Controlled Substances Act (CSA), but testing, the portion of the facility used substituted, positive (for a drug or drug not when used pursuant to a valid for collecting specimens shall be metabolite), or invalid. prescription or when used as otherwise secured during the time a specimen is Oxidizing Adulterant. A substance authorized by law. Hundreds of drugs collected. that acts alone or in combination with are covered under Schedule I and II and (c) Chain of Custody. A Federal CCF other substances to oxidize drugs or while it is not feasible to test routinely shall be properly completed by a drug metabolites to prevent the for all of them, Federal drug testing collector for each urine specimen detection of the drugs or drug programs shall test for drugs as follows: collected for a Federal agency to metabolites, or affects the reagents in (1) Federal agency applicant and document the collection of the either the initial or confirmatory drug random drug testing programs shall, at specimen and the transfer of the test. Examples of these agents include, a minimum, test urine specimens for specimen to the laboratory for testing. but are not limited to, nitrites, marijuana and cocaine; (d) Access to Authorized Personnel pyridinium chlorochromate, chromium (2) Federal agency applicant and Only. No unauthorized personnel shall (VI), bleach, iodine, halogens, random drug testing programs may also be permitted in any part of the peroxidase, and peroxide. test urine specimens for opiates, designated collection site when urine Quality Control Sample. A sample amphetamines, and phencyclidine; specimens are collected or stored. used to evaluate whether or not the (3) When conducting reasonable (e) Privacy. The procedure for analytical procedure is operating within suspicion, post accident, or unsafe collecting a urine specimen shall allow predefined tolerance limits. Calibrators, practice testing, a Federal agency may individual privacy unless there is controls, negative urine samples, and have a urine specimen tested for any reason to believe that a particular donor blind samples are collectively referred drug listed in Schedule I or II of the may alter or substitute the specimen to to as ‘‘quality control samples’’ and each CSA; and be provided. as a ‘‘sample.’’ (4) Federal agency drug testing (f) Integrity and Identity of Specimen. Reason to Believe. Reason to believe programs shall have validity tests The collector shall take the following that a particular individual may alter or performed on urine specimens, as minimum precautions to ensure that a substitute the urine specimen as provided under section 2.4(g). urine specimen is correctly documented provided in section 4(c) of Executive (b) Any agency covered by these as being provided by a specific donor Order 12564. guidelines shall petition the Secretary in and that the donor has not adulterated, Sample. A representative portion of a writing for approval to include in its substituted, or diluted the specimen: urine specimen or quality control testing protocols any drugs (or classes of (1) To deter the dilution of a specimen sample used for testing. drugs) not listed for Federal agency at the collection site, a toilet bluing

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agent shall be placed in a toilet tank provide his/her specimen in the privacy the specimen. The time from urination wherever possible, so the reservoir of of a stall or otherwise partitioned area to temperature measurement is critical water in the toilet bowl always remains that allows for individual privacy. and in no case shall exceed 4 minutes. blue. There shall be no other source of (8) The collector shall note any (13) If the temperature of the water (e.g., no shower or sink) in the unusual behavior or appearance on the specimen is outside the range of 32°– enclosure where urination occurs. Federal CCF. 38°C/90°–100°F, that is a reason to (2) When a donor arrives at the (9) In the exceptional event that an believe that the donor may have altered collection site, the collector shall agency-designated collection site is not or substituted the specimen, and request the donor to present photo accessible and there is an immediate another specimen shall be collected identification. If the donor does not requirement for specimen collection under direct observation of a person of have proper photo identification, the (e.g., an accident investigation), a public the same gender and both specimens collector shall contact the supervisor of rest room may be used according to the shall be forwarded to the laboratory for the donor, the coordinator of the drug following procedures: A person of the testing. The agency shall select the testing program, or any other agency same gender as the donor shall observer if there is no collector of the official who can positively identify the accompany the donor into the public same gender available. A donor may donor. If the donor’s identity cannot be rest room which shall be made secure volunteer to have his or her oral established, the collector shall not during the collection procedure. If temperature taken to provide evidence proceed with the collection. possible, a toilet bluing agent shall be to counter the reason to believe the (3) If the donor fails to arrive at the placed in the bowl and any accessible donor may have altered or substituted assigned time or if the donor fails to toilet tank. The collector shall remain in the specimen caused by the specimen’s remain present through the completion the rest room, but outside the stall, until temperature falling outside the of the collection, the collector shall the specimen is collected. If no bluing prescribed range. contact the appropriate authority to agent is available to deter specimen (14) Immediately after the specimen is obtain guidance on the action to be dilution, the collector shall instruct the collected, the collector shall also inspect taken. donor not to flush the toilet until the the specimen to determine if this is any (4) The collector shall ask the donor specimen is delivered to the collector. sign indicating that the specimen may to remove any unnecessary outer After the collector has possession of the not be a valid urine specimen. Any garments such as a coat or jacket that specimen, the donor will be instructed unusual finding shall be noted on the might conceal items or substances that to flush the toilet and to participate with Federal CCF. could be used to tamper with or the collector in completing the chain of (15) A specimen suspected of not adulterate the donor’s urine specimen. custody procedures. being a valid urine specimen shall be The collector shall ensure that all (10) Upon receiving the specimen forwarded to the laboratory for testing. personal belongings such as a purse or from the donor, the collector shall (16) When there is any reason to briefcase remain with the outer determine the volume of urine in the believe that a donor may have altered or garments. The donor may retain his or specimen bottle/container. substituted the specimen, another her wallet. The collector directs the (i) If the volume is at least 30 specimen shall be obtained as soon as donor to empty his or her pockets and milliliters (mL), the collector will possible under the direct observation of display the items to ensure that no items proceed with step (11) below. a person of the same gender and both are present that could be used to (ii) If the volume is less than 30 mL specimens shall be forwarded to the adulterate the specimen. If nothing is and the temperature is within the laboratory for testing. The agency shall there that can be used to adulterate a acceptable range specified in step (13) select the observer if there is no specimen, the donor places the items below, the specimen is discarded and a collector of the same gender available. back into the pockets and the collection second specimen shall be collected. The (17) Both the donor and the collector procedure continues. If the donor donor may be given a reasonable shall keep the specimen bottle/container refuses to show the collector the items amount of liquid to drink for this in view at all times prior to its being in his or her pockets, this is considered purpose (e.g., an 8 ounce glass of water sealed and labeled. If the specimen is a ‘‘refusal to test.’’ If an item is found every 30 minutes, but not to exceed a transferred from a specimen collection that appears to have been brought to the maximum of 24 ounces). If the donor container to a specimen bottle, the collection site with the intent to fails for any reason to provide 30 mL of collector shall request the donor to adulterate the specimen, a direct urine for the second specimen collected, observe the transfer of the specimen and observation collection procedure is the collector shall contact the the placement of the tamper-evident used. If the item appears to be appropriate authority to obtain guidance label/seal on the bottle. inadvertently brought to the collection on the action to be taken. (18) The collector and the donor shall site, the collector shall secure the item (iii) If the volume is less than 30 mL be present at the same time during and continue with the normal collection and the temperature is outside the procedures outlined in paragraphs (19) procedure. acceptable range specified in step (13) to (22) of this section. (5) The donor shall be instructed to below, a second specimen shall be (19) The collector shall place the wash and dry his or her hands prior to collected using the procedure specified tamper-evident label/seal on the urination. in step (13) below. specimen bottle. The collector shall (6) After washing hands, the donor (11) After the specimen has been record the date of the collection on the shall remain in the presence of the provided and submitted to the collector, tamper-evident label/seal. collector and shall not have access to the donor shall be allowed to wash his (20) The donor shall initial the any water fountain, faucet, soap or her hands. tamper-evident label/seal on the dispenser, cleaning agent, or any other (12) Immediately after the specimen is specimen bottle for the purpose of materials which could be used to collected, the collector shall measure certifying that it is the specimen adulterate the specimen. the temperature of the specimen. The collected from him or her. (7) The collector shall give the donor temperature measuring device used (21) The collector shall ensure that all a clean specimen bottle or specimen must accurately reflect the temperature the information required on the Federal collection container. The donor may of the specimen and not contaminate CCF is provided.

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(22) The donor shall be asked to read used for the drug test. If there is no Section 2.3 Laboratory Personnel and sign a statement on the Federal CCF additional urine available for the second (a) Day-to-Day Management. certifying that the specimen identified specimen bottle (Bottle B), the first (1) The laboratory shall have a as having been collected from him or specimen bottle (Bottle A) shall responsible person (RP) to assume her is in fact the specimen he or she nevertheless be processed for testing. professional, organizational, provided. (3) A minimum of 15 mL of urine educational, and administrative (23) Based on a reason to believe that shall be poured into the second responsibility for the laboratory’s urine the donor may alter or substitute the specimen bottle (Bottle B). drug testing facility. specimen to be provided, a higher level (2) This individual shall have supervisor shall review and concur in (4) All requirements of this part shall documented scientific qualifications in advance with any decision by a be followed with respect to Bottle A and analytical forensic toxicology. Minimum collector to obtain a specimen under Bottle B, including the requirements qualifications are: direct observation. The person directly that a copy of the Federal CCF (i) Certification as a laboratory observing the specimen collection shall accompany the two bottles processed director by the State in forensic or be of the same gender. The agency shall under split sample procedures. clinical laboratory toxicology; or select the observer if there is no (5) The collector shall send the split (ii) A Ph.D. in one of the natural collector of the same gender available. specimens (Bottle A and Bottle B) at the (24) The collector shall sign the same time to the laboratory that will be sciences with an adequate Federal CCF. testing the Bottle A specimen. undergraduate and graduate education in biology, chemistry, and (25) The urine specimen and Federal (6) If the test of the primary (Bottle A) pharmacology or toxicology; or CCF are now ready for shipment. If the specimen is verified positive, (iii) Training and experience specimen is not immediately prepared adulterated, or substituted by the MRO, comparable to a Ph.D. in one of the for shipment, it shall be appropriately the MRO shall report the result to the natural sciences, such as a medical or safeguarded during temporary storage. agency. Only the donor may request scientific degree with additional (26) While any part of the above chain through the MRO that the split (Bottle training and laboratory/research of custody procedures is being B) specimen be tested by a second experience in biology, chemistry, and performed, it is essential that the urine certified laboratory to reconfirm the pharmacology or toxicology; and specimen and Federal CCF be under the positive, adulterated, or substituted (iv) In addition to the requirements in control of the collector. If the collector result reported by the primary (i), (ii), and (iii) above, minimum leaves the collection site momentarily, laboratory. The MRO shall honor the qualifications also require: the urine specimen and Federal CCF request if it is made within 72 hours shall be taken with him or her or shall (A) Appropriate experience in after informing the donor that a positive, analytical forensic toxicology including be secured. After the collector returns to adulterated, or substituted result was the collection site, the custody process experience with the analysis of being reported to the agency. The biological material for drugs of abuse, will continue. If the collector is leaving second laboratory shall test the split for an extended period of time, the and specimen in accordance with the (B) Appropriate training and/or specimen and Federal CCF shall be requirements in section 2.4 pertaining to packaged for shipment to the laboratory experience in forensic applications of retesting for drugs, adulterants, or analytical toxicology, e.g., publications, before he or she leaves the collection substitution. site. court testimony, research concerning (g) Collection Control. If the specimen (7) Any action taken by a Federal analytical toxicology of drugs of abuse, and Federal CCF are not immediately agency as a result of an MRO verified or other factors which qualify the prepared for transfer to the laboratory, positive, adulterated, or substituted test individual as an expert witness in they shall be appropriately safeguarded result (e.g., removing a donor from forensic toxicology. until the specimen and Federal CCF are performing a safety-sensitive function) (3) This individual shall be engaged prepared for transfer to the laboratory. may proceed whether Bottle B is or is in and responsible for the day-to-day (h) Split Specimens. An agency may, not tested. management of the drug testing but is not required to, use a split (i) Transportation to Laboratory. A laboratory even where another specimen method of collection. If the collector shall arrange to ship the individual has overall responsibility for urine specimen is split into two collected specimens to the certified an entire multi-speciality laboratory. specimen bottles (hereinafter referred to laboratory. The specimens shall be (4) This individual shall be as Bottle A and Bottle B) the following placed in containers designed to responsible for ensuring that there are procedure shall be used: minimize the possibility of damage enough personnel with adequate (1) The donor shall urinate into either during shipment, for example, specimen training and experience to supervise a specimen bottle or specimen boxes or padded mailers; and those and conduct the work of the drug testing collection container. The collector, in containers shall be securely sealed to laboratory. He or she shall assure the the presence of the donor, after eliminate the possibility of undetected continued competency of laboratory determining specimen temperature, tampering. The collector shall ensure personnel by documenting their in- pours the urine into two specimen that the Federal CCF is enclosed within service training, reviewing their work bottles that are labeled Bottle A and the container sealed for shipment to the performance, and verifying their skills. Bottle B or, if Bottle A was used to drug testing laboratory. Since specimens (5) This individual shall be collect the specimen, pours an are sealed in packages that would responsible for the laboratory‘s having a appropriate amount into Bottle B. A indicate any tampering during transit to procedure manual which is complete, minimum of 45 mL of urine is required the laboratory and couriers, express up-to-date, available for laboratory when using a split specimen procedure, carriers, and postal service personnel do personnel, and followed by those i.e., 30 mL for Bottle A and 15 mL for not have access to the Federal CCFs, personnel. The procedure manual shall Bottle B. there is no requirement that such be reviewed, signed, and dated by this (2) The Bottle A specimen, containing personnel document chain of custody responsible person whenever a minimum of 30 mL of urine, is to be for the package during transit. procedures are first placed into use or

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changed or when a new individual (d) Other Personnel. Other technical information on the specimen bottle assumes responsibility for management and nontechnical staff shall have the label/seal to the information on the of the drug testing laboratory. Copies of necessary training and skills for the accompanying Federal CCF. all procedures and dates on which they tasks assigned. (2) The following discrepancies are are in effect shall be maintained. (e) Training. The laboratory shall considered to be fatal flaws and the (Specific contents of the procedure make available continuing education laboratory must stop the testing process manual are described in paragraph programs to meet the needs of and reject the specimen for testing and 2.4(q)(1).) laboratory personnel. indicate the reason for rejecting the (6) This individual shall be (f) Files. Each laboratory personnel specimen on the Federal CCF: responsible for maintaining a quality file shall include, at a minimum, a (i) The specimen ID number on the assurance program to assure the proper resume, any professional certification or specimen bottle label/seal does not performance and reporting of all test license, a job description, and match the ID number on the Federal results; for maintaining acceptable documentation to show that the CCF or the ID number is missing either analytical performance for all controls individual has been properly trained to on the Federal CCF or on the specimen and standards; for maintaining quality perform his or her job. bottle label/seal; (ii) The specimen bottle label/seal is control testing; and for assuring and Section 2.4 Laboratory Analysis broken or shows evidence of tampering documenting the validity, reliability, Procedures accuracy, precision, and performance on the specimen bottle from a single (a) Security and Chain of Custody. characteristics of each test and test specimen collection or on the primary (1) Drug testing laboratories shall be (Bottle A) specimen from a split system. secure at all times. They shall have in (7) This individual shall be specimen collection (and the split place sufficient security measures to specimen cannot be designated as the responsible for taking all remedial control access to the premises and to actions necessary to maintain primary (Bottle A) specimen); ensure that no unauthorized personnel (iii) The collector’s printed name and satisfactory operation and performance handle specimens or gain access to the signature are omitted on the Federal of the laboratory in response to quality laboratory processes or to areas where CCF; or control systems not being within records are stored. Access to these (iv) There is an insufficient amount of performance specifications, errors in secured areas shall be limited to urine for analysis in the specimen bottle result reporting or in analysis of specifically authorized individuals from a single specimen collection or in performance testing results. This whose authorization is documented. the primary (Bottle A) specimen from a individual shall ensure that specimen With the exception of personnel split specimen collection (unless the results are not reported until all authorized to conduct inspections on split specimen can be designated as the corrective actions have been taken and behalf of Federal agencies for which the primary (Bottle A) specimen). he or she can assure that the results laboratory is engaged in urine testing or (3) The following discrepancies are provided are accurate and reliable. on behalf of the Secretary or emergency considered to be correctable flaws: (b) Certifying Test Results. The personnel (e.g., firefighters and medical (i) If a collector failed to sign the certified laboratory shall have one or rescue teams), all authorized visitors Federal CCF, the laboratory must more certifying scientists, as defined in and maintenance and service personnel attempt to recover the collector’s section 1.2, who review all pertinent shall be escorted at all times. The signature before reporting the test result. data and quality control results to attest laboratory shall maintain a record that If the collector can provide a to the validity of the laboratory’s test documents the dates, time of entry and memorandum for record recovering the results. A laboratory may designate exit, escort and purpose of entry of signature, the laboratory may report the certifying scientists that only certify authorized visitors, maintenance test result for the specimen. If the results that are reported negative and personnel, and service personnel laboratory cannot recover the collector’s certifying scientists that certify results accessing secured areas. signature, the laboratory must report a that are reported both negative and non- (2) Laboratories shall use chain of rejected for testing result and indicate negative. custody procedures to maintain control the reason for the rejected for testing (c) Day-to-Day Operations and and accountability of specimens from result on the Federal CCF. Supervision of Analysts. The receipt through completion of testing, (ii) If a specimen is submitted using laboratory’s urine drug testing facility reporting of results, during storage, and a non-Federal form or an expired shall have an individual(s) to be continuing until final disposition of Federal CCF, the laboratory must test responsible for day-to-day operations specimens. The date and purpose shall the specimen and also attempt to obtain and to supervise the technical analysts. be documented on a laboratory chain of a memorandum for record explaining This individual(s) shall have at least a custody form each time a specimen is why a non-Federal form or an expired bachelor’s degree in the chemical or handled or transferred, and every Federal CCF was used and ensure that biological sciences or medical individual in the chain shall be the form used contains all the required technology or equivalent. He or she identified. Accordingly, authorized information. If the laboratory cannot shall have training and experience in technicians shall be responsible for each obtain a memorandum for record from the theory and practice of the urine specimen or aliquot in their the collector, the laboratory must report procedures used in the laboratory, possession and shall sign and complete a rejected for testing result and indicate resulting in his or her thorough appropriate entries on the laboratory the reason for the rejected for testing understanding of quality control chain of custody forms for those result on the report to the MRO. practices and procedures; the review, specimens or aliquots as they are (4) Specimen bottles will normally be interpretation, and reporting of test received. retained within the laboratory’s results; maintenance of chain of (b) Receiving. accession area until all analyses have custody; and proper remedial actions to (1) After opening a shipping package been completed. Aliquots and be taken in response to test systems and gaining access to a specimen and its laboratory chain of custody forms shall being out of control limits or detecting accompanying Federal CCF, an be used by laboratory personnel aberrant test or quality control results. accessioner shall compare the conducting initial and confirmatory

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tests while the original specimen bottles presumptive positives due to structural (g) Validity Testing. A certified and Federal CCFs remain in secure analogues; a valid analytical result laboratory shall: storage. cannot be obtained using immunoassay (1) Determine the creatinine (c) Short-Term Refrigerated Storage. technique ‘‘A’’ and immunoassay concentration on every specimen; Specimens that do not receive an initial technique ‘‘B’’ is used in an attempt to (2) Determine the specific gravity on test within 7 days of arrival at the obtain a valid analytical result. every specimen for which the creatinine laboratory shall be placed in secure (f) Confirmatory Drug Test. concentration is less than 20 mg/dL; refrigeration units. Temperatures shall (1) A specimen identified as positive (3) Determine the pH on every not exceed 6°C. A certified laboratory on an initial drug test shall be specimen; must have the capability to ensure confirmed for the class(es) of drugs (4) Perform one or more validity tests proper storage conditions in the event of screened positive on the initial drug test for oxidizing adulterants on every a prolonged power failure. using gas chromatography/mass specimen; and (d) Specimen Processing. A laboratory spectrometry (GC/MS) at the cutoff (5) Perform additional validity tests will normally process specimens by values listed in this paragraph. Each when the following conditions are grouping them into batches. The confirmatory drug test shall provide a observed: number of specimens in each batch may quantitative result. When the (i) Abnormal physical characteristics; vary significantly. Every batch shall concentration of a drug or metabolite (ii) Reactions or responses satisfy the quality control requirements exceeds the linear range of the standard characteristic of an adulterant obtained in section 2.5. curve, the certified laboratory may during initial or confirmatory drug tests (e) Initial Drug Test. (1) The initial record the result as ‘‘exceeds the linear (e.g., non-recovery of internal standards, drug test shall use an immunoassay range of the test’’ or as ‘‘greater than or unusual response); or (iii) Possible unidentified interfering which meets the requirements of the equal to (insert the value for the upper substance or adulterant. Food and Drug Administration for limit of the linear range),’’ or may dilute The choice of additional validity tests commercial distribution. The following an aliquot of the specimen to obtain an is dependent on the observed indicators initial cutoff levels shall be used when accurate quantitative result when the or characteristics as described in (i), (ii), screening specimens to determine concentration is above the upper limit whether they are negative for these five and (iii) of this section. of the linear range. (h) Reporting Results. drugs or classes of drugs: (1) The laboratory shall report a test CONFIRMATORY DRUG TEST LEVEL result directly to the agency’s MRO INITIAL DRUG TEST LEVEL within an average of 5 working days (ng/mL) (ng/mL) after receipt of the specimen by the Marijuana metabolite 1 ...... 15 laboratory using the Federal CCF and/or Marijuana metabolites ...... 50 Cocaine metabolite 2 ...... 150 an electronic report. Before any test Cocaine metabolites ...... 300 Opiates result is reported, it must be certified as Opiate metabolites ...... 2,000 Morphine ...... 2,000 correct by a certifying scientist. Phencyclidine ...... 25 Codeine ...... 2,000 (2) A urine specimen from a single Amphetamines ...... 1,000 6-Acetylmorphine 3 ...... 10 specimen collection or the primary Phencyclidine ...... 25 (Bottle A) specimen from a split (2) These test levels are subject to Amphetamines specimen collection is reported negative change by the Department of Health and Amphetamine ...... 500 Methamphetamine 4 ...... 500 when each initial drug test is negative Human Services as advances in or it is negative on a confirmatory drug technology or other considerations 1 Delta-9-tetrahydrocannabinol-9-carboxylic test and each specimen validity test warrant identification of these acid. result indicates that the specimen is a substances at other concentrations. The 2 Benzoylecgonine. 3 Test for 6-AM when the morphine con- valid urine specimen. agency requesting the authorization to centration is greater than or equal to 2,000 ng/ (3) A urine specimen from a single include other drugs shall submit to the mL. specimen collection or the primary Secretary in writing the agency’s 4 Specimen must also contain amphetamine (Bottle A) specimen from a split proposed initial drug test methods, at a concentration greater than or equal to 200 ng/mL. specimen collection is reported positive testing levels, and proposed for a specific drug when the initial drug performance test program. (2) These test levels are subject to test is positive and the confirmatory (3) A negative specimen shall be change by the Department of Health and drug test is positive. discarded or may be pooled for use in Human Services as advances in (4) A urine specimen from a single the laboratory’s internal quality control technology or other considerations specimen collection or the primary program unless validity test results warrant identification of these (Bottle A) specimen from a split indicate that the specimen may not be substances at other concentrations. The specimen collection is reported a valid specimen. agency requesting the authorization to adulterated when: (4) Multiple initial drug tests (also include other drugs shall submit to the (i) The pH is less than 3 or greater known as rescreening) for the same drug Secretary in writing the agency’s than or equal to 11 using either a pH or drug class may be performed proposed confirmatory test methods, meter or a colorimetric pH test for the provided that all tests meet all testing levels, and proposed initial test on the first aliquot and a pH Guideline cutoffs and quality control performance test program. meter for the confirmatory test on the requirements (see section 2.5(b)). (3) A specimen that tests negative on second aliquot; Examples: a test is performed by confirmatory drug tests shall be (ii) The nitrite concentration is greater immunoassay technique ‘‘A’’ for all discarded or may be pooled for use in than or equal to 500 mcg/mL using drugs using the HHS cutoff levels, but the laboratory’s internal quality control either a nitrite colorimetric test or a presumptive positive amphetamines are program unless validity test results general oxidant colorimetric test for the forwarded for immunoassay technique indicate that the specimen may not be initial test on the first aliquot and a ‘‘B’’ to eliminate any possible a valid specimen. different confirmatory test (e.g., multi-

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wavelength spectrophotometry, ion test on the first aliquot and a different oxidant colorimetric test for both the chromatography, capillary confirmatory test (e.g., multi-wavelength initial test and the confirmatory test or electrophoresis) on the second aliquot; spectrophotometry) with a greater than using either initial test and the nitrite (iii) The presence of chromium (VI) is or equal to 100 mcg/mL dodecylbenzene concentration is greater than or equal to verified using either a general oxidant sulfonate-equivalent cutoff on the 200 mcg/mL but less than 500 mcg/mL colorimetric test (with a greater than or second aliquot; or for a different confirmatory test (e.g., equal to 50 mcg/mL chromium (VI)- (viii) The presence of any other multi-wavelength spectrophotometry, equivalent cutoff) or a chromium (VI) adulterant not specified in 4(iii) through ion chromatography, capillary colorimetric test (chromium (VI) 4(vii) of this section is verified using an electrophoresis) on two separate concentration greater than or equal to 50 initial test on the first aliquot and a aliquots; mcg/mL) for the initial test on the first different confirmatory test on the (iv) The possible presence of aliquot and a different confirmatory test second aliquot. chromium (VI) is determined using the (e.g., multi-wavelength (5) A urine specimen from a single same chromium (VI) colorimetric test spectrophotometry, ion specimen collection or the primary with a cutoff greater than or equal to 50 chromatography, atomic absorption (Bottle A) specimen from a split mcg/mL chromium (VI) for both the spectrophotometry, capillary specimen collection is reported initial test and the confirmatory test on electrophoresis, inductively coupled substituted when the creatinine two separate aliquots; plasma-mass spectrometry) with the concentration is less than 2 mg/dL and (v) The possible presence of a halogen chromium (VI) concentration greater the specific gravity is less than or equal (e.g., bleach, iodine, fluoride) is than or equal to the LOD of the to 1.0010 or greater than or equal to determined using the same halogen confirmatory test on the second aliquot; 1.0200 on both the initial and colorimetric test with a cutoff greater (iv) The presence of halogen (e.g., confirmatory creatinine tests (i.e., the than or equal to the LOD for both the bleach, iodine, fluoride) is verified same colorimetric test may be used to initial test and the confirmatory test on using either a general oxidant test both aliquots) and on both the two separate aliquots or relying on the colorimetric test (with a greater than or initial and confirmatory specific gravity odor of the specimen as the initial test; equal to 200 mcg/mL nitrite-equivalent tests (i.e., a refractometer is used to test (vi) The possible presence of cutoff or a greater than or equal to 50 both aliquots) on two separate aliquots. glutaraldehyde is determined by using mcg/mL chromium (VI)-equivalent (6) A urine specimen from a single the same aldehyde test (aldehyde cutoff) or halogen colorimetric test specimen collection or the primary present) or characteristic immunoassay (halogen concentration greater than or (Bottle A) specimen from a split response on one or more drug equal to the LOD) for the initial test on specimen collection is reported dilute immunoassay tests for both the initial the first aliquot and a different when the creatinine concentration is test and the confirmatory test on two confirmatory test (e.g., multi-wavelength greater than or equal to 2 mg/dL but less separate aliquots; spectrophotometry, ion than 20 mg/dL and the specific gravity (vii) The possible presence of an chromatography, inductively coupled is greater than 1.0010 but less than oxidizing adulterant is determined by plasma-mass spectrometry) with a 1.0030 on a single aliquot. using the same general oxidant specific halogen concentration greater (7) A urine specimen from a single colorimetric test (with a greater than or than or equal to the LOD of the specimen collection or the primary equal to 200 mcg/mL nitrite-equivalent confirmatory test on the second aliquot; (Bottle A) specimen from a split cutoff, a greater than or equal to 50 mcg/ (v) The presence of glutaraldehyde is specimen collection is reported as an mL chromium (VI)-equivalent cutoff, or verified using either an aldehyde test invalid result when: a halogen concentration is greater than (aldehyde present) or the characteristic (i) Inconsistent creatinine or equal to the LOD) for both the initial immunoassay response on one or more concentration and specific gravity test and the confirmatory test on two drug immunoassay tests for the initial results are obtained (i.e., the creatinine separate aliquots; test on the first aliquot and GC/MS for concentration is less than 2 mg/dL on (viii) The possible presence of a the confirmatory test with the both the initial and confirmatory surfactant is determined by using the glutaraldehyde concentration greater creatinine tests and the specific gravity same surfactant colorimetric test with a than or equal to the LOD of the analysis is greater than 1.0010 but less than greater than or equal to 100 mcg/mL on the second aliquot; 1.0200 on the initial and/or dodecylbenzene sulfonate-equivalent (vi) The presence of pyridine confirmatory specific gravity test, the cutoff for both the initial test and the (pyridinium chlorochromate) is verified specific gravity is less than or equal to confirmatory test on two separate using either a general oxidant 1.0010 on both the initial and aliquots or a foam/shake test for the colorimetric test (with a greater than or confirmatory specific gravity tests and initial test; equal to 200 mcg/mL nitrite-equivalent the creatinine concentration is greater (ix) Interference occurs on the cutoff or a greater than or equal to 50 than or equal to 2 mg/dL on either or immunoassay drug tests on two separate mcg/mL chromium (VI)-equivalent both the initial or confirmatory aliquots (i.e., valid immunoassay drug cutoff) or a chromium (VI) colorimetric creatinine tests); test results cannot be obtained); test (chromium (VI) concentration (ii) The pH is greater than or equal to (x) Interference with the GC/MS drug greater than or equal to 50 mcg/mL) for 3 and less than 4.5 or greater than or confirmation assay occurs on at least the initial test on the first aliquot and equal to 9 and less than 11 using either two separate aliquots of the specimen GC/MS for the confirmatory test with a colorimetric pH test or pH meter for and the laboratory is unable to identify the pyridine concentration greater than the initial test and a pH meter for the the interfering substance; or equal to the LOD of the analysis on confirmatory test on two separate (xi) The physical appearance of the the second aliquot; aliquots; specimen is such that testing the system (vii) The presence of a surfactant is (iii) The nitrite concentration is may damage the laboratory’s verified by using a surfactant greater than or equal to 200 mcg/mL instruments; or colorimetric test with a greater than or using a nitrite colorimetric test or (xii) If the physical appearances of equal to 100 mcg/mL dodecylbenzene greater than or equal to the equivalent Bottles A and B (when a split specimen sulfonate-equivalent cutoff for the initial of 200 mcg/mL nitrite using a general collection is used) are clearly different,

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the test result for Bottle A is one of the designed to ensure confidentiality of the (a) Marijuana Metabolite (number) reasons stated in (i) through (xi) of this information. Results may not be (b) Cocaine Metabolite (number) section and/or was screened negative for provided verbally by telephone. The (c) Opiates (number) drugs. laboratory must ensure the security of (1) Codeine (number) (8) The laboratory shall reject a the data transmission and limit access to (2) Morphine (number) specimen for testing when a fatal flaw any data transmission, storage, and (3) 6-AM (number) occurs as described in paragraph retrieval system. (d) Phencyclidine (number) 2.4(b)(2) or when a correctable flaw as (14) For all test results, a laboratory (e) Amphetamines (number) described in paragraph 2.4(b)(3) is not may fax, courier, mail, or electronically (1) Amphetamine (number) recovered. The laboratory will indicate transmit a legible image or copy of the (2) Methamphetamine (number) on the Federal CCF that the specimen completed Federal CCF, and/or forward (v) Adulterated (number) was rejected for testing and provide the a computer-generated electronic report. (vi) Substituted (number) reason for reporting the rejected for However, for non-negative results, the (vii) Invalid Result (number) testing result. laboratory must fax, courier, mail, or (16) The laboratory shall make (9) The laboratory must report all non- electronically transmit a legible image available copies of all analytical results negative test results for a specimen. For or copy of the completed Federal CCF. for Federal drug testing programs when example, a specimen can be positive for (15) The laboratory shall provide to requested by HHS or any Federal agency a specific drug and adulterated. the agency official responsible for for which the laboratory is performing (10) For a specimen that is tested coordination of the drug-free workplace positive for a drug, the laboratory shall drug testing services. program a semi-annual statistical (17) Unless otherwise instructed by report the specimen as positive and summary report of urinalysis testing of specify the drug for which the specimen the agency in writing, all records Federal employees and shall not include pertaining to a given urine specimen is positive. The concentration of the in the summary any personal drug shall be provided to the MRO only shall be retained by the drug testing identifying information. In order to laboratory for a minimum of 2 years. when the MRO requests such avoid sending data from which it is information. The MRO’s request may (i) Long-Term Storage. Long-term likely that information about a donor’s ¥ ° either be a general request covering all frozen storage ( 20 C or less) ensures test result can be readily inferred, the such results or be on a case by case that positive, adulterated, substituted, laboratory must not send a summary basis. When the concentration of an and invalid urine specimens will be report if the agency has fewer than five analyte exceeds the linear range of the available for any necessary retest. specimen test results in a six-month standard curve, the laboratory may Unless otherwise authorized in writing period. When that situation occurs, the report to the MRO that the quantitative by the agency, drug testing laboratories laboratory must send the agency a report value ‘‘exceeds the linear range of the shall retain and place in properly indicating that not enough specimens test,’’ that the quantitative value is secured long-term frozen storage for a were tested to permit providing a ‘‘greater than or equal to (insert the minimum of 1 year all specimens value for the upper limit of the linear summary report. The summary report reported positive, adulterated, range),’’ or may report an accurate shall include test results that are substituted, or invalid. Within this 1- quantitative value above the upper limit reported within the six-month period. year period, an agency may request the of the linear range that was obtained by Normally, the summary report is sent laboratory to retain the specimen for an diluting an aliquot of the specimen. The within 14 calendar days after the end of additional period of time. If no such MRO shall not disclose the the six-month period covered by the request is received from the agency, the concentration of the drug to the agency. report. The summary report shall laboratory may discard the specimen at (11) The laboratory shall provide contain the following information: the end of this 1-year period. quantitative values for confirmed opiate Reporting Period: (inclusive dates) (j) Retesting a Specimen for Drugs. results for morphine or codeine that are Laboratory Name and Address (1) A second laboratory shall use its greater than or equal to 15,000 ng/mL, Federal Agency Name confirmatory drug test when retesting an even if the MRO has not requested (i) Specimen Results Reported (total aliquot of a single specimen or testing quantitative values for the test result. number) a split (Bottle B) specimen for the drug (12) For a specimen that is found to By Type of Test or drug metabolite that was reported be adulterated or substituted, the (a) Pre-employment (number) positive in the single specimen or the laboratory shall report the specimen as (b) Post-Accident (number) primary (Bottle A) specimen by the first adulterated or substituted and shall (c) Random (number) laboratory. provide the numerical values that (d) Reasonable Suspicion/Cause (2) Because some drugs or drug support the adulterated (when (number) metabolites may deteriorate during applicable) or substituted result. For a (e) Return-to-Duty (number) storage, the retest of an aliquot of a specimen that has an invalid result for (f) Follow-up (number) single specimen or the test of a split one of the reasons stated in paragraphs (g) Type of Test Not Noted on CCF (Bottle B) specimen is not subject to a 2.4(h)(7)(iv) to (xii), the laboratory shall (number) specific drug cutoff requirement, but contact the MRO and both will decide (ii) Specimens Reported must provide data sufficient to confirm if testing by another certified laboratory (a) Negative (number) the presence of the drug or metabolite. would be useful in being able to report (b) Negative and Dilute (number) (3) If the second laboratory fails to a positive or adulterated result. If no (iii) Specimens Reported as Rejected for reconfirm the presence of the drug or further testing is necessary, the Testing (total number) drug metabolite that was reported by the laboratory then reports the invalid result By Reason first laboratory, the second laboratory to the MRO. (a) Fatal flaw (number) shall attempt to determine the reason for (13) The laboratory may transmit (b) Uncorrected Flaw (number) not reconfirming the presence of the results to the MRO by various electronic (iv) Specimens Reported as Positive drug or drug metabolite by conducting means (for example, teleprinters, (total number) specimen validity tests. The second facsimile, or computer) in a manner By Drug laboratory shall conduct the same

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specimen validity tests it would evaluation of the procedural aspects of thereafter. There shall be written conduct on a single specimen or a the laboratory’s drug testing operation. procedures for instrument set-up and primary (Bottle A) specimen. The (p) Documentation. The drug testing normal operation, a schedule for second laboratory reports all test results laboratories shall maintain and make checking critical operating to the MRO. documents of all aspects of the testing characteristics for all instruments, (k) Retesting a Specimen for process available for at least 2 years. tolerance limits for acceptable function Adulterants. This 2-year period may be extended checks, and instructions for major (1) A second laboratory shall use the upon written notification by HHS or by troubleshooting and repair. Records required confirmatory validity test any Federal agency for which laboratory shall be available on preventive specified in paragraph 2.4(h)(4) and the services are being provided. The maintenance. same confirmatory criterion specified in required documentation shall include (4) There shall be written procedures paragraph 2.4(h)(4) to reconfirm an personnel files on all individuals for the actions to be taken when systems adulterant result when retesting an authorized to have access to specimens; are out of acceptable limits or errors are aliquot from a single specimen Federal CCFs and laboratory chain of detected. There shall be documentation collection or when testing a split (Bottle custody forms; quality assurance/quality that these procedures are followed and B) specimen. control records; procedure manuals; all that all necessary corrective actions are (2) The second laboratory may only test data (including calibration curves taken. There shall also be in place retest an aliquot from a single specimen and any calculations used in systems to verify all stages of testing and collection or test a split (Bottle B) determining test results); reports; reporting and documentation that these specimen for the adulterant reported by performance records on performance procedures are followed. the first laboratory. testing; performance on certification (l) Retesting a Specimen for inspections; and hard copies of (5) A laboratory shall make available Substitution. computer-generated data. The laboratory a qualified individual to testify in an (1) A second laboratory shall use its shall be required to maintain method administrative or disciplinary confirmatory creatinine test and validation data and any documents for proceeding against a Federal employee confirmatory specific gravity test, when any specimen under legal challenge for when that proceeding is based on a non- retesting an aliquot of a single specimen an indefinite period. negative result reported by the or testing a split (Bottle B) specimen, to (q) Additional Requirements for laboratory. reconfirm that the creatinine Certified Laboratories. (6) The laboratory shall not enter into concentration was less than 2 mg/dL (1) Each laboratory shall have a any relationship with an agency’s MRO and the specific gravity was less than or procedure manual which includes the that may be construed as a potential equal to 1.0010 or greater than or equal principles of each test, preparation of conflict of interest or derive any to 1.0200. reagents, standards and controls, financial benefit by having an agency (2) The second laboratory may only calibration procedures, derivation of use a specific MRO. retest an aliquot from a single specimen results, linearity of methods, sensitivity of the methods, cutoff values, Section 2.5 Quality Assurance and collection or test a split (Bottle B) Quality Control specimen to reconfirm the substituted mechanisms for reporting results, result reported by the first laboratory. controls, criteria for unacceptable (a) General. Drug testing laboratories (m) Subcontracting. Drug testing specimens and results, corrective shall have a quality assurance program laboratories shall not subcontract and actions to be taken when the test which encompasses all aspects of the shall perform all work with their own systems are outside of acceptable limits, testing process including but not limited personnel and equipment unless reagents and expiration dates, and to specimen accessioning, chain of otherwise authorized by the Secretary. references. Copies of all procedures and custody, security and reporting of (n) Laboratory Facilities. dates on which they are in effect shall results, initial and confirmatory testing, (1) Laboratory facilities shall comply be maintained as part of the manual. certification of calibrators and controls, with applicable provisions of any State (2) Laboratory calibrators and controls and validation of analytical procedures. licensor requirements. shall be prepared using pure drug The performance characteristics (e.g., (2) Laboratories certified in reference materials, stock standard accuracy, precision, limit of detection accordance with Subpart C of these solutions obtained from other (LOD), limit of quantitation (LOQ), Guidelines shall have the capability, at laboratories, or standard solutions specificity) shall be documented for the same laboratory premises, of obtained from commercial each test as appropriate. Validation of performing initial and confirmatory manufacturers. The calibrators and procedures shall document that tests for the five classes of drugs controls shall be properly labeled as to carryover does not affect the donor’s (marijuana, cocaine, opiates, content and concentration. The specimen results. Periodic re- phencyclidine, and amphetamines) and standards (e.g., pure reference materials, verification of analytical procedures is performing the validity tests specified in stock standard solutions, purchased required. Quality assurance procedures these Guidelines. standards) shall be labeled with the shall be designed, implemented, and (o) Inspections. The Secretary, a following dates: when received (if reviewed to monitor the conduct of each Federal agency, or any organization applicable); when prepared or opened; step of the testing process. performing laboratory certification on when placed in service; and expiration (b) Laboratory Quality Control behalf of the Secretary may inspect the date. Requirements for Initial Drug Tests. laboratory at any time. Federal agency (3) Volumetric pipettes and measuring contracts with laboratories for drug devices shall be certified for accuracy or Each analytical run of specimens to be testing, as well as contracts for be checked by gravimetric, colorimetric, screened shall include: collection site services, shall permit the or other verification procedure. (1) Sample(s) certified to contain no agency to conduct unannounced Automatic pipettes and dilutors shall be drug (i.e., negative urine samples); inspections. In addition, prior to the checked for accuracy and (2) At least one control fortified with award of a contract the agency may reproducibility before being placed in drug or metabolite targeted at 25 percent carry out pre-award inspections and service and checked periodically above the cutoff;

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(3) At least one control fortified with (1) The refractometer shall report and shall have the following calibrators and drug or metabolite targeted at 75 percent display the specific gravity to four controls when the screening result of the cutoff; decimal places. The refractometer shall indicates that the pH is below the lower (4) A sufficient number of calibrators be interfaced with a laboratory decision point in use: to ensure and document the linearity of information management system (i) One calibrator at 4; the assay method over time in the (LIMS), computer, and/or generate a (ii) One calibrator at 7; concentration area of the cutoff. After hard copy of the digital electronic (iii) One control in the range of 2 to acceptable values are obtained for the display to document the numerical 2.8; and known calibrators, those values will be result. (iv) One control in the range 3.2 to 4. used to calculate sample data; (2) The initial and confirmatory (6) An initial or confirmatory pH (5) A minimum of 10 percent of the specific gravity tests shall have a meter test, if a pH screening test is used, total specimens and quality control calibrator or control at 1.0000. shall have the following calibrators and samples in each analytical run shall be (3) The initial and confirmatory controls when the screening result quality control samples; and specific gravity tests shall have the indicates that the pH is above the upper (6) One percent of each run, with a following controls: decision point in use: minimum of at least one sample, shall (i) One control targeted at 1.0020; (i) One calibrator at 7; be the laboratory’s blind quality control (ii) One control in the range of 1.0040 (ii) One calibrator at 10; samples to appear as routine specimens to 1.0180; and (iii) One control in the range of 10 to to the laboratory analysts. (iii) One control greater than or equal 10.8; and (c) Laboratory Quality Control to 1.0200 but not greater than 1.0250. (iv) One control in the range of 11.2 Requirements for Confirmatory Drug (g) Requirements for performing pH to 12. Tests. tests. (h) Requirements for performing Each analytical run of specimens to be (1) Colorimetric pH tests that have the oxidizing adulterant tests. confirmed shall include: dynamic range of 2 to 12 to support the (1) The initial test shall include an (1) Sample(s) certified to contain no 3 and 11 pH cutoffs and pH meters must appropriate calibrator at a cutoff drug (i.e., negative urine samples); be capable of measuring pH to one specified in sections 2.4(h)(4) and (7) for (2) Positive calibrator(s) and control(s) decimal place. Colorimetric pH tests, the compound of interest, a control fortified with drug or metabolite; dipsticks, and pH paper that have a without the compound of interest (i.e., (3) At least one control with drug or narrow dynamic range and do not a certified negative control), and at least metabolite targeted at 25 percent above support the cutoffs may be used only to one control with one of the compounds the cutoff; and determine if an initial pH validity test of interest at a measurable (4) At least one calibrator or control must be performed. concentration. that is targeted at or below 40 percent (2) pH screening tests shall have, at a (2) A confirmatory test for a specific of the cutoff. minimum, the following controls: oxidizing adulterant shall use a different (d) Laboratory Quality Control (i) One control below the lower analytical method than that used for the Requirements for Specimen Validity decision point in use; initial test. Each confirmatory test batch Tests. (ii) One control between the decision shall include an appropriate calibrator, (1) Each validity test result shall be points in use; and a control without the compound of based on performing an initial validity (iii) One control above the upper interest (i.e., a certified negative test on one aliquot and a confirmatory decision point in use. control), and a control with the validity test on a second aliquot; and (3) An initial colorimetric pH test compound of interest at a measurable (2) Each analytical run of specimens shall have the following calibrators and concentration. for which an initial or confirmatory controls: (i) Requirements for performing nitrite validity test is being performed shall (i) One calibrator at 3; tests. The initial and confirmatory include the appropriate calibrators and (ii) One calibrator at 11; nitrite tests shall have a calibrator at the controls. (iii) One control in the range of 2 to cutoff concentration, a control without (e) Requirements for performing 2.8; nitrite (i.e., certified negative urine), one creatinine tests. (iv) One control in the range 3.2 to 4; control in the range of 200 mcg/mL to (1) The creatinine concentration shall (v) One control in the range of 4.5 to 400 mcg/mL, and one control in the be measured to one decimal place on 9; range of 500 mcg/mL to 625 mcg/mL. both the initial creatinine test and the (vi) One control in the range of 10 to (j) Requirements for performing confirmatory creatinine test. 10.8; ‘‘other’’ adulterant tests. (2) The initial creatinine test shall (vii) One control in the range of 11.2 (1) The initial and confirmatory tests have a calibrator at 2 mg/dL. to 12. for any ‘‘other’’ adulterant that may be (3) The initial creatinine test shall (4) An initial pH meter test, if a pH identified in the future shall satisfy the have a control in the range of 1.0 mg/ screening test is not used, shall have the requirements in section 2.5(d). dL to 1.5 mg/dL, a control in the range following calibrators and controls: (2) The confirmatory test for ‘‘other’’ of 3 mg/dL to 20 mg/dL, and a control (i) One calibrator at 4; adulterants shall use a different in the range of 21 mg/dL to 25 mg/dL. (ii) One calibrator at 7; analytical principle or chemical reaction (4) The confirmatory creatinine test (iii) One calibrator at 10; than that used for the initial test. (performed on those specimens with a (iv) One control in the range of 2 to (3) The initial and confirmatory tests creatinine concentration less than 2 mg/ 2.8; for adulterants in this section shall dL on the initial test) shall have a (v) One control in the range 3.2 to 4; include an appropriate calibrator, a calibrator at 2 mg/dL, a control in the (vi) One control in the range of 10 to control without the compound of range of 1.0 mg/dL to 1.5 mg/dL, and a 10.8; and interest (i.e., a certified negative control in the range of 3 mg/dL to 4 mg/ (vii) One control in the range of 11.2 control), and a control with the dL. to 12. compound of interest at a measurable (f) Requirements for performing (5) An initial or confirmatory pH concentration. specific gravity tests. meter test, if a pH screening test is used, (k) Agency Blind Sample Program.

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(1) Agencies shall only use blind have been systematic, the Secretary may adulterated, substituted, or invalid test quality control samples that have been also require review and reanalysis of result automatically indicate that a certified by the supplier to be negative previously run specimens. donor has tampered with a specimen. (i.e., certified by immunoassay and GC/ (6) Should a false positive error occur The review of a non-negative test result MS to contain no drug), drug positive on a blind performance test sample and shall be performed by the MRO before (i.e., certified by immunoassay and GC/ the error is determined to be a technical the result is transmitted to the agency’s MS to contain a drug(s)/metabolite(s) or methodological error, the laboratory designated representative. Staff under between 1.5 and 2 times the initial drug shall submit all data from the batch of the direct, personal supervision of the test cutoff concentration), adulterated specimens which included the false MRO may review and report a negative (i.e., certified to be adulterated with a positive specimen. In addition, the test result to the agency’s designated specific adulterant using an appropriate laboratory shall retest all specimens representative. confirmatory validity test(s)), or analyzed positive for that drug or (c) MRO Review of Positive, substituted (i.e., the creatinine metabolite from the time of final Adulterated, Substituted, or Invalid Test concentration and specific gravity resolution of the error back to the time Results. satisfy the criteria for a substituted of the last satisfactory performance test (1) Prior to making a final decision on specimen using confirmatory creatinine cycle. This retesting shall be a specimen that was reported positive, and specific gravity tests, respectively). documented by a statement signed by adulterated, substituted, or an invalid The supplier shall also provide the the Responsible Person. The Secretary test result by the laboratory, the MRO expiration date for each quality control may require an on-site review of the shall interview the donor to determine sample to ensure that each quality laboratory which may be conducted if the donor has a valid medical control sample will give the expected unannounced during any hours of explanation for the test result. This result when it is submitted and correctly operation of the laboratory. The action could include a review of the tested by a laboratory before the Secretary has the option of revoking donor’s medical history and a review of expiration date. (section 3.13) or suspending (section any other biomedical factors. The MRO (2) During the initial 90-day period of 3.14) the laboratory’s certification or shall review medical records made any new drug testing program, each recommending that no further action be available by the donor when a result agency shall submit blind performance taken if the case is one of less serious could have resulted from taking a test samples to each laboratory it error in which corrective action has legally prescribed medication. After contracts with in the amount of at least already been taken, thus reasonably making a determination, the MRO 20 percent of the total number of assuring that the error will not occur reports the verified result to the specimens submitted (up to a maximum again. agency’s designated representative. of 200 blind samples) and thereafter a (2) When a laboratory reports an minimum of 3 percent blind samples Section 2.6 Reporting and Review of invalid result because of one of the (up to a maximum of 100 blind samples) Results reasons specified in paragraphs submitted per quarter. (a) MRO Qualifications. 2.4(h)(7)(iv) to (xii), the MRO and the (3) Approximately 75 percent of the (1) An MRO shall be a licensed laboratory shall determine if additional blind quality control samples shall be physician (Doctor of Medicine or testing by another HHS-certified negative (i.e., certified to contain no Osteopathy). laboratory may be useful in resolving drug), approximately 15 percent shall be (2) An MRO shall have knowledge the reason for the invalid result and positive for one or more drugs, and about and clinical experience in possibly being able to report a positive approximately 10 percent shall be either controlled substance abuse disorders, or adulterated result. If the MRO and the adulterated or substituted. The positive detailed knowledge of alternative laboratory agree that no further testing samples shall be spiked only with those medical explanations for laboratory would be useful, the MRO shall report drugs for which the agency is testing. positive drug test results, knowledge the invalid result as ‘‘Test Cancelled— (4) The agency shall investigate any about issues relating to adulterated and Invalid Result (specify reason for the unsatisfactory blind performance test substituted specimens, and knowledge invalid result)’’ to the agency and sample results and submit its findings to about possible medical causes for indicate one of the following actions: the Secretary. The Secretary shall specimens that may be reported as (i) An immediate direct observed continue the investigation to ensure that having an invalid result. collection is not required because the the laboratory has corrected the cause of (3) An MRO may be an employee of explanation provided by the donor for the unsatisfactory performance test the agency or a contractor for the the invalid result is acceptable with no result. A report of the Secretary’s agency; however, an MRO shall not be further action required unless a negative investigative findings and the corrective an employee or agent of or have any test result is required (i.e, pre- action taken by the laboratory shall be financial interest in the laboratory for employment, return-to-duty, or follow- sent to the agency contracting officer. which the MRO is reviewing drug up test); or The Secretary shall ensure notification testing results. Additionally, an MRO (ii) An immediate direct observed of the finding to all other Federal shall not derive any financial benefit by collection is required because the agencies for which the laboratory is having an agency use a specific drug explanation provided by the donor for engaged in urine drug testing and testing laboratory or have any agreement the invalid result is not acceptable. coordinate any necessary action. with the laboratory that may be (d) Verification for Opiates; Review (5) Should a false positive error occur construed as a potential conflict of for Prescription Medication. Before the on a blind performance test sample and interest. MRO verifies a confirmed positive result the error is determined to be an (b) MRO Review of Results. An for opiates, he or she shall determine administrative error (clerical, sample essential part of the drug testing that there is clinical evidence—in mixup, etc.), the Secretary shall require program is the final review of each test addition to the urine test result—of the laboratory to take corrective action result reported by a laboratory. A illegal use of any opium, opiate, or to minimize the occurrence of the positive drug test result does not opium derivative (e.g., morphine/ particular error in the future; and, if automatically identify a donor as an codeine) listed in Schedule I or II of the there is reason to believe the error could illegal drug user nor does an Controlled Substances Act. This

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requirement does not apply if the explanation for the adulteration result, (5) Failed to reconfirm one or more laboratory confirms the presence of 6- the MRO reports a failed to reconfirm drugs, reconfirmed one or more drugs, acetylmorphine (i.e., the presence of (specify drug(s)) and cancels both tests. and adulterated. The MRO reports to the this metabolite is proof of heroin use) or If there is no legitimate medical agency a reconfirmed result (specify the morphine or codeine concentration explanation, the MRO reports a failed to drug(s)) and a failed to reconfirm result is greater than or equal to 15,000 ng/mL reconfirm (specify drug(s)) and a refusal (specify drug(s)). The MRO tells the and the donor does not present a to test to the agency and indicates the agency that it may take action based on legitimate medical explanation for the adulterant that is present in the urine the reconfirmed drug(s) although presence of morphine or codeine at or specimen. The MRO gives the donor 72 Laboratory B failed to reconfirm one or above this concentration. Consumption hours to request that Laboratory A more drugs and found that the specimen of food products must not be considered retests the single or Bottle A specimen was adulterated. The MRO shall notify a legitimate medical explanation for the for the adulterant. If Laboratory A the appropriate regulatory office donor having morphine or codeine at or reconfirms the adulterant, the MRO regarding the test results for the above this concentration. reports refusal to test and indicates the specimen. (e) Donor Request to MRO for Retest. adulterant present. If Laboratory A fails (6) Failed to reconfirm one or more (1) For a positive, adulterated, or to reconfirm the adulterant, the MRO drugs, reconfirmed one or more drugs, substituted result reported on a single cancels both tests and directs the agency and substituted. The MRO reports to the specimen or a primary (Bottle A) to immediately collect another agency a reconfirmed result (specify specimen, a donor may request through specimen using a direct observed drug(s)) and a failed to reconfirm result the MRO that an aliquot from the single collection procedure. The MRO shall (specify drug(s)). The MRO tells the specimen or the split (Bottle B) notify the appropriate regulatory office agency that it may take action based on specimen be tested by a second HHS- about the failed to reconfirm and the reconfirmed drug(s) although certified laboratory to verify the result cancelled test. Laboratory B failed to reconfirm one or reported by the first laboratory. For a (2) Failed to reconfirm a single or all more drugs and found that the specimen single specimen or primary (Bottle A) drug positive results and substituted. If was substituted. The MRO shall notify specimen reported as an invalid result, the donor provides a legitimate medical the appropriate regulatory office a donor may not request that an aliquot explanation for the substituted result, regarding the test results for the from the single specimen or the split the MRO reports a failed to reconfirm specimen. (7) Failed to reconfirm one or more (Bottle B) specimen be tested by a (specify drug(s)) and cancels both tests. drugs, reconfirmed one or more drugs, second HHS-certified laboratory. If there is no legitimate medical (2) The donor has 72 hours (from the and not adulterated or substituted. The explanation, the MRO reports a failed to time the MRO notified the donor that MRO reports a reconfirmed result reconfirm (specify drug(s)) and a refusal his or her specimen was reported (specify drug(s)) and a failed to to test (substituted) to the agency. The positive, adulterated, or substituted) to reconfirm result (specify drug(s)). The MRO gives the donor 72 hours to request a retest of an aliquot from the MRO tells the agency that it may take request Laboratory A to review the single specimen or to test the split action based on the reconfirmed drug(s) creatinine and specific gravity results (Bottle B) specimen. although Laboratory B failed to for the single or Bottle A specimen. If (3) If the single specimen or split reconfirm one or more drugs. The MRO the original creatinine and specific (Bottle B) specimen cannot be tested by shall notify the appropriate regulatory gravity results confirm that the a second laboratory (e.g., insufficient office regarding the test results for the specimen was substituted, the MRO volume, lost in transit, split (Bottle B) specimen. reports a refusal to test (substituted) to not available), the MRO shall direct the (8) Failed to reconfirm one or more the agency. If the original creatinine and agency to immediately collect another drugs, reconfirmed one or more drugs, specific gravity results from Laboratory specimen under direct observation. and invalid result. The MRO reports to (4) If a donor chooses not have an A fail to confirm that the specimen was the agency a reconfirmed result (specify aliquot from the single specimen or the substituted, the MRO cancels both tests drug(s)) and a failed to reconfirm result split (Bottle B) specimen tested by a and directs the agency to immediately (specify drug(s)). The MRO tells the second HHS-certified laboratory, a collect another specimen using a direct agency that it may take action based on Federal agency may have a single or observed collection procedure. The the reconfirmed drug(s) although split specimen retested as part of a legal MRO shall notify the appropriate Laboratory B failed to reconfirm one or or administrative proceeding to defend regulatory office about the failed to more drugs and reported an invalid an original positive, adulterated, or reconfirm and cancelled test. result. The MRO shall notify the substituted result. (3) Failed to reconfirm a single or all appropriate regulatory office regarding (f) Result Consistent with Legal Drug drug positive results and not the test results for the specimen. Use. If the MRO determines there is a adulterated or substituted. The MRO (9) Failed to reconfirm substitution or legitimate medical explanation for the reports to the agency a failed to adulteration. The MRO reports to the positive drug test result, he or she shall reconfirm result (specify drug(s)), agency a failed to reconfirm result normally take no further action and cancels both tests, and notifies the (specify adulterant or not substituted) report the test result as negative. appropriate regulatory office. and cancels both tests. The MRO shall (g) Laboratory Result Not Reconfirmed (4) Failed to reconfirm a single or all notify the appropriate regulatory office by a Second Laboratory. After a second drug positive results and invalid result. regarding the test results for the laboratory tests an aliquot of the single The MRO reports to the agency a failed specimen. specimen or the split (Bottle B) to reconfirm result (specify drug(s) and (10) Failed to reconfirm a single or all specimen, the MRO shall take the gives the reason for the invalid result), drug positive results and reconfirmed an following actions when the second cancels both tests, directs the agency to adulterated or substituted result. The laboratory reports the following results: immediately collect another specimen MRO reports to the agency a (1) Failed to reconfirm a single or all using a direct observed collection reconfirmed result (adulterated or drug positive results and adulterated. If procedure, and notifies the appropriate substituted) and a failed to reconfirm the donor provides a legitimate medical regulatory office. result (specify drug(s)). The MRO tells

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the agency that it may take action based for a single specimen or primary (Bottle conducting urine drug testing for on the reconfirmed result (adulterated A) specimen to the agency, the MRO Federal agencies. Therefore, results from or substituted) although Laboratory B shall report whether the specimen was laboratories certified under these failed to reconfirm the drug(s) result. negative, dilute, positive (specify drug), Guidelines must be interpreted with a (11) Failed to reconfirm a single or all refusal to test (adulterated or complete understanding of the total drug positive results and failed to substituted), or test cancelled (state collection, analysis, and reporting reconfirm the adulterated or substituted reason). When reporting the result for a process before a final conclusion is result. The MRO reports to the agency retest of an aliquot of a single specimen made. a failed to reconfirm result (specify or the test of a split (Bottle B) specimen drug(s) and specify adulterant or Section 3.2 Goals and Objectives of to the agency, the MRO shall report Certification substituted) and cancels both tests. The reconfirmed, failed to reconfirm (state MRO shall notify the appropriate reason), refusal to test (adulterated or (a) Uses of Urine Drug Testing. Urine regulatory office regarding the test substituted), or cancel both test results drug testing is an important tool to results for the specimen. as described in section 2.6(g). The MRO identify drug users in a variety of (12) Failed to reconfirm at least one shall not disclose any numerical values settings. In the proper context, urine drug and reconfirmed the adulterated to the agency. drug testing can be used to deter drug result. The MRO reports to the agency abuse in general. To be a useful tool, the a reconfirmed result (specify drug(s) and Section 2.7 Protection of Employee testing procedure must be capable of adulterated) and a failed to reconfirm Records detecting drugs, drug metabolites, result (specify drug(s)). The MRO tells Consistent with 5 U.S.C. 522a(m) and adulterants, or substituted specimens the agency that it may take action based 48 CFR 24.101–24.104, all laboratory according to sections 2.4(e), 2.4(f), and on the reconfirmed drug(s) and the contracts shall require that the 2.4(g) to protect the rights of the Federal adulterated result although Laboratory B contractor comply with the Privacy Act, employees being tested. failed to reconfirm one or more drugs. 5 U.S.C. 522a. In addition, laboratory (b) Need to Set Standards; (13) Failed to reconfirm at least one contracts shall require compliance with Inspections. The ability to accurately drug and failed to reconfirm the patient access and confidentiality determine the presence or absence of adulterated result. The MRO reports to provisions of sec. 503 of Public Law specific drugs/metabolites or to the agency a reconfirmed result (specify 100–71. The agency shall establish a accurately determine the validity of a drug(s)) and a failed to reconfirm result Privacy Act System of Records or urine specimen is critical to achieving (specify drug(s) and specify adulterant). modify an existing system, or use any the goals of the testing program and to The MRO tells the agency that it may applicable Government-wide system of protect the rights of the Federal employees being tested. Standards have take action based on the reconfirmed records to cover the agency’s records of been set which laboratories engaged in drug(s) although Laboratory B failed to employee urinalysis results. The Federal employee urine drug testing reconfirm one or more drugs and failed contract and the Privacy Act System of shall meet to achieve the required to reconfirm the adulterated result. Records shall specifically require that (14) Failed to reconfirm an accuracy of test results. These employee records be maintained and adulterated result and failed to laboratories will be evaluated by the used with the highest regard for reconfirm a substituted result. The MRO Secretary or the Secretary’s designee as employee privacy. reports to the agency a failed to defined in section 1.2 in accordance reconfirm result ((specify adulterant) Section 2.8 Individual Access to Test with these Guidelines. Applicant and not substituted) and cancels both and Laboratory Certification Results laboratories shall test three cycles of performance testing samples that tests. The MRO shall notify the In accordance with sec. 503 of Public challenge the laboratory’s ability to appropriate regulatory office regarding Law 100–71, any Federal employee who correctly test for drugs and to correctly the test results for the specimen. is the subject of a drug test shall, upon perform specimen validity tests. (15) Failed to reconfirm an written request, have access to any Applicant laboratories shall undergo an adulterated result and reconfirmed a records relating to his or her drug test initial inspection and upon certification substituted result. The MRO reports to and any records relating to the results of are also required to undergo a second the agency a reconfirmed result any relevant certification, review, or inspection within 3 months after being (substituted) and a failed to reconfirm revocation-of-certification proceedings. result (specify adulterant). The MRO certified. Certified laboratories are tells the agency that it may take action Subpart C—Certification of required to analyze quarterly based on the substituted result although Laboratories Engaged in Urine Drug performance testing samples that Laboratory B failed to reconfirm the Testing for Federal Agencies challenge the laboratories to correctly test for drugs and to correctly perform adulterated result. Section 3.1 Introduction (16) Failed to reconfirm a substituted validity tests and are required to result and reconfirmed an adulterated Urine drug testing is a critical undergo periodic inspections. result. The MRO reports to the agency component of efforts to combat drug (c) Urine Drug Testing Applies a reconfirmed result (adulterated) and a abuse in our society. Many laboratories Analytical Forensic Toxicology. The failed to reconfirm result (not are familiar with good laboratory possible impact of a non-negative test substituted). The MRO tells the agency practices but may be unfamiliar with the result on an individual’s livelihood or that it may take action based on the special procedures required when drug rights, together with the possibility of a adulterated result although Laboratory B test results are used in the employment legal challenge of the result, sets this failed to reconfirm the substituted context. Accordingly, the following are type of test apart from most clinical result. minimum standards to certify laboratory testing. In fact, urine drug (h) Reporting Final Results. The MRO laboratories engaged in urine drug testing should be considered a special shall report the final results of the tests testing for Federal agencies. application of analytical forensic in writing and in a manner designed to Certification, even at the highest level, toxicology. That is, in addition to the ensure confidentiality of the does not guarantee accuracy of each application of appropriate analytical information. When reporting the result result reported by a laboratory methodology, the specimen must be

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treated as evidence, and all aspects of laboratory under these Guidelines shall (5) The laboratory’s compliance with the testing procedure must be be a determination that these standards as reflected in any laboratory documented and available for possible qualification requirements have been inspections; and court testimony. Laboratories engaged in met. (6) Any other factors affecting the urine drug testing for Federal agencies reliability and accuracy of drug or Section 3.7 Quality Assurance and will require the services and advice of validity tests and reporting done by the Quality Control a qualified forensic toxicologist, or laboratory. individual with equivalent Certified laboratories shall have a (c) Corrective Action by Certified qualifications (both training and quality assurance program which Laboratories. A laboratory must meet all experience) to address the specific encompasses all aspects of the testing the pertinent provisions of these needs of the Federal drug testing process, including but not limited to Guidelines in order to qualify for and program, including the demands of specimen accessioning, chain of maintain certification. The Secretary has chain of custody of specimens, security, custody, security and reporting of broad discretion to take appropriate proper documentation of all records, results, initial and confirmatory testing, action to ensure the full reliability and storage of non-negative specimens for and validation of analytical procedures. accuracy of drug and validity testing later or independent testing, As specified in these Guidelines, quality and reporting, to resolve problems presentation of evidence in court, and control procedures shall be designed, related to drug and validity testing, and expert witness testimony. implemented, and reviewed to monitor to enforce all standards set forth in these testing. Guidelines. The Secretary shall have the Section 3.3 General Certification authority to issue directives to any Requirements Section 3.8 Security and Chain of laboratory suspending the use of certain A laboratory must meet all the Custody analytical procedures when necessary to pertinent provisions of these Guidelines Laboratories shall meet the security protect the integrity of the testing in order to qualify for and maintain and chain of custody requirements process; order any laboratory to certification under these standards. provided in section 2.4(a). undertake corrective actions to respond to material deficiencies identified by an Section 3.9 One-Year Storage for Section 3.4 Capability to Test for Five inspection or through proficiency Positive, Adulterated, Substituted, and Classes of Drugs and to Conduct testing; order any laboratory to send Invalid Specimens Validity Tests aliquots of urine specimens to another To be certified, a laboratory must be All positive, adulterated, substituted, laboratory for retesting when necessary capable of testing for marijuana, and invalid specimens shall be retained to ensure the accuracy of testing under cocaine, opiates, amphetamines, and in accordance with the provisions of these Guidelines; order the review of phencyclidine using the initial section 2.4(i) of these Guidelines. results for specimens tested under the immunoassay and confirmatory GC/MS Section 3.10 Documentation Guidelines for private-sector employers/ methods and conducting the specimen clients to the extent necessary to ensure validity tests as specified in these The laboratory shall maintain and the full reliability of drug and validity Guidelines. The certification program make available for at least 2 years testing for Federal agencies; and order will be limited to these five classes of documentation in accordance with the any other action necessary to address drugs and specimen validity tests in specifications in section 2.4(p). deficiencies in drug or validity testing, accordance with the methods specified Section 3.11 Reports analysis, specimen collection, chain of in these Guidelines (sections 2.4(e), (f), custody, reporting of results, or any and (g)). The laboratory will be The laboratory shall report test results other aspect of the certification program. inspected and performance tested for in accordance with the specifications in these drugs and validity tests. Certified section 2.4(h). Section 3.13 Revocation laboratories must clearly inform all non- Section 3.12 Certification (a) General. The Secretary shall regulated, private-sector employers/ revoke certification of any laboratory clients when their specimens are being (a) General. The Secretary may certify certified under these provisions or tested using procedures that are any laboratory that meets the standards accept revocation by an HHS-recognized different from those for which the in these Guidelines to conduct urine certification program in accordance laboratory is certified (i.e., testing drug testing. In addition, the Secretary with these Guidelines if the Secretary specimens not under the Guidelines). may consider to be certified any determines that revocation is necessary laboratory that is certified by an HHS- to ensure the full reliability and Section 3.5 Initial and Confirmatory recognized certification program in accuracy of drug and validity tests and Capability at Same Site accordance with these Guidelines. the accurate reporting of test results. Certified laboratories shall have the (b) Criteria. In determining whether to (b) Factors to Consider. The Secretary capability to perform initial and certify a laboratory or to accept the shall consider the following factors in confirmatory drug tests and initial and certification of an HHS-recognized determining whether revocation is confirmatory validity tests at the same certification program in accordance necessary: laboratory site. with these Guidelines, the Secretary (1) Unsatisfactory performance in shall consider the following criteria: analyzing and reporting the results of Section 3.6 Personnel (1) The adequacy of the laboratory drug and validity tests; for example, a Laboratory personnel shall meet the facilities; false positive error in reporting the requirements specified in section 2.3 of (2) The expertise and experience of results of an employee’s drug test; these Guidelines. These Guidelines the laboratory personnel; (2) Unsatisfactory participation in establish the exclusive standards for (3) The excellence of the laboratory’s performance evaluations or laboratory qualifying or certifying those laboratory quality assurance/quality control inspections; personnel involved in urinalysis testing program; (3) A material violation of a whose functions are prescribed by these (4) The performance of the laboratory certification standard or a contract term Guidelines. A certification of a on any performance tests; or other condition imposed on the

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laboratory by a Federal agency using the (c) Effective Date. A suspension shall by the laboratory shall to the greatest laboratory’s services; be effective immediately. A proposed extent possible be carried out in a (4) Conviction for any criminal revocation shall be effective 30 days manner identical to that applied to offense committed as an incident to after written notice is given or, if review routine specimens, unless otherwise operation of the laboratory; or is requested, upon the reviewing specified. (5) Any other cause which materially official’s decision to uphold the (e) Agency PT Samples. Any certified affects the ability of the laboratory to proposed revocation. If the reviewing laboratory shall be subject to receiving ensure the full reliability and accuracy official decides not to uphold the and testing PT samples (see section of drug and validity tests and the suspension or proposed revocation, the 2.5(k)) submitted by a Federal agency. A accurate reporting of results. suspension shall terminate immediately certified laboratory is expected to (c) Period and Terms. The period and and any proposed revocation shall not correctly test and report each agency terms of revocation shall be determined take effect. submitted PT sample (that is, report a by the Secretary and shall depend upon (d) HHS-Recognized Certification negative sample as negative, a drug the facts and circumstances of the Program. The Secretary’s responsibility positive sample as positive, an revocation and the need to ensure under this section may be carried out by adulterated sample as adulterated, or a accurate and reliable drug and validity an HHS-recognized certification substituted sample as substituted). testing of Federal employees. program in accordance with these (f) Reporting PT Sample Results. The laboratory shall report results of PT Section 3.14 Suspension Guidelines. (e) Public Notice. The Secretary will program samples to the certifying (a) Criteria. Whenever the Secretary publish in the Federal Register the organization in the same manner as has reason to believe that revocation name, address, and telephone number of specified in section 2.4(h) for routine may be required and that immediate any laboratory that has its certification specimens. action is necessary in order to protect suspended or revoked under section Section 3.18 PT Program Samples the interests of the United States and its 3.13 or section 3.14, respectively, and employees, the Secretary may the name of any laboratory which has its (a) Drug PT Samples. Each PT cycle immediately suspend a laboratory’s suspension lifted. The Secretary shall shall have samples that contain the certification to conduct urine drug and provide to any member of the public drugs and drug metabolites listed in validity testing for Federal agencies. The upon request the written notice sections 2.4(e) and (f). For some Secretary may also accept suspension of provided to a laboratory that has its samples, the composition will consist of certification by an HHS-recognized certification suspended or revoked, as the parent drug as well as metabolites. certification program in accordance well as the reviewing official’s written Also, more than one drug class may be with these Guidelines. decision which upholds or denies the included in one sample, but generally (b) Period and Terms. The period and suspension or proposed revocation no more than two drugs will be present terms of suspension shall be determined under the procedures of subpart D. in any one sample. For any particular by the Secretary and shall depend upon PT cycle, the samples in each set of the facts and circumstances of the Section 3.16 Recertification samples going to the laboratories may suspension and the need to ensure Following revocation, a laboratory vary but, within any annual period, all accurate and reliable drug and validity may apply for recertification. Unless laboratories participating in the PT testing of Federal employees. otherwise provided by the Secretary in program will have analyzed the same the notice of revocation under section Section 3.15 Notice total set of samples. 3.13(a) or the reviewing official’s (b) Composition of the Drug PT (a) Written Notice. When a laboratory decision under section 4.9(e) or 4.14(a), Samples. PT program samples shall is suspended or the Secretary seeks to a laboratory which has had its satisfy, but are not limited to, one of the revoke certification, the Secretary shall certification revoked may reapply for following criteria: immediately serve the laboratory with certification as an applicant laboratory. (1) A drug or drug metabolite written notice of the suspension or concentration will be at least 20 percent proposed revocation by facsimile mail, Section 3.17 Performance Testing (PT) above the cutoff for either the initial personal service, or registered or Requirement for Certification drug test or the confirmatory drug test certified mail, return receipt requested. (a) An Initial and Continuing depending on which is to be evaluated; This notice shall state the following: Requirement. The PT program is a part (2) For retest samples, the drug or (1) The reasons for the suspension or of the initial evaluation of a laboratory drug metabolite concentration may be as proposed revocation; seeking certification (both PT and low as 40 percent of the cutoff; (2) The terms of the suspension or laboratory inspection are required) and (3) For routine samples, the drug or proposed revocation; and of the continuing assessment of drug metabolite concentration may be (3) The period of suspension or laboratory performance necessary to below the cutoff for special purposes; proposed revocation. maintain this certification. (4) A negative sample shall contain no (b) Opportunity for Informal Review. (b) Three Initial Cycles Required. target drug analyte at a concentration The written notice shall state that the Successful participation in three PT greater than 10 percent of the laboratory will be afforded an cycles of testing shall be required before confirmatory cutoff; opportunity for an informal review of a laboratory is eligible to be considered (5) Samples may be fortified with the suspension or proposed revocation for certification. interfering substances. if it so requests in writing within 30 (c) Four Cycles Per Year. After (c) Specimen Validity Testing PT days of the date the laboratory received certification, laboratories shall be Samples. Each PT cycle shall contain the notice, or if expedited review is challenged with at least 10 PT samples samples that challenge a laboratory’s requested, within 3 days of the date the on a quarterly cycle. ability to identify substituted and laboratory received the notice. Subpart (d) Laboratory Procedures Identical adulterated specimens. For any D contains detailed procedures to be for PT Samples and Routine Specimens. particular PT cycle, the samples in each followed for an informal review of the All procedures associated with the set of samples going to the laboratories suspension or proposed revocation. handling and testing of the PT samples may vary but, within any annual period,

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all laboratories participating in the PT 50 percent of the challenges for each An applicant laboratory reporting any program will have analyzed the same drug. An applicant laboratory that fails such error will be disqualified. total set of specimen validity testing PT to successfully quantitate at least 50 (b) Evaluation of Certified samples. percent of the challenges for each drug Laboratories. (d) Composition of the Specimen will result in disqualification. (1) Requirement for No False Validity Testing PT Samples. Specimen (6) An applicant laboratory shall Positives. A certified laboratory that validity testing PT samples shall satisfy, maintain an overall grade of 80 percent reports a false positive drug result for a but are not limited to, one of the for the three cycles of PT samples that PT sample may be subject to suspension following criteria: challenge the laboratory’s ability to or revocation of its certification. The (1) The nitrite concentration will be at conduct specimen validity tests (i.e., to most serious false positive is by drug least 20 percent above the cutoff; correctly identify and confirm 80 class, such as reporting THCA in a (2) The pH will be less than 2.75 or percent of the total specimen validity negative PT sample or reporting cocaine greater than 11.25; testing challenges). An applicant metabolite in a PT sample containing (3) The concentration of an oxidant laboratory that achieves a score on any only opiates. An identification or will be at a level sufficient to challenge one of the initial PT cycles such that it reporting error within a class (e.g., a laboratory’s ability to identify and can no longer achieve a total grade of 80 reporting codeine for morphine) is confirm the oxidant; percent over the three consecutive PT unacceptable, but is less serious than a (4) The creatinine concentration will cycles for the specimen validity testing misidentification of a class. be between 0 and 20 mg/dL; samples will result in disqualification. (2) Requirement to Identify and (5) The specific gravity will be less (7) For quantitative specimen validity Confirm 90 Percent of Total Drug than or equal to 1.0050 or between tests, an applicant laboratory shall Challenges. Failure of a certified 1.0170 and 1.0230. obtain quantitative values for at least 80 laboratory to maintain a grade of 90 percent of the total challenges that percent over two consecutive PT cycles Section 3.19 Evaluation of PT Sample (i.e., to identify 90 percent of the total Results satisfy the following criteria: (i) Nitrite and creatinine drug challenges and to correctly confirm (a) Initial Certification of Applicant concentrations are within ±20 percent or 90 percent of the total drug challenges) Laboratories. ±2 standard deviations of the calculated may result in suspension or revocation (1) An applicant laboratory shall not reference group mean; of the laboratory’s certification. report any false positive drug test result (ii) pH values are within ±0.3 pH (3) Requirement to Quantitate 80 on any PT sample during the initial units of the calculated reference group Percent of Total Drug Challenges Within certification process. A false positive mean; and ±20 Percent or ±2 Standard Deviations. drug result will automatically disqualify (iii) Specific gravity values are within Quantitative values reported by a a laboratory from further consideration. ±0.0003 specific gravity units of the certified laboratory over two (2) An applicant laboratory shall calculated reference group mean. consecutive PT cycles must be within maintain an overall grade of 90 percent An applicant laboratory that achieves ±20 percent or ±2 standard deviations of for the three cycles of PT samples that a score on any one initial PT cycle such the calculated reference group mean challenge the laboratory’s ability to that it cannot achieve a total grade of 80 (whichever is larger) for at least 80 conduct drug tests (i.e., it must correctly percent over three consecutive PT percent of the total drug challenges. A identify and confirm 90 percent of the cycles for the specimen validity testing certified laboratory that fails to achieve total drug challenges). A laboratory samples will be disqualified. the 80 percent requirement may have its which achieves a score on any one cycle (8) An applicant laboratory shall not certification suspended or revoked. of the initial certification process such obtain any quantitative value on a (4) Requirement to Quantitate within that it can no longer achieve a grade of specimen validity testing sample that 50 Percent of Calculated Reference 90 percent over three consecutive PT differs by more than ±50 percent for Group Mean. A certified laboratory shall cycles will be immediately disqualified nitrite and creatinine concentrations, not obtain any quantitative value on a from further consideration. ±0.8 units for pH measurements, or drug challenge that differs by more than (3) An applicant laboratory shall ±0.0006 units for specific gravity from ±50 percent from the calculated obtain quantitative values over the three the calculated reference group means. reference group mean. More than one initial PT cycles that are within ±20 An applicant laboratory that reports error of this type for the same drug class percent or ±2 standard deviations of the such an error for an initial certification over two consecutive PT cycles may calculated reference group mean PT sample will be disqualified. result in suspension or revocation of the (whichever range is larger) for at least 80 (9) For qualitative specimen validity laboratory’s certification. percent of the total drug challenges. tests, an applicant laboratory shall (5) Requirement to Successfully Detect Failure to satisfy this requirement for correctly report at least 80 percent of the and Quantitate 50 Percent of the Total the total drug challenges will result in challenges for each qualitative specimen Drug Challenges for Any Individual disqualification. validity test over the three initial PT Drug. For each drug, a certified (4) An applicant laboratory shall not cycles. Failure to correctly report at laboratory must successfully detect and obtain any quantitative value on a drug least 80 percent for each qualitative quantitate in accordance with challenge sample that differs by more specimen validity test will result in paragraphs (b)(3) and (b)(4) of this than 50 percent from the calculated disqualification. section at least 50 percent of the total reference group mean. An applicant (10) An applicant laboratory shall not drug challenges. laboratory that obtains a quantitative report any sample as adulterated with a (6) No False Adulterated or value that differs by more than 50 compound that is not present in the Substituted Specimen Validity Testing percent on any drug challenge sample sample, adulterated based on pH when Sample Result. A certified laboratory will result in disqualification. the calculated group reference mean is shall not report any sample as (5) An applicant laboratory shall within the acceptable pH range, or adulterated with a compound that is not successfully detect and quantitate in substituted when the calculated group present in the sample, adulterated based accordance with paragraphs (a)(2), means for both creatinine and specific on pH when the calculated group (a)(3), and (a)(4) of this section at least gravity are within the acceptable range. reference mean is within the acceptable

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pH range, or substituted when the challenges may have its certification the certified or applicant laboratory to calculated group means for both suspended or revoked. these Guidelines. The laboratory’s creatinine and specific gravity are (11) Procedures When Requirements operation shall be consistent with good within the acceptable range. A certified in Paragraphs (b)(1)—(b)(10) of this forensic laboratory practice and shall be laboratory that reports this type of error Section Are Not Met. The laboratory in compliance with these Guidelines. It may have its certification suspended or shall be allowed 5 working days in is the laboratory’s responsibility to revoked. which to provide any explanation for its correct deficiencies identified during (7) Requirement to Identify and unsuccessful performance, including the inspection consistent with these Confirm 80 Percent of the Total administrative error or methodological Guidelines and with good forensic Specimen Validity Testing Challenges. error, and to develop and submit a plan laboratory practice. In accordance with A certified laboratory shall maintain an for implementing corrective actions to sections 3.13 and 3.14, deficiencies overall grade of 80 percent over two address the source of the error within 30 identified at inspections may be the consecutive PT cycles that challenge the days. The Secretary may revoke or basis for suspending or revoking a laboratory’s ability to conduct specimen suspend the laboratory’s certification or laboratory’s certification. validity tests (i.e., to correctly identify take no further action, depending on the and confirm 80 percent of the total seriousness of the errors and whether Section 3.21 Results of Inadequate specimen validity testing challenges). A there is evidence that the source of the Performance certified laboratory that fails to maintain poor performance has been corrected Failure of a laboratory to comply with a grade of 80 percent over two and that current performance meets the any aspect of these Guidelines may lead consecutive PT cycles may have its requirements for a certified laboratory to revocation or suspension of certification suspended or revoked. under these Guidelines. The Secretary certification as provided in sections 3.13 (8) Requirement to Correctly may require that additional performance and 3.14 of these Guidelines. Quantitate 80 Percent of the Total tests be carried out to determine Section 3.22 Listing of Certified Challenges for Quantitative Specimen whether the source of the poor Laboratories Validity Tests. For quantitative performance has been removed. If the specimen validity tests, a certified Secretary determines to suspend or A Federal Register listing of laboratory shall obtain quantitative revoke the laboratory’s certification, the laboratories certified by HHS will be values for at least 80 percent of the total laboratory’s official status will become updated and published periodically. challenges that satisfy the following ‘‘Suspended’’ or ‘‘Revoked’’ until the Laboratories which are in the applicant criteria: suspension or revocation is lifted or stage of HHS certification are not to be (i) Nitrite and creatinine until any recertification process is considered as meeting the minimum concentrations are within ±20 percent or complete. requirements in these Guidelines. A ±2 standard deviations of the calculated (c) Eighty Percent of Participating laboratory is not certified until HHS has reference group mean; Laboratories Must Detect Drug or sent the laboratory an HHS letter of (ii) pH values are within ±0.3 pH Specimen Validity Testing Challenge. A certification. units of the calculated reference group laboratory’s performance shall be Subpart D—Procedures for Review of mean; and evaluated for all drug and specimen Suspension or Proposed Revocation of (iii) Specific gravity values are within validity testing challenges unless the a Certified Laboratory ±0.0003 specific gravity units of the overall response from participating calculated reference group mean. laboratories indicates that less than 80 Section 4.1 Applicability A certified laboratory that fails to percent of them were able to correctly These procedures apply when: achieve 80 percent over two consecutive report the drug or specimen validity (a) The Secretary has notified a PT cycles may have its certification testing challenge. laboratory in writing that its suspended or revoked. (d) Participation Required. Failure to certification to perform urine drug (9) Requirement to Report No More participate in a PT cycle or to testing under these Mandatory than One Quantitative Error for a participate satisfactorily may result in Guidelines for Federal Workplace Drug Quantitative Specimen Validity Test. A the suspension or revocation of a Testing Programs has been suspended or certified laboratory shall not obtain any laboratory’s certification. that the Secretary proposes to revoke quantitative value on a specimen such certification. validity testing sample that differs by Section 3.20 Inspections (b) The laboratory has, within 30 days more than ±50 percent for nitrite and (a) Frequency. Prior to laboratory of the date of such notification or within creatinine concentrations, ±0.8 unit for certification under these Guidelines and 3 days of the date of such notification pH measurements, or ±0.0006 units for at least twice a year after certification, when seeking an expedited review of a specific gravity from the calculated a team of two or more qualified and suspension, requested in writing an reference group means. More than one trained inspectors shall conduct an on- opportunity for an informal review of error of this type for the same site inspection of laboratory premises. the suspension or proposed revocation. adulterant, for creatinine, for pH, or for Inspections shall document the overall specific gravity over two consecutive PT ability of the laboratory to satisfy the Section 4.2 Definitions cycles may result in suspension or certification requirements specified in Appellant. Means the laboratory revocation of a laboratory’s certification. these Guidelines. which has been notified of its (10) Requirement for Each Qualitative (b) Inspectors. The Secretary shall suspension or proposed revocation of its Specimen Validity Test. For each establish criteria for the selection of certification to perform urine drug and/ qualitative specimen validity test, a inspectors to ensure high quality, or validity testing and has requested an certified laboratory shall correctly report unbiased, and thorough inspections. informal review thereof. at least 80 percent of the challenges for The inspectors shall perform Respondent. Means the person or each qualitative specimen validity test inspections consistent with the persons designated by the Secretary in over two consecutive PT cycles. A guidance in section 3.12(b). implementing these Guidelines certified laboratory that fails to correctly (c) Inspection Performance. Inspectors (currently the National Laboratory report at least 80 percent of the shall assess the overall compliance of Certification Program is located in the

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Division of Workplace Programs, the laboratory attempts to regain proposed revocation (respondent’s Substance Abuse and Mental Health compliance with the Mandatory brief). Services Administration). Guidelines for Federal Workplace Drug (c) Reply Briefs. Within 5 days after Reviewing Official. Means the person Testing Programs or the parties receiving the opposing party’s or persons designated by the Secretary otherwise attempt to settle the dispute. submission, or 20 days after receiving who will review the suspension or As part of an abeyance agreement, the acknowledgment of the request for proposed revocation. The reviewing parties can agree to extend the time review, whichever is later, each party official may be assisted by one or more period for requesting review of the may submit a short reply not to exceed of his or her employees or consultants suspension or proposed revocation. If 10 double-spaced pages. in assessing and weighing the scientific abeyance begins after a request for (d) Cooperative Efforts. Whenever and technical evidence and other review has been filed, the appellant feasible, the parties should attempt to information submitted by the appellant shall notify the reviewing official at the develop a joint review file. and respondent on the reasons for the end of the abeyance period advising (e) Excessive Documentation. The suspension and proposed revocation. whether the dispute has been resolved. reviewing official may take any If the dispute has been resolved, the appropriate step to reduce excessive Section 4.3 Limitation on Issues request for review will be dismissed. If Subject to Review documentation, including the return of the dispute has not been resolved, the or refusal to consider documentation The scope of review shall be limited review procedures will begin at the found to be irrelevant, redundant, or to the facts relevant to any suspension point at which they were interrupted by unnecessary. or proposed revocation, the necessary the abeyance agreement with such interpretations of those facts, the modifications to the procedures as the Section 4.8 Opportunity for Oral Mandatory Guidelines for Federal reviewing official deems appropriate. Presentation Workplace Drug Testing Programs, and (a) Electing Oral Presentation. If an other relevant law. The legal validity of Section 4.7 Preparation of the Review File and Written Argument opportunity for an oral presentation is the Mandatory Guidelines shall not be desired, the appellant shall request it at subject to review under these The appellant and the respondent the time it submits its written request procedures. each participate in developing the file for review to the reviewing official. The for the reviewing official and in reviewing official will grant the request Section 4.4 Specifying Who Represents submitting written arguments. The the Parties if the official determines that the procedures for development of the decision-making process will be The appellant’s request for review review file and submission of written substantially aided by oral presentations shall specify the name, address, and argument are: and arguments. The reviewing official phone number of the appellant’s (a) Appellant’s Documents and Brief. may also provide for an oral representative. In its first written Within 15 days after receiving the presentation at the official’s own submission to the reviewing official, the acknowledgment of the request for initiative or at the request of the respondent shall specify the name, review, the appellant shall submit to the respondent. address, and phone number of the reviewing official the following (with a (b) Presiding Official. The reviewing respondent’s representative. copy to the respondent): (1) A review file containing the official or designee will be the presiding Section 4.5 The Request for Informal documents supporting appellant’s official responsible for conducting the Review and the Reviewing Official’s argument, tabbed and organized oral presentation. Response chronologically, and accompanied by an (c) Preliminary Conference. The Within 30 days of the date of the index identifying each document. Only presiding official may hold a prehearing notice of the suspension or proposed essential documents should be conference (usually a telephone revocation, the appellant must submit a submitted to the reviewing official. conference call) to consider any of the written request to the reviewing official (2) A written statement, not to exceed following: simplifying and clarifying seeking review, unless some other time 20 double-spaced pages, explaining why issues; stipulations and admissions; period is agreed to by the parties. A respondent’s decision to suspend or limitations on evidence and witnesses copy must also be sent to the propose revocation of appellant’s that will be presented at the hearing; respondent. The request for review must certification is wrong (appellant’s brief). time allotted for each witness and the include a copy of the notice of (b) Respondent’s Documents and hearing altogether; scheduling the suspension or proposed revocation, a Brief. Within 15 days after receiving a hearing; and any other matter that will brief statement of why the decision to copy of the acknowledgment of the assist in the review process. Normally, suspend or propose revocation is wrong, request for review, the respondent shall this conference will be conducted and the appellant’s request for an oral submit to the reviewing official the informally and off the record; however, presentation, if desired. following (with a copy to the appellant): the presiding official may, at his or her Within 5 days after receiving the (1) A review file containing discretion, produce a written document request for review, the reviewing official documents supporting respondent’s summarizing the conference or will send an acknowledgment and decision to suspend or revoke transcribe the conference, either of advise the appellant of the next steps. appellant’s certification to perform which will be made a part of the record. The reviewing official will also send a urine drug and/or validity testing, (d) Time and Place of Oral copy of the acknowledgment to the tabbed and organized chronologically, Presentation. The presiding official will respondent. and accompanied by an index attempt to schedule the oral identifying each document. Only presentation within 30 days of the date Section 4.6 Abeyance Agreement essential documents should be appellant’s request for review is Upon mutual agreement of the parties submitted to the reviewing official. received or within 10 days of to hold these procedures in abeyance, (2) A written statement, not exceeding submission of the last reply brief, the reviewing official will stay these 20 double-spaced pages in length, whichever is later. The oral presentation procedures for a reasonable time while explaining the basis for suspension or will be held at a time and place

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determined by the presiding official witness or any other person may be the proposed revocation and will attempt to following consultation with the parties. basis for a criminal prosecution under issue the decision within 7–10 days of (e) Conduct of the Oral Presentation. 18 U.S.C. 1505 or 1001. the date of the oral presentation or (1) General. The presiding official is (g) Post-hearing Procedures. At his or within 3 days of the date on which the responsible for conducting the oral her discretion, the presiding official transcript is received or the date of the presentation. The presiding official may may require or permit the parties to last submission by either party, be assisted by one or more of his or her submit post-hearing briefs or proposed whichever is later. All other provisions employees or consultants in conducting findings and conclusions. Each party set forth in section 4.14 will apply. the oral presentation and reviewing the may submit comments on any major (f) Transmission of Written evidence. While the oral presentation prejudicial errors in the transcript. Communications. Because of the will be kept as informal as possible, the importance of timeliness for these presiding official may take all necessary Section 4.9 Expedited Procedures for Review of Immediate Suspension expedited procedures, all written steps to ensure an orderly proceeding. communications between the parties (2) Burden of Proof/Standard of Proof. (a) Applicability. When the Secretary and between either party and the In all cases, the respondent bears the notifies a laboratory in writing that its reviewing official shall be by facsimile burden of proving by a preponderance certification to perform urine drug and/ or overnight mail. of the evidence that its decision to or validity testing has been immediately suspend or propose revocation is suspended, the appellant may request Section 4.10 Ex Parte Communications appropriate. The appellant, however, an expedited review of the suspension has a responsibility to respond to the and any proposed revocation. The Except for routine administrative and respondent’s allegations with evidence appellant must submit this request in procedural matters, a party shall not and argument to show that the writing to the reviewing official within communicate with the reviewing or respondent is wrong. 3 days of the date the laboratory presiding official without notice to the (3) Admission of Evidence. The rules received notice of the suspension. The other party. of evidence do not apply and the request for review must include a copy Section 4.11 Transmission of Written presiding official will generally admit of the suspension and any proposed Communications by Reviewing Official all testimonial evidence unless it is revocation, a brief statement of why the and Calculation of Deadlines clearly irrelevant, immaterial, or unduly decision to suspend and propose repetitious. Each party may make an revocation is wrong, and the appellant’s Because of the importance of a timely opening and closing statement, may request for an oral presentation, if review, the reviewing official should present witnesses as agreed upon in the desired. A copy of the request for review normally transmit written prehearing conference or otherwise, and must also be sent to the respondent. communications to either party by may question the opposing party’s (b) Reviewing Official’s Response. As facsimile or overnight mail in which witnesses. Since the parties have ample soon as practicable after the request for case the date of transmission or day opportunity to prepare the review file, review is received, the reviewing official following mailing will be considered the a party may introduce additional will send an acknowledgment with a date of receipt. In the case of documentation during the oral copy to the respondent. communications sent by regular mail, presentation only with the permission (c) Review File and Briefs. Within 7 the date of receipt will be considered 3 of the presiding official. The presiding days of the date the request for review days after the date of mailing. In official may question witnesses directly is received, but no later than 2 days counting days, include Saturdays, and take such other steps necessary to before an oral presentation, each party Sundays, and holidays. However, if a ensure an effective and efficient shall submit to the reviewing official the due date falls on a Saturday, Sunday, or consideration of the evidence, including following: (1) A review file containing Federal holiday, then the due date is the setting time limitations on direct and essential documents relevant to the next Federal working day. cross-examinations. review, tabbed, indexed, and organized Section 4.12 Authority and (4) Motions. The presiding official chronologically, and (2) a written Responsibilities of Reviewing Official may rule on motions including, for statement, not to exceed 20 double- example, motions to exclude or strike spaced pages, explaining the party’s In addition to any other authority redundant or immaterial evidence, position concerning the suspension and specified in these procedures, the motions to dismiss the case for any proposed revocation. No reply brief reviewing official and the presiding insufficient evidence, or motions for is permitted. official, with respect to those authorities summary judgment. Except for those (d) Oral Presentation. If an oral involving the oral presentation, shall made during the hearing, all motions presentation is requested by the have the authority to issue orders; and opposition to motions, including appellant or otherwise granted by the examine witnesses; take all steps argument, must be in writing and be no reviewing official, the presiding official necessary for the conduct of an orderly more than 10 double-spaced pages in will attempt to schedule the oral hearing; rule on requests and motions; length. The presiding official will set a presentation within 7–10 days of the grant extensions of time for good reasonable time for the party opposing date of appellant’s request for review at reasons; dismiss for failure to meet the motion to reply. a time and place determined by the deadlines or other requirements; order (5) Transcripts. The presiding official presiding official following consultation the parties to submit relevant shall have the oral presentation with the parties. The presiding official information or witnesses; remand a case transcribed and the transcript shall be may hold a pre-hearing conference in for further action by the respondent; made a part of the record. Either party accordance with section 4.8(c) and will waive or modify these procedures in a may request a copy of the transcript and conduct the oral presentation in specific case, usually with notice to the the requesting party shall be responsible accordance with the procedures of parties; reconsider a decision of the for paying for its copy of the transcript. sections 4.8(e), (f), and (g). reviewing official where a party (f) Obstruction of Justice or Making of (e) Written Decision. The reviewing promptly alleges a clear error of fact or False Statements. Obstruction of justice official shall issue a written decision law; and to take any other action or the making of false statements by a upholding or denying the suspension or necessary to resolve disputes in

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accordance with the objectives of these DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION: procedures. HUMAN SERVICES Background Section 4.13 Administrative Record Substance Abuse and Mental Health The Mandatory Guidelines for Federal Services Administration The administrative record of review Workplace Drug Testing Programs (Guidelines) were first published in the consists of the review file; other Proposed Revisions to Mandatory submissions by the parties; transcripts Federal Register on April 11, 1988 (53 Guidelines for Federal Workplace Drug FR 11970), and have since been revised or other records of any meetings, Testing Programs conference calls, or oral presentation; in the Federal Register on June 9, 1994 evidence submitted at the oral AGENCY: Substance Abuse and Mental (59 FR 29908), and on September 30, presentation; and orders and other Health Services Administration, HHS. 1997 (62 FR 51118). The Guidelines documents issued by the reviewing and ACTION: Notice of proposed revisions to establish the scientific and technical presiding officials. mandatory guidelines. guidelines for Federal workplace drug testing programs and establish standards Section 4.14 Written Decision SUMMARY: The Department of Health and for certification of laboratories engaged Human Services (‘‘HHS’’ or in urine drug testing for Federal (a) Issuance of Decision. The ‘‘Department’’) is proposing to establish agencies under authority of Pub. L. 100– reviewing official shall issue a written scientific and technical guidelines for 71, 5 U.S.C. section 7301 note, and E.O. decision upholding or denying the the testing of hair, sweat, and oral fluid 12564. suspension or proposed revocation. The specimens in addition to urine In developing and organizing the decision will set forth the reasons for specimens; scientific and technical proposed revisions to the Guidelines, the decision and describe the basis guidelines for using on-site tests to test there are a number of issues presented therefor in the record. Furthermore, the urine and oral fluid at the collection in this preamble, that include the reviewing official may remand the site; requirements for the certification of rationale for the order and manner of matter to the respondent for such instrumented initial test facilities; and presentation of what is proposed and further action as the reviewing official added standards for collectors, on-site why. These issues are first presented by deems appropriate. testers, and medical review officers. general topic area, and later presented (b) Date of Decision. The reviewing DATES: Submit comments on or before in summary, as they appear in the text official will attempt to issue his or her July 12, 2004. of the proposed Guidelines. decision within 15 days of the date of ADDRESSES: You may submit comments, the oral presentation, the date on which History of the HHS Certification identified by (insert docket number and/ Program for Federal Employee Drug the transcript is received, or the date of or RIN number), by any of the following the last submission by either party, Testing Programs, and Related methods: Knowledge whichever is later. If there is no oral • E-mail: [email protected]. Include presentation, the decision will normally docket number and/or RIN number in Since the beginning of the program in be issued within 15 days of the date of the subject line of the message. 1988, many challenges have been receipt of the last reply brief. Once • Fax: 301–443–3031 overcome and lessons learned from the issued, the reviewing official will • Mail: 5600 Fishers Lane, Rockwall specific and rigorous HHS certification immediately communicate the decision II, Suite 815, Rockville, Maryland of laboratories to perform forensic to each party. 20857. workplace testing for job applicants and (c) Public Notice. If the suspension • Hand Delivery/Courier: 5515 Executive Branch Federal employees. and proposed revocation are upheld, the Security Lane, Suite 815, Rockville, The initial Guidelines were published revocation will become effective Maryland 20852. for a 60-day public comment period, immediately and the public will be • Information Collection and were first published as a final notified by publication of a notice in the Requirements: Submit comments to the notice in the Federal Register in April Federal Register. If the suspension and Office of Information and Regulatory of 1988. Originally, it was believed that proposed revocation are denied, the Affairs, OMB, New Executive Office fewer than 10 laboratories would apply revocation will not take effect and the Building, 725 17th Street, NW., for HHS certification under the suspension will be lifted immediately. Washington, DC 20502, Attn: Desk Guidelines to conduct Federal employee Public notice will be given by Officer for SAMHSA. Because of delays drug testing, and that the Department publication in the Federal Register. in receipt of mail, comments may also would not require even that many to test be sent to 202–395–6974 (fax). the urine specimens from all Federal Section 4.15 Court Review of Final Instructions: All submissions received agencies. Administrative Action; Exhaustion of must include the agency name and This situation changed very quickly Administrative Remedies docket number or Regulatory when the Department of Transportation Information Number (RIN) for this Before any legal action is filed in (DOT) published a final drug testing rulemaking. All comments will be rule (54 FR 49854) in December 1989 for court challenging the suspension or available for public review at 5515 proposed revocation, respondent shall its regulated transportation industries. Security Lane, Suite 815, Rockville, DOT required its regulated industries to exhaust administrative remedies Maryland 20852. provided under this subpart, unless use drug testing laboratories that were FOR FURTHER INFORMATION CONTACT: otherwise provided by Federal Law. The certified by HHS. This requirement reviewing official’s decision, under Walter F. Vogl, Ph.D., Drug Testing began a close relationship between HHS section 4.9(e) or 4.14(a), constitutes final Section, Division of Workplace and DOT. Additionally, the Nuclear agency action and is ripe for judicial Programs, CSAP, 5600 Fishers Lane, Regulatory Commission (NRC) in its review as of the date of the decision. Rockwall II, Suite 815, Rockville, Fitness for Duty program contained in Maryland 20857, 301–443–6014 (voice), 10 CFR Part 26 requires its licensees to [FR Doc. 04–7985 Filed 4–6–04; 12:39 pm] 301–443–3031 (fax), [email protected] use drug testing laboratories certified by BILLING CODE 4162–20–P (e-mail). HHS.

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As the Guidelines received both Department began, as discussed below, presented at the June 2000 DTAB public and judicial support, the private a dedicated assessment of drug testing meeting. The initial, work-in-progress sector chose to incorporate the using alternative specimens and drug draft Guidelines were placed on our requirement to use only a laboratory testing technologies, including head web site and the public was invited to that has HHS certification under the hair, oral fluid (saliva), and sweat, for submit supplemental information and Guidelines, for employee drug testing. possible application in Federal informal comments to help improve our Between July 1988 and early 1990, 50 workplace drug testing programs. knowledge base. Twenty-eight separate laboratories had received HHS commenters submitted comments on the The Added Specimens—Major Change certification under the Guidelines, first working draft. The comments were while another 100 laboratories were The Department proposes to expand summarized and presented at the next awaiting certification. the kinds of specimens that may be DTAB meeting held in September 2000. In developing the preamble for the tested under Federal agency workplace At the September 2000 DTAB meeting, proposed expansion and revision of the drug testing programs. The proposed the second working draft of the Guidelines, it has been very helpful to addition of head hair, oral fluid, and Guidelines was presented and, again, keep in sight important areas of sweat specimens are the result of a comments were requested from all consideration that have remained directed Department process that began interested parties. At the December 2000 visible as the program matured over the with a 3-day scientific meeting of the DTAB meeting, the public comments ensuing fifteen years. These include, but DTAB held in April 1997 to discuss submitted were used to prepare the are not limited to, custody and control drug testing of alternative specimens third working draft of the Guidelines. that ensures donor specimen identity and using new testing technologies as As the DTAB continued to work on and integrity, specimen collection they apply to workplace drug testing the Guidelines, the Department initiated procedures, analytical testing methods, programs. The entire meeting was open a voluntary pilot PT program. PT quality control and quality assurance, to the public. The first two days samples were developed and produced reporting results, the role of the medical consisted of presentations on the at government expense. The PT samples review officer (MRO), and HHS principles and criteria of workplace were sent to several laboratories for certification issues that include testing drug testing program requirements and testing at the laboratories’ own expense, site inspections and performance testing industry representatives discussing using the procedures that they routinely (PT) samples. alternative specimens (hair, oral fluid, use to test head hair, oral fluid, and The Department has remained sweat as well as urine) and technologies sweat specimens. This pilot PT program committed to maintaining the integrity (non-instrument based on-site tests). began in April 2000 and was necessary of the entire Drug-Free Federal The presentations focused on the for two reasons. First, it was necessary Workplace Program by identifying and following areas for each specimen/ to determine if it was possible to using the most accurate, reliable drug technology: specimen collection and prepare stable and accurate PT samples testing technology available. To chain of custody, initial test reagents for the different types of specimens that accomplish that goal, the Department and procedures, confirmatory test would be needed as part of a laboratory collaborates with the DOT, NRC, procedures, internal quality control certification program. Second, the Federal regulators, researchers, the program, reporting test results, results reported by the laboratories testing industry, and both public and interpreting test results, and external would indicate if the PT program could private sector employers on an on-going quality assurance program. Industry establish credibility, precision, basis on scientific and program matters. coordinators selected the presenters for accuracy, and reliability in drug testing As the number and types of commercial the alternative specimens and with alternative specimens. Based on workplace drug testing products and technologies to ensure a thoroughly the information obtained from four testing options have increased over the unbiased review based on the science rounds of PT samples, it appears that past decade, the Department, through available. On the third day, the public valid PT samples can be prepared, SAMHSA’s Drug Testing Advisory was given an opportunity to make although some further refinement is Board (DTAB), has expressed increasing official statements or comments. needed, and that over time some interest in assessing these new products Following this meeting, the DTAB laboratories testing alternative and procedures for possible use in members continued reviewing the large specimens have been able to achieve Federal agency employee testing amount of information presented at the performance levels approaching those programs. meeting. Their efforts resulted in the levels applied to urine testing Laboratory-based testing using identification of specific requirements laboratories. The criteria for laboratory- automated screening tests at necessary for the scientific, based hair, oral fluid, and sweat testing, instrumented initial test facilities (IITFs) administrative, and procedural integrity and for POCT urine and oral fluid tests was proposed by the same group of of a comprehensive workplace drug have been developed and proposed by individuals that developed the testing program, which includes the industry-lead working groups. Guidelines as an area of interest alternative specimens and technologies. Although performance in the pilot PT immediately after the Guidelines were They developed a chart summarizing program has been encouraging, with first published in 1988. At that time, the workplace drug testing program individual laboratory and group industries regulated by the NRC began requirements, reviewed the technical performance improving over time, there using this approach as part of their materials submitted to them, and are still three serious concerns. First, the Fitness for Duty programs to allow job identified the necessary workplace drug data from the pilot PT program to date applicants access to nuclear power testing requirements for each alternative show that not all participants have plants. A study of 10 sites (including specimen/testing technology. developed the capability to test for all both NRC licensee and other private The DTAB has continued its required drug classes, nor to perform sector sites) was conducted where such evaluation of the information submitted such tests with acceptable accuracy. an IITF was used. Point of collection by the industry representatives on Second, some drug classes are more test (POCT) devices were also being alternative specimens and technologies difficult to detect than others, for any developed, but with non-instrumented, since September 1997. The first working given type of specimen. Third, the visually read end-points. By 1997, the draft of the new Guidelines was specific drug classes that are difficult to

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detect varies by the type of specimen. confirmed with a more sophisticated contact with hair as it develops in and That means that special awareness will technique, most frequently by gas emerges from the skin. Sweat and be required to select the most chromatography/mass spectrometry sebum can deposit drugs and/or appropriate type of specimen to be (GC/MS). Tandem mass spectrometry metabolites on the hair shaft that in turn collected from a specific donor, when (MS/MS) using GC or liquid are absorbed into the hair shaft during use of a specific drug is suspected. This chromatography (LC) separation has and after its formation. Sweat can be public comment period is intended to emerged in recent years as the testing responsible for drug incorporation at provide an opportunity for all interested method of choice in order to increase distal segments of hair which does not parties to review the testing criteria and sensitivity and selectivity and to correspond to the time of drug associated specimen-specific analyze polar compounds without ingestion. procedures, to be sure that required derivitization.10,15,16 There are a number of factors that performance is achievable and Hair consists of a hair follicle and hair may influence the amount of drug sustainable when implemented. shaft. At the base of the follicle (bulb) incorporated into hair (e.g., drug dose, are highly vascularized matrix cells. As length of exposure, drug chemical Alternative Specimens matrix cells in the dermis of the skin structure, charge). Of particular concern The use of specimens other than urine move outward during growth, they form are environmental contamination and in workplace drug testing programs layers of a hair shaft that include the the role of hair color. have become a frequent topic in outer protectant cuticle, central cortex Concern has been raised about scientific meetings worldwide. This and inner medulla. Hair grows in three environmental contamination where a includes organizations such as the stages: about 85 percent of hair follicles person may claim, for example, that the Society of Forensic Toxicologists, The are in active growth (anagen), while the drug is present because the individual International Association of Forensic others are in a transition phase (catagen) was in a room where others were using Toxicologists, the Society of Hair before the resting phase (telogen). At the marijuana or cocaine. While washing Testing, and the American Academy of vertex region of the scalp, the average the hair sample may remove some of the Forensic Sciences. The most frequently growth rate of hair is about 0.4 contamination, ultimately we can discussed specimens are hair, oral fluid, millimeters per day or approximately 1 differentiate environmental and sweat. Until recently it was centimeter per month.1 The Department contamination from actual use because considered too soon for the forensic is proposing to permit agencies as part of the presence of the metabolite, which community to apply these alternative of their Federal workplace program to is not present when environmental specimens to workplace drug testing. test hair with lengths of about 1.5 inches contamination is the source of the drug. Current scientific literature provides long, representing a time period of 90 The role of hair color is also a major much of the information that was not days, and to use these specimens for concern. Melanin, which is responsible previously available in peer reviewed pre-employment, random, return-to- for pigmentation in hair, is produced in literature. Addition of these specimens duty, or follow-up testing. the hair bulb and incorporated into the to the Federal Workplace Drug Testing Analytes for the regulated drugs cells that form the cortex and medulla Program would complement urine drug tested in hair are marijuana metabolite during growth of the hair shaft. Melanin testing and aid in combating the threat (delta-9-tetrahydrocannabinol-9- is a polyanionic polymer of two types: from industries devoted to suborning carboxylic acid (THCA)), cocaine eumelanin and pheomelanin, the drug testing through adulteration, (parent drug and metabolites quantity of each determine hair color. substitution, and dilution. (benzoylecgonine, norcocaine, and Eumelanin concentration is highest in The preamble provides a list of cocaethylene)), phencyclidine (parent black hair and lowest in red hair while scientific studies that were used in drug (PCP)), opiates (codeine, morphine, pheomelanin concentration is highest in making the policy decisions. The and heroin metabolite (6- red hair and lowest in black hair.2 Department asks whether commenters acetylmorphine (6-AM)), and Melanin is absent in white hair. are aware of any other studies or data amphetamines (amphetamine, Animal studies have shown that hair that would cast more light on the methamphetamine, color influences drug incorporation appropriateness of using any of the methylenedioxymethamphetamine with black hair containing the most and alternative specimens or on limitations (MDMA), methylenedioxyamphetamine yellow (non-pigmented) hair the least.7 on how the specimens should be used. (MDA), and In vitro studies in which black, brown, methylenedioxyethylamphetamine and blond hair from drug-free human Hair (MDEA)). subjects were placed in a solution of The Department is proposing that hair Drugs and drug metabolites may be benzoylecgonine showed the highest testing be included in the Federal incorporated into hair by several concentration of the drug in black hair Workplace Drug Testing Program. Hair different pathways.1,3-7 As drugs and and the least in blond.8 Although there testing increases the time period over their metabolites travel through the have been a limited number of human which drug use can be detected as body in blood, they passively diffuse clinical controlled studies, data show compared to urine, sweat, or oral fluid. from the bloodstream into the base of that higher concentrations of some Hair is easily collected, transported and the hair follicle. Drugs and/or drugs are found in dark hair when stored, is less likely to transmit bio- metabolites are embedded into the hair compared to blond or red hair (e.g., organisms than urine or oral fluid, and as bands during the growth process. The codeine2, cocaine9, amphetamine10). is more difficult to adulterate than amount of drug in the hair band is The limited population studies urine. As separation techniques and proportional to the concentration in the published in peer reviewed literature at detection sensitivity and specificity blood when the hair was formed. The this time do not indicate a significant have improved, scientists are now able distance of the drug bands from the skin association between hair color or race to detect and quantify drugs and/or can estimate the time of drug use. Drugs and drug analyte.11 13 In one study, metabolites in hair at picogram levels. and/or metabolites may also be 1852 people that classified themselves Like other drug testing specimens, drugs incorporated into hair via secretions of as ‘‘black’’ or ‘‘white’’ showed no in hair are initially detected using an the apocrine sweat glands and evidence of a group adversely affected immunoassay technique and results are sebaceous glands, which are in close by hair testing, compared to urine

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testing, for cocaine and marijuana specimen volumes and amount of drug methods.34 Mechanical saliva testing.11 The examination of 500 are lower in oral fluid than in urine stimulation (i.e., chewing gum) can also positive hair samples for each of three specimens, current analytical methods lower drug concentrations in oral drugs (cannabinoids, cocaine, and (e.g., immunoassay, GC/MS, GC/MS/ fluid.33 To avoid saliva stimulation amphetamine) revealed little statistical MS, LC/MS/MS) have the required some recommend spitting into a cup, evidence of selective binding of drugs to sensitivity to be used for oral fluid but some donors may be opposed to hair of a particular color.12 Statistical specimen testing.23-26 spitting, especially when observed, and examination of 2791 data points that As with the other relatively new test may experience dry mouth. include heroin and its metabolites, specimens for drugs of abuse testing, The Department finds that the cocaine and its metabolites, MDMA and less is known about the collection difficulties associated with its analogs, and amphetamine and pharmacokinetics and disposition of oral fluid collection procedures are not methamphetamine failed to detect a drugs into oral fluid as compared to functionally different than other significant hair color effect.13 urine.3,28-30 Science shows that opiates, specimen collection difficulties Despite these suspected limitations, PCP, amphetamines and cocaine and currently encountered with urine. the Department still proposes to go most drugs including prescription Therefore, despite these known forward with incorporation of this new medications enter oral fluid through limitations, the Department proposes to technology as an alternative to urine for passive diffusion of the drug from the incorporate this new technology as an Federal agencies who may find it useful blood stream into the oral fluid. optional selection for Federal agencies in certain missions and tasks that only However, the active component of because oral fluid testing may be useful individual Federal agencies can marijuana (delta-9-tetrahydrocannabinol in certain missions and tasks that only identify. Though there continues to be (THC)) does not diffuse into oral individual Federal agencies can some question about the effect of hair fluid.26,31,32 The only way to detect identify. color on the amount of a drug or its marijuana use is through the presence of Sweat metabolite present in hair, there is no the parent drug (THC) in the oral fluid question about the fact that the drug or because the parent drug was present in The incorporation of drugs into sweat metabolite is present. The purpose of the oral cavity. Unfortunately, further is poorly understood but possible the Federal Workplace Drug Testing scientific study is needed to be able to mechanisms appear to be passive Program is to ensure the safety of the differentiate between whether the diffusion of drugs from blood into sweat workplace which it does in two ways. parent drug was present in the oral gland and transdermal migration of First, it identifies individuals in security cavity due to drug use or environmental drugs to the skin surface, where it is or safety sensitive positions who have contamination, i.e. the individual was dissolved in sweat.3,36,37 The time been using drugs, and second, it acts as present in a room when others smoked interval between drug consumption and a deterrent for people who might marijuana, for example. detection in sweat depends on the otherwise use drugs lest they be In order to protect Federal workers nature of the particular drug or drug detected. Hair testing can improve the from incorrect test results for marijuana, metabolite and the sensitivity of success of the program because it the Department proposes that a second analytical method used.3,36,38 increases the time period over which biological specimen, a urine specimen, Sweat may be collected as liquid drug use can be detected as compared will need to be collected under the perspiration,38 on sweat wipes,20,39 or to urine; it is easily collected, current Guidelines at the same time the with a sweat patch.40-44 Sweat collection transported and stored; it is less likely oral fluid specimen is obtained, is a non-invasive procedure 37,38 and to transmit bio-organisms than urine; primarily for the purpose of testing for privacy during collection does not and is more difficult to adulterate. marijuana when the oral fluid specimen appear to be a concern.38 Commercially is positive for marijuana. The available sweat patches may be worn for Oral Fluid Department will revise the Guidelines an extended period of time, are Testing methods for drugs in oral when the science is available to waterproof, and are generally accepted fluid have been developed in recent differentiate between actual use and by patients.39 Currently, there are a years and have been extensively used in environmental contamination. limited number of commercially some tested populations (e.g., Analytes for the regulated drugs available collection devices,20,39 only therapeutic drug monitoring, risk tested in oral fluid are marijuana (parent one of which is FDA-cleared. Attempts assessment in the insurance industry, drug (THC)), cocaine (parent drug or to remove or tamper with the FDA- and non-Federal workplace testing).17-19 metabolite benzoylecgonine), PCP cleared sweat patch are usually visible Many studies support the use of oral (parent drug), opiates (codeine, to personnel trained to remove them.3,37 fluid as a specimen for forensic drug morphine, and 6–AM), and Sweat patch contamination issues testing.20,21 amphetamines (amphetamine, continue to be a concern.3,39,45 For Oral fluid offers some advantages over methamphetamine, MDMA, MDA, example, one study suggests that sweat other types of specimens.22 Oral fluid is MDEA). patches are susceptible to readily accessible and its collection is The pH of oral fluid can affect contamination by a drug that is on the perceived as less invasive than a urine incorporation of some drugs.33-35 skin before the sweat patch is applied specimen collection. Oral fluid Salivary pH ranges from about 6.2 to and by absorption into the patch collections can easily be observed and, 7.4. Increased saliva flow rate raises the through the surface of the protecting therefore, the specimen is less pH up to a maximum of 8.0 due to membrane.39 Other studies indicate that susceptible to adulteration or higher bicarbonate levels. Oral fluid the polyurethane (outer) layer is substitution by the donor. Drugs can be collection devices cause some impermeable to molecules larger than detected in oral fluids within one hour stimulation of saliva flow. Studies have dimer water.45 Based on that of use making oral fluids useful in found that concentrations of drugs (e.g., information, the Department believes detecting very recent drug use.27 cocaine and its metabolites) in non- that external absorption of any drugs Substitution can be identified by stimulated oral fluid specimens were through the outer layer is not possible measuring an endogenous component greater than the concentrations of under normal circumstances. With (IgG) in the specimen. Although the specimens collected using other regard to contamination from a drug

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present on the skin before applying the environment.39 The amount of sweat required specimen validity tests, (8) use sweat patch, the Department proposes collected for testing is small and the HHS cutoffs, and (9) submit all non- that the skin area be washed with soap drug concentration low. Therefore, the negative specimens to a full service and cool water or with a disposable analytical procedures used for HHS-certified laboratory for required towelette. Then the collector must measurement of drugs and/or their additional testing. In meeting these thoroughly clean the skin area where metabolites in sweat must be very criteria, the IITF will meet Guideline the patches will be worn with alcohol sensitive. Confirmation of drug analytes requirements of the initial test section of wipes prior to application. However, the in sweat are routinely confirmed by GC/ an HHS-certified laboratory. Department encourages researchers to 54 MS and sometimes with LC/MS/ POCT for Drugs conduct further research in this area. MS.38 The Department knows from direct Currently, sweat testing is used in the POCT devices for drugs of abuse were experience both at the National Institute private sector for monitoring drug use first available in the early 1990s. POCTs on Drug Abuse and the Substance Abuse during substance abuse treatment 37 and include non-instrumented devices with and Mental Health Services is also used in the criminal justice visually read endpoints as well as semi- Administration that some individuals system.17 Sweat also appears to be well automated or automated instrumented may not be able to wear the sweat patch suited for return-to-duty and follow-up testing devices with machine read for the optimal period of time. Skin testing for workplace testing.3,20 endpoints. Drug tests conducted with sensitivity and rash are factors that can these devices utilize competitive only be known after the patch is applied The Added Types of Testing Options binding immunoassays, the same for the first time. and Locations—Major Change scientific principle as the initial tests The Department also knows from Instrumented Initial Test Facility (IITF) conducted in certified laboratories. direct experience that if the patch is The development and commercial applied in a normally visible area of the The Department proposes to include availability of POCT products has body, such as the upper arm, that there IITF options in the Guidelines. An IITF evolved to include both urine and oral could be a stigmatizing effect on the is basically the screening part of a fluid specimens at this time, with more wearer. screening and confirmatory laboratory, specimens likely to be added in the Despite these known limitations, the but established in locations to future. The Department has learned a Department proposes to incorporate this potentially more quickly and great deal from collaboration with the new technology as an optional selection economically meet special local testing National Institute on Drug Abuse, the for Federal agencies because sweat needs. The Department has learned a Administrative Office of the U.S. Courts, testing may be useful in certain great deal from the experience of the the Federal Probation and Parole Office, missions and tasks that only individual NRC, where such urine-based facilities and the Department of Defense (DoD) Federal agencies can identify. were permitted beginning in 1990. Armed Forces drug testing program Unlike urine, head hair, or oral fluid, These IITFs were intended to support office. Collectively, these collaborations the use of a sweat patch detects drug use the periodic large testing needs of and the results of actual product that occurred shortly before the patch is nuclear-fueled electrical power assessments 58 have provided the applied and while the device remains generating facilities, whenever facility experience and knowledge to propose applied to the skin.3,20,37,46 The window maintenance and fuel rod replacements procedures in the Guidelines to more of detection for the sweat patch is for as were needed, at which time hundreds of uniformly assess the on-going long as the patch remains on the skin maintenance workers needed to be performance of these devices in Federal and is a cumulative measure of drug allowed timely access into the secured drug testing applications. ingestion.3,37 areas of the nuclear power plant. Non-instrumented POCT for urine Unlike urine, primarily the parent The numbers and fixed locations of testing have been subjected to drug is found in sweat; however, some IITFs make them more ‘‘like’’ evaluations by investigators drug metabolites may also be laboratories. Presently there are fewer independent of the manufacturers and detected.3,20,36,37,47 Some drugs and than 60 laboratories HHS-certified to found to perform similar to that of the drug metabolites that have been perform workplace urine drug testing instrumented immunoassay tests in detected in sweat are THC,51 for Federal agencies. With the rigorous certified laboratories.55-58 These tests amphetamine, methamphetamine,20,48 certification, performance testing, and were conducted on both spiked and codeine, morphine, 6–AM, inspection requirements proposed for donor specimens with and without drug heroin,40,43,45,47,49,50 PCP,72 and the IITF, it is unlikely that the total analytes. Little difference in the cocaine, benzoylecgonine, ecgonine number of laboratory and laboratory performance of these devices was methylester.20,44,47,52 Investigations to ‘‘like’’ facilities will increase very much, observed between tests conducted by compare the detection of drugs in sweat or even double to 120 in total. Thus, the laboratory technicians and laymen who to other specimens are IITF could be certified in much the had been trained in the proper ongoing.38-41,47,48,51,53,54 same fashion as a laboratory with procedures for conducting and reading Analytes for the regulated drugs inspections and PT, with the focus the tests.55,56 tested in sweat are marijuana (parent exclusively on initial drug and validity Non-instrumented POCTs for oral drug (THC)), cocaine (parent drug or testing. fluid have been characterized by only metabolite benzoylecgonine), PCP The Department proposes that IITFs one group of independent (parent drug), opiates (codeine, should: (1) Be at a permanent location, investigators.59 Their study was morphine, and 6–AM), and (2) meet program forensic standards, (3) performed on spiked oral fluid at amphetamines (amphetamine, participate in open and blind concentrations consistent with the methamphetamine, MDMA, MDA, and proficiency testing, (4) have a rigorous proposed cutoffs. This study found MDEA). quality assurance program, (5) be device variability and difficulty in The amount of sweat excreted is subject to site inspections, (6) use detecting cannabinoids, but suggests the variable for each person and between instrumented immunoassay tests for rapid evolution of the technology individuals and is dependent upon their drugs which meet FDA requirements for should overcome current problems daily activities, emotional state, and commercial distribution, (7) conduct relating to targeted analyte and

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manufacturer’s cutoff and provide an pre-employment, return to duty and Manner of Presentation and the Use of assay consistent with proposed HHS follow-up testing. Plain Language—Major Change ‘‘ cutoffs. The investigators felt that there POCT testing of oral fluid is most Although the order of presentation in is every reason to be optimistic about suited for situations that require quick, the proposed revisions to the Guidelines the future for drug testing using oral negative results such as in emergency/ has been retained, the manner of fluid matrix.’’ 59 Presently, there are no crisis management. It is most suited for presentation has been totally revised. POCT devices that have received FDA This ‘‘improved’’ process has been based clearance for drugs of abuse in hair or reasonable suspicion/cause and post- on the experience and very positive sweat. accident. It may be least suited for POCTs could potentially be employed random testing. Oral fluid is not suited public feedback that other Federal almost anywhere, with hundreds, if not for return to duty, follow-up testing and agencies have had when they used a thousands of testing sites possible. The pre-employment. In order to protect similar process. The goal of the HHS value and utility of the POCT is that it Federal workers from incorrect test process was to revise the manner of provides quick, negative drug results results for marijuana, a second presentation to use ‘‘plain language,’’ and validity test results and has the biological specimen, a urine specimen, and address complex issues by using added benefit of not requiring a fixed will need to be collected at the same simple questions to identify each specific topic. Unfortunately, these facility, expensive test equipment, and time the oral fluid specimen is obtained. highly trained testing personnel; Guidelines are scientifically based and moreover, POCTs could be run in low POCT for Specimen Validity Testing the answers are often complex. Wherever possible, the questions and numbers, infrequently, and at any given Specimen validity POCT devices for location, as needed. These factors make answers have been organized as a group the detection of substitution and the it very difficult, if not impossible to use for a specific specimen, testing option, presence of adulterants have become a laboratory ‘‘like’’ inspection and or related topic. The Department quality assurance process. The use of more widely used in the past three understands that such organization may highly trained laboratory personnel years. Specimen validity POCTs include produce some repetition, for example provides no specific or added value to non-instrumented devices with visually when reading about head hair, oral any oversight process, beyond the actual read endpoints as well as semi- fluid, or sweat, and seeing identical testing of sample POCT devices. automated or automated instrumented information presented for collection Further, the sheer potential number and testing devices with machine read end site, donor identification, or diverse locations of sites where POCT points. Specimen validity tests confidentiality, as repeated text. devices might be used by choice, make conducted with these devices utilize Because this change in format is large-scale, routine, or scheduled on-site colorimetric assays, the same scientific significantly different than the current inspections a logistic and budgeting principle as the initial tests conducted Guidelines, major changes from the nightmare. in certified laboratories. current Guidelines will be noted in the In order to provide an equivalent discussion of each subpart. Non-instrumented specimen validity program of on-going quality assurance POCT for urine testing have been Organization of Draft Guidelines—No for POCT devices, the Department Major Change proposes a certification process under subjected to evaluations by independent which POCT device manufacturers investigators and were able to detect Within the text for the proposed 60-62 would provide tests for evaluation to be abnormal urine specimens. These revisions to the Guidelines, the order of placed on the list of SAMHSA-certified tests were conducted on spiked presentation of topics follows the devices published by the Secretary. This specimens with drug analytes. Results existing Guidelines, with expanded would be followed by periodic from these preliminary studies are details to address the added specimens additional testing as new lots of variable; however, they demonstrate the (head hair, oral fluid, sweat), testing manufactured tests become available as ability of the devices to detect options (IITF and POCT), and related well as PT sample requirements, adulterants and creatinine. This is why issues. This seems to be the most training of POCT testers, and on-going the Department will incorporate the appropriate way to permit those already quality assurance requirements. This is evaluation of the accuracy and familiar with the existing Guidelines to a complex area that will benefit from reliability of specimen validity testing do a detailed comparison with what is public comments now, and from lessons as part of the POCT device evaluation being proposed. For those relatively few learned over time. process. first-time readers of the Guidelines, they may wish to first review the current Advantages of POCTs Urine Specimen Validity Testing Guidelines so as to understand the POCT products could potentially be current proposal. Where there are no On August 21, 2001, HHS published employed almost anywhere. The value changes to specific sections in the a notice in the Federal Register (66 FR and utility of the FDA-cleared and proposed revisions to the Guidelines, 43876), proposing that the Mandatory SAMHSA-certified POCT is that it will that has been stated in the preamble. provide quick, negative drug and Guidelines be revised to include HHS Contractor—No Major Change specimen validity test results. Those specific standards for determining the specimens that test presumptively validity of urine specimens collected by In accordance with current practice, positive for drugs or indicate that Federal agencies under the Federal the HHS contractor performs certain additional specimen validity testing is Workplace Drug Testing Program. The functions on behalf of the Department. necessary would then be referred for Department has issued a final revision These functions include maintaining a confirmatory testing. with comments to the Mandatory laboratory inspection program and a PT POCT testing of urine is most suited Guidelines as they currently exist program that satisfy the requirements for situations that require quick, implementing the urine specimen described in the Guidelines. These negative drug and specimen validity test validity testing requirements. These activities include, but are not limited to, results such as in emergency/crisis requirements have been incorporated in reviewing inspection reports submitted management. It may be least suited for this revision. by inspectors, reviewing PT results

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submitted by laboratories, preparing reasonable suspicion/cause test, recent drug use. Based on the detection inspection and PT result reports, and reconfirmed, rejected for testing, window, oral fluid is most suited for making recommendations to the responsible person, responsible reasonable suspicion/cause and post- Secretary regarding certification, technician, return to duty test, accident. It may be least suited for continued certification, or suspension/ specimen, split specimen, substituted random testing if prior notice (greater revocation of laboratories’ certification. specimen, and standard. Every effort has than 24 hours) is given. Because of the It is important to note that while the been made to define terms such that short detection window, oral fluid is not contractor gathers and evaluates they would apply to each type of suited for return to duty, and follow-up information provided to it by inspectors specimen collected, as appropriate. testing. In order to protect Federal or laboratories, all final decisions Section 1.6 specifies what an agency workers from incorrect test results for regarding laboratory certification, is required to do to protect employee marijuana, a second biological suspension or revocation of certification records. It is the same policy as specimen, a urine specimen, will need status is retained within the described in the current Guidelines to be collected at the same time the oral Department. except it has been amended to include fluid specimen is obtained. In addition, the contractor has records at IITFs, POCT sites, specimen Hair historically collected certain fees from collection sites, and records produced the laboratories for services related to and maintained by medical review Hair is useful for detecting drug use the certification process, specifically for officers. for longer time intervals, i.e., weeks (>7– laboratory application and inspection 10 days) to months. Based on the and PT activities for laboratories Subpart B—Specimens—Major Change detection window, hair is most suited applying to become HHS-certified, and In section 2.1, the Department for pre-employment and random testing. in the process of maintaining HHS- proposes to expand the urine drug The window of detection is much longer certification. All fees that are collected testing program for Federal agencies to than that of urine. Hair may be used for by the contractor are applied to its costs permit testing head hair, oral fluid, and return to duty and follow-up testing under the contract. sweat specimens. The Department depending on the time of last known This same process, which has been wants to make it very clear to agencies drug use. Hair is not suited for used since the inception of the that there is no requirement that they reasonable suspicion/cause and post- laboratory certification program, will use hair, saliva or sweat as part of their accident because it takes 7–10 days for also be used by the HHS contractor to drug testing program, but rather that drug or drug metabolites to appear in collect similar fees from laboratories agencies may use those specimens. If hair. that seek, achieve, and continue HHS- they choose to use these alternative Sweat Patch certification for testing additional types specimens then agencies are required to of specimens (e.g., hair, oral fluid, follow these Guidelines. The window of detection for the sweat), and from IITFs that seek, In section 2.2, in order to guide sweat patch is for as long as the patch achieve, and continue HHS-certification Federal agencies, the Department has remains on the skin and is a cumulative to test hair, oral fluid, sweat, or urine. added to the Guidelines a chart measure of drug ingestion. The sweat The Department also contributes indicating in what circumstances each patch may not be useful for pre- funds to this contract for purposes not specimen can be collected. employment, random, reasonable directly related to laboratory suspicion/cause and post accident drug certification activities, such as Urine testing because it must be worn for days evaluating the technologies and Laboratory based urine testing has after its application. The sweat patch is instruments and providing an traditionally been used for pre- best used for return to duty and follow- assessment of their potential employment, random, reasonable up testing. applicability to workplace drug testing suspicion/cause, post-accident, return- The Department is specifically programs. to-duty, and follow-up testing. requesting public comment on the Drug ingestion for a 3–5 day interval appropriateness of the reasons for Subpart A—Applicability preceding the specimen collection can defining and limiting the selection of Sections 1.1, 1.2, 1.3, and 1.4 contain usually be identified in urine. Based on specimens for the different types of the same policies as described in the the detection window, urine is most testing proposed in this notice. current Guidelines with regard to who suited for random, return to duty and Commenters are requested to submit is covered by the Guidelines, who is follow-up testing. supporting documentation if responsible for the development and Because of the increasingly evident recommending that other reasons for implementation of the Guidelines, how potential that Federal agency workplace testing would be appropriate for some of a Federal agency requests a change from urine-based drug testing has the the types of specimens being collected. these Guidelines, and how these potential for being seriously In section 2.3, the Department Guidelines are revised. compromised by clandestine products proposes to prohibit routinely collecting In section 1.5, where terms are and procedures intended to mask more than one type of specimen from a defined, the Department proposes to current drug use, especially when given donor at the same time except when an add or revise several of the definitions sufficient time to obtain these products, oral fluid specimen is collected. This contained in the Guidelines. These urine drug testing may be least suited restriction is appropriate because it include, for example, new or revised for pre-employment. prevents Federal agencies from definitions for adulterated specimen, expecting an individual to provide certifying scientist, collector, Oral Fluid multiple specimens each time he or she confirmatory validity test, dilute Drug detection times for the regulated is selected for a drug test and then specimen, failed to reconfirm, follow-up analytes in oral fluid range from less attempting to compare results from test, initial validity test, IITF, invalid than one to approximately 24 hours. different types of specimens. It is result, non-negative specimen, oxidizing Drugs may be detected in urine longer expected that different results would be adulterant, POCT facility, post-accident after drug use than in oral fluid. This obtained for the different types of test, pre-employment, random test, makes oral fluid useful in detecting very specimens because the windows of

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detection are different, as explained wishes to routinely test its specimens prevalent in the workplace. The 2002 above. If a problem occurs during the for any drug not included in the National Survey on Drug Use and collection of one type of specimen (e.g., Guidelines must obtain approval from Health (NSDUH)) (available on the shy bladder for a urine specimen, the Department before expanding its Internet at http://www.samhsa.gov/oas/ insufficient specimen available), program. A specimen may be tested for nhsda.htm 63) indicates that the permission can be obtained from the any drug listed in Schedule I or II of the estimated number of people using Federal agency to collect an alternative Controlled Substances Act when there is ecstasy, the generic name for MDMA, specimen. reasonable suspicion/cause to believe within the past year and within the In section 2.4, the Department that a donor may have used a drug not month before the survey was taken, proposes to establish the requirement included in these Guidelines. When exceeded that found for heroin, crack for all specimens to be collected as split reasonable suspicion/cause exists to test cocaine, LSD, and PCP. This is further specimens, and in section 2.5 to for another drug, the Department is supported by Drug Abuse Warning establish a minimum quantity that must proposing that a Federal agency must Network (DAWN) data 64 which finds be collected for each type of specimen. document the possibility that the use of that MDMA was on the list of the top For hair, 100 mg of head hair was the another drug exists, attach the 10 drugs mentioned in emergency room quantity recommended by the hair documentation to the original Federal visits, just below methamphetamine and testing industry. For oral fluid, the drug testing custody and control form was one of the top ten of drugs seized Department is proposing that 2 mL be (Federal CCF), and ensure that the HHS- and sent to Federal, State and municipal collected in a collection tube rather than certified laboratory has the capability to crime laboratories, as noted in the allowing oral fluid to be collected test for the additional drug. The HHS- National Forensic Laboratory directly into a collection device that certified laboratory is expected to Information System (NFLIS) 2002 does not provide an accurate validate the test methods for this Annual Report.65 In 2000, the measurement of the volume of oral fluid additional drug and to use the same prevalence of MDMA found in active collected. This approach allows quality control criteria that are used for duty Army personnel exceeded that of establishing specific cutoffs for oral the other drug analyses described in the methamphetamine.66 Thus, Federal fluid testing. For sweat, since the ‘‘sweat Guidelines. The Department believes agencies may elect to test for additional patch’’ is the only FDA-cleared device this proposed policy is sufficient to drugs including MDMA, under section currently available, the quantity of ensure that this testing for an additional 3.2(a) of the Mandatory Guidelines. sweat collected is determined by the drug would be forensically and The Department is specifically length of time the patch is worn. scientifically supportable. interested in obtaining information on Requiring that the patch be worn at least Section 3.3 restates the policy in the the ability of the various immunoassay 3 days but no more than 7 days ensures current Guidelines that specimens may test kits to detect MDMA, within the that a sufficient amount of sweat is not be used for any unauthorized amphetamine class of drugs. The collected that could possibly contain a purposes. Department is aware that DoD drug tests measurable amount of drugs or drug Sections 3.4, 3.5, 3.6, and 3.7 list the members of the uniformed services for metabolites. For urine, the Department proposed cutoff concentrations for each MDMA using an additional initial test is proposing to eliminate the single type of specimen collected. As focused on that drug. Based on this specimen collection procedure and to previously stated in this preamble, the experience from DoD, if drug testing is require each Federal agency to use the Department is proposing to adopt the proposed at the cutoffs in this split specimen collection procedure. cutoff concentrations that were document, the Department believes that The 45 mL requirement ensures that recommended by the industry working the only sensitive and specific manner each Federal employee is offered the groups. Based on the results from the PT to perform the initial test for same opportunity to have the split testing program, it appears that some methamphetamine, amphetamine, and specimen tested by a second laboratory. industry proposed cutoff concentrations MDMA is to use two separate initial for the alternative specimens are tests, one for methamphetamine and Subpart C—Drug and Validity Tests— currently set at what appears to be amphetamine and a second initial test Major Change approaching a limit of quantitation that for MDMA. Recommendations on using Section 3.1 contains the same policy reflect the analytical capabilities of one a single amphetamine test kit or the that is in the current Guidelines or two laboratories to detect extremely need to use separate test kits are regarding which tests must be low drug concentrations. The requested. performed on a specimen. A Federal Department believes that each The Department periodically reviews agency is required to test each specimen laboratory testing a specific type of the cutoff for all drugs authorized for for marijuana and cocaine, and is specimen for a particular drug must be workplace drug testing and revises those authorized to also test for opiates, able to accurately determine the cutoffs as necessary to maximize the amphetamines, and phencyclidine. The concentration for a drug or drug deterrent effect of the program. As a Department realizes that most Federal metabolite that is less than the cutoff result of this review, the initial test agencies already test for all five drug concentration, as well as concentrations cutoff for marijuana was lowered in classes authorized by the existing equal to or greater than the cutoff. The 1994 and both the initial test and Guidelines, but has not made this a Department is specifically requesting confirmatory test cutoff for opiates was mandatory requirement. The comments on the appropriateness of raised in 1998. These changes were Department will continue to rely on the these cutoff concentrations and the instituted after review of the science individual agencies and departments to ability of laboratories to meet this supporting the change, the technical determine their testing needs above the requirement. capabilities of the certified laboratories minimum. The one new requirement is Since the late 1980’s, a number of and the effect of the change on the that each Federal agency is required to recommendations have been made that deterrent intent of workplace drug ensure that each specimen is tested to additional drugs be considered for testing. determine if it is a valid specimen. inclusion in workplace drug testing. The Department proposes to lower the The policy in section 3.2 remains Over the past decade, MDMA and its cutoff concentration for cocaine and unchanged. Any Federal agency that analogues have become increasingly amphetamine analytes. Reductions in

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initial and confirmatory cutoffs for most cutoff in order to report a specimen Section 3.18 reiterates the criteria to drugs in urine will increase the time positive for methamphetamine. This report a urine specimen as dilute. period in which those drugs will be ‘‘methamphetamine reporting rule’’ is Sections 3.19, 3.20, 3.21, and 3.22 found.67 The proposed lower cutoffs retained because of concerns and reiterate the criteria that will be used to will produce an increase in the number experience that extremely high report a urine specimen as an invalid of urine specimens that are identified as concentrations of pseudoephedrine and/ result and propose the criteria that will containing cocaine metabolites and or ephedrine in a urine specimen can be used to report a head hair, oral fluid, amphetamines.68-70 The cutoff still lead to inappropriate reporting of a and sweat patch, respectively, as an reductions proposed in this revision are methamphetamine positive result when invalid result. The Department believes estimated to identify 10–20 percent in fact there is no methamphetamine these proposed criteria for each type of more urine specimens containing present at a concentration above the specimen collected are appropriate to cocaine metabolites 68,69 and 5–24 cutoff. Additionally, this requirement to ensure that each specimen is a valid percent more urine specimens confirm the presence of amphetamine at specimen. containing amphetamines.70 Data a concentration below the cutoff is provided by currently certified included for reporting a hair, oral fluid, Subpart D—Collectors—Major Change laboratories are consistent with these or sweat patch methamphetamine In section 4.1, the Department is estimates and will increase the deterrent positive result. The confirmatory testing proposing to expand the requirements effect of the program and allow early for amphetamines would be expanded for donor confidentiality for collectors. identification of substance use by to test for MDMA, MDA, and MDEA. Section 4.2 describes what specific individuals. The lowering of these The Department believes that the training requirements individuals are cutoffs should not result in increased certified laboratories have the capability required to have before they may serve claims of passive exposure.71 to accurately test urine specimens using as a collector. The capability of HHS-certified these revised cutoff concentrations. Section 4.3 proposes that another laboratories to respond to these changes Additionally, the revised cutoff person, such as another employee of the has been evaluated. Since the beginning concentrations will increase the organization or company responsible for of this program, laboratories certified by windows of detection for these drugs, providing collection site services, must HHS have exhibited significantly less thereby, increasing the number of provide the training for an individual to quantitative variability when analyzing specimens that may be reported become a collector and specifies the PT samples than applicant laboratories. positive. qualifications for this individual to be a Evaluations of their performance since In sections 3.8, 3.9, and 3.10, the trainer. 1990 have also shown that the Department is proposing which validity In section 4.4, the Department quantitative variability of the certified tests must be conducted on head hair, proposes what an organization must do laboratory population has continued to oral fluids and sweat patches. In section before it allows an individual to serve decrease for all drugs. Evaluations of 3.11, the Department then reiterates performance for the testing of cocaine which validity tests must be conducted as a collector. The Department believes and amphetamines have found that on a urine specimen. The Department these proposed expanded requirements certified laboratories have demonstrated believes these policies are necessary to are necessary to ensure that a collector the precision and accuracy necessary for identify those individuals who are knows the entire collection procedure, the proposed cutoff revisions. Certified attempting to suborn a drug test. There how to interact with the donor, how to laboratories demonstrated their ability are many products marketed on the maintain chain of custody, how to to meet current Guideline requirements Internet and in highly publicized complete the Federal CCF, and how to through the testing of quarterly PT market-focused publications that offer transfer the specimen for testing. samples containing amphetamine, different approaches to suborn drug Subpart E—Collection Sites methamphetamine, and tests. At this time, many products are benzoylecgonine. Documentation of focused on defeating the well- The collection site requirements in their capabilities with method established, mature urine drug testing this subpart are essentially the same as validations has demonstrated the program. The Department believes as those described in the current precision and accuracy of the method alternative specimens become Guidelines, with variations for down to 40 percent of the current increasingly used, attempts to suborn specimen collection that would vary cutoffs. In addition, laboratories have alternative specimen drug tests will around privacy issues required for the been challenged quarterly with PT increase. The Department also collection of a urine specimen, that samples which contained drug recognizes that validity testing proposed would not be required for head hair, concentrations at 40 percent of the for alternative specimens is not as oral fluid, or sweat specimens, based on current cutoff and higher. robust as for urine, but is confident that the experience and input from For urine, the Department proposes to this testing will be refined over time. participating industry-led working lower the initial test cutoff In sections 3.12, 3.13, 3.14, and 3.15, groups for each type of specimen. concentration for cocaine metabolites the Department reiterates the criteria In sections 5.5, 5.6, 5.7, and 5.8, the from 300 ng/mL to 150 ng/mL with a that a laboratory will use to report a Department is proposing specific corresponding decrease of the urine specimen as adulterated and privacy requirements when collecting confirmatory test cutoff concentration proposes the criteria that a laboratory head hair, oral fluid, sweat patch, and from 150 ng/mL to 100 ng/mL. will use to report a head hair, oral fluid, urine specimens, respectively. The Additionally, the initial test cutoff and sweat patch, respectively, as privacy requirements for urine are the concentration for amphetamines would adulterated. same as those described in the current be decreased from 1000 ng/mL to 500 Section 3.16 describes the proposed Guidelines. ng/mL and the confirmatory test cutoff requirements to report an oral fluid For hair, the Department proposes concentration decreased from 500 ng/ specimen as substituted. The that head hair is the only type of hair mL to 250 ng/mL. The Department Department also reiterates the current to collect for a hair sample. The continues to require the presence of requirements with regard to a urine Department believes this is appropriate amphetamine at a concentration below specimen being reported as substituted. because collecting hair only from the

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head is the least invasive area to collect specimen. If the FDA has cleared a extent that Federal agencies lack the a hair sample and affords the donor the collection device, it has been clinical or technical expertise required most privacy. If head hair is not determined that the device does not to fulfill their requirements under this available, the Department believes it is affect the specimen collected. If the FDA proposal, they are free to enter into more appropriate to conduct a drug test has not cleared a collection device, the Economy Act transfers with the using a different specimen rather than Federal agency must only use a Department. attempting to collect hair from another collection device that does not affect the Subpart I—HHS Certification of body site. specimen collected. This requirement Laboratories and IITFs—Major Change For sweat, the Department proposes arises from incidents in the past where that the sweat patch may only be specimen containers themselves, or Section 9.1 reaffirms the goals and applied to the donor’s upper arm, or liners in the lids of specimen containers objectives of the certification program back. The primary site for a sweat patch were found to absorb drugs present in that are the same as those described in is the upper arm; however, applying a a urine specimen. This means that the the current Guidelines. patch to a donor’s chest or back is actual drug concentration in the Section 9.2 describes who has the reasonable if the donor prefers to use specimen was reduced simply by its authority to certify laboratories or IITFs these alternative sites to conceal the fact presence in that particular type of to conduct testing for Federal agencies. that they are wearing a sweat patch. specimen container. Since the This is the same policy as in the current For oral fluid, the Department Department is proposing drug testing Guidelines. proposes that the donor provide an oral using alternative specimens and Section 9.3 describes the process that fluid specimen directly into an technologies, it is reasonable to believe a laboratory or IITF must follow to appropriate container. This approach that new and different specimen become certified to conduct testing for will ensure that a minimum amount of collection devices will be used to collect a Federal agency. The Department oral fluid is collected and can then be Federal employee drug test specimens. believes that including a description of split for on-site testing or sent to a The Department requests specific the certification process will be laboratory for both initial and comments on this requirement. extremely helpful to those laboratories confirmatory testing. or IITFs that are interested in applying For each type of specimen collected, Subpart H—Specimen Collection for certification. It is also important to Procedure—Major Change the collector and the donor are the only understand that a laboratory or IITF individuals present while the specimen In section 8.1, the Department is needs to be certified for each sample is being collected, except when a direct proposing to establish the basic type it wants to test (e.g., hair, oral fluid, observed collection is used to collect a requirements that would apply to sweat, urine) since the testing urine specimen and the observer is collecting any type of specimen. This procedures are different for each. present with the donor. includes a requirement for the collector Section 9.5 describes the to provide identification to the donor if specifications for the PT samples. The Subpart F—Federal Drug Testing the donor asks, explain the basic requirements in this section are the Custody and Control Forms collection procedures to the donor, same as in the current Guidelines. The requirement to collect a Federal request that the donor read the Sections 9.6, 9.7, 9.8, and 9.9 describe agency specimen using an OMB- instructions on the back of the Federal the proposed PT requirements for an approved form is the same as in the CCF, and answer any reasonable and applicant laboratory to conduct testing current Guidelines. An OMB-approved appropriate questions the donor may for each type of specimen. The Federal CCF must be used for each type have regarding the collection procedure. performance testing requirements for of specimen collected. The form for In sections 8.2, 8.3, 8.4, and 8.5, the the urine testing program are the same each type of specimen will be Department is proposing the collection as those in the current Guidelines and developed with the assistance of each procedure to be used to collect each the Department is proposing that similar industry working group and Federal type of specimen. The collection requirements apply to the other types of agencies and approval will be requested procedure for urine is essentially the specimens. from OMB and comment sought from same as that described in the current Sections 9.10, 9.11, 9.12, and 9.13 the public prior to these Guidelines Guidelines. The major change is that a describe the proposed PT requirements being implemented. The Department split specimen collection would be that apply to a certified laboratory for seeks comments on whether it would be required for all specimen collections, each type of specimen. The PT preferable, and practical, to have a including urine. requirements for the urine testing single Federal CCF that could be used In section 8.6, the Department is program are the same as those in the for all the various specimens, rather proposing to require that a Federal current Guidelines and the Department than a multiplicity of forms. The agency conduct an annual inspection of is proposing that similar requirements Department also seeks comment on each collection site that is used for its apply to the other types of specimens. whether it would be useful to add a workplace drug testing program. If Sections 9.14, 9.15, 9.16, and 9.17 requirement that employees and others several Federal agencies are using the describe the proposed PT requirements could not alter the Federal CCF in any same collection site, then only one for an applicant IITF to become certified way, e.g., could not write comments on Federal agency is required to conduct an for each type of specimen tested. The it. inspection. The Department believes Department is including requirements this requirement will ensure that for an IITF in this section because of the Subpart G—Collection Device collectors and collection sites satisfy all similarity of an IITF to the part of a Section 7.1 describes what is the collection requirements in these laboratory that performs initial testing. considered to be the collection device Guidelines for each type of specimen Thus, the same requirements will apply that is used to collect each type of collected. For the Department to directly to an IITF as to that portion of a specimen. carry out this responsibility for a laboratory which performs initial In section 7.2, the Department Federal agency, the Department would testing. describes the proposed policy on which incur substantial financial and Sections 9.18, 9.19, 9.20, and 9.21 devices may be used to collect a administrative costs. However, to the describe the proposed PT requirements

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for an HHS-certified IITF to remain notice regarding these actions. It is to challenge each laboratory with 20 certified to test each type of specimen. possible for a laboratory or IITF to lose percent blind samples to determine if a Section 9.22 describes the inspection certification for one sample type while laboratory is making either requirements for an applicant laboratory retaining certification to test another administrative or technical errors in the or IITF to become certified. As noted type. This is because the kinds of testing testing of specimens. above, the Department is including procedures used to test one type of In section 10.3, the Department is requirements for an IITF in this section sample can be very different from proposing how a blind sample is to be because of the similarity of an IITF to procedures and equipment used to test submitted to a laboratory. This section the part of a laboratory that performs another sample type. provides more detail on how to initial testing. Thus, the same Section 9.31 restates the policy in the complete the Federal CCF and ensure requirements will apply to an IITF as to current Guidelines that a list of HHS- proper submission of the blind samples that portion of a laboratory which certified laboratories and IITFs will be to the laboratory or IITF. performs initial testing. published monthly in the Federal In section 10.4, the Department is Section 9.23 describes the inspection Register. The list will also indicate the proposing the procedure to be used to requirements for an HHS-certified types of specimens for which each investigate errors associated with blind laboratory or IITF to remain certified. laboratory or IITF is certified to test. samples. This proposed procedure The Department proposes to change the provides direction and detail on how to requirement that a certified laboratory Subpart J—Blind Samples Submitted by evaluate information on what led to an or IITF be inspected by a team of three an Agency inconsistent result. inspectors to a requirement that a Section 10.1 continues to require the Subpart K—Laboratory—Major Change certified laboratory or IITF be inspected supplier of a blind sample to ensure that by at least one inspector. The number of the contents have been validated and This subpart has basically the same inspectors used for maintenance are stable until the expiration date. requirements that are contained in the inspections would vary depending on Additionally, the Department proposes current Guidelines with the following the size of the laboratory. The that drug positive blind samples must changes. Department believes that one trained have concentrations sufficiently above Section 11.4 describes a new policy inspector may be sufficient to conduct the cutoff concentrations used to give a for when the responsible person (RP) a thorough inspection of extremely positive result. This requirement leaves a certified laboratory. As stated in small laboratories. ensures that sample degradation will the current Guidelines, the RP assumes In section 9.24, the Department is not affect the blind sample and the professional, organizational, proposing the requirements for an laboratory will always report a positive educational, and administrative individual to serve as an inspector for result. The Department also proposes responsibility for the laboratory’s drug the HHS-certification program. The that blind samples for the urine testing testing facility. The Department believes proposed requirements have been used program contain adulterants or satisfy it is essential to ensure that drug testing for the past several years and are being substitution criteria to challenge a is routinely performed under the incorporated into the Guidelines. An laboratory’s capability to identify direction and supervision of an individual may serve as an inspector for adulterated or substituted specimens. individual with such qualifications. In the Secretary if he or she has experience The specific requirement for urine this section, the Department proposes and an educational background similar specimens is based on the donor privacy requirements to ensure this takes place. to that required for either the issue associated with providing a urine Additionally, the Secretary will begin responsible person or the certifying specimen, where direct observation is the process of suspension or revocation scientist as described in subpart K for a not used, and the potential exists for an in accordance with the Guidelines if the laboratory, or as a responsible adulterant to be added to the collected RP leaves and no RP is approved within technician as described in subpart M, specimen before it is turned over to the 180 days. This requirement is essential has read and thoroughly understands collector. There are no similar donor to protect the interests of the United the policies and requirements contained privacy issues associated with the States and its employees to ensure that in these Guidelines and in other collection of head hair, oral fluid, or an HHS-certified laboratory has an guidance consistent with these sweat. individual that can fully attest to the Guidelines provided by the Secretary, The Department seeks comment on forensic and scientific supportability of submits a resume and documentation of whether the proposed reduction of the the laboratory’s testing program. qualifications to HHS, attends approved blind sample rate to one percent will be Section 11.9 requires that a laboratory training, and submits an acceptable sufficient to achieve the objectives of must be HHS-certified separately for inspection report and performs sending blind samples to laboratories each type of specimen that it wants to acceptably as a trainee inspector on an especially with respect to the newer test for a Federal agency. The separate inspection. specimens with which laboratories, certification is necessary because of the Section 9.25 describes what happens collectors and others are less familiar at differences among urine, head hair, oral when an applicant laboratory or IITF this time. fluid, and sweat specimens in all phases fails to satisfy the PT requirements or In section 10.2, the Department is of collection, testing, reporting and on- the inspection requirements. The proposing to reduce the 20 percent going inspection and performance consequences are the same as currently requirement for blind samples, for each testing. An HHS certification for a apply to laboratories in the current type of specimen to be tested (i.e., urine, laboratory performing urine tests would Guidelines. head hair, oral fluid, or sweat) to 3 provide no quality assurance about that Sections 9.27, 9.28, and 9.29 apply percent during the initial 90-day period laboratory performing testing on other the same requirements that are in the of a new Federal agency program specimens. current Guidelines regarding the factors because the 20 percent requirement is In section 11.15, the Department used to revoke the certification of a excessive and redundant. Since the proposes to allow the use of additional laboratory or an IITF, directing a beginning of the urine testing program, analytical procedures for the laboratory or IITF to immediately there has never been any evidence to confirmatory drug tests. For some of the suspend testing, and the issuance of a suggest that each Federal agency needs types of specimens, the confirmatory

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drug tests may be performed by LC/MS, In section 11.33, the Department has including establishing a new GC/MS/MS, and LC/MS/MS in addition revised the summary report that a organization to oversee compliance, to to the GC/MS that has been traditionally laboratory must provide to a Federal do inspections, and to maintain the PT used to test urine specimens. The agency to include validity test results. requirements. As we did so, however, Department believes these additional Additionally, the frequency of the report logistical challenges developed that confirmatory methods are scientifically has been significantly reduced from could not be readily overcome. valid, based on on-going reviews of the monthly to semiannually. The Instead, the Department is adopting a scientific and forensic literature, and the Department believes that a semiannual principle that if a Federal agency assessment of a DTAB working group report is sufficient to track the chooses to use POCTs, then it accepts that has studied these newer effectiveness of an agency’s program. some of the same responsibilities for instruments and technologies. These In section 11.34, the Department is ensuring compliance within their additional confirmatory methods are the proposing a more detailed description of agency as the Department currently methods and instruments that have been what information a donor is entitled to maintains for the laboratory-based identified by the industry-led working receive upon request through the MRO Federal drug testing program. The groups that must be used to successfully and the Federal agency. The Department specifics of these requirements are detect and report the cutoff believes access to the proposed addressed below. concentrations proposed in subpart C. information is appropriate and Section 12.2 establishes criteria for In sections 11.18, 11.19, 11.20, and sufficient. the Secretary to certify a POCT for use 11.21, the Department is proposing to Section 11.35 describes the in the Federal drug testing program. The use the same analytical and quality information a certified laboratory must device must be FDA-cleared for the control requirements for conducting provide to its private sector clients purposes of detecting drugs of abuse validity tests for each type of specimen when it is using procedures to test its and it must be determined by the collected. The Department has specimens that are different than those Secretary that it effectively determines intentionally proposed to use the same used to test Federal agency specimens. the presence or absence of drugs and the validity of a specimen, either as an requirements for each type of specimen Subpart L—Point of Collection Test integral function of the POCT device or based on the established requirements (POCT)—Major Change as a set of compatible devices or for a urine specimen; however, Employees of Federal agencies are in procedures. The second standard is information may become available some cases located in remote areas of applied because FDA’s premarket during the public comment period to the country if they are serving with the notification clearance process ensures suggest that the requirements for each Department of Interior, or overseas if that a device is substantially equivalent type of specimen should be different. they are serving with the Department of to a legally marketed device, but does In sections 11.22, 11.23, 11.24, and State. They are often in locations with not ensure that the device will satisfy 11.25, the Department reiterates the few employees as is often the case when minimum performance requirements specific analytical requirements to they are serving on American Indian that are necessary for its use in the conduct each validity test for a urine reservations or in embassies in small Federal drug testing program. specimen and proposes the specific foreign countries. It is often unrealistic Section 12.4 identifies the two types analytical requirements to conduct each to expect that a drug testing program in of POCTs currently available, both of validity test for head hair, oral fluid, such places would operate in the same which could be considered for and sweat patch specimen collected. fashion as one that serves employees in Secretarial certification: non- The Department believes these the Washington, DC, area. It is in these instrumented devices where end results requirements will ensure that the circumstances and in cases where it is are determined visually or instrumented validity test results reported by a critical to receive an immediate test devices where results are obtained by laboratory are scientifically supportable. result that POCT tests play an important instrumental evaluation. Sections 11.26, 11.27, 11.28, and role. Section 12.5 provides manufacturers a 11.29 describe in detail how a certified Yet a POCT offers a particular list of what they must provide the laboratory is required to report test challenge to the Federal drug testing Secretary in order to have their device results to MROs for each type of program because the device that is used or devices included on the list of specimen collected. These sections to produce a negative test result is really SAMHSA-certified devices. Among the include the details of urine specimen equivalent to a laboratory test to which requirements, the manufacturer must validity testing, and also propose that the normal laboratory procedures and provide 100 POCT devices and related laboratories report drug and/or requirements cannot readily apply. testing procedures so that the Secretary metabolite concentrations to the MROs Thus, while the sections of the may analyze the devices for on all specimens reported as positive. Guidelines related to specimens, effectiveness when testing for drugs and The Department understands that the collection procedures, collections sites, specimen validity. data exist, and can be reported chain of custody, drug and validity Section 12.7 indicates that to remain electronically as part of the normal testing and others do apply, it is on the list of SAMHSA-certified workflow, and no longer pose a barrier necessary to establish requirements devices, the manufacturer must agree to or significant burden to laboratories. In particular to POCTs. In addition, it provide to the Secretary any design fact, the Department believes that presents logistical problems on how to changes or alterations that have been requiring MROs to request ensure compliance with the made to the device so that the Secretary concentrations by exception would requirements of these Guidelines and may determine if additional testing is create an extra burden to the MRO and thus ensure the integrity of the program necessary to ensure effectiveness and 50 the laboratory, and slow the reporting of when any one agency choosing to use POCTs as outlined so that the Secretary the final test result by the MRO to the POCT may have many remote sites all can ensure the continued quality of the Federal agency. The Department over the United States and in many device. encourages public comment on the cases all over the world. Section 12.8 is critical to the use of appropriateness of this proposed To address the logistical problem, the POCTs within the Federal drug testing requirement. Department considered several options program. This section lays out the

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responsibilities of the Federal agency in for approval but in so doing must information is available to the donor, order for it to use POCT. provide a statement to the Secretary and what type of relationship is If a Federal agency chooses to use describing what has been done to prohibited between a manufacturer of a POCT, then it must use only POCTs that address the problem that led to the POCT device or a POCT site operation are on the list of SAMHSA-certified device’s removal. and a Medical Review Officer. Also, devices, ensure that only trained testers To further ensure the integrity of the what type of relationship can exist are used and provide them with a system, the Guidelines require that one between a manufacturer of a POCT standard operating procedures manual, of every 10 negative samples must be device or a POCT site operation and an ensure that the requirements of the sent to an HHS-certified laboratory for HHS-certified laboratory is discussed. regulation are fulfilled, accomplish the confirmation. The results of this process inspection of the POCT test sites, will be given to the Federal agency. Subpart M—Instrumented Initial Test accomplish proficiency testing, To date, POCT tests have only been Facility (IITF)—Major Change maintain records on the trainers as well developed for oral fluid and urine. If, in In this subpart, the Department as inspections, investigate failures, the future, POCTs are developed for hair proposes the requirements for a new make available all Federal agency and/or sweat and the POCTs are cleared type of facility. It is being called an records for the POCT-related activities by the FDA, the Department will review instrumented initial test facility (IITF). for periodic inspection by the Secretary, the devices to evaluate, among other An IITF is essentially a laboratory that and other responsibilities. For the things, whether they use the cutoff only conducts initial tests for drugs and Department to directly carry out this identified by these Guidelines, what validity tests. The facility is at a responsibility for the Federal agency, their performance is around that cutoff, permanent location and uses the Department would incur substantial and whether the observed lot to lot instrumented initial tests. An IITF must administrative and financial costs. variability is appropriate for the satisfy most of the same requirements as However, to the extent that Federal program’s needs. Section 12.11 if it were the section of a laboratory that agencies lack the clinical or technical identifies the responsibility of the performs only initial drug and validity expertise required to fulfill their Secretary to inspect a Federal agency testing and was located in an HHS- requirements under this proposal, they using POCT. These responsibilities certified laboratory. An IITF is certified are free to enter into Economy Act include, but are not limited to, under the same provisions as a transfers within the Department. conducting a semiannual inspection of laboratory as indicated above in subpart With regard to performance testing, each Federal agency that uses POCT. I. One significant difference is that the the Federal agency will provide sets of These inspections will include a review IITF is managed by a responsible HHS-contractor prepared PT samples of the Federal agency’s records, technician (RT) whose qualifications are periodically to the POCT testing sites to standard operating procedure manual, described in section 13.6, and differ ensure reliability and integrity of the POCT tester training records, POCT slightly from those of a responsible system. The results of the proficiency device quarterly PT results, and POCT person as required for laboratories. tests will be forwarded to the Federal quality assurance data maintained by An IITF may be certified to test head agency. Where errors have occurred the each POCT tester and site. hair, oral fluid, sweat, and/or urine Federal agency must act to investigate Section 12.16 presents the specimens as stated in section 13.2. It is the cause of the error and determine requirements that a POCT tester must also important to understand that an whether it was an error in procedure or meet. It should be kept in mind that the IITF needs to be certified for each a failure of the device. If the error was individual is not just a collector but in sample type it wants to test (e.g., hair, a procedural one, the Federal agency some capacity functions as a technician oral fluid, sweat, urine), since the must assess the reason for error and take in so far as the individual must perform testing procedures are different for each. corrective action to ensure compliance the POCT test, determine specimen An IITF must test specimens using the with the Guidelines in the future. validity, perform analysis on periodic same drug cutoff concentrations as used If the error is with the device, the PT challenges, interpret and document for the initial tests conducted by the Federal agency must immediately notify test results, and when required, forward HHS-certified laboratories as stated in the Secretary who may suspend the use the specimens with non-negative test section 13.3. The Department is of the device within the agency. The results to an HHS-certified laboratory including these requirements for an IITF Department, after considering the for confirmatory testing. Thus the in this section because of the similarity information, may suspend the use of the training and experience requirements of an IITF to the part of a laboratory that device throughout the Federal drug reflect this additional responsibility. performs initial testing. Thus, the same testing program by informing the To ensure that the process is carried requirements will apply to an IITF as agencies through the Federal Register out appropriately the Department has in that portion of laboratory. and notifying the manufacturer of the section 12.18 outlined how a POCT Section 13.8 describes a new policy problem. The manufacturer then has 30 should be conducted step by step. These for when the responsible technician days to provide information for the procedures should be part of the Federal (RT) leaves a certified laboratory. The Secretary’s consideration at which time agency standard operating procedure RT assumes professional, the Secretary will decide what action manual. Again the process pays special organizational, educational, and needs to be taken. Additionally, the attention to the integrity of the test administrative responsibility for the Secretary will notify the FDA of any results and the specimen, chain of IITF drug testing. The Department error with a device so that the FDA can custody, collection procedures, believes it is essential to ensure that evaluate whether an action under the recordkeeping, and reporting. drug testing is routinely performed Food, Drug, and Cosmetic Act is The Guidelines for a POCT mirror the under the direction and supervision of necessary. provision in subparts K and M in that an individual with such qualifications. The Secretary is also authorized to they discuss how a negative result In this section, the Department proposes remove a device from the list of should be reported as well as what must requirements to ensure this takes place. SAMHSA-certified devices in the happen to a specimen with non-negative Additionally, the Secretary will begin absence of a suspension. A results. The Guidelines further discuss the process of suspension or revocation manufacturer may resubmit the device reporting requirements, what in accordance with the Guidelines if the

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RT leaves and no RT is approved within the Federal Register of those entities oral fluid or urine specimen when the 180 days. This requirement is essential and boards that have been approved. primary specimen was reported to protect the interests of the United In section 14.2, the Department is substituted. It should be noted that a States and its employees to ensure that proposing the specific training head hair or sweat patch sample cannot an HHS-certified IITF has an individual requirements before a physician may be reported as substituted. that can fully attest to the forensic and serve as an MRO for Federal agencies. In sections 15.10, 15.11, 15.12, and scientific supportability of the IITF This training should occur before the 15.13, the Department is proposing the testing program. physician takes the required actions an MRO must take after The Department proposes in section examination. receiving the split specimen result from 13.16 that an IITF be required to retain In section 14.3, the Department the second laboratory for each type of records for a period of 2 years, which is proposes that an individual who works specimen. the same period required for under the direct supervision of an MRO Section 15.14 describes how an MRO laboratories. may conduct the review and report of a reports the split specimen result to a The Department proposes in section negative result. However, the MRO must Federal agency. It is the same procedure 13.17 that an IITF submit a semiannual review 5 percent of the negative results that is used to report the result on the report on the numbers of specimens reported by staff to ensure that the staff primary specimen. In section 15.15, the Department tested for Federal agencies, again the are properly performing the review proposes to require that the certified same requirement as for laboratories. process. laboratory retain a split specimen for the In section 13.18, the Department In sections 14.4, 14.5, 14.6, and 14.7, the Department proposes the procedure same length of time that the primary proposes what information would be specimen is retained. available to a donor from an IITF, again an MRO must follow to review the the same requirement as for laboratories. results reported for each type of Subpart P—Criteria for Rejecting a In sections 13.19 and 13.20, the specimen. For specimens reported as Specimen for Testing—Major Change invalid by the laboratory, the Department proposes to prohibit and The Department proposes to include permit the same types of relationships Department proposes to allow the MRO to direct the agency to have another this subpart to describe how between the IITF and the MRO as laboratories, IITFs, or MROs are to between the laboratory and the MRO. specimen collected. The Department requests comments on whether the same handle errors or discrepancies that arise The Department proposes in section type of specimen or one of the other with the use of the Federal CCF. They 13.21 that an IITF report a negative types of specimens should be collected were not contained in the current result to an MRO within 3 working days when this occurs. Guidelines; however, most of the of receipt of the specimen and that Section 14.8 describes how the donor policies were previously established in negative results may be reported may request the testing of a split guidance documents. The Department electronically. Reporting a negative specimen. believes there is a need to establish result electronically is the same Section 14.9 describes how the MRO specific guidance on how a laboratory, requirement as for a specimen that is reports a primary specimen test result to IITF, or MRO must handle determined to be negative on an initial a Federal agency. discrepancies. Since the forms used to test conducted by a certified laboratory. Section 14.10 describes the transfer the custody of a specimen from In section 13.22, the Department relationship that is prohibited between the collector to the POCT tester have not proposes how a specimen that is an MRO and a laboratory, POCT tester, yet been developed, the Department presumptive drug positive, adulterated, or IITF. cannot propose a specific list of possible substituted, or invalid must be shipped errors or discrepancies that would need to an HHS-certified laboratory for Subpart O—Split Specimen Tests— to be corrected and included in this confirmatory testing. Major Change section. The Department, however, fully Subpart N—Medical Review Officer Section 15.1 amends the current expects to include this list when the (MRO)—Major Change Guidelines by giving the donor the right final Guidelines are developed. to have a split specimen tested when a In section 16.1, the Department In Section 14.1, the Department primary specimen was reported proposes those discrepancies that are establishes who may serve as an MRO, substituted or adulterated. This section considered to be fatal flaws, that is, the including the requirement that the also proposes to give a Federal agency laboratory or IITF must not test a individual successfully complete an the option to have a split specimen specimen when one of the fatal flaws examination administered by a tested as part of a legal or administrative occurs. The Department is specifically nationally recognized entity that proceeding to defend an original requesting comments on any additional certifies MROs or subspecialty board for positive, adulterated, or substituted fatal flaws that may apply to the physicians performing a review of result if a donor chooses not have the collection of head hair, sweat, and oral Federal employee drug test results, split specimen tested. fluid or fatal flaws that may occur when which has been approved by the In section 15.2, the Department is the collector transfers the specimen to a Secretary. This section also establishes proposing the policy on how a second POCT tester (if the POCT tester is not the requirements for nationally laboratory tests each type of split the collector). recognized entities that seek approval specimen when the primary specimen Section 16.2 identifies only two errors by the Secretary to certify MROs or for was reported positive for a drug(s). that the Department believes must be subspecialty boards for physicians In sections 15.3, 15.4, 15.5, and 15.6, corrected (recovered) by obtaining a performing a review of Federal the Department is proposing the policies memorandum for record (MFR) from the employee drug test results to submit on how a second laboratory will test collector before the laboratory or IITF their qualifications and sample each type of split specimen when the can report a test result to the MRO. The examination. Based on an annual primary specimen was reported Department is specifically requesting objective review of the qualifications adulterated. Similarly, sections 15.7 and comments on any additional correctable and content of the examination, the 15.8 describe the proposed policies on errors that may apply to the collection Secretary shall annually publish a list in how a second laboratory will test a split of head hair, sweat, and oral fluid or

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correctable errors that may occur when of laboratories and simply expanding Again with regard to oral fluids, the the collector transfers the specimen to a them to include IITFs. preamble mentions a possibility of an POCT tester (if the POCT tester is not individual having a ‘‘dry mouth.’’ The Electronic Technology Applications the collector). Department would appreciate any Section 16.3 describes the types of The Department is aware that there comments on whether the Department omissions and discrepancies that has been a great deal of discussion in should adopt a specific procedure for occasionally occur on the Federal CCF. recent years concerning the application ‘‘dry mouth’’ as it has for ‘‘shy bladder’’ When an omission or discrepancy of electronic technology to the operation under urine. occurs that is considered to be of drug testing programs. Electronic With regard to proper cleansing of the insignificant, the laboratory or IITF may signatures on documents, electronic skin prior to the application of a sweat proceed with testing the specimen and storage and transmission of records, and patch, the Department is requesting reporting a result without taking any appropriate security precautions for comment on the proposal that the skin action to recover or correct the error, confidential information are all issues of area be washed with soap and cool omission, or discrepancy. Although substantial interest as applied to Federal water or with a disposable towelette each of these errors, omissions, or testing programs. The Department seeks followed by a thorough cleaning of the discrepancies are considered comment on the extent to which this skin area where the patches will be insignificant, the Department believes discussion should be reflected in the worn with alcohol wipes. that requiring collectors to be trained new version of the guidelines, and on The Department defines in section 1.5 ‘‘ and certified will significantly reduce whether specific provisions concerning both confirmatory validity test’’ and ‘‘ the occurrence of such errors, electronic technology applications to confirmatory drug test.’’ The omissions, or discrepancies. However, Federal drug testing programs should be confirmatory validity test means putting a different aliquot of the specimen when a collector, laboratory, or IITF included. through the same analytical method. A makes an error, omission, or Impact of These Guidelines on confirmatory drug test involves a second discrepancy more than once a month, Government Regulated Industries analytical procedure performed on a the Department is proposing that the The Department is well aware that different aliquot. The Department MRO contacts the collector, laboratory, these proposed changes to the requests comments on whether the or IITF and directs the collector or Guidelines may impact the DOT and utilization of these procedures is laboratory to take immediate action to NRC regulated industries depending on sufficient. prevent the recurrence of the error, their decisions to incorporate the final In section 2.2, the Department is omission, or discrepancy. The Guidelines into their programs under proposing to limit the use of alternative Department is requesting specific their own authorities. specimens for only those reasons listed. comments on the proposal to have the The Department is requesting comments Issues of Special Interest MRO track these types of problems as on the appropriateness of the reasons well as identifying other insignificant The Department requests public listed and supporting documentation if omissions or discrepancies that have not comment on all aspects of this notice. recommending changes. been included for the Federal CCF. However, the Department is providing In section 2.5, the Department Public comments are requested for the following list of issues or areas for requires that a sweat patch should be possible omissions or discrepancies that which specific comments are requested. worn at least three days and no more may occur when completing a Federal In the preamble discussion on than 7 days. While the Department CCF to document collecting head hair, alternative specimen issues, there are believes that this is an adequate time sweat, and oral fluid specimens or conflicting studies that hair color affects period, the Department seeks comments insignificant types of discrepancies that the amount of drug deposited into the and additional science on whether the may occur when the collector transfers hair. In other words, some studies permitted time period should be longer the specimen to a POCT tester (if the purport that a drug user with dark hair or shorter, and what time frame should POCT tester is not the collector). is more likely to test positive because a be used in specific circumstances. In section 16.4, the Department drug is more likely to be deposited in Sections 3.4, 3.5, 3.6, and 3.7 list the proposes to identify those discrepancies black hair as compared to blond hair proposed cutoff concentrations for each that must be corrected before an MRO while other studies refute these type of specimen collected. The can report a test to the Federal agency. findings. The Department is requesting Department is specifically requesting If one of these errors occurs and it is not specific comments on this hair color comments on the appropriateness of corrected by obtaining an MFR from the bias issue as it applies to the testing of these proposed cutoffs and the changes collector, IITF, or laboratory, the MRO individuals in a workplace in the cutoffs for urine. Additionally, is required to cancel the test. The environment. the Department is interested in Department is requesting specific With regard to testing oral fluid obtaining information on the ability of comments on any other errors that must specimens for marijuana, there is the various immunoassay test kits to be corrected before the MRO can report scientific evidence that the parent detect MDMA within the amphetamine a test result or discrepancies that may marijuana compound (THC) in oral fluid class of drugs. occur and must be corrected when the is not from plasma, but is residual THC In section 7.2, the Department is collector transfers the specimen to a present either from smoking a marijuana requiring a Federal agency to only use POCT tester (if the POCT tester is not cigarette or from oral contamination. To a collection device that does not affect the collector). ensure that a THC result on an oral fluid the specimen collected. The Department specimen is from active exposure, the Subpart Q—Laboratory/IITF is requesting specific comments on this Department is proposing to always Suspension/Revocation Procedures requirement. collect a urine specimen with an oral In section 11.13, the Department In this subpart, the Department is fluid specimen that would be available establishes criteria for laboratories retaining the procedures that were if the oral fluid specimen was positive validating an initial drug test. These described in the current Guidelines to for THC. The Department is requesting criteria are significantly different from suspend or revoke the HHS-certification comments on this proposed policy. those that are currently in the

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Guidelines and thus the Department 7. Rollins D.E., Wilkins D.G., Gygi S.P., Sensitivity, specificity, and efficiency in specifically seeks comments on this Slawson M.H., and Nagasawa P.R. (1997). detecting opiates in oral fluid with the  change. Testing for drugs of abuse in hair— Cozart Opiate Microplate EIA and GC–MS In sections 11.18, 11.19, 11.20, and Experimental observations and indications following controlled codeine administration. 11.21, the Department is proposing to for future research. Forensic Sci Review, J Anal Toxicol, 27:402. 9:24. 24. Kim I., Barnes A.J., Schepers R., use the same analytical and quality 8. Reid R.W., O’Connor F.L., and Crayton Moolchan E.T., Wilson L., Cooper G., Reid C., control requirements for conducting J.W. (1994). The in vitro differential binding Hand C., Huestis M.A. (2003). Sensitivity and validity tests for each type of specimen of benzoylecgonine to pigmented human hair specificity of the Cozart microplate EIA collected. The Department is requesting samples. J Toxicol Clin Toxicol, 32:405. cocaine oral fluid at proposed screening and specific comments on this proposed 9. Henderson G.L., Harkley M.R., Zhou C., confirmation cutoffs. Clin Chem, 49:9. policy. Jones R.T., and Jacob P. (1998). Incorporation 25. Dams R., Huestis M.A., Lambert W.E., Sections 11.26, 11.27, 11.28, and of isotopically labeled cocaine into human and Murphy C.M. (2003). Matrix effect in bio- 11.29 propose to allow a laboratory to hair: race as a factor. J Anal Toxicol, 22:156. analysis of illicit drugs with LC–MS/ 10. Borges C.R., Wilkins D.G., and Rollins MS:influence of ionization type, sample report quantitative values for non- D.E. (2001). Amphetamine and N- preparation and biofluid. J Am Soc Mass negative specimens rather than waiting acetylamphetamine incorporation into hair: Spectrom, 14:1290. for the MRO to request the information. an investigation of the potential role of drug 26. Niedbala R.S., Kardos K.W., Fritch D.F., The Department is requesting comments basicity in hair color bias. J Anal Toxicol, Kardos S., Fries T., and Waga J. (2001). on this change in reporting test results. 25:221. Detection of marijuana use by oral fluid and In sections 14.4, 14.5, 14.6, and 14.7, 11. Hoffman B.H. (1999). Analysis of race urine analysis following single-dose the Department is proposing to allow effects on drug-test results. J Occup Environ administration of smoked and oral marijuana. the MRO to direct the agency to have Med, 41:612. J Anal Toxicol, 25:289. another specimen collected when an 12. Kelly R.C., Mieczkowshi T., Sweeney 27. Cone E.J. (1997). New Developments in invalid test result is reported. The S.A., and Bourland J.A. (2000). Hair analysis Biological Measures of Drug Prevalence. In: for drugs of abuse. Hair color and race L. Harrison and A. Hughes (Eds.) The Department is requesting comments on differentials or systematic differences in drug Validity of Self-Reporting Drug Use: whether the same type of specimen or preferences? Forensic Sci Int, 107:63. Improving the Accuracy of Survey Estimates. another type of specimen should be 13. Mieczkowshi T. and Newel R. (2000). NIDA Res Monogr 167:108. collected. Statistical examination of hair color as a 28. Schramm W., Smith R.H., Craig P.A., In sections 16.1, 16.2, and 16.3, the potential biasing factor in hair analysis. and Kidwell D.A. (1992). Drugs of abuse in Department is requesting specific Forensic Sci Int, 107:13. saliva: a review. J Anal Toxicol, 16:1. comments on any additional fatal flaws, 14. Slawson M.H., Wilkins D.G., and 29. Ho¨ld K.M., de Boer, D., Zuidema, J., correctable errors, omissions or Rollins D.E. (1998). The incorporation of and Maes. R.A.A. (1995). Saliva as an discrepancies that may apply to the drug into hair: relationship of hair color and analytical tool in toxicology, Int J Drug melanin concentration to phencyclidine Testing, 1:1. collection of head hair, sweat, and oral incorporation. J Anal Toxicol, 22:406. 30. Jenkins A.J., Oyler J.M., and Cone E.J. fluid or that may occur when the 15. Uhl M. (1997). Determination of drugs (1995). Comparison of heroin and cocaine collector transfers a specimen to a point in hair using GC/MS/MS. Forensic Sci Int, concentrations in saliva with concentrations of collection test (POCT) tester. 84:281. in blood and plasma. J Anal Toxicol, 19:359. Additionally, the Department is 16. Pichini S., Pacifici R., Altieri I., 31. Hawks R.L. (1982). The constituents of requesting comments on the Pellegrini M., and Zuccaro P. (1999). cannabis and the disposition and metabolism requirement that MROs track these Determination of opiates and cocaine in hair of cannabinoids. In Hawks RL (Ed): The types of problems. as trimethylsilyl derivatives using gas Analysis of Cannabinoids in Biological In section 16.4, the Department is chromatography—tandem mass Fluids, NIDA Research Monograph Series 42; requesting specific comment on any spectrometry. J Anal Toxicol, 23:343. U.S. Government Printing Office; 17. Cone E.J. (2001). Legal, workplace, and Washington, DC; p. 125. other errors that must be corrected treatment drug testing with alternative 32. Samyn N., Verstraete A., van Haeren C., before an MRO can report a test. biological matrices on a global scale. Forensic and Kintz P. (1999). Analysis of drugs of Sci Int, 121:7. abuse in saliva, Forensic Sci Rev, 11:1. References 18. Yacoubian G.S., Wish E.D., and Perez 33. Mucklow J.C., Bending M.R., Kahn 1. Nakahara Y. (1999). Hair analysis for D.M. (2001). A comparison of saliva testing G.C., Dollery C.T. (1978). Drug concentration abused and therapeutic drugs. J Chromatogr to urinalysis in an arrestee population. J of in saliva. Clin Pharmacol Ther, 5:563. B Biomed Sci Appl, 733:161. Psychoactive Drugs, 33:289. 34. Cone E.J. (1993). Saliva testing for 2. Rollins D.E., Wilkins D.G., Krueger G.G., 19. Wish E.D. and Yacoubian G.S. (2002). drugs of abuse. Ann NY Acad Sci, 694:91. Augsburger M.P., Mizuno A., O’Neal C., A comparison of the Intercept oral 35. Wolff F., Farrell M., Marsden J., Borges C.R., and Slawson M.H. (2003). The specimen collection device to laboratory Monteiro M.G., Ali R., Welch S., and Strang effect of hair color on the incorporation of urinalysis among Baltimore city arrestees. J. (1999). A review of biological indicators of codeine into human hair. J Anal Toxicol, Federal Probation, 66:27. illicit drug use, practical considerations and 27:545. 20. Caplan Y.H. and Goldberger B.A. clinical usefulness. Addiction, 94:1279. 3. Huestis M.A. and Cone E.J. (1998). (2001). Alternative specimens for workplace 36. Skopp G. and Potsch L. (1999). Alternative Testing Matrices, in Drug Abuse drug testing. J Anal Toxicol, 25:396. Perspiration versus saliva-basic aspects Handbook, edited by S.B. Karch, CRC Press, 21. Cone E.J., Presley L., Lehrer M., Seiter concerning their use in roadside drug testing. Boca Raton, FL. W., Smith M., Kardos K.W., Fritch D., Int J Legal Med, 112:213. 4. Kidwell D.A. and Blank D.L. (1996). Salamone S., Niedbala R.S. (2002). Oral fluid 37. Cone E.J. and Preston K.L. (1999). Drug Environmental Exposure—The Stumbling testing for drugs of abuse: positive prevalence testing in support of drug-abuse treatment Block of Hair Testing, in Drug Testing in rates by Intercept TM immunoassay screening programs. AACC Therapeutic Drug Hair, edited by P. Kintz, CRC Press, Boca and GC–MS–MS confirmation and suggested Monitoring And Toxicology Education Raton, FL. cutoff concentrations. J Anal Toxicol, 26:541. Article 175:184. 5. Cone E.J. and Joseph R.E. (1996). The 22. Kidwell D.A., Holland J.C., and 38. Crouch D.J., Cook R.F., Trudeau J.V., Potential for Bias in Hair Testing for Drugs Athanaselis S. (1998). Testing for drugs of Dove D.C., Robinson J.J., Webster H.L., and of Abuse, in Drug Testing in Hair, edited by abuse in saliva and sweat. J Chromatogr, Fatah A.A. (2001). The detection of drugs of P. Kintz, CRC Press, Boca Raton, FL. 713:111. abuse in liquid perspiration. Technical Note, 6. Henderson G.L. (1993). Mechanisms of 23. Barnes A.J, Kim I., Schepers R., J Anal Toxicol, 1:625. drug incorporation into hair. Forensic Sci Int, Moolchan E.T., Wilson L., Cooper G., Reid C., 39. Kidwell D.A., Kidwell J.D., Shinohara 63:19. Hand C., and Huestis M.A. (2003). F., Harper C., Roarty K., Bernadt K.,

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McCaulley R.A., and Smith F.P. (2003). 56. Kadehjian L.J. (2001). Performance of 72. Fay J.F., and Niedbala, S. (1995). Sweat Comparison of daily urine, sweat, and skin five non-instrumented urine drug-testing eluate analysis for phencyclidine by STC swabs among cocaine users. Forensic Sci Int, devices with challenging near-cutoff Diagnostics PCP Micro-Plate EIA and GC/MS. 133:63. specimens. J Anal Toxicol, 25:670. Presentation Society of Forensic 40. Kintz P., Brenneisen R., Brundeli P., 57. Peace M.R, Tarnai L.D., Poklis A. Toxicologists. and Mangin P. (1997). Sweat testing for (2002). Performance evaluation of four on- heroin and metabolites in a heroin site drug-testing devices for detection of Executive Order 12866: Economic maintenance program. Cl Chem, 43:736. drugs of abuse in urine. J Anal Toxicol, Impact 41. Levisky J.A., Bowerman D.L., Jenkins 24:589. In accordance with Executive Order 58. SAMHSA study entitled ‘‘On-site W.W., Johnson D.G., Levisky J.S., and Karch 12866, the agency has submitted the S.B. (2001). Comparison of urine to sweat Testing: An Evaluation of Non-Instrumented patch results in court ordered testing, Drug Test Devices,’’ dated January 29, 1999, Guidelines for review by the Office of Forensic Sci Int, 122:65. available on the Internet at http:// Management and Budget. However, 42. Skopp G., Potsch L., Eser H.P., and www.workplace.samhsa.gov/ResourceCenter/ because the Mandatory Guidelines will Moller M.R. (1996). Preliminary practical r409.htm. not have an annual impact of $100 findings on drug monitoring by a 59. Walsh J.M., Flegel R., Crouch D.J., million or more, and will not have a transcutaneous collection device. J Forensic Cangianelli L., Baudys J. (2003). An material adverse effect on the economy, Sci, 41:933. evaluation of rapid point-of-collection oral fluid drug-testing devices. J Anal Toxicol, productivity, competition, jobs, the 43. Huestis M.A., Cone E.J., Wong C.J., environment, public health or safety, or Umbricht A., and Preston K.L. (2000) 27:429. Monitoring opiate use in substance abuse 60. Peace M.R. and Tarnai L.D. (2002). State, local or tribal governments, they treatment patients with sweat and urine drug Performance evaluation of three on-site are not subject to the detailed analysis testing. J Anal Toxicol, 24:509. adulterant detection devices for urine requirements of section 6(a)(3)(C) of 44. Warren M., Fortner N., Fogerson R., specimens. J Anal Toxicol, 26:464. Executive Order 12866. and Sutliff J. (1996). Detection of cocaine and 61. Wong B., Nguyen P., Wong R., and Tse its metabolites using the PharmChekTM sweat H. (2002). Adulterants: Its detection and Paperwork Reduction Act of 1995 patch. Presentation Society of Forensic effects on urine drug screens. Abstract: Society of Forensic Toxicologists 2002 These proposed revised Mandatory Toxicologists. Guidelines contain information 45. Fogerson R., Schoendorfer D., Fay J., Meeting. 62. Wong R. (2002). The effect of collections which are subject to review and Spiehler V. (1997). Qualitative detection by the Office of Management and of opiates in sweat by EIA and GC-MS. J Anal adulterants on urine screen for drugs of abuse: Detection by an on-site dipstick Toxicol, 21:451. Budget (OMB) under the Paperwork device. Am Clin Lab, 21:37. 46. Spiehler V., Fay J., Fogerson R., Reduction Act of 1995 (the PRA) (44 63. Report entitled ‘‘2002 National Survey Schoendorfer D., and Niedbala R.S. (1996). U.S.C. 3507(d)). The title, description on Drug Use and Health (National Household Enzyme immunoassay validation for and respondent description of the Survey on Drug Abuse),’’ available on the qualitative detection of cocaine in sweat. Cl Internet at http://www.samhsa.gov/oas/ information collections are shown in the Chem, 42:34. nhsda.htm. following paragraphs with an estimate 47. Preston L.P., Huestis M.A., Wong C.J., 64. Report entitled ‘‘Emergency Department of the annual reporting, disclosure and Umbricht A., and Goldberger B.A. (1999). Trends From DAWN: Final Estimates 1995– recordkeeping burden. Included in the Monitoring cocaine use in substance-abuse- 2002,’’ available on the Internet at http:// estimate is the time for reviewing treatment patients by sweat and urine testing. dawninfo.samhsa.gov. instructions, searching existing data J Anal Toxicol, 23:313. 65. Report entitled ‘‘Year 2002 Annual 48. Suzuki S., Inoue T., Hori H., and sources, gathering and maintaining the Report National Forensic Laboratory data needed, and completing and Inayama S. (1989). Analysis of Information System (NFLIS).’’ methamphetamine in hair, nail, sweat, and 66. Bruins M.R, Okano C.K., Lyons T.P., reviewing the collection of information. saliva by mass fragmentography. J Anal and Lukey B.J. (2002). Drug-positive rates for Title: Proposed Revisions to the Toxicol, 13:176. the army from fiscal years 1991 to 2000 and Mandatory Guidelines for Federal 49. Kintz P., Tracqui A., Mangin P., and for the National Guard from fiscal years 1997 Workplace Drug Testing Programs. Edel Y. (1996). Sweat testing in opioid users to 2000. Mil Med, 167:379. Description: The Mandatory with a sweat patch. J Anal Toxicol, 20 393. 67. Jones R.T. (1997). Pharmacokinetics of Guidelines establish the scientific and 50. Fay J., Fogerson R., Schoendorfer D., cocaine considerations when assessing Niedbala R.S., and Spiehler V. (1996). technical guidelines for Federal drug cocaine use by urinalysis. NIDA Research testing programs and establish standards Detection of methamphetamine in sweat by Monograph, 175:221. EIA and GC-MS. J Anal Toxicol, 20:398. 68. Wingert W.W. (1997). Lowering cutoffs for certification of laboratories engaged 51. Kintz P., Cirimele V., and Ludes B. for initial and confirmation testing for in drug testing for Federal agencies (2000). Detection of cannabis in oral fluid cocaine and marijuana: large scale study of under authority of Public Law 100–71, (saliva) and forehead wipes (sweat) from effects on the rates of drug-positive results. 5 U.S.C. 7301 note, and Executive Order impaired drivers. J Anal Toxicol, 24:557. Clin Chem, 43:100. 12564. Federal drug testing programs 52. Fogerson R. and Sutliff J. (1995). 69. Cone E.J., Sampson-Cone A.H., Darwin test applicants to sensitive positions, Testing for cocaine and opiate use with the W.D., Huestis M.A., and Oyler, J.M. (2003). individuals involved in accidents, PharmChekTM Sweat Patch, presentation Urine testing for cocaine abuse: Metabolic Society of Forensic Toxicologists. individuals for cause, and random and excretion patterns following different testing of persons in sensitive positions. 53. Sampyn N., DeBoeck G., and Verstrate routes of administration and methods for A.G. (2002). The use of oral fluid and sweat detection of false negative results. J Anal The program has depended on urine wipes for the detection of drugs of abuse in Toxicol, 27:386. testing since 1988; the reporting, drivers. J Forensic Sci, 47:1380. 70. Oyler J.M., Cone E.J., Joseph R.E. Jr, recordkeeping and disclosure 54. Samyn N., De Boeck G., Wood M., Moolchan E.T., and Huestis M.A. (2002). requirements associated with urine Lamaaras C.T.J., DeWaard S., Brookhuis K.A., Duration of detectable methamphetamine testing are approved under OMB control Verstraete A.G., and Riedel W.J. (2002). and amphetamine excretion in urine after number 0930–0158. Since 1988 several Plasma, oral fluid and sweat wipe ecstasy controlled oral administration of products have appeared on the market concentrations in controlled and real life methamphetamine to humans. Clin Chem, making it easier for individuals to conditions. Forensic Sci Int, 128:90. 48:1703. 55. Crouch D.J., Hersch R.K., Cook R.F., 71. Cone A.J., Yousefnejad D., Hillsgrove adulterate the urine sample. The Frank J.F., and Walsh J.M. (2002). A field M.J., Holicky B., and Darwin W.D. (1995). proposed changes to the Guidelines evaluation of five on-site drug-testing Passive inhalation of cocaine. J Anal Toxicol, address this concern. Also, scientific devices. J Anal Toxicol, 26:493. 19:399. advances in the use of head hair, sweat,

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and oral fluid in detecting drugs have In an effort to shorten the time for The burden estimates in the tables made it possible for these specimens to negative results to be reported to the below are based on the following be used in Federal programs with the Federal agency, the proposed changes number of respondents: 38,000 donors same level of confidence that has been also establish criteria for an IITF that who apply for employment in testing applied to the use of urine. The will only perform initial tests and not designated positions, 100 collectors, 50 proposed changes establish when these confirmatory tests, and POCTs or on-site urine testing laboratories, 10 hair testing alternative specimens may be used, the testing kits, as well as POCT testers. laboratories,10 oral fluid testing procedures that must be used in Description of Respondents: laboratories, 2 sweat testing laboratories, collecting a sample, and the certification Individuals or households; Businesses 25 IITFs, 30 POCT manufacturers, 50 process for approving a laboratory to or other for-profit; Not-for-profit POCT testers, and 100 MROs. test these alternative specimens. institutions.

ESTIMATE OF ANNUAL REPORTING BURDEN

No. of re- Responses/re- Hours/re- Section Purpose spondents spondent sponse Total hours

9.3(c), 9.4(a) and Laboratory or IITF 9.4(a) and (b) required to submit (b) application for certification ...... 50 1 3 150 9.24(b)(3) Materials to submit to become an HHS inspector ...... 200 1 2 400 11.4(a) Laboratory submits qualifications of alternate RP to HHS ...... 50 1 2 100 11.4(d) Laboratory submit information to HHS on new RP ...... 25 1 2 50 11.32(a) Specifications for laboratory semi-annual statistical re- port of test results to each Federal agency ...... 72 5 0.5 180 12.5 Specifies what a POCT manufacturer must submit to HHS to be approved ...... 30 1 1 30 12.7(a) Specifies what a POCT manufacturer must submit to HHS to remain on approved list ...... 30 1 0.5 15 12.14(b) Requirements for POCT manufacturer statement of action to overcome problems that cause a device to be removed from the approved list ...... 1 1 3 3 13.8(a) Information an IITF must submit to HHS for an RT ...... 25 1 2 50 13.8(d) Information an IITF must submit to HHS for a new RT candidate ...... 25 1 2 50 13.17(a) Specifies contents of IITF semi-annual statistical re- port to Federal agencies served ...... 25 5 0.5 63 13.22(d) Specifies how IITF reports test results for specimen that is presumptive drug positive, adulterated, sub- stituted or invalid ...... 25 100 0.05 (3 min) 125 15.14 Specifies that MRO must report all verified split speci- men test results to the Federal agency ...... 100 5 0.05 (3 min) 25 17.1(b); 17.5(a) Specifies content of request for informal review of sus- pension/proposed revocation of certification ...... 1 1 3 3 17.4 Specifies information appellant provides in first written submission when laboratory or IITF suspension/rev- ocation is proposed ...... 1 1 0.5 0.5 17.6 Requires appellant to notify reviewing official of resolu- tion status at end of abeyance period ...... 1 1 0.5 0.5 17.7(a) Specifies contents of appellant submission for review 1 1 50 50 17.9(a) Specifies content of appellant request for expedited review of suspension or proposed revocation ...... 1 1 3 3 17.9(c) Specifies contents of review file and briefs ...... 1 1 50 50

Total ...... 456 ...... 1,358

The following reporting requirements 8.5(a)(8) and (14)); collector annotates calculated a separate reporting burden are also in the proposed Guidelines, but the Federal CCF when a sample is a for these requirements because they are have not been addressed in the above blind sample (section 10.3(a)); and MRO included in the burden hours estimated reporting burden table: collector must notifies the Federal agency and HHS for collectors to complete Federal CCFs report any unusual donor behavior or when an error occurs on a blind sample and for MROs to report results to appearance on the Federal CCF (sections (section 10.4(c)). SAMHSA has not Federal agencies.

ESTIMATE OF ANNUAL DISCLOSURE BURDEN

No. of re- Responses/re- Hours/re- Section Purpose spondents spondent sponse Total hours

4.4(c) Collector is given name and phone of Federal agency point of contact ...... 100 1 0.05 (3 min) 5 11.33(b) Information on drug test that laboratory must provide to donor through MRo ...... 50 10 3 1,500

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ESTIMATE OF ANNUAL DISCLOSURE BURDEN—Continued

No. of re- Responses/re- Hours/re- Section Purpose spondents spondent sponse Total hours

12.24 Information related to drug test that POCT tester must provide to donor through MRO ...... 50 10 1 500 13.18 Information related to drug test that IITF must provide to donor through MRO ...... 25 10 2 500 14.8(b) MRO must inform donor of right to request split speci- men test when non-negative result is reported ...... 100 5 3 1,500

Total ...... 325 ...... 4,005

The following disclosure laboratory is not testing their specimen are not being tested under the requirements are also included in the under the Guidelines (section 11.35). Guidelines, this is also a standard proposed Guidelines, but have not been SAMHSA believes having the collector business practice and not considered an addressed in the above disclosure explain the collection procedure to the additional burden because it ensures burden table: the collector must explain donor and to answer any questions is a that a private sector client is not being the basic collection procedure to the standard business practice and not a mislead into believing that its donor and answer any questions disclosure burden. With regard to specimens are being tested under the (section 8.1(b) and (d)); and a laboratory requiring a laboratory to inform a Guidelines. must tell private sector clients when the private sector client that its specimens

ESTIMATE OF ANNUAL RECORDKEEPING BURDEN

No. of re- Responses/re- Hours/re- Section Purpose spondents spondent sponse Total hours

8.2–8.5 Collector completes Federal CCF for each type of specimen collected ...... 100 380 0.07 (4 min) 2,660 11.8(a) Laboratory completes Federal CCF upon receipt of specimen and before reporting result ...... 50 760 0.05 (3 min) 1,900 12.18(c) POCT tester completes Federal CCF for primary spec- imen and documents chain of custody ...... 50 100 0.05 (3 min) 250 13.12(a) IITF completes Federal CCF upon receipt of specimen and before reporting result ...... 25 1520 0.05 (3 min) 1,900 14.3(a)(4) MRO completes the Federal CCF before reporting the result ...... 100 380 0.05 (3 min) 1,900 15.1(b) Donor must request the split to be tested in writing ..... 300 1 0.05 (3 min) 15

Total ...... 625 ...... 8,625

The proposed Guidelines contain a procedure. These recordkeeping supportability of the test results. number of recordkeeping requirements requirements are an integral part of the Therefore, they are considered to be that SAMHSA considers not to be an collection procedure and are essential to standard business practice and are not additional recordkeeping burden. In documenting the chain of custody for considered a burden for this analysis. subpart D, a trainer is required to the specimens collected. The burden for This same opinion applies to the document the training of an individual these entries is included in the recordkeeping requirements for POCT to be a collector (section 4.3(a)) and that recordkeeping burden estimated to testers in section 12.23, for IITFs in the documentation be maintained in the complete the Federal CCF and is, section 13.16(a), and for MROs in collector’s training file (section 4.4(b)). therefore, not considered an additional section 14.3(a)(5). SAMHSA believes this training recordkeeping burden. Subparts K and Thus the total annual response documentation is common practice and M describe a number of recordkeeping burden associated with the testing of is not considered an additional burden. requirements for laboratories and these alternative specimens by the new In subpart F, if a collector uses an instrumented initial test facilities (IITFs) laboratories and Instrumented Initial incorrect form to collect a Federal associated with their testing procedures, Test Facilities (IITFs) and Point of agency specimen, the collector is maintaining chain of custody, and Collection Test sites is estimated to be required to provide a statement (section keeping records (i.e., sections 11.1(a), 13,888 hours (that is, the sum of the 6.2(b)) explaining why an incorrect form 11.1(d), 11.2(b), 11.2(c), 11.2(d), 11.7(c), total hours from the above tables). This was used to document collecting the 11.8(b), 11.8(c), 11.8(e), 11.13(b), is in addition to the 1,788,089 hours specimen. SAMHSA believes this is an 11.14(c), 11.16, 11.17(c), 11.17(d), currently approved by OMB under extremely infrequent occurrence and 11.31(a), 13.4(a), 13.4(d), 13.5, 13.7(b), control number 0930–0158 for urine does not create a significant additional 13.7(c), 13.7(d), 13.10(c), 13.11(c), testing under the existing Mandatory recordkeeping burden. Subpart H 13.12(b), 13.12(c), 13.12(e), 13.13, and Guidelines. (sections 8.5(a)(8) and (14)) requires 13.16(a)). These recordkeeping As required by section 3507(d) of the collectors to enter any information on requirements are necessary for any PRA, the Secretary has submitted a copy the Federal CCF of any unusual findings laboratory or IITF to conduct forensic of these proposed revised Mandatory during the urine specimen collection drug testing and to ensure the scientific Guidelines to OMB for its review.

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Comments on the information collection collected? 5.6 What are the privacy requirements requirements are specifically solicited 2.3 Can more than one type of specimen be when collecting an oral fluid specimen? in order to: (1) Evaluate whether the collected at the same time from the same 5.7 What are the privacy requirements proposed collection of information is donor? when collecting a sweat patch sample? 2.4 How is each type of specimen to be 5.8 What are the privacy requirements necessary for the proper performance of collected? when collecting a urine specimen? HHS’s functions, including whether the 2.5 What is the minimum quantity of information will have practical utility; specimen to be collected? Subpart F—Federal Drug Testing Custody (2) evaluate the accuracy of HHS’s and Control Forms Subpart C—Drug and Validity Tests estimate of the burden of the proposed 6.1 What form is used for the collection of collection of information, including the 3.1 Which tests must be performed on a a specimen? validity of the methodology and specimen? 6.2 What happens if a Federal CCF is not 3.2 Can a specimen be tested for additional available or is not used? assumptions used; (3) enhance the drugs? quality, utility, and clarity of the 3.3 May any of the specimens be used for Subpart G—Collection Device information to be collected; and (4) other purposes? 7.1 What is a collection device? minimize the burden of the collection of 3.4 What are the cutoff concentrations for 7.2 Which collection devices may be used? hair samples? information on those who are to Subpart H—Specimen Collection Procedure respond, including through the use of 3.5 What are the cutoff concentrations for appropriate automated, electronic, oral fluid specimens? 8.1 What must the collector do before starting a specimen collection mechanical, or other technological 3.6 What are the cutoff concentrations for sweat patch samples? procedure? collection techniques or other forms of 3.7 What are the cutoff concentrations for 8.2 What procedure is used to collect a information technology. urine specimens? head hair sample? OMB is required to make a decision 3.8 What validity tests must be performed 8.3 What procedure is used to collect an concerning the collection of information on a hair sample? oral fluid specimen? contained in these proposed Guidelines 3.9 What validity tests must be performed 8.4 What procedure is used to collect a between 30 and 60 days after on an oral fluid specimen? sweat patch sample? publication of this document in the 3.10 What validity tests must be performed 8.5 What procedure is used to collect a urine specimen? Federal Register. Therefore, a comment on a sweat patch sample? 3.11 What validity tests must be performed 8.6 What are the responsibilities of a to OMB is best assured of having its full on a urine specimen? Federal agency that uses a collection effect if OMB receives it within 30 days 3.12 What criteria are used to report a hair site? of publication. This does not affect the sample as adulterated? Subpart I—HHS Certification of Laboratories deadline for the public to comment to 3.13 What criteria are used to report an oral and IITFs HHS on the proposed Guidelines. fluid specimen as adulterated? Organizations and individuals 3.14 What criteria are used to report a sweat 9.1 What are the goals and objectives of desiring to submit comments on the patch sample as adulterated? HHS-certification? 3.15 What criteria are used to report a urine 9.2 Who has the authority to certify information collection requirements laboratories and IITFs that want to test should direct them to the Office of specimen as adulterated? 3.16 What criteria are used to report an oral specimens for Federal agencies? Information and Regulatory Affairs, fluid specimen as substituted? 9.3 What is the process for a laboratory or OMB. (address above). 3.17 What criteria are used to report a urine IITF to become HHS-certified and to maintain that certification? Charles G. Curie, specimen as substituted? 3.18 What criteria are used to report a urine 9.4 How does a laboratory or IITF apply to Administrator, SAMHSA. specimen as dilute? become HHS-certified? Dated: April 2, 2004. 3.19 What criteria are used to report a hair 9.5 What are the qualitative and Tommy G. Thompson, sample as an invalid result? quantitative specifications of a performance test (PT) sample? Secretary. 3.20 What criteria are used to report an oral 9.6 What are the PT requirements for an For the reasons set forth in the fluid specimen as an invalid result? 3.21 What criteria are used to report a sweat applicant laboratory to conduct hair preamble, the Department proposes to patch sample as an invalid result? testing? revise the Mandatory Guidelines for 3.22 What criteria are used to report a urine 9.7 What are the PT requirements for an Federal Workplace Drug Testing specimen as an invalid result? applicant laboratory to conduct oral fluid Programs to read as follows: testing? Subpart D—Collectors 9.8 What are the PT requirements for an Mandatory Guidelines for Federal 4.1 Who may collect a specimen? applicant laboratory to conduct sweat Workplace Drug Testing Programs 4.2 What are the requirements to be a patch testing? trained collector for a Federal agency? 9.9 What are the PT requirements for an Subpart A—Applicability 4.3 How is a collector’s training applicant laboratory to conduct urine Sec. documented? specimen testing? 1.1 Whom do these Guidelines cover? 4.4 What must an organization do before a 9.10 What are the PT requirements for an 1.2 Who is responsible for developing and collector is permitted to collect HHS-certified laboratory to conduct hair implementing these Guidelines? specimens for a Federal agency? testing? 1.3 How does a Federal agency request a 9.11 What are the PT requirements for an change from these Guidelines? Subpart E—Collection Sites HHS-certified laboratory to conduct oral 1.4 How are these Guidelines revised? 5.1 Where can a collection for a drug test fluid testing? 1.5 What do the terms used in these take place? 9.12 What are the PT requirements for an Guidelines mean? 5.2 What are the requirements for a HHS-certified laboratory to conduct 1.6 What is an agency required to do to collection site? sweat patch testing? protect employee records? 5.3 How long must collection site records 9.13 What are the PT requirements for an be stored? HHS-certified laboratory to conduct Subpart B—Specimens 5.4 How does the collector ensure the urine testing? 2.1 What types of specimens may be security of a specimen at the collection 9.14 What are the PT requirements for an collected? site? applicant IITF to conduct hair testing? 2.2 Under what circumstances can the 5.5 What are the privacy requirements 9.15 What are the PT requirements for an different types of specimens be when collecting a hair sample? applicant IITF to conduct oral fluid

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testing? 11.7 What security measures must an HHS- 11.35 What information must an HHS- 9.16 What are the PT requirements for an certified laboratory maintain? certified laboratory provide to its private applicant IITF to conduct sweat patch 11.8 What are the internal laboratory chain sector clients? testing? of custody requirements for a specimen Subpart L—Point of Collection Test (POCT) 9.17 What are the PT requirements for an or an aliquot? applicant IITF to conduct urine testing? 11.9 Which type of specimens may an HHS- 12.1 What is the goal of this subpart? 9.18 What are the PT requirements for an certified laboratory test? 12.2 What POCT devices may be used in a HHS-certified IITF to conduct hair 11.10 What test(s) does an HHS-certified Federal Workplace Drug Testing testing? laboratory conduct on a specimen Program? 9.19 What are the PT requirements for an received after a POCT? 12.3 What is the rationale for the additional HHS-certified IITF to conduct oral fluid 11.11 What test(s) does a HHS-certified requirements to use POCT devices testing? laboratory conduct on a specimen besides FDA clearance? 9.20 What are the PT requirements for an received from an IITF? 12.4 What types of POCT devices are there? HHS-certified IITF to conduct sweat 11.12 What are the requirements for an 12.5 What must a POCT device patch testing? initial drug test? manufacturer submit to the Secretary to 9.21 What are the PT requirements for an 11.13 What must an HHS-certified have its POCT device initially included HHS-certified IITF to conduct urine laboratory do to validate an initial drug on the list of SAMHSA-certified POCTs? testing? test? 12.6 What criteria will the Secretary use to 9.22 What are the inspection requirements 11.14 What are the batch quality control place a POCT device on the list of for an applicant laboratory or IITF? requirements when conducting an initial SAMHSA-certified POCTs? 9.23 What are the maintenance inspection drug test? 12.7 What is required for a FDA cleared requirements for an HHS-certified 11.15 What are the requirements for a POCT device to continue on the list of laboratory or IITF? confirmatory drug test? SAMHSA-certified devices? 9.24 Who can inspect an HHS-certified 11.16 What must an HHS-certified 12.8 What are the responsibilities of a laboratory or IITF and when may the laboratory do to validate a confirmatory Federal agency that wishes to conduct inspection be conducted? drug test method? POCT? 9.25 What happens if an applicant 11.17 What are the quality control 12.9 What are the qualitative and laboratory or IITF does not satisfy the requirements when conducting a quantitative specifications for PT minimum requirements for either the PT confirmatory drug test? samples that are used to evaluate test program or the inspection program? 11.18 What are the analytical and quality devices submitted by manufacturers or 9.26 What happens if an HHS-certified control requirements for conducting for a Federal agency to evaluate a POCT laboratory or IITF does not satisfy the validity tests on hair samples? site and tester? minimum requirements for either the PT 11.19 What are the analytical and quality 12.10 What are the inspection requirements program or the inspection program? control requirements for conducting for a Federal agency wishing to use a 9.27 What factors are considered in validity tests on oral fluid specimens? POCT? determining whether revocation of a 11.20 What are the analytical and quality 12.11 What is the responsibility of the laboratory’s or IITF’s certification is control requirements for conducting Secretary to inspect a Federal agency necessary? validity tests on sweat patch samples? using a POCT? 9.28 What factors are considered in 11.21 What are the analytical and quality 12.12 What is a failure for the purposes of determining whether to suspend a control requirements for conducting the POCT? laboratory or IITF? validity tests on urine specimens? 12.13 What is the responsibility of the 9.29 How does the Secretary notify a 11.22 What are the requirements for Secretary when a failure is reported? laboratory or IITF that action is being conducting each validity test on a hair 12.14 How can a manufacturer apply to taken against the laboratory or IITF? sample? have a device reinstated on the list of 9.30 May a laboratory or IITF that had its 11.23 What are the requirements for SAMHSA-certified devices? certification revoked be recertified to test conducting each validity test on an oral 12.15 What types of specimens may be Federal agency specimens? fluid specimen? tested using a POCT? 9.31 Where is the list of HHS-certified 11.24 What are the requirements for 12.16 What are the requirements to be a laboratories and IITFs published? conducting each validity test on a sweat POCT tester? patch sample? 12.17 What happens if a POCT site or tester Subpart J—Blind Samples Submitted by an 11.25 What are the requirements for does not satisfy the minimum technical Agency conducting each validity test on a urine requirements? 10.1 What are the requirements for Federal specimen? 12.18 What are the requirements for agencies to submit blind samples to 11.26 What are the requirements for an conducting a POCT? HHS-certified laboratories or IITFs? HHS-certified laboratory to report a hair 12.19 What are the quality control 10.2 What are the requirements for a blind test result? requirements when conducting POCTs? sample? 11.27 What are the requirements for an 12.20 What action must be taken when a 10.3 How is a blind sample submitted to the HHS-certified laboratory to report an oral POCT quality control sample fails? HHS-certified laboratory or IITF? fluid test result? 12.21 What does a POCT tester do with a 10.4 What happens if an inconsistent result 11.28 What are the requirements for an specimen after conducting a POCT? is reported on a blind sample? HHS-certified laboratory to report a 12.22 How is a POCT negative result sweat patch test result? reported? Subpart K—Laboratory 11.29 What are the requirements for an 12.23 How long must records generated at 11.1 What is a standard operating HHS-certified laboratory to report a urine the POCT site be retained? procedure manual? test result? 12.24 What POCT information is available 11.2 What are the responsibilities of the 11.30 How long must an HHS-certified to the donor? responsible person (RP)? laboratory retain a specimen? 12.25 What statistical summary report must 11.3 What scientific qualifications in 11.31 How long must an HHS-certified a Federal agency provide to the analytical toxicology must the RP have? laboratory retain records? Secretary? 11.4 What happens when the RP is absent 11.32 What statistical summary report must 12.26 What type of relationship is or leaves an HHS-certified laboratory? an HHS-certified laboratory provide? prohibited between a manufacturer of a 11.5 What qualifications must an individual 11.33 What information is available to the POCT device or a POCT site operation have to certify a result reported by an donor? and an MRO? HHS-certified laboratory? 11.34 What type of relationship is 12.27 What type of relationship can exist 11.6 What qualifications and training must prohibited between an HHS-certified between a manufacturer of a POCT other laboratory personnel have? laboratory and an MRO? device or a POCT site operation and an

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HHS-certified laboratory? 14.10 What type of relationship is Subpart Q—Laboratory/IITF Suspension/ prohibited between an MRO and an Revocation Procedures Subpart M—Instrumented Initial Test HHS-certified laboratory, POCT tester, or Facility (IITF) 17.1 When may an HHS-certified laboratory HHS-certified IITF? or IITF be suspended? 13.1 What is an HHS-certified IITF? Subpart O—Split Specimen Tests 17.2 What definitions are used for this 13.2 Which types of specimens may be subpart? tested at an HHS-certified IITF? 15.1 When may a split specimen be tested? 17.3 Are there any limitations on issues 13.3 What cutoff concentrations are used by 15.2 How does an HHS-certified laboratory subject to review? an HHS-certified IITF for the drug tests? test a split hair, oral fluid, sweat, or 17.4 Who represents the parties? 13.4 What must be included in the HHS- urine specimen when the primary 17.5 When must a request for informal certified IITFs standard operating specimen was reported positive? review be submitted? procedure manual? 15.3 How does an HHS-certified laboratory 17.6 What is an abeyance agreement? 13.5 What must the HHS-certified IITF do test a split hair sample for adulterants 17.7 What procedure is used to prepare the to validate an initial drug test? when the primary sample was reported review file and written argument? 13.6 What qualifications must the adulterated? 17.8 When is there an opportunity for oral responsible technician (RT) have? 15.4 How does an HHS-certified laboratory presentation? 13.7 What are the responsibilities of an RT? test a split oral fluid specimen for 17.9 Are there expedited procedures for 13.8 What happens when an RT is absent or adulterants when the primary specimen review of immediate suspension? leaves an HHS-certified IITF? was reported adulterated? 17.10 Are any types of communications 13.9 What qualifications must an individual prohibited? have to certify a test result reported by 15.5 How does an HHS-certified laboratory test a split sweat patch sample for 17.11 How are communications transmitted an HHS-certified IITF? by a reviewing official? 13.10 What qualifications and training must adulterants when the primary sample was reported adulterated? 17.12 What is the authority and other HHS-certified IITF personnel have? responsibilities of the reviewing official? 13.11 What security measures must an 15.6 How does an HHS-certified laboratory test a split urine specimen for 17.13 What administrative records are HHS-certified IITF maintain? maintained? 13.12 What are the internal IITF chain of adulterants when the primary specimen was reported adulterated? 17.14 What are the requirements for a custody requirements for a specimen or written decision? 15.7 How does an HHS-certified laboratory an aliquot? 17.15 Is there a review of the final test a split oral fluid specimen for 13.13 What are the batch quality control administrative action? requirements when conducting the substitution when the primary specimen initial tests for drugs? was reported substituted? Authority: E.O. 12564 and sec. 503 of Pub. 13.14 What are the analytical and quality 15.8 How does an HHS-certified laboratory L. 110–71. control requirements for conducting test a split urine specimen for Subpart A—Applicability initial validity tests? substitution when the primary specimen 13.15 What action is taken after an HHS- was reported substituted? Section 1.1 Whom Do These certified IITF tests a specimen? 15.9 Who receives the split specimen Guidelines Cover? 13.16 How long must an HHS-certified IITF result? retain records? 15.10 What action(s) does the MRO take (a) These Guidelines apply to: 13.17 What statistical summary report must after receiving the split hair sample (1) Executive Agencies as defined in an HHS-certified IITF provide? result from the second laboratory? 5 U.S.C. 105; 13.18 What IITF information is available to 15.11 What action(s) does the MRO take (2) The Uniformed Services, as the donor? after receiving the split oral fluid defined in 5 U.S.C. 2101(3) (but 13.19 What type of relationship is specimen result from the second excluding the Armed Forces as defined prohibited between an HHS-certified laboratory? in 5 U.S.C. 2101(2)); IITF and an MRO? 15.12 What action(s) does the MRO take (3) Any other employing unit or 13.20 What type of relationship can exist after receiving the split sweat patch authority of the Federal Government between an HHS-certified IITF and an sample result from the second except the United States Postal Service, HHS-certified laboratory? laboratory? 13.21 How does an HHS-certified IITF the Postal Rate Commission, and 15.13 What action(s) does the MRO take report a negative test result? employing units or authorities in the after receiving the split urine specimen 13.22 How does an HHS-certified IITF Judicial and Legislative Branches; and result from the second laboratory? handle a specimen that is presumptive (4) The Intelligence Community, as drug positive, adulterated, substituted, or 15.14 How does an MRO report a split defined by E.O. 12333, are subject to invalid? specimen test result to an agency? these Guidelines only to the extent 13.23 Where is the list of HHS-certified 15.15 How long must an HHS-certified laboratory retain a split specimen? agreed to by the head of the affected IITFs published? Agency; and Subpart N—Medical Review Officer (MRO) Subpart P—Criteria for Rejecting a (5) Laboratories, instrumented initial Specimen for Testing 14.1 Who may serve as an MRO? test facilities, and point of collection 14.2 What are the training requirements 16.1 What discrepancies require an HHS- tests that provide drug testing services before a physician can serve as an MRO? certified laboratory or IITF to report a to the Federal agencies. 14.3 What are the responsibilities of an hair, oral fluid, sweat, or urine specimen (b) The Guidelines do not apply to MRO? as rejected for testing? drug testing under authority other than 14.4 What must an MRO do when 16.2 What discrepancies require an HHS- Executive Order 12564, including reviewing a hair test result? certified laboratory or IITF to report a testing of persons in the criminal justice 14.5 What must an MRO do when hair, oral fluid, sweat, or urine specimen system, such as, arrestees, detainees, reviewing an oral fluid test result? as rejected for testing unless the probationers, incarcerated persons, or discrepancy is corrected? 14.6 What must an MRO do when parolees.1 reviewing a sweat patch test result? 16.3 What discrepancies are not sufficient to require an HHS-certified laboratory or 14.7 What must an MRO do when 1 reviewing a urine test result? IITF to reject a hair, oral fluid, sweat, or Although HHS has no authority to regulate the transportation industry, the Department of 14.8 Who may request a test of a split urine specimen for testing or an MRO to Transportation (DOT) does have such authority. specimen? cancel a test? DOT is required by law to develop requirements for 14.9 How does the MRO report a primary 16.4 What discrepancies may require an its regulated industry that ‘‘incorporate the specimen test result to an agency? MRO to cancel a test? Department of Health and Human Services

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Section 1.2 Who Is Responsible For Calibrator. A solution of known Donor. The individual from whom a Developing and Implementing These concentration in the appropriate matrix specimen is collected. Guidelines? that is used to define expected outcomes Failed to Reconfirm. The result (a) Executive Order 12564 and Public of a measurement procedure or to reported when a laboratory is unable to Law 100–71 require the Department of compare the response obtained with the corroborate the original result (i.e., Health and Human Services (HHS) to response of a test specimen aliquot/ positive, adulterated, substituted) establish scientific and technical sample. The concentration of the reported to the medical review officer. guidelines for Federal workplace drug analyte of interest in the calibrator is Federal Drug Testing Custody and testing programs. known within limits ascertained during Control Form (Federal CCF). The Office (b) The Secretary has the its preparation. Calibrators may be used of Management and Budget (OMB) responsibility to implement these to establish a calibration curve over a approved form that is used to document Guidelines. range of interest. the collection, custody, and transport of Canceled Test. The MRO determines a specimen from the time the specimen Section 1.3 How Does a Federal that the result reported by the laboratory is collected until it is received by the Agency Request a Change From These cannot support reporting either a testing site (i.e., certified laboratory, Guidelines? positive or a negative test to the instrumented initial test facility). The (a) Each Federal agency must ensure employer. form may also be used to report the test that its workplace drug testing program Certifying Scientist (CS). The result to the Medical Review Officer. complies with the provisions of these individual responsible for verifying the Follow-up Test. A specimen collected Guidelines unless a waiver has been chain of custody and scientific from a donor to ensure that the donor obtained from the Secretary. reliability of a non-negative or invalid remains drug-free after being reinstated (b) To obtain a waiver, a Federal test result. to a testing designated position. agency must submit a written request to Certifying Technician (CT). The HHS. The Department of Health and the Secretary that describes the specific individual responsible for verifying the Human Services. change for which a waiver is sought and chain of custody and scientific Initial Drug Test. The test used to a detailed justification for the change. reliability of a negative test result. differentiate a negative specimen from Chain of Custody (COC). Procedures one that requires further testing for Section 1.4 How Are These Guidelines to account for the integrity of each drugs or drug metabolites. Revised? specimen or aliquot by tracking its Initial Validity Test. The first test (a) In order to ensure the full handling and storage from point of used to determine if a specimen is reliability and accuracy of drug and specimen collection to final disposition adulterated, diluted, or substituted. validity tests, the accurate reporting of of the specimen and its aliquots. Instrumented Initial Test Facility test results, and the integrity and Chain of Custody Document. A (IITF). A location where initial testing, efficacy of Federal drug testing document used by a laboratory to reporting of results, and recordkeeping programs, the Secretary may make maintain the security of the specimen are performed under the supervision of changes to these Guidelines to reflect and all aliquots of a specimen during a responsible technician. improvements in the available science testing and storage. The document, Invalid Result. The result reported and technology. which may account for an entire test when a scientifically supportable (b) The changes will be published in batch, must include the names and analytical test result cannot be final as a notice in the Federal Register. signatures of all individuals who established for a specimen. handled the specimen or aliquots and Laboratory. A location where initial Section 1.5 What Do the Terms Used and confirmatory testing is performed in These Guidelines Mean? the date and purpose of the access. Collection Site. A place where donors under the supervision of an RP and The following definitions are adopted: present themselves for the purpose of where CSs perform the final review and Accessioner. The individual who providing a specimen. release of test results. receives the specimens at the laboratory Collector. A person who instructs and Medical Review Officer (MRO). A or IITF and signs the Federal drug assists donors at a collection site and licensed physician who reviews, testing custody and control form. receives the specimen provided by the verifies, and reports a specimen test Aliquot. A fractional part of a donor. result to the agency. specimen used for testing. It is taken as Confirmatory Drug Test. A second Negative Result. The result reported a sample representing the whole analytical procedure performed on a by an HHS-certified laboratory, IITF, or specimen. different aliquot of the original POCT tester to an MRO when a Adulterated. A specimen containing specimen to identify and quantify the specimen contains no drug or the either a substance that is not a normal presence of a specific drug or drug concentration of the drug is less than constituent for that type of specimen or metabolite. the cutoff concentration for that drug or containing an endogenous substance at Confirmatory Validity Test. A second drug class. a concentration that is not a normal test performed on a different aliquot of Non-Negative Result. The result physiological concentration. the original specimen to further support reported by an HHS-certified laboratory Batch. A number of specimens that a validity test result. when a specimen is either adulterated, are being handled and tested as a group. Control. A sample used to evaluate substituted, or contains a drug or drug whether an analytical procedure or test metabolite at or above the established scientific and technical guidelines dated April 11, is operating within predefined tolerance cutoff concentration. 1988, and any amendments to those guidelines ***’’ See, e.g., 49 U.S.C. 20140(c)(2). In carrying limits. Oxidizing Adulterant. A substance out its mandate, DOT requires by regulation that its Cutoff. The concentration used to that acts alone or in combination with federally-regulated employers use only HHS- establish and report a specimen as other substances to oxidize drug or drug certified laboratories in the testing of employees, 49 negative or positive. metabolites to prevent the detection of CFR 40.81, and incorporates the scientific and technical aspects of the guidelines in its Dilute Specimen. Refers to a specimen the drugs or drug metabolites, or affects regulations. The DOT regulated industry should with less than normal physiological the reagents in either the initial or refer to the DOT regulations at 49 CFR part 40. constituents. confirmatory drug test. Examples of

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these agents include, but are not limited Sample. A representative portion of a Section 2.2 Under What to, nitrites, pyridinium chlorochromate, specimen or quality control material Circumstances Can the Different Types chromium (VI), bleach, iodine, used for testing. of Specimens Be Collected? halogens, peroxidase, and peroxide. Secretary. The Secretary of Health and Performance Testing (PT) Sample. A Human Services or the Secretary’s Type of Reason for test sample sent to a testing facility that is designee. The Secretary’s designee may specimen used to evaluate the performance of a be a contractor or other recognized Hair ...... Pre-employment, random, facility’s test procedure. organization which acts on behalf of the return to duty, follow-up Point of Collection Test (POCT). A Secretary in implementing these Oral Fluid ...... Pre-employment, random, drug or validity test conducted at a Guidelines. reasonable suspicion/ collection site to obtain a preliminary Specimen. Fluid or material derived cause, post-accident result as to whether a specimen may from the body which may be Sweat (patch) Return to duty, follow-up contain a drug/drug metabolite or is not subdivided, concurrently collected, or Urine ...... Pre-employment, random, a valid specimen. two specimens collected almost reasonable suspicion/ POCT Site. A collection site where a simultaneously if a split specimen is cause, post-accident, re- point of collection test is conducted. required. turn to duty, follow-up Positive Result. The result reported by Split Specimen. A specimen collected a laboratory when a specimen contains at the collection site that is fluid or Section 2.3 Can More Than One Type a drug or drug metabolite greater than or material derived from the body which of Specimen Be Collected at the Same equal to the cutoff concentration. has been subdivided or concurrently Time From the Same Donor? Post-accident Test. A specimen collected and independently sealed in Yes, more than one type of specimen collected from a donor after the donor the presence of the donor. For urine, may be collected at the same time from is involved in a job-related accident. one void that is subdivided. For hair, the donor, but only in the following Pre-employment Test. A specimen one harvest that is subdivided by circumstances: collected from a donor who is applying strands. For oral fluid, one specimen (a) When an oral fluid specimen is for a testing designated position. collected that is subdivided or two collected, a urine specimen must also be Quality Control (QC) Sample. A specimens collected almost collected; or calibrator, control, or negative sample. simultaneously. For sweat, two separate (b) If a problem occurs during the patches that are applied and removed These samples are collectively referred collection of one type of specimen (e.g., simultaneously. to as ‘‘quality control samples’’ and each shy bladder for a urine specimen, as a ‘‘sample.’’ Standard. Reference material of known purity or a solution containing a insufficient specimen available), Random Test. A specimen collected permission can be obtained from the from a donor who is selected at random reference material at a known concentration. Federal agency to collect an alternative from a group of individuals who are specimen. included in a workplace drug testing Substituted. A specimen that could program. not have been derived from the donor’s Section 2.4 How Is Each Type of Reasonable Suspicion/Cause Test. A body at the time of collection because it Specimen To Be Collected? is inconsistent with normal physiology. specimen collected from a donor when Each type of specimen is to be there is sufficient evidence to indicate Section 1.6 What Is an Agency collected as a split specimen as that the donor may have used an illicit Required To Do To Protect Employee described in section 2.5. substance. Records? Reconfirmed. The result reported Section 2.5 What Is the Minimum when a laboratory is able to corroborate Consistent with 5 U.S.C. 522a(m) and Quantity of Specimen To Be Collected the original result (i.e., positive, 48 CFR 24.101–24.104, all agency for Each Type of Specimen? contracts with laboratories, IITFs, POCT adulterated, substituted) reported to the (a) Hair: 100 mg head hair (divided as Medical Review Officer. testers, collectors, and MROs must require that they comply with the follows: 2 samples with approximately Rejected for Testing. The result 50 mg per sample) reported by a laboratory or test facility Privacy Act, 5 U.S.C. 522a. In addition, the contracts must require compliance (b) Oral Fluid: 2 mL collected as a when it does not perform any tests on ‘‘neat specimen’’ (divided as follows: at the specimen because of a fatal flaw or with employee access and confidentiality provisions of section 503 least 1.5 mL for the primary specimen an unrecovered correctable error. and at least 0.5 mL for the split Responsible Person (RP). The person of Public Law 100–71. The agency must specimen) who assumes professional, establish a Privacy Act System of (c) Sweat: 2 FDA-cleared patches organizational, educational, and Records or modify an existing system, or worn up to 7 days administrative responsibility for the use any applicable Government-wide (d) Urine: 45 mL (divided as follows: day-to-day management of the HHS- system of records to cover the records of at least 30 mL for the primary specimen certified laboratory. employee drug test results. All contracts and at least 15 mL for the split Responsible Technician (RT). The and the Privacy Act System of Records specimen) person who assumes professional, must specifically require that employee organizational, educational, and records be maintained and used with Subpart C—Drug and Validity Tests administrative responsibility for the the highest regard for employee privacy. Section 3.1 Which Tests Must Be day-to-day management of the HHS- Subpart B—Specimens Performed on a Specimen? certified instrumented initial test facility. Section 2.1 What Types of Specimens (a) Federal agency applicant and Return to Duty Test. A specimen May Be Collected? random drug testing programs must at a collected from a donor to ensure that the A Federal agency may collect head minimum test for marijuana and donor is drug free prior to being hair, oral fluid (saliva), sweat (patch), or cocaine; reinstated in a testing designated urine for its workplace drug-testing (b) Federal agency applicant and position. program in keeping with section 2.2. random drug testing programs are also

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authorized to test for opiates, CONFIRMATORY TEST CUTOFF 2 Specimen must also contain Amphetamine at a concentration greater than or equal to the amphetamines, and phencyclidine; and CONCENTRATION limit of detection. (c) Each specimen must be tested to determine if it is a valid specimen. (pg/mg) Section 3.6 What Are the Cutoff Concentrations for Sweat Patch Section 3.2 Can a Specimen Be Tested Marijuana metabolite 1 ...... 0.05 Samples? for Additional Drugs? Cocaine: Cocaine 2 ...... 500 INITIAL TEST CUTOFF CONCENTRATION (a) Any specimen collected from a Cocaine metabolites 2 ...... 50 donor that is suspected to contain a Opiates: (ng/patch) Schedule I or II drug of the Controlled Morphine ...... 200 Substances Act (other than the drugs Codeine ...... 200 Marijuana metabolites ...... 4 6–Acetylmorphine 3 ...... 200 listed in section 3.1, or when used Cocaine metabolites ...... 25 Phencyclidine ...... 300 Opiate metabolites 1 ...... 25 pursuant to a valid prescription or when Amphetamines: Phencyclidine ...... 20 used as otherwise authorized by law) Amphetamine ...... 300 Amphetamines 2 ...... 25 may be tested for that drug on a case- Methamphetamine 4 ...... 300 MDMA ...... 25 by-case basis. The Federal agency must MDMA ...... 300 1 Labs are permitted to initial test all speci- request the HHS-certified laboratory to MDA ...... 300 mens for 6–AM at 25 ng/patch. test for that additional drug, include a MDEA ...... 300 2 Methamphetamine is the target analyte. justification to test a specific specimen 1 Delta–9–tetrahydrocannabinol–9–car- for the drug, and ensure that the HHS- boxylic acid. CONFIRMATORY TEST CUTOFF certified laboratory has the capability to 2 Cocaine concentration is greater than or CONCENTRATION equal to confirmatory cutoff and test for the drug and has established Benzoylecgonine (BZE)/Cocaine ratio is great- properly validated initial and er than or equal to 0.05 or Cocaethylene (CE) (ng/patch) confirmatory analytical methods. greater than or equal to 50 pg/mg or norcocaine (NC) greater than or equal to 50 THC parent drug ...... 1 (b) A Federal agency covered by these pg/mg. Cocaine 1 ...... 25 Guidelines must petition the Secretary 3 Specimen must also contain Morphine at a Opiates 2 ...... 25 in writing for approval to routinely test concentration greater than or equal to 200 pg/ Phencyclidine ...... 20 for any drug class not listed in section mg. Amphetamines: 4 Specimen must also contain Amphetamine Amphetamine ...... 25 3.1. Such approval must be limited to at a concentration greater than or equal to 50 Methamphetamine 3 ...... 25 the use of the appropriate science and pg/mg. MDMA ...... 25 technology and must not otherwise limit Section 3.5 What Are the Cutoff MDA ...... 25 agency discretion to test for any drug MDEA ...... 25 Concentrations for Oral Fluid tested under paragraph (a) of this Specimens? 1 Cocaine or Benzoylecgonine. section. 2 Morphine, Codeine, or 6-Acetylmorphine. 3 Specimen must also contain Amphetamine Section 3.3 May Any of the Specimens INITIAL TEST CUTOFF CONCENTRATION at a concentration greater than or equal to the Be Used for Other Purposes? limit of detection. (ng/mL) (a) Federal agency specimens Section 3.7 What Are the Cutoff collected pursuant to Executive Order THC Parent drug and metabolite ... 4 Concentrations for Urine Specimens? 12564, Public Law 100–71, and these Cocaine metabolites ...... 20 Opiate metabolites 1 ...... 40 Guidelines must only be tested for drugs INITIAL TEST CUTOFF CONCENTRATION Phencyclidine ...... 10 and to determine their validity unless Amphetamines 2 ...... 50 (ng/mL) otherwise authorized by law. MDMA ...... 50 (b) These Guidelines are not intended Marijuana metabolites ...... 50 1 Labs are permitted to initial test all speci- to prohibit any Federal agency Cocaine metabolites ...... 150 mens for 6-AM using a 4 ng/mL cutoff. 1 specifically authorized by law to test a 2 Methamphetamine is the target analyte. Opiate metabolites ...... 2000 Phencyclidine ...... 25 specimen for additional classes of drugs Amphetamines 2 ...... 500 in its workplace drug testing program. CONFIRMATORY TEST CUTOFF MDMA ...... 500 CONCENTRATION Section 3.4 What Are the Cutoff 1 Labs are permitted to initial test all speci- Concentrations for Hair Samples? mens for 6–AM using a 10 ng/mL cutoff. (ng/mL) 2 Methamphetamine is the target analyte. INITIAL TEST CUTOFF CONCENTRATION THC Parent drug ...... 2 Cocaine 1 ...... 8 CONFIRMATORY TEST CUTOFF (pg/mg) Opiates: CONCENTRATION Morphine ...... 40 Marijuana metabolites ...... 1 Codeine ...... 40 (ng/mL) Cocaine metabolites ...... 500 6-Acetylmorphine ...... 4 1 Opiate metabolites1 ...... 200 Phencyclidine ...... 10 Marijuana metabolite ...... 15 Cocaine metabolite 2 ...... 100 Phencyclidine ...... 300 Amphetamines: Opiates: Amphetamines2 ...... 500 Amphetamine ...... 50 2 Morphine ...... 2000 MDMA ...... 500 Methamphetamine ...... 50 MDMA ...... 50 Codeine ...... 2000 3 1 Laboratories are permitted to initial test all MDA ...... 50 6-acetylmorphine ...... 10 specimens for 6–acetylmorphine (6–AM) using MDEA ...... 50 Phencyclidine ...... 25 a 200 pg/mg cutoff. Amphetamines: 2 Methamphetamine is the target analyte. 1 Cocaine or Benzoylecgonine. Amphetamine ...... 250

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CONFIRMATORY TEST CUTOFF (iii) Possible unidentified interfering concentration of the adulterant is above CONCENTRATION—Continued substance or adulterant. the concentration of the calibrator used (b) The choice of additional validity to verify that the adulterant was present (ng/mL) tests is dependent on the observed in the sample. indicators or characteristics as described Methamphetamine4 ...... 250 in (2)(i) through (iii) of this section. Section 3.13 What Criteria Are Used MDMA ...... 250 To Report an Oral Fluid Specimen as MDA ...... 250 Section 3.10 What Validity Tests Must Adulterated? MDEA ...... 250 Be Performed on a Sweat Patch Sample? A primary (Tube A) oral fluid 1 Delta-9-tetrahydrocannabinol-9-carboxylic (a) For each primary (Patch A) sweat specimen is reported adulterated when acid. patch sample, an HHS-certified the concentration of the adulterant is 2 Benzoylecgonine. laboratory or IITF must: above the concentration of the calibrator 3 If a laboratory uses both initial test kits to (1) Determine the lactic acid screen a specimen concurrently, it may report used to verify that the adulterant was 6–AM alone. concentration on every specimen; and present in the specimen. 4 Specimen must also contain Amphetamine (2) Perform additional validity tests at a concentration greater than or equal to 100 when the following conditions are Section 3.14 What Criteria Are Used ng/mL. observed: To Report a Sweat Patch Sample as Adulterated? Section 3.8 What Validity Tests Must (i) Abnormal physical characteristics Be Performed on a Hair Sample? (e.g., Patch A and Patch B have different A primary (Patch A) sweat patch color, unusual odor); sample is reported adulterated when the (a) For each primary (Sample A) head (ii) Reactions or responses concentration of the adulterant is above hair sample, an HHS-certified laboratory characteristic of an adulterant obtained the concentration of the calibrator used or IITF must: during initial or confirmatory drug tests to verify that the adulterant was present (1) Determine the integrity of the head (e.g., non-recovery of standards, unusual in the sample. hair sample by performing a digestion response); or test; (iii) Possible unidentified interfering Section 3.15 What Criteria Are Used (2) Perform microscopic substance or adulterant. To Report a Urine Specimen as identification; (b) The choice of additional validity Adulterated? (3) Perform a dye test; tests is dependent on the observed A primary (Bottle A) urine specimen (4) Determine solubility of head hair indicators or characteristics as described is reported adulterated when: in methanol; and in (2)(i) through (iii) of this section. (a) The pH is less than 3 or greater (5) Perform additional validity tests than or equal to 11 using either a pH when the following conditions are Section 3.11 What Validity Tests Must meter or a colorimetric pH test for the observed: Be Performed on a Urine Specimen? (i) Abnormal physical characteristics initial test on the first aliquot and a pH (a) For each primary (Bottle A) urine meter for the confirmatory test on the (e.g., Sample A and Sample B have specimen, an HHS-certified laboratory different hair color, mixture of different second aliquot; or IITF must: (b) The nitrite concentration is greater types of head hair); (1) Determine the creatinine than or equal to 500 mcg/mL using (ii) Reactions or responses concentration on every specimen; characteristic of an adulterant obtained either a nitrite colorimetric test or a (2) Determine the specific gravity on general oxidant colorimetric test for the during initial or confirmatory drug tests every specimen for which the creatinine (e.g., non-recovery of standards, unusual initial test on the first aliquot and a concentration is less than 20 mg/dL; different confirmatory test (e.g., multi- response); or (3) Determine the pH on every wavelength spectrophotometry, ion (iii) Possible unidentified interfering specimen; substance or adulterant. (4) Perform one or more validity tests chromatography, capillary (b) The choice of additional validity for oxidizing adulterants on every electrophoresis) on the second aliquot; (c) The presence of chromium (VI) is tests is dependent on the observed specimen; and indicators or characteristics as described (5) Perform additional validity tests verified using either a general oxidant in (5)(i) through (iii) of this section. when the following conditions are colorimetric test (with a greater than or equal to 50 mcg/mL chromium (VI)- Section 3.9 What Validity Tests Must observed: (i) Abnormal physical characteristics equivalent cutoff) or a chromium (VI) Be Performed on an Oral Fluid (e.g., unusual odor or color, semi-solid colorimetric test (chromium (VI) Specimen? characteristics); concentration greater than or equal to 50 (a) For each primary (Tube A) oral (ii) Reactions or responses mcg/mL) for the initial test on the first fluid specimen, an HHS-certified characteristic of an adulterant obtained aliquot and a different confirmatory test laboratory or IITF must: during initial or confirmatory drug tests (e.g., multi-wavelength (1) Determine the immunoglobulins (e.g., non-recovery of standards, unusual spectrophotometry, ion (IgG) concentrations on every specimen; response); or chromatography, atomic absorption and (iii) Possible unidentified interfering spectrophotometry, capillary (2) Perform additional validity tests substance or adulterant. electrophoresis, inductively coupled when the following conditions are (b) The choice of additional validity plasma-mass spectrometry) with the observed: tests is dependent on the observed chromium (VI) concentration greater (i) Abnormal physical characteristics indicators or characteristics as described than or equal to the limit of detection (e.g., unusual color or texture, unusual in (5)(i) through (iii) of this section. (LOD) of the confirmatory test on the odor, semi-solid characteristics); second aliquot; (ii) Reactions or responses Section 3.12 What Criteria Are Used (d) The presence of halogen (e.g., characteristic of an adulterant obtained To Report a Hair Sample as bleach, iodine, fluoride) is verified during initial or confirmatory drug tests Adulterated? using either a general oxidant (e.g., non-recovery of standards, unusual A primary (Sample A) head hair colorimetric test (with a greater than or response); or sample is reported adulterated when the equal to 200 mcg/mL nitrite-equivalent

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cutoff or a greater than or equal to 50 Section 3.17 What Criteria Are Used specimen may damage the laboratory’s mcg/mL chromium (VI)-equivalent To Report a Urine Specimen as instruments; or cutoff) or halogen colorimetric test Substituted? (d) If the physical appearances of (halogen concentration greater than or A primary (Bottle A) urine specimen Tubes A and B are clearly different, the equal to the LOD) for the initial test on is reported substituted when the test result for Tube A is one of the the first aliquot and a different creatinine concentration is less than 2 reasons stated in (a) through (c) of this confirmatory test (e.g., multi-wavelength mg/dL on both the initial and section and/or was screened negative for spectrophotometry, ion confirmatory creatinine tests (i.e., the drugs. chromatography, inductively coupled same colorimetric test may be used to Section 3.21 What Criteria Are Used plasma-mass spectrometry) with a test both aliquots) and the specific To Report a Sweat Patch Sample as an specific halogen concentration greater gravity is less than or equal to 1.0010 or Invalid Result? greater than or equal to 1.0200 on both than or equal to the LOD of the A primary (Patch A) sweat patch the initial and confirmatory specific confirmatory test on the second aliquot; sample is reported as an invalid result gravity tests (i.e., a refractometer is used (e) The presence of glutaraldehyde is when: to test both aliquots) on two separate verified using either an aldehyde test (a) Interference occurs on the aliquots. (aldehyde present) or the characteristic immunoassay drug tests on two separate immunoassay response on one or more Section 3.18 What Criteria Are Used aliquots (i.e., valid immunoassay drug drug immunoassay tests for the initial To Report a Urine Specimen as Dilute? test results cannot be obtained); (b) Interference with the drug test on the first aliquot and gas A primary (Bottle A) urine specimen confirmatory assay occurs on at least chromatography/mass spectrometry is reported dilute when the creatinine two separate aliquots of the specimen (GC/MS) for the confirmatory test with concentration is greater than or equal to and the laboratory is unable to identify the glutaraldehyde concentration greater 2 mg/dL but less than 20 mg/dL and the the interfering substance; specific gravity is greater than 1.0010 than or equal to the LOD of the analysis (c) The physical appearance of the but less than 1.0030 on a single aliquot. on the second aliquot; specimen is such that testing the system (f) The presence of pyridine Section 3.19 What Criteria Are Used may damage the laboratory’s (pyridinium chlorochromate) is verified To Report a Hair Sample as an Invalid instruments; or using either a general oxidant Result? (d) If the physical appearances of colorimetric test (with a greater than or A primary (Sample A) head hair Patches A and B are clearly different, equal to 200 mcg/mL nitrite-equivalent sample is reported as an invalid result the test result for Patch A is one of the cutoff or a greater than or equal to 50 when: reasons stated in (a) through (c) of this mcg/mL chromium (VI)-equivalent (a) Interference occurs on the section and/or was screened negative for cutoff) or a chromium (VI) colorimetric immunoassay drug tests on two separate drugs. test (chromium (VI) concentration aliquots (i.e., valid immunoassay drug Section 3.22 What Criteria Are Used greater than or equal to 50 mcg/mL) for test results cannot be obtained); To Report a Urine Specimen as an the initial test on the first aliquot and (b) Interference with the drug Invalid Result? confirmatory assay occurs on at least GC/MS for the confirmatory test with A primary (Bottle A) urine specimen the pyridine concentration greater than two separate aliquots of the specimen and the laboratory is unable to identify is reported as an invalid result when: or equal to the LOD of the analysis on (a) Inconsistent creatinine the second aliquot; the interfering substance; (c) The physical appearance of the concentration and specific gravity (g) The presence of a surfactant is specimen is such that testing the system results are obtained (i.e., the creatinine verified by using a surfactant may damage the laboratory’s concentration is less than 2 mg/dL on colorimetric test with a greater than or instruments; or both the initial and confirmatory equal to 100 mcg/mL dodecylbenzene (d) If the physical appearances of creatinine tests and the specific gravity sulfonate-equivalent cutoff for the initial Samples A and B are clearly different, is greater than 1.0010 but less than test on the first aliquot and a different the test result for Sample A is one of the 1.0200 on the initial and/or confirmatory test (e.g., multi-wavelength reasons stated in (a) through (c) of this confirmatory specific gravity test, the spectrophotometry) with a greater than section and/or was screened negative for specific gravity is less than or equal to or equal to 100 mcg/mL dodecylbenzene drugs. 1.0010 on both the initial and sulfonate-equivalent cutoff on the confirmatory specific gravity tests and Section 3.20 What Criteria Are Used the creatinine concentration is greater second aliquot; or To Report an Oral Fluid Specimen as an than or equal to 2 mg/dL on either or (h) The presence of any other Invalid Result? both the initial or confirmatory adulterant not specified in (c) through A primary (Tube A) oral fluid creatinine tests); (g) of this section is verified using an specimen is reported as an invalid result (b) The pH is greater than or equal to initial test on the first aliquot and a when: 3 and less than 4.5 or greater than or different confirmatory test on the (a) Interference occurs on the equal to 9 and less than 11 using either second aliquot. immunoassay drug tests on two separate a colorimetric pH test or pH meter for aliquots (i.e., valid immunoassay drug the initial test and a pH meter for the Section 3.16 What Criteria Are Used test results cannot be obtained); confirmatory test on two separate To Report an Oral Fluid Specimen as (b) Interference with the drug aliquots; Substituted? confirmatory assay occurs on at least (c) The nitrite concentration is greater than or equal to 200 mcg/mL using a A primary (Tube A) oral fluid two separate aliquots of the specimen and the laboratory is unable to identify nitrite colorimetric test or greater than specimen is reported substituted when the interfering substance; or equal to the equivalent of 200 mcg/ the IgG concentration is less than 0.10 (c) The physical appearance of the mL nitrite using a general oxidant mcg/mL. specimen is such that testing the colorimetric test for both the initial test

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and the confirmatory test or using either section and/or was screened negative for Federal agency that employs its own initial test and the nitrite concentration drugs. collectors) must: is greater than or equal to 200 mcg/mL (a) Ensure that each individual that Subpart D—Collectors but less than 500 mcg/mL for a different serves as a collector has been properly confirmatory test (e.g., multi-wavelength Section 4.1 Who May Collect a trained before the individual is spectrophotometry, ion Specimen? permitted to collect a specimen; chromatography, capillary (b) Maintain a copy of the records that (a) An individual who has been electrophoresis) on two separate document the collector’s training; and trained to collect a particular type of aliquots; (c) Provide to the collector the name (d) The possible presence of specimen (i.e., head hair, oral fluid, and telephone number of the Federal chromium (VI) is determined using the sweat, or urine). agency representative to contact about same chromium (VI) colorimetric test (b) The immediate supervisor of a problems or issues that may arise during with a cutoff greater than or equal to 50 donor may not act as the collector when a specimen collection procedure. mcg/mL chromium (VI) for both the that donor is tested unless no other Subpart E—Collection Sites initial test and the confirmatory test on collector is available. two separate aliquots; (c) An employee working for a testing Section 5.1 Where Can a Collection for (e) The possible presence of a halogen facility must not act as a collector if the a Drug Test Take Place? (e.g., bleach, iodine, fluoride) is employee could link the identity of the donor to the donor’s drug test result. (a) A collection site may be a determined using the same halogen permanent or temporary facility located colorimetric test with a cutoff greater Section 4.2 What Are the either at the work site or at a remote than or equal to the LOD for both the Requirements To Be a Trained Collector site. initial test and the confirmatory test on For a Federal Agency? (b) The selection of an appropriate two separate aliquots or relying on the An individual is considered to be a collection site will depend on the type odor of the specimen as the initial test; of specimen being collected. For (f) The possible presence of trained collector for a particular type of specimen when the individual has: example, a urine specimen is normally glutaraldehyde is determined by using collected in some type of restroom, the same aldehyde test (aldehyde (a) Read and understands these Guidelines; while a head hair sample may be present) or characteristic immunoassay collected in a private office. response on one or more drug (b) Read and understands any immunoassay tests for both the initial guidance provided by the Federal Section 5.2 What Are the test and the confirmatory test on two agency, which is consistent with these Requirements for a Collection Site? Guidelines; separate aliquots; A facility that is used as a collection (g) The possible presence of an (c) Demonstrated proficiency by completing five consecutive error-free site must have the following: oxidizing adulterant is determined by (a) A suitable clean surface for mock collections for a particular type of using the same general oxidant handling the specimen and completing specimen; and colorimetric test (with a greater than or the required paperwork; (d) Successfully completed a training equal to 200 mcg/mL nitrite-equivalent (b) A secure temporary storage course by an established organization cutoff, a greater than or equal to 50 mcg/ capability to maintain a specimen until for the particular type or types of mL chromium (VI)-equivalent cutoff, or it is tested or shipped to the laboratory; a halogen concentration is greater than specimen(s) for which the individual is (c) The ability to provide the donor or equal to the LOD) for both the initial being trained. privacy that is appropriate for the test and the confirmatory test on two Section 4.3 How Is a Collector’s specimen being collected; separate aliquots; Training Documented? (d) The ability to restrict access to (h) The possible presence of a only authorized personnel during the (a) A trainer must monitor and surfactant is determined by using the collection; same surfactant colorimetric test with a evaluate the knowledge and (e) The ability to restrict access to greater than or equal to 100 mcg/mL performance of the individual being collection supplies; and dodecylbenzene sulfonate-equivalent trained, in person or by means that (f) The ability to store records cutoff for both the initial test and the provides real-time observation and securely. confirmatory test on two separate interaction between the trainer and aliquots or a foam/shake test for the trainee, and attest in writing that the Section 5.3 How Long Must Collection initial test; mock collections are error-free. Site Records Be Stored? (i) Interference occurs on the (b) The trainer must be an individual Collection site records must be stored immunoassay drug tests on two separate who has demonstrated necessary for a minimum of 2 years by the aliquots (i.e., valid immunoassay drug knowledge, skills, and abilities by collector or the collector’s employer. test results cannot be obtained); having: (j) Interference with the drug (1) Regularly conducted collections Section 5.4 How Does the Collector confirmatory assay occurs on at least for a period of at least one year; or Ensure the Security of a Specimen at the two separate aliquots of the specimen (2) Successfully completed a ‘‘train Collection Site? and the laboratory is unable to identify the trainer’’ course given by an (a) A collector must do the following the interfering substance; established organization. to maintain the security of a specimen: (k) The physical appearance of the (1) Not allow unauthorized personnel Section 4.4 What Must an specimen is such that testing the system to enter the collection site during the Organization Do Before a Collector Is may damage the laboratory’s collection; Permitted To Collect Specimens for a instruments; or (2) Perform only one specimen (l) If the physical appearances of Federal Agency? collection at a time; Bottles A and B are clearly different, the An organization (e.g., self-employed (3) Restrict access to collection test result for Bottle A is one of the individual, third party administrator supplies before and during the reasons stated in (a) through (j) of this that provides a collection service, collection;

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(4) Ensure that he or she is the only (c) The agency believes that the donor (1) If a collection device has been person other than the donor to handle may tamper with or substitute the cleared by the FDA for the purpose of the unsealed specimen; specimen to be provided; or testing a specimen for drugs, it is (5) Ensure that chain of custody is (d) During a routine collection, the deemed not to affect the specimen maintained and documented throughout temperature of the specimen collected is collected. the entire collection procedure; outside the acceptable range, the (2) If a collection device has not been (6) Ensure that specimens transported collector observed materials brought to cleared by the FDA, a Federal agency to an HHS-certified laboratory or IITF the collection site or donor conduct must only use a device that does not are placed in containers that will indicated a possible attempt to affect the specimen collected. minimize the possibility of damage adulterate or substitute a specimen, or (b) These Guidelines do not determine during shipment (e.g., specimen boxes the collector believes that the specimen if a collection device must be cleared by or padded mailers); and has been adulterated (e.g., the specimen the FDA. (7) Ensure that the Federal CCF is is blue, exhibits excessive foaming when shaken, has smell of bleach). Subpart H—Specimen Collection enclosed with the split specimens Procedure within each container that is sealed for Subpart F—Federal Drug Testing shipment to the HHS-certified Custody and Control Forms Section 8.1 What Must the Collector laboratory or IITF. Do Before Starting a Specimen Section 6.1 What Form Is Used for (b) Since specimens are sealed in Collection Procedure? Collecting a Specimen? packages that would indicate any The collector must: tampering during transit to the HHS- (a) Federal agencies are required to (a) Provide identification to the donor certified laboratory or IITF and couriers, use an OMB-approved Federal CCF to if the donor asks; express carriers, and postal service document the collection of each type of (b) Explain the basic collection personnel do not have access to the specimen at the collection site. procedure to the donor; Federal CCF or split specimens, there is (b) There is a separate OMB-approved (c) Request the donor to read the no requirement that such personnel Federal CCF for each type of specimen instructions on the back of the Federal document chain of custody for the collected. CCF; and package during transit. Section 6.2 What Happens if a Federal (d) Answer any reasonable and Section 5.5 What Are the Privacy CCF Is Not Available or Is Not Used? appropriate questions the donor may Requirements When Collecting a Hair (a) When the collector either by have regarding the collection procedure. Sample? mistake or as the only means to Section 8.2 What Procedure Is Used To document a collection under difficult The collector collects head hair from Collect a Head Hair Sample? circumstances (e.g., post-accident test the donor. The donor must be allowed (a) The collector must use the with insufficient time to obtain the CCF) privacy while the collector obtains the following procedure to collect a head uses a non-Federal form for a Federal head hair sample. agency specimen collection, the use of hair sample: (1) When the donor arrives at the Section 5.6 What Are the Privacy a non-Federal form is not a reason for collection site, the collector shall Requirements When Collecting an Oral the laboratory to reject the specimen for request the donor to present photo Fluid Specimen? testing or for the MRO to cancel the test. (b) If the testing facility or the MRO identification. If the donor does not The donor provides the sample discovers the use of the incorrect form, have proper photo identification, the directly into an appropriate container a signed statement must be obtained collector shall contact the supervisor of under the direct observation of the from the collector stating the reason the donor or an agency representative collector. Only the collector may be why a Federal CCF was not used to who can positively identify the donor. present while the donor provides the collect the Federal agency specimen. If the donor’s identity cannot be oral fluid specimen. established, the collector must not Subpart G—Collection Device proceed with the collection. Section 5.7 What Are the Privacy (2) If the donor fails to arrive at the Requirements When Collecting a Sweat Section 7.1 What Is a Collection assigned time or if the donor fails to Patch Sample? Device? remain present through the completion The sweat patch is applied to the A collection device, for the purposes of the collection, the collector must donor’s upper arm or back by the of these Guidelines, is considered to be contact the agency to obtain guidance collector. The donor must be allowed the following for each type of specimen on the action to be taken. collected: privacy while the collector applies or (3) The collector shall ask the donor (a) For urine, it is the single-use removes the patch. to remove any unnecessary outer plastic specimen container. Section 5.8 What Are the Privacy (b) For head hair, it is the foil or other garments such as a coat or jacket and Requirements When Collecting a Urine specimen guide and single-use plastic any hat or hood. Specimen? bag or other container in which the (4) The collector must use a Federal specimen is placed. CCF to document collecting a head hair The collector must give the donor (c) For oral fluid, it is the single-use sample. visual privacy while providing the plastic specimen container. (5) In the presence of the donor, the specimen unless: (d) For sweat, it is the patch placed on collector must clean the scissors that (a) A previous drug test was reported the skin. will be used to cut the head hair with either positive for a drug, adulterated, an alcohol wipe prior to obtaining a substituted, invalid result, or canceled Section 7.2 Which Collection Devices head hair sample. because the split specimen was not May Be Used? (6) If the collector sees any evidence tested; (a) Only a collection device that does that the donor has lice in his or her head (b) The drug test is a return-to-duty or not affect the specimen collected may be hair, the collector immediately stops the a follow-up test; used. collection procedure and contacts the

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agency to obtain permission to collect a who can positively identify the donor. (9) The Tube A specimen, containing different type of specimen. If the donor’s identity cannot be a minimum of 1.5 mL of oral fluid, is (7) Using scissors, the collector will established, the collector must not to be used for the drug test. If there is cut the donor’s head hair in a line near proceed with the collection. no additional oral fluid available for the the rear of the crown toward the back (2) If the donor fails to arrive at the second specimen tube (Tube B), the first and as close to the scalp as possible. assigned time or if the donor fails to specimen tube (Tube A) shall Approximately one-and-one-half inches remain present through the completion nevertheless be processed for testing. of the hair closest to the scalp is actually of the collection, the collector must (10) A minimum of 0.5 mL of oral tested, even if the head hair is long. If contact the appropriate authority to fluid shall be transferred into the second the hair is less than one-and-one-half obtain guidance on the action to be specimen tube (Tube B). inches long, then the width of the taken. (11) The collector places a tamper- sample collected will need to be (3) The collector shall ask the donor evident label/seal from the Federal CCF increased. The weight of hair needed for to remove any unnecessary outer across the top of each tube and records testing is 100 mg. The head hair sample garments such as a coat or jacket that the date of the collection on the tamper- collected from the donor must meet that might conceal items or substances that evident labels/seals. requirement. could be used to tamper with or (12) The donor initials the tamper- (8) The collector places the head hair adulterate the donor’s oral fluid evident labels/seals on the specimen sample in the foil packet (collection specimen. The collector must ensure tubes. device), root-end extending out that all personal belongings such as a (13) The collector asks the donor to approximately one-quarter inch from purse or briefcase remain with the outer read and sign a statement on the Federal the slated end of the foil. The collector garments. The donor may retain his or CCF certifying that the specimen then subdivides the head hair sample her wallet. The collector directs the identified as having been collected from into two approximately equal head hair donor to empty his or her pockets and him or her. samples (Sample A and Sample B). display the items to ensure that no items (14) The collector must sign the Sample B is placed in a second foil. are present that could be used to Federal CCF. (9) The collector folds both foils adulterate the specimen. If nothing is (15) The split oral fluid specimen and lengthwise and each sample is placed there that can be used to adulterate a Federal CCF are now ready for transfer inside an envelope with root-ends to the specimen, the donor places the items to an HHS-certified laboratory or IITF. (16) After completing the oral fluid left. back into the pockets and the collection specimen collection procedure, the (10) The collector places the seals procedure continues. If the donor collector must also collect a urine from the Federal CCF on the bottom of refuses to show the collector the items specimen following the procedures the envelopes and records the date of in his or her pockets, this is considered described in section 8.5. the collection on the tamper-evident a ‘‘refusal to test.’’ If an item is found (17) The collector must send the oral labels/seals. that appears to have been brought to the fluid and urine split specimens at the (11) The donor initials the tamper- collection site with the intent to same time to an HHS-certified evident labels/seals. adulterate or if the item appears to be laboratory or IITF or transfer the (12) The collector asks the donor to inadvertently brought to the collection specimens to the POCT tester (if a POCT read and sign a statement on the Federal site, the collector must secure the item CCF certifying that the head hair is being conducted). and continue with the normal collection (b) If the split specimens and Federal samples were collected from him or her. procedure. (13) The collector must sign the CCF are not immediately prepared for (4) The collector must confirm with Federal CCF. transfer to an HHS-certified laboratory (14) The split head hair samples and the donor that the donor has not had or IITF or tested using a POCT, they Federal CCF are now ready for transfer anything in his or her mouth for 10 must be appropriately safeguarded until to an HHS-certified laboratory or IITF. minutes prior to providing the oral fluid the specimens and Federal CCF are (15) The collector must send the split specimen. If the donor has had anything prepared for transfer to an HHS-certified (Sample A and Sample B) head hair in his or her mouth within the last 10 laboratory or IITF or tested using a samples at the same time to the HHS- minutes, wait 10 minutes prior to POCT. certified laboratory or IITF. beginning the collection process. (b) If the split head hair samples and (5) The collector will give the donor Section 8.4 What Procedure Is Used To Federal CCF are not immediately a clean specimen tube. Collect a Sweat Patch Sample? prepared for transfer to an HHS-certified (6) Under direct observation, the (a) The collector must use the laboratory or IITF, they must be collector will instruct the donor to following procedure to collect a sweat appropriately safeguarded until the expectorate (to spit) 2 mL of oral fluid patch sample: head hair samples and Federal CCF are into the specimen tube. This can be (1) When a donor arrives at the prepared for transfer to the laboratory. accomplished over a 15 minute time collection site, the collector shall period or until the appropriate volume request the donor to present photo Section 8.3 What Procedure Is Used To of specimen is collected. identification. If the donor does not Collect an Oral Fluid Specimen? (7) Both the donor and the collector have proper photo identification, the (a) The collector must use the must keep the specimen tube in view at collector shall contact the supervisor of following procedure to collect an oral all times prior to its being sealed and the donor or an agency representative fluid specimen: labeled. who can positively identify the donor. (1) When a donor arrives at the (8) The collector, in the presence of If the donor’s identity cannot be collection site, the collector shall the donor, mixes the specimen and established, the collector must not request the donor to present photo transfers the oral fluid into two proceed with the collection. identification. If the donor does not specimen tubes that are labeled Tube A (2) If the donor fails to arrive at the have proper photo identification, the and Tube B. A minimum of 2 mL of oral assigned time or if the donor fails to collector shall contact the supervisor of fluid is required, i.e., 1.5 mL for Tube remain present through the completion the donor or an agency representative A and 0.5 mL for Tube B. of the collection, the collector must

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contact the appropriate authority to indicating that the sweat patches may obtain guidance on the action to be obtain guidance on the action to be not be valid samples (e.g., the donor taken. taken. tampered with the sweat patches). (4) The collector shall ask the donor (3) The collector shall ask the donor (10) Samples suspected of not being to remove any unnecessary outer to remove any unnecessary outer valid sweat patch samples must be garments such as a coat or jacket that garments such as a coat or jacket that forwarded to an HHS-certified might conceal items or substances that might conceal items or substances that laboratory or IITF for testing with any could be used to adulterate or substitute could be used to tamper with or unusual findings noted on the Federal the urine specimen. The collector must adulterate the sweat patch. The collector CCF. ensure that all personal belongings such must ensure that all personal belongings (11) The collector must place the as a purse or briefcase remain with the such as a purse or briefcase remain with sweat patches in appropriate containers outer garments. The donor may retain the outer garments. The donor may and secure them with tamper-evident his or her wallet. The collector directs retain his or her wallet. The collector labels/seals. The collector must record the donor to empty his or her pockets directs the donor to empty his or her the date of the collection on the tamper- and display the items to ensure that no pockets and display the items to ensure evident labels/seals. items are present that could be used to that no items are present that could be (12) The donor must initial the adulterate or substitute the specimen. If used to adulterate the sweat patch. If tamper-evident labels/seals. nothing is there that can be used to nothing is there that can be used to (13) The donor must be asked to read adulterate or substitute a specimen, the adulterate the sweat patch, the donor and sign a statement on the Federal CCF donor places the items back into the places the items back into the pockets certifying that the sweat patch identified pockets and the collection procedure and the collection procedure continues. as having been collected from him or continues. If the donor refuses to show If the donor refuses to show the her. the collector the items in his or her collector the items in his or her pockets, (14) The collector must sign the pockets, this is considered a ‘‘refusal to this is considered a ‘‘refusal to test.’’ If Federal CCF. test.’’ If an item is found that appears to an item appears to be inadvertently (15) The split sweat patch samples have been brought to the collection site brought to the collection site, the and Federal CCF are now ready for with the intent to adulterate or collector must secure the item and transfer to an HHS-certified laboratory substitute the specimen, a direct continue with the normal collection or IITF. observation collection procedure is procedure. (16) The collector must send the split used. If the item appears to be (4) The collector will show the donor specimens at the same time to an HHS- inadvertently brought to the collection two clean sealed sweat patches. certified laboratory or IITF. site, the collector must secure the item (5) The collector asks the donor to (b) If the specimen and Federal CCF and continue with the normal collection thoroughly clean the skin area with soap are not immediately prepared for procedure. and cool water or with a disposable transfer to the laboratory or IITF, they (5) The donor shall be instructed to towelette and then the collector must must be appropriately safeguarded until wash and dry his or her hands prior to thoroughly clean the skin area with the specimen and Federal CCF are urination. alcohol wipes where the sweat patches prepared for transfer to the laboratory or (6) After washing hands, the donor will be worn prior to application. IITF. must remain in the presence of the (6) The collector will place the two collector and must not have access to sweat patches on the upper arm Section 8.5 What Procedure Is Used To any water fountain, faucet, soap (preferable location) or the back. Collect a Urine Specimen? dispenser, cleaning agent, or any other (7) The donor must wear the sweat (a) The collector must use the materials which could be used to patches for no less than three and no following procedure to collect a urine adulterate the specimen. more than seven days before returning specimen: (7) The collector will provide the to the collection site. A unique number (1) To deter the dilution of a specimen donor a clean specimen collection is imprinted on each patch to aid with at the collection site, a toilet bluing container. The donor may provide his/ chain-of-custody identification. On rare agent shall be placed in a toilet tank her specimen in the privacy of a stall or occasions, the sweat patch can produce wherever possible, so the reservoir of otherwise partitioned area that allows an allergic reaction similar to that for water in the toilet bowl always remains for individual privacy. other adhesive bandage products. When blue. There must be no other source of (8) The collector shall note any this occurs, the donor shall return to the water (e.g., no shower or sink) in the unusual behavior or appearance on the collection site and the collector must enclosure where urination occurs. Federal CCF. remove the sweat patch and then (2) When a donor arrives at the (9) In the exceptional event that an request permission from the Federal collection site, the collector shall agency-designated collection site is not agency to collect another type of request the donor to present photo accessible and there is an immediate specimen. The sweat patch procedure is identification. If the donor does not requirement for specimen collection cancelled by the collector and notifies have proper photo identification, the (e.g., an accident investigation), a public the medical review officer and the collector shall contact the supervisor of rest room may be used according to the Federal agency. the donor, the coordinator of the drug following procedures: A person of the (8) After the sweat patches (Sample A testing program, or any other agency same gender as the donor shall and Sample B) are worn for the proper official who can positively identify the accompany the donor into the public time, the donor returns to the collection donor. If the donor’s identity cannot be rest room which must be made secure site. The collector removes the two established, the collector must not during the collection procedure. If sweat patches from the donor within proceed with the collection. possible, a bluing agent shall be placed several minutes. (3) If the donor fails to arrive at the in the bowl and any accessible toilet (9) Immediately before and after the assigned time or if the donor fails to tank. The collector shall remain in the sweat patches are removed, the collector remain present through the completion rest room, but outside the stall, until the must inspect the two sweat patches to of the collection, the collector must specimen is collected. If no bluing agent determine if there are any signs contact the appropriate authority to is available to deter specimen dilution,

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the collector shall instruct the donor not (15) A specimen suspected of not transfer to a POCT tester (if a POCT is to flush the toilet until the specimen is being a valid urine specimen must be being conducted). delivered to the collector. After the forwarded to an HHS-certified (27) The collector must send the split collector has possession of the laboratory for testing. specimens (Bottle A and Bottle B) at the specimen, the donor will be instructed (16) When there is any reason to same time to an HHS-certified to flush the toilet and to participate with believe that a donor may have laboratory or IITF or transfer to a POCT the collector in completing the chain of adulterated or substituted the specimen, tester (if a POCT is being conducted). custody procedures. another specimen must be obtained as (b) If the split specimen bottles and (10) Upon receiving the specimen soon as possible under the direct Federal CCF are not immediately from the donor, the collector must observation of a person of the same prepared for transfer to an HHS-certified determine the volume of urine in the gender and both specimens (i.e., from laboratory or IITF or transferred to a specimen container. the first and second collections) shall be POCT tester, they must be appropriately (i) If the volume is at least 45 mL, the forwarded to an HHS-certified safeguarded until the split specimen collector will proceed with step (11) laboratory for testing. The agency shall bottles and Federal CCF are prepared for below. select the observer if there is no (ii) If the volume is less than 45 mL transfer to an HHS-certified laboratory collector of the same gender available. or IITF. and the temperature is within the (17) Both the donor and the collector acceptable range specified in step (13) must keep the specimen container in Section 8.6 What Are the below, the specimen is discarded and a view at all times. The collector shall Responsibilities of a Federal Agency second specimen must be collected. The request the donor to observe the transfer That Uses a Collection Site? donor may be given a reasonable of the specimen from the collection (a) A Federal agency must ensure that amount of liquid to drink for this container to the two specimen bottles purpose (e.g., an 8 ounce glass of water collectors and collection sites satisfy all and the placement of the tamper-evident requirements in subparts D, E, F, G, and every 30 minutes, but not to exceed a labels/seals on the bottles. maximum of 24 ounces). If the donor H when collecting agency specimens. (18) The collector, in the presence of fails for any reason to provide 30 mL of (b) A Federal agency (or only one the donor, pours the urine into two urine for the second specimen collected, Federal agency when several agencies specimen bottles that are labeled Bottle the collector must contact the are using the same collection site) must A and Bottle B, 30 mL for Bottle A and appropriate authority to obtain guidance conduct an annual inspection of each 15 mL for Bottle B. on the action to be taken. collection site used to collect agency (iii) If the volume is less than 45 mL (19) The Bottle A specimen, specimens. Additionally, a Federal and the temperature is outside the containing a minimum of 30 mL of agency must respond to reports of acceptable range specified in step (13) urine, is to be used for the drug test. If collector and collection site deficiencies below, a second specimen must be there is no additional urine available for reported to them and must take collected using the procedure specified the second specimen bottle (Bottle B), appropriate action to preclude the in step (13) below. the first specimen bottle (Bottle A) shall recurrence of such deficiencies. (11) After the donor has given the nevertheless be processed for testing. Subpart I—HHS Certification of specimen to the collector, the donor (20) A minimum of 15 mL of urine Laboratories and IITFs shall be allowed to wash his or her shall be poured into the second hands. specimen bottle (Bottle B). Section 9.1 What Are the Goals and (12) Immediately after the specimen is (21) The collector must place the Objectives of HHS-Certification? collected, the collector must measure tamper-evident labels/seals on the the temperature of the specimen. The specimen bottles. The collector must (a) Drug testing is an important tool to temperature measuring device used record the date of the collection on the identify drug users in a variety of must accurately reflect the temperature tamper-evident labels/seals. settings. In the proper context, drug of the specimen and not contaminate (22) The donor must initial the testing can be used to deter drug abuse the specimen. The time from urination tamper-evident labels/seals on the split in general. To be a useful tool, all testing ‘‘ to temperature measurement is critical specimen bottles. must satisfy good forensic laboratory and in no case shall exceed 4 minutes. (23) The collector asks the donor to practices’’ and the testing procedures (13) If the temperature of the read and sign a statement on the Federal must be capable of detecting drugs or specimen is outside the range of 32°¥38 CCF certifying that the specimen metabolites at established cutoff °C/90°¥100 °F, that is a reason to identified was collected from him or concentrations. believe that the donor may have her. (b) Reliable discrimination between adulterated or substituted the specimen; (24) Based on a reason to believe that the presence, or absence, of specific another specimen must be collected the donor may adulterate or substitute drugs or their metabolites is critical, not under direct observation of a person of the specimen to be provided, a higher only to achieve the goals of the testing the same gender and both specimens level supervisor must review and program but to protect the rights of the (i.e., from the first and second concur in advance with any decision by Federal employees being tested. Thus, collections) must be forwarded to the a collector to obtain a specimen under standards have been set in order to laboratory for testing. The agency shall direct observation. The person directly achieve maximum accuracy of test select the observer if there is no observing the specimen collection must results. collector of the same gender available. be of the same gender. The agency shall (c) Because of the possible impact of (14) Immediately after the specimen is select the observer if there is no a positive test result on an individual’s collected, the collector shall also inspect collector of the same gender available. livelihood or rights, extra care is the specimen to determine if this is any (25) The collector must sign the required in the handling of the sign indicating that the specimen may Federal CCF. specimen and all other aspects of the not be a valid urine specimen. Any (26) The split specimens and Federal testing procedure. Thus, the testing unusual finding shall be noted on the CCF are now ready for transfer to an procedure must be carefully Federal CCF. HHS-certified laboratory or IITF or documented.

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Section 9.2 Who Has the Authority To (h) Successfully participate in both (4) The concentration of drug or Certify Laboratories and IITFs That the maintenance PT and inspection metabolite is at another concentration Want To Test Specimens for Federal programs (i.e., successfully test the for a special purpose; Agencies? required quarterly sets of maintenance (5) A negative sample will not contain (a) The Secretary has broad discretion PT samples, undergo an inspection 3 a measurable amount of a drug or to take appropriate action to ensure the months after being certified, and metabolite; or full reliability and accuracy of drug undergo maintenance inspections every (6) A PT sample may contain an testing and reporting, to resolve 6 months thereafter); interfering substance or an adulterant or problems related to drug testing, and to (i) Respond in an appropriate, timely, satisfy the criteria for a substituted enforce all standards set forth in these and complete manner to required specimen (as appropriate). Guidelines. The Secretary has the corrective action in the event of failure (b) For each PT cycle, the set of PT authority to issue directives to any in either the maintenance PT or samples going to each laboratory or IITF laboratory or IITF suspending the use of inspection program for which will vary but, within each calendar year, certain analytical procedures when suspension and/or revocation are each laboratory or IITF will analyze necessary to protect the integrity of the proposed by the Secretary; essentially the same total set of samples. testing process; ordering any laboratory (j) Satisfactorily complete a special (c) The laboratory or IITF must, to the or IITF to undertake corrective actions inspection and corrective remedial greatest extent possible, handle, test, to respond to material deficiencies action to maintain or restore and report a PT sample in a manner identified by an inspection or through certification when material deficiencies identical to that used for a donor performance testing; ordering any occur in either the PT program, specimen, unless otherwise specified. inspection program, or in operations laboratory or IITF to send specimens or Section 9.6 What Are the PT and reporting; specimen aliquots to another laboratory Requirements for an Applicant (k) Stop testing Federal agency for retesting when necessary to ensure Laboratory To Conduct Hair Testing? the accuracy of testing under these specimens should PT, maintenance Guidelines; ordering the review of inspection, special inspection, or other (a) An applicant laboratory that seeks results for specimens tested under the material deficiencies indicate that there certification to conduct hair testing Guidelines for private sector clients to is an imminent harm to the government must satisfy the following criteria on 3 the extent necessary to ensure the full and its employees requiring that consecutive sets of PT samples: reliability of drug testing for Federal immediate suspension and revocation (1) Have no false positive results; agencies; and ordering any other action procedures be imposed by the Secretary; (2) Correctly identify and confirm at necessary to address deficiencies in and least 90 percent of the total drug drug testing, analysis, specimen (l) Follow the HHS procedures in challenges on the 3 sets of PT samples; (3) Correctly determine the collection, chain of custody, reporting of subpart Q that will be used for all quantitative values for at least 80 results, or any other aspect of the actions associated with the suspension and/or revocation of HHS-certification percent of the total drug challenges to be certification program. ± ± (b) A laboratory or IITF is prohibited for each type of specimen and type of within 20 percent or 2 standard from stating or implying that it is certification held. deviations of the calculated reference certified by HHS under these Guidelines group mean; Section 9.4 How Does a Laboratory or (4) Have no quantitative value on a to test a particular specimen unless it IITF Apply To Become HHS-Certified? holds such certification for each type of drug concentration that differs by more specimen it wants to test for Federal (a) A laboratory or IITF interested in than 50 percent from the calculated agencies. becoming HHS-certified must submit an reference group mean; and OMB-approved application form. (5) For an individual drug, must Section 9.3 What Is the Process for a (b) The application form requires the correctly detect and quantify at least 50 Laboratory or IITF To Become HHS- applicant laboratory or IITF to provide percent of the total drug challenges. Certified and To Maintain That detailed information on both the (6) Must not obtain any quantitative Certification? administrative and analytical value on a validity test sample that ± A laboratory or IITF that wants to procedures the laboratory or IITF differs by more than 50 percent from become an HHS-certified laboratory or proposes to use for testing Federal the calculated reference group means; IITF must: agency specimens after it is certified. (7) For qualitative validity test samples, must correctly report at least (a) Read and understand these Section 9.5 What Are the Qualitative Guidelines; 80 percent of the challenges for each and Quantitative Specifications of a qualitative validity test sample over the (b) Request an OMB-approved Performance Test (PT) Sample? application; 3 sets of PT samples; and (c) Submit a completed application (a) A PT sample must satisfy one of (8) Must not report any sample as for each type of specimen and type of the following criteria: adulterated with a compound that is not certification applied for; (1) Contains one or more of the drugs present in the sample. (d) Have its application reviewed as and metabolites in the drug classes (b) Failure to achieve any one of the complete and accepted by HHS; listed in sections 3.4, 3.5, 3.6, and 3.7. requirements will result in (e) Successfully complete the PT (2) The concentration of a drug or disqualification. challenges in 3 consecutive sets of metabolite is at least 20 percent above Section 9.7 What Are the PT initial PT samples as required for each the cutoff concentration for either the Requirements for an Applicant type of specimen for which certification initial drug test or the confirmatory drug Laboratory To Conduct Oral Fluid is applied for; test depending on which is to be (f) Satisfy all the requirements for an evaluated; Testing? initial inspection; (3) The concentration of a drug or (a) An applicant laboratory that seeks (g) Receive a letter of certification metabolite is as low as 40 percent of the certification to conduct oral fluid testing from the Secretary before being able to cutoff concentration when the PT must satisfy the following criteria on 3 test specimens for Federal agencies; sample is designated as a retest sample; consecutive sets of PT samples:

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(1) Have no false positive results; (8) Must not report any sample as on pH when the calculated group (2) Correctly identify and confirm at adulterated with a compound that is not reference mean is within the acceptable least 90 percent of the total drug present in the sample. pH range, or substituted when the challenges on the 3 sets of PT samples; (b) Failure to achieve any one of the calculated group means for both (3) Correctly determine the requirements will result in creatinine and specific gravity are quantitative values for at least 80 disqualification. within the acceptable range. percent of the total drug challenges to be (b) Failure to achieve any one of the ± ± Section 9.9 What Are the PT within 20 percent or 2 standard Requirements for an Applicant requirements will result in deviations of the calculated reference Laboratory To Conduct Urine Testing? disqualification. group mean; Section 9.10 What Are the PT (4) Have no quantitative value on a (a) An applicant laboratory that seeks Requirements for an HHS-Certified drug concentration that differs by more certification to conduct urine testing Laboratory To Conduct Hair Testing? than 50 percent from the calculated must satisfy the following criteria on 3 reference group mean; consecutive sets of PT samples: (a) A laboratory certified to conduct (5) For an individual drug, correctly (1) Have no false positive results; hair testing must satisfy the following detect and quantify at least 50 percent (2) Correctly identify and confirm at criteria on the maintenance PT samples of the total drug challenges; least 90 percent of the total drug to maintain its certification: (6) Must not obtain any quantitative challenges on the 3 sets of PT samples; (1) Have no false positive results; (3) Correctly determine the value on a validity test sample that (2) Correctly identify and confirm at quantitative values for at least 80 differs by more than ±50 percent from least 90 percent of the total drug percent of the total drug challenges to be the calculated reference group means; challenges over 2 consecutive PT cycles; within ±20 percent or ±2 standard (7) For qualitative validity test (3) Correctly quantify at least 80 deviations of the calculated reference samples, must correctly report at least percent of the total drug challenges group mean; 80 percent of the challenges for each within ±20 percent or ±2 standard (4) Have no quantitative value on a qualitative validity test sample over the deviations of the appropriate reference drug concentration that differs by more 3 sets of PT samples; and or peer group mean (whichever range is than 50 percent from the calculated (8) Must not report any sample as larger) over 2 consecutive PT cycles; reference group mean; (4) Have no more than one adulterated with a compound that is not (5) For an individual drug, correctly quantitative result that differs by more present in the sample. detect and quantify at least 50 percent than 50 percent from the target value (b) Failure to achieve any one of the of the total drug challenges; requirements will result in (6) Must correctly identify and report over 2 consecutive PT cycles; disqualification. at least 80 percent of the total validity (5) For any individual drug, correctly testing challenges over the 3 sets of PT detect and quantify at least 50 percent Section 9.8 What are the PT of the total drug challenges; Requirements for an Applicant samples; (6) Must not report any validity test Laboratory To Conduct Sweat Patch (7) For each specific validity test, sample as adulterated (that is not Testing? must correctly report at least 80 percent of the challenges for the specific validity adulterated); (a) An applicant laboratory that seeks test over the 3 sets of PT samples; (7) Correctly identify and confirm at certification to conduct sweat patch (8) For quantitative specimen validity least 80 percent of the total validity test testing must satisfy the following tests, must obtain quantitative values for challenges over 2 consecutive PT cycles; criteria on 3 consecutive sets of initial at least 80 percent of the total challenges (8) For quantitative validity tests, PT samples: that satisfy the following criteria: must obtain quantitative values for at (1) Have no false positive results; (i) Nitrite and creatinine least 80 percent of the total challenges; (2) Correctly identify and confirm at concentrations are within ±20 percent or (9) Have no more than one least 90 percent of the total drug ±2 standard deviations of the calculated quantitative value on a validity test challenges on the 3 sets of PT samples; reference group mean; sample that differs by more than ±50 (3) Correctly determine the (ii) pH values are within ±0.3 pH percent from the calculated reference quantitative values for at least 80 units of the calculated reference group group means; and percent of the total drug challenges to be mean; and (10) For each qualitative specimen within ±20 percent or ±2 standard (iii) Specific gravity values are within validity test, must correctly report at deviations of the calculated reference ±0.0003 specific gravity units of the least 80 percent of the challenges for group mean; calculated reference group mean; each qualitative specimen validity test (4) Have no quantitative value on a (9) Must not obtain any quantitative over 2 consecutive PT cycles. drug concentration that differs by more value on a specimen validity testing (b) Failure to participate in a PT cycle than 50 percent from the calculated sample that differs by more than ±50 or to participate satisfactorily may result reference group mean; and percent for nitrite and creatinine in suspension or revocation of an HHS- (5) For an individual drug, correctly concentrations, ±0.8 units for pH certified laboratory’s certification for detect and quantify at least 50 percent measurements, or ±0.0006 units for hair testing. of the total drug challenges. specific gravity from the calculated Section 9.11 What Are the PT (6) Must not obtain any quantitative reference group means; Requirements for an HHS-Certified value on a validity test sample that (10) For qualitative specimen validity Laboratory To Conduct Oral Fluid differs by more than ±50 percent from tests, must correctly report at least 80 Testing? the calculated reference group means; percent of the challenges for each (7) For qualitative validity test qualitative specimen validity test over (a) A laboratory certified to conduct samples, must correctly report at least the 3 sets of PT samples; and oral fluid testing must satisfy the 80 percent of the challenges for each (11) Must not report any sample as following criteria on the maintenance qualitative validity test sample over the adulterated with a compound that is not PT samples to maintain its certification: 3 sets of PT samples; and present in the sample, adulterated based (1) Have no false positive results;

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(2) Correctly identify and confirm at (7) Correctly identify and confirm at sample that differs by more than ±50 least 90 percent of the total drug least 80 percent of the total validity test percent for nitrite and creatinine challenges over 2 consecutive PT cycles; challenges over 2 consecutive PT cycles; concentrations, ±0.8 unit for pH (3) Correctly quantify at least 80 (8) For quantitative validity tests, measurements, or ±0.0006 units for percent of the total drug challenges must obtain quantitative values for at specific gravity from the calculated within ±20 percent or ±2 standard least 80 percent of the total challenges; reference group means; and deviations of the appropriate reference (9) Have no more than one (10) For each qualitative specimen or peer group mean (whichever range is quantitative value on a validity test validity test, must correctly report at larger) over 2 consecutive PT cycles; sample that differs by more than ±50 least 80 percent of the challenges for (4) Have no more than one percent from the calculated reference each qualitative validity test over 2 quantitative result that differs by more group means; and consecutive PT cycles. than 50 percent from the target value (10) For each qualitative specimen (b) Failure to participate in a PT cycle over 2 consecutive PT cycles; validity test, must correctly report at or to participate satisfactorily may result (5) For any individual drug, correctly least 80 percent of the challenges for in suspension or revocation of an HHS- detect and quantify at least 50 percent each qualitative specimen validity test certified laboratory’s certification for of the total drug challenges; over 2 consecutive PT cycles. urine testing. (6) Must not report any validity test (b) Failure to participate in a PT cycle sample as adulterated (that is not or to participate satisfactorily may result Section 9.14 What Are the PT adulterated); in suspension or revocation of an HHS- Requirements for an Applicant IITF To (7) Correctly identify and confirm at certified laboratory’s certification for Conduct Hair Testing? least 80 percent of the total validity test sweat patch testing. (a) An applicant IITF that seeks challenges over 2 consecutive PT cycles; Section 9.13 What Are the PT certification to conduct hair testing (8) For quantitative validity tests, Requirements for an HHS-Certified must satisfy the following criteria on 3 must obtain quantitative values for at Laboratory To Conduct Urine Testing? consecutive sets of PT samples: least 80 percent of the total challenges; (1) Correctly identify and report at (9) Have no more than one (a) A laboratory certified to conduct least 80 percent of the total drug quantitative value on a validity test urine testing must satisfy the following challenges using its initial drug tests sample that differs by more than ±50 criteria on the maintenance PT samples over 3 sets of PT samples; percent from the calculated reference to maintain its certification: (2) Correctly identify and report at (1) Have no false positive results; least 80 percent of the total validity test group means; and (2) Correctly identify and confirm at (10) For each qualitative specimen challenges using its initial validity tests least 90 percent of the total drug validity test, must correctly report at challenges over 2 consecutive PT cycles; over 3 sets of PT samples; least 80 percent of the challenges for (3) Correctly quantify at least 80 (3) For each specific drug test, must each qualitative specimen validity test percent of the total drug challenges correctly identify and report at least 50 over 2 consecutive PT cycles. within ±20 percent or ±2 standard percent of the drug challenges for a (b) Failure to participate in a PT cycle deviations of the appropriate reference specific drug test over 3 sets of PT or to participate satisfactorily may result or peer group mean (whichever range is samples; and in suspension or revocation of an HHS- larger) as measured over 2 consecutive (4) For each specific validity test, certified laboratory’s certification for PT cycles; must correctly identify and report at oral fluid testing. (4) Have no more than one least 50 percent of the challenges for a specific validity test over 3 sets of PT Section 9.12 What Are the PT quantitative result that differs by more samples. Requirements for an HHS-Certified than 50 percent from the target value over 2 consecutive PT cycles; (b) Failure to achieve any one of the Laboratory To Conduct Sweat Patch requirements will result in Testing? (5) For any individual drug, correctly detect and quantify at least 50 percent disqualification. (a) A laboratory certified to conduct of the total drug challenges; Section 9.15 What Are the PT sweat patch testing must satisfy the (6) Must not report any validity test following criteria on the maintenance Requirements for an Applicant IITF To sample as adulterated (that is not Conduct Oral Fluid Testing? PT samples to maintain its certification: adulterated) or substituted (that is not (1) Have no false positive results; substituted); (a) An applicant IITF that seeks (2) Correctly identify and confirm at (7) Correctly identify and confirm at certification to conduct oral fluid testing least 90 percent of the total drug least 80 percent of the total validity test must satisfy the following criteria on 3 challenges over 2 consecutive PT cycles; challenges over 2 consecutive PT cycles; consecutive sets of PT samples: (3) Correctly quantify at least 80 (8) For quantitative specimen validity (1) Correctly identify and report at percent of the total drug challenges tests, must obtain quantitative values for least 80 percent of the total drug within ±20 percent or ±2 standard at least 80 percent of the total challenges challenges using its initial drug tests deviations of the appropriate reference that satisfy the following criteria: over 3 sets of PT samples; or peer group mean (whichever range is (i) Nitrite and creatinine (2) Correctly identify and report at larger) over 2 consecutive PT cycles; concentrations are within ±20 percent or least 80 percent of the total validity test (4) Have no more than one ±2 standard deviations of the calculated challenges using its initial validity tests quantitative result that differs by more reference group mean; over 3 sets of PT samples; than 50 percent from the target value (ii) pH values are within ±0.3 pH (3) For each specific drug test, must over 2 consecutive PT cycles; units of the calculated reference group correctly identify and report at least 50 (5) For any individual drug, correctly mean; and percent of the drug challenges for a detect and quantify at least 50 percent (iii) Specific gravity values are within specific initial drug test over 3 sets of of the total drug challenges; ±0.0003 specific gravity units of the PT samples; and (6) Must not report any validity test calculated reference group mean; (4) For each specific validity test, sample as adulterated (that is not (9) No more than one quantitative must correctly identify and report at adulterated); value on a specimen validity testing least 50 percent of the challenges for a

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specific initial validity test over 3 sets (ii) pH values are within ±0.3 pH (3) For each specific drug test, must of PT samples. units of the calculated reference group correctly identify and report at least 50 (b) Failure to achieve any one of the mean; and percent of the drug challenges for a requirements will result in (iii) Specific gravity values are within specific initial drug test over 2 disqualification. ±0.0003 specific gravity units of the consecutive PT cycles; and Section 9.16 What Are the PT calculated reference group mean; (4) For each specific validity test, (6) Must not obtain any quantitative Requirements for an Applicant IITF To must correctly identify and report at value on an initial validity test sample Conduct Sweat Patch Testing? least 50 percent of the challenges for a that differs by more than ±50 percent for specific initial validity test over 2 (a) An applicant IITF that seeks nitrite and creatinine concentrations, consecutive PT cycles. certification to conduct sweat patch ±0.8 units for pH measurements, or (b) Failure to satisfy the standards testing must satisfy the following ±0.0006 units for specific gravity from may result in suspension or proposed criteria on 3 consecutive sets of PT the calculated reference group means; revocation of an HHS-certified IITF’s samples: and certification for oral fluid testing. (1) Correctly identify and report at (7) For qualitative initial validity Section 9.20 What Are the PT least 80 percent of the total drug tests, must correctly identify and report Requirements for an HHS-Certified IITF challenges using its initial drug tests at least 80 percent of the challenges for To Conduct Sweat Patch Testing? over 3 sets of PT samples; each qualitative initial validity test over (2) Correctly identify and report at 3 sets of PT samples. (a) An HHS-certified IITF must satisfy least 80 percent of the total validity test (b) Failure to achieve any one of the the following criteria on the challenges using its initial validity tests requirements will result in maintenance PT samples to maintain its over 3 sets of PT samples; disqualification. certification to conduct sweat patch (3) For each specific drug test, must testing: correctly identify and report at least 50 Section 9.18 What Are the PT (1) Correctly identify and report at percent of the drug challenges for a Requirements for an HHS-Certified IITF least 80 percent of the total initial drug specific initial drug test over 3 sets of To Conduct Hair Testing? test challenges as measured over 2 PT samples; and (a) An HHS-certified IITF must satisfy consecutive PT cycles; (4) For each specific validity test, the following criteria on the (2) Correctly identify and report at must correctly identify and report at maintenance PT samples to maintain its least 80 percent of the initial validity least 50 percent of the challenges for a certification to conduct hair testing: test challenges over 2 consecutive PT specific initial validity test over 3 sets (1) Correctly identify and report at cycles; of PT samples. least 80 percent of the total initial drug (3) For each specific drug test, must (b) Failure to achieve any one of the test challenges as measured over 2 correctly identify and report at least 50 requirements will result in consecutive PT cycles; percent of the drug challenges for a disqualification. (2) Correctly identify and report at specific initial drug test over 2 Section 9.17 What Are the PT least 80 percent of the initial validity consecutive PT cycles; and Requirements for an Applicant IITF To test challenges over 2 consecutive PT (4) For each specific validity test, Conduct Urine Testing? cycles; must correctly identify and report at (a) An applicant IITF that seeks (3) For each specific drug test, must least 50 percent of the challenges for a certification to conduct urine testing correctly identify and report at least 50 specific initial validity test over 2 must satisfy the following criteria on 3 percent of the drug challenges for a consecutive PT cycles. consecutive sets of PT samples: specific initial drug test over 2 (b) Failure to satisfy the standards (1) Correctly identify and report at consecutive PT cycles; and may result in suspension or proposed least 80 percent of the total drug (4) For each specific validity test, revocation of an HHS-certified IITF’s challenges using its initial drug tests must correctly identify and report at certification for sweat patch testing. least 50 percent of the challenges for a over 3 sets of PT samples; Section 9.21 What Are the PT specific initial validity test over 2 (2) Correctly identify and report at Requirements for an HHS-Certified IITF consecutive PT cycles. least 80 percent of the total validity test to Conduct Urine Testing? challenges using its initial validity tests (b) Failure to satisfy the standards over 3 sets of PT samples; may result in suspension or proposed (a) An HHS-certified IITF must satisfy (3) For each specific drug test, must revocation of an HHS-certified IITF’s the following criteria on the correctly identify and report at least 50 certification for hair testing. maintenance PT samples to maintain its certification to conduct urine testing: percent of the drug challenges for a Section 9.19 What Are the PT specific initial drug test over 3 sets of (1) Correctly identify and report at Requirements for an HHS-Certified IITF least 80 percent of the total initial drug PT samples; To Conduct Oral Fluid Testing? (4) For each specific validity test, test challenges as measured over 2 must correctly identify and report at (a) An HHS-certified IITF must satisfy consecutive PT cycles; least 50 percent of the challenges for a the following criteria on the (2) Correctly identify and report at specific initial validity test over 3 sets maintenance PT samples to maintain its least 80 percent of the initial validity of PT samples; certification to conduct oral fluid test challenges over 2 consecutive PT (5) For quantitative specimen validity testing: cycles; tests, must obtain quantitative values for (1) Correctly identify and report at (3) For each specific drug test, must at least 80 percent of the total initial least 80 percent of the total initial drug correctly identify and report at least 50 validity test challenges that satisfy the test challenges as measured over 2 percent of the drug challenges for a following criteria: consecutive PT cycles; specific initial drug test over 2 (i) Nitrite and creatinine (2) Correctly identify and report at consecutive PT cycles; concentrations are within ±20 percent or least 80 percent of the initial validity (4) For each specific validity test, ±2 standard deviations of the calculated test challenges over 2 consecutive PT must correctly identify and report at reference group mean; cycles; least 50 percent of the challenges for a

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specific initial validity test over 2 Section 9.23 What Are the Section 9.26 What Happens if an HHS- consecutive PT cycles; Maintenance Inspection Requirements Certified Laboratory or IITF Does Not (5) For quantitative validity tests, for an HHS-Certified Laboratory or IITF? Satisfy the Minimum Requirements for Either the PT Program or the Inspection must obtain quantitative values for at (a) An HHS-certified laboratory or Program? least 80 percent of the total initial IITF must undergo an inspection 3 validity test challenges that satisfy the months after becoming certified and (a) If an HHS-certified laboratory or following criteria: then an inspection every 6 months IITF fails to satisfy the minimum (i) Nitrite and creatinine thereafter. requirements for certification, the concentrations are within ±20 percent or (b) An HHS-certified laboratory or laboratory or IITF is given a period of ±2 standard deviations of the calculated IITF is inspected by one or more time (e.g., 5 or 30 working days reference group mean; inspectors. The number of inspectors depending on the nature of the issue) to (ii) pH values are within ±0.3 pH required is dependent on the workload provide any explanation for its units of the calculated reference group of the laboratory or IITF. performance and evidence that any mean; and (c) Each inspector conducts an deficiency has been corrected. (iii) Specific gravity values are within independent evaluation and review of (b) A laboratory’s or IITF’s ±0.0003 specific gravity units of the the HHS-certified laboratory’s or IITF’s certification may be revoked, calculated reference group mean; procedures for each type of specimen suspended, or no further action taken (6) Must not obtain any quantitative and facilities using guidance provided depending on the seriousness of the value on an initial validity test sample by the Secretary. errors and whether there is evidence that differs by more than ±50 percent for (d) To remain certified, an HHS- that any deficiency has been corrected nitrite and creatinine concentrations, certified laboratory or IITF must and that current performance meets the ±0.8 units for pH measurements, or continue to satisfy the minimum requirements for a certified laboratory or ±0.0006 units for specific gravity from requirements as stated in these IITF. the calculated reference group means; Guidelines for that type of specimen. (c) An HHS-certified laboratory or and IITF may be required to undergo a Section 9.24 Who Can Inspect an special inspection or to test additional (7) For qualitative validity tests, must HHS-Certified Laboratory or IITF and PT samples, depending on the nature of correctly identify and report at least 80 When May the Inspection Be the performance, to verify that any percent of the challenges for each Conducted? deficiency has been corrected. qualitative initial validity test over 2 consecutive PT cycles. (a) The Secretary or a Federal agency (d) If an HHS-certified laboratory’s or may conduct an inspection at any time. IITF’s certification is revoked or (b) Failure to satisfy the standards (b) An individual may serve as an suspended in accordance with the may result in suspension or proposed inspector for the Secretary if he or she process described in subpart Q, the revocation of an HHS-certified IITF’s satisfies the following criteria: laboratory or IITF is not permitted to certification for urine testing. (1) Has experience and an educational test specimens for Federal agencies until Section 9.22 What Are the Inspection background similar to that required for the suspension is lifted or the laboratory Requirements for an Applicant either the responsible person or the or IITF has successfully completed the Laboratory or IITF? certifying scientist as described in certification requirements as a new subpart K for a laboratory or as a applicant laboratory or IITF. (a) An applicant laboratory or IITF is responsible technician as described in inspected by a team of at least two Section 9.27 What Factors Are subpart M; inspectors. Considered in Determining Whether (2) Has read and thoroughly (b) Each inspector conducts an Revocation of a Laboratory’s or IITF’s understands the policies and Certification Is Necessary? independent review and evaluation of requirements contained in these all aspects of the laboratory’s or IITF’s Guidelines and in other guidance (a) The Secretary shall revoke testing procedures and facilities using consistent with these Guidelines certification of any laboratory or IITF an inspection checklist. provided by the Secretary; certified in accordance with these (c) To become certified, an applicant (3) Submits a resume and Guidelines if the Secretary determines laboratory or IITF must satisfy the documentation of qualifications to HHS; that revocation is necessary to ensure minimum requirements as stated in (4) Attends approved training; and the full reliability and accuracy of drug these Guidelines. (5) Submits an acceptable inspection and validity tests and the accurate (d) An applicant laboratory or IITF report and performs acceptably as a reporting of test results. must be separately inspected for each trainee inspector on an inspection. (b) The Secretary shall consider the type of specimen for which it has following factors in determining applied. The inspection for each type of Section 9.25 What Happens if an whether revocation is necessary: specimen may be conducted Applicant Laboratory or IITF Does Not (1) Unsatisfactory performance in concurrently, but the inspectors must Satisfy the Minimum Requirements for analyzing and reporting the results of review all appropriate data in distinct Either the PT Program or the Inspection drug and validity tests; for example, a audits. Program? false positive error in reporting the (e) An applicant laboratory or IITF If an applicant laboratory or IITF fails results of an employee’s drug test; that applies for certification to conduct to satisfy the requirements established (2) Unsatisfactory participation in testing of different types of specimens, for the initial certification process, the performance evaluations or inspections; but does not satisfy the minimum applicant laboratory must start the (3) A material violation of a requirements for each type of specimen, initial certification process from the certification standard or a contract term may be certified for those types of beginning for the type of specimen for or other condition imposed on the specimens for which it has satisfied the which they were applying to become laboratory or IITF by a Federal agency minimum requirements. certified. using the laboratory’s or IITF’s services;

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(4) Conviction for any criminal (c) A suspension must be effective program, the agency must submit at offense committed as an incident to immediately. A proposed revocation least three percent blind samples along operation of the laboratory or IITF; or must be effective 30 days after written with its donor specimens. (5) Any other cause that materially notice is given or, if review is requested, (c) After the initial 90-day period, the affects the ability of the laboratory or upon the reviewing official’s decision to agency must submit one percent blind IITF to ensure the full reliability and uphold the proposed revocation. If the samples along with its donor specimens accuracy of drug and validity tests and reviewing official decides not to uphold based on the projected total number of the accurate reporting of results. the suspension or proposed revocation, specimens that will be collected per (c) The period and terms of revocation the suspension must terminate year. Every effort should be made to shall be determined by the Secretary immediately and any proposed ensure that some of the blind samples and shall depend upon the facts and revocation shall not take effect. are submitted quarterly. circumstances of the revocation and the (d) The Secretary will publish in the (d) Of the blind samples submitted, need to ensure accurate and reliable Federal Register the name, address, and approximately 80 percent of the blind drug and validity testing of Federal telephone number of any laboratory or samples must be negative and 20 employees. IITF that has its certification revoked or percent non-negative. Section 9.28 What Factors Are suspended under section 9.27 or section 9.28, respectively, and the name of any Section 10.2 What Are the Considered in Determining Whether To Requirements for a Blind Sample? Suspend a Laboratory or IITF? laboratory or IITF that has its suspension lifted. The Secretary shall (a) A blind sample that is drug (a) Whenever the Secretary has reason provide to any member of the public positive must be validated by the to believe that revocation may be upon request the written notice supplier as to its content using required and that immediate action is provided to a laboratory or IITF that has appropriate initial and confirmatory necessary in order to protect the its certification suspended or revoked, tests. interests of the United States and its as well as the reviewing official’s (b) A blind sample that is negative employees, the Secretary may written decision which upholds or (i.e., certified to contain no drug) must immediately suspend (either partially or denies the suspension or proposed be validated by the supplier as negative fully) a laboratory’s or IITF’s revocation under the procedures of using appropriate initial and certification to conduct drug and subpart Q. confirmatory tests. validity testing for Federal agencies. (c) The supplier must provide (b) The period and terms of Section 9.30 May a Laboratory or IITF information regarding the shelf life of suspension shall be determined by the That Had Its Certification Revoked Be the blind sample. Secretary and shall depend upon the Recertified To Test Federal Agency (d) For a blind sample that is drug facts and circumstances of the Specimens? positive, the concentration of the drug it suspension and the need to ensure Following revocation, a laboratory or contains should be between 1.5 and 2 accurate and reliable drug and validity IITF may apply for recertification. times the initial drug test cutoff testing of Federal employees. Unless otherwise provided by the concentration and must be spiked or Section 9.29 How Does the Secretary Secretary in the notice of revocation contain one or more of the drugs or Notify a Laboratory or IITF That Action under section 9.29(a) or the reviewing metabolites listed in sections 3.3, 3.4, Is Being Taken Against the Laboratory official’s decision under section 17.9(e) 3.5, and 3.6. or IITF? or 17.14(a), a laboratory or IITF which (e) For hair, oral fluid, sweat patch, has had its certification revoked may (a) When a laboratory or IITF is and urine, a blind sample that is reapply for certification as an applicant adulterated must have the suspended or the Secretary seeks to laboratory or IITF. revoke certification, the Secretary shall characteristics to clearly show that it is immediately serve the laboratory or IITF Section 9.31 Where Is the List of HHS- an adulterated sample at the time it is with written notice of the suspension or Certified Laboratories or IITFs validated by the supplier. proposed revocation by facsimile mail, Published? (f) For oral fluid and urine, a blind personal service, or registered or sample that is substituted must have the (a) The list of HHS-certified characteristics to clearly show that it is certified mail, return receipt requested. laboratories and IITFs and the type of This notice shall state the following: a substituted sample at the time it is specimen for which each is certified is validated by the supplier. (1) The reasons for the suspension or published monthly in the Federal proposed revocation; Register. Section 10.3 How Is a Blind Sample (2) The terms of the suspension or (b) An applicant laboratory or IITF is Submitted to an HHS-Certified proposed revocation; and not included on the list. Laboratory or IITF? (3) The period of suspension or proposed revocation. Subpart J—Blind Samples Submitted by (a) A blind sample is submitted using (b) The written notice shall state that an Agency the same Federal CCF as used for a the laboratory or IITF will be afforded donor specimen. The collector provides an opportunity for an informal review of Section 10.1 What Are the the required information to ensure that the suspension or proposed revocation Requirements for Federal Agencies To the Federal CCF has been properly if it so requests in writing within 30 Submit Blind Samples to HHS-Certified completed as well as providing days of the date the laboratory or IITF Laboratories or IITFs? fictitious initials on the specimen label/ received the notice, or if expedited (a) Each Federal agency is required to seal. The collector must indicate that review is requested, within 3 days of the have both negative and non-negative the sample is a blind sample on the date the laboratory or IITF received the blind samples for each type of donor MRO copy where a donor would notice. Subpart Q contains detailed specimen being submitted to an HHS- normally provide a signature. procedures to be followed for an certified laboratory or IITF. (b) A collector must distribute the informal review of the suspension or (b) During the initial 90-day period of required number of blind samples proposed revocation. a new Federal agency drug testing throughout the total number of donor

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specimens rather than submitting them (8) Reporting procedures; and Section 11.3 What Scientific as a single group of samples. (9) Computers, software, laboratory Qualifications in Analytical Toxicology information management systems. Must the RP Have? Section 10.4 What Happens if an Inconsistent Result Is Reported on a (c) All procedures in the SOP manual The RP must have documented Blind Sample? must be in compliance with these scientific qualifications in analytical Guidelines and other guidance provided toxicology. If an HHS-certified laboratory reports by the Secretary. Minimum qualifications are: an inconsistent result on a blind sample (d) A copy of all procedures that have (a) Be certified as a laboratory director (e.g., a laboratory reports a negative been replaced or revised and the dates by the State in forensic or clinical result on a blind sample that was on which they were in effect must be laboratory toxicology; have a Ph.D. in supposed to be positive, a laboratory maintained for 2 years to allow the one of the natural sciences or have reports a positive result on a blind laboratory to retrieve the procedures training and experience comparable to a sample that was supposed to be that were used to test a specimen. Ph.D. in one of the natural sciences with negative, an IITF reports a negative training and laboratory/research result on a blind sample that was Section 11.2 What Are the experience in biology, chemistry, and supposed to be positive, a laboratory or Responsibilities of the Responsible pharmacology or toxicology; IITF cannot obtain a valid drug test Person (RP)? (b) Have experience in forensic result): (a) Manage the day-to-day operations toxicology with emphasis on the (a) The MRO must contact supplier of of the drug testing laboratory even collection and analysis of biological the blind sample and attempt to where another individual has overall specimens for drugs of abuse; determine if the supplier made a responsibility for an entire multi- (c) Have experience in forensic mistake when preparing the blind specialty laboratory. applications of analytical toxicology sample; (b) Ensure that there are enough (e.g., publications, court testimony, (b) The MRO must contact the personnel with adequate training and conducting research on the toxicology of collector and determine if the collector experience to supervise and conduct the drugs of abuse) or qualify as an expert made an error when preparing the blind work of the drug testing laboratory. The witness in forensic toxicology; and sample for shipment to the laboratory; RP must ensure the continued (d) Be found to fulfill RP (c) If there is no obvious reason for the competency of laboratory personnel by responsibilities and qualifications upon inconsistent result, the MRO must documenting their in-service training, interview by HHS-trained inspectors notify both the Federal agency for which reviewing their work performance, and during each on-site inspection of the the blind sample was submitted and the verifying their skills. laboratory. Secretary; and (c) Maintain a complete, current SOP Section 11.4 What Happens When the (d) The Secretary shall investigate the manual that is available for personnel in RP Is Absent or Leaves an HHS-Certified blind sample error. A report of the the drug testing laboratory, and Laboratory? Secretary’s investigative findings and followed by those personnel. The SOP the corrective action taken by the HHS- (a) All HHS-certified laboratories manual must be reviewed, signed, and must have multiple RPs or an alternate certified laboratory or IITF must be sent dated by the RP(s) whenever procedures to the Federal agency. The Secretary RP. Extremely small certified are first placed into use or changed or laboratories may request a waiver from shall ensure notification of the finding when a new individual assumes to all other Federal agencies for which the Secretary to this requirement under responsibility for management of the special circumstance. An alternate RP the laboratory or IITF is engaged in drug drug testing laboratory. testing and coordinate any necessary must be able to fulfill the (d) Maintain a quality assurance responsibilities of an RP, and must meet action to prevent the recurrence of the program to assure the proper error. the qualifications of a certifying performance and reporting of all test scientist. The laboratory must submit Subpart K—Laboratory results; verify and monitor acceptable documentation satisfactory to the analytical performance for all controls Secretary which shows the credentials Section 11.1 What Is a Standard and standards; monitor quality control Operating Procedure Manual? of the prospective RP and which must testing; document the validity, be approved by the Secretary, and found (a) An HHS-certified laboratory must reliability, accuracy, precision, and acceptable during on-site inspections of have a standard operating procedure performance characteristics of each test the laboratory. (SOP) manual that describes, in detail, and test system. (b) When an HHS-certified laboratory all laboratory operations. When (e) Implement all remedial actions is without the RP and alternate RP for followed, it ensures that all specimens necessary to maintain satisfactory 14 calendar days or less (e.g., vacation, are tested using the same procedures operation and performance of the illness, business trip), the certified and in a consistent manner. laboratory in response to quality control laboratory may continue testing Federal (b) The SOP manual must include, but systems not being within performance agency specimens under the direction of is not limited to, a detailed description specifications, errors in result reporting a certifying scientist. of the following: or in analysis of performance testing (c) When an RP permanently leaves (1) Chain-of-custody procedures; results, and deficiencies identified an HHS-certified laboratory: (2) Accessioning; during inspections. This individual (1) An HHS-certified laboratory may (3) Security; must ensure that sample results are not maintain its certification and continue (4) Quality control/quality assurance reported until all corrective actions have testing Federal agency specimens under programs; been taken and he or she can assure that the direction of an alternate RP for a (5) Analytical methods and the results provided are accurate and period of up to 180 days while seeking procedures; reliable. to hire and receive the Secretary’s (6) Equipment and maintenance (f) Qualify as a certifying scientist for approval of the new permanent RP. programs; positive, adulterated, and substituted (2) The Secretary, in accordance with (7) Personnel training; test results. these Guidelines, will suspend a

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laboratory’s certification for all permitted to work independently with Section 11.11 What Test(s) Does an specimens if the laboratory does not regulated specimens. HHS-Certified Laboratory Conduct on a have a permanent RP within 180 days. Specimen Received From an IITF? Section 11.7 What Security Measures The suspension will be lifted upon the Must an HHS-Certified Laboratory An HHS-certified laboratory conducts Secretary’s approval of the new Maintain? the confirmatory test(s) for the non- permanent RP. (d) When a new RP candidate has (a) An HHS-certified laboratory must negative result(s) identified by the IITF. been identified, the laboratory must control access to the drug testing Section 11.12 What Are the submit to the Secretary the candidate’s facility, specimens, aliquots, and Requirements for an Initial Drug Test? current resume or curriculum vitae, records. (a) An initial drug test must be an arrange to have official academic (b) Authorized visitors must be immunoassay test or a test that transcript(s) submitted by the escorted at all times, except for combines a chromatographic separation candidate’s institution(s) of higher individuals conducting inspections (i.e., coupled with an appropriate detector. learning, copies of diplomas and any for the Department, a Federal agency, a licensures, a training plan (not to exceed state, or other accrediting agency) or (b) A laboratory must validate an 90 days) to transition into the RP emergency personnel (such as, initial drug test before using it to test position, and an itemized defense of the firefighters and medical rescue teams). specimens. candidate’s qualifications compared to (c) A laboratory must maintain a (c) Initial drug test kits must meet the the minimum RP qualifications record that documents the dates, time of FDA requirements for commercial described in the Guidelines. entry and exit, and purpose of entry of distribution. (e) The laboratory must fulfill other authorized escorted visitors accessing (d) A laboratory may conduct a inspection and PT criteria as required secured areas. second initial drug test on a specimen prior to conducting Federal agency prior to the confirmatory drug test. If the testing under a new RP. Section 11.8 What Are the Internal laboratory uses a second initial drug Laboratory Chain of Custody Section 11.5 What Qualifications Must test, the second initial drug test is Requirements for a Specimen or an subject to the same requirements as the an Individual Have To Certify a Result Aliquot? Reported By an HHS-Certified first initial drug test. Laboratory? (a) An HHS-certified laboratory must Section 11.13 What Must an HHS- use chain of custody procedures to (a) The individual (i.e., the certifying Certified Laboratory Do To Validate an maintain control and accountability of Initial Drug Test? scientist) who certifies a non-negative or specimens from receipt through invalid result test result must have: completion of testing, reporting of (a) The laboratory must demonstrate (1) A bachelor’s degree in the results, during storage, and continuing and document for each initial test: chemical or biological sciences, medical until final disposition of the specimens. (1) The ability to differentiate positive technology, or similar field; (b) An HHS-certified laboratory must and negative samples; (2) Training and experience in the use chain of custody procedures to analytical methods and procedures used (2) The performance of the test around document the handling and transfer of by the laboratory that are relevant to the the cutoff concentration; and aliquots throughout the testing process results that the individual certifies; and (3) The performance of the test results and until final disposal. (3) Training and experience in at several concentrations between 0 and reviewing and reporting test results, (c) The date and purpose must be 150 percent of the cutoff concentration. maintenance of chain of custody, and documented on an appropriate chain of (b) Performance of new lots must be understanding proper remedial action in custody document each time a specimen verified prior to being placed into response to problems that may arise. or aliquot is handled or transferred, and service. (b) The individual (i.e., the certifying every individual in the chain must be Section 11.14 What Are the Batch technician) who certifies a negative test identified. Quality Control Requirements When result must have: (d) Chain of custody must be Conducting an Initial Drug Test? (1) Training and experience in the maintained and documented by using analytical methods and procedures used either hard copy procedures or (a) Each batch of specimens must by the laboratory that are relevant to the electronic procedures. contain the following QC samples: results that the individual certifies; and (e) Each individual that handles a (1) At least one control certified to (2) Training and experience in specimen or aliquot must sign and contain no drug or metabolite; reviewing and reporting test results, complete the chain of custody (2) At least one positive control with maintenance of chain of custody, and document when the specimen or aliquot the drug or metabolite targeted at 25 understanding proper remedial action in is received. percent above the cutoff; response to problems that may arise. Section 11.9 Which Type of Specimens (3) At least one control with the drug Section 11.6 What Qualifications and May an HHS-Certified Laboratory Test? or metabolite targeted at 75 percent of Training Must Other Laboratory A laboratory must be HHS-certified the cutoff; and Personnel Have? separately for each type of specimen (4) At least one control that appears (a) All laboratory staff (e.g., that it wants to test for a Federal agency. as a donor specimen to the laboratory technicians, administrative staff) must analysts. Section 11.10 What Test(s) Does an have the appropriate training and skills (b) At least 10 percent of the samples HHS-Certified Laboratory Conduct on a for the tasks assigned. in the batch must be calibrators and Specimen Received After a POCT? (b) Each individual working in an controls. HHS-certified laboratory must be An HHS-certified laboratory must test (c) A laboratory must document that properly trained (i.e., receive training in the specimen in the same manner as a any carryover that may occur between each area of work that the individual specimen that had not been previously aliquots during the initial testing will be performing) before he or she is tested. process is detectable and corrected.

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Section 11.15 What Are the Section 11.19 What Are the Analytical Section 11.23 What Are the Requirements for a Confirmatory Drug and Quality Control Requirements for Requirements for Conducting Each Test? Conducting Validity Tests on Oral Fluid Validity Test on an Oral Fluid (a) The analytical method used must Specimens? Specimen? combine chromatographic separation (a) Each validity test result must be (a) The initial test for a specific and mass spectrometric identification based on performing an initial validity validity test must use a different (e.g., GC/MS, liquid chromatography/ test on one aliquot and a confirmatory analytical principle or chemical reaction mass spectrometry (LC/MS), GC/MS/ than that used for the confirmatory test; validity test on a second aliquot; and MS, LC/MS/MS). (b) Each initial and confirmatory (b) A confirmatory drug test must be (b) Each analytical run of specimens validity test that is quantitative must validated before the laboratory can use for which an initial or confirmatory include an appropriate calibrator, a it to test specimens. validity test is being performed must control without the compound of Section 11.16 What Must an HHS- include the appropriate calibrators and interest (i.e., a certified negative Certified Laboratory Do To Validate a controls. control), and a control with the Confirmatory Drug Test Method? Section 11.20 What Are the Analytical compound of interest at a measurable concentration; and An HHS-certified laboratory must and Quality Control Requirements for (c) Each initial and confirmatory demonstrate and document for each Conducting Validity Tests on Sweat validity test that is qualitative must confirmatory drug test: Patch Samples? (a) The linear range of the analysis; include a control without the compound (b) The limit of detection; (a) Each validity test result must be of interest (i.e., a certified negative (c) The limit of quantitation; based on performing an initial validity control), and a control with the (d) The accuracy and precision at the test on one aliquot and a confirmatory compound of interest at a measurable cutoff concentration; validity test on a second aliquot; and concentration. (e) The accuracy and precision at 40 (b) Each analytical run of sweat patch Section 11.24 What Are the percent of the cutoff concentration; and Requirements for Conducting Each (f) The potential for interfering samples for which an initial or Validity Test on a Sweat Patch Sample? substances. confirmatory validity test is being performed must include the appropriate (a) The initial test for a specific Section 11.17 What Are the Quality calibrators and controls. validity test must use a different Control Requirements When Conducting analytical principle or chemical reaction a Confirmatory Drug Test? Section 11.21 What Are the Analytical and Quality Control Requirements for than that used for the confirmatory test; (a) Each batch of specimens must Conducting Validity Tests on Urine (b) Each initial and confirmatory contain, at a minimum, the following Specimens? validity test that is quantitative must QC samples: include an appropriate calibrator, a (1) A single-point calibrator with its (a) Each validity test result must be control without the compound of drug concentration at the cutoff; based on performing an initial validity interest (i.e., a certified negative (2) At least one control certified to test on one aliquot and a confirmatory control), and a control with the contain no drug or metabolite; validity test on a second aliquot; and compound of interest at a measurable (3) At least one positive control with concentration; and (b) Each analytical run of specimens the drug or metabolite targeted at 25 (c) Each initial and confirmatory for which an initial or confirmatory percent above the cutoff; and validity test that is qualitative must (4) At least one control targeted at or validity test is being performed must include a control without the compound below 40 percent of the cutoff. include the appropriate calibrators and of interest (i.e., a certified negative (b) At least 10 percent of the samples controls. in each batch must be calibrators and control), and a control with the controls. Section 11.22 What Are the compound of interest at a measurable (c) The linear range, limit of Requirements for Conducting Each concentration. detection, and limit of quantitation must Validity Test on a Hair Sample? Section 11.25 What Are the be documented and periodically re- (a) The initial test for a specific Requirements for Conducting Each evaluated for each confirmatory drug Validity Test on a Urine Specimen? test. validity test must use a different (d) A laboratory must document that analytical principle or chemical reaction (a) The requirements for measuring any carryover that may occur between than that used for the confirmatory test; creatinine concentration are as follows: aliquots/extracts in the confirmatory (b) Each initial and confirmatory (1) The creatinine concentration must batch is detectable and corrected. validity test that is quantitative must be measured to one decimal place on both the initial creatinine test and the include an appropriate calibrator, a Section 11.18 What Are the Analytical confirmatory creatinine test; control without the compound of and Quality Control Requirements for (2) The initial creatinine test must interest (i.e., a certified negative Conducting Validity Tests on Hair have a calibrator at 2 mg/dL; control), and a control with the Samples? (3) The initial creatinine test must compound of interest at a measurable (a) Each validity test result must be have a control in the range of 1.0 mg/ concentration; and based on performing an initial validity dL to 1.5 mg/dL, a control in the range test on one aliquot and a confirmatory (c) Each initial and confirmatory of 3 mg/dL to 20 mg/dL, and a control validity test on a second aliquot; and validity test that is qualitative must in the range of 21 mg/dL to 25 mg/dL; (b) Each analytical run of hair samples include a control without the compound and for which an initial or confirmatory of interest (i.e., a certified negative (4) The confirmatory creatinine test validity test is being performed must control), and a control with the (performed on those specimens with a include the appropriate calibrators and compound of interest at a measurable creatinine concentration less than 2 mg/ controls. concentration. dL on the initial test) must have a

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calibrator at 2 mg/dL, a control in the (vii) One control in the range of 11.2 Section 11.26 What Are the range of 1.0 mg/dL to 1.5 mg/dL, and a to 12; Requirements for an HHS-Certified control in the range of 3 mg/dL to 4 mg/ (5) An initial or confirmatory pH Laboratory to Report a Hair Test Result? dL. meter test, if a pH screening test is used, (a) An HHS-certified laboratory must (b) The requirements for measuring must have the following calibrators and report a test result directly to the specific gravity are as follows: controls when the screening result agency’s MRO within an average of 5 (1) The refractometer must report and indicates that the pH is below the lower working days after receipt of the sample display specific gravity to four decimal decision point in use: using the Federal CCF and/or an places. The refractometer must be (i) One calibrator at 4; electronic report. Before any test result interfaced with a laboratory information is reported, it must be certified by a management system (LIMS), computer, (ii) One calibrator at 7; certifying scientist. and/or generate a hard copy of the (iii) One control in the range of 2 to (b) A primary (Sample A) head hair digital electronic display to document 2.8; and sample is reported negative when each the numerical result; (iv) One control in the range 3.2 to 4; (2) The initial and confirmatory and initial drug test is negative or it is negative on a confirmatory drug test and specific gravity tests must have a (6) An initial or confirmatory pH each validity test result indicates that calibrator or control at 1.0000; and meter test, if a pH screening test is used, (3) The initial and confirmatory the sample is a valid head hair sample. must have the following calibrators and (c) A primary (Sample A) head hair specific gravity tests must have the controls when the screening result following controls: sample is reported positive for a specific indicates that the pH is above the upper drug when the initial drug test is (i) One control targeted at 1.0020; decision point in use: (ii) One control in the range of 1.0040 positive and the confirmatory drug test (i) One calibrator at 7; to 1.0180; and is positive. (iii) One control greater than or equal (ii) One calibrator at 10; (d) A primary (Sample A) head hair to 1.0200 but not greater than 1.0250. (iii) One control in the range of 10 to sample is reported adulterated for a (c) Requirements for measuring pH 10.8; and specific adulterant when the initial are as follows: (iv) One control in the range of 11.2 validity test is positive and the (1) Colorimetric pH tests that have the to 12. confirmatory validity test is positive. dynamic range of 2 to 12 to support the (d) Requirements for performing (e) A primary (Sample A) head hair 3 and 11 pH cutoffs and pH meters must oxidizing adulterant tests are as follows: sample is reported as an invalid result if an interfering substance or physical be capable of measuring pH to one (1) The initial test must include an characteristic prevents the laboratory decimal place. Colorimetric pH tests, appropriate calibrator at the cutoff from obtaining a valid negative or dipsticks, and pH paper that have a specified in sections 11.29(d)(3), (4), positive drug test result. narrow dynamic range and do not and (6) for the compound of interest, a (f) An HHS-certified laboratory shall support the cutoffs may be used only to control without the compound of reject a head hair sample for testing determine if an initial pH validity test interest (i.e., a certified negative when a fatal flaw occurs as described in must be performed; control), and at least one control with (2) pH screening tests must have, at a section 16.1 or when a correctable flaw one of the compounds of interest at a minimum, the following controls: as described in section 16.2 is not measurable concentration; and (i) One control below the lower recovered. The laboratory will indicate decision point in use; (2) A confirmatory test for a specific on the Federal CCF that the specimen (ii) One control between the decision oxidizing adulterant must use a was rejected for testing and provide the points in use; and different analytical method than that reason for reporting the rejected for (iii) One control above the upper used for the initial test. Each testing result. decision point in use; confirmatory test batch must include an (g) An HHS-certified laboratory must (3) An initial colorimetric pH test appropriate calibrator, a control without report all non-negative test results for a must have the following calibrators and the compound of interest (i.e., a sample. For example, a head hair controls: certified negative control), and a control sample can be positive for a specific (i) One calibrator at 3; with the compound of interest at a drug and adulterated. (ii) One calibrator at 11; measurable concentration. (h) An HHS-certified laboratory must (iii) One control in the range of 2 to (e) The requirements for measuring report the concentration of the drug or 2.8; the nitrite concentration are that the metabolite for a positive result. (iv) One control in the range 3.2 to 4; initial and confirmatory nitrite tests (i) An HHS-certified laboratory must (v) One control in the range of 4.5 to must have a calibrator at the cutoff report numerical values that support a 9; concentration, a control without nitrite sample that is reported adulterated or (vi) One control in the range of 10 to (i.e., certified negative urine), one invalid (as appropriate). 10.8; and control in the range of 200 mcg/mL to (vii) One control in the range of 11.2 (j) When the concentration of an 400 mcg/mL, and one control in the analyte exceeds the linear range of the to 12; range of 500 mcg/mL to 625 mcg/mL. (4) An initial pH meter test, if a pH standard curve, an HHS-certified screening test is not used, must have the (f) The requirements for performing laboratory may report to the MRO that following calibrators and controls: other adulterant tests are that the initial the quantitative value exceeds the linear (i) One calibrator at 4; and confirmatory tests for any ‘‘other’’ range of the test, that the quantitative (ii) One calibrator at 7; adulterant that may be identified in the value is greater than or equal to (insert (iii) One calibrator at 10; future must include an appropriate the value for the upper limit of the (iv) One control in the range of 2 to calibrator, a control without the linear range), or may report an accurate 2.8; compound of interest (i.e., a certified quantitative value above the upper limit (v) One control in the range 3.2 to 4; negative control), and a control with the of the linear range that was obtained by (vi) One control in the range of 10 to compound of interest at a measurable diluting an aliquot of the dissolved head 10.8; and concentration. hair sample.

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(k) An HHS-certified laboratory may (g) An HHS-certified laboratory shall (b) A primary (Patch A) sweat patch transmit a result to the MRO by various reject an oral fluid specimen for testing sample is reported negative when each electronic means (for example, when a fatal flaw occurs as described in initial drug test is negative or it is teleprinters, facsimile, or computer) in a section 16.1 or when a correctable flaw negative on a confirmatory drug test and manner designed to ensure as described in section 16.2 is not each validity test result indicates that confidentiality of the information. A recovered. The laboratory will indicate the sample is a valid sweat patch result may not be reported verbally by on the Federal CCF that the specimen sample. telephone. A laboratory must ensure the was rejected for testing and provide the (c) A primary (Patch A) sweat patch security of the data transmission and reason for reporting the rejected for sample is reported positive for a specific limit access to any data transmission, testing result. drug when the initial drug test is storage, and retrieval system. (h) An HHS-certified laboratory must positive and the confirmatory drug test (l) For all test results, an HHS- report all non-negative test results for a is positive. certified laboratory may fax, courier, specimen. For example, an oral fluid (d) A primary (Patch A) sweat patch mail, or electronically transmit a legible specimen can be positive for a specific sample is reported adulterated for a image or copy of the completed Federal drug and adulterated. specific adulterant when the initial CCF, and/or forward a computer- (i) An HHS-certified laboratory must validity test is positive and the generated electronic report. However, report the concentration of the drug or confirmatory validity test is positive. for non-negative results, the laboratory metabolite for a positive result. (e) A primary (Patch A) sweat patch sample is reported as an invalid result must fax, courier, mail, or electronically (j) An HHS-certified laboratory must if an interfering substance or physical transmit a legible image or copy of the report numerical values that support a characteristic prevents the laboratory completed Federal CCF. specimen that is reported adulterated, from obtaining a valid negative or substituted, or invalid (as appropriate). Section 11.27 What Are the positive drug test result. Requirements for an HHS-Certified (k) When the concentration of an (f) An HHS-certified laboratory shall Laboratory to Report an Oral Fluid Test analyte exceeds the linear range of the reject a primary (Patch A) sweat patch Result? standard curve, an HHS-certified sample for testing when a fatal flaw (a) An HHS-certified laboratory must laboratory may report to the MRO that occurs as described in section 16.1 or report a test result directly to the the quantitative value exceeds the linear when a correctable flaw as described in agency’s MRO within an average of 5 range of the test, that the quantitative section 16.2 is not recovered. The working days after receipt of the value is greater than or equal to (insert laboratory will indicate on the Federal specimen using the Federal CCF and/or the value for the upper limit of the CCF that the sample was rejected for an electronic report. Before any test linear range), or may report an accurate testing and provide the reason for result is reported, it must be certified by quantitative value above the upper limit reporting the rejected for testing result. a certifying scientist. of the linear range that was obtained by (g) An HHS-certified laboratory must (b) A primary (Tube A) oral fluid diluting an aliquot of the specimen. report all non-negative test results for a specimen is reported negative when (l) An HHS-certified laboratory may sample. For example, a sweat patch each initial drug test is negative or it is transmit a result to the MRO by various sample can be positive for a specific negative on a confirmatory drug test and electronic means (for example, drug and adulterated. each validity test result indicates that teleprinters, facsimile, or computer) in a (h) An HHS-certified laboratory must the specimen is a valid oral fluid manner designed to ensure report the concentration of the drug or specimen. confidentiality of the information. A metabolite for a positive result. (c) A primary (Tube A) oral fluid result may not be reported verbally by (i) An HHS-certified laboratory must specimen is reported positive for a telephone. A laboratory must ensure the report numerical values that support a specific drug when the initial drug test security of the data transmission and specimen that is reported adulterated or is positive and the confirmatory drug limit access to any data transmission, invalid (as appropriate). test is positive. For only those oral fluid storage, and retrieval system. (j) When the concentration of an tests that result in a confirmed positive (m) For all test results, an HHS- analyte exceeds the linear range of the for marijuana, the laboratory must not certified laboratory may fax, courier, standard curve, an HHS-certified report the result for the oral fluid mail, or electronically transmit a legible laboratory may report to the MRO that specimen to the MRO but, instead must image or copy of the completed Federal the quantitative value exceeds the linear test the primary (Bottle A) urine CCF, and/or forward a computer- range of the test, that the quantitative specimen for marijuana and report that generated electronic report. However, value is greater than or equal to (insert result in accordance with section 11.29. for non-negative results, the laboratory the value for the upper limit of the (d) A primary (Tube A) oral fluid must fax, courier, mail, or electronically linear range), or may report an accurate specimen is reported adulterated for a transmit a legible image or copy of the quantitative value above the upper limit specific adulterant when the initial completed Federal CCF. of the linear range that was obtained by diluting an aliquot of the eluted sweat validity test is positive and the Section 11.28 What Are the patch sample. confirmatory validity test is positive. Requirements for an HHS-Certified (e) A primary (Tube A) oral fluid (k) An HHS-certified laboratory may Laboratory To Report a Sweat Patch specimen is reported as an invalid result transmit a result to the MRO by various Test Result? if an interfering substance or physical electronic means (for example, characteristic prevents the laboratory (a) An HHS-certified laboratory must teleprinters, facsimile, or computer) in a from obtaining a valid negative or report a test result directly to the manner designed to ensure positive drug test result. agency’s MRO within an average of 5 confidentiality of the information. A (f) A primary (Tube A) oral fluid working days after receipt of the sample result may not be reported verbally by specimen is reported substituted if the using the Federal CCF and/or an telephone. A laboratory must ensure the sample does not exhibit the electronic report. Before any test result security of the data transmission and characteristics of a normal oral fluid is reported, it must be certified by a limit access to any data transmission, specimen. certifying scientist. storage, and retrieval system.

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(l) For all test results, an HHS- (4) The presence of halogen (e.g., initial and confirmatory specific gravity certified laboratory may fax, courier, bleach, iodine, fluoride) is verified tests (i.e., a refractometer is used to test mail, or electronically transmit a legible using either a general oxidant both aliquots) on two separate aliquots. image or copy of the completed Federal colorimetric test (with a greater than or (f) A primary (Bottle A) urine CCF, and/or forward a computer- equal to 200 mcg/mL nitrite-equivalent specimen is reported dilute when the generated electronic report. However, cutoff or a greater than or equal to 50 creatinine concentration is greater than for non-negative results, the laboratory mcg/mL chromium (VI)-equivalent or equal to 2 mg/dL but less than 20 mg/ must fax, courier, mail, or electronically cutoff) or halogen colorimetric test dL and the specific gravity is greater transmit a legible image or copy of the (halogen concentration greater than or than 1.0010 but less than 1.0030 on a completed Federal CCF. equal to the LOD) for the initial test on single aliquot. the first aliquot and a different (g) A primary (Bottle A) urine Section 11.29 What Are the confirmatory test (e.g., multi-wavelength specimen is reported as an invalid result Requirements for an HHS-Certified spectrophotometry, ion when: Laboratory To Report a Urine Test chromatography, inductively coupled (1) Inconsistent creatinine Result? plasma-mass spectrometry) with a concentration and specific gravity (a) An HHS-certified laboratory must specific halogen concentration greater results are obtained (i.e., the creatinine report a test result directly to the than or equal to the LOD of the concentration is less than 2 mg/dL on agency’s MRO within an average of 5 confirmatory test on the second aliquot; both the initial and confirmatory working days after receipt of the (5) The presence of glutaraldehyde is creatinine tests and the specific gravity specimen using the Federal CCF and/or verified using either an aldehyde test is greater than 1.0010 but less than an electronic report. Before any test (aldehyde present) or the characteristic 1.0200 on the initial and/or result is reported, it must be certified by immunoassay response on one or more confirmatory specific gravity test, the a certifying scientist. drug immunoassay tests for the initial specific gravity is less than or equal to (b) A primary (Bottle A) urine test on the first aliquot and GC/MS for 1.0010 on both the initial and specimen is reported negative when the confirmatory test with the confirmatory specific gravity tests and each initial drug test is negative or it is glutaraldehyde concentration greater the creatinine concentration is greater negative on a confirmatory drug test and than or equal to the LOD of the analysis than or equal to 2 mg/dL on either or each validity test result indicates that on the second aliquot; both the initial or confirmatory the specimen is a valid urine specimen. (6) The presence of pyridine creatinine tests); (c) A primary (Bottle A) urine (pyridinium chlorochromate) is verified (2) The pH is greater than or equal to specimen is reported positive for a using either a general oxidant 3 and less than 4.5 or greater than or specific drug when the initial drug test colorimetric test (with a greater than or equal to 9 and less than 11 using either is positive and the confirmatory drug equal to 200 mcg/mL nitrite-equivalent a colorimetric pH test or pH meter for test is positive. cutoff or a greater than or equal to 50 the initial test and a pH meter for the (d) A primary (Bottle A) urine mcg/mL chromium (VI)-equivalent confirmatory test on two separate specimen is reported adulterated when: cutoff) or a chromium (VI) colorimetric aliquots; (1) The pH is less than 3 or greater test (chromium (VI) concentration (3) The nitrite concentration is greater than or equal to 11 using either a pH greater than or equal to 50 mcg/mL) for than or equal to 200 mcg/mL using a meter or a colorimetric pH test for the the initial test on the first aliquot and nitrite colorimetric test or greater than initial test on the first aliquot and a pH GC/MS for the confirmatory test with or equal to the equivalent of 200 mcg/ meter for the confirmatory test on the the pyridine concentration greater than mL nitrite using a general oxidant second aliquot; or equal to the LOD of the analysis on colorimetric test for both the initial test (2) The nitrite concentration is greater the second aliquot; and the confirmatory test or using either than or equal to 500 mcg/mL using (7) The presence of a surfactant is initial test and the nitrite concentration either a nitrite colorimetric test or a verified by using a surfactant is greater than or equal to 200 mcg/mL general oxidant colorimetric test for the colorimetric test with a greater than or but less than 500 mcg/mL for a different initial test on the first aliquot and a equal to 100 mcg/mL dodecylbenzene confirmatory test (e.g., multi-wavelength different confirmatory test (e.g., multi- sulfonate-equivalent cutoff for the initial spectrophotometry, ion wavelength spectrophotometry, ion test on the first aliquot and a different chromatography, capillary chromatography, capillary confirmatory test (e.g., multi-wavelength electrophoresis) on two separate electrophoresis) on the second aliquot; spectrophotometry) with a greater than aliquots; (3) The presence of chromium (VI) is or equal to 100 mcg/mL dodecylbenzene (4) The possible presence of verified using either a general oxidant sulfonate-equivalent cutoff on the chromium (VI) is determined using the colorimetric test (with a greater than or second aliquot; or same chromium (VI) colorimetric test equal to 50 mcg/mL chromium (VI)- (8) The presence of any other with a cutoff greater than or equal to 50 equivalent cutoff) or a chromium (VI) adulterant not specified in 4(iii) through mcg/mL chromium (VI) for both the colorimetric test (chromium (VI) 4(vii) of this section is verified using an initial test and the confirmatory test on concentration greater than or equal to 50 initial test on the first aliquot and a two separate aliquots; mcg/mL) for the initial test on the first different confirmatory test on the (5) The possible presence of a halogen aliquot and a different confirmatory test second aliquot. (e.g., bleach, iodine, fluoride) is (e.g., multi-wavelength (e) A primary (Bottle A) urine determined using the same halogen spectrophotometry, ion specimen is reported substituted when colorimetric test with a cutoff greater chromatography, atomic absorption the creatinine concentration is less than than or equal to the LOD for both the spectrophotometry, capillary 2 mg/dL and the specific gravity is less initial test and the confirmatory test on electrophoresis, inductively coupled than or equal to 1.0010 or greater than two separate aliquots or relying on the plasma-mass spectrometry) with the or equal to 1.0200 on both the initial odor of the specimen as the initial test; chromium (VI) concentration greater and confirmatory creatinine tests (i.e., (6) The possible presence of than or equal to the LOD of the the same colorimetric test may be used glutaraldehyde is determined by using confirmatory test on the second aliquot; to test both aliquots) and on both the the same aldehyde test (aldehyde

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present) or characteristic immunoassay laboratory may report to the MRO that Section 11.32 What Statistical response on one or more drug the quantitative value exceeds the linear Summary Report Must an HHS-Certified immunoassay tests for both the initial range of the test, that the quantitative Laboratory Provide? test and the confirmatory test on two value is greater than or equal to (insert (a) An HHS-certified laboratory must separate aliquots; the value for the upper limit of the provide to each Federal agency for (7) The possible presence of an linear range), or may report an accurate which testing is conducted a oxidizing adulterant is determined by quantitative value above the upper limit semiannual statistical summary report using the same general oxidant of the linear range that was obtained by for each type of specimen tested that colorimetric test (with a greater than or diluting an aliquot of the specimen. contains the following information: equal to 200 mcg/mL nitrite-equivalent cutoff, a greater than or equal to 50 mcg/ (m) An HHS-certified laboratory may Reporting Period: (inclusive dates) mL chromium (VI)-equivalent cutoff, or transmit a result to the MRO by various Laboratory Name and Address Federal Agency Name a halogen concentration is greater than electronic means (for example, (1) Specimen Results Reported (total or equal to the LOD) for both the initial teleprinters, facsimile, or computer) in a manner designed to ensure number) test and the confirmatory test on two By Type of Test: separate aliquots; confidentiality of the information. A result may not be reported verbally by (i) Pre-employment (number) (8) The possible presence of a (ii) Post-Accident (number) surfactant is determined by using the telephone. A laboratory must ensure the security of the data transmission and (iii) Random (number) same surfactant colorimetric test with a (iv) Reasonable Suspicion/Cause limit access to any data transmission, greater than or equal to 100 mcg/mL (number) storage, and retrieval system. dodecylbenzene sulfonate-equivalent (v) Return-to-Duty (number) cutoff for both the initial test and the (n) For all test results, an HHS- (vi) Follow-up (number) confirmatory test on two separate certified laboratory may fax, courier, (vii) Type of Test Not Noted on CCF aliquots or a foam/shake test for the mail, or electronically transmit a legible (number) initial test; image or copy of the completed Federal (2) Specimens Reported (9) Interference occurs on the CCF, and/or forward a computer- (i) Negative (number) immunoassay drug tests on two separate generated electronic report. However, (ii) Negative and Dilute (number) aliquots (i.e., valid immunoassay drug for non-negative results, the laboratory (3) Specimens Reported as Rejected test results cannot be obtained); must fax, courier, mail, or electronically for Testing (total number) (10) Interference with the GC/MS drug transmit a legible image or copy of the By Reason: confirmation assay occurs on at least completed Federal CCF. (i) Fatal flaw (number) two separate aliquots of the specimen (ii) Uncorrected Flaw (number) and the laboratory is unable to identify Section 11.30 How Long Must an HHS- (4) Specimens Reported as Positive the interfering substance; Certified Laboratory Retain a Specimen? (total number) (11) The physical appearance of the By Drug: specimen is such that testing the system (a) An HHS-certified laboratory must (i) Marijuana Metabolite (number) may damage the laboratory’s retain a specimen that was reported (ii) Cocaine Metabolite (number) instruments; or either drug positive, adulterated, (iii) Opiates: (12) If the physical appearances of substituted, or as an invalid result for a (A) Codeine (number) Bottles A and B are clearly different, the minimum of 1 year. (B) Morphine (number) test result for Bottle A is one of the (b) A retained specimen must be kept (C) 6-AM (number) (iv) Phencyclidine (number) reasons stated in (i) through (xi) of this in a secured location that is appropriate section and/or was screened negative for (v) Amphetamines: for that type of specimen (e.g., frozen (A) Amphetamine (number) drugs. storage (¥20°C or less) for urine) to (h) An HHS-certified laboratory shall (B) Methamphetamine (number) ensure its availability for any necessary reject a primary (Bottle A) urine (C) MDMA retesting during an administrative or specimen for testing when a fatal flaw (D) MDA judicial proceeding. occurs as described in section 16.1 or (E) MDEA when a correctable flaw as described in (c) Within the 1-year storage period, a (5) Adulterated (number) section 16.2 is not recovered. The Federal agency may request a laboratory (6) Substituted (number) laboratory will indicate on the Federal to retain a specimen for an additional (7) Invalid Result (number) CCF that the specimen was rejected for period of time. If no such request is (b) The report must be submitted by testing and provide the reason for received, a specimen may be discarded, mail, fax, or email within 14 working reporting the rejected for testing result. except that the laboratory must be days after the end of the semiannual (i) An HHS-certified laboratory must required to maintain any specimens period. The summary report must not report all non-negative test results for a under legal challenge for an indefinite include any personal identifying specimen. For example, a specimen can period. information. be positive for a specific drug and (c) The HHS-certified laboratory must adulterated. Section 11.31 How Long Must an HHS- make available copies of an agency’s test (j) An HHS-certified laboratory must Certified Laboratory Retain Records? results when requested by the Secretary report the concentration of the drug or or by the Federal agency for which the (a) An HHS-certified laboratory must metabolite for a positive result. laboratory is performing drug-testing (k) An HHS-certified laboratory must retain all records generated to support services. report numerical values that support a test results for at least 2 years. (d) The HHS-certified laboratory must specimen that is reported adulterated, (b) A Federal agency may instruct, in make available qualified personnel to substituted, or invalid (as appropriate). writing, the laboratory to maintain testify in a proceeding against a Federal (l) When the concentration of an records associated with a particular employee when that proceeding is based analyte exceeds the linear range of the specimen under legal challenge for an on a test result reported by the HHS- standard curve, an HHS-certified indefinite period. certified laboratory.

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Section 11.33 What Information Is Section 11.35 What Information Must POCT device, or as a set of compatible Available to the Donor? an HHS-Certified Laboratory Provide To devices or procedures as established in Its Private Sector Clients? section 12.6. (a) A Federal employee who is the When an HHS-certified laboratory (b) The Secretary will publish a list of subject of a drug test may, upon written the POCT devices that are SAMHSA- request through the MRO and the uses procedures to test private sector client specimens that are different from certified for use in the Federal Federal agency, have access to any Workplace Drug Testing Program in the those for which it is certified, it must records relating to his or her drug test, Federal Register. any records relating to the results of any inform the private sector client that its relevant certification, review, or specimens are not being tested under Section 12.3 What Is the Rationale for revocation of certification proceedings, the Guidelines. the Additional Requirements To Use POCT Devices Besides FDA Clearance? and access to a documentation package. Subpart L—Point of Collection Test (b) A standard documentation (POCT) The FDA clears POCT drug test package provided by an HHS-certified devices by making a finding of Section 12.1 What Is the Goal of This substantial equivalence to a legally laboratory must consist of the following Subpart? items: marketed device. FDA’s determination (a) Employees of Federal agencies are of substantial equivalence does not (1) A cover sheet that provides a brief in some cases located in remote areas of ensure that the test will satisfy description of the drug testing the country if they are serving with the minimum performance requirements procedures and any specimen validity Department of Interior, or overseas if that are necessary for use in the Federal tests performed on the donor’s they are serving with the Department of Workplace Drug Testing Program. specimen; State. They are often in locations with Therefore, due to the critically (2) A table of contents page that lists few employees as is often the case when important nature of testing under these by page number all documents and they are serving on American Indian Guidelines, there is need for additional materials in the package; reservations or in embassies in small assurance in the Federal Workplace (3) A copy of the Federal CCF with foreign countries. It is often unrealistic Drug Testing Program that the FDA- any attachments, internal chain of to expect that a drug testing program in cleared kits are effectively finding drugs custody records for the specimen, such places would operate in the same at the specified cutoff concentrations memoranda (if any) generated by the fashion as one that serves employees in and effectively determining the absence laboratory, and a copy of the electronic the Washington, DC, area. It is in these of drugs. report (if any) generated by the circumstances and in cases where it is Section 12.4 What Types of POCT laboratory; critical to receive an immediate test Devices Are There? result that POCT tests play an important (4) A brief description of the role. POCT devices are: laboratory’s initial drug and validity test (b) Yet a POCT offers a particular (a) Non-instrumented for which the procedures, instrumentation, batch challenge to the Federal Workplace endpoint result is obtained by visual quality control requirements, and copies Drug Testing Program because the evaluation (i.e., read by human eye); or (b) Instrumented for which the result of the initial test data for the donor’s device that is used to produce a negative is obtained by instrumental evaluation specimen with all calibrators and test result is really equivalent to a (e.g., densitometer, spectrophotometer, controls identified and copies of all laboratory test to which the normal fluorometer). internal chain of custody documents laboratory procedures and requirements related to the initial tests; cannot readily apply. Thus, while the Section 12.5 What Must a POCT (5) A brief description of the sections of the Guidelines related to Device Manufacturer Submit to the laboratory’s confirmatory drug and specimens, collection procedures, Secretary To Have Its POCT Device validity test procedures, collections sites, chain of custody, drug Initially Included on the List of instrumentation, batch quality control and validity testing and others do apply, SAMHSA-Certified POCTs? requirements, and copies of the it is necessary to establish requirements A POCT device manufacturer must confirmatory test data for the donor’s particular to POCTs. submit the following to the Secretary: specimen with all calibrators and (c) This subpart establishes the (a) A copy of the FDA letter stating controls identified and copies of all criteria for POCT devices that may be that the FDA has cleared the specific internal chain of custody documents used as part of the Federal Workplace POCT device; related to the confirmatory tests; and Drug Testing Program, when Federal (b) A copy of the labeling submitted (6) A copy of the resume or agencies may use a POCT, what the to FDA for the cleared device; curriculum vitae for the certifying responsibilities are of a Federal agency (c) A self-certification that the device scientist that certified the test result. which chooses to use a POCT, and the meets the requirements contained in the procedures that must be followed in FDA’s good manufacturing practices Section 11.34 What Type of using a POCT. regulations; Relationship Is Prohibited Between an (d) A description of the storage HHS-Certified Laboratory and an MRO? Section 12.2 What POCT Devices May requirements for the device; Be Used in a Federal Workplace Drug (e) A total of 100 POCT devices and (a) An MRO must not be an employee, Testing Program? related testing procedures in agent of, or have any financial interest (a) A POCT device that may be used representative numbers from all in an HHS-certified laboratory for which in a Federal Workplace Drug Testing currently available manufactured lots of the MRO is reviewing drug test results. Program is one which: the device for HHS testing to evaluate (b) An MRO must not derive any (1) Is FDA-cleared; and the performance of the POCT device(s) financial benefit by having a Federal (2) Effectively determines the for drug and validity testing; and agency use a specific HHS-certified presence or absence of drugs and (f) An accounting of the expiration laboratory that may be construed as a determines the validity of a specimen, date and number of devices for each potential conflict of interest. either as an integral function of the existing manufactured lot of the device.

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Section 12.6 What Criteria Will the (e) Inspect the POCT sites periodically (g) For urine only PT samples, the Secretary Use To Place a POCT Device to ensure compliance with these specific gravity must be between 1.0000 on the List of SAMHSA-Certified Guidelines; and 1.0010 or between 1.0200 and POCTs? (f) Ensure that on a quarterly basis 1.0300. (a) The Secretary shall evaluate the sets of HHS-contractor prepared PT (h) For urine only PT samples, the pH POCT devices submitted by the samples (that satisfy the requirements in must be between 1 and 3 or between 10 manufacturer using the following section 12.9) are submitted to challenge to 12. criteria: the performance of each POCT drug and (i) For oral fluid only PT samples, the (1) Correctly identify at least 80 validity test device at each site; IgG must be between 0.1 and 1.0. percent of the total drug challenges; (g) Maintain records on those who Section 12.10 What Are the Inspection (2) For an individual drug, correctly have been SAMHSA-certified as POCT Requirements for a Federal Agency identify at least 80 percent of the total testers including records of their Wishing To Use a POCT? drug challenges; training; (3) Correctly identify at least 80 (h) Retain records on the results of the (a) Each Federal agency is to inspect percent of the total validity test PT samples and the results of all POCTs each POCT site periodically to ensure challenges; by test and by specimen; compliance with these Guidelines; and (4) For each specific validity test, (i) Provide semiannual reports to the (b) The Federal agency must maintain correctly report at least 80 percent of the Secretary with regard to the use of the a record of the inspections for a challenges for the specific validity test; POCT device(s) in keeping with section minimum of 2 years. and 12.25; Section 12.11 What Is the (5) Must not report any sample as (j) Investigate each failure as provided Responsibility of the Secretary To adulterated with a compound that is not in section 12.12 and determine whether Inspect a Federal Agency Using POCT? present in the sample. it was related to failure to follow (a) The Secretary shall conduct a (b) The Secretary will use PT samples procedure in which case to take action semiannual inspection of each Federal as described in section 12.9 to evaluate against the POCT tester or whether it agency that uses POCT. the POCT device. was related to the POCT device itself; (b) The inspection will review the and Section 12.7 What Is Required for a Federal agency’s records to include: FDA Cleared POCT Device To Continue (k) If any failure under (j) of this (1) The Federal agency’s standard on the List of SAMHSA-Certified section is related to the device itself, operating procedure manual; Devices? immediately inform the Secretary who (2) POCT tester training records; shall temporarily suspend the use of the (3) POCT device quarterly PT results; To maintain a POCT device on the POCT device. SAMHSA-certified list, the and manufacturer: Section 12.9 What Are the Qualitative (4) POCT quality assurance data (a) Must agree to submit any design and Quantitative Specifications for PT maintained by each POCT tester and changes or alterations made to the Samples That Are Used To Evaluate site. device after it has been SAMHSA- Test Devices Submitted by Section 12.12 What Is a Failure for the certified, so that the Secretary may Manufacturers or for a Federal Agency Purposes of the POCT? determine whether additional testing is To Evaluate a POCT Site and Tester? A failure means the following: required; and A PT sample that is used to evaluate (b) Must submit 50 POCT devices and (a) For a drug POCT, the device failed test devices submitted by manufacturers related testing procedures annually to to properly identify a negative or or to challenge a POCT drug or validity the Secretary in representative numbers positive PT sample; test device is a sample: from all currently available (b) For a validity POCT, the device (a) That contains one or more drugs or manufactured lots of the device for HHS failed to identify a PT sample that was metabolites in the drug classes for testing to evaluate the performance of adulterated, substituted or diluted; or which each POCT device must have the the POCT device(s) for drug and validity (c) The device reported a false capability to test. testing using criteria established in negative after confirmation by a (b) The concentration of the drugs section 12.6. laboratory in keeping with section and/or metabolites are at least 20 12.21(b). Section 12.8 What Are the percent above the cutoff concentration Responsibilities of a Federal Agency or between 50 and 75 percent of the Section 12.13 What Is the That Wishes To Conduct POCT? cutoff concentration for the initial test. Responsibility of the Secretary When a Failure Is Reported? A Federal agency which seeks to (c) That contains no measurable conduct POCT as part of its Federal amount of a target drug and/or (a) If, after reviewing the information Workplace Drug Testing Program must: metabolite (i.e., a negative sample). from the Federal agency and all other (a) Use only POCT devices that are on (d) That may contain an interfering agencies using the same device as well the SAMHSA-certified list published by substance, an adulterant, or a specimen as the circumstances of the failure, the the Secretary in accordance with section that meets the criteria for a substituted Secretary determines that there is a 12.2(b); specimen that would challenge the problem with the device, the Secretary (b) Develop a standard operating POCT validity tests. may: procedure manual for POCT testers to (e) For urine only PT samples, the (1) Temporarily suspend the use of use; nitrite concentration must be between the device in the Federal Workplace (c) Ensure that POCT testers meet the 650 mcg/mL and 800 mcg/mL or Drug Testing Program if immediate requirements of section 12.16; between 250 mcg/mL and 400 mcg/mL. action is necessary in order to protect (d) Ensure that all other pertinent (f) For urine only PT samples, the the interests of the United States and its requirements of these Guidelines are creatinine concentration must be employees; or adhered to including the requirements between 5 mg/dL and 20 mg/dL or (2) Remove the device from the with regard to POCT sites; between 1 mg/dL and 5 mg/dL. SAMHSA-certified list.

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(b) If the Secretary suspends the use Section 12.16 What Are the POCT tester must send the urine split of the device, the Secretary shall: Requirements To Be a POCT Tester? specimen bottles to an HHS-certified (1) Inform all Federal agencies which (a) An individual is considered to be laboratory for testing rather than the oral are using the device of the action by a POCT tester for a specific POCT fluid specimen tubes. For all other placing notice in the Federal Register of device when the Federal agency presumptive positive drug test results such action; and documents that the individual has: on an oral fluid POCT, the POCT tester (2) Notify the manufacturer that the (1) Received supervised and validated may only send the oral fluid split device may be removed from the list of training in how to use and interpret the specimen tubes to the HHS-certified SAMHSA-certified devices. In this results of the POCT device; laboratory for testing. event, the manufacturer has 30 days (2) Received training on chain of (f) The POCT tester must complete the from the date of notification to reply. custody, reporting, and recordkeeping POCTs on an aliquot before beginning (3) Based on the Secretary’s procedures; the testing of another specimen using investigation and any information (3) Read and understands these POCTs. provided by the manufacturer, the Guidelines; and Section 12.19 What Are the Quality Secretary shall decide whether the (4) Demonstrated proficiency that has Control Requirements When Conducting device should remain on the list of been documented by the Federal agency POCTs? SAMHSA-certified devices. by completing five consecutive error- (a) For drug POCTs: (i) If the Secretary determines that the free POCTs. (1) Each day testing is performed device is to be removed from the list of (b) An individual may be trained to using devices with visually read SAMHSA-certified devices, the list will use all or some of the devices on the list endpoints (i.e., a color appearing or be revised accordingly. of SAMHSA-certified devices. disappearing that indicates a positive (ii) If the Secretary decides that it is Section 12.17 What Happens if a result using that device), each not to be removed from the list of POCT Site or Tester Does Not Satisfy the individual performing drug tests using SAMHSA-certified devices, the Minimum Technical Requirements? these devices must test at least one suspension will be lifted by publication negative control (i.e., a sample certified of a notice in the Federal Register. The POCT site or tester may not perform POCTs for a Federal agency to contain no drug or drug metabolite) (c) If the Secretary has cause to until acceptable performance has been and one positive control (i.e., a sample remove the device from the list of documented. with the concentration of the drugs or SAMHSA-certified devices in the metabolites in the range of 25 percent absence of a need for immediate action, Section 12.18 What Are the above the cutoff concentration) before the Secretary shall notify the Requirements for Conducting a POCT? donor specimens are tested. These manufacturer that the device may be (a) A donor must not have access to quality control samples must be tested removed from the list of SAMHSA- the POCT device. and the results interpreted with the certified devices. In this event, the (b) After the donor leaves the positive control testing positive and the manufacturer has 30 days from the date collection site and after the split negative control testing negative before of notification to reply. Based on the specimens are labeled and sealed by the donor specimens are tested and reported Secretary’s investigation and any collector, a POCT tester (which may be each day. information provided by the the collector) is permitted to break the (2) Each day testing is performed manufacturer, the Secretary will decide label/seal on the primary specimen and using devices with semi-automated or whether the device should remain on remove an aliquot to conduct the POCT. automated testing devices with machine the approved list. (c) The POCT tester must maintain read endpoints (i.e., spectrophotometer), (d) If the Secretary determines that and document chain of custody for the at least one negative control (i.e., a there is a problem with the device, the primary specimen and the aliquot used sample certified to contain no drug or Secretary shall notify the FDA so that for the POCT on an OMB-approved drug metabolite) and one positive the FDA can evaluate whether any custody and control form. control (i.e., a sample with the action under the Food, Drug, and (d) If the aliquot tests negative on the concentration of the drugs or Cosmetic Act is necessary. drug POCTs, the aliquot, primary, and metabolites in the range of 25 percent Section 12.14 How Can a split specimens must be discarded above the cutoff concentration) must be Manufacturer Apply To Have a Device unless the split specimens are to be tested on each device used. These Reinstated on the List of SAMHSA- submitted as part of the quality quality control samples must be tested Certified Devices? assurance program. and the results interpreted with the (e) If the aliquot tests presumptive positive control testing positive and the (a) The manufacturer may reapply for drug positive, adulterated, substituted, negative control testing negative before SAMHSA-certification in accordance or invalid on the POCTs, the primary donor specimens are tested and reported with section 12.5. specimen must be resealed using a new each day. (b) Upon reapplication, the tamper-evident label/seal and sent with (b) For validity POCTs, each day manufacturer must submit a statement the split specimen to an HHS-certified testing is performed, at least one control describing what has been done to laboratory for testing. The POCT tester that is normal for the specific validity overcome the problems that resulted in must initial and date the new label/seal test and one control that is abnormal the device being removed from the list that was used to reseal the primary must be tested. The results must be of SAMHSA-certified devices. specimen. The POCT tester must report correct before donor specimens are Section 12.15 Which Types of the POCT result on the OMB-approved tested. Specimens May Be Tested Using a custody and control form. The aliquot (c) At least one specimen out of every POCT? used to conduct the POCTs is discarded. 10 specimens that test negative must be When a POCT is conducted on an oral submitted to an HHS-certified (a) Oral fluid (saliva) fluid specimen aliquot and it is laboratory as part of a quality assurance (b) Urine presumptive positive for marijuana, the program.

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Section 12.20 What Action Must Be (1) A brief description of the POCT use a specific POCT device that may be Taken When a POCT Quality Control procedures, quality control construed as a potential conflict of Sample Fails? requirements, copies of the POCT test interest. data for the donor’s specimen with all For (a) or (b) in section 12.19, the Section 12.27 What Type of calibrators and controls identified as failed quality control sample must be Relationship Can Exist Between a related to the POCTs; sent to an HHS-certified laboratory. The Manufacturer of a POCT Device or a (2) A copy of the Federal CCF with POCT tester must successfully test QC POCT Site Operation and an HHS- any attachments, internal chain of samples until acceptable results are Certified Laboratory? custody records for the specimen, obtained before testing donor memoranda (if any) generated by the A manufacturer of a POCT device or specimens. If acceptable QC results POCT tester, and a copy of the report a POCT site operation can freely enter cannot be obtained, donor specimens generated by the POCT tester; into any relationship with an HHS- must be sent directly to an HHS- (3) A copy of the resume or Certified laboratory. certified laboratory. curriculum vitae for the POCT tester; Subpart M—Instrumented Initial Test Section 12.21 What Does a POCT and Facility (IITF) Tester Do With a Specimen After (4) A copy of the Federal agency Conducting a POCT? documentation of training of the POCT Section 13.1 What Is an HHS-Certified tester for the specific POCT device. IITF? (a) Each presumptive positive, adulterated, or substituted specimen Section 12.25 What Statistical An HHS-certified IITF: together with its split is sent to an HHS- Summary Report Must a Federal Agency (a) Is a facility at a permanent location certified laboratory for additional Provide to the Secretary? that conducts only instrumented initial testing. drug and validity tests (as described for (a) A Federal agency must provide the an HHS-certified laboratory in subpart (b) A POCT tester must send one of Secretary a semiannual statistical every 10 negative specimens together K); summary report that contains the (b) Has satisfied the certification with its split to an HHS-certified following information: laboratory to be tested for quality requirements for each type of specimen (1) The number of specimens tested the IITF wants to test; control purposes. Other negative (2) The number grouped by reason for specimens must be discarded. (c) Has passed 3 consecutive sets of test as follows: PT samples for each type of specimen to Section 12.22 How is a POCT Negative (i) Random be tested and an initial inspection Result Reported? (ii) All others reasons combined before becoming HHS-certified; (a) A negative result is reported (3) The number that were: (d) Participates in a quarterly directly to an MRO within 3 (on (i) Screened positive for each drug maintenance PT sample program and is average) working days after the POCT is (listed separately) inspected every 6 months; and conducted. (ii) Screened as adulterated (e) Is managed by a full-time (b) A POCT tester may report a (iii) Screened as substituted responsible technician (RT). (iv) Invalid Result negative test result to an MRO using an Section 13.2 Which Types of electronic report format. The electronic (4) The total number of quality control Specimens May Be Tested at an HHS- report must be transmitted to the MRO samples tested Certified IITF? in a manner that ensures the (i) The number of acceptable QC sample (a) Hair results confidentiality and security of the (b) Oral fluid (saliva) information. (ii) The number of failed QC sample (c) Sweat (patch) (c) A POCT tester may not report test results (d) Urine results telephonically. However, the (b) The report must be submitted by MRO may contact the POCT tester by mail, fax, or email within 14 working Section 13.3 What Cutoff telephone if he or she has any concern days after the end of the semiannual Concentrations Are Used by an HHS- regarding the negative result. period. Certified IITF for the Drug Tests? (c) The Federal agency must make Section 12.23 How Long Must Records An HHS-certified IITF must use the available copies of an agency’s POCT Generated at the POCT Site Be same cutoff concentrations for its initial drug and validity test results when Retained? drug tests as listed for a hair sample in requested by the Secretary. section 3.3, for an oral fluid specimen All records must be retained for at (d) The Federal agency must make in section 3.4, for a sweat patch sample least 2 years by the POCT tester or the available the POCT tester to testify in a in section 3.5, and for a urine specimen tester’s employer. proceeding against a Federal employee in section 3.6. Section 12.24 What POCT Information when that proceeding is based on a test result that begins with a POCT. Section 13.4 What Must Be Included in Is Available to the Donor? the HHS-Certified IITF’s Standard (a) An employee tested by a Federal Section 12.26 What Type of Operating Procedure Manual? Relationship Is Prohibited Between a agency workplace drug testing program (a) An HHS-certified IITF must have Manufacturer of a POCT Device or a may, upon written request through the a standard operating procedure (SOP) POCT Site Operation and an MRO? MRO and the Federal agency, have manual that describes, in detail, all IITF access to any records relating to his or (a) An MRO must not be an employee, operations. her drug test, any records relating to the agent of, or have any financial interest (b) The SOP manual must include, but results of any relevant review of the in a manufacturer of a POCT device or is not limited to, a detailed description POCT, and have access to a POCT site operation for which the MRO of the following: documentation package. is reviewing drug test results. (1) Chain-of-custody procedures; (b) The documentation package must (b) An MRO must not derive any (2) Accessioning; contain the following: financial benefit by having an agency (3) Security;

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(4) Quality control/quality assurance whenever procedures are first placed (d) When a new RT candidate has programs; into use or changed or when a new been identified, the IITF must submit to (5) Analytical methods and individual assumes responsibility for the Secretary the candidate’s current procedures; management of the IITF. resume or curriculum vitae, arrange to (6) Equipment and maintenance (d) Verify and maintain a quality have official academic transcript(s) programs; assurance program to assure the proper submitted by the candidate’s (7) Personnel training; performance and reporting of all test institution(s) of higher learning, copies (8) Reporting procedures; and results; monitor acceptable analytical of diplomas and any licensures, a (9) Computers, software, laboratory performance for all controls and training plan (not to exceed 90 days) to information management systems. standards; monitor quality control transition into the RT position, and an (c) All procedures in the SOP manual testing; document the validity, itemized defense of the candidate’s must be in compliance with these reliability, accuracy, precision, and qualifications compared to the Guidelines and other guidance performance characteristics of each minimum RT qualifications described in documents. device/system used at that testing the Guidelines. (d) A copy of all procedures that have facility. (e) The HHS-certified IITF must fulfill been replaced or revised and the dates (e) Implement all remedial actions other inspection and PT criteria as on which they were in effect must be necessary to maintain satisfactory required prior to conducting Federal maintained by the HHS-certified IITF to operation and performance of the testing agency testing under a new RT. allow the IITF to retrieve the procedures facility in response to quality control that were used to test a specimen. systems not being within performance Section 13.9 What Qualifications Must specifications, errors in result reporting an Individual Have To Certify a Test Section 13.5 What Must the HHS- or in analysis of performance testing Result Reported By an HHS-Certified Certified IITF Do To Validate an Initial results. This individual must ensure IITF? Drug Test? that sample results are not reported The individual who certifies a The HHS-certified IITF must satisfy until all corrective actions have been negative test result must have: the same validation requirements as taken and he or she can assure that the (a) Training and experience in the described in section 11.13. results provided are accurate and analytical methods and procedures used Section 13.6 What Qualifications Must reliable. by the IITF that are relevant to the the Responsible Technician (RT) Have? (f) Qualify as an operator of the initial results that the individual certifies; and test analyzers used at the IITF. (b) Training and experience in An RT must have the following reviewing and reporting test results, Section 13.8 What Happens When the qualifications: maintenance of chain of custody, and RT Is Absent or Leaves an HHS-Certified (a) A bachelor’s degree in the understanding proper remedial action in IITF? chemical or biological sciences, medical response to problems that may arise. technology, or similar field; (a) All HHS-certified IITFs must have (b) Training and experience in the an RT and an alternate RT. An alternate Section 13.10 What Qualifications and analytical methods and procedures used RT must be able to fulfill the Training Must Other IITF Personnel by the IITF that are relevant to the responsibilities of an RT and must meet Have? results; the qualifications of a certifying (a) All IITF staff (e.g., technicians, (c) Training and experience in scientist. The laboratory must submit administrative staff) must have the reviewing and reporting test results, documentation satisfactory to the appropriate training and skills for the maintenance of chain of custody, Secretary which shows the credentials tasks assigned. recordkeeping, and understanding of the prospective RT and which must (b) Each individual working in an proper remedial action in response to be approved by the Secretary, and found HHS-certified IITF must be properly problems that may arise; and acceptable during on-site inspections of trained before he or she is permitted to (d) Be found to fulfill RT the IITF. work independently in any area of the responsibilities and qualifications upon (b) When the HHS-certified IITF is facility with Federal agency specimens. interview by HHS-trained inspectors without the RT and alternate RT for 14 (c) The training file for each during each on-site inspection of the calendar days or less (e.g., vacation, individual must include, at a minimum, HHS-certified IITF. illness, business trip), the certified IITF a resume, documentation of training may continue testing Federal agency provided, and any applicable Section 13.7 What Are the specimens under the direction of a professional certifications or licenses. Responsibilities of an RT? certifying scientist. Training files should be maintained An RT must: (c) When an RT permanently leaves a separate from personnel files. (a) Manage the day-to-day operations certified IITF: of the IITF. (1) The HHS-certified IITF may Section 13.11 What Security Measures (b) Ensure that there are enough maintain its certification and continue Must an HHS-Certified IITF Maintain? personnel with adequate training and testing Federal agency specimens under (a) An HHS-certified IITF must experience to conduct and operate the the direction of an alternate RT for a control access to the facility and ensure work of the IITF. The RT must ensure period of up to 180 days while seeking that no unauthorized individual can the continued competency of testing to hire and receive the Secretary’s gain access to specimens, aliquots, or facility personnel by documenting their approval of the new permanent RT. records. in-service training, reviewing their work (2) The Secretary, in accordance with (b) Authorized visitors must be performance, and verifying their skills. these Guidelines, will suspend an IITF’s escorted at all times except for (c) Maintain a complete, current SOP certification for all specimens if the IITF individuals authorized to conduct manual that is available for personnel at does not have a permanent replacement inspections on behalf of Federal, state, the IITF, and followed by those RT within 180 days. The suspension or other accrediting agencies or personnel. The SOP manual must be will be lifted upon the Secretary’s emergency personnel (e.g., firefighters reviewed, signed, and dated by the RT approval of the new permanent RT. and medical rescue teams).

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(c) An HHS-certified IITF must using chain of custody procedures to an procedures and any specimen validity maintain a record that documents the HHS-certified laboratory for tests performed on the donor’s dates, time of entry and exit, and confirmatory testing. specimen; purpose of entry of authorized visitors Section 13.16 How Long Must an HHS- (2) A table of contents page that lists and authorized escorts to accessing Certified IITF Retain Records? by page number all documents and secured areas. materials in the package; (a) An HHS-certified IITF must retain (3) A copy of the Federal CCF with Section 13.12 What Are the Internal all records generated to support test any attachments, internal chain of IITF Chain of Custody Requirements for results for at least 2 years. custody records for the specimen, a Specimen or an Aliquot? (b) A Federal agency may request the memoranda (if any) generated by the (a) An HHS-certified IITF must use HHS-certified IITF to maintain records IITF, and a copy of the electronic report chain of custody procedures to maintain associated with a particular specimen (if any) generated by the IITF; control and accountability of specimens under legal challenge for an indefinite from receipt through completion of period. (4) A brief description of the testing, reporting of results, during laboratory’s initial drug and validity test Section 13.17 What Statistical storage, and continuing until final procedures, instrumentation, batch Summary Report Must an HHS-Certified disposition of the specimens. quality control requirements, and copies (b) An HHS-certified IITF must use IITF Provide? of the initial test data for the donor’s chain of custody procedures to (a) An HHS-certified IITF must specimen with all calibrators and document the handling and transfer of provide to each Federal agency for controls identified and copies of all aliquots throughout the testing process which testing is conducted a internal chain of custody documents and until final disposal. semiannual statistical summary report related to the initial tests; and (c) The date and purpose must be that contains the following information: (5) A copy of the resume or documented on an appropriate chain of (1) Number of specimens tested curriculum vitae for the certifying custody document each time a specimen (2) The number grouped by reason for scientist that certified the test result. test as follows: or aliquot is handled or transferred, and Section 13.19 What Type of every individual in the chain must be (i) Random Relationship Is Prohibited Between an identified. (ii) All others reasons combined HHS-Certified IITF and an MRO? (d) Chain of custody must be (3) The number that were: maintained and documented by using (a) An MRO must not be an employee, (i) Screened positive for each drug either hard copy procedures or agent of, or have any financial interest (listed separately) electronic procedures. in an IITF for which the MRO is (ii) Screened as adulterated (e) Each individual that handles a (iii) Screened as substituted reviewing drug test results. specimen or aliquot must sign and (iv) Rejected for Testing (b) An MRO must not derive any complete the chain of custody (v) Invalid Result financial benefit by having an agency document when the specimen or aliquot use a specific instrumented initial test is received. (b) The report must be submitted by mail, fax, or e-mail within 14 working facility or have any agreement with the Section 13.13 What Are the Batch days after the end of the semiannual IITF that may be construed as a Quality Control Requirements When period. potential conflict of interest. Conducting the Initial Tests for Drugs? (c) The HHS-certified IITF must make Section 13.20 What Type of The HHS-certified IITF must satisfy available copies of an agency’s test Relationship Can Exist Between an the same quality control requirements as results when requested by the Secretary HHS-Certified IITF and an HHS- described in section 11.14 for an HHS- or by the Federal agency for which the Certified Laboratory? certified laboratory. IITF is performing drug-testing services. (d) The HHS-certified IITF must make An HHS-certified IITF can freely enter Section 13.14 What Are the Analytical available qualified personnel to testify into any relationship with an HHS- and Quality Control Requirements for in a proceeding against a Federal certified laboratory. Conducting Initial Validity Tests? employee when that proceeding is based Section 13.21 How Does an HHS- An HHS-certified IITF must satisfy on a test result reported by the HHS- Certified IITF Report a Negative Test the same initial validity test certified IITF. Result? requirements described in sections Section 13.18 What IITF Information Is (a) An HHS-certified IITF may 11.18, 11.19, 11.20, and 11.21 and Available to the Donor? sections 11.22, 11.23, 11.24, and 11.25 transmit a result to the MRO by various for each type of specimen, as (a) An employee tested by a Federal electronic means (for example, appropriate. agency workplace drug testing program teleprinters, facsimile, or computer) in a may, upon written request through the manner designed to ensure Section 13.15 What Action Is Taken MRO and the Federal agency, have confidentiality of the information. A After an HHS-Certified IITF Tests a access to any records relating to his or result may not be reported verbally by Specimen? her drug test, any records relating to the telephone. An IITF must ensure the (a) A specimen that is negative on results of any relevant certification, security of the data transmission and initial drug tests and has acceptable review, or revocation of certification limit access to any data transmission, initial validity test results is discarded proceedings, and access to a storage, and retrieval system. and reported as negative to the MRO documentation package. (b) For all test results, an HHS- within 3 days (on average) working days (b) A standard documentation certified IITF may fax, courier, mail, or after receipt of the specimen. package provided by an HHS-certified electronically transmit a legible image (b) A specimen that is presumptive IITF must contain the following items: or copy of the completed Federal CCF, drug positive, adulterated, substituted, (1) A cover sheet that provides a brief and/or forward a computer-generated or invalid is immediately forwarded description of the drug testing electronic report.

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Section 13.22 How Does an HHS- (a) The collection procedures for each to test to the agency because the Certified IITF Handle a Specimen That type of specimen collected; specimen was adulterated. Is Presumptive Drug Positive, (b) The procedures for conducting (d) When an HHS-certified laboratory Adulterated, Substituted, or Invalid? POCT tests; or IITF reports an invalid result on the (c) How to interpret test results primary (Sample A) head hair sample, (a) The remaining specimen is reported by laboratories; the MRO contacts the donor to resealed using a tamper-evident label/ (d) Chain of custody, reporting, and determine if there is a valid medical seal; recordkeeping requirements for explanation for the invalid result. If the (b) The individual resealing the regulated specimens; and donor is unable to provide an remaining specimen initials and dates (e) The HHS Mandatory Guidelines explanation, the MRO reports a test the tamper-evident label/seal; for Federal Workplace Drug Testing cancelled result and directs the agency (c) The resealed specimen and split Programs. to collect another specimen from the specimen are sent to an HHS-certified donor. If the second specimen collected laboratory for confirmatory testing Section 14.3 What Are the exhibits the same behavior as the first within one day after completing the Responsibilities of the MRO? specimen, the MRO again reports the initial drug and/or validity tests; and (a) The MRO must: result for the second specimen as test (d) The HHS-certified IITF provides (1) Review the information on the cancelled and recommends to the the test result(s) on the OMB-approved MRO copy of the Federal CCF that was agency that no further action is chain of custody form used to report received from the collector and the required. initial test results. report received from the HHS-certified (e) When an HHS-certified laboratory Section 13.23 Where Is the List of laboratory, HHS-certified IITF, or POCT or IITF reports a rejected for testing HHS-Certified IITFs Published? site; result (e.g., lice) on the primary (Sample (2) Interview the donor when A) head hair sample, the MRO reports (a) The list of current HHS-certified required; a test cancelled result to the agency and IITFs is published monthly in the (3) Make a determination regarding directs the agency to collect another Federal Register. the test result; sample from the donor. (b) An applicant IITF is not included (4) Report the verified result to the on the list. Federal agency; and Section 14.5 What Must an MRO Do When Reviewing an Oral Fluid Test Subpart N—Medical Review Officer (5) Maintain the records (for a Result? (MRO) minimum of 2 years) and the confidentiality of the information. (a) When a HHS-certified laboratory, Section 14.1 Who May Serve as an (b) The review of a non-negative test HHS-certified IITF, or POCT tester MRO? result must be performed by the MRO reports a negative result on the primary (a) A licensed physician who: before the result is transmitted to the (Tube A) oral fluid specimen, the MRO (1) Has either a Doctor of Medicine agency’s designated representative. Staff reports a negative result to the agency. (M.D.) or Doctor of Osteopathy (D.O.) under the direct, personal supervision (b) When an HHS-certified laboratory degree; of the MRO may review and report a reports a positive result on the primary (2) Has knowledge regarding the negative test result to the agency’s (Tube A) oral fluid specimen, the MRO pharmacology and toxicology of illicit designated representative. The MRO contacts the donor to determine if there drugs; must cancel the result for any agency’s is any valid medical explanation for the (3) Has the training necessary to serve specimen that is not collected or tested positive result. If the donor provides a as an MRO as set out in section 14.2; in accordance with these Guidelines. valid medical explanation, the MRO and reports the test result as negative to the (4) Has satisfactorily completed an Section 14.4 What Must an MRO Do agency. If the donor is unable to provide examination administered by a When Reviewing a Hair Test Result? a valid medical explanation, the MRO nationally recognized entity that (a) When the HHS-certified laboratory reports a positive result to the agency. certifies MROs or subspecialty board for or IITF reports a negative result on the (c) When an HHS-certified laboratory physicians performing a review of primary (Sample A) head hair sample, reports an adulterated or substituted Federal employee drug test results, the MRO reports a negative result to the result on the primary (Tube A) oral fluid which has been approved by the agency. specimen, the MRO contacts the donor Secretary. (b) When the HHS-certified laboratory to determine if there is a valid (b) Nationally recognized entities that reports a positive result on the primary explanation for the adulterated or certify MROs or subspecialty boards for (Sample A) head hair sample, the MRO substituted result. If the donor is unable physicians performing a review of contacts the donor to determine if there to provide a valid explanation, the MRO Federal employee drug test results that is any valid medical explanation for the reports a refusal to test to the agency seek approval by the Secretary must positive result. If the donor provides a because the specimen was adulterated submit their qualifications and sample valid medical explanation, the MRO or substituted. examination. Based on an annual reports the test result as negative to the (d) When an HHS-certified laboratory objective review of the qualifications agency. If the donor is unable to provide or IITF reports an invalid result on the and content of the examination, the a valid medical explanation, the MRO primary (Tube A) oral fluid specimen, Secretary shall annually publish a list in reports a positive result to the agency. the MRO contacts the donor to the Federal Register of those entities (c) When an HHS-certified laboratory determine if there is a valid explanation and boards that have been approved. reports an adulterated result on the for the invalid result. If the donor is primary (Sample A) head hair sample, unable to provide an explanation, the Section 14.2 What Are the Training the MRO contacts the donor to MRO reports a test cancelled result and Requirements Before a Physician Can determine if there is a valid medical directs the agency to collect another Serve as an MRO? explanation for the adulterated result. If specimen from the donor. If the second A physician must receive training that the donor is unable to provide a valid specimen collected exhibits the same includes a thorough review of: explanation, the MRO reports a refusal behavior as the first specimen, the MRO

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again reports the result for the second Section 14.7 What Must an MRO Do result on the primary (Bottle A) urine specimen as test cancelled and When Reviewing a Urine Test Result? specimen, the MRO contacts the donor recommends to the agency that no (a) When an HHS-certified laboratory, to determine if there is a valid medical further action is required. HHS-certified IITF, or POCT tester explanation for the adulterated or (e) When an HHS-certified laboratory reports a negative result on the primary substituted result. If the donor is unable or IITF reports a rejected for testing (Bottle A) urine specimen, the MRO to provide a valid medical explanation, result on the primary (Tube A) oral fluid reports a negative result to the agency. the MRO reports a refusal to test to the specimen, the MRO reports a test (b) When an HHS-certified laboratory, agency because the specimen was cancelled result to the agency and HHS-certified IITF, or POCT tester adulterated or substituted. directs the agency to collect another reports a negative and dilute result on (f) When an HHS-certified laboratory specimen from the donor. the primary (Bottle A) urine specimen, or IITF reports an invalid result on the the MRO contacts the donor to primary (Bottle A) urine specimen, the Section 14.6 What Must an MRO Do determine if there is any possible MRO contacts the donor to determine if When Reviewing a Sweat Patch Test explanation for the urine specimen there is a valid medical explanation for Result? being dilute. If there appears to be a the invalid result. If the donor is unable legitimate medical explanation, the (a) When an HHS-certified laboratory to provide an explanation, provides a MRO reports a negative result to the valid prescription for some medications or IITF reports a negative result on the agency without indicating that the primary (Patch A) sweat patch sample, (e.g., Tolmetin, Flagyl, Cipro), or denies specimen was dilute. If there is no having tampered with the specimen, the the MRO reports a negative result to the legitimate medical explanation, the agency. MRO reports a test cancelled result and MRO directs the agency to immediately directs the agency to collect another (b) When an HHS-certified laboratory collect another specimen from the specimen from the donor using a direct reports a positive result on the primary donor. observed collection. If the second (c) When an HHS-certified laboratory (Patch A) sweat patch sample, the MRO specimen collected using a direct reports a positive result on the primary contacts the donor to determine if there observed collection procedure exhibits (Bottle A) urine specimen, the MRO is any valid medical explanation for the the same behavior as the first specimen, contacts the donor to determine if there positive result. If the donor provides a the MRO again reports the result for the valid medical explanation, the MRO is any valid medical explanation for the positive result. If the donor provides a second specimen as test cancelled and reports the test result as negative to the recommends to the agency that no agency. If the donor is unable to provide valid medical explanation, the MRO reports the test result as negative to the further action is required because the a valid medical explanation, the MRO donor is taking a valid prescription reports a positive result to the agency. agency. If the donor is unable to provide a valid medical explanation, the MRO medication that interferes with the drug (c) When an HHS-certified laboratory reports a positive result to the agency. test or there is some unknown reports an adulterated result on the If a laboratory also reports that the endogenous substance present in the primary (Patch A) sweat patch sample, specimen is dilute, the MRO directs the donor’s urine that prevents getting a the MRO contacts the donor to agency to have the donor provide valid drug test result. determine if there is a valid explanation another specimen using a direct (g) When an HHS-certified laboratory for the adulterated result. If the donor is observed collection procedure (when or IITF reports a rejected for testing unable to provide a valid explanation, the MRO was reporting the result as result on the primary (Bottle A) urine the MRP reports a refusal to test to the negative). For a positive result, the MRO specimen, the MRO reports a test agency because the specimen was may ignore the dilute result. cancelled result to the agency and adulterated. (d) When an HHS-certified laboratory directs the agency to immediately (d) When an HHS-certified laboratory reports a positive result for opiates on collect another specimen from the or IITF reports an invalid result on the the primary (Bottle A) urine specimen, donor. primary (Patch A) sweat patch sample, the MRO must determine that there is Section 14.8 Who May Request a Test the MRO contacts the donor to clinical evidence in addition to the of a Split Specimen? determine if there is a valid explanation urine test result of illegal use of any opium, opiate, or opium derivative (e.g., for the invalid result. If the donor is (a) For a positive, adulterated, or morphine/codeine) listed in Schedule I unable to provide an explanation, the substituted result reported on a primary or II of the Controlled Substances Act. MRO reports a test cancelled result and specimen, a donor may request through However, this requirement does not directs the agency to collect another the MRO that the split specimen be apply if the laboratory confirms the specimen from the donor. If the second tested by a second HHS-certified presence of 6-acetylmorphine (i.e., the specimen collected using a direct laboratory to verify the result reported presence of this metabolite is proof of observed collection procedure exhibits by the first laboratory. the same behavior as the first specimen, heroin use) or the morphine or codeine concentration is greater than or equal to (b) The donor has 72 hours (from the the MRO again reports the result for the 15,000 ng/mL and the donor does not time the MRO notified the donor that second specimen as test cancelled and present a legitimate medical explanation his or her specimen was reported recommends to the agency that no for the presence of morphine or codeine positive, adulterated, or substituted) to further action is required. at or above this concentration. request a test of the split specimen. The (e) When an HHS-certified laboratory Consumption of food products must not MRO must inform the donor that he or or IITF reports a rejected for testing be considered a legitimate medical she has the right to request a test of the result on the primary (Patch A) sweat explanation for the donor having split specimen when the MRO informs patch sample, the MRO reports a test morphine or codeine at or above this the donor that a positive, adulterated, or cancelled result to the agency and concentration. substituted result is being reported to directs the agency to collect another (e) When an HHS-certified laboratory the Federal agency on the primary sample. reports an adulterated or substituted specimen.

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Section 14.9 How Does the MRO positive, adulterated, or substituted Section 15.5 How Does an HHS- Report a Primary Specimen Test Result result. Certified Laboratory Test a Split Sweat to an Agency? Patch Sample for Adulterants When the Section 15.2 How Does an HHS- Primary Sample Was Reported (a) The MRO must report all verified Certified Laboratory Test a Split Hair, Adulterated? results to an agency by either faxing a Oral Fluid, Sweat, or Urine Specimen completed MRO copy of the Federal When the Primary Specimen Was (a) The second laboratory must test CCF, transmitting a scanned image of Reported Positive? the split sweat patch sample using the laboratory’s confirmatory test(s) for the the completed MRO copy of the Federal (a) The testing of a split head hair, CCF, or faxing a separate report using a adulterant(s) reported in the primary oral fluid, sweat, or urine specimen for sample. letter/memorandum format. a drug or metabolite is not subject to the (b) A verified result may not be (b) The second laboratory is only testing cutoff concentrations established required to confirm the presence of the reported to the agency until the MRO for each type of specimen collected. has completed the review process. adulterant(s) using the limit of detection (b) The laboratory is only required to (LOD) of its confirmatory test(s). (c) The MRO must send a hard copy confirm the presence of the drug or of either the completed MRO copy of (c) The second laboratory may only metabolite that was reported present in conduct the confirmatory test(s) needed the Federal CCF or the separate letter/ the primary head hair, oral fluid, sweat, memorandum report for all non- to reconfirm the adulterant(s) reported or urine specimen. by the primary laboratory. negative results. (c) For urine only, if the second (d) The MRO must not disclose laboratory fails to reconfirm the Section 15.6 How Does an HHS- numerical values to the Federal agency. presence of the drug or drug metabolite Certified Laboratory Test a Split Urine Specimen for Adulterants When the Section 14.10 What Type of that was reported by the first laboratory, Primary Specimen Was Reported Relationship Is Prohibited Between an the second laboratory must conduct Adulterated? MRO and an HHS-Certified Laboratory, validity tests in an attempt to determine POCT Tester, or an HHS-Certified IITF? the reason for being unable to reconfirm (a) A laboratory must use one of the the presence of the drug or drug following criteria to reconfirm an (a) An MRO must not be an employee, metabolite. The second laboratory adulterated result when testing a split agent of, or have any financial interest should conduct the same validity tests (Bottle B) specimen: in an HHS-certified laboratory, POCT as it would conduct on a primary (1) pH must be measured using the tester, or HHS-certified IITF for which specimen and reports those results to laboratory’s confirmatory pH test with the MRO is reviewing drug test results. the MRO. the appropriate cutoff (i.e., either less (b) An MRO must not derive any Section 15.3 How Does an HHS- than 3 or greater than or equal to 11); financial benefit by having an agency (2) Nitrite must be measured using the Certified Laboratory Test a Split Hair use a specific HHS-certified laboratory, laboratory’s confirmatory nitrite test Sample for Adulterants When the POCT tester, or HHS-certified IITF or with a cutoff concentration of greater Primary Sample Was Reported have any agreement with the laboratory, than or equal to 500 mcg/mL; or Adulterated? POCT tester, or IITF that may be (3) For adulterants without a specified construed as a potential conflict of (a) The second laboratory must test cutoff (e.g., glutaraldehyde, surfactant, interest. the split head hair sample using the chromium (VI), pyridine, halogens (such laboratory’s confirmatory test(s) for the Subpart O—Split Specimen Tests as bleach, iodine), peroxidase, peroxide, adulterant(s) reported in the primary other oxidizing agents), the laboratory Section 15.1 When May a Split sample. must use its confirmatory validity test at Specimen Be Tested? (b) The second laboratory is only an established limit of detection (LOD) required to confirm the presence of the to reconfirm the presence of the (a) A donor has the right to request adulterant(s) using the limit of detection through the MRO that the split adulterant. (LOD) of its confirmatory test(s). (b) The second laboratory may only specimen be tested at a different HHS- (c) The second laboratory may only conduct the confirmatory validity test(s) certified laboratory when the primary conduct the confirmatory test(s) needed needed to reconfirm the adulterant specimen was determined by the MRO to reconfirm the adulterant(s) reported result reported by the primary to be positive, adulterated, or by the primary laboratory. laboratory. substituted (as appropriate for each type of specimen collected). Section 15.4 How Does an HHS- Section 15.7 How Does an HHS- (b) A donor has 72 hours to initiate Certified Laboratory Test a Split Oral Certified Laboratory Test a Split Oral the request after being informed of the Fluid Specimen for Adulterants When Fluid Specimen for Substitution When result by the MRO. The donor must the Primary Specimen Was Reported the Primary Specimen Was Reported document this request in writing to the Adulterated? Substituted? MRO. (a) The second laboratory must test The second laboratory must test the (c) If the split specimen cannot be the split oral fluid specimen using the split (Tube B) specimen using the tested by a second laboratory (e.g., laboratory’s confirmatory test(s) for the laboratory’s confirmatory IgG test and insufficient specimen, lost in transit, adulterant(s) reported in the primary determine that the IgG concentration is split not available), the MRO shall direct specimen. less than 0.10 mcg/mL. the Federal agency to immediately (b) The second laboratory is only collect another specimen. required to confirm the presence of the Section 15.8 How Does an HHS- (d) If a donor chooses not have the adulterant(s) using the limit of detection Certified Laboratory Test a Split Urine split specimen tested by a second HHS- (LOD) of its confirmatory test(s). Specimen for Substitution When the certified laboratory, a Federal agency (c) The second laboratory may only Primary Specimen Was Reported may have a split specimen retested as conduct the confirmatory test(s) needed Substituted? part of a legal or administrative to reconfirm the adulterant(s) reported (a) A laboratory must use the proceeding to defend an original by the primary laboratory. following criteria to reconfirm a

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substituted result when testing a split cancels both tests, and notifies the HHS explanation for the adulteration result, (Bottle B) specimen: office responsible for coordination of the MRO reports a failed to reconfirm (1) The creatinine must be measured the drug-free workplace program. (specify drug(s)) and cancels both tests. using the laboratory’s confirmatory (c) Failed to reconfirm one or more If there is no legitimate medical creatinine test with a cutoff drugs, reconfirmed one or more drugs. explanation, the MRO reports a failed to concentration of less than 2 mg/dL; and The MRO reports to the agency a failed reconfirm (specify drug(s)) and a refusal (2) The specific gravity must be to reconfirm result (specify drug(s)) and to test to the agency and indicates the measured using the laboratory’s a reconfirmed result (specify drug(s)). adulterant that is present in the urine confirmatory specific gravity test with The MRO tells the agency that it may specimen. The MRO gives the donor 72 the specified cutoffs of less than 1.0010 take action based on the reconfirmed hours to request that Laboratory A retest or greater than or equal to 1.0200. drug(s) although the second laboratory the primary specimen for the adulterant. (b) The second laboratory may only failed to reconfirm one or more drugs. If Laboratory A reconfirms the conduct the confirmatory validity test(s) (d) Failed to reconfirm the adulterant, the MRO reports refusal to needed to reconfirm the validity test adulteration or substitution result. The test and indicates the adulterant result(s) reported by the primary MRO reports to the agency a failed to present. If Laboratory A fails to laboratory. reconfirm result (specify not adulterated reconfirm the adulterant, the MRO or substituted), cancels both tests, and cancels both tests and directs the agency Section 15.9 Who Receives the Split notifies the HHS office responsible for to immediately collect another Specimen Result? coordination of the drug-free workplace specimen using a direct observed The second laboratory must transmit program. collection procedure. The MRO shall the result directly to the MRO. notify the appropriate regulatory office Section 15.12 What Action(s) Does the about the failed to reconfirm and Section 15.10 What Action(s) Does the MRO Take After Receiving the Split MRO Take After Receiving the Split Hair cancelled test. Sweat Patch Sample Result From the (c) Failed to reconfirm a single or all Sample Result From the Second Second Laboratory? drug positive results and substituted. If Laboratory? The MRO takes the following actions the donor provides a legitimate medical The MRO takes the following actions when the second laboratory reports the explanation for the substituted result, when the second laboratory reports the result for the split sweat patch sample the MRO reports a failed to reconfirm result for the split head hair sample as: as: (specify drug(s)) and cancels both tests. (a) Reconfirmed the drug(s). The MRO (a) Reconfirmed the drug(s) and/or If there is no legitimate medical reports reconfirmed to the agency. adulteration result. The MRO reports explanation, the MRO reports a failed to (b) Failed to reconfirm the drug(s). reconfirmed to the agency. reconfirm (specify drug(s)) and a refusal The MRO reports to the agency a failed (b) Failed to reconfirm the drug(s). to test (substituted) to the agency. The to reconfirm result (specify drug(s)), The MRO reports to the agency a failed MRO gives the donor 72 hours to cancels both tests, and notifies the HHS to reconfirm result (specify drug(s)), request Laboratory A to review the office responsible for coordination of cancels both tests, and notifies the HHS creatinine and specific gravity results the drug-free workplace program. office responsible for coordination of for the primary specimen. If the original (c) Failed to reconfirm one or more the drug-free workplace program. creatinine and specific gravity results drugs, reconfirmed one or more drugs. (c) Failed to reconfirm one or more confirm that the specimen was The MRO reports to the agency a failed drugs, reconfirmed one or more drugs. substituted, the MRO reports a refusal to to reconfirm result (specify drug(s)) and The MRO reports to the agency a failed test (substituted) to the agency. If the a reconfirmed result (specify drug(s)). to reconfirm result (specify drug(s)) and original creatinine and specific gravity The MRO tells the agency that it may a reconfirmed result (specify drug(s)). results from Laboratory A fail to confirm take action based on the reconfirmed The MRO tells the agency that it may that the specimen was substituted, the drug(s) although the second laboratory action based on the reconfirmed drug(s) MRO cancels both tests and directs the failed to reconfirm one or more drugs. although the second laboratory failed to agency to immediately collect another (d) Failed to reconfirm the reconfirm one or more drugs. specimen using a direct observed adulteration result. The MRO reports to (d) Failed to reconfirm the collection procedure. The MRO shall the agency a failed to reconfirm result adulteration result. The MRO reports to notify the HHS office responsible for (specify not adulterated), cancels both the agency a failed to reconfirm result coordination of the drug-free workplace tests, and notifies the HHS office (specify not adulterated), cancels both program about the failed to reconfirm responsible for coordination of the drug- tests, and notifies the HHS office and cancelled test. free workplace program. responsible for coordination of the drug- (d) Failed to reconfirm a single or all free workplace program. drug positive results and not Section 15.11 What Action(s) Does the adulterated or substituted. The MRO MRO Take After Receiving the Split Oral Section 15.13 What Action(s) Does the reports to the agency a failed to Fluid Specimen Result From the Second MRO Take After Receiving the Split reconfirm result (specify drug(s)), Laboratory? Urine Specimen Result From the Second cancels both tests, and notifies the HHS The MRO takes the following actions Laboratory? office responsible for coordination of when the second laboratory reports the The MRO takes the following actions the drug-free workplace program. result for the split oral fluid specimen when the second laboratory reports the (e) Failed to reconfirm a single or all as: result for the split urine specimen as: drug positive results and invalid result. (a) Reconfirmed the drug(s), (a) Reconfirmed the drug(s), The MRO reports to the agency a failed adulteration, and/or substitution result. adulteration, and/or substitution result. to reconfirm result (specify drug(s) and The MRO reports reconfirmed to the The MRO reports reconfirmed to the gives the reason for the invalid result), agency. agency. cancels both tests, directs the agency to (b) Failed to reconfirm the drug(s). (b) Failed to reconfirm a single or all immediately collect another specimen The MRO reports to the agency a failed drug positive results and adulterated. If using a direct observed collection to reconfirm result (specify drug(s)), the donor provides a legitimate medical procedure, and notifies the HHS office

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responsible for coordination of the drug- program regarding the test results for the failed to reconfirm result (not free workplace program. specimen. substituted). The MRO tells the agency (f) Failed to reconfirm one or more (k) Failed to reconfirm a single or all that it may take action based on the drugs, reconfirmed one or more drugs, drug positive results and reconfirmed an adulterated result although Laboratory B and adulterated. The MRO reports to adulterated or substituted result. The failed to reconfirm the substituted the agency a reconfirmed result (specify MRO reports to the agency a result. drug(s)) and a failed to reconfirm result reconfirmed result (adulterated or Section 15.14 How Does an MRO (specify drug(s)). The MRO tells the substituted) and a failed to reconfirm Report a Split Specimen Test Result to agency that it may take action based on result (specify drug(s)). The MRO tells an Agency? the reconfirmed drug(s) although the agency that it may take action based Laboratory B failed to reconfirm one or on the reconfirmed result (adulterated (a) The MRO must report all verified more drugs and found that the specimen or substituted) although Laboratory B results to an agency by either faxing a was adulterated. The MRO shall notify failed to reconfirm the drug(s) result. completed MRO copy of the Federal the HHS office official responsible for (l) Failed to reconfirm a single or all CCF, transmitting a scanned image of coordination of the drug-free workplace drug positive results and failed to the completed MRO copy of the Federal program regarding the test results for the reconfirm the adulterated or substituted CCF, or faxing a separate report using a specimen. result. The MRO reports to the agency letter/memorandum format. (g) Failed to reconfirm one or more a failed to reconfirm result (specify (b) A verified result may not be drugs, reconfirmed one or more drugs, drug(s) and specify adulterant or reported to the agency until the MRO and substituted. The MRO reports to the substituted) and cancels both tests. The has completed the review process. agency a reconfirmed result (specify MRO shall notify the HHS office (c) The MRO must send a hard copy drug(s)) and a failed to reconfirm result responsible for coordination of the drug- of either the completed MRO copy of (specify drug(s)). The MRO tells the free workplace program regarding the the Federal CCF or the separate letter/ test results for the specimen. agency that it may take action based on memorandum report for all non- (m) Failed to reconfirm at least one the reconfirmed drug(s) although negative results. drug and reconfirmed the adulterated Laboratory B failed to reconfirm one or (d) The MRO must not disclose result. The MRO reports to the agency numerical values to the agency. more drugs and found that the specimen a reconfirmed result (specify drug(s) and was substituted. The MRO shall notify adulterated) and a failed to reconfirm Section 15.15 How Long Must an HHS- the HHS office responsible for result (specify drug(s)). The MRO tells Certified Laboratory Retain a Split coordination of the drug-free workplace the agency that it may take action based Specimen? program regarding the test results for the on the reconfirmed drug(s) and the specimen. A split specimen is retained for the adulterated result although Laboratory B same period of time that a primary (h) Failed to reconfirm one or more failed to reconfirm one or more drugs. drugs, reconfirmed one or more drugs, specimen is retained and under the (n) Failed to reconfirm at least one same storage conditions. This applies and not adulterated or substituted. The drug and failed to reconfirm the MRO reports a reconfirmed result even for those cases when the split adulterated result. The MRO reports to specimen is tested by a second (specify drug(s)) and a failed to the agency a reconfirmed result (specify reconfirm result (specify drug(s)). The laboratory and the second laboratory drug(s)) and a failed to reconfirm result does not confirm the original result MRO tells the agency that it may take (specify drug(s) and specify adulterant). action based on the reconfirmed drug(s) reported by the first laboratory on the The MRO tells the agency that it may primary specimen. although Laboratory B failed to take action based on the reconfirmed reconfirm one or more drugs. The MRO drug(s) although Laboratory B failed to Subpart P—Criteria for Rejecting a shall notify the HHS office responsible reconfirm one or more drugs and failed Specimen for Testing for coordination of the drug-free to reconfirm the adulterated result. Section 16.1 What Discrepancies workplace program regarding the test (o) Failed to reconfirm an adulterated results for the specimen. Require an HHS-Certified Laboratory or result and failed to reconfirm a IITF to Report a Hair, Oral Fluid, Sweat, (i) Failed to reconfirm one or more substituted result. The MRO reports to drugs, reconfirmed one or more drugs, or Urine Specimen as Rejected for the agency a failed to reconfirm result Testing? and invalid result. The MRO reports to ((specify adulterant) and not the agency a reconfirmed result (specify substituted) and cancels both tests. The The following discrepancies are drug(s)) and a failed to reconfirm result MRO shall notify the HHS office considered to be fatal flaws and the (specify drug(s)). The MRO tells the responsible for coordination of the drug- laboratory or IITF must stop the testing agency that it may take action based on free workplace program regarding the process, reject the specimen for testing, the reconfirmed drug(s) although test results for the specimen. and indicate the reason for rejecting the Laboratory B failed to reconfirm one or (p) Failed to reconfirm an adulterated specimen on the Federal CCF: more drugs and reported an invalid result and reconfirmed a substituted (a) The specimen ID number on the result. The MRO shall notify the HHS result. The MRO reports to the agency specimen label/seal does not match the office responsible for coordination of a reconfirmed result (substituted) and a ID number on the Federal CCF or the ID the drug-free workplace program failed to reconfirm result (specify number is missing either on the Federal regarding the test results for the adulterant). The MRO tells the agency CCF or on the specimen label/seal; specimen. that it may take action based on the (b) The specimen label/seal is broken (j) Failed to reconfirm substitution or substituted result although Laboratory B or shows evidence of tampering on the adulteration. The MRO reports to the failed to reconfirm the adulterated primary specimen and the split agency a failed to reconfirm result result. specimen cannot be re-designated as the (specify adulterant or not substituted) (q) Failed to reconfirm a substituted primary specimen; and cancels both tests. The MRO shall result and reconfirmed an adulterated (c) The collector’s printed name and notify the HHS office responsible for result. The MRO reports to the agency signature are omitted on the Federal coordination of the drug-free workplace a reconfirmed result (adulterated) and a CCF; or

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(d) There is an insufficient amount of (6) A phone number is missing/ (c) The above omissions and specimen/sample for analysis in the incorrect; discrepancies are considered primary specimen unless the split (7) A fax number is missing/incorrect; insignificant only when they occur no specimen can be re-designated as the (8) A ‘‘reason for test’’ box is not more than once a month. The primary specimen. marked; expectation is that each trained collector (e) For hair only, an HHS-certified (9) A ‘‘drug tests to be performed’’ box and HHS-certified laboratory and IITF laboratory or IITF may reject a head hair is not marked; will make every effort to ensure that the sample if it contains lice. (10) A specimen collection box is not Federal CCF is properly completed and marked; that all the information is correct. When Section 16.2 What Discrepancies (11) The observed box is not marked an error occurs more than once a month, Require an HHS-Certified Laboratory or (if applicable); the MRO must direct the collector, IITF to Report a Hair, Oral Fluid, Sweat, (12) The collection site address is laboratory, or IITF (whichever is or Urine Specimen as Rejected for missing; responsible for the error) to immediately Testing Unless the Problem is (13) The collector’s printed name is take corrective action to prevent the Corrected? missing but the collector’s signature is properly recorded; recurrence of the error. The following discrepancies are (14) The time of collection is not Section 16.4 What Discrepancies May considered to be correctable: indicated; Require an MRO To Cancel a Test? (a) If a collector failed to sign the (15) The date of collection is not Federal CCF, the laboratory or IITF must indicated; (a) An MRO must attempt to correct attempt to recover the collector’s (16) Incorrect name of delivery the following errors: signature before reporting the test result. service; (1) The donor’s signature is missing If the collector can provide a (17) The collector has changed or on the MRO copy of the Federal CCF memorandum for record recovering the corrected information by crossing out and the collector failed to provide a signature, the laboratory or IITF may the original information on either the comment that the donor refused to sign report the test result for the specimen. Federal CCF or specimen label/seal the form; If the laboratory or IITF cannot recover without dating and initialing the (2) The certifying scientist failed to the collector’s signature, the laboratory change; or sign the hard copy (Copy 1) of the or IITF must report a rejected for testing (18) The donor’s name inadvertently Federal CCF for a specimen being result and indicate the reason for the appears on the laboratory copy of the reported drug positive, adulterated, rejected for testing result on the Federal Federal CCF or on the tamper-evident substituted, rejected for testing, or CCF. labels used to seal the specimens. invalid test result (as appropriate for (b) If a specimen is submitted using a (19) For urine only, the collector each type of specimen collected); or non-Federal form or an expired Federal failed to check the specimen (3) The electronic report provided by CCF, the laboratory or IITF must test the temperature box and the ‘‘Remarks’’ line the HHS-certified laboratory or IITF specimen and also attempt to obtain a did not have a comment regarding the does not contain all the data elements memorandum for record explaining why temperature being out of range. If the required for the HHS standard a non-Federal form or an expired collector cannot provide a electronic laboratory or IITF report for a Federal CCF was used and ensure that memorandum for record (MFR) to attest specimen being reported drug positive, the form used contains all the required to the fact that he or she did measure adulterated, substituted, rejected for information. If the laboratory or IITF the specimen temperature, the testing, or invalid test result. cannot obtain a memorandum for record laboratory may report the test result for (b) If error (a)(1) occurs, the MRO from the collector, the laboratory or IITF the specimen but indicates that the must contact the collector to obtain a must report a rejected for testing result collector could not provide an MFR to statement to verify that the donor and indicate the reason for the rejected recover the omission. refused to sign the MRO copy. If the (b) The following omissions and for testing result on the report to the collector cannot provide such a discrepancies on the Federal CCF that MRO. statement, the MRO must cancel the are made at the laboratory or IITF are test. Section 16.3 What Discrepancies Are considered insignificant and should not (c) If error (a)(2) occurs, the MRO Not Sufficient To Require a Laboratory cause an MRO to cancel a test: must obtain a statement from the CS or IITF To Reject a Hair, Oral Fluid, (1) The testing laboratory or IITF fails that he or she inadvertently forgot to Sweat, or Urine Specimen for Testing or to indicate the correct name and address sign the CCF, but did, in fact, properly an MRO To Cancel a Test? in the results section when a different conduct the certification review. laboratory or IITF name and address is (a) The following omissions and (d) If error (a)(3) occurs, the MRO printed at the top of the Federal CCF; must contact the HHS-certified discrepancies on the Federal CCF that is (2) The accessioner fails to print his received by the HHS-certified laboratory laboratory or IITF and require the HHS- or her name; certified laboratory or IITF to modify its or IITF are considered insignificant and (3) The certifying scientist fails to electronic reports and to retransmit a should not cause an HHS-certified print his or her name; corrected electronic report. laboratory or IITF to reject a specimen (4) The certifying scientist or cause an MRO to cancel a test: accidentally initials the Federal CCF Subpart Q—Laboratory or IITF (1) An incorrect laboratory name and rather than providing a signature for a Suspension/Revocation Procedures address appears at the top of the form; non-negative result (CS initials are Section 17.1 When May an HHS- (2) Incomplete/incorrect/unreadable acceptable for a negative result); employer name or address; (5) The accessioner fails to mark one Certified Laboratory or IITF Be (3) MRO name is missing; of the ‘‘primary specimen bottle seal Suspended? (4) Incomplete/incorrect MRO intact’’ boxes, but the laboratory These procedures apply when: address; reported a ‘‘rejected for testing’’ result (a) The Secretary has notified an HHS- (5) A transposition of numbers in the with an appropriate comment on the certified laboratory or IITF in writing donor’s SSN; ‘‘Remarks’’ line. that its certification to perform drug

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testing under these Guidelines has been suspension or proposed revocation, a (b) Respondent’s Documents and suspended or that the Secretary brief statement of why the decision to Brief. Within 15 days after receiving a proposes to revoke such certification. suspend or propose revocation is wrong, copy of the acknowledgment of the (b) The HHS-certified laboratory or and the appellant’s request for an oral request for review, the respondent shall IITF has, within 30 days of the date of presentation, if desired. submit to the reviewing official the such notification or within 3 days of the (b) Within 5 days after receiving the following (with a copy to the appellant): date of such notification when seeking request for review, the reviewing official (1) A review file containing an expedited review of a suspension, will send an acknowledgment and documents supporting respondent’s requested in writing an opportunity for advise the appellant of the next steps. decision to suspend or revoke an informal review of the suspension or The reviewing official will also send a appellant’s certification to perform drug proposed revocation. copy of the acknowledgment to the and/or validity testing, tabbed and respondent. organized chronologically, and Section 17.2 What Definitions Are accompanied by an index identifying Used for This Subpart? Section 17.6 What Is an Abeyance Agreement? each document. Only essential Appellant. Means the HHS-certified documents should be submitted to the laboratory or IITF which has been Upon mutual agreement of the parties reviewing official. notified of its suspension or proposed to hold these procedures in abeyance, (2) A written statement, not exceeding revocation of its certification to perform the reviewing official will stay these 20 double-spaced pages in length, drug and/or validity testing and has procedures for a reasonable time while explaining the basis for suspension or requested an informal review thereof. the laboratory or IITF attempts to regain proposed revocation (respondent’s Respondent. Means the person or compliance with the Guidelines or the brief). persons designated by the Secretary in parties otherwise attempt to settle the (c) Reply Briefs. Within 5 days after implementing these Guidelines. dispute. As part of an abeyance receiving the opposing party’s Reviewing Official. Means the person agreement, the parties can agree to submission, or 20 days after receiving or persons designated by the Secretary extend the time period for requesting acknowledgment of the request for who will review the suspension or review of the suspension or proposed review, whichever is later, each party proposed revocation. The reviewing revocation. If abeyance begins after a may submit a short reply not to exceed official may be assisted by one or more request for review has been filed, the 10 double-spaced pages. of his or her employees or consultants appellant shall notify the reviewing (d) Cooperative Efforts. Whenever in assessing and weighing the scientific official at the end of the abeyance feasible, the parties should attempt to and technical evidence and other period advising whether the dispute has develop a joint review file. information submitted by the appellant been resolved. If the dispute has been (e) Excessive Documentation. The and respondent on the reasons for the resolved, the request for review will be reviewing official may take any suspension and proposed revocation. dismissed. If the dispute has not been appropriate step to reduce excessive resolved, the review procedures will documentation, including the return of Section 17.3 Are There Any Limitation begin at the point at which they were or refusal to consider documentation on Issues Subject To Review? interrupted by the abeyance agreement found to be irrelevant, redundant, or The scope of review shall be limited with such modifications to the unnecessary. to the facts relevant to any suspension procedures as the reviewing official Section 17.8 When Is There an or proposed revocation, the necessary deems appropriate. Opportunity for Oral Presentation? interpretations of those facts, the Mandatory Guidelines for Federal Section 17.7 What Procedure Is Used (a) Electing Oral Presentation. If an Workplace Drug Testing Programs, and To Prepare the Review File and Written opportunity for an oral presentation is other relevant law. The legal validity of Argument? desired, the appellant shall request it at these Guidelines shall not be subject to The appellant and the respondent the time it submits its written request review under these procedures. each participate in developing the file for review to the reviewing official. The for the reviewing official and in reviewing official will grant the request Section 17.4 Who Represents the submitting written arguments. The if the official determines that the Parties? procedures for development of the decision-making process will be The appellant’s request for review review file and submission of written substantially aided by oral presentations shall specify the name, address, and argument are: and arguments. The reviewing official phone number of the appellant’s (a) Appellant’s Documents and Brief. may also provide for an oral representative. In its first written Within 15 days after receiving the presentation at the official’s own submission to the reviewing official, the acknowledgment of the request for initiative or at the request of the respondent shall specify the name, review, the appellant shall submit to the respondent. address, and phone number of the reviewing official the following (with a (b) Presiding Official. The reviewing respondent’s representative. copy to the respondent): official or designee will be the presiding (1) A review file containing the official responsible for conducting the Section 17.5 When Must a Request for documents supporting appellant’s oral presentation. Informal Review Be Submitted? argument, tabbed and organized (c) Preliminary Conference. The (a) Within 30 days of the date of the chronologically, and accompanied by an presiding official may hold a prehearing notice of the suspension or proposed index identifying each document. Only conference (usually a telephone revocation, the appellant must submit a essential documents should be conference call) to consider any of the written request to the reviewing official submitted to the reviewing official. following: simplifying and clarifying seeking review, unless some other time (2) A written statement, not to exceed issues; stipulations and admissions; period is agreed to by the parties. A 20 double-spaced pages, explaining why limitations on evidence and witnesses copy must also be sent to the respondent’s decision to suspend or that will be presented at the hearing; respondent. The request for review must propose revocation of appellant’s time allotted for each witness and the include a copy of the notice of certification is wrong (appellant’s brief). hearing altogether; scheduling the

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hearing; and any other matter that will summary judgment. Except for those party’s position concerning the assist in the review process. Normally, made during the hearing, all motions suspension and any proposed this conference will be conducted and opposition to motions, including revocation. No reply brief is permitted. informally and off the record; however, argument, must be in writing and be no (d) Oral Presentation. If an oral the presiding official may, at his or her more than 10 double-spaced pages in presentation is requested by the discretion, produce a written document length. The presiding official will set a appellant or otherwise granted by the summarizing the conference or reasonable time for the party opposing reviewing official, the presiding official transcribe the conference, either of the motion to reply. will attempt to schedule the oral which will be made a part of the record. (5) Transcripts. The presiding official presentation within 7–10 days of the (d) Time and Place of Oral shall have the oral presentation date of appellant’s request for review at Presentation. The presiding official will transcribed and the transcript shall be a time and place determined by the attempt to schedule the oral made a part of the record. Either party presiding official following consultation presentation within 30 days of the date may request a copy of the transcript and with the parties. The presiding official appellant’s request for review is the requesting party shall be responsible received or within 10 days of for paying for its copy of the transcript. may hold a prehearing conference in submission of the last reply brief, (f) Obstruction of Justice or Making of accordance with section 17.8(c) and will whichever is later. The oral presentation False Statements. Obstruction of justice conduct the oral presentation in will be held at a time and place or the making of false statements by a accordance with the procedures of determined by the presiding official witness or any other person may be the sections 17.8(e), (f), and (g). following consultation with the parties. basis for a criminal prosecution under (e) Written Decision. The reviewing (e) Conduct of the Oral Presentation. 18 U.S.C. 1505 or 1001. official shall issue a written decision (1) General. The presiding official is (g) Post-hearing Procedures. At his or upholding or denying the suspension or responsible for conducting the oral her discretion, the presiding official proposed revocation and will attempt to presentation. The presiding official may may require or permit the parties to issue the decision within 7–10 days of be assisted by one or more of his or her submit post-hearing briefs or proposed the date of the oral presentation or employees or consultants in conducting findings and conclusions. Each party within 3 days of the date on which the the oral presentation and reviewing the may submit comments on any major transcript is received or the date of the evidence. While the oral presentation prejudicial errors in the transcript. last submission by either party, will be kept as informal as possible, the Section 17.9 Are There Expedited whichever is later. All other provisions presiding official may take all necessary set forth in section 17.14 will apply. steps to ensure an orderly proceeding. Procedures for Review of Immediate (2) Burden of Proof/Standard of Proof. Suspension? (f) Transmission of Written In all cases, the respondent bears the (a) Applicability. When the Secretary Communications. Because of the burden of proving by a preponderance notifies a laboratory or IITF in writing importance of timeliness for these of the evidence that its decision to that its certification to perform drug expedited procedures, all written suspend or propose revocation is and/or validity testing has been communications between the parties appropriate. The appellant, however, immediately suspended, the appellant and between either party and the has a responsibility to respond to the may request an expedited review of the reviewing official shall be by facsimile respondent’s allegations with evidence suspension and any proposed or overnight mail. and argument to show that the revocation. The appellant must submit Section 17.10 Are Any Types of respondent is wrong. this request in writing to the reviewing Communications Prohibited? (3) Admission of Evidence. The rules official within 3 days of the date the of evidence do not apply and the laboratory or IITF received notice of the Except for routine administrative and presiding official will generally admit suspension. The request for review must procedural matters, a party shall not all testimonial evidence unless it is include a copy of the suspension and communicate with the reviewing or clearly irrelevant, immaterial, or unduly any proposed revocation, a brief presiding official without notice to the repetitious. Each party may make an statement of why the decision to other party. opening and closing statement, may suspend and propose revocation is present witnesses as agreed upon in the wrong, and the appellant’s request for Section 17.11 How Are prehearing conference or otherwise, and an oral presentation, if desired. A copy Communications Transmitted by the may question the opposing party’s of the request for review must also be Reviewing Official? witnesses. Since the parties have ample sent to the respondent. opportunity to prepare the review file, (a) Because of the importance of a (b) Reviewing Official’s Response. As timely review, the reviewing official a party may introduce additional soon as practicable after the request for documentation during the oral should normally transmit written review is received, the reviewing official communications to either party by presentation only with the permission will send an acknowledgment with a of the presiding official. The presiding facsimile or overnight mail in which copy to the respondent. case the date of transmission or day official may question witnesses directly (c) Review File and Briefs. Within 7 following mailing will be considered the and take such other steps necessary to days of the date the request for review date of receipt. In the case of ensure an effective and efficient is received, but no later than 2 days communications sent by regular mail, consideration of the evidence, including before an oral presentation, each party the date of receipt will be considered 3 setting time limitations on direct and shall submit to the reviewing official the days after the date of mailing. cross-examinations. following: (4) Motions. The presiding official (1) A review file containing essential (b) In counting days, include may rule on motions including, for documents relevant to the review, Saturdays, Sundays, and holidays. example, motions to exclude or strike tabbed, indexed, and organized However, if a due date falls on a redundant or immaterial evidence, chronologically; and Saturday, Sunday, or Federal holiday, motions to dismiss the case for (2) A written statement, not to exceed then the due date is the next Federal insufficient evidence, or motions for 20 double-spaced pages, explaining the working day.

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Section 17.12 What Is the Authority submissions by the parties; transcripts immediately communicate the decision and Responsibilities of the Reviewing or other records of any meetings, to each party. Official? conference calls, or oral presentation; (c) Public Notice. If the suspension In addition to any other authority evidence submitted at the oral and proposed revocation are upheld, the specified in these procedures, the presentation; and orders and other revocation will become effective documents issued by the reviewing and reviewing official and the presiding immediately and the public will be presiding officials. official, with respect to those authorities notified by publication of a notice in the involving the oral presentation, shall Section 17.14 What Are the Federal Register. If the suspension and have the authority to issue orders; Requirements for a Written Decision? proposed revocation are denied, the examine witnesses; take all steps (a) Issuance of Decision. The revocation will not take effect and the necessary for the conduct of an orderly suspension will be lifted immediately. hearing; rule on requests and motions; reviewing official shall issue a written Public notice will be given by grant extensions of time for good decision upholding or denying the reasons; dismiss for failure to meet suspension or proposed revocation. The publication in the Federal Register. deadlines or other requirements; order decision will set forth the reasons for Section 17.15 Is There a Review of the the decision and describe the basis the parties to submit relevant Final Administrative Action? information or witnesses; remand a case therefor in the record. Furthermore, the for further action by the respondent; reviewing official may remand the Before any legal action is filed in waive or modify these procedures in a matter to the respondent for such court challenging the suspension or specific case, usually with notice to the further action as the reviewing official proposed revocation, respondent shall parties; reconsider a decision of the deems appropriate. exhaust administrative remedies reviewing official where a party (b) Date of Decision. The reviewing provided under this subpart, unless promptly alleges a clear error of fact or official will attempt to issue his or her otherwise provided by Federal Law. The law; and to take any other action decision within 15 days of the date of reviewing official’s decision, under the oral presentation, the date on which necessary to resolve disputes in section 17.9(e) or 17.14(a), constitutes the transcript is received, or the date of accordance with the objectives of these final agency action and is ripe for the last submission by either party, procedures. judicial review as of the date of the whichever is later. If there is no oral Section 17.13 What Administrative presentation, the decision will normally decision. Records Are Maintained? be issued within 15 days of the date of [FR Doc. 04–7984 Filed 4–6–04; 12:39 pm] The administrative record of review receipt of the last reply brief. Once BILLING CODE 4162–20–P consists of the review file; other issued, the reviewing official will

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Part IV

Environmental Protection Agency 40 CFR Part 63 Site-Specific Rulemaking for Packaging Corporation of America’s Pulp and Paper Mill Located in Tomahawk, WI, in Pursuant to the Joint State/EPA Agreement To Pursue Regulatory Innovation; Direct Final Rule and Proposed Rule

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ENVIRONMENTAL PROTECTION methodology currently prescribed by public meetings. Nevertheless, in the AGENCY the Pulp and Paper Industry NESHAP. ‘‘Proposed Rules’’ section of this Federal Additionally, the revisions are Register, EPA is publishing a separate 40 CFR Part 63 consistent with the Innovations document with the same title that will [FRL–7646–6] Agreement by allowing PCA’s serve as the proposal to amend the Pulp Tomahawk Mill to achieve superior and Paper Industry NESHAP if RIN 2090–AA33 environmental performance through significant adverse comments are filed. regulatory flexibility. Site-Specific Rulemaking for If we receive any significant adverse DATES: This direct final rule will be Packaging Corporation of America’s comments, we will publish a timely effective on June 14, 2004 without withdrawal in the Federal Register Pulp and Paper Mill Located in further notice, unless EPA receives informing the public that this direct Tomahawk, WI, Pursuant to the Joint adverse comments by May 13, 2004. If final rule will not take effect. We will State/EPA Agreement To Pursue EPA receives adverse comments, the address all public comments in a Regulatory Innovation Agency will publish a timely subsequent final rule based on the withdrawal in the Federal Register AGENCY: Environmental Protection proposed rule. We will not institute a Agency. informing the public that this rule will not take effect. second comment period on this direct ACTION: Direct final rule. final rule. Any parties interested in ADDRESSES: Comments may be commenting must do so at this time. SUMMARY: The U.S. Environmental submitted by mail by sending two (2) Protection Agency (EPA or the Agency) copies of your comments to the Air and Docket is taking direct final action to approve Radiation Docket and Information revisions to the National Emissions Center, Environmental Protection EPA has established an official public Standards for Hazardous Air Pollutants Agency, Mailcode: 6102T, 1200 docket for this action under Docket ID from the Pulp and Paper Industry (Pulp Pennsylvania Ave., NW., Washington, No. OAR–2003–0205. The official and Paper Industry NESHAP). DC 20460, Attention Docket ID No. public docket consists of the documents Collectively, these revisions comprise a OAR–2003–0205. Comments may also specifically referenced in this action, site-specific rule to control Hazardous be submitted electronically, or through any public comments received, and Air Pollutants (HAPs) applicable only to hand delivery/courier, following the other information related to this action. the semi-chemical pulp and paper mill detailed instructions as provided in the Although a part of the official docket, currently owned and operated by proposed rule action with the same title the public docket does not include Packaging Corporation of America located in the ‘‘Proposed Rules’’ section Confidential Business Information (CBI) (PCA) in Tomahawk, Wisconsin (the of today’s Federal Register. or other information statutorily Tomahawk Mill). EPA is adopting these FOR FURTHER INFORMATION CONTACT: Ms. restricted from disclosure. The official revisions pursuant to the Clean Air Act Eileen L. Furey or Mr. Eaton R. Weiler public docket is the collection of (CAA) and the Joint State/EPA at U.S. EPA, Region 5, 77 West Jackson materials that is available for public Agreement to Pursue Regulatory Boulevard, Chicago, Illinois 60604. Ms. viewing at the Air and Radiation Docket Innovation (Innovations Agreement). Furey or Mr. Weiler can be reached at and Information Center in the EPA The Pulp and Paper Industry (312) 886–7950 or (312) 886–6041, Docket Center (EPA/DC), EPA West, NESHAP currently requires semi- respectively (or by e-mail at: Room B102, 1301 Constitution Ave., chemical pulp and paper mills to [email protected] or NW., Washington, DC. The EPA Docket control the HAP emissions from the air [email protected]). Center Public Reading Room is open stack for the collection of equipment SUPPLEMENTARY INFORMATION: from 8:30 a.m. to 4:30 p.m., Monday comprising the Low Volume High through Friday, excluding legal Concentration (LVHC) system. Neither Regulated Entities holidays. The telephone number for the the Pulp and Paper Industry NESHAP, This site-specific revision to the Pulp Reading Room is (202) 566–1744, and nor any other Federal or State and Paper Industry NESHAP, which the telephone number for the Air and regulation, requires such mills to governs the emission of HAPs from the Radiation Docket is (202) 566–1742. control HAPs that may be contained in pulp and paper industry, applies only to the liquid condensates from the LVHC a single source, PCA’s Tomahawk, Electronic Access system. This site-specific rule allows Wisconsin pulp and paper mill. You may access this Federal Register PCA’s Tomahawk Mill to control the document electronically through the HAPs generated in the LVHC system by Direct Final Rule EPA Internet under the ‘‘Federal condensing them into a liquid and EPA is issuing these revisions as a Register’’ listings at http:// treating them via anaerobic direct final rule, without prior proposal, biodegradation in the facility’s because we consider the revisions to be www.epa.gov/fedrgstr/. wastewater treatment system. In other noncontroversial and anticipate no An electronic version of the public words, the site-specific rule allows significant adverse comments. docket is available through EPA’s PCA’s Tomahawk Mill to control the Additionally, EPA is aware that most electronic public docket and comment HAPs generated in the LVHC system persons with an interest in this system, EPA Dockets. You may use EPA from an emission point and with a proposed rule have already been Dockets at http://www.epa.gov/edocket/ technology not addressed by the Pulp afforded at least two opportunities to to submit or view public comments, and Paper Industry NESHAP. comment on its merits. In April 2003, access the index listing of the contents As a result, PCA will maintain and again in September 2003, PCA of the official public docket, and to compliance with the CAA and achieve sponsored public meetings regarding the access those documents in the public a reduction in HAPs emitted to the project that is described at length in docket that are available electronically. environment significantly superior to today’s rule. EPA believes that PCA Once in the system, select ‘‘search,’’ that which would have been achieved made every reasonable effort to invite then key in the appropriate docket through compliance with the control all potential stakeholders to those identification number.

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Outline of Today’s Document control HAPs emitted by such sources. system. Semi-chemical mills must The information presented in this ‘‘Major sources’’ are those that emit (or enclose the numerous equipment preamble is arranged as follows: have the potential to emit) at least 10 systems comprising the LVHC system, tons per year of any single HAP (e.g. and route the HAP-containing air I. Authority methanol), or 25 tons per year of any emissions through a closed-vent system II. Background combination of HAPs. Additionally, A. Background of the Pulp and Paper to a control device. The positive Industry NESHAP section 112 specifies that EPA’s pressure portions of the closed vent 1. Background of the Pulp and Paper regulations promulgated thereunder system must be designed and operated Industry NESHAP Generally must require major sources of HAPs to with no detectable leaks. Regulated 2. The Requirements of the Pulp and Paper attain the maximum achievable mills may choose among four control Industry NESHAP as Applied to PCA’s reduction in HAP emissions, taking into device options for destroying the Tomahawk Mill consideration cost, non-air quality collected HAPs. The control device B. Overview of the Regulatory Innovation health and environmental impacts, and must: (1) Reduce the total HAP Agreements energy requirements. In essence, emissions by 98 percent or more by 1. The Joint State/EPA Agreement To regulations promulgated pursuant to Pursue Regulatory Innovation weight; (2) reduce total HAP (Innovations Agreement) section 112 must ensure that all concentration at the outlet of the 2. The WDNR/EPA Memorandum of regulated HAP sources achieve the level thermal oxidizer to 20 parts per million Agreement of control that is already being achieved or less by volume, corrected to 10 3. The WDNR/PCA Environmental by the lower (12% lowest) emitting percent oxygen on a dry basis; (3) Cooperative Agreement sources in each industrial category or reduce total HAP emissions using a III. The Site-Specific Rule subcategory. See 42 U.S.C. 7412(d)(3). thermal oxidizer designed and operated A. Rationale and Background of the Site- This approach provides assurance to at a minimum temperature of 871 Specific Rule U.S. citizens that regulated sources will B. Environmental Benefit of the Site- degrees Centigrade and a minimum Specific Rule employ good control measures to limit residence time of 0.75 seconds; or (4) C. Overview of the Site-Specific Rule their HAP emissions. reduce the total HAP emissions using a IV. Statutory and Executive Order Reviews EPA identified the pulp and paper boiler, lime kiln, or recovery furnace by A. Executive Order 12866: Regulatory industry as a major source requiring introducing the HAP emission stream Planning and Review regulation under section 112 of the with the primary fuel or into the flame B. Paperwork Reduction Act CAA. Accordingly, on April 15, 1998, zone. See 40 CFR 63.443(d). Neither the C. Regulatory Flexibility Act EPA promulgated the Pulp and Paper Pulp and Paper Industry NESHAP, nor D. Unfunded Mandates Reform Act Industry NESHAP (See 63 FR 18503). any other federal or state regulation, E. Executive Order 13132: Federalism The Pulp and Paper Industry NESHAP, F. Executive Order 13175: Consultation requires semi-chemical pulp and paper 40 CFR 63.440 through 63.459, mills to control the HAPs that may be and Coordination With Indian Tribal subcategorized the pulp and paper Governments contained in the liquid condensates G. Executive Order 13045: Protection of industry according to seven different generated in the LVHC system (‘‘pulping Children From Environmental Health pulping processes (kraft, sulfite, semi- process condensates’’). and Safety Risks chemical, soda, mechanical wood H. Executive Order 13211: Actions That pulping, secondary fiber pulping, or B. Overview of the Regulatory Significantly Affect Energy Supply, non-wood pulping), and established Innovation Agreements Distribution, or Use different emissions standards for each 1. The Joint State/EPA Agreement To I. National Technology Transfer such process. For a thorough and Advancement Act Pursue Regulatory Innovation detailed discussion on the background, (Innovations Agreement) J. Executive Order 12898: Federal Actions development, and promulgation of the To Address Environmental Justice in Pulp and Paper Industry NESHAP, the EPA announced the Innovations Minority Populations and Low-Income reader is referred to the following Web Agreement on May 5, 1998 (63 FR Populations 24874). Through this agreement, EPA K. Executive Order 12998: Civil Justice site: http://www.epa.gov/ttn/atw/pulp/ Reform pulppg.html. The website contains links and senior State environmental officials L. Congressional Review Act to all relevant Federal Register notices, jointly committed to encouraging new background documents, enabling and innovative approaches to I. Authority documents, fact sheets, and rule improvement of the nation’s EPA issues this regulation under the summary documents. environment. The parties to the authority provided by sections 112 and Innovations Agreement agreed that the 2. The Requirements of the Pulp and 301(a)(1) of the CAA, 42 U.S.C. 7412 following seven principles would guide Paper Industry NESHAP as Applied to and 7601(a)(1). EPA has determined that the process of developing, testing and PCA’s Tomahawk Mill this rulemaking is subject to the implementing regulatory innovations: provisions of section 307(d) of the CAA, PCA uses a sodium carbonate semi- experimentation; environmental 42 U.S.C. 7607(d). chemical process to produce performance; smarter approaches; unbleached corrugating medium at the stakeholder involvement; measuring II. Background Tomahawk Mill. In order to prevent and verifying results; accountability/ A. Background of the Pulp and Paper pollution of the air by HAPs generated enforcement; and State-EPA Industry NESHAP during semi-chemical pulping partnership. The Innovations Agreement processes, the Pulp and Paper Industry encouraged ‘‘prudent risk taking’’ as a 1. Background of the Pulp and Paper NESHAP requires the collection and necessary component of the effort to Industry NESHAP Generally control of HAP emissions from a continue the nation’s progress towards Section 112 of the CAA, 42 U.S.C. collection of equipment systems. This protection of human health and the 7412 et seq., requires EPA first to collection of equipment systems (which environment. identify, by industrial category or includes the digester and evaporator The Innovations Agreement subcategory, ‘‘major sources’’ of HAPs, systems) is referred to in the Pulp and established a process by which the and then to promulgate regulations to Paper Industry NESHAP as the LVHC States would develop innovation

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proposals and obtain prompt review and Tomahawk Mill to comply with the then NESHAP.) In lieu of controlling the acceptance or rejection by EPA. The recently-enacted Pulp and Paper HAPs from the LVHC system at the success of any innovation project would Industry NESHAP, the company LVHC air stack, the WDNR/PCA be measured by its environmental discovered that, due to its unique Agreement allowed PCA to route the impact, improved efficiency, or other process configuration, the vast majority LVHC air emissions at its Tomahawk relevant indicator of superior of HAPs generated in the LVHC system Mill through a series of indirect contact performance. partition to the pulping process condensers and hardpipe the resulting condensates. PCA used these pulping process condensates to an 2. The WDNR/EPA Memorandum of condensates as process water in other anaerobic digester for biodegradation. Agreement facility operations, which allowed the Additionally, the WDNR/PCA To carry out the purposes of the HAPs in the condensates to be emitted Agreement required PCA to conduct a Innovations Agreement, on March 25, to the air. Recognizing the opportunity second full-scale performance test of its 1999 the Wisconsin Department of to destroy a far greater quantity of HAPs wastewater treatment system in order to Natural Resources (WDNR) and Region by treating the condensates instead of identify and develop enforceable 5 EPA entered into a Memorandum of the LVHC air stack emissions, PCA operating parameters and a monitoring Agreement (MOA). The MOA proposed an environmental pilot project plan, acceptable to EPA, that would recognized that the Wisconsin to WDNR. In lieu of treatment of the ensure continuous compliance with the legislature had established an LVHC air stack emissions via thermal more stringent level of HAP destruction. Environmental Cooperation Pilot destruction (as contemplated by the Finally, the WDNR/PCA Agreement Program, which provided WDNR the Pulp and Paper Industry NESHAP), PCA identified certain provisions of the Pulp statutory authority to develop up to ten proposed to treat the condensed HAPs and Paper Industry NESHAP with pilot projects with companies willing to via biodegradation in the Tomahawk which PCA’s Tomahawk Mill would be test alternative approaches to traditional Mill’s anaerobic wastewater treatment required to comply regardless of, or command and control regulations. (Wis. system. because of, its use of an alternative Stat. Sec. 299.80). Many of the goals of WDNR concurred with PCA’s treatment technology. See 68 FR 7706, the Wisconsin pilot program were conclusions about the environmental 7707–7708 (February 18, 2003), where similar to those articulated in the benefits of the proposed project and, on EPA adopted a similar amendment to Innovations Agreement. The Wisconsin August 27, 1999, submitted PCA’s the Pulp and Paper NESHAP. pilot program required any participating proposal to Region 5 as one appropriate Pursuant to the WDNR/PCA company to enter into an environmental for evaluation under the terms of the Agreement, during October of 2002, cooperative agreement with WDNR. In MOA. EPA’s Office of Air Quality PCA performed the second full-scale return for operational flexibility and Planning and Standards (OAQPS) performance test of the Tomahawk variances from applicable state thereafter requested PCA to conduct a Mill’s anaerobic wastewater treatment regulations, participating pilot full-scale study of the ability of its system. The test further verified that companies agreed to achieve anaerobic wastewater treatment system PCA’s anaerobic wastewater treatment environmental performance superior to to achieve a level of HAP destruction system was capable of achieving a more that which would be achieved through superior to that which would be stringent level of HAP destruction than compliance with existing regulations. achieved through compliance with the would be accomplished through Participating companies further agreed Pulp and Paper Industry NESHAP. The compliance with the Pulp and Paper to establish environmental management full-scale treatability study successfully Industry NESHAP. Importantly, through systems at their facilities to ensure established that PCA’s anaerobic system the test results, PCA, EPA and WDNR regular auditing and reporting of could: (1) Destroy the same HAPs as are identified enforceable operating environmental performance and required to be controlled under the Pulp parameters, and also developed a compliance. and Paper Industry NESHAP; and (2) monitoring plan that ensures WDNR and Region 5 recognized in the destroy a significantly greater quantity continuous achievement of the more MOA that EPA would not be a party to of those HAPs than would be destroyed stringent level of HAP destruction. these state-company agreements, but through compliance with the Pulp and The WDNR/PCA Agreement specified provided that when Federal Paper NESHAP. In June 2001, OAQPS that in the event a site-specific rule for involvement was needed or helpful, and Region 5 approved PCA’s PCA’s Tomahawk Mill was not Region 5 would promptly identify and, innovation project as one appropriate to finalized, the WDNR/PCA Agreement when appropriate, take the necessary pursue. would terminate. EPA agreed to take no federal steps to implement a pilot On September 10, 2002, pursuant to enforcement action against PCA for project. WDNR and EPA agreed that the Wisconsin Environmental violations of the requirements of 40 CFR when a project undertaken pursuant to Cooperation Pilot Program, and with 63.443(c) and (d) at the Tomahawk a Wisconsin environmental cooperative Region 5 EPA’s support under the MOA, facility until EPA either revised the agreement required a change in the WDNR and PCA entered into an Pulp and Paper Industry NESHAP to regulatory requirements of a federally Environmental Cooperative Agreement include a Federal site-specific rule for authorized or delegated program, the (WDNR/PCA Agreement). The WDNR/ PCA’s Tomahawk Mill, or notified the agencies would follow applicable PCA Agreement required PCA’s company that EPA had decided that a Federal procedures for the necessary Tomahawk Mill to achieve site-specific rule was inappropriate, rule or program changes. The agencies approximately double the destruction of improper or inadequate. Finally, the specifically intended that any such HAPs over what would be achieved WDNR/PCA Agreement specified that, changes would be federally enforceable. through compliance with 40 CFR provided certain conditions were 63.443(c) and(d) (as explained below, satisfied and subject to the approval of 3. The WDNR/PCA Environmental EPA actually believes the facility will U.S. EPA and WDNR, PCA’s rights and Cooperative Agreement achieve a greater than five-fold increase obligations under the agreement could As explained at greater length below, in HAP destruction over what would be transferred to any subsequent owner when PCA began to investigate what have been achieved through compliance of the Tomahawk Mill. Among other changes would be necessary at its with the Pulp and Paper Industry things, a transferee would be obligated

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to demonstrate that it had the financial the Tomahawk Mill mixed the pulping wastewater treatment plant are and technical capability to assume the process condensates with other reuse destroyed by anaerobic biodegradation.1 obligations of the WDNR/PCA water streams and routed them to other The maximum quantity of HAPs Agreement. uncontrolled production processes at available for destruction at PCA’s For a copy of the WDNR/PCA the mill. Testing conducted by PCA Tomahawk Mill through compliance Agreement, and associated fact sheets revealed that the condensates from the with 40 CFR 63.443(d) is approximately and public notices, the reader is referred two indirect contact condensers 0.6 pounds of HAP per ODTP. The Pulp to the following Web site: http:// following the digester system contained and Paper Industry NESHAP requires www.dnr.state.wi.us/org/caer/cea/ecpp/ approximately 2.5 pounds of HAPs per that 98 percent of the approximately 0.6 agreements/pca/. ODTP—in other words, approximately pounds (i.e. 0.59 pounds HAPs/ODTP) six times the quantity of HAPS, as be destroyed. As indicated above, by III. The Site-Specific Rule methanol, that could potentially be hardpiping the pulping process A. Rationale and Background of the treated as LVHC air emissions, as condensates to the anaerobic basins of Site-Specific Rule currently prescribed by the Pulp and the wastewater treatment plant, approximately 3.0 pounds of HAPs per Existing semi-chemical mills subject Paper Industry NESHAP. EPA, WDNR, and PCA concluded that ODTP are available for destruction and, to the Pulp and Paper Industry the destruction of HAPs contained in in actuality, more than 96 percent of the NESHAP, including PCA’s Tomahawk the pulping process condensates from approximately 3.0 pounds (i.e. at least Mill, were required to comply with the the Tomahawk Mill’s LVHC system— 2.9 pounds/ODTP) are destroyed. In applicable provisions of the Pulp and rather than destruction of HAPs short, by condensing the HAPs from the Paper Industry NESHAP by April 16, contained in the air stack emissions entire LVHC system and routing them to 2001. In 1999, while preparing to from the LVHC system—would result in the anaerobic wastewater treatment comply with the Pulp and Paper greater overall reduction of HAPs system for treatment, PCA is able to Industry NESHAP at its Tomahawk emitted to the environment. EPA, destroy approximately five times the Mill, PCA recognized that to properly WDNR, and PCA further reasoned that mass of HAPs that it would otherwise design and operate a Pulp and Paper PCA’s Tomahawk Mill would be able to destroy through compliance with the Industry NESHAP-compliant treat the HAPs contained in the pulping Pulp and Paper Industry NESHAP. incineration control device, it needed to process condensates by hardpiping C. Overview of the Site-Specific Rule condition the air emissions from the them to the basins of PCA Tomahawk’s digester system. Accordingly, PCA state-of-the-art wastewater treatment EPA’s rule allows PCA, in lieu of installed two in-series indirect contact plant for anaerobic biodegradation. controlling HAPs in the Tomahawk condensers following the digester Such alternative treatment would yield Mill’s LVHC air stack emissions, to system, which conditioned the air significant cost savings to PCA, since control the HAPs partitioning from emissions by reducing the moisture the company would not need to design those air emissions to the pulping content. and install an incinerator to control the process condensates. More particularly, Before designing the incineration HAPs contained in the air emissions EPA’s rule allows PCA to: (1) Install a control device, PCA next sought to from the LVHC system at the Tomahawk closed-vent system to collect the HAP- characterize (for HAP content, flow rate, Mill. containing air emissions from the LVHC moisture content, etc.) the air emissions EPA then authorized PCA to proceed system; (2) route the emissions through from the two new indirect contact to implement the project for the entire a series of indirect contact condensers; condensers. PCA’s testing surprisingly LVHC system (as opposed to just the and (3) hardpipe the resulting pulping revealed that the HAP content in the digester system), and requested PCA to process condensates to the anaerobic LVHC air emissions was far less than conduct full scale testing upon basins of the facility’s wastewater the company had expected. The air completion of the project. PCA treatment plant. The anaerobic basins of emissions from the digester system at proceeded thereafter to install a third the wastewater treatment plant must the Tomahawk Mill contained indirect contact condenser, and collect achieve a destruction efficiency of at approximately 0.4 pounds of HAPs, as and route the HAP-containing air least 1.0 pound of HAPs per ODTP by methanol, per Oven Dried Ton of Pulp emissions from the entire LVHC system anaerobic biodegradation, i.e. (ODTP). Background studies for the through the third indirect contact approximately twice the quantity of Pulp and Paper Industry NESHAP had condenser. what would have been achieved by the led PCA to believe that these air facility under the current Pulp and emissions would contain greater than B. Environmental Benefit of the Site- Paper Industry NESHAP. EPA and PCA two pounds of HAPs, as methanol, per Specific Rule actually anticipate that the HAP ODTP. PCA’s subsequent full-scale testing destruction in the wastewater treatment PCA then undertook a study to demonstrated that, with the installation plant anaerobic basins will significantly determine why the HAP content of the of the third indirect contact condenser, exceed the 1.0 pound per ODTP digester system’s air emissions was far approximately 85 percent of the HAPs requirement. As stated above, the less than expected. PCA determined in the entire LVHC system partition to average HAP destruction efficiency of that, because of the unique process the pulping process condensates. While the wastewater treatment system is configuration at its Tomahawk Mill, the the air emissions from the entire LVHC approximately 3.0 pounds per ODTP. vast majority of the HAPs contained in system contain approximately 0.6 the air emissions from the digester pounds of HAPs per ODTP, the pulping 1 For purposes of calculating a HAP destruction system partitioned to the condensate process condensates contain efficiency, EPA required PCA to assume that the concentration of HAPs in the wastewater treatment stream produced by the indirect contact approximately 3.0 pounds of HAPs per plant effluent was equal to the detection limit condensers. Under the Pulp and Paper ODTP. Full-scale testing at PCA’s concentration. Use of the detection limit Industry NESHAP (or any other Federal Tomahawk Mill further verified that concentration result in a 96 percent HAP or State regulation), the Tomahawk Mill between 96 and 100 percent of the HAPs destruction efficiency calculation. No HAPs were actually detected in the wastewater treatment plant is not required to treat any pulping contained in the pulping process effluent, potentially signifying a 100% destruction process condensates and, at that time, condensates and hardpiped to the efficiency.

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To allow PCA to achieve this superior Under the site-specific rule (and or provide information to or for a environmental performance and remain analogous to the excess emission Federal agency. This includes the time in compliance with the CAA, EPA is allowance of 40 CFR 63.443(e)(1)), needed to review instructions; develop, promulgating limited revisions to the PCA’s Tomahawk Mill will be deemed acquire, install, and utilize technology Pulp and Paper Industry NESHAP, in compliance with the Pulp and Paper and systems for the purposes of Subpart S, 40 CFR 63.440 though Industry NESHAP so long as it complies collecting, validating, and verifying 63.459. The revisions collectively with all applicable provisions, information, processing and comprise a site-specific rule applicable including the requirement that it maintaining information, and disclosing only to PCA’s Tomahawk Mill. Under achieve the established destruction and providing information; adjust the the site-specific rule, PCA’s Tomahawk efficiency standard, no less than 99 existing ways to comply with any Mill may comply with either the percent of the operating time. previously applicable instructions and otherwise applicable control technology requirements; train personnel to be able IV. Statutory and Executive Order requirements of the Pulp and Paper to respond to a collection of Reviews. Industry NESHAP, or the control information; search data sources; technology requirements of the site- A. Executive Order 12866: Regulatory complete and review the collection of specific rule. Planning and Review information; and transmit or otherwise Like the otherwise applicable disclose the information. Under Executive Order 12866 (58 FR An agency may not conduct or provisions of the Pulp and Paper 51735), the Agency must determine Industry NESHAP, the site-specific rule sponsor, and a person is not required to whether this regulatory action is respond to a collection of information requires PCA’s Tomahawk Mill to ‘‘significant’’ and therefore subject to enclose the LVHC system and vent the unless it displays a currently valid OMB formal review by the Office of control number. The OMB control air emissions to a closed-vent system. Management and Budget (OMB) and to The standards and monitoring numbers for EPA’s regulations in 40 the requirements of the Executive Order, CFR are listed in 40 CFR part 9. requirements for the enclosures and which include assessing the costs and closed-vent system included in the rule benefits anticipated as a result of this C. Regulatory Flexibility Act are equivalent (except for formatting regulatory action. The Order defines The Regulatory Flexibility Act (RFA), and reference changes) to the otherwise ‘‘significant regulatory’’ action as one as amended by the Small Business applicable Pulp and Paper Industry that is likely to result in a rule that may: Regulatory Enforcement Fairness Act of NESHAP requirements. (1) Have an annual effect on the 1996 (SBREFA), 5 U.S.C. 601 et seq., The site-specific rule allows PCA’s economy of $100 million or more or generally requires an agency to prepare Tomahawk Mill to use an alternative adversely affect in a material way the a regulatory flexibility analysis of any treatment technology to control the economy, a sector of the economy, rule subject to notice and public HAPs collected in the closed-vent productivity, competition, jobs, the comment rulemaking requirements system. The rule allows PCA to treat its environment, public health or safety, or unless the agency certifies that the rule HAPs at an emission point not State, local, or tribal governments or will not have a significant economic addressed by the Pulp and Paper communities; (2) create a serious impact on a substantial number of small Industry NESHAP. PCA may route the inconsistency or otherwise interfere entities. Small entities include small collected air emissions through a series with an action taken or planned by businesses, small not-for-profit of indirect contact condensers and another agency; (3) materially alter the enterprises, and small governmental hardpipe the resulting pulping process budgetary impact of entitlements, jurisdictions. The subject of this site- condensates in a closed collection grants, user fees, or loan programs or the specific rulemaking, PCA, is not a small system to the wastewater treatment rights and obligations of recipients business. This rule does not apply to plant for anaerobic biodegradation. The thereof; or (4) raise novel legal or policy small businesses, small not-for-profit standards and monitoring requirements issues arising out of legal mandates, the enterprises, or small governmental for the closed collection system are President’s priorities, or the principles jurisdictions. Further, it is a site-specific equivalent (except for formatting and set forth in the Executive Order. rule with limited applicability to only reference changes) to those required by Because this rule affects only one one pulp and paper mill in the nation. the Pulp and Paper Industry NESHAP facility, it is not a rule of general After considering the economic impacts for kraft mills (which must collect and applicability. EPA has determined that of today’s final rule on small entities, I treat pulping process condensates). this rule is not a ‘‘significant regulatory certify that this rule will not have a The site-specific rule establishes a action’’ under the terms of Executive significant economic impact on a minimum destruction efficiency Order 12866 and is therefore not subject substantial number of small entities. standard of 1.0 pound of HAPs per to OMB review. ODTP, and further requires PCA to D. Unfunded Mandates Reform Act monitor, and maintain within specified B. Paperwork Reduction Act Title II of the Unfunded Mandates limits, several operating parameters to This action does not impose an Reform Act of 1995 (UMRA), Pub. L. ensure continuous compliance with the information collection burden under the 104–4, establishes requirements for HAP destruction efficiency standard. provisions of the Paperwork Reduction Federal agencies to assess the effects of PCA must conduct quarterly Act, 44 U.S.C. 3501 et seq., since it their regulatory actions on State, local, performance testing of the anaerobic applies to only one facility. It is exempt and Tribal governments and the private wastewater treatment system to verify from OMB review under the Paperwork sector. Under section 202 of the UMRA, compliance with the minimum HAP Reduction Act because it is a site- EPA generally must prepare a written destruction efficiency standard. Finally, specific rule, directed to fewer than ten statement, including cost benefit PCA’s Tomahawk Mill must continue to persons. 44 U.S.C. 3502(3), (10); 5 CFR analysis, for proposed and final rules comply with all applicable 1320.3(c), 1320.4 and 1320.5. with ‘‘Federal mandates’’ that may result recordkeeping and reporting Burden means the total time, effort, or in expenditures by State, local, and requirements of the general provisions financial resources expended by persons Tribal governments in the aggregate, or at subpart A, 40 CFR 63.10. to generate, maintain, retain, or disclose by the private sector, of $100 million or

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more in any one year. Before defined in the Executive Order to feasible alternatives considered by the promulgating an EPA rule for which a include regulations that have Agency. written statement is needed, section 205 ‘‘substantial direct effects on the States, This rule is not subject to the of the UMRA generally requires EPA to on the relationship between the national Executive Order because it is not identify and consider a reasonable government and the States, or on the economically significant as defined in number of regulatory alternatives and distribution of power and Executive Order 12866, and because the adopt the least costly, most cost- responsibilities among the various Agency believes the environmental effective or least burdensome alternative levels of government.’’ health or safety risks addressed by this that achieves the objectives of the rule. To the extent that this rule gives rise action do not present a disproportionate The provisions of section 205 do not to federalism concerns, they have been risk to children. This rule will require apply when they are inconsistent with addressed via EPA’s direct consultation PCA to achieve a greater reduction of applicable law. Moreover section 205 with Wisconsin, the affected State. As HAPs emitted to the environment by allows EPA to adopt an alternative other noted above, this rule was developed allowing it to use an alternative than the least costly, most cost-effective pursuant to the State-sponsored WDNR/ treatment technology not currently or least burdensome alternative if the PCA Agreement and the MOA between allowed by the existing the Pulp and Administrator publishes with the final WDNR and Region 5 EPA. Paper Industry NESHAP. Therefore, no additional risk to public health, rule an explanation of why that F. Executive Order 13175: Consultation including children’s health, is expected alternative was not adopted. Before EPA and Coordination With Indian Tribal establishes any regulatory requirements Governments to result from this action. that may significantly or uniquely affect H. Executive Order 13211: Actions That small governments, including Tribal Executive Order 13175, entitled Significantly Affect Energy Supply, governments, it must have developed ‘‘Consultation and Coordination with Distribution, or Use under section 203 of the UMRA a small Indian Tribal Governments’’ (65 FR government agency plan. The plan must 67249, November 6, 2000), requires EPA This rule is not a ‘‘significant energy provide for notifying affected small to develop a process that is accountable action’’ as defined in Executive Order governments, enabling officials of to ensure ‘‘meaningful and timely input 13211, ‘‘Actions Concerning Regulations affected small governments to have by Tribal officials in the development of That Significantly Affect Energy Supply, meaningful and timely input in the regulatory policies that have Tribal Distribution, or Use’’ (66 FR 28355, May development of the EPA regulatory implications.’’ ‘‘Policies that have Tribal 22, 2001) because it is not likely to have proposal with significant Federal implications’’ is defined in the a significant adverse effect on the mandates, and informing, educating, Executive Order to include regulations supply, distribution, or use of energy. It and advising small governments on that have ‘‘substantial direct effects on will not result in increased energy compliance with the regulatory one or more Indian tribes, on the prices, increased cost of energy requirements. As used here, ‘‘small relationship between the Federal distribution, or an increased government’’ has the same meaning as government and the Indian tribes, or on dependence on foreign supplies of that contained under 5 U.S.C. 601(5), the distribution of power and energy. that is, governments of cities, counties, responsibilities between the Federal government and Indian tribes.’’ I. National Technology Transfer towns, townships, villages, school Advancement Act districts, or special districts, with a This rule does not have Tribal population of less than fifty thousand. implications. It will not have substantial Section 12(d) of the National As discussed above, this rule will direct effects on Tribal governments, on Technology Transfer and Advancement have limited application. It applies only the relationship between the Federal Act of 1995 (NTTAA), Pub. L. 104–113, to the PCA’s pulp and paper mill government and Indian tribes, or on the section 12(d) (15 U.S.C. 272 note) located in Tomahawk, Wisconsin. This distribution of power and directs EPA to use voluntary consensus site-specific rule does not impose any responsibilities between the Federal standards in its regulatory activities additional costs on PCA’s Tomahawk government and Indian tribes, as unless such practice is inconsistent with Mill. EPA has determined that this site- specified in Executive Order 13175. applicable law or otherwise impractical. specific rule does not contain a Federal Thus, Executive Order 13175 does not Voluntary consensus standards are mandate that may result in expenditures apply to this rule. technical standards (for example, material specifications, test methods, by State, local, or Tribal governments, in G. Executive Order 13045: Protection of sampling procedures, and business the aggregate, or by the private sector of Children From Environmental Health $100 million or more in any one year. practices) developed or adopted by and Safety Risks Thus, this rule is not subject to the voluntary consensus standard bodies. requirements of section 202 and 205 of Executive Order 13045, ‘‘Protection of The NTTAA directs EPA to provide the UMRA. EPA has also determined Children from Environmental Health Congress, through OMB, explanations that this rule contains no regulatory Risks and Safety Risks’’ (62 FR 19885, when the Agency decides not to use requirements that might significantly or April 23, 1997), applies to any rule that: available and applicable voluntary uniquely affect small governments. (1) Is determined to be ‘‘economically consensus standards. This rule uses all significant,’’ as defined in Executive available and applicable voluntary E. Executive Order 13132: Federalism Order 12886; and (2) concerns an consensus standards. Executive Order 13132, entitled environmental health or safety risk that ‘‘Federalism’’ (64 FR 43255, August 10, EPA has reason to believe may have a J. Executive Order 12898: Federal 1999), requires EPA to develop an disproportionate effect on children. If Actions To Address Environmental accountable process to ensure the regulatory action meets both criteria, Justice in Minority Populations and ‘‘meaningful and timely input by State the Agency must evaluate the Low-Income Populations and local officials in the development of environmental health or safety effects of Executive Order 12898, ‘‘Federal regulatory policies that have federalism the planned rule on children and Actions to Address Environmental implications.’’ The phrase, ‘‘Policies that explain why the planned regulation is Justice in Minority Populations and have federalism implications’’ is preferable to potentially effective and Low-Income Populations’’ (February 11,

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1994) is designed to address the List of Subjects in 40 CFR Part 63 (ii) Each LVHC system shall be environmental and human health Air pollution control, Environmental enclosed and the HAP emissions shall conditions of minority and low-income protection, Hazardous substances, be vented into a closed-vent system. The populations. EPA is committed to Reporting and recordkeeping enclosures and closed-vent system shall addressing environmental justice requirements. meet requirements specified in concerns and has assumed a leadership paragraph (b)(6) of this section. role in environmental justice initiatives Dated: April 7, 2004. (iii) The HAP emissions shall be to enhance environmental quality for all Michael O. Leavitt, routed as follows: citizens of the United States. The Administrator. (A) The HAP emissions collected in Agency’s goals are to ensure that no I For the reasons set out in the the closed-vent system from the digester segment of the population, regardless of preamble, title 40, chapter I of the Code system shall be routed through the race, color, national origin, income, or of Federal Regulations is amended as primary indirect contact condenser, net worth bears disproportionately high follows: secondary indirect contact condenser, adverse human health or environmental and evaporator indirect contact impacts as a result of EPA’s policies, PART 63—NATIONAL EMISSION condenser; and programs, and activities. Today’s action STANDARDS FOR HAZARDOUS AIR (B) The HAP emissions collected in applies to one facility in Tomahawk, POLLUTANTS FOR SOURCE the closed-vent system from the Wisconsin, and will have no CATEGORIES evaporator system and foul condensate disproportionate impacts on minority or I 1. The authority citation for part 63 standpipe shall be routed through the low income communities. Overall, the continues to read as follows: evaporator indirect contact condenser. project being undertaken at PCA’s (3) Collection and routing of pulping Authority: 42 U.S.C. 7401 et seq. Tomahawk Mill, if successful, will process condensates. (i) The owner or produce environmental performance Subpart S—National Emission operator shall collect the pulping superior to that expected through Standards for Hazardous Air Pollutants process condensates from the following compliance with existing regulations. From the Pulp and Paper Industry equipment systems: K. Executive Order 12988: Civil Justice (A) Primary indirect contact Reform I 2. Amend § 63.459 by adding condenser; paragraph (b) to read as follows: (B) Secondary indirect contact In issuing this rule, EPA has taken the condenser; and necessary steps to eliminate drafting § 63.459 Alternative standards. errors and ambiguity, minimize (C) Evaporator indirect contact * * * * * condenser. potential litigation, and provide a clear (b) Tomahawk Wisconsin Mill. (1) (ii) The collected pulping process legal standard for affected conduct, as Applicability. (i) The provisions of this condensates shall be conveyed in a required by section 3 of Executive Order paragraph (b) apply to the owner or closed collection system that is 12988, entitled Civil Justice Reform (61 operator of the stand-alone semi- designed and operated to meet the FR 4729, February 7, 1996). chemical pulp and paper mill located at requirements specified in paragraph N9090 County Road E in Tomahawk, L. Congressional Review Act (b)(7) of this section. Wisconsin, referred to as the Tomahawk (iii) The collected pulping process The Congressional Review Act, 5 Mill. U.S.C. 801 et seq., as amended by the (ii) The owner or operator is not condensates shall be routed in the Small Business Regulatory Enforcement required to comply with the provisions closed collection system to the Fairness Act of 1996, generally provides of this paragraph (b) if the owner and wastewater treatment plant anaerobic that before a rule may take effect, the operator chooses to comply with the basins for biodegradation. agency promulgating the rule must otherwise applicable sections of this (iv) The pulping process condensates submit a rule report, which includes a subpart and provides the EPA with shall be discharged into the wastewater copy of the rule, to each House of the notice. treatment plant anaerobic basins below Congress and to the Comptroller General (iii) If the owner or operator chooses the liquid surface of the wastewater of the United States. Section 804 to comply with the provisions of this treatment plant anaerobic basins. exempts from section 801 the following paragraph (b) the owner or operator (4) HAP destruction efficiency types of rules: (1) Rules of particular shall comply with all applicable requirements of the wastewater applicability; (2) rules relating to agency provisions of this part, including this treatment plant. (i) The owner or management or personnel; and (3) rules subpart, except the following: operator shall achieve a destruction of agency organization, procedure, or (A) Section 63.443(b); efficiency of at least one pound of HAPs practice that do not substantially affect (B) Section 63.443(c); and per ton of ODP by biodegradation in the the rights or obligations of non-agency (C) Section 63.443(d). wastewater treatment plant. parties. EPA is not required to submit a (2) Collection and routing of HAP (ii) The following calculation shall be rule report regarding today’s action emissions. (i) The owner or operator performed to determine the HAP under section 801 because this is a rule shall collect the total HAP emissions destruction efficiency by biodegradation of particular applicability. from each LVHC system. in the wastewater treatment plant:

[]()RME× RME+×() PPC PPC−×() ABD ABD × 834. = fr c fr c fr c HAPd ODPr

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Where: paragraph (b)(4) of this section by closure mechanism in such a way that conducting a performance test pursuant the valve or closure mechanism cannot HAPd = HAP destruction efficiency of wastewater treatment plant (pounds to the requirements specified in be opened without breaking the seal. (v) For each enclosure opening, the of HAPs per ton of ODP); paragraph (b)(8) of this section. (v) The owner or operator may seek to owner or operator shall perform, at least RME = flow rate of raw mill effluent fr establish or reestablish the parameter once every 30 days, a visual inspection (millions of gallons per day); RME = HAP concentration of raw mill ranges, and/or the parameters required of the closure mechanism specified in c to be monitored as provided in paragraph (b)(6)(ii) of this section to effluent (milligrams per liter); paragraphs (b)(5)(i) through (v) of this ensure the opening is maintained in the PPCfr = flow rate of pulping process condensates (millions of gallons per section, by following the provisions of closed position and sealed. § 63.453(n)(1) through (4). (vi) For each closed-vent system day); (6) Standards and monitoring required by paragraph (b)(2) of this PPC = HAP concentration of pulping c requirements for each enclosure and section, the owner or operator shall process condensates (milligrams per closed-vent system. perform a visual inspection every 30 liter); (i) The owner or operator shall days and at other times as requested by ABD = flow rate of anaerobic basin fr comply with the design and operational the Administrator. The visual discharge (millions of gallons per requirements specified in paragraphs inspection shall include inspection of day); (b)(6)(ii) through (iv) of this section, and ABD = HAP concentration of anaerobic ductwork, piping, enclosures, and c the monitoring requirements of connections to covers for visible basin discharge (milligrams per liter); paragraphs (b)(6)(v) through (x) of this and evidence of defects. section for each enclosure and closed- (vii) For positive pressure closed-vent ODP = rate of production of oven dried r vent system used for collecting and systems, or portions of closed-vent pulp (tons per day). routing of HAP emissions as specified in systems, the owner or operator shall (5) Monitoring requirements and paragraph (b)(2) of this section. demonstrate no detectable leaks as parameter ranges. (i) The owner or (ii) Each enclosure shall be specified in paragraph (b)(6)(iii) of this operator shall install, calibrate, operate, maintained at negative pressure at each section, measured initially and annually and maintain according to the enclosure or hood opening as by the procedures in § 63.457(d). manufacturer’s specifications a demonstrated by the procedures (viii) For each enclosure that is continuous monitoring system (CMS, as specified in § 63.457(e). Each enclosure maintained at negative pressure, the defined in § 63.2), using a continuous or hood opening closed during the owner or operator shall demonstrate recorder, to monitor the following initial performance test shall be initially and annually that it is parameters: maintained in the same closed and maintained at negative pressure as (A) Evaporator indirect contact sealed position as during the specified in § 63.457(e). condenser vent temperature; performance test at all times except (ix) For each valve or closure (B) Pulping process condensates flow when necessary to use the opening for mechanism as specified in paragraph rate; sampling, inspection, maintenance, or (b)(6)(iv)(B) of this section, the owner or (C) Wastewater treatment plant repairs. operator shall perform an inspection at effluent flow rate; and (iii) Each component of the closed- least once every 30 days to ensure that (D) Production rate of ODP. vent system that is operated at positive the valve is maintained in the closed (ii) The owner or operator shall pressure shall be designed for and position and the emissions point gas additionally monitor, on a daily basis, operated with no detectable leaks as stream is not diverted through the in each of the four anaerobic basins, the indicated by an instrument reading of bypass line. ratio of volatile acid to alkalinity (VA/ less than 500 parts per million by (x) If an inspection required by A ratio). The owner or operator shall use volume above background, as measured paragraph (b)(6) of this section identifies the test methods identified for by the procedures specified in visible defects in ductwork, piping, determining acidity and alkalinity as § 63.457(d). enclosures, or connections to covers specified in 40 CFR 136.3, Table 1B. (iv) Each bypass line in the closed- required by paragraph (b)(6) of this (iii) The temperature of the evaporator vent system that could divert vent section, or if an instrument reading of indirect contact condenser vent shall be streams containing HAPs to the 500 parts per million by volume or maintained at or below 140 °F on a atmosphere without meeting the routing greater above background is measured, continuous basis. requirements specified in paragraph or if the enclosure openings are not (iv) The VA/A ratio in each of the four (b)(2) of this section shall comply with maintained at negative pressure, then anaerobic basins shall be maintained at either of the following requirements: the following corrective actions shall be or below 0.5 on a continuous basis. (A) On each bypass line, the owner or taken as soon as follows: (A) The owner or operator shall operator shall install, calibrate, (A) A first effort to repair or correct measure the methanol concentration of maintain, and operate according to the the closed-vent system shall be made as the outfall of any basin (using NCASI manufacturer’s specifications a flow soon as practicable but no later than 5 Method DI/MEOH 94.03) when the VA/ indicator that provides a record of the calendar days after the problem is A ratio of that basin exceeds the presence of gas stream flow in the identified. following: bypass line at least once every 15 (B) The repair or corrective action (1) 0.38, or minutes. The flow indicator shall be shall be completed no later than 15 (2) The highest VA/A ratio at which installed in the bypass line in such a calendar days after the problem is the outfall of any basin has previously way as to indicate flow in the bypass identified. measured non-detect for methanol line; or (7) Standards and monitoring (using NCASI Method DI/MEOH 94.03). (B) For bypass line valves that are not requirements for the pulping process (B) If the outfall of that basin computer controlled, the owner or condensates closed collection system. (i) measures detect for methanol, the owner operator shall maintain the bypass line The owner or operator shall comply or operator shall verify compliance with valve in the closed position with a car with the design and operational the emission standard specified in seal or seal placed on the valve or requirements specified in paragraphs

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(b)(7)(ii) through (iii) of this section, and (8) Quarterly performance testing. (i) (9) Recordkeeping requirements. (i) monitoring requirements of paragraph The owner or operator shall, within 45 The owner or operator shall comply (b)(7)(iv) for the equipment systems in days after the beginning of each quarter, with the recordkeeping requirements as paragraph (b)(3) of this section used to conduct a performance test. specified in Table 1 of subpart S of part route the pulping process condensates (ii) The owner or operator shall use 63 as it pertains to § 63.10. in a closed collection system. NCASI Method DI/HAPS–99.01 to (ii) The owner or operator shall (ii) Each closed collection system collect a grab sample and determine the comply with the recordkeeping shall meet the individual drain system HAP concentration of the Raw Mill requirements as specified in § 63.454(b). requirements specified in §§ 63.960, Effluent, Pulping Process Condensates, (iii) The owner or operator shall 63.961, and 63.962, except that the and Anaerobic Basin Discharge for the comply with the recordkeeping closed vent systems shall be designed quarterly performance test conducted requirements as specified in § 63.453(d). during the first quarter each year. and operated in accordance with (10) Reporting requirements. (i) Each paragraph (b)(6) of this section, instead (iii) For each of the remaining three quarters, the owner or operator may use owner or operator shall comply with the of in accordance with § 63.693 as reporting requirements as specified in specified in § 63.692(a)(3)(ii), NCASI Method DI/MEOH 94.03 as a surrogate to collect and determine the Table 1 of § 63.10. (b)(3)(ii)(A), and (b)(3)(ii)(B)(5)(iii); and (ii) Each owner or operator shall (iii) If a condensate tank is used in the HAP concentration of the Raw Mill Effluent, Pulping Process Condensates, comply with the reporting requirements closed collection system, the tank shall as specified in § 63.455(d). meet the following requirements: and Anaerobic Basin Discharge. (11) Violations. (i) Failure to comply (A) The fixed roof and all openings (iv) The sample used to determine the HAP or Methanol concentration in the with any applicable provision of this (e.g., access hatches, sampling ports, Raw Mill Effluent, Pulping Process part shall constitute a violation. gauge wells) shall be designed and Condensates, or Anaerobic Basin (ii) Periods of excess emissions shall operated with no detectable leaks as Discharge shall be a composite of four not constitute a violation provided the indicated by an instrument reading of grab samples taken evenly spaced over time of excess emissions (excluding less than 500 parts per million above an eight hour time period. periods of startup, shutdown, or background, and vented into a closed- (v) The Raw Mill Effluent grab malfunction) divided by the total vent system that meets the requirements samples shall be taken from the raw mill process operating time in a semi-annual of paragraph (b)(6) of this section and effluent composite sampler. reporting period does not exceed one routed in accordance with paragraph (vi) The Pulping Process Condensates percent. All periods of excess emission (b)(2) of this section; and grab samples shall be taken from a line (including periods of startup, shutdown, (B) Each opening shall be maintained tap on the closed condensate collection and malfunction) shall be reported, and in a closed, sealed position (e.g., system prior to discharge into the shall include: covered by a lid that is gasketed and wastewater treatment plant. (A) Failure to monitor a parameter, or latched) at all times that the tank (vii) The Anaerobic Basic Discharge contains pulping process condensates or maintain a parameter within minimum grab samples shall be taken subsequent or maximum (as appropriate) ranges as any HAPs removed from a pulping to the confluence of the four anaerobic process condensate stream except when specified in paragraph (b)(5), (b)(6), or basin discharges. (b)(7) of this section; and it is necessary to use the opening for (viii) The flow rate of the Raw Mill (B) Failure to meet the HAP sampling, removal, or for equipment Effluent, Pulping Process Condensates, destruction efficiency standard inspection, maintenance, or repair. and Anaerobic Basin Discharge, and the specified in paragraph (b)(4) of this (iv) For each pulping process production rate of ODP shall be section. condensate closed collection system averaged over eight hours. used to comply with paragraph (b)(3) of (ix) The data collected as specified in (iii) Notwithstanding paragraph this section, the owner or operator shall paragraphs (b)(5) and (b)(8) of this (b)(11)(ii) of this section, any excess perform a visual inspection every 30 section shall be used to determine the emissions that present an imminent days and shall comply with the HAP destruction efficiency of the threat to public health or the inspection and monitoring requirements wastewater treatment plant as specified environment, or may cause serious harm specified in § 63.964 except for the in paragraph (b)(4)(ii) of this section. to public health or the environment, closed-vent system and control device (x) The HAP destruction efficiency shall constitute a violation. inspection and monitoring requirements shall be at least as great as that specified [FR Doc. 04–8311 Filed 4–12–04; 8:45 am] specified in § 63.964(a)(2). by paragraph (b)(4)(i) of this section. BILLING CODE 6560–50–P

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ENVIRONMENTAL PROTECTION control methodology currently is taking direct final action to approve AGENCY prescribed by the Pulp and Paper the revisions, without prior proposal, Industry NESHAP. Additionally, the because we consider the revisions to be 40 CFR Part 63 proposed revisions are consistent with noncontroversial and anticipate no [FRL–7646–7] the Innovations Agreement by allowing significant adverse comments. PCA’s Tomahawk Mill to achieve Additionally, EPA is aware that most RIN 2090–AA33 superior environmental performance persons with an interest in this through regulatory flexibility. proposed rule have already been Site-Specific Rulemaking for DATES: Comments on this rulemaking afforded at least two opportunities to Packaging Corporation of America’s must be received on or before May 13, comment on its merits. In April 2003, Pulp and Paper Mill Located in 2004. and again in September 2003, PCA Tomahawk, WI, Pursuant to the Joint Public Hearing: Commenters may sponsored public meetings regarding the State/EPA Agreement To Pursue request a public hearing no later than project that is described at length in Regulatory Innovation April 27, 2004. Commenters requesting today’s rule. EPA believes that PCA made every reasonable effort to invite AGENCY: Environmental Protection a public hearing should specify the Agency. basis for their request. If EPA all potential stakeholders to those determines that there is sufficient public meetings. EPA has explained its ACTION: Proposed rule. reason to hold a public hearing, it will reasons for the revisions in the preamble SUMMARY: The U.S. Environmental be held on May 17, 2004, at 10 a.m. to the direct final rule. If we receive no adverse comment, we Protection Agency (EPA or the Agency) Requests to present oral testimony must will not take further action on this is proposing to adopt limited revisions be made by May 3, 2004. Persons proposed rule. If we receive adverse to the National Emissions Standards for interested in requesting a hearing, comment, we will withdraw the direct Hazardous Air Pollutants from the Pulp attending a hearing, or presenting oral final rule and it will not take effect. We and Paper Industry (Pulp and Paper testimony at a hearing should call Ms. will address all public comments in a Industry NESHAP). Collectively, these Eileen L. Furey or Mr. Eaton R. Weiler subsequent final rule based on this revisions comprise a site-specific rule to at (312) 886–7950 or (312) 886–6041, proposed rule. We will not institute a control Hazardous Air Pollutants respectively. second comment period on this action. ADDRESSES: (HAPs) applicable only to the semi- To make comments by mail, Any parties interested in commenting chemical pulp and paper mill currently send two (2) copies of your comments must do so at this time. owned and operated by Packaging to the Air and Radiation Docket and Corporation of America (PCA) in Information Center, Environmental Docket Tomahawk, Wisconsin (the Tomahawk Protection Agency, Mailcode: 6102T, EPA has established an official public Mill). EPA is proposing these revisions 1200 Pennsylvania Ave., NW., docket for this action under Docket ID pursuant to the Clean Air Act (CAA) Washington, DC, 20460, Attention No. OAR–2003–0205. The official and the Joint State/EPA Agreement to Docket ID OAR–2003–0205. Comments public docket consists of the documents Pursue Regulatory Innovation also may be submitted electronically, or specifically referenced in this action, (Innovations Agreement). through hand delivery/courier. Follow any public comments received, and The Pulp and Paper Industry the detailed instructions as provided in other information related to this action. NESHAP currently requires semi- the SUPPLEMENTARY INFORMATION section. Although a part of the official docket, chemical pulp and paper mills to If a public hearing is held, it will take the public docket does not include control the HAP emissions from the air place at the Valdas V. Adamkus Confidential Business Information (CBI) stack for the collection of equipment Environmental Resource Center meeting or other information the disclosure of comprising the Low Volume High rooms on the 12th floor of the Metcalf which is restricted by statute. The Concentration (LVHC) system. Neither Federal Building, 77 West Jackson Blvd, official public docket is the collection of the Pulp and Paper Industry NESHAP, Chicago, Illinois. materials that is available for public nor any other federal or state regulation, FOR FURTHER INFORMATION CONTACT: Ms. viewing at the Air and Radiation Docket requires such mills to control HAPs that Eileen L. Furey or Mr. Eaton R. Weiler and Information Center in the EPA may be contained in the liquid at U.S. EPA, Region 5, 77 West Jackson Docket Center, (EPA/DC) EPA West, condensates from the LVHC system. The Boulevard, Chicago, Illinois 60604. Ms. Room B102, 1301 Constitution Ave., proposed revisions allow PCA’s Furey or Mr. Weiler can be reached at NW., Washington, DC. The EPA Docket Tomahawk Mill to control the HAPs (312) 886–7950 or (312) 886–6041, Center Public Reading Room is open generated in the LVHC system by respectively (or by e-mail at: from 8:30 a.m. to 4:30 p.m., Monday condensing them into a liquid and [email protected] or through Friday, excluding legal treating them via anaerobic [email protected]). holidays. The telephone number for the biodegradation in the facility’s SUPPLEMENTARY INFORMATION: Reading Room is (202) 566–1744, and wastewater treatment system. In other the telephone number for the Air and words, the proposed revisions allow Regulated Entities Radiation Docket is (202) 566–1742. PCA’s Tomahawk Mill to control the This site-specific revision to the Pulp Certain types of information will not HAPs generated in the LVHC system and Paper Industry NESHAP, which be placed in the EPA Dockets. from an emission point and with a governs the emission of HAPs from the Information claimed as CBI and other technology not addressed by the Pulp pulp and paper industry, applies only to information statutorily restricted from and Paper Industry NESHAP. a single source, PCA’s Tomahawk, disclosure, which is not included in the Under the proposed revisions, PCA Wisconsin pulp and paper mill. official public docket, will not be would maintain compliance with the available for public viewing in EPA’s CAA and achieve a reduction in HAPs Direct Final Rule electronic public docket. EPA’s policy is emitted to the environment significantly In a document with the same title that that copyrighted material will not be superior to that which would have been is located in the ‘‘Rule and Regulations’’ placed in EPA’s electronic public docket achieved through compliance with the section of today’s Federal Register, EPA but will be available only in printed,

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paper form in the official public docket. access those documents in the public The system is an ‘‘anonymous access’’ To the extent feasible, publicly available docket that are available electronically. system, which means EPA will not docket materials will be made available Once in the system, select ‘‘search,’’ know your identity, e-mail address, or in EPA’s electronic public docket. When then key in the appropriate docket other contact information unless you a document is selected from the index identification number. provide it in the body of your comment. list in EPA Dockets, the system will Submission of Comments By E-mail identify whether the document is available for viewing in EPA’s electronic You may submit comments Comments may be sent by electronic public docket. Although not all docket electronically, by mail, by facsimile, or mail (e-mail) to a-and-r- materials may be available through hand delivery/courier. To [email protected], Attention Docket ID electronically, you may still access any ensure proper receipt by EPA, identify No. OAR–2003–0205. In contrast to of the publicly available docket the appropriate docket identification EPA’s electronic public docket, EPA’s e- materials through the docket facility number in the subject line on the first mail system is not an ‘‘anonymous identified above. EPA intends to work page of your comment. Please ensure access’’ system. If you send an e-mail towards providing electronic access to that your comments are submitted comment directly to the Docket without all of the publicly available docket within the specified comment period. going through EPA’s electronic public materials through EPA’s electronic Comments received after the close of the docket, EPA’s e-mail system public docket. comment period will be marked ‘‘late.’’ automatically captures your e-mail For public commenters, it is EPA is not required to consider these address. E-mail addresses that are important to note that EPA’s policy is late comments. automatically captured by EPA’s e-mail that public comments, whether Electronically system are included as part of the submitted electronically or in paper, If you submit an electronic comment comment that is placed in the official will be made available for public as prescribed below, EPA recommends public docket, and made available in viewing in EPA’s electronic public that you include your name, mailing EPA’s electronic public docket. docket as EPA receives them and address, and an e-mail address or other By Disk or CD ROM without change, unless the comment contact information in the body of your contains copyrighted material, CBI, or comment. Also include this contact You may submit comments on a disk other information statutorily restricted information on the outside of any disk or CD ROM that you mail to the mailing from disclosure. When EPA identifies a or CD ROM you submit, and in any address identified in the next paragraph. comment containing copyrighted cover letter accompanying the disk or These electronic submissions will be material, EPA will provide a reference CD ROM. This ensures that you can be accepted in WordPerfect or ASCII file to that material in the version of the identified as the submitter of the format. Avoid the use of special comment that is placed in EPA’s comment and allows EPA to contact you characters and any form of encryption. electronic public docket. The entire in case EPA cannot read your comment By Mail printed comment, including the due to technical difficulties or needs copyrighted material, will be available further information on the substance of Send two (2) copies of your comments in the public docket. Public comments your comment. EPA’s policy is that EPA to the Air and Radiation Docket and submitted on computer disks that are will not edit your comment, and any Information Center, Environmental mailed or delivered to the Docket will identifying or contact information Protection Agency, Mailcode: 6102T, be transferred to EPA’s electronic public provided in the body of a comment will 1200 Pennsylvania Ave., NW., docket. Public comments that are be included as part of the comment that Washington, DC, 20460, Attention mailed or delivered to the Docket will is placed in the official public docket, Docket ID No. OAR–2003–0205. be scanned and placed in EPA’s and made available in EPA’s electronic By Hand Delivery or Courier electronic public docket. Where public docket. If EPA cannot read your practical, physical objects will be comment due to technical difficulties Deliver your comments to: photographed, and the photograph will and cannot contact you for clarification, Environmental Protection Agency, EPA be placed in EPA’s electronic public EPA may not be able to consider your Docket Center, 1301 Constitution docket along with a brief description comment. Avenue, NW., Washington, DC 20004, written by the docket staff. Attention Docket ID No. OAR–2003– By EPA’s Electronic Public Docket Electronic Access 0205. Such deliveries are only accepted Your use of EPA’s electronic public during the Docket’s normal hours of You may access this Federal Register docket to submit comments to EPA operation as identified in above. document electronically through the electronically is EPA’s preferred method EPA Internet under the Federal Register for receiving comments. Go directly to By Facsimile listings at http://www.epa.gov/fedrgstr/. EPA Dockets at http://www.epa.gov/ Fax your comments to: (202) 566– An electronic version of the public edocket, and follow the online 1741, Attention Docket ID No. OAR– docket is available through EPA’s instructions for submitting comments. 2003–0205. electronic public docket and comment To access EPA’s electronic public system, EPA Dockets. You may use EPA docket from the EPA Internet Home Dated: April 7, 2004. Dockets at http://www.epa.gov/edocket/ Page, select ‘‘Information Sources,’’ Michael O. Leavitt, to submit or view public comments, ‘‘Dockets,’’ and ‘‘EPA Dockets.’’ Once in Administrator. access the index listing of the contents the system, select ‘‘search,’’ and then [FR Doc. 04–8312 Filed 4–12–04; 8:45 am] of the official public docket, and to key in Docket ID No. OAR–2003–0205. BILLING CODE 6560–50–P

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Part V

Department of Housing and Urban Development 24 CFR Part 320 Removal of Regulation Specifying Minimum Face Value of Ginnie Mae Securities; Proposed Rule

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DEPARTMENT OF HOUSING AND In its continual pursuit to ensure tribal government, or on the private URBAN DEVELOPMENT efficient secondary mortgage market sector, within the meaning of the operations, Ginnie Mae routinely Unfunded Mandates Reform Act of 24 CFR Part 320 evaluates and enhances its offerings and 1995. [Docket No. FR–4856–P–01] services to remain attractive to investors. To this end, Ginnie Mae Regulatory Flexibility Act RIN 2503–AA17 would like to offer investors different The Secretary, in accordance with the denominations of Ginnie Mae Removal of Regulation Specifying Regulatory Flexibility Act (5 U.S.C. guaranteed securities. Accordingly, this Minimum Face Value of Ginnie Mae 605(b)), has reviewed this rule before proposed rule would remove the Securities publication and by approving it certifies existing regulation at 24 CFR 320.5(c), that this rule would not have a AGENCY: The Government National which provides, ‘‘The face amount of significant economic impact on a Mortgage Association (Ginnie Mae), any security cannot be less than substantial number of small entities. HUD. $25,000.’’ After this rule becomes There are no anti-competitive ACTION: Proposed rule. effective, the minimum face amount for discriminatory aspects of the rule with various Ginnie Mae securities will be regard to small entities, and there are no SUMMARY: This proposed rule would published in Ginnie Mae’s Mortgage- unusual procedures that would need to remove the regulation that specifies the Backed Securities Guide. be complied with by small entities. The current minimum face amount of any Findings and Certifications rule would remove an existing security issued by the Government regulation. Although HUD has National Mortgage Association (Ginnie Environmental Impact determined that this rule would not Mae). The proposed removal of the This rule would remove an existing have a significant economic impact on regulation would allow Ginnie Mae to regulation. The rule would not direct, a substantial number of small entities, offer alternative denominations of its provide for assistance or loan and HUD welcomes comments regarding any securities. mortgage insurance for, or otherwise less burdensome alternative to this rule DATES: Comment Due Date: June 14, govern or regulate, real property that will meet HUD’s objectives as 2004. acquisition, disposition, leasing, described in this preamble. rehabilitation, alteration, demolition, or ADDRESSES: Interested persons are Executive Order 13132, Federalism invited to submit comments regarding new construction, or establish, revise, or this rule to the Regulations Division, provide for standards for construction or Executive Order 13132 (entitled Office of the General Counsel, Room construction materials, manufactured ‘‘Federalism’’) prohibits an agency from 10276, Department of Housing and housing, or occupancy. Therefore, in publishing any rule that has federalism Urban Development, 451 Seventh Street, accordance with 24 CFR 50.19(c)(1), this implications if the rule either imposes SW., Washington, DC 20410–0500. rule is categorically excluded from the substantial direct compliance costs on Communications should refer to the requirements of the National State and local governments and is not above docket number and title. Environmental Policy Act (42 U.S.C. required by statute, or the rule preempts Facsimile (FAX) comments are not 4321 et seq.). State law, unless the agency meets the acceptable. A copy of each Executive Order 12866, Regulatory consultation and funding requirements communication submitted will be Planning and Review of section 6 of the Executive Order. This available for public inspection and rule does not have federalism The Office of Management and Budget copying between 8 a.m. and 5 p.m. implications and does not impose (OMB) reviewed this rule under weekdays at the above address. substantial direct compliance costs on Executive Order 12866 (entitled State and local governments and does FOR FURTHER INFORMATION CONTACT: Tom Regulatory Planning and Review). OMB Weakland, Senior Vice President, Office not preempt State law within the determined that this rule is a meaning of the Executive Order. of Program Operations, Government ‘‘significant regulatory action’’ as National Mortgage Association, Room defined in section 3(f) of the order List of Subjects in 24 CFR Part 320 6216, Department of Housing and Urban (although not economically significant, Development, 451 Seventh Street, SW., as provided in section 3(f)(1) of the Mortgages, Securities. Washington, DC 20410; telephone (202) order). Any changes made to the rule Accordingly, for the reasons described 708–2884 (this is not a toll-free subsequent to its submission to OMB in the preamble, HUD proposes to number). Speech- or hearing-impaired are identified in the docket file, which amend 24 CFR part 320 as follows: individuals may access this number is available for public inspection in the through TTY by calling the toll-free Regulations Division, Room 10276, PART 320—GUARANTY OF Federal Information Relay Service at Office of General Counsel, Department MORTGAGE-BACKED SECURITIES 800–877–8339. of Housing and Urban Development, SUPPLEMENTARY INFORMATION: Ginnie 451 Seventh Street, SW., Washington, 1. The authority citation for part 320 Mae is a wholly owned corporation of DC 20410–0500. continues to read as follows: the Federal government that increases Unfunded Mandates Reform Act Authority: 12 U.S.C. 1721(g) and 1723a(a), the flow of credit for the housing and 42 U.S.C. 3535(d). market. Ginnie Mae guarantees The Unfunded Mandates Reform Act 2. Amend § 320.5 by removing and securities that are issued by private of 1995 (2 U.S.C. 1531–1538) establishes reserving paragraph (c). lenders and backed by pools of mortgage requirements for Federal agencies to loans insured by HUD or guaranteed by assess the effects of their regulatory § 320.5 Securities. the Department of Veterans Affairs, or actions on State, local, and tribal * * * * * other government agencies. Ginnie Mae governments and on the private sector. guarantees the timely payment of This proposed rule would not impose a (c) [Reserved] principal and interest on the securities. Federal mandate on any State, local, or * * * * *

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Dated: March 18, 2004. Ronald A. Rosenfeld, President, Government National Mortgage Association. [FR Doc. 04–8341 Filed 4–12–04; 8:45 am] BILLING CODE 4210–66–P

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Part VI

The President Proclamation 7770—National Former Prisoner of War Recognition Day, 2004

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Federal Register Presidential Documents Vol. 69, No. 71

Tuesday, April 13, 2004

Title 3— Proclamation 7770 of April 9, 2004

The President National Former Prisoner of War Recognition Day, 2004

By the President of the United States of America

A Proclamation

Americans look to our veterans as examples of honor and patriotism. These loyal citizens have risked capture, imprisonment, and their lives to protect our homeland and advance freedom abroad. As we observe National Former Prisoner of War Recognition Day, we honor brave Americans who have demonstrated extraordinary courage in the face of hardship and terror. Today, nine out of ten former prisoners of war are veterans of World War II. These Americans helped to liberate millions and defeat tyranny around the world, and survived unspeakable horrors for the cause of freedom. From enduring hard labor in German and Japanese POW camps to the torturous Bataan Death March, these proud patriots showed strength of char- acter and incredible resolve in captivity. Their devotion to duty and love of country stand as a measure of service few others will attain. America will never forget these quiet heroes and all of our former prisoners of war who suffered adversity in Korea, Vietnam, the Persian Gulf, Somalia, Kosovo, Iraq, and other conflicts. Our Nation is grateful to our former pris- oners of war for their sacrifice to help protect the democratic ideals that make our country strong. Because of the dedication of these men and women in uniform, people in our own country and in lands far away can live in freedom. These citizens inspire us, and we will always remember their service for liberty’s blessings. NOW, THEREFORE, I, GEORGE W. BUSH, President of the United States of America, by virtue of the authority vested in me by the Constitution and laws of the United States, do hereby proclaim April 9, 2004, as National Former Prisoner of War Recognition Day. I call upon all Americans to join me in remembering all former American prisoners of war who suffered the hardships of enemy captivity. I also call upon Federal, State, and local government officials and private organizations to observe this day with appropriate ceremonies and activities. IN WITNESS WHEREOF, I have hereunto set my hand this ninth day of April, in the year of our Lord two thousand four, and of the Independence of the United States of America the two hundred and twenty-eighth. W

[FR Doc. 04–8568 Filed 4–12–04; 11:31 am] Billing code 3195–01–P

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Reader Aids Federal Register Vol. 69, No. 71 Tuesday, April 13, 2004

CUSTOMER SERVICE AND INFORMATION CFR PARTS AFFECTED DURING APRIL

Federal Register/Code of Federal Regulations At the end of each month, the Office of the Federal Register General Information, indexes and other finding 202–741–6000 publishes separately a List of CFR Sections Affected (LSA), which aids lists parts and sections affected by documents published since Laws 741–6000 the revision date of each title. 39 ...... 17033, 17034, 17901, Presidential Documents 1 CFR 17903, 17905, 17906, 17909, 51...... 18801 Executive orders and proclamations 741–6000 17911, 17913, 17914, 17915, The United States Government Manual 741–6000 3 CFR 17917, 17918, 17919, 17921, 17924, 17925, 19313, 19618 Other Services Proclamations: 25...... 18246 741–6020 7765...... 18465 Electronic and on-line services (voice) 39...... 18250 Privacy Act Compilation 741–6064 7766...... 18467 7767...... 18469 71 ...... 17283, 19314, 19315, Public Laws Update Service (numbers, dates, etc.) 741–6043 19316, 19317, 19318, 19319 TTY for the deaf-and-hard-of-hearing 741–6086 7768...... 19077 7769...... 19030 73...... 18471 7770...... 19751 97...... 17284 ELECTRONIC RESEARCH 135...... 18472 World Wide Web 5 CFR Proposed Rules: 39 ...... 17072, 17073, 17076, Full text of the daily Federal Register, CFR and other publications Proposed Rules: 1650...... 18294 17077, 17080, 17082, 17084, is located at: http://www.gpoaccess.gov/nara/index.html 1653...... 18294 17086, 17088, 17091, 17095, Federal Register information and research tools, including Public 1655...... 18294 17097, 17101, 17103, 17105, Inspection List, indexes, and links to GPO Access are located at: 1690...... 18294 17107, 17109, 17111, 17113, http://www.archives.gov/federallregister/ 17115, 17610, 17984, 17987, 7 CFR E-mail 17989, 17991, 17993, 17996, 772...... 18471 18304, 18306, 18843, 18845, FEDREGTOC-L (Federal Register Table of Contents LISTSERV) is 905...... 19079 18848, 19132, 19135 an open e-mail service that provides subscribers with a digital 929...... 18803 71 ...... 18308, 18309, 18508, form of the Federal Register Table of Contents. The digital form 982...... 19082 19359, 19360 of the Federal Register Table of Contents includes HTML and 983...... 17844 PDF links to the full text of each document. 984...... 17899 15 CFR To join or leave, go to http://listserv.access.gpo.gov and select Proposed Rules: 774...... 17926 Online mailing list archives, FEDREGTOC-L, Join or leave the list 330...... 17984 (orchange settings); then follow the instructions. 926...... 19118 16 CFR PENS (Public Law Electronic Notification Service) is an e-mail 1033...... 19292 Proposed Rules: service that notifies subscribers of recently enacted laws. 1124...... 18834 316...... 18851 To subscribe, go to http://listserv.gsa.gov/archives/publaws-l.html 8 CFR 801...... 18686 and select Join or leave the list (or change settings); then follow 802...... 18686 Proposed Rules: 803...... 18686 the instructions. 103...... 18296 FEDREGTOC-L and PENS are mailing lists only. We cannot 17 CFR respond to specific inquiries. 9 CFR Proposed Rules: Reference questions. Send questions and comments about the 1...... 17899 30...... 17998 2...... 17899 Federal Register system to: [email protected] 232...... 17864 3...... 17899 240...... 17864 The Federal Register staff cannot interpret specific documents or 301...... 18245 249...... 17864 regulations. 309...... 18245 309...... 18245 19 CFR FEDERAL REGISTER PAGES AND DATE, APRIL 310...... 18245 311...... 18245 Proposed Rules: 17033–17282...... 1 313...... 18245 24...... 18296 17283–17584...... 2 318...... 18245 20 CFR 17585–17898...... 5 319...... 18245 17899–18244...... 6 320...... 18245 641...... 19014 18245–18470...... 7 Proposed Rules: 11 CFR 404...... 18310 18471–18800...... 8 18801–19076...... 9 Proposed Rules: 110...... 18301, 18841 21 CFR 19077–19310...... 12 Ch. 1 ...... 17285 19311–19752...... 13 12 CFR 173...... 17297 335...... 19085 201...... 18255 1700...... 18808 206...... 18728 Proposed Rules: 250...... 18728 222...... 19123 312...... 17927 1710...... 19126 314...... 18728 522...... 17585 14 CFR 573...... 19320 25...... 19311 600...... 18728

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601...... 18728 110...... 17119 65...... 17597, 17600 613...... 19329 606...... 18255 117 ...... 17122, 17616, 17618, 67 ...... 17312, 17606, 17608 616...... 19329 610...... 18255 18004 Proposed Rules: 617...... 19329 807...... 18472 165...... 18794, 18797 67 ...... 17381, 17619, 17620 619...... 19329 1308...... 17034 622...... 19329 45 CFR Proposed Rules: 36 CFR 623...... 19329 Ch. 1 ...... 17615 223...... 18813 1206...... 19110 625...... 19329 400...... 17928 626...... 19329 46 CFR 22 CFR Proposed Rules: 628...... 19329 126...... 18810 13...... 17355 515...... 17941 630...... 19329 632...... 19329 47 CFR 24 CFR 37 CFR 636...... 19329 Proposed Rules: 401...... 17299 1...... 17946 637...... 19329 320...... 19746 2...... 18275, 18832 642...... 19329 39 CFR 22...... 17063 651...... 19329 26 CFR 24...... 17063 111...... 17059 652...... 19329 1...... 17586 25...... 18275 653...... 19329 Proposed Rules: 27...... 17946 Proposed Rules: Proposed Rules: 111...... 19363 73 ...... 17070, 17071, 19328 1 ...... 17117, 17477, 18314 19...... 18244 74...... 17946 301...... 17117 40 CFR 45...... 17584 90...... 17946, 17959 52...... 17584 29 CFR 9...... 19105 101...... 17946 52 ...... 17302, 17929, 18815 Proposed Rules: 35...... 17570 63...... 19106, 19734 49 CFR 1981...... 17587 0...... 17124 68...... 18819 1...... 17124, 18006 192...... 18228 Proposed Rules: 80...... 17932 11...... 18857 219...... 19270 1910...... 17774 147...... 18478 13...... 18007 375...... 17313 1917...... 19361 166...... 17303 54...... 18508 541...... 17960 1918...... 19361 180 ...... 17304, 18255, 18263, 61...... 17124, 18006 542...... 17960 18275, 18480 30 CFR 69...... 17124, 18006 543...... 17960 257...... 17308 73 ...... 17124, 17125, 18860, 571...... 18496 75...... 17480 745...... 18489 19363, 19364 1104...... 18498 931...... 19321 Proposed Rules: 80...... 18007 1572...... 17969 Proposed Rules: 52 ...... 17368, 17374, 18006, 87...... 19140 Proposed Rules: 200...... 19137 18319, 18323, 18853 541...... 18010 63 ...... 18327, 18338, 19139, 48 CFR 31 CFR 544...... 18861 19743 Ch. 1...... 17740, 17770 571...... 17622, 18015 1...... 17298 81...... 17374, 18853 1...... 17741 572...... 17622 103...... 19093, 19098 86...... 17532 2...... 17741, 17764 240...... 17272 122...... 18166 4...... 17768 136...... 18166 50 CFR 32 CFR 8...... 17741 141...... 18166 15...... 17768 17...... 18279, 18499 199...... 17035 143...... 18166 29...... 17769 92...... 17318 2001...... 17052 257...... 17380 31...... 17764 216...... 17973 Proposed Rules: 300...... 19363 45...... 17741 223...... 18444 519...... 18314 403...... 18166 49...... 17741 224...... 18444 430...... 18166 52...... 17741, 17770 622...... 19346 33 CFR 455...... 18166 53...... 17741 648...... 17980, 18291 101...... 17927 465...... 18166 601...... 19329 660 ...... 17329, 18444, 19347 104...... 17927 602...... 19329 679 ...... 17982, 19116, 19358 42 CFR 117 ...... 17055, 17057, 17595, 603...... 19329 Proposed Rules: 17597, 18473, 19103, 19325 411...... 17933 604...... 19329 17 ...... 17383, 17627, 17634, 165...... 18473, 19326 414...... 17935 605...... 19329 18016, 18018, 18035, 18515, 167...... 18476 424...... 17933 606...... 19329 18516, 18770, 19364, 19620 402...... 18811 609...... 19329 229...... 19365 Proposed Rules: 44 CFR 611...... 19329 300...... 19147 100...... 18002 64...... 17310 612...... 19329 635...... 19147

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REMINDERS Brucellosis in cattle and Major systems acquisition; Indiana; comments due by The items in this list were bison— comments due by 4-23- 4-21-04; published 3-22- editorially compiled as an aid State and area 04; published 2-23-04 [FR 04 [FR 04-06214] to Federal Register users. classifications; 04-03707] Maine; comments due by 4- Inclusion or exclusion from comments due by 4-20- Obsolete research and 21-04; published 3-22-04 this list has no legal 04; published 2-20-04 development contracting [FR 04-06209] significance. [FR 04-03723] procedures; removal; Maryland; comments due by Plant-related quarantine, comments due by 4-23- 4-21-04; published 3-22- domestic: 04; published 2-23-04 [FR 04 [FR 04-06305] 04-03695] RULES GOING INTO Mexican fruit fly; comments Ohio; comments due by 4- EFFECT APRIL 13, 2004 due by 4-19-04; published Procedures, guidance, and 21-04; published 3-22-04 2-18-04 [FR 04-03429] information; comments [FR 04-06303] due by 4-23-04; published ENVIRONMENTAL Environmental statements; COMMERCE DEPARTMENT 2-23-04 [FR 04-03699] PROTECTION AGENCY availability, etc.: National Oceanic and Publicizing contract actions; Air quality implementation Atmospheric Administration comments due by 4-23- Coastal nonpoint pollution plans; approval and control program— Fishery conservation and 04; published 2-23-04 [FR promulgation; various management: 04-03704] Minnesota and Texas; States: Open for comments Caribbean, Gulf, and South Research and development Florida; published 2-13-04 until further notice; Atlantic fisheries— contracting; comments published 10-16-03 [FR HEALTH AND HUMAN Gulf of Mexico reef fish; due by 4-23-04; published SERVICES DEPARTMENT 2-23-04 [FR 04-03696] 03-26087] red grouper rebuilding Pesticides; tolerances in food, Food and Drug plan; comments due by Sealed bidding; comments Administration due by 4-23-04; published animal feeds, and raw 4-20-04; published 2-20- agricultural commodities: Animal drugs, feeds, and 04 [FR 04-03754] 2-23-04 [FR 04-03697] related products: Federal Acquisition Regulation Aminoethoxyvinylglycine COURT SERVICES AND (FAR): hydrochloride; comments Natamycin; published 4-13- OFFENDER SUPERVISION Special emergency due by 4-19-04; published 04 AGENCY FOR THE 2-18-04 [FR 04-03371] DISTRICT OF COLUMBIA procurement authority; INTERIOR DEPARTMENT comments due by 4-23- FEDERAL Surface Mining Reclamation Semi-annual agenda; Open for 04; published 2-23-04 [FR COMMUNICATIONS and Enforcement Office comments until further 04-03690] COMMISSION Permanent program and notice; published 12-22-03 [FR 03-25121] EDUCATION DEPARTMENT Common carrier services: abandoned mine land Nondiscrimination on basis of Federal-State Joint Board reclamation submissions: DEFENSE DEPARTMENT sex in education programs on Universal Service— New Mexico; published 4- Acquisition regulations: receiving Federal Interstate services of non- 13-04 Competition requirements; assistance; comments due price cap incumbent STATE DEPARTMENT comments due by 4-23- by 4-23-04; published 3-9- local exchange carriers 04 [FR 04-05156] Acquisition regulations: 04; published 2-23-04 [FR and interexchange 04-03705] ENERGY DEPARTMENT Miscellaneous amendments; carriers; multi- published 4-13-04 Contractor qualifications Physician panel determinations association group plan; relating to contract on worker requests for comments due by 4-23- TRANSPORTATION placement; comments due assistance in filing for State 04; published 3-24-04 DEPARTMENT by 4-23-04; published 2- workers’ compensation [FR 04-06560] Federal Aviation 23-04 [FR 04-03702] benefits; guidelines; Telecommunications Act of Administration Cost principles and comments due by 4-23-04; 1996; implementation— Airworthiness directives: procedures; comments published 3-24-04 [FR 04- Pay telephone Airbus; published 3-9-04 due by 4-23-04; published 06555] reclassification and Boeing; published 3-9-04 2-23-04 [FR 04-03708] ENERGY DEPARTMENT compensation Dassault; published 3-9-04 Debarment, suspension, and Federal Energy Regulatory provisions; comments business ethics; improper Commission due by 4-21-04; McDonnell Douglas; business practices and Electric rate and corporate published 4-6-04 [FR published 3-9-04 contractor qualifications; regulation filings: 04-07804] comments due by 4-23- Virginia Electric & Power Telecommunications service COMMENTS DUE NEXT 04; published 2-23-04 [FR Co. et al.; Open for providers; biennial WEEK 04-03703] comments until further regulatory review; Freedom of Information Act; notice; published 10-1-03 comments due by 4-19- AGRICULTURE implementation; comments [FR 03-24818] 04; published 3-18-04 [FR DEPARTMENT due by 4-23-04; published ENVIRONMENTAL 04-05657] 2-23-04 [FR 04-03693] Agricultural Marketing PROTECTION AGENCY Wireless telecommunications Service Government supply sources; Air quality implementation services— contractor use; comments Dried prunes produced in— plans; approval and Wireless radio services; due by 4-23-04; published promulgation; various rules streamlining and California; comments due by 2-23-04 [FR 04-03694] States: harmonization; biennial 4-23-04; published 3-26- Insurance requirements; California; comments due by regulatory review; 04 [FR 04-06704] comments due by 4-23- 4-21-04; published 3-22- comments due by 4-23- AGRICULTURE 04; published 2-23-04 [FR 04 [FR 04-06212] 04; published 2-23-04 DEPARTMENT 04-03692] Delaware; comments due by [FR 04-03730] Animal and Plant Health Laws inapplicable to 4-23-04; published 3-24- Practice and procedure: Inspection Service commercial subcontracts; 04 [FR 04-06562] Regulatory fees; assessment Interstate transportation of comments due by 4-23- Illinois; comments due by 4- and collection; comments animals and animal products 04; published 2-23-04 [FR 21-04; published 3-22-04 due by 4-21-04; published (quarantine): 04-03706] [FR 04-06307] 4-14-04 [FR 04-08260]

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Radio stations; table of HOMELAND SECURITY National air tour safety 04; published 3-9-04 assignments: DEPARTMENT standards; comments due [FR 04-05168] Georgia; comments due by Coast Guard by 4-19-04; published 1- Harnesses for use on 4-19-04; published 3-16- Anchorage regulations: 16-04 [FR 04-01129] school bus seats; 04 [FR 04-05918] Maryland; Open for Airworthiness directives: correction; comments Kentucky; comments due by comments until further Airbus; comments due by 4- due by 4-23-04; 4-19-04; published 3-16- notice; published 1-14-04 19-04; published 3-5-04 published 3-24-04 [FR 04 [FR 04-05911] [FR 04-00749] [FR 04-04936] C4-05168] TREASURY DEPARTMENT FEDERAL DEPOSIT Ports and waterways safety: BAE Systems (Operations) INSURANCE CORPORATION San Francisco Bay, et al., Ltd.; comments due by 4- Comptroller of the Currency CA; regulated navigation 23-04; published 3-24-04 Agency information collection Agency information collection activities; proposals, activities; proposals, area; comments due by [FR 04-06504] 4-19-04; published 2-19- Boeing; comments due by submissions, and approvals; submissions, and approvals; comments due by 4-20-04; comments due by 4-20-04; 04 [FR 04-03596] 4-19-04; published 3-5-04 [FR 04-04928] published 1-21-04 [FR 04- published 1-21-04 [FR 04- JUSTICE DEPARTMENT 01161] 01161] Drug Enforcement General Electric Co.; TREASURY DEPARTMENT Administration comments due by 4-23- FEDERAL RESERVE Thrift Supervision Office SYSTEM Precursors and essential 04; published 2-23-04 [FR Agency information collection chemicals; importation and 04-03679] Agency information collection activities; proposals, activities; proposals, exportation: McDonnell Douglas; comments due by 4-19- submissions, and approvals; submissions, and approvals; International sales of listed comments due by 4-20-04; comments due by 4-20-04; chemicals; use of Internet 04; published 3-5-04 [FR 04-04927] published 1-21-04 [FR 04- published 1-21-04 [FR 04- to arrange; comments due 01161] 01161] by 4-19-04; published 2- Pratt & Whitney; comments due by 4-20-04; published FEDERAL TRADE 17-04 [FR 04-03355] 2-20-04 [FR 04-03682] COMMISSION NATIONAL AERONAUTICS LIST OF PUBLIC LAWS Rolls-Royce Corp.; Controlling the Assault of Non- AND SPACE ADMINISTRATION comments due by 4-23- This is a continuing list of Solicited Pornography and public bills from the current Federal Acquisition Regulation 04; published 2-23-04 [FR Marketing Act of 2003: session of Congress which (FAR): 04-03681] Definitions, implementation, have become Federal laws. It Schweizer Aircraft Corp.; and reporting Special emergency may be used in conjunction comments due by 4-19- requirements; comments procurement authority; with ‘‘PLUS’’ (Public Laws 04; published 2-19-04 [FR due by 4-20-04; published comments due by 4-23- Update Service) on 202–741– 04-03495] 4-9-04 [FR 04-08088] 04; published 2-23-04 [FR 6043. This list is also 04-03690] Airworthiness standards: Fair and Accurate Credit available online at http:// Transactions Act; NATIONAL ARCHIVES AND Special conditions— www.archives.gov/ implementation: RECORDS ADMINISTRATION Boeing Model 727-100/- federal—register/public—laws/ Fair credit reporting Organization, functions, and 200 series airplanes; public—laws.html. provisions; comments due authority delegations: comments due by 4-19- The text of laws is not by 4-23-04; published 2- Official seals and logos; 04; published 3-19-04 published in the Federal 24-04 [FR 04-03978] comments due by 4-20- [FR 04-06150] Register but may be ordered 04; published 2-20-04 [FR GENERAL SERVICES CenTex Aerospace, Inc.; in ‘‘slip law’’ (individual 04-03573] ADMINISTRATION diamond DA20-C1 pamphlet) form from the katana airplanes; Federal Acquisition Regulation POSTAL SERVICE Superintendent of Documents, Procurement system: comments due by 4-22- U.S. Government Printing (FAR): 04; published 3-23-04 Purchasing of property and Office, Washington, DC 20402 Special emergency [FR 04-06454] services; comments due (phone, 202–512–1808). The procurement authority; Class E airspace; comments text will also be made comments due by 4-23- by 4-23-04; published 3- 24-04 [FR 04-06395] due by 4-19-04; published available on the Internet from 04; published 2-23-04 [FR 3-5-04 [FR 04-05033] GPO Access at http:// SECURITIES AND 04-03690] www.gpoaccess.gov/plaws/ EXCHANGE COMMISSION TRANSPORTATION HEALTH AND HUMAN DEPARTMENT index.html. Some laws may SERVICES DEPARTMENT Securities: not yet be available. Federal Railroad Food and Drug International financial Administration H.R. 254/P.L. 108–215 Administration reporting standards; Form 20-F amendment; Railroad safety: To authorize the President of Human drugs: comments due by 4-19- Locomotive horns use at the United States to agree to Prescription drug marketing; 04; published 3-18-04 [FR highway-rail grade certain amendments to the effective date delay; 04-05982] crossings; requirement for Agreement between the comments due by 4-23- SMALL BUSINESS sounding; comments due Government of the United 04; published 2-23-04 [FR ADMINISTRATION by 4-19-04; published 2- States of America and the 04-03856] Government of the United Disaster loan areas: 13-04 [FR 04-03181] Mexican States concerning the Reports and guidance TRANSPORTATION documents; availability, etc.: Maine; Open for comments establishment of a Border until further notice; DEPARTMENT Evaluating safety of Environment Cooperation published 2-17-04 [FR 04- National Highway Traffic Commission and a North antimicrobial new animal 03374] Safety Administration drugs with regard to their American Development Bank, microbiological effects on TRANSPORTATION Motor vehicle safety and for other purposes. (Apr. bacteria of human health DEPARTMENT standards: 5, 2004; 118 Stat. 579) concern; Open for Federal Aviation Child restraint systems— H.R. 3926/P.L. 108–216 comments until further Administration Harnesses for use on Organ Donation and Recovery notice; published 10-27-03 Air carrier certification and school bus seats; Improvement Act (Apr. 5, [FR 03-27113] operations: comments due by 4-23- 2004; 118 Stat. 584)

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H.R. 4062/P.L. 108–217 and for other purposes. (Apr. enacted public laws. To 5, 2004; 118 Stat. 591) subscribe, go to http:// To provide for an additional Public Laws Electronic listserv.gsa.gov/archives/ temporary extension of Last List April 5, 2004 Notification Service publaws-l.html programs under the Small (PENS) Note: This service is strictly Business Act and the Small for E-mail notification of new Business Investment Act of PENS is a free electronic mail laws. The text of laws is not 1958 through June 4, 2004, notification service of newly available through this service. PENS cannot respond to specific inquiries sent to this address.

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