5–25–04 Tuesday Vol. 69 No. 101 May 25, 2004

Pages 29651–29844

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1 II Federal Register / Vol. 69, No. 101 / Tuesday, May 25, 2004

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2 III

Contents Federal Register Vol. 69, No. 101

Tuesday, May 25, 2004

Agency for International Development Coast Guard NOTICES RULES Meetings: Ports and waterways safety: Voluntary Foreign Aid Advisory Committee, 29686 Savannah River, GA; security zones, 29653–29656 St. Simons Sound and Atlantic Ocean, GA; security zone, Agricultural Marketing Service 29656–29658 PROPOSED RULES Raisins produced from grapes grown in— Commerce Department California, 29672 See Census Bureau See International Trade Administration Agriculture Department See National Oceanic and Atmospheric Administration See Agricultural Marketing Service See Farm Service Agency Defense Department See Forest Service See Army Department See Navy Department Alcohol, Tobacco, Firearms, and Explosives Bureau PROPOSED RULES NOTICES Federal Acquisition Regulation (FAR): Agency information collection activities; proposals, Payment withholding, 29837–29839 submissions, and approvals, 29755 Delaware River Basin Commission Antitrust Division NOTICES NOTICES Meetings and hearings, 29706–29707 National cooperative research notifications: Education Department National Electronics Manufacturing Initiative, Inc., 29755–29756 NOTICES Petrotechnical Open Standards Consortium, Inc., 29756 Agency information collection activities; proposals, submissions, and approvals, 29707–29708 Army Department Employee Benefits Security Administration NOTICES NOTICES Environmental statements; availability, etc.: Agency information collection activities; proposals, 2nd Brigade, 25th Infantry Division, HI; transformation to submissions, and approvals, 29756–29757 Stryker Brigade Combat Team, 29702–29703 Energy Department Census Bureau See Energy Efficiency and Renewable Energy Office NOTICES See Federal Energy Regulatory Commission Surveys, determinations, etc.: Manufacturing area; annual, 29689–29690 Energy Efficiency and Renewable Energy Office NOTICES Centers for Disease Control and Prevention Meetings: NOTICES Federal Energy Management Advisory Committee, 29708 Grant and cooperative agreement awards: Association of State and Territorial Public Health Environmental Protection Agency Nutrition Directors, 29730 RULES Grants and cooperative agreements; availability, etc.: Air programs; approval and promulgation; State plans for Enhancing State capacity to address child and adolescent designated facilities and pollutants: health through violence prevention; correction, Virginia, 29658–29662 29730–29731 PROPOSED RULES Air programs; approval and promulgation; State plans for Children and Families Administration designated facilities and pollutants: NOTICES Virginia, 29675–29676 Agency information collection activities; proposals, Air quality implementation plans; approval and submissions, and approvals, 29731–29732 promulgation; various States: Grants and cooperative agreements; availability, etc.: Maryland, 29674–29675 Field initiated child care research projects, 29732–29740 NOTICES Agency information collection activities; proposals, Civil Rights Commission submissions, and approvals, 29717–29727 NOTICES Confidential business information and data transfer, 29727– Meetings; State advisory committees: 29728 Pennsylvania, 29688–29689 Water programs: Rhode Island, 29689 Spill prevention, control, and countermeasure rule; Various States, 29689 clarifications, 29728–29730

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Executive Office of the President Fish and Wildlife Service See Presidential Documents RULES Endangered Species Act: Farm Service Agency Incidental take permit revocation regulations; withdrawn, 29669–29670 NOTICES PROPOSED RULES Grants and cooperative agreements; availability, etc.: Endangered Species Act: Tree Assistance Program; California tree losses due to Incidental take permit revocation regulations, 29681– wild fires, 29686–29687 29685

Federal Aviation Administration RULES Food and Drug Administration Airworthiness directives: RULES Goodrich Avionics Systems, Inc.; correction, 29651 Human drugs, medical devices, and biological products: Class E airspace, 29651–29652 Human cells, tissues, and cellular and tissue-based Class E airspace; correction, 29653 products; donors eligibility determination, 29785– PROPOSED RULES 29834 Airworthiness directives: NOTICES Cessna; withdrawn, 29672–29673 Reports and guidance documents; availability, etc.: NOTICES Human cells, tissues, and cellular and tissue-based Agency information collection activities; proposals, products; donors eligibility determination, 29834– submissions, and approvals, 29775 29835 Exemption petitions; summary and disposition; correction, Veterinary Medicinal Products, International Cooperation 29775–29777 on Harmonisation of Technical Requirements for Meetings: Approval— RTCA Government/Industry Air Traffic Management Residues of veterinary drugs in human food; Advisory Committee, 29777 carcinogenicity testing; studies to evaluate safety, Reports and guidance documents; availability, etc.: 29740–29742 Supplemental type certificate projects; workload priorities; policy statement and comment request, Forest Service 29778 NOTICES Meetings: Federal Communications Commission Resource Advisory Committees— PROPOSED RULES Davy Crockett National Forest, 29687 Common carrier services: Reports and guidance documents; availability, etc.: International telecommunications; U.S. providers; Joint counterpart Endangered Species Act consultation reporting requirements, 29676–29681 regulations; alternative consultation agreements on proposed projects that support National Fire Plan, Federal Emergency Management Agency 29749–29750 RULES Tribal Watershed Forestry Assistance Program; interim Flood elevation determinations: guideline, 29687–29688 Various States, 29662–29664 Watershed Forestry Assistance Program; interim guideline, 29688

Federal Energy Regulatory Commission NOTICES General Services Administration Meetings; Sunshine Act, 29715–29717 PROPOSED RULES Applications, hearings, determinations, etc.: Federal Acquisition Regulation (FAR): Acadia Power Partners, LLC, et al., 29708–29715 Payment withholding, 29837–29839

Federal Highway Administration Health and Human Services Department NOTICES See Centers for Disease Control and Prevention Environmental statements; notice of intent: See Children and Families Administration Salt Lake County, UT, 29778 See Food and Drug Administration See National Institutes of Health Federal Railroad Administration RULES Homeland Security Department Freight and other non-passenger trains and equipment; See Coast Guard brake system safety standards; end-of-train devices; See Federal Emergency Management Agency civil penalties schedule adjustment, 29664–29669 NOTICES Exemption petitions, etc.: Interior Department Norfolk Southern Corp., 29778–29779 See Fish and Wildlife Service Union Pacific Railroad Co., 29779–29780 See Land Management Bureau Traffic control systems; discontinuance or modification: See National Park Service Union Pacific Railroad Co., 29780–29781 See Reclamation Bureau

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Internal Revenue Service National Aeronautics and Space Administration PROPOSED RULES PROPOSED RULES Income taxes: Federal Acquisition Regulation (FAR): Modified accelerated cost recovery system property Payment withholding, 29837–29839 acquired in like-kind exchange or as result of involuntary conversion; depreciation; cross reference National Archives and Records Administration Hearing cancelled, 29673 NOTICES NOTICES Agency information collection activities; proposals, Agency information collection activities; proposals, submissions, and approvals, 29757 submissions, and approvals, 29783–29784 Meetings: National Highway Traffic Safety Administration Taxpayer Advocacy Panels, 29784 NOTICES Motor vehicle safety standards; exemption petitions, etc.: International Trade Administration Kumho Tire Co., Inc., 29781–29782 NOTICES Applications, hearings, determinations, etc.: National Institutes of Health Case Western Reserve University et al., 29690 NOTICES Jackson Laboratory, 29690–29691 Agency information collection activities; proposals, submissions, and approvals, 29742 Justice Department See Alcohol, Tobacco, Firearms, and Explosives Bureau National Oceanic and Atmospheric Administration See Antitrust Division RULES Fishery conservation and management: Labor Department Alaska; fisheries of Exclusive Economic Zone— See Employee Benefits Security Administration Bering Sea and Aleutian Islands rock sole, 29670– 29671 Land Management Bureau NOTICES NOTICES Environmental statements; availability, etc.: Closure of public lands: Monterey Bay National Marine Sanctuary, CA; cabled Nevada, 29742–29743 observatory installation, 29691–29692 Coal leases, exploration licenses, etc.: Environmental statements; record of decision: Colorado, 29743–29744 Caribbean Fishery Management Council; fishery Environmental statements; notice of intent: management plans; essential fish habitat Elko County, NV; Newmont Mining Corp. Emigrant Mine requirements, 29693 Project; plan of operations, 29744–29745 Marine mammals: Meetings: Incidental taking; authorization letters, etc.— Resource Advisory Councils— U.S. Army Engineers Corps; Alafia River Navigation Central Montana, 29745 Channel, Tampa, FL; expanding and deepening; Opening of public lands: bottlenose dolphins, 29693–29696 Oregon, 29745–29746 Vandenberg Air Force Base, CA; harbor activities Public land orders: related to Delta IV/Evolved Expendable Launch Wyoming, 29746 Vehicle; Pacific harbor seal, etc., 29696–29701 Realty actions; sales, leases, etc.: Meetings: New Mexico, 29746–29747 Pacific Fishery Management Council, 29701 Oregon, 29747–29748 Permits: Wyoming, 29748–29749 Exempted fishing, 29701–29702 Recreation management restrictions, etc.: Castle Rocks State Park and Inter-Agency Recreation National Park Service Area, ID; bolting and placement of fixed anchors to NOTICES rocks and overnight camping prohibited, 29749 Meetings: Reports and guidance documents; availability, etc.: Acadia National Park Advisory Commission, 29752 Joint counterpart Endangered Species Act consultation Cape Cod National Seashore Advisory Commission, regulations; alternative consultation agreements on 29752–29753 proposed projects that support National Fire Plan, Gettysburg National Military Park Advisory Commission, 29749–29750 29753 Resource management plans, etc.: National Register of Historic Places: Bishop Field Office, CA, 29750 Pending nominations, 29753–29754 Iron County, UT, 29750–29751 Survey plat filings: National Science Foundation Maine, 29751–29752 NOTICES Agency information collection activities; proposals, Maritime Administration submissions, and approvals, 29757–29758 NOTICES Antarctic Conservation Act of 1978; permit applications, Meetings: etc., 29758–29759 National Defense Tank Vessel Construction Assistance; Meetings: competitive proposals request for construction of up Proposal reviews, 29759 to five new tank vessels; conference call, 29781 Meetings; Sunshine Act, 29759

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Navy Department Surface Transportation Board NOTICES NOTICES Privacy Act: Railroad services abandonment: Systems of records, 29703–29706 Burlington Northern & Santa Fe Railway Co., 29782– 29783

Nuclear Regulatory Commission Transportation Department NOTICES See Federal Aviation Administration Environmental statements; availability, etc.: See Federal Highway Administration Message Pharmaceuticals, Inc., 29760 See Federal Railroad Administration Walter Reed Army Medical Center, DC, 29760–29761 See Maritime Administration Meetings; Sunshine Act, 29761 See National Highway Traffic Safety Administration Operating licenses, amendments; no significant hazards See Surface Transportation Board considerations; biweekly notices, 29761–29772 Reports and guidance documents; availability, etc.: Treasury Department Construction Inspection Program Framework Document, See Internal Revenue Service 29772–29773 Applications, hearings, determinations, etc.: Veterans Affairs Department Dominion Nuclear Connecticut, Inc., 29759–29760 NOTICES Meetings: Presidential Documents Professional Certification and Licensure Advisory EXECUTIVE ORDERS Committee, 29784 Government agencies and employees: Veterans Affairs Department Facilities Structural Safety National Oceanic and Atmospheric Administration; Advisory Committee, 29784 amendment to EO 11023 for the performance of certain functions by the Secretary of Commerce (EO 13341), 29841–29844 Separate Parts In This Issue

Part II Presidio Trust Health and Human Services Department, Food and Drug NOTICES Administration, 29785–29835 Environmental statements; notice of intent: Presidio Trust Management Plan— Part III Public Health Service Hospital district, 29773–29774 Defense Department; General Services Administration; National Aeronautics and Space Administration, Reclamation Bureau 29837–29839 NOTICES Environmental statements; availability, etc.: Part IV Columbia Basin Project, WA; Banks Lake Drawdown, Executive Office of the President, Presidential Documents, 29754–29755 29841–29844

Securities and Exchange Commission Reader Aids NOTICES Self-regulatory organizations; proposed rule changes: Consult the Reader Aids section at the end of this issue for National Association of Securities Dealers, Inc., 29774– phone numbers, online resources, finding aids, reminders, 29775 and notice of recently enacted public laws. To subscribe to the Federal Register Table of Contents Small Business Administration LISTSERV electronic mailing list, go to http:// NOTICES listserv.access.gpo.gov and select Online mailing list Meetings: archives, FEDREGTOC-L, Join or leave the list (or change Veterans Business Affairs Advisory Committee, 29775 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 Executive Orders: 11023 (Amended by EO 13341)...... 29843 13341...... 29843 7 CFR Proposed Rules: 989...... 29672 14 CFR 39...... 29651 71 (2 documents) ...... 29651, 29653 Proposed Rules: 39...... 29672 21 CFR 210...... 29786 211...... 29786 820...... 29786 1271...... 29786 26 CFR Proposed Rules: 1...... 29673 33 CFR 165 (2 documents) ...... 29653, 29656 40 CFR 62...... 29658 Proposed Rules: 52...... 29674 62...... 29675 44 CFR 65...... 29662 47 CFR Proposed Rules: 1...... 29676 43...... 29676 63...... 29676 48 CFR Proposed Rules: 14...... 29838 32...... 29838 52...... 29838 49 CFR 232...... 29664 50 CFR 17...... 29669 679...... 29670 Proposed Rules: 17...... 29681

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Rules and Regulations Federal Register Vol. 69, No. 101

Tuesday, May 25, 2004

This section of the FEDERAL REGISTER modify any TAWS where both the DEPARTMENT OF TRANSPORTATION contains regulatory documents having general TAWS and any other device are applicability and legal effect, most of which connected to the same baro set Federal Aviation Administration are keyed to and codified in the Code of potentiometer. This AD also prohibits Federal Regulations, which is published under 14 CFR Part 71 50 titles pursuant to 44 U.S.C. 1510. future installation or reconfiguration of any TAWS8000 TAWS that does not The Code of Federal Regulations is sold by incorporate hardware ‘‘Mod C’’. [Docket No. FAA–2004–17721; Airspace the Superintendent of Documents. Prices of Docket No. 04–ACE–ACE–33] new books are listed in the first FEDERAL Need for the Correction REGISTER issue of each week. Modification of Class E Airspace; The FAA incorrectly referred to Mosby, MO paragraph (d)(1) in the Compliance DEPARTMENT OF TRANSPORTATION column of paragraph (e)(2). The correct AGENCY: Federal Aviation reference is (e)(1). This action corrects Administration (FAA), DOT. Federal Aviation Administration the table in paragraph (e) of AD 2004– ACTION: Direct final rule; request for 08–15, Amendment 39–13584. comments. 14 CFR Part 39 This correction is needed to ensure SUMMARY: This action amends Title 14 [Docket No. 2003–CE–47–AD; Amendment that the affected airplane owners/ 39–13584; AD 2004–08–15] Code of Federal Regulations, part 71 (14 operators do the corrective action after CFR 71) by revising Class E airspace at RIN 2120–AA64 the inspection required in paragraph Mosby, MO. On March 1, 2004, a (e)(1). redefined airport reference point (ARP) Airworthiness Directives; Goodrich Correction of Publication for Clay County Regional Airport was Avionics Systems, Inc. TAWS8000 published in the National Flight Data Terrain Awareness Warning System I Accordingly, the publication of April Digest. A review of controlled airspace AGENCY: Federal Aviation 21, 2004 (69 FR 21393), of Amendment at Mosby, MO revealed the Class E Administration, DOT. 39–13584; AD 2004–08–15, which was airspace area extending upward from ACTION: Final rule; correction. the subject of FR Doc. 04–8792, is 700 feet Above Ground Level (AGL) corrected as follows: does not comply with FAA Orders. This SUMMARY: This document makes a action incorporates the revised ARP, correction to Airworthiness Directive PART 39—AIRWORTHINESS expands the area slightly to comply (AD) 2004–08–15, which was published DIRECTIVES with the criteria for 700 feet above in the Federal Register on April 21, ground level (AGL) airspace required for 2004 (69 FR 21393), and applies to all § 39.13 [Corrected] diverse departures, modifies the extension and brings the Mosby, MO Goodrich Avionics Systems, Inc. I On page 21395, in § 39.13 [Amended], Class E airspace area into compliance (Goodrich) TAWS8000 terrain 2., replace the text in the Compliance awareness warning systems (TAWS) with FAA Orders. column of paragraph (e)(2) of the AD that are installed on airplanes. We with the following text: Before further DATES: This direct final rule is effective incorrectly referred to paragraph (d)(1) flight after the inspection required in on 0901 UTC, September 30, 2004. in the Compliance column of paragraph paragraph (e)(1) of this AD.’’ Comments for inclusion in the Rules (e)(2). The correct reference is (e)(1). Docket must be received on or before This action corrects the table in I Action is taken herein to correct this July 26, 2004. reference in AD 2004–08–15 and to add paragraph (e) of AD 2004–08–15, ADDRESSES: Send comments on this Amendment 39–13584. this AD correction to § 39.13 of the proposal to the Docket Management EFFECTIVE DATE: The effective date of Federal Aviation Regulations (14 CFR System, U.S. Department of this AD remains June 7, 2004. 39.13). Transportation, Room Plaza 401, 400 FOR FURTHER INFORMATION CONTACT: The effective date remains June 7, Seventh Street, SW., Washington, DC Brenda S. Ocker, Aerospace Engineer, 2004. 20590–0001. You must identify the FAA, Chicago Aircraft Certification Issued in Kansas City, Missouri, on May docket number FAA–2004–17721/ Office, 2300 East Devon Avenue, Des 18, 2004. Airspace Docket No. 04–ACE–33, at the Plaines, Illinois 60018; telephone: (847) beginning of your comments. You may 294–7126; facsimile: (847) 294–7834. James E. Jackson, also submit comments on the Internet at SUPPLEMENTARY INFORMATION: Acting Manager, Small Airplane Directorate, http://dms.dot.gov. You may review the Aircraft Certification Service. public docket containing the proposal, Discussion [FR Doc. 04–11704 Filed 5–24–04; 8:45 am] any comments received, and any final On April 13, 2004, FAA issued AD BILLING CODE 4910–13–P disposition in person in the Dockets 2004–08–15, Amendment 39–13584 (69 Office between 9 a.m. and 5 p.m., FR 21393), that applies to all Goodrich Monday through Friday, except Federal TAWS8000 terrain awareness warning holidays. The Docket Office (telephone systems (TAWS) that are installed on 1–800–647–5527) is on the plaza level airplanes. This AD requires you to of the Department of Transportation inspect the TAWS installation and NASSIF Building at the above address.

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FOR FURTHER INFORMATION CONTACT: an adverse or negative comment is February 26, 1979); and (3) if Brenda Mumper, Air Traffic Division, received within the comment period, promulgated, will not have a significant Airspace Branch, ACE–520A, DOT the regulation will become effective on economic impact, positive or negative, Regional Headquarters Building, Federal the date specified above. After the close on a substantial number of small entities Aviation Administration, 901 Locust, of the comment period, the FAA will under the criteria of the Regulatory Kansas City, MO 64106; telephone: publish a document in the Federal Flexibility Act. (816) 329–2524. Register indicating that no adverse or List of Subjects in 14 CFR Part 71 SUPPLEMENTARY INFORMATION: This negative comments were received and amendment to 14 CFR 71 modifies the confirming the date on which the final rule will become effective. If the FAA Airspace, Incorporation by reference, Class E airspace area extending upward Navigation (air). from 700 feet above the surface at does receive, within the comment Mosby, MO. The Clay County Regional period, an adverse or negative comment, Adoption of the Amendment Airport ARP has been redefined. An or written notice of intent to submit examination of controlled airspace for such a comment, a document I Accordingly, the Federal Aviation Clay County Regional Airport revealed withdrawing the direct final rule will be Administration amends 14 CFR part 71 it does not meet the criteria for 700 feet published in the Federal Register, and as follows: AGL airspace required for diverse a notice of proposed rulemaking may be departures as specified in FAA Order published with a new comment period. PART 71—DESIGNATION OF CLASS A, 7400.2E, Procedures for Handling Comments Invited CLASS B, CLASS C, CLASS D, AND Airspace Matters. The criteria in FAA CLASS E AIRSPACE AREAS; Interested parties are invited to AIRWAYS; ROUTES; AND REPORTING Order 7400.2E for an aircraft to reach participate in this rulemaking by POINTS 1200 feet AGL is based on a standard submitting such written data, views, or climb gradient of 200 feet per mile plus arguments, as they may desire. I 1. The authority citation for part 71 the distance from the airport reference Comments that provide the factual basis continues to read as follows: point to the end of the outermost supporting the views and suggestions runway. Any fractional part of a mile is presented are particularly helpful in Authority: 49 U.S.C. 106(g), 40103, 40113, converted to the next higher tenth of a developing reasoned regulatory 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– mile. The review also identified that the decisions on the proposal. Comments 1963 Comp., p. 389. extension to the Mosby, MO Class E are specifically invited on the overall airspace area is incorrectly defined. This regulatory, aeronautical, economic, §71.1 [Amended] amendment incorporates the revised environmental, and energy-related I 2. The incorporation by reference in 14 Clay County Regional Airport ARP into aspects of the proposal. the legal description, expands the CFR 71.1 of Federal Aviation Communications should identify both Administration Order 7400.9L, dated airspace area from a 6.4-mile radius to docket numbers and be submitted in September 2, 2003, and effective a 6.5-mile radius of Clay County triplicate to the address listed above. September 16, 2003, is amended as Regional Airport, redefines the Commenters wishing the FAA to centerline of the Mosby, MO Class E acknowledge receipt of their comments follows: ° airspace area extension as a 343 versus on this notice must submit with those * * * * * ° a 340 bearing from the Mosby comments a self-addressed, stamped nondirectional radio beacon (NDB), and Paragraph 6005 Class E airspace areas postcard on which the following extending upward from 700 feet or more brings the legal description of the statement is made: ‘‘Comments to above the surface of the earth. Mosby, MO Class E airspace area into Docket No. FAA–2004–17221/Airspace * * * * * compliance with FAA Orders 7400.2E No. 04–ACE–33.’’ The postcard will be and 8260.19C, Flight Procedures and date/time stamped and returned to the ACE MO E5 Mosby, MO Airspace. This area will be depicted on commenter. Mosby, Clay County Regional Airport, MO appropriate aeronautical charts. Class E (Lat. 39°19′57″ N., long. 94°18′35″ W.) airspace areas extending upward from Agency Findings Mosby NDB 700 feet or more above the surface of the The regulations adopted herein will (Lat. 39°20′46″ N., long. 94°18′27″ W.) earth are published in paragraph 6005 of not have a substantial direct effect on FAA Order 7400.9L, Airspace the States, on the relationship between That airspace extending upward from 700 Designations and Reporting Points, the national Government and the States, feet above the surface within a 6.5-mile dated September 2, 2003, and effective or on the distribution of power and radius of Clay County Regional Airport and within 2.5 miles each side of the 343° bearing September 16, 2003, which is responsibilities among the various from the Mosby NDB extending from the 6.5- incorporated by reference in 14 CFR levels of government. Therefore, it is mile radius of the airport to 7 miles north of 71.1. The Class E airspace designation determined that this final rule does not the NDB. listed in this document will be have federalism implications under published subsequently in the Order. Executive Order 13132. * * * * * The FAA has determined that this The Direct Final Rule Procedure Issued in Kansas City, MO, on May 11, regulation is noncontroversial and 2004. The FAA anticipates that this unlikely to result in adverse or negative Paul J. Sheridan regulation will not result in adverse or comments. For the reasons discussed in negative comment and, therefore, is the preamble, I certify that this Acting Manager, Air Traffic Division, Central Region. issuing it as a direct final rule. Previous regulation (1) is not a ‘‘significant actions of this nature have not been regulatory action’’ under Executive [FR Doc. 04–11788 Filed 5–24–04; 8:45 am] controversial and have not resulted in Order 12866; (2) is not a ‘‘significant BILLING CODE 4910–13–M adverse comments or objections. Unless rule’’ under Department of a written adverse or negative comment, Transportation (DOT) Regulatory or a written notice of intent to submit Policies and Procedures (44 FR 11034,

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DEPARTMENT OF TRANSPORTATION Issued in Kansas City, MO, on May 13, FOR FURTHER INFORMATION CONTACT: 2004. LTJG Anthony Quirino, Coast Guard Federal Aviation Administration Paul J. Sheridan, Marine Safety Office Savannah, (912) Acting Manager, Air Traffic Division, Central 652–4353, ext 235. 14 CFR Part 71 Region. SUPPLEMENTARY INFORMATION: [FR Doc. 04–11787 Filed 5–24–04; 8:45 am] [Docket No. FA–2004–17427; Airspace Regulatory Information Docket No. 04–ACE–27] BILLING CODE 4910–13–M On April 8, 2004, we published a Modification of Class E Airspace; notice of proposed rulemaking (NPRM) entitled Security Zones and Regulated Oshkosh, NE DEPARTMENT OF HOMELAND Navigation Areas; Savannah River, GA SECURITY AGENCY: Federal Aviation in the Federal Register (69 FR 18797). Administration (FAA), DOT. Coast Guard We received one letter commenting on ACTION: Direct final rule; request for the proposed rule. No public hearing comments; correction. 33 CFR Part 165 was requested, and none was held. Under 5 U.S.C. 553(d)(3), the Coast SUMMARY: This action corrects a direct [COTP Savannah–04–040] Guard finds that good cause exists for final rule; request for comments that making this rule effective less than 30 was publised in the Federal Register on RIN 1625–AA00, AA11 days after publication in the Federal Tuesday, May 11, 2004, (69 FR 26029) Register. This rule is needed to provide Security Zones and Regulated [FR Doc. 04–10636]. It corrects an error for the security of the public, the G–8 Navigation Area; Savannah River, GA in the legal description. Summit and its participants, and the DATES: This direct final rule is effective AGENCY: Coast Guard, DHS. safety of the waterways due to the potential for hostile and violent acts on 0901 UTC, August 5, 2004. ACTION: Temporary final rule. from demonstrators protesting the G–8. FOR FURTHER INFORMATION CONTACT: Law enforcement officials require Brenda Mumper, Air Traffic Division, SUMMARY: The Coast Guard is sufficient time to put security measures Airspace Branch, ACE–520A, DOT establishing temporary security zones in place for the start of the G–8 summit Regional Headquarters Building, Federal and a temporary regulated navigation on June 8th. Therefore, it is in the Aviation Administration, 901 Locust, area, from June 5, 2004, through June public interest to have these regulations Kansas City, MO 64106; telephone: 11, 2004, for the G–8 Summit to be held effective less than 30 days after (816) 329–2524. in Sea Island, Georgia. These rules are required to provide for the security of publication in the Federal Register. SUPPLEMENTARY INFORMATION: the public, the G–8 Summit and its Background and Purpose History participants, and the safety of the The G8 (Group of 8) is an informal Federal Register document 04–10636, waterways due to the potential for hostile and violent acts from group of eight countries—Canada, published on Tuesday, May 11, 2004, France, Germany, Italy, Japan, Russia, (69 FR 26029) modified Class E airspace demonstrators protesting the G–8. These temporary security zones prohibit the the United Kingdom and the United areas at Oshkosh, NE. The modification States—whose leaders meet to discuss entry of all vessels and persons into all corrected discrepancies in the broad economic and foreign policies. waters of the Savannah River from Port dimensions controlled airspace for The 30th G8 summit will be held in Sea Wentworth south, including the Back diverse departures from Garden County Island, Georgia, from June 8 through River, the Elba Island South Channel, Airport, expanded the area by .5 mile, June 10, 2004. corrected errors in the location of the and the Intracoastal Waterway Alternate Cities that have recently hosted Oshkosh, NE nondirectional radio Route in the vicinity of St. Augustine conferences or summits similar to the beacon used in the legal description, Creek, to the boundary of the temporary G–8 Summit have experienced redefined the extension to the airspace regulated navigation area that is located significant property damage, and their area and brought the legal description of in the vicinity of the south east tip of law enforcement officers and public the Oshkosh, NE Class E airspace area Elba Island at the western portion of the citizens have sustained personal injuries into compliance with FAA Order Lower Flats Range. The temporary from a segment of protestors engaged in 7400.2E, Procedures for Handling regulated navigation area controls the violent demonstrations against those Airspace Matters. However, the line in movement of all vessels operating on summits and their agendas. Examples the legal description identifying the the Intracoastal Waterway in the include the September 2003 World airport was not in the correct format. vicinity of Fields Cut and south through Trade Organization (WTO) Ministerial Elba Island Cut to St. Augustine Creek. I Accordingly, pursuant to the authority in Cancun, Mexico; the 2003 G–8 delegated to me, the legal description of DATES: This rule is effective from 8 a.m. Summit in Calgary, Canada, the 2001 G– Oshkosh, NE Class E airspace, as on June 5, 2004 until 4 p.m. on June 11, 8 Summit in Genoa, Italy; and the 1999 publised in the Federal Register on 2004. World Trade Organization in Seattle, Tuesday, May 11, 2004, (69 FR 26029) ADDRESSES: Comments and material Washington. These conferences and [FR Doc. 04–10636] is corrected as received from the public, as well as summits experienced an influx of follows: documents indicated in this preamble as protestors, and in particular protest being available in the docket, are part of groups opposing international trade PART 71—[AMENDED] docket [COTP Savannah 04–040] and who have a propensity for violence and are available for inspection or copying a desire to engage in hostile acts against, § 71.1 [Corrected] at Marine Safety Office Savannah, 100 among others, summit attendees, I On page 26030, Column 2, third W. Oglethorpe Ave., Suite 1017, conference venues, the general public, paragraph, second line, change ‘‘Garden Savannah, Georgia 31401 between 8 business and municipal buildings, and County Airport, NE’’ to read ‘‘Oshkosh, a.m. and 4 p.m., Monday through law enforcement officials. Information Garden County Airport, NE’’. Friday, except Federal holidays. and intelligence indicates that there is

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potential for similar acts to be attempted and benefits under section 6(a)(3) of that Collection of Information during the upcoming June G–8 Summit Order. The Office of Management and This rule calls for no new collection in Savannah, Georgia. Budget has not reviewed it under that of information under the Paperwork This history has heightened the need Order. It is not ‘‘significant’’ under the Reduction Act of 1995 (44 U.S.C. 3501– for the development and regulatory policies and procedures of 3520). implementation of various security the Department of Homeland Security measures in the vicinity of the (DHS). Federalism Savannah River, particularly around We expect the economic impact of A rule has implications for federalism venue areas established for the this rule to be so minimal that a full under Executive Order 13132, dignitaries and official parties attending Regulatory Evaluation under the Federalism, if it has a substantial direct the G–8 Summit, critical port facilities regulatory policies and procedures of effect on State or local governments and and infrastructure, bridges, and the DHS is unnecessary. Although the would either preempt State law or navigable waterways. The Coast Guard security zone applies to a large section impose a substantial direct cost of has determined from information of the Savannah River, traffic will be compliance on them. We have analyzed provided by local, state, and federal law allowed to pass through the zone with this rule under that Order and have enforcement officials that vessels or the permission of the Captain of the Port determined that it does not have persons in close proximity to the G–8 of Savannah or his designated implications for federalism. Summit may launch hostile or violent representatives. Before the effective acts from the waterways adjacent to the Unfunded Mandates Reform Act period, we will issue maritime Summit and from the waterways advisories widely available to users of The Unfunded Mandates Reform Act adjacent to where Summit attendees are the river. of 1995 (2 U.S.C. 1531–1538) requires staying. The potential for these acts Federal agencies to assess the effects of poses a security threat to the public, the Small Entities their discretionary regulatory actions. In G–8 Summit and its participants, and particular, the Act addresses actions the flow of commerce on the navigable Under the Regulatory Flexibility Act that may result in the expenditure by a waterways. (5 U.S.C. 601–612), we have considered State, local, or tribal government, in the The temporary security zones and whether this rule will have a significant aggregate, or by the private sector of temporary regulated navigation area economic impact on a substantial $100,000,000 or more in any one year. (RNA) are necessary to mitigate these number of small entities. The term Though this rule will not result in such threats and protect the public, the G–8 ‘‘small entities’’ comprises small expenditure, we do discuss the effects of Summit attendees, law enforcement businesses, not-for-profit organizations this rule elsewhere in this preamble. officers, and the flow of commerce on that are independently owned and the waterways from persons attempting operated and are not dominant in their Taking of Private Property hostile and violent acts. fields, and governmental jurisdictions This rule will not affect a taking of The temporary security zones and with populations of less than 50,000. private property or otherwise have temporary regulated navigation area are The Coast Guard certifies under 5 taking implications under Executive being established to mitigate these U.S.C. 605(b) that this rule will not have Order 12630, Governmental Actions and threats and are necessary to protect the a significant economic impact on a Interference with Constitutionally public, the G–8 conference and substantial number of small entities. We Protected Property Rights. attendees, law enforcement officers, the did not receive any comments from Civil Justice Reform Port of Savannah and commerce within small entities or other information the port from persons attempting hostile following our (NPRM) on April 8, 2004 This rule meets applicable standards and violent acts. (69 FR 18797) stating that this rule in sections 3(a) and 3(b)(2) of Executive Please note that elsewhere in today’s would have a significant economic Order 12988, Civil Justice Reform, to Federal Register, we have published impact on them. minimize litigation, eliminate another final rule, entitled ‘‘Security ambiguity, and reduce burden. Zone, St. Simons Sound and the Assistance for Small Entities Protection of Children Atlantic Ocean, GA’’ that is also intended to provide security of the Under section 213(a) of the Small We have analyzed this rule under public, the G–8 Summit and its Business Regulatory Enforcement Executive Order 13045, Protection of participants, and the safety of the Fairness Act of 1996 (Pub. L. 104–121), Children from Environmental Health waterways during this same period— we offered to assist small entities in Risks and Safety Risks. This rule is not June 5, 2004, until 4 p.m. on June 11, understanding this rule so that they economically significant and does not 2004. could better evaluate its effects on them create environmental risks to health or and participate in the rulemaking risks to safety that may Discussion of Comments and Changes process. Small businesses may send disproportionately affect children. We received one letter offering comments on the actions of Federal Indian Tribal Governments support of the rule and the increased employees who enforce, or otherwise security and protection that it provides. determine compliance with, federal This rule does not have tribal The Coast Guard agrees with this regulations to the Small Business and implications under Executive Order comment and no changes to the final Agriculture Regulatory Enforcement 13175, Consultation and Coordination rule were made. Ombudsman and the Regional Small with Indian Tribal Governments, Business Regulatory Fairness Boards. because it does not have a substantial Regulatory Evaluation The Ombudsman evaluates these direct effect on one or more Indian This rule is not a ‘‘significant actions annually and rates each agency’s tribes, on the relationship between the regulatory action’’ under section 3(f) of responsiveness to small business. If you Federal Government and Indian tribes, Executive Order 12866, Regulatory wish to comment on the actions by or on the distribution of power and Planning and Review, and does not employees of the Coast Guard, call 1– responsibilities between the Federal require an assessment of potential costs 800–REG–FAIR (1–888–734–3247). Government and Indian tribes.

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Energy Effects River to Port Wentworth at approximate 32°04′15″ N, 080°58′00″ W, and ° ′ ″ ° ′ ″ We have analyzed this rule under point 32 08 47 N, 081 06 36 W; then continuing south and west and Executive Order 13211, Actions all waters of the Savannah River from including all waters of Elba Island Cut Concerning Regulations That shore to shore and surface to bottom and the Intracoastal waterway, from Significantly Affect Energy Supply, south and east of this imaginary line shore to shore and surface to bottom, to Distribution, or Use. We have downriver to an imaginary line starting Elba Island Cut Light 10 (Light List, Vol. determined that it is not a ‘‘significant at the south east tip of Elba Island at III no. 35900) at St. Augustine Creek. All approximate point 32°04′19″ N, coordinates are based upon North energy action’’ under that order because ° ′ ″ it is not a ‘‘significant regulatory action’’ 080 58 27 W and extending due north American Datum 83 (NAD 83). under Executive Order 12866 and is not across the Savannah River and through (b) Definitions. The following definitions apply to likely to have a significant adverse effect Red Buoy #36 to approximate point ° ′ ″ ° ′ ″ this section: on the supply, distribution, or use of 32 0 40 N, 080 58 19 W. All coordinates are based upon North Designated Representatives means energy. The Administrator of the Office Coast Guard Patrol Commanders of Information and Regulatory Affairs American Datum 83 (NAD 83). (2) Security Zone, Back River. All including Coast Guard coxswains, petty has not designated them as a significant waters of the Back River south and east officers and other officers operating energy action. Therefore, they do not of the Highway 17 bridge from shore to Coast Guard vessels, and federal, state, require a Statement of Energy Effects shore and surface to bottom easterly to and local officers designated by or under Executive Order 13211. where the Back River meets the assisting the Captain of the Port of Environment Savannah River. Savannah, to regulate the movement of (3) Security Zone, South Channel Elba We have analyzed these rules under vessels within the RNA and restrict Island. All waters of the South Channel Commandant Instruction M16475.lD, vessels and persons from entering the south of Elba Island, from shore to shore which guides the Coast Guard in security zones. and surface to bottom, from the Slow speed means the speed at which complying with the National intersection of the Savannah River and a vessel proceeds when it is fully off Environmental Policy Act of 1969 the South Channel and continuing south plane, completely settled in the water (NEPA)(42 U.S.C. 4321–4370f), and easterly to an imaginary line starting at and not creating excessive wake. Due to have concluded that there are no factors the south east tip of Elba Island at the different speeds at which vessels of in this case that would limit the use of approximate point 32°04′19″ N, different sizes and configurations may a categorical exclusion under section 080°58′27″ W and extending south travel while in compliance with this 2.B.2 of the Instruction. Therefore, these westerly following the northern edge of definition, no specific speed is assigned rules are categorically excluded, under Elba Island Cut channel to the north east to slow speed. In no instance should figure 2–1, paragraph (34)(g), of the tip of McQueen Island at approximate slow speed be interpreted as a speed Instruction, from further environmental position 32°04′08″ N, 080°58′55″ W. All less than that required to maintain documentation. coordinates are based upon North steerageway. A vessel is not proceeding List of Subjects in 33 CFR Part 165 American Datum 83 (NAD 83). at slow speed if it is: (4) Security Zone, Intracoastal Harbors, Marine safety, Navigation (1) On a plane; Waterway Alternate Route. All waters of (water), Reporting and recordkeeping (2) In the process of coming up onto the Intracoastal Waterway Alternate requirements, Security measures, or coming off a plane; or Route from shore to shore and surface (3) Creating an excessive wake. Waterways. to bottom from St. Augustine Creek Day (c) Regulations— I For the reasons discussed in the Beacon A18 (Light List, Vol. III, no. (1) Security Zones. The regulations in preamble, the Coast Guard amends 33 35960) to Day Beacon A12 (Light List, this paragraph apply to the zones in Part 165 as follows: Vol. III, no. 35945). paragraph (a)(1) through (a)(4) of this (5) Regulated navigation area; section. Entry into or remaining within PART 165—REGULATED NAVIGATION Intracoastal Waterway Fields Cut, the security zones by vessels or persons AREAS AND LIMITED ACCESS AREAS Savannah River, and St. Augustine is prohibited unless authorized by the I 1. The authority citation for part 165 Creek. All waters of the Intracoastal Coast Guard Captain of the Port, continues to read as follows: Waterway from shore to shore and Savannah, Georgia or that officer’s surface to bottom from Fields Cut Buoy Authority: 33 U.S.C. 1226, 1231; 50 U.S.C. designated representatives. Vessels 191, 195; 46 U.S.C. Chapter 701; 33 CFR 48 (Light List, Vol. III, no. 35865) at moored, docked or anchored in the 1.05–1(g), 6.04–1, 6.04–6, and 160.5; Pub. L. Wright River south and west to the security zones when they become 107–295, 116 Stat. 2064; Department of Savannah River, and including all effective must remain in place unless Homeland Security Delegation No. 0170.1. waters of the Savannah River in the ordered by or given permission from the vicinity of Lower Flats Range, from COTP to do otherwise. Vessels or I 2. From 8 a.m. on June 5, 2004, until shore to shore and surface to bottom, persons desiring to enter or transit the 4 p.m. on June 11, 2004 add a new southeast of an imaginary line starting at areas encompassed by the security temporary § 165.T07–040 to read as the south east tip of Elba Island at zones may contact the Coast Guard on follows: approximate point 32°04′19″ N, VHF Channel Marine 16 or at (912) 652– § 165.T07–040 Temporary Security Zones 080°58′27″ W and extending due north 4353 to seek permission to enter or and Temporary Regulated Navigation Area, across the Savannah River and through transit the area. If permission is granted, Savannah River, GA Red Buoy #36 to approximate point all persons and vessels must comply (a) Locations— 32°04′40″ N, 080°58′19″ W to an with the instructions of the Captain of (1) Security Zone, Savannah River. An imaginary line starting at the western tip the Port or that officer’s designated imaginary line starting at Channel Light of Jones Island at the intersection of the representatives. 22, (Light List Volume III, Number Intracoastal Waterway and extending (2) Regulated Navigation Area. The 5090), at the intersection of the Middle southwesterly across the Savannah regulations in this paragraph apply to River and the Savannah River and River intersecting through Green buoy the area in paragraph (a)(5) of this crossing due West over the Savannah ‘‘35’’ to Bird Island at approximate point section.

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(i) All vessels and persons entering Island, and St. Simons Sound. citizens have sustained personal injuries and transiting through the regulated Additional security zones prohibit from a segment of protestors engaged in navigation area shall proceed entering closer than 100-yards to eight violent demonstrations against those continuously and at a slow speed. In no specified bridges located in the vicinity summits and their agendas. Examples instance should slow speed be of these waters. include the September 2003 World interpreted as a speed less than that DATES: This rule is effective from 8 a.m. Trade Organization (WTO) Ministerial required to maintain steerageway. June 5, 2004, until 4 p.m. on June 11, in Cancun, Mexico; the 2003 G–8 Nothing in this rule alleviates vessels or 2004. Summit in Calgary, Canada, the 2001 operators from complying with all state ADDRESSES: Marine Safety Office G–8 Summit in Genoa, Italy; and the and local laws in the area. Savannah maintains the public docket 1999 World Trade Organization in (ii) All vessels and persons shall for this rulemaking. Comments and Seattle, Washington. These conferences comply with orders from the Coast material received from the public, as and summits experienced an influx of Guard Captain of the Port of Savannah well as documents indicated in this protestors, and in particular protest or that officer’s designated preamble as being available in the groups opposing international trade representatives, regulating their speed, docket, are part of docket [COTP who have a propensity for violence and a desire to engage in hostile acts against, course, direction and movements within Savannah 04–041] and will be available among others, summit attendees, the RNA. for inspection or copying at Marine conference venues, the general public, All vessels and persons shall obtain Safety Office Savannah, 100 W. business and municipal buildings, and the permission of the Captain of the Port Oglethorpe Ave., Suite 1017, Savannah, law enforcement officials. Information or that officer’s designated Georgia 31401, between 8 a.m. and 4 and intelligence indicates that there is representatives prior to entering or p.m., Monday through Friday, except potential for similar acts to be attempted transiting via VHF Channel 16. Federal holidays. (d) Effective period: This section is during the upcoming June G–8 Summit FOR FURTHER INFORMATION CONTACT: effective from 8 a.m. on June 5, 2004 in Savannah, Georgia. until 4 p.m. on June 11, 2004. LTJG Anthony Quirino, Coast Guard This history has heightened the need Marine Safety Office Savannah, (912) for the development and Dated: May 17, 2004. 652–4353, ext. 235. implementation of various security Harvey E. Johnson, Jr., SUPPLEMENTARY INFORMATION: measures in the vicinity of St. Simons Rear Admiral, U.S. Coast Guard, Commander, Sound. In particular, there is a need for Regulatory Information Seventh Coast Guard District. additional security around venue areas [FR Doc. 04–11887 Filed 5–21–04; 12:12 pm] On April 8, 2004, we published a established for the dignitaries and BILLING CODE 4910–15–P notice of proposed rulemaking (NPRM) official parties attending the G–8 entitled Security Zone, St. Simons Summit, bridges, and waterways used Sound and the Atlantic Ocean, GA, in by commercial shipping. The Coast DEPARTMENT OF HOMELAND the Federal Register (69 FR 18794). We Guard has determined from information SECURITY received 2 letters commenting on the provided by local, state, and federal law proposed rule. No public meeting was enforcement officials that vessels or Coast Guard requested, and none was held. persons in close proximity to the G–8 Under 5 U.S.C. 553(d)(3), the Coast Summit may launch hostile or violent 33 CFR Part 165 Guard finds that good cause exists for acts from the waterways adjacent to the [COTP Savannah–04–041] making this rule effective less than 30 Summit and from the waterways days after publication in the Federal adjacent to where Summit attendees are RIN 1625–AA00 Register. This rule is necessary to staying. The potential for these acts Security Zone, St. Simons Sound and minimize danger and provide security poses a security threat to the public, the the Atlantic Ocean, GA for the public and participants of the G8 G–8 Summit and its participants, and Conference. Law enforcement officials the flow of commerce on the navigable AGENCY: Coast Guard, DHS. require sufficient time to put security waterways. ACTION: Temporary final rule. measures in place prior to the start of The security zones mitigate these the conference on June 8, 2004. threats and are necessary to protect the SUMMARY: The Coast Guard is Therefore, it is in the public interest to public, the G–8 Summit attendees, law establishing security zones, from June 5, have these regulations effective less enforcement officers, and the flow of 2004, through June 11, 2004, for the than 30-days after publication in the commerce on the waterways from G–8 Summit to be held in Sea Island, Federal Register. persons attempting hostile and violent Georgia. These security zones are acts. Please note that elsewhere in Background and Purpose required to provide for the security of today’s Federal Register, we have the public, the G–8 Summit and its The G8 (Group of 8) is an informal published another final rule, entitled participants, and the safety of the group of eight countries—Canada, ‘‘Security Zones and Regulated waterways due to the potential for France, Germany, Italy, Japan, Russia, Navigation Areas; Savannah River, GA,’’ hostile and violent acts from the United Kingdom and the United that is also intended to provide security demonstrators protesting the G–8 States—whose leaders meet to discuss of the public, the G–8 Summit and its Conference. This rule prohibits the broad economic and foreign policies. participants, and the safety of the entry of all vessels and persons into the The 30th G8 Summit will be held in Sea waterways during this same period— waters in the vicinity of Sea Island, Island, Georgia, from June 8 through June 5, 2004, until 4 p.m. on June 11, Jekyll Island, and all waters of the June 10, 2004. 2004. Atlantic Ocean from the baselines of Sea Cities that have recently hosted Island, St. Simons Island and Jekyll conferences or summits similar to the Discussion of Rule Island extending seaward to a distance G–8 Summit have experienced In our NPRM (69 FR 18794) we of 3 nautical miles, as well as waters on significant property damage, and their advised vessels transiting the the Hampton River, Jones Creek, Lanier law enforcement officers and public Intracoastal waterway to exit and enter

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at Altamaha Sound as an alternate route the Department of Homeland Security determined that it does not have around the security zone. Due to (DHS). implications for federalism. shoaling in Altamaha Sound, published We expect the economic impact of Unfunded Mandates Reform Act in Local Notice to Mariners (08/04), this rule to be so minimal that a full vessels should instead use Doboy Regulatory Evaluation under the The Unfunded Mandates Reform Act Sound, 2 miles north, to exit and enter regulatory policies and procedures of of 1995 (2 U.S.C. 1531–1538) requires the Intracoastal waterway. DHS is unnecessary. Federal agencies to assess the effects of their discretionary regulatory actions. In Discussion of Comments and Changes Small Entities particular, the Act addresses actions We received two letters offering Under the Regulatory Flexibility Act that may result in the expenditure by a comments on the proposed rule. One (5 U.S.C. 601–612), we have considered State, local, or tribal government, in the comment recommended using whether this rule would have a aggregate, or by the private sector of consistent language that prohibits the significant economic impact on a $100,000,000 or more in any one year. entry of all vessels and persons substantial number of small entities. Though this rule would not result in throughout the rule. We agree. As a The term ‘‘small entities’’ comprises such expenditure, we do discuss the result of this comment, language that small businesses, not-for-profit effects of this rule elsewhere in this prohibits the entry of all vessels and organizations that are independently preamble. persons is now consistently used owned and operated and are not throughout this rule. dominant in their fields, and Taking of Private Property The other letter requested advance governmental jurisdictions with This rule would not affect a taking of permission to enter and transit the populations of less than 50,000. private property or otherwise have security zones, and commented that the The Coast Guard certifies under 5 taking implications under Executive regulation was overbroad because it U.S.C. 605(b) that this rule would not Order 12630, Governmental Actions and shut down traffic on the Intracoastal have a significant economic impact on Interference with Constitutionally waterway. Granting pre-approval to a substantial number of small entities. Protected Property Rights. transit these security zones is This rule would affect the following impracticable because of the numerous entities, some of which might be small Civil Justice Reform unknown exigencies that may exist. entities: The owners or operators of This rule meets applicable standards Moreover, numerous alternatives do vessels intending to transit or anchor in in sections 3(a) and 3(b)(2) of Executive exist, including transiting offshore of a portions of St. Simons Sound, the Order 12988, Civil Justice Reform, to the security zones, weather permitting, Intracoastal waterway and the Atlantic minimize litigation, eliminate or delaying a voyage until after Ocean covered by this security zone. We ambiguity, and reduce burden. expiration of the security zones. Finally, received no comments from owners of Protection of Children although authorization to transit the such small entities. Therefore, owners security zone may not be provided in are encouraged to contact the Captain of We have analyzed this rule under advance, requests for permission to the Port to seek permission to transit Executive Order 13045, Protection of transit the zone immediately may still these security zones. Children from Environmental Health be granted by the COTP Savannah. This Risks and Safety Risks. This rule is not approach provides COTP Savannah the Assistance for Small Entities an economically significant rule and flexibility to enforce this rule as threats Under section 213(a) of the Small does not create an environmental risk to and conditions dictate. Business Regulatory Enforcement health or risk to safety that may Although the G–8 Summit is Fairness Act of 1996 (Pub. L. 104–121), disproportionately affect children. scheduled to take place from June 8 we want to assist small entities in Indian Tribal Governments through June 10, 2004, it is necessary to understanding this rule so that they can make the security zones effective from better evaluate its effects on them and This rule does not have tribal June 5 through June 11, 2004, to provide participate in the rulemaking. If the rule implications under Executive Order security for arriving and departing G–8 affects your small business, 13175, Consultation and Coordination summit attendees and allow law organization, or governmental with Indian Tribal Governments, enforcement officials time to stand up jurisdiction and you have questions because it does not have a substantial and stand down from patrolling the concerning its provisions or options for direct effect on one or more Indian security zones. compliance, please contact the person tribes, on the relationship between the We made one technical change in the listed under FOR FURTHER INFORMATION Federal Government and Indian tribes, text of the regulation. The references in CONTACT. or on the distribution of power and (a)(1) and (a)(2) to the location responsibilities between the Federal coordinates being based on North Collection of Information Government and Indian tribes. This rule calls for no new collection American Datum 83 have been moved Energy Effects into a note for the entire paragraph (a). of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– We have analyzed this rule under Regulatory Evaluation 3520). Executive Order 13211, Actions This rule is not a ‘‘significant Concerning Regulations That regulatory action’’ under section 3(f) of Federalism Significantly Affect Energy Supply, Executive Order 12866, Regulatory A rule has implications for federalism Distribution, or Use. We have Planning and Review, and does not under Executive Order 13132, determined that it is not a ‘‘significant require an assessment of potential costs Federalism, if it has a substantial direct energy action’’ under that order because and benefits under section 6(a)(3) of that effect on State or local governments and it is not a ‘‘significant regulatory action’’ Order. The Office of Management and would either preempt State law or under Executive Order 12866 and is not Budget has not reviewed it under that impose a substantial direct cost of likely to have a significant adverse effect Order. It is not ‘‘significant’’ under the compliance on them. We have analyzed on the supply, distribution, or use of regulatory policies and procedures of this rule under that Order and have energy. The Administrator of the Office

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of Information and Regulatory Affairs requirements, Security measures, Simons Sound and the Atlantic Ocean, has not designated it as a significant Waterways. from surface to bottom, encompassed by energy action. Therefore, it does not I For the reasons discussed in the a line commencing from the north east require a Statement of Energy Effects preamble, the Coast Guard amends 33 point of Little St. Simons Island at ° ′ ″ ° ′ ″ under Executive Order 13211. CFR part 165 as follows: 31 15 24 N, 081 16 55 W; thence, easterly seaward into the waters of the Environment PART 165—REGULATED NAVIGATION Atlantic Ocean out to a distance of 3 ° ′ ″ We have analyzed this rule under AREAS AND LIMITED ACCESS AREAS nautical miles at 31 15 24 N, 081°11′55″ W; thence southerly Commandant Instruction M16475.lD, I 1. The authority citation for part 165 following the contour of the baseline at which guides the Coast Guard in continues to read as follows: a distance of 3 nautical miles to complying with the National Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. 31°00′44″ N, 081°19′35″ W; thence Environmental Policy Act of 1969 Chapter 701; 50 U.S.C. 191, 195; 33 CFR westerly to the southern tip of Jekyll (NEPA)(42 U.S.C. 4321–4370f), and 1.05–1(g), 6.04–1, 6.04–6, and 160.5; Pub. L. Island at 31°00′44″ N, 081°26′03″ W; have concluded that there are no factors 107–295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1. thence northwesterly to the south side in this case that would limit the use of of the Sidney Lanier bridge at 31°06′48″ a categorical exclusion under section I 2. From 8 a.m. on June 5, 2004, until N, 081°29′40″ W; thence continuing 2.B.2 of the Instruction. Therefore, this 4 p.m. on June 11, 2004, add a new northeasterly to the northern tip of rule is categorically excluded, under temporary § 165.T07–041 to read as Lanier Island at 31°11′06″ N, 081°25′17″ figure 2–1, paragraph (34)(g), of the follows: W; thence continuing northeasterly to Instruction, from further environmental the Hampton River at 31°17′36″ N, § 165.T07–041 Temporary security zones, ° ′ ″ documentation. St. Simons Sound, GA. 081 20 33 W; thence back to the original point. List of Subjects in 33 CFR Part 165 (a) Locations. The following areas are security zones: (2) Security zone, Bridges. All waters Harbors, Marine safety, Navigation (1) Security zone; St. Simons Sound from surface to bottom within 100-yards (water), Reporting and recordkeeping and the Atlantic Ocean. All waters of St. of the following bridges:

Roadway Bridge Located at

(i) Jekyll Island Causeway ...... Cedar Creek ...... 31°05.318′ N, 081°28.780′ W. (ii) Jekyll Island Causeway ...... Jekyll Creek ...... 31°02.808′ N, 081°25.347′ W. (iii) Highway 17 ...... Sidney Lanier ...... 31°06.982′ N, 081°29.094′ W. (iv) Saint Simons Causeway ...... Terry Creek ...... 31°09.697′ N, 081°28.137′ W. (v) Saint Simons Causeway ...... Back River ...... 31°09.868′ N, 081°26.766′ W. (vi) Saint Simons Causeway ...... Little River ...... 31°10.120′ N, 081°26.200′ W. (vii) Saint Simons Causeway ...... MacKay River ...... 31°10.276′ N, 081°25.494′ W. (viii) Saint Simons Causeway ...... Frederica River ...... 31°10.050′ N, 081°24.782′ W.

Note to § 165.T07–041(a): All coordinates 4353 to seek permission to enter or ACTION: Direct final rule. are based upon North American Datum 83 transit the zones. If permission is (NAD 83). granted, all persons and vessels must SUMMARY: EPA is taking direct final (b) Definitions. As used in this comply with the instructions of the action to approve the commercial and section, designated representatives Captain of the Port or that officer’s industrial solid waste incinerator means Coast Guard Patrol Commanders designated representatives. (CISWI) section 111(d)/129 plan (the including Coast Guard coxswains, petty Dated: May 17, 2004. ‘‘plan’’) submitted to EPA on September officers and other officers operating Harvey E. Johnson, Jr., 8, 2003 by the Virginia Department of Coast Guard vessels, and federal, state, Rear Admiral, U.S. Coast Guard, Commander, Environmental Quality (DEQ). The plan and local officers designated by or Seventh Coast Guard District. includes supplemental information assisting the Captain of the Port of [FR Doc. 04–11886 Filed 5–21–04; 12:12 pm] submitted on August 11, and September 30, 2003, and April 6, 2004. The plan Savannah (COTP) to restrict vessels and BILLING CODE 4910–15–P persons from entering the security establishes emission limits, monitoring, zones. operating, and recordkeeping requirements for commercial and (c) Regulations. Entry into or ENVIRONMENTAL PROTECTION industrial solid waste incinerator units transiting within the security zones by AGENCY for which construction commenced on vessels or persons is prohibited unless or before November 30, 1999. Submittal authorized by the Coast Guard Captain 40 CFR Part 62 and approval of the plan fulfills a Clean of the Port, Savannah, Georgia or that Air Act (the Act) requirement for the officer’s designated representatives. [VA141–5075a; FRL–7666–5] Commonwealth of Virginia. Vessels docked, moored, or anchored in Approval and Promulgation of State security zones when they become Air Quality Plans for Designated DATES: This rule is effective on July 26, effective must remain in place unless Facilities and Pollutants, 2004 without further notice, unless EPA ordered by or given permission from the Commonwealth of Virginia; Control of receives written comment by June 24, COTP to do otherwise. Vessels or Emissions From Commercial and 2004. If EPA receives such comments, it persons desiring to enter or transit the Industrial Solid Waste Incinerator Units will publish a timely withdrawal of the areas encompassed by the security direct final rule in the Federal Register zones may contact the Coast Guard on AGENCY: Environmental Protection and inform the public that the rule will VHF Channel Marine 16 or at (912) 652– Agency (EPA). not take effect.

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ADDRESSES: Submit your comments, 2190, or by e-mail at procedures for adoption and submittal identified by VA141–5075 by one of the [email protected]. of State plans are codified in 40 CFR following methods: SUPPLEMENTARY INFORMATION: part 60, subpart B. A. Federal eRulemaking Portal: http://www.regulations.gov. Follow the I. Background II. Review of the Virginia CISWI Plan on-line instructions for submitting Sections 111(d)/129 of the Act require EPA has reviewed the Virginia CISWI comments. states to submit plans to control certain plan in the context of the requirements B. E-mail: [email protected]. pollutants (designated pollutants) at of 40 CFR part 60, and subparts B and C. Mail: Walter Wilkie, Chief, Air existing solid waste combustor facilities DDDD. A summary of the review is Quality Analysis Branch, Mailcode (designated facilities) whenever provided below. 3AP22, U.S. Environmental Protection Agency, Region III, 1650 Arch Street, standards of performance have been A. Identification of Enforceable State Philadelphia, Pennsylvania 19103. established under section 111(b) for new Mechanism(s) for Implementing the EG sources of the same type, and EPA has D. Hand Delivery: At the previously- On September 8, 2003, the DEQ established emission guidelines (EG) for listed EPA Region III address. Such submitted to EPA the required plan, such existing sources. A designated deliveries are only accepted during the including an enforceable mechanism, pollutant is any pollutant for which no Docket’s normal hours of operation, and the State Air Pollution Control Board’s air quality criteria have been issued, and special arrangements should be made Regulation for the Control and which is not included on a list for deliveries of boxed information. Abatement of Air Pollution, Emission published under section 108(a) or Instructions: Direct your comments to Standards for Commercial/Industrial section 112(b)(1)(A) of the Act, but Docket ID No. VA141–5075. EPA’s Solid Waste Incinerators (Rule 4–45). In emissions of which are subject to a policy is that all comments received addition, related applicable Regulations standard of performance for new will be included in the public docket for General Administration were stationary sources. However, section without change, including any personal submitted on August 11, 2003 and April 129 of the Act, also requires EPA to information provided, unless the 6, 2004. comment includes information claimed promulgate EG for CISWI units that emit to be Confidential Business Information a mixture of air pollutants. These B. Demonstration of Legal Authority (CBI) or other information whose pollutants include organics (dioxins/ DEQ’s authority is explained in detail disclosure is restricted by statute. Do furans), carbon monoxide, metals in its August 11, 2003 letter to EPA. The not submit information that you (cadmium, lead, mercury), acid gases DEQ cites its authority under the Air consider to be CBI or otherwise (hydrogen chloride, sulfur dioxide, and Pollution Control Law of Virginia at protected through regulations.gov or e- nitrogen oxides) and particulate matter Title 10.1, Chapter 13, Code of Virginia. mail. The Federal regulations.gov (including opacity). On December 1, This is also discussed in the plan website is an ‘‘anonymous access’’ 2000 (65 FR 75338), EPA promulgated narrative, Section I, Legal Authority— system, which means EPA will not CISWI unit new source performance State, and the Attorney General’s Office know your identity or contact standards and EG, 40 CFR part 60, certification of authority in a July 1, information unless you provide it in the subparts CCCC and DDDD, respectively. 1998 letter. The DEQ has sufficient body of your comment. If you send an The designated facility to which the EG statutory and regulatory authority to e-mail comment directly to EPA without apply is each existing CISWI unit, as implement and enforce the plan. going through regulations.gov, your e- stipulated in subpart DDDD, that mail address will be automatically commenced construction on or before C. Inventory of CISWI Units in Virginia captured and included as part of the November 30, 1999. See 40 CFR 60.2550 Affected by the EG comment that is placed in the public for details. The plan contains a DEQ inventory of docket and made available on the Section 111(d) of the Act requires that known existing CISWI units that are Internet. If you submit an electronic ‘‘designated’’ pollutants, regulated subject to the plan. comment, EPA recommends that you under standards of performance for new include your name and other contact stationary sources by section 111(b) of D. Inventory of Emissions From CISWI information in the body of your the Act, must also be controlled at Units in Virginia comment and with any disk or CD–ROM existing sources in the same source The submitted plan contains an you submit. If EPA cannot read your category to a level stipulated in an estimate of emissions from each affected comment due to technical difficulties emission guidelines (EG) document. facility. Emissions estimates are and cannot contact you for clarification, Section 129 of the Act specifically provided for organics (dioxins/furans), EPA may not be able to consider your addresses solid waste combustion and carbon monoxide, acid gases (hydrogen comment. Electronic files should avoid emissions controls based on what is chloride, sulphur dioxide, and nitrogen the use of special characters, any form commonly referred to as ‘‘maximum oxides), metals (cadmium, lead, of encryption, and be free of any defects achievable control technology’’ (MACT). mercury), and particulate matter. or viruses. Section 129 requires EPA to promulgate Copies of the documents relevant to a MACT based emission guideline (EG) E. Emission Limitations for CISWI Units this action are available for public document for CISWI units, and then The state CISWI regulation, Rule 4– inspection during normal business requires states to develop plans that 45, includes emission limitation hours at the Air Protection Division, implement the EG requirements. The requirements that are at least as U.S. Environmental Protection Agency, CISWI EG under 40 CFR part 60, subpart protective as those in the EG, subpart Region III, 1650 Arch Street, DDDD, establish emission and operating DDDD. Philadelphia, Pennsylvania 19103; and requirements under the authority of the the Virginia Department of Act, sections 111(d) and 129. These F. Compliance Schedules Environmental Quality, 629 East Main requirements must be incorporated into Rule 4–45 contains an expeditious Street, Richmond, Virginia 23219. a State plan that is ‘‘at least as compliance schedule provision (9 VAC FOR FURTHER INFORMATION CONTACT: protective’’ as the EG, and is Federally- 5–40–6420 A) that requires final James B. Topsale, P.E., at (215) 814– enforceable upon approval by EPA. The compliance on or before October 3,

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2004, and it includes separate extend to documents or information (1) 167, 205, 211 or 213, to enforce the provisions for extending the compliance that are generated or developed before requirements or prohibitions of the state date. Both the Federal and Virginia the commencement of a voluntary plan, independently of any state plans require that a compliance date environmental assessment; (2) that are enforcement effort. In addition, citizen extension must be submitted to the prepared independently of the enforcement under section 304 of the respective implementing air pollution assessment process; (3) that demonstrate Clean Air Act is likewise unaffected by control agency on or before December 3, a clear, imminent and substantial this, or any, state audit privilege or 2003. Neither air pollution control danger to the public health or immunity law. agency has the authority under the Act environment; or (4) that are required by III. Final Action and related rules to grant or approve an law. extension request submitted after On January 12, 1997, the EPA is approving the Virginia CISWI December 3, 2003. As the Federal plan Commonwealth of Virginia Office of the plan for controlling designated implementing agency, EPA has no Attorney General provided a legal pollutants under sections 111(d) and record of receiving a compliance date opinion that states that the Privilege 129 of the Act. Accordingly, EPA is extension request. Therefore, under the law, Va. Code Sec. 10.1–1198, precludes amending 40 CFR part 62 to reflect this Virginia plan, final compliance is granting a privilege to documents and action. As a result, the Federal plan is required on or before October 3, 2004. information ‘‘required by law,’’ no longer applicable, as of the effective including documents and information date of this action. H. Testing, Monitoring, Recordkeeping, ‘‘required by Federal law to maintain This approval is based on the and Reporting Requirements program delegation, authorization or rationale discussed above and in further Rule 4–45 includes the applicable approval,’’ since Virginia must ‘‘enforce detail in the technical support source compliance testing, monitoring, Federally authorized environmental document (TSD) associated with this recordkeeping, and reporting programs in a manner that is no less action. The DEQ has committed, as part requirements of the EG. stringent than their Federal of the plan, to consult with EPA and counterparts. * * *’’ The opinion obtain its concurrence before I. A Record of the Public Hearing on the concludes that ‘‘[r]egarding § 10.1–1198, implementing certain actions as State Plan therefore, documents or other described in the plan narrative, section A public hearing for the plan was information needed for civil or criminal J, Discretionary Authority, and held in Richmond, Virginia, on August enforcement under one of these Regulation for General Administration 27, 2003. The DEQ provided evidence of programs could not be privileged (9 VAC 5–20–80), Relationship of state complying with the public notice and because such documents and regulations to Federal regulations. other hearing requirements of subpart B. information are essential to pursuing As stated above, EPA has no record of receiving a CISWI unit compliance date J. Provision for Annual State Progress enforcement in a manner required by extension request on or before December Reports to EPA Federal law to maintain program delegation, authorization or approval.’’ 3, 2003, as required by the Federal plan. The DEQ will submit to EPA on an Virginia’s Immunity law, Va. Code As a result, neither EPA or the DEQ now annual basis a report which details the Sec. 10.1–1199, provides that ‘‘[t]o the have the authority to approve an progress in the enforcement of the plan. extent consistent with requirements extension request submitted to either The first progress report will be imposed by Federal law,’’ any person agency after the noted date. Therefore, submitted to EPA within one year after making a voluntary disclosure of EPA is taking no action to approve those approval of the Virginia plan. information to a state agency regarding provisions of Rule 4–45 that relate to a In 1995, Virginia adopted legislation a violation of an environmental statute, compliance date extension request, that provides, subject to certain regulation, permit, or administrative sections 9 VAC 5–40–6420 B through conditions, for an environmental order is granted immunity from 6421 and 6422 B.2. Final compliance or assessment (audit) ‘‘privilege’’ for administrative or civil penalty. The closure for all affected units must be voluntary compliance evaluations Attorney General’s January 12, 1997 achieved on or before October 3, 2004. performed by a regulated entity. The opinion states that the quoted language There are other Rule 4–45 provisions legislation further addresses the relative renders this statute inapplicable to that are not relevant or germane to this burden of proof for parties either enforcement of any Federally authorized plan approval action. Those provisions, asserting the privilege or seeking programs, since ‘‘no immunity could be for example, include requirements disclosure of documents for which the afforded from administrative, civil, or relating to odor control. A listing of the privilege is claimed. Virginia’s criminal penalties because granting Commonwealth rule provisions that are legislation also provides, subject to such immunity would not be consistent not part of the plan, except for those certain conditions, for a penalty waiver with Federal law, which is one of the noted in the previous paragraph, are for violations of environmental laws criteria for immunity.’’ identified in the plan, Attachment A, when a regulated entity discovers such Therefore, EPA has determined that and DEQ’s April 6, 2004 letter, violations pursuant to a voluntary Virginia’s Privilege and Immunity Attachment C. compliance evaluation and voluntarily statutes will not preclude the As provided by 40 CFR 60.28(c), any discloses such violations to the Commonwealth from enforcing its revisions to the Virginia plan will not be Commonwealth and takes prompt and section 111(d)/129 program consistent considered part of the applicable plan appropriate measures to remedy the with the Federal requirements. In any until submitted by the DEQ in violations. Virginia’s Voluntary event, because EPA has also determined accordance with 40 CFR 60.28(a) or (b), Environmental Assessment Privilege that a state audit privilege and as applicable, and until approved by Law, Va. Code Sec. 10.1–1198, provides immunity law can affect only state EPA in accordance with 40 CFR part 60, a privilege that protects from disclosure enforcement and cannot have any subpart B. documents and information about the impact on Federal enforcement EPA is publishing this rule without content of those documents that are the authorities, EPA may at any time invoke prior proposal because the Agency product of a voluntary environmental its authority under the Clean Air Act, views this as a noncontroversial assessment. The Privilege Law does not including, for example, sections 113, amendment and anticipates no adverse

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comments. This action simply reflects relationship between the Federal the Federal Register. This rule is not a already existing Federal requirement for Government and Indian tribes, or on the ‘‘major rule’’ as defined by 5 U.S.C. state air pollution control agencies and distribution of power and 804(2). existing CISWI units that are subject to responsibilities between the Federal C. Petitions for Judicial Review the provisions of 40 CFR part 60, Government and Indian tribes, as subparts B and DDDD, respectively. specified by Executive Order 13175 (65 Under section 307(b)(1) of the Clean However, in the ‘‘Proposed Rules’’ FR 67249, November 9, 2000). This Air Act, petitions for judicial review of section of today’s Federal Register, EPA action also does not have Federalism this action must be filed in the United is publishing a separate document that implications because it does not have States Court of Appeals for the will serve as the proposal to approve the substantial direct effects on the States, appropriate circuit by July 26, 2004. 111(d) plan should relevant adverse or on the relationship between the national Filing a petition for reconsideration by critical comments be filed. This rule government and the States, or on the the Administrator of this final rule does will be effective July 26, 2004 without distribution of power and not affect the finality of this rule for the further notice unless the Agency responsibilities among the various purposes of judicial review nor does it receives relevant adverse comments by levels of government, as specified in extend the time within which a petition June 24, 2004. If EPA receives adverse Executive Order 13132 (64 FR 43255, for judicial review may be filed, and comments, EPA will publish a timely August 10, 1999). This action merely shall not postpone the effectiveness of withdrawal in the Federal Register approves a state rule implementing a such rule or action. This action, informing the public that the rule did Federal standard, and does not alter the approving the Virginia CISWI plan, may not take effect. EPA will address all relationship or the distribution of power not be challenged later in proceedings to public comments in a subsequent final and responsibilities established in the enforce its requirements. (See section rule based on the proposed rule. The Clean Air Act. This rule also is not 307(b)(2).) EPA will not institute a second subject to Executive Order 13045 comment period on this action. Any ‘‘Protection of Children from List of Subjects in 40 CFR Part 62 parties interested in commenting must Environmental Health Risks and Safety Environmental protection, do so at this time. Please note that if Risks’’ (62 FR 19885, April 23, 1997), Administrative practice and procedure, EPA receives adverse comment on an because it is not economically Air pollution control, Aluminum, amendment, paragraph, or section of significant. Fertilizers, Fluoride, Intergovernmental In reviewing 111(d)/129 plan this rule and if that provision may be relations, Paper and paper products submissions, EPA’s role is to approve severed from the remainder of the rule, industry, Phosphate, Reporting and state choices, provided that they meet EPA may adopt as final those provisions recordkeeping requirements, Sulfur the criteria of the Clean Air Act. In this of the rule that are not the subject of an oxides, Sulfur acid plants, Waste context, in the absence of a prior adverse comment. treatment and disposal. existing requirement for the State to use III. Administrative Requirements voluntary consensus standards (VCS), Dated: May 18, 2004. A. General Requirements EPA has no authority to disapprove a Richard J. Kampf, 111(d)/129 plan submission for failure Acting Regional Administrator, Region III. Under Executive Order 12866 (58 FR to use VCS. It would thus be I 51735, October 4, 1993), this action is inconsistent with applicable law for 40 CFR part 62 is amended as follows: not a ‘‘significant regulatory action’’ and EPA, when it reviews a 111(d)/129 plan PART 62—[AMENDED] therefore is not subject to review by the submission, to use VCS in place of a Office of Management and Budget. For 111(d)/129 plan submission that I 1. The authority citation for part 62 this reason, this action is also not otherwise satisfies the provisions of the continues to read as follows: subject to Executive Order 13211, Clean Air Act. Thus, the requirements of Authority: 42 U.S.C. 7401 et seq. ‘‘Actions Concerning Regulations That section 12(d) of the National Significantly Affect Energy Supply, Technology Transfer and Advancement Subpart VV—Virginia Distribution, or Use’’ (66 FR 28355, May Act of 1995 (15 U.S.C. 272 note) do not 22, 2001). This action merely approves apply. This rule does not impose an I 2. A new center heading, after state law as meeting Federal information collection burden under the requirements and imposes no additional § 62.11620, consisting of §§ 62.11621, provisions of the Paperwork Reduction 62.11622, 62.11623 is added to read as requirements beyond those imposed by Act of 1995 (44 U.S.C. 3501 et seq.). state law. Accordingly, the follows: Administrator certifies that this rule B. Submission to Congress and the Emissions From Existing Commercial will not have a significant economic Comptroller General Industrial Solid Waste Incinerators impact on a substantial number of small The Congressional Review Act, 5 (CISWI) Units—Section 111(d)/129 Plan entities under the Regulatory Flexibility U.S.C. 801 et seq., as added by the Small Act (5 U.S.C. 601 et seq.). Because this Business Regulatory Enforcement § 62.11621 Identification of plan. rule approves pre-existing requirements Fairness Act of 1996, generally provides Section 111(d)/129 CISWI plan under state law and does not impose that before a rule may take effect, the submitted on September 8, 2003, any additional enforceable duty beyond agency promulgating the rule must including related supplemental that required by state law, it does not submit a rule report, which includes a information submitted on August 11, contain any unfunded mandate or copy of the rule, to each House of the and September 30, 2003, and April 6, significantly or uniquely affect small Congress and to the Comptroller General 2004. governments, as described in the of the United States. EPA will submit a Unfunded Mandates Reform Act of 1995 report containing this rule and other § 62.11622 Identification of sources. (Pub. L. 104–4). This rule also does not required information to the U.S. Senate, The plan applies to all affected CISWI have tribal implications because it will the U.S. House of Representatives, and units for which construction not have a substantial direct effect on the Comptroller General of the United commenced on or before November 30, one or more Indian tribes, on the States prior to publication of the rule in 1999.

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§ 62.11623 Identification of plan. FOR FURTHER INFORMATION CONTACT: environmental impact assessment has Effective date of the plan is July 26, Doug Bellomo, P.E. Hazard been prepared. 2004. Identification Section, Mitigation Regulatory Flexibility Act [FR Doc. 04–11771 Filed 5–24–04; 8:45 am] Division, Emergency Preparedness and Response Directorate, FEMA, 500 C BILLING CODE 6560–50–P The Mitigation Division Director for Street, SW., Washington, DC 20472, the Emergency Preparedness and (202) 646–2903. Response Directorate certifies that this DEPARTMENT OF HOMELAND SUPPLEMENTARY INFORMATION: The rule is exempt from the requirements of SECURITY modified BFEs are not listed for each the Regulatory Flexibility Act because community in this interim rule. modified BFEs are required by the Flood Federal Emergency Management However, the address of the Chief Disaster Protection Act of 1973, 42 Agency Executive Officer of the community U.S.C. 4105, and are required to where the modified BFE determinations maintain community eligibility in the 44 CFR Part 65 are available for inspection is provided. NFIP. No regulatory flexibility analysis Any request for reconsideration must has been prepared. [Docket No. FEMA –B–7446] be based on knowledge of changed Regulatory Classification Changes in Flood Elevation conditions or new scientific or technical Determinations data. This interim rule is not a significant The modifications are made pursuant regulatory action under the criteria of AGENCY: Federal Emergency to Section 201 of the Flood Disaster Section 3(f) of Executive Order 12866 of Management Agency (FEMA), Protection Act of 1973, 42 U.S.C. 4105, September 30, 1993, Regulatory Emergency Preparedness and Response and are in accordance with the National Planning and Review, 58 FR 51735. Directorate, Department of Homeland Flood Insurance Act of 1968, 42 U.S.C. Security. 4001 et seq., and with 44 CFR Part 65. Executive Order 12612, Federalism ACTION: Interim rule. For rating purposes, the currently This rule involves no policies that effective community number is shown have federalism implications under SUMMARY: This interim rule lists and must be used for all new policies communities where modification of the Executive Order 12612, Federalism, and renewals. dated October 26, 1987. Base (1% annual-chance) Flood The modified BFEs are the basis for Elevations (BFEs) is appropriate because the floodplain management measures Executive Order 12778, Civil Justice of new scientific or technical data. New that the community is required to either Reform flood insurance premium rates will be adopt or to show evidence of being This rule meets the applicable calculated from the modified BFEs for already in effect in order to qualify or standards of Section 2(b)(2) of Executive new buildings and their contents. to remain qualified for participation in Order 12778. DATES: These modified BFEs are the National Flood Insurance Program currently in effect on the dates listed in (NFIP). List of Subjects in 44 CFR Part 65 the table below and revise the Flood These modified BFEs, together with Insurance Rate Maps in effect prior to the floodplain management criteria Flood insurance, Floodplains, this determination for the listed required by 44 CFR 60.3, are the Reporting and recordkeeping communities. minimum that are required. They requirements. From the date of the second should not be construed to mean that I Accordingly, 44 CFR Part 65 is publication of these changes in a the community must change any amended to read as follows: newspaper of local circulation, any existing ordinances that are more person has ninety (90) days in which to stringent in their floodplain PART 65—[AMENDED] request through the community that the management requirements. The Mitigation Division Director for the community may at any time enact I 1. The authority citation for Part 65 Emergency Preparedness and Response stricter requirements of its own, or continues to read as follows: Directorate reconsider the changes. The pursuant to policies established by the Authority: 42 U.S.C. 4001 et seq.; modified BFEs may be changed during other Federal, State, or regional entities. Reorganization Plan No. 3 of 1978, 3 CFR, the 90-day period. The changes BFEs are in accordance 1978 Comp., p. 329; E.O. 12127, 44 FR 19367, ADDRESSES: The modified BFEs for each with 44 CFR 65.4. 3 CFR, 1979 Comp., p. 376. community are available for inspection at the office of the Chief Executive National Environmental Policy Act § 65.4 [Amended] Officer of each community. The This rule is categorically excluded I 2. The tables published under the respective addresses are listed in the from the requirements of 44 CFR Part authority of § 65.4 are amended as table below. 10, Environmental Consideration. No follows:

Date and name of news- State and county Location and paper where notice was Chief executive office Effective date of Community case No. published of community modification No.

Arizona: Maricopa City of Phoenix March 18, 2004, March 25, The Honorable Skip Rimsza, Mayor, June 24, 2004 ...... 040051 (04–09–0654X). 2004, Arizona Business City of Phoenix, 200 West Wash- Cazette. ington Street, 11th Floor, Phoe- nix, Arizona 85003–1611. Pima ...... Town of Marana March 25, 2004, April 1, The Honorable Bobby Sutton, Jr., April 22, 2004 ...... 040118 (04–09–0750P). 2004, Daily Territorial. Mayor, Town of Marana, 13251 North Lon Adams Road, Marana, Arizona 85653.

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Date and name of news- State and county Location and paper where notice was Chief executive office Effective date of Community case No. published of community modification No.

Pima ...... Town of Marana March 25, 2004, April 1, The Honorable Bobby Sutton Jr., July 1, 2004 ...... 040118 (03–09–0698P). 2004, Daily Territorial. Mayor, Town of Marana, 13251 North Lon Adams Road, Marana, Arizona 85653. Pima ...... City of Tucson April 8, 2004, April 15, The Honorable Bob Walkup, Mayor, July 15, 2004 ...... 040076 (03–09–1711P). 2004, Daily Territorial. City of Tucson, City Hall, 255 West Alameda Street, Tucson, Arizon 85701. Pima ...... Unicorporated March 25, 2004, April 1, The Honorable Sharon Bronson, July 1, 2004 ...... 040073 Areas (03–09– 2004, Daily Territorial. Chair, Pima County Board of Su- 0698P). pervisors, 130 West Congress Street, 11th Floor, Tucson, Ari- zona 85701. California: Humboldt ...... City of Arcata February 10, 2004, Feb- The Honorable Robert Ornelas, May 18, 2004 ...... 060061 (03–09–0824P). ruary 17, 2004, Arcata Mayor, City of Arcata, 736 F Eye. Street, Arcata, California 95521. Los Angeles ... City of Burbank ... February 11, 2004, Feb- The Honorable Stacey Murphy, May 19, 2004 ...... 065018 ruary 18, 2004, Burbank Mayor, City of Burbank, P.O. Box Leader. 6459, Burbank, California 91510– 6459. Los Angeles ... City of Los Ange- March 11, 2004, March 18, The Honorable James K. Hahn, June 17, 2004 ...... 060137 les (04–09– 2004, Los Angeles Mayor, City of Los Angeles, 200 0102P). Times. North Spring Street, Room 303, Los Angeles, California 90012. Placer ...... Unincorporated February 4, 2004, Feb- The Honorable Rex Bloomfield, January 8, 2004 ...... 060239 Areas (03–09– ruary 11, 2004, The Chairman, Placer County, Board 1212P). Rocklin Placer Herald. of Supervisors, 175 Fulweiler Av- enue, Auburn, California 95603. Riverside ...... City of Moreno April 1, 2004, April 8, The Honorable Frank West, Mayor, July 8, 2004 ...... 065074 Valley (04–09– 2004, Press—Enterprise. City of Moreno Valley, 14177 0122P). Frederick Street, Moreno Valley, California 92552. San Diego ...... City of Chula March 5, 2004, March 12, The Honorable Stephen C. Padilla, June 11, 2004 ...... 065021 Vista (03–09– 2004, Chula Vista Star Mayor, City of Chula Vista, City 0900P). News. Hall, 276 Fourth Avenue, Chula Vista, California 91910. San Diego ...... City of Oceanside April 1, 2004, April 8, The Honorable Terry Johnson, July 8, 2004 ...... 060294 (04–09–0309P). 2004, North County Mayor, City of Oceanside, 300 Times. North Coast Highway, Oceanside, California 92054. San Diego ...... City of San Diego April 8, 2004, April 15, The Honorable Dick Murphy, Mayor, July 15, 2004 ...... 060295 (04–09–0108P). 2004, San Diego Daily City of San Diego, 202 C Street, Transcript. 11th Floor, San Diego, California 92101. San Diego ...... Unincorporated April 8, 2004, April 15, The Honorable Dianne Jacob, July 15, 2004 ...... 060284 Areas (03–09– 2004, San Diego Union- Chairwoman, San Diego County 1209P). Tribune. Board of Supervisors, 1600 Pa- cific Highway, San Diego, Cali- fornia 92101. Ventura ...... City of Simi Val- February 12, 2004, Feb- The Honorable William Davis, January 30, 2004 .... 060421 ley (04–09– ruary 19, 2004, Ventura Mayor, City of Simi Valley, 2929 0234P). County Star. Tapo Canyon Road, Simi Valley, California 93063–2199. Colorado: Adams ...... City of Brighton February 4, 2004, Feb- The Honorable Jan Pawlowski, May 12, 2004 ...... 080004 (03–08–0621P). ruary 11, 2004, Brighton Mayor, City of Brighton, 22 South Standard Blade. Fourth Avenue, Brighton, Colo- rado 80601. Adams ...... Unincorporated February 4, 2004, Feb- The Honorable Elaine T. Valente, May 12, 2004 ...... 08001 Areas (03–08– ruary 11, 2004, Brighton Chair, Adams County Board of 0621P). Standard Blade. Commissioners, 450 South Fourth Avenue, Brighton, Colo- rado 80601. Adams ...... Unincorporated February 6, 2004, Feb- The Honorable Elaine T. Valente, May 14, 2004 ...... 08001 Areas (02–08– ruary 13, 2004, Eastern Chair, Adams County Board of 398P). Colorado News. Commissioners, 450 South Fourth Avenue, Brighton, Colo- rado 80601.

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Date and name of news- State and county Location and paper where notice was Chief executive office Effective date of Community case No. published of community modification No.

Arapahoe ...... City of Littleton March 11, 2004, March 18, The Honorable John Ostermiller, March 1, 2004 ...... 080017 (03–08–0691P). 2004, Littleton Inde- Mayor, City of Littleton, 2255 pendent. West Berry Avenue, Littleton, Col- orado 80165. Douglas ...... Town of Parker February 19, 2004, Feb- The Honorable Gary Lasater, May 27, 2004 ...... 080310 (04–08–0033P). ruary 26, 2004, Douglas Mayor, Town of Parker, 20120 County News Press. East Mainstreet, Parker, Colorado 80138. El Paso ...... Unincorporated March 10, 2004, March 17, The Honorable Chuck Brown, Chair, June 16, 2004 ...... 080059 Areas (03–08– 2004, El Paso County El Paso County Board of Com- 0406P). News. missioners, 27 East Vermijo Ave- nue, Colorado Springs, Colorado 80903–2208. El Paso ...... Unincorporated March 17, 2004, March 24, The Honorable Chuck Brown, Chair, June 23, 2004 ...... 080059 Areas (03–08– 2004, El Paso County El Paso County Board of Com- 0449P). News. missioners, 27 East Vermijo Ave- nue, Colorado Springs, Colorado 80903–2208. El Paso ...... Unincorporated March 17, 2004, March 24, The Honorable Chuck Brown, Chair, June 23, 2004 ...... 080059 Areas (03–08– 2004, El Paso County El Paso County Board of Com- 0617P). News. missioners, 27 East Vermijo Ave- nue, Colorado Springs, Colorado 80903–2208. Jefferson ...... City of Lakewood March 25, 2004, April 1, The Honorable Steve Burkholder, July 1, 2004 ...... 085075 (03–08–0305P). 2004, Lakewood Sen- Mayor, City of Lakewood, Lake- tinel. wood Civic Center South, 480 South Allison Parkway, Lake- wood, Colorado 80226. Jefferson ...... Unincorporated February 25, 2004, March The Honorable Michelle Lawrence, June 2, 2004 ...... 080087 Areas (03– 3, 2004, Evergreen Can- Chairperson, Jefferson County 080479P). yon Courier. Board of Commissioners, 100 Jefferson County Parkway, Gold- en, Colorado 80419–5550. Jefferson ...... City of West- January 29, 2004, Feb- The Honorable Ed Moss, Mayor, May 6, 2004 ...... 080008 minster (03– ruary 5, 2004, West- City of Westminster, 4800 West 08–0520P). minster Window. 92nd Avenue, Westminster, Colo- rado 80031. Hawaii: Hawaii ...... Hawaii County February 12, 2004, Feb- The Honorable Harry Kim, Mayor, January 20, 2004 .... 155166 (03–09–1531P). ruary 19, 2004, Hawaii Hawaii County, 25 Aupuni Street, Tribune Herald. Hilo, Hawaii 96720. Maui ...... Maui County (03– March 25, 2004, April 1, The Honorable Alan M. Arawaka, July 1, 2004 ...... 150003 09–0438P). 2004, Maui News. Mayor, Maui County, 200 South High Street, Wailuku, Hawaii 96793–2155. Utah: Sevier ...... City of Salina February 25, 2004, March The Honorable Marilyn S. Ander- June 2, 2004 ...... 490132 (04–08–0072P). 3, 2004, Richfield Reap- son, Mayor, City of Salina, P.O. er. Box 69, Salina, Utah 84654. Washington: King City of Bellevue February 26, 2004, March The Honorable Connie Marshall, June 3, 2004 ...... 530074 (03–10–0399P). 4, 2004, King County Mayor, City of Bellevue, P.O. Box Journal. 90012, Bellevue, Washington 98009–9012.

(Catalog of Federal Domestic Assistance No. DEPARTMENT OF TRANSPORTATION ACTION: Final rule; adjustment of 83.100, ‘‘Flood Insurance.’’) schedule of civil penalties. Dated: May 18, 2004. Federal Railroad Administration Anthony S. Lowe, SUMMARY: This document amends the 49 CFR Part 232 Mitigation Division Director, Emergency schedule of civil penalties for violations Preparedness and Response Directorate. [FRA Docket No. PB–9; Notice No. 22] of part 232 to make it consistent with [FR Doc. 04–11760 Filed 5–24–04; 8:45 am] the primary final rule in this proceeding RIN 2130–AB52 BILLING CODE 9110–11–P or with subsequent changes made in the text of the regulation in response to Brake System Safety Standards for petitions for reconsideration. These Freight and Other Non-Passenger changes are technical amendments Trains and Equipment; End-of-Train Devices made solely to the schedule of civil penalties contained in appendix A to AGENCY: Federal Railroad part 232, are a statement of agency Administration (FRA), DOT. policy, and are consistent with FRA’s

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intent when issuing the final rule and initial response to the petitions and then Paragraph (d) of this section requires the its response to petitions for issue a follow-up response addressing performance of a Class I brake test on reconsideration in this proceeding. The the issues pertaining to other portions of any car added to a train via a Class II adjustments will enhance FRA’s safety the final rule. See id. On April 10, 2002, brake test at the next forward location enforcement program by ensuring that FRA published its second response to where facilities are available for the regulated community is fully aware petitions for reconsideration addressing performing such a test. The clarifying of its potential civil penalty liability and all other outstanding issues raised in the adjustment directs the reader to the by ensuring that appropriate civil petitions for reconsideration. See 67 FR footnote following the schedule of civil penalties are assessed when taking 17556–85. penalties, which makes clear that the enforcement actions. This document amends the schedule penalties associated with the failure to DATES: Effective Date: The revision of of civil penalties contained in appendix perform a proper Class I brake test Appendix A to part 232 is effective May A to part 232 to make it consistent with would be applicable in these instances. 25, 2004. the January 2001 final rule or with the Fourth, FRA is also amending the changes made in the text in response to penalty schedule items associated with ADDRESSES: Any petition for petitions for reconsideration. These Class III brake tests requirements reconsideration should reference FRA changes are technical adjustments or contained in § 232.211. When issuing its Docket No. PB–9, Notice No. 22, and be corrections made solely to the schedule second response to petitions for submitted in triplicate to the FRA of civil penalties contained in Appendix reconsideration of the final rule, FRA Docket Clerk, Office of Chief Counsel, A to part 232, are a statement of agency added a paragraph (d) containing a RCC–10, 1120 Vermont Avenue, NW., policy, and are consistent with FRA’s modified Class III brake test in those Mail Stop 10, Washington, DC 20590. intent when issuing the final rule and instances where the continuity of a FOR FURTHER INFORMATION CONTACT: its response to petitions for train’s brake pipe is broken or James Wilson, FRA Office of Safety, reconsideration in this proceeding. The interrupted with the train otherwise RRS–14, 1120 Vermont Avenue, NW., adjustments will enhance FRA’s safety remaining unchanged. See 67 FR 17583. Stop 25, Washington, DC 20590 enforcement program by ensuring that However, at the time the provision was (telephone 202–493–6259), or Thomas the regulated community is fully aware added, no specific civil penalty was Herrmann, Trial Attorney, Office of the of its potential civil penalty liability and associated to a violation of the new Chief Counsel, RCC–10, 1120 Vermont by ensuring appropriate civil penalties provision. This document amends the Avenue, NW., Stop 10, Washington, DC are assessed when taking enforcement schedule of civil penalties by adding a 20590 (telephone 202–493–6053). actions. specific reference to paragraph (d) of SUPPLEMENTARY INFORMATION: this section and assigns a certain civil Discussion of Corrections and penalty consistent with a partial failure Background Modifications to perform a Class III brake test. On January 17, 2001, FRA published This document is making six Fifth, the items in the schedule a final rule revising the Federal safety corrections or adjustments to the related to the extended haul train standards governing braking systems schedule of civil penalties contained in provisions of § 232.213 are being and equipment used in freight and other Appendix A to part 232. First, the listed clarified to include a potential civil non-passenger railroad train operations. civil penalties associated with § 232.205 penalty amount for the general See 66 FR 4104–217. The effective date are being corrected to reflect the operation provision of paragraph (b) of of the final rule was May 31, 2001. See changes made to this section by FRA this section. This penalty is currently 66 FR 9906 (February 12, 2001) and 66 second response to petitions for applied to situations where an extended FR 29501 (May 31, 2001). The final rule reconsideration. In that response, a new haul train is operated outside the contained staggered implementation paragraph (b) was added to this section restrictions contained in paragraph (a) dates with the majority of the rule to clarify the inspection requirements that are not otherwise specifically becoming applicable on April 1, 2004. related to the addition of solid blocks of covered by the penalties associated with See 49 CFR 232.1(b) and 66 FR 4193. In cars, and paragraph (f) of the section that paragraph. For example, this would response to the final rule, FRA received was removed to avoid duplication. See include such acts as exceeding the six petitions for reconsideration from 69 FR 17573–75, 17582. Thus, what allowable number of pick-ups or set- seven parties raising various issues were paragraphs (b) through (e) of this outs with an extended haul train. related to a number of the provisions section in the January 2001 final rule are Finally, FRA is making corrections to contained in the final rule. now paragraphs (c) through (f). the penalty items associated with On August 1, 2001, FRA published an However, the penalty schedule was §§ 232.213(a)(2)–(3), (5)(i), and (8), and initial response to the petitions for never modified to reflect these changes. 232.217(c). The items associated with reconsideration of the final rule Consequently, FRA is correcting the these sections direct the reader to addressing those issues raised in the penalty schedule items for this section footnote (2) at the end of the schedule petitions related to the periodic to reflect the above-noted amendments. of civil penalties. Because there is only maintenance and testing requirements Secondly, a typographical error in the one footnote at the end of the penalty prescribed in subpart D of the final rule. penalty schedule amount associated schedule, the reference for the above- See 66 FR 39683. FRA believed that it with § 232.207(a) is also being corrected. noted provisions is being corrected to was necessary to address these issues as The January 2001 final rule showed the cite to footnote (1). quickly as possible because the periodic civil penalty for a complete failure to maintenance and testing requirements perform a Class IA brake test as $15,000. General Information prescribed in subpart D of the final rule See 66 FR 4212. This should have read As the amendments contained in this had a compliance date of August 1, $5,000 and is being so corrected. document are minor corrections or 2001. Due to the complexity of some of Third, the penalty schedule items adjustments to the existing schedule of the issues raised in the petitions for associated with the Class II brake test civil penalties associated with part 232, reconsideration on other provisions of provisions of § 232.209 are being which constitutes a general statement of the final rule, FRA decided to address adjusted by adding a clarifying citation agency policy relating potential civil the issues related to subpart D in its for paragraph (d) of this section. penalty assessment amounts, FRA is

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issuing this document as a final rule. 26, 1999) as required by the National regulatory provision contained in part FRA views the amendments as technical Environmental Policy Act (42 U.S.C. 232, this document will not result in the corrections to a general statement of 4321 et seq.), other environmental expenditure, in the aggregate, of agency policy and not a substantive statutes, Executive Orders, and related $120,700,000 or more in any one year, rule. Consequently, FRA believes that, regulatory requirements. FRA has and thus preparation of such a pursuant to 5 U.S.C. 553(b)(3)(A) and determined that this document is not a statement is not required. (B), this action is both exempted from major FRA action (requiring the the requirement for prior public notice preparation of an environmental impact Energy Impact and that good cause exists for finding statement or environmental assessment) Executive Order 13211 requires that prior public notice of this action is because it is categorically excluded from Federal agencies to prepare a Statement unnecessary. detailed environmental review pursuant of Energy Effects for any ‘‘significant to section 4(c) of FRA’s Procedures. Regulatory Impact energy action.’’ 66 FR 28355 (May 22, Federalism Implications 2001). Under the Executive Order, a Executive Order 12866 and DOT ‘‘significant energy action’’ is defined as Regulatory Policies and Procedures FRA believes it is in compliance with any action by an agency (normally Executive Order 13132. Because the This final rule has been evaluated in published in the Federal Register) that modifications contained in this final accordance with Executive Order 12866 promulgates or is expected to lead to the rule merely correct and adjust the and DOT policies and procedures. The promulgation of a final rule or schedule of civil penalties associated modifications contained in this final regulation, including notices of inquiry, with part 232 and because no changes rule are not considered significant advance notices of proposed or modifications are being made to any because they are intended merely to rulemaking, and notices of proposed regulatory provision contained in part correct and adjust the schedule of civil rulemaking: (1)(i) That is a significant penalties associated with part 232 232, this document will not have a regulatory action under Executive Order consistent with FRA’s intent when substantial effect on the States, on the 12866 or any successor order, and (ii) is publishing the primary final rule in this relationship between the national likely to have a significant adverse effect proceeding on January 17, 2001. No government and the States, or on the on the supply, distribution, or use of changes or modifications are being distribution of power and energy; or (2) that is designated by the made to any regulatory provision responsibilities among the various Administrator of the Office of contained in part 232. There is no levels of government. This final rule Information and Regulatory Affairs as a economic impact caused by the will not have federalism implications significant energy action. FRA has corrections and clarifications contained that impose any direct compliance costs evaluated this final rule in accordance in this final rule. on State and local governments. with Executive Order 13211. Because Regulatory Flexibility Act Unfunded Mandates Reform Act of 1995 the modifications contained in this final rule merely correct and adjust the The Regulatory Flexibility Act of 1980 Pursuant to Section 201 of the Unfunded Mandates Reform Act of 1995 schedule of civil penalties associated (5 U.S.C. 601 et seq.) requires a review with part 232 and because no changes of rules to assess their impact on small (Pub. L. 104–4, 2 U.S.C. 1531), each Federal agency ‘‘shall, unless otherwise or modifications are being made to any entities. FRA certifies that this final rule regulatory provision contained in part does not have a significant impact on a prohibited by law, assess the effects of Federal regulatory actions on State, 232, FRA has determined that this substantial number of small entities. document will not have a significant Because the modifications contained in local, and tribal governments, and the private sector (other than to the extent adverse effect on the supply, this final rule merely correct and adjust distribution, or use of energy. the schedule of civil penalties that such regulations incorporate requirements specifically set forth in Consequently, FRA has determined that associated with part 232 and because no this regulatory action is not a changes or modifications are being law).’’ Section 202 of the Act (2 U.S.C. 1532) further requires that ‘‘before ‘‘significant energy action’’ within the made to any regulatory provision meaning of Executive Order 13211. contained in part 232, FRA has promulgating any general notice of concluded that there are no substantial proposed rulemaking that is likely to List of Subjects in 49 CFR Part 232 economic impacts on small units of result in the promulgation of any rule that includes any Federal mandate that Penalties, Railroad power brakes, government, businesses, or other Railroad safety. organizations. may result in expenditure by State, local, and tribal governments, in the Adoption of the Amendments Paperwork Reduction Act aggregate, or by the private sector, of Because the modifications contained $100,000,000 or more (adjusted I For the reasons set forth in the in this final rule merely correct and annually for inflation) in any 1 year, and preamble, part 232 of chapter II, subtitle adjust the schedule of civil penalties before promulgating any final rule for B of title 49 of the Code of Federal associated with part 232 and because no which a general notice of proposed Regulations is amended to read as changes or modifications are being rulemaking was published, the agency follows: made to any regulatory provision shall prepare a written statement’’ contained in part 232, this final rule detailing the effect on State, local, and PART 232—[AMENDED] tribal governments and the private does not change any of the information I sector. The statutory figure of 1. The authority citation for part 232 is collection requirements contained in revised to read as follows: part 232. $100,000,000 has been adjusted upward for inflation to $120,700,000. Because Authority: 49 U.S.C. 20102–20103, 20107, Environmental Impact the modifications contained in this final 20133, 20141, 20301–20303, 20306, 21301– FRA has evaluated this final rule in rule merely correct and adjust the 21302, 21304; 28 U.S.C. 2461, note; 49 CFR accordance with its ‘‘Procedures for schedule of civil penalties associated 1.49 (c), (m). Considering Environmental Impacts’’ with part 232 and because no changes I 2. Appendix A to part 232 is revised (FRA’s Procedures) (64 FR 28545, May or modifications are being made to any to read as follows:

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APPENDIX A TO PART 232.—SCHEDULE OF CIVIL PENALTIES 1

Willful Section Violation violation

Subpart A—General 232.15 Movement of power brake defects: (a) Improper movement, general ...... (1) (1) (11) Failure to make determinations and provide notification of en route defect ...... $2,500 $5,000 (b) Complete failure to tag ...... 2,500 5,000 (1) Insufficient tag or record ...... 1,000 2,000 (2), (4) Improper removal of tag ...... 2,000 4,000 (3) Failure to retain record of tag ...... 2,000 4,000 (c) Improper loading or purging ...... 2,500 5,000 (e) Improper placement of defective equipment ...... 2,500 5,000 232.19 Availability of records (1) (1) Subpart B—General Requirements 232.103 All train brake systems: (a)–(c), (h)–(i) Failure to meet general design requirements ...... 2,500 5,000 (d) Failure to have proper percentage of operative brakes from Class I brake test ...... 5,000 7,500 (e) Operating with less than 85 percent operative brakes ...... 5,000 7,500 (f) Improper use of car with inoperative or ineffective brakes ...... 2,500 5,000 (g) Improper display of piston travel ...... 2,500 5,000 (m) Failure to stop train with excess air flow or gradient ...... 2,500 5,000 (n) Securement of unattended equipment: ...... (1) Failure to apply sufficient number of hand brakes; failure to develop or implement procedure to verify number applied ...... 5,000 7,500 (2) Failure to initiate emergency ...... 2,500 5,000 (3) Failure to apply hand brakes on locomotives ...... 2,500 5,000 (4) Failure to adopt or comply with procedures for securing unattended locomotive ...... 5,000 7,500 (o) Improper adjustment of air regulating devices ...... 2,500 5,000 (p) Failure to hold supervisors jointly responsible ...... 2,500 5,000 232.105 Locomotives: (a) Air brakes not in safe and suitable condition ...... 1,000–5,000 2,000–7,500 (b) Not equipped with proper hand or parking brake ...... 5,000 7,500 (c)(1) Failure to inspect/repair hand or parking brake ...... 2,500 5,000 (2) Failure to properly stencil, tag, or record ...... 2,000 4,000 (d) Excess leakage from equalizing reservoir ...... 2,500 5,000 (e) Improper use of feed or regulating valve braking ...... 2,500 5,000 (f) Improper use of passenger position ...... 2,500 5,000 (g) Brakes in operative condition ...... 2,500 5,000 232.107 Air sources/cold weather operations: (a)(1), (2) Failure to adopt or comply with monitoring program for yard air sources ...... 5,000 7,500 (3) Failure to maintain records ...... 2,500 5,000 (b) Failure to blow condensation ...... 2,500 5,000 (c) Use of improper chemicals ...... 5,000 7,500 (d) Failure to equip or drain yard air reservoirs ...... 2,500 5,000 (e) Failure to adopt or comply cold weather operating procedures ...... 5,000 7,500 232.109 Dynamic brakes: (a) Failure to provide information ...... 5,000 7,500 (b) Failure to make repairs ...... 5,000 7,500 (c) Failure to properly tag ...... 2,500 5,000 (d) Failure to maintain record of repair ...... 2,000 4,000 (e) Improper deactivation ...... 2,500 5,000 (f) Improper use of locomotive as controlling unit ...... 2,500 5,000 (g) Locomotive not properly equipped with indicator ...... 2,500 5,000 (h) Rebuilt locomotive not properly equipped ...... 2,500 5,000 (j) Failure to adopt or comply with dynamic brake operating rules ...... 5,000 7,500 (k) Failure to adopt or comply with training on operating procedures ...... 5,000 7,500 232.111 Train handling information: (a) Failure to adopt and comply with procedures ...... 5,000 7,500 (b) Failure to provide specific information ...... 2,500 5,000 Subpart C—Inspection and Testing Requirements 232.203 Training requirements: (a) Failure to develop or adopt program ...... 7,500 11,000 (b)(1)–(9) Failure to address or comply with specific required item or provision of program ...... 5,000 7,500 (c) Failure to adopt or comply with two-way EOT program ...... 5,000 7,500 (d) Failure to adopt or comply with retaining valve program ...... 5,000 7,500 (e) Failure to maintain adequate records ...... 5,000 7,500 (f) Failure to adopt and comply with periodic assessment plan ...... 7,500 11,000 232.205 Class I brake test—initial terminal inspection: (a) Complete failure to perform inspection ...... (1)10,000 15,000 (c)(1)–(4), (6)–(8) Partial failure to perform inspection ...... 5,000 7,500 (c)(5) Failure to properly adjust piston travel (per car) ...... 2,500 5,000 (d) Failure to use carman when required ...... 5,000 7,500

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APPENDIX A TO PART 232.—SCHEDULE OF CIVIL PENALTIES 1—Continued

Willful Section Violation violation

(e) Failure to provide proper notification ...... 2,500 5,000 (f) Failure to void compressed air ...... 2,500 5,000 232.207 Class IA brake tests—1,000-mile inspection: (a) Complete failure to perform inspection ...... (1)5,000 7,500 (b)(1)–(6) Partial failure to perform inspection ...... 2,500 5,000 (c) Failure to properly designate location ...... 5,000 7,500 (c)(1) Failure to perform at designated location ...... 5,000 7,500 (c)(2) Failure to provide notification ...... 2,500 5,000 232.209 Class II brake tests—intermediate inspection: (a) Complete failure to perform inspection ...... (1)5,000 7,500 (b)(1)–(5), (c) Partial failure to perform inspection ...... 2,500 5,000 (d) Failure to conduct Class I after Class II pick-up ...... (1) (1) 232.211 Class III brake tests—trainline continuity inspection: (a) Complete failure to perform inspection ...... 5,000 7,500 (b)(1)–(4), (c) Partial failure to perform inspection ...... 2,500 5,000 (d) Failure to restore air pressure at rear ...... 2,500 2,500 232.213 Extended haul trains: (a)(1) Failure to properly designate an extended haul train ...... 5,000 7,500 (a)(2)–(3), (5)(i), (8) Failure to perform inspections ...... (1) (1) (a)(4) Failure to remove defective car (per car) ...... 2,000 4,000 (a)(5)(ii), (6) Failure to conduct inbound inspection ...... 5,000 7,500 (a)(7) Failure to maintain record of defects (per car) ...... 2,000 4,000 (b) Improper movement or use of extended haul train ...... 5,000 7,500 232.215 Transfer train brake tests: (a) Failure to perform inspection ...... 5,000 7,500 (b) Failure to perform on cars added ...... 2,500 5,000 232.217 Train brake system tests conducted using yard air: (a) Failure to use suitable device ...... 2,500 5,000 (b) Improper connection of air test device ...... 5,000 7,500 (c) Failure to properly perform inspection ...... (1) (1) (d) Failure to calibrate test device ...... 2,500 5,000 (e) Failure to use accurate device ...... 2,500 5,000 232.219 Double heading and helper service: (a) Failure to perform inspection or inability to control brakes ...... 2,500 5,000 (b) Failure to make visual inspection ...... 2,500 5,000 (c) Use of improper helper link device ...... 2,500 5,000 Subpart D—Periodic Maintenance and Testing Requirements 232.303 General requirements: (b)–(d) Failure to conduct inspection or test when car on repair track ...... 2,500 5,000 (e) Improper movement of equipment for testing ...... 2,500 5,000 (e)(1) Failure to properly tag equipment for movement ...... 2,000 5,000 (e)(2)–(4) Failure to retain record or improper removal of tag or card ...... 2,000 4,000 (f) Failure to stencil or track test information ...... 2,500 5,000 232.305 Repair track air brake tests: (a) Failure to test in accord with required procedure ...... 2,500 5,000 (b)–(d) Failure to perform test ...... 2,500 5,000 232.307 Single car tests: (a) Failure to test in accord with required procedure ...... 2,500 5,000 (b)–(c) Failure to perform test ...... 2,500 5,000 232.309 Repair track air brake test and single car test equipment and devices: (a)–(f) Failure to properly test or calibrate ...... 2,500 5,000 Subpart E—End-of-Train Devices 232.403 Design standards for one-way devices: (a)–(g) Failure to meet standards ...... 2,500 5,000 232.405 Design standards for two-way devices: (a)–(i) Failure to meet standards ...... 2,500 5,000 232.407 Operating requirements for two-way devices: (b) Failure to equip a train ...... 5,000 7,500 (c) Improper purchase ...... 2,500 5,000 (f)(1) Failure of device to be armed and operable ...... 5,000 7,500 (f)(2) Insufficient battery charge ...... 2,500 5,000 (f)(3) Failure to activate the device ...... 2,500 5,000 (g) Improper handling of en route failure, freight or other non-passenger ...... 5,000 7,500 (h) Improper handling of en route failure, passenger ...... 5,000 7,500 232.409 Inspection and testing of devices: (a) Failure to have unique code ...... 2,500 5,000 (b) Failure to compare quantitative values ...... 2,500 5,000 (c) Failure to test emergency capability ...... 5,000 7,500 (d) Failure to properly calibrate ...... 2,500 5,000

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APPENDIX A TO PART 232.—SCHEDULE OF CIVIL PENALTIES 1—Continued

Willful Section Violation violation

Subpart F—Introduction of New Brake System Technology 232.503 Process to introduce new technology: (b) Failure to obtain FRA approval ...... 10,000 15,000 232.505 Pre-revenue service acceptance testing plan: (a) Failure to obtain FRA approval ...... 5,000 7,500 (b) Failure to comply with plan ...... 2,500 5,000 (f) Failure to test previously used technology ...... 5,000 7,500 1 A penalty may be assessed against an individual only for a willful violation. Generally, when two or more violations of these regulations are discovered with respect to a single unit of equipment that is placed or continued in service by a railroad, the appropriate penalties set forth above are aggregated up to a maximum of $11,000 per day. An exception to this rule is the $15,000 penalty for willful violation of § 232.503 (failure to get FRA approval before introducing new technology) with respect to a single unit of equipment; if the unit has additional violative conditions, the penalty may routinely be aggregated to $15,000. Although the penalties listed for failure to perform the brake inspections and tests under § 232.205 through § 232.209 may be assessed for each train that is not properly inspected, failure to perform any of the inspections and tests re- quired under those sections will be treated as a violation separate and distinct from, and in addition to, any substantive violative conditions found on the equipment contained in the train consist. Moreover, the Administrator reserves the right to assess a penalty of up to $22,000 for any viola- tion where circumstances warrant. See 49 CFR part 209, appendix A. Failure to observe any condition for movement of defective equipment set forth in § 232.15(a) will deprive the railroad of the benefit of the movement-for-repair provision and make the railroad and any responsible individuals liable for penalty under the particular regulatory section(s) concerning the substantive defect(s) present on the equipment at the time of movement. Failure to provide any of the records or plans required by this part pursuant to § 232.19 will be considered a failure to maintain or develop the record or plan and will make the railroad liable for penalty under the particular regulatory section(s) concerning the retention or creation of the document involved. Failure to properly perform any of the inspections specifically referenced in § 232.209, § 232.213, and § 232.217 may be assessed under each section of this part or this chapter, or both, that contains the requirements for performing the referenced inspection.

Issued in Washington, DC, on May 18, This rule affects only 50 CFR 17.22(b)(8) Background 2004. and 17.32(b)(8). In the Proposed Rules On June 12, 1997 (62 FR 32189), we Allan Rutter, section of today’s Federal Register is a published proposed revisions to our Federal Railroad Administrator. rulemaking proposal to reestablish the general permitting regulations in 50 CFR [FR Doc. 04–11696 Filed 5–24–04; 8:45 am] provisions of 50 CFR 17.22(b)(8) and part 13 to identify the situations in BILLING CODE 4910–06–P 17.32(b)(8). which permit provisions in part 13 would not apply to individual DATES: This rule is effective May 25, incidental take permits. On June 17, DEPARTMENT OF THE INTERIOR 2004. 1999 (64 FR 32706), we published final regulations that included a provision, ADDRESSES: The complete file for this Fish and Wildlife Service hereafter referred to as the Permit rule is available, by appointment, Revocation Rule, that described during normal business hours, at 4401 50 CFR Part 17 circumstances under which incidental North Fairfax Drive, Room 420, take permits could be revoked. The RIN 1018–AT64 Arlington, VA 22203. You may call 703/ Permit Revocation Rule, which was 358–2171 to make an appointment to Withdrawal of Regulations Governing codified at 50 CFR 17.22(b)(8) view the files. Incidental Take Permit Revocation (endangered species) and 17.32(b)(8) FOR FURTHER INFORMATION CONTACT: Rick (threatened species), provided that an AGENCY: Fish and Wildlife Service, Sayers, Chief, Branch of Consultation incidental take permit ‘‘may not be Interior. and Habitat Conservation Planning, at revoked * * * unless continuation of ACTION: Final rule. 4401 North Fairfax Drive, Room 420, the permitted activity would be inconsistent with the criterion set forth Arlington, VA 22203 (Telephone 703/ SUMMARY: We, the U.S. Fish and in 16 U.S.C. 1539(a)(2)(B)(iv) and the 358–2106, Facsimile 703/358–1735). Wildlife Service (Service), withdraw the inconsistency has not been remedied in regulations in part 17 of title 50 of the SUPPLEMENTARY INFORMATION: This rule a timely fashion.’’ The criterion in 16 Code of Federal Regulations (CFR) applies to the U.S. Fish and Wildlife U.S.C. 1539(a)(2)(B)(iv)—that ‘‘the regarding the revocation of incidental Service only. Therefore, the use of the taking will not appreciably reduce the take permits issued under the authority terms ‘‘Service’’ and ‘‘we’’ in this notice likelihood of the survival and recovery of the Endangered Species Act (ESA). refers exclusively to the U.S. Fish and of the species in the wild’’—is On December 11, 2003, the U.S. District Wildlife Service. substantially identical to the definition Court for the District of Columbia in of ‘‘jeopardize the continued existence Spirit of the Sage Council v. Norton, This rule applies only to 50 CFR of’’ in the joint Department of the Civil Action No. 98–1873 (D.D.C.), 17.22(b)(8) and 17.32(b)(8), which Interior/Department of Commerce invalidated 50 CFR 17.22(b)(8) and pertain to revocation of incidental take regulations implementing section 7 of 17.32(b)(8), the regulations addressing permits. Regulations in 50 CFR 17.22(c) the Endangered Species Act (50 CFR Service authority to revoke incidental and 17.32(c) that pertain to Safe Harbor 402.02). In essence, the Permit take permits under certain Agreements (SHAs) and in 50 CFR Revocation Rule authorized the Service circumstances. The court ruled that we 17.22(d) and 17.32(d) that pertain to to revoke an incidental take permit if did not follow the public notice and Candidate Conservation Agreements continuation of the permitted activity comment procedures required by the with Assurances (CCAAs) are not would jeopardize the continued Administrative Procedure Act (APA). affected by this final rule. existence of the listed species and the

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jeopardy situation is not remedied in a PART 17—ENDANGERED AND ∑ Hand Delivery to the Federal timely fashion. On September 30, 1999 THREATENED WILDLIFE AND PLANTS Building: 709 West 9th Street, Room (64 FR 52676), we published a 420A, Juneau, AK; correction to the regulations I 1. The authority citation for part 17 ∑ Fax: 907–586–7557; promulgated in our June 17, 1999 (64 FR continues to read as follows: ∑ E-mail: [email protected] 32706), final rule; however, the Authority: 16 U.S.C. 1361–1407; 16 U.S.C. Include in the subject line of the e-mail correction was not associated with 1531–1544; 16 U.S.C. 4201–4245; Pub. L. 99– comment the document identifier: permit revocation. 625, 100 Stat. 3500; unless otherwise noted. bsairel04l1; or ∑ Webform at the Federal On February 11, 2000 (65 FR 6916), § 17.22 [Amended] we published a request for additional eRulemaking Portal: I 2. Amend § 17.22 by removing public comment on specific regulatory http:www.regulations.gov. Follow the paragraph (b)(8). changes included in the June 17, 1999 instructions at that site for submitting comments. (64 FR 32706), final rule, including the § 17.32 [Amended] Permit Revocation Rule. Based on our FOR FURTHER INFORMATION CONTACT: Josh I 3. Amend § 17.32 by removing review of the comments we received in Keaton, 907–586–7228. paragraph (b)(8). response to the February 11, 2000 (65 SUPPLEMENTARY INFORMATION: NMFS FR 6916), request for comments, we Dated: April 12, 2004. manages the groundfish fishery in the published a notice on January 22, 2001 Craig Manson, BSAI according to the FMP prepared by (66 FR 6483), that affirmed the Assistant Secretary for Fish and Wildlife and the North Pacific Fishery Management provisions of the June 17, 1999 (64 FR Parks. Council under authority of the 32706), final rule, including the Permit [FR Doc. 04–11740 Filed 5–24–04; 8:45 am] Magnuson-Stevens Fishery Revocation Rule. BILLING CODE 4310–55–P Conservation and Management Act. The plaintiffs in Spirit of the Sage Regulations governing fishing by U.S. Council v. Norton, Civil Action No. 98– vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 1873 (D.D.C.), challenged the validity of DEPARTMENT OF COMMERCE the Permit Revocation Rule. On and 50 CFR part 679. December 11, 2003, the court ruled that National Oceanic and Atmospheric The Administrator, Alaska Region, the public notice and comment Administration NMFS, has determined that the initial procedures followed by the Service TAC for rock sole in the BSAI, specified when promulgating the Permit 50 CFR Part 679 in the final 2004 harvest specifications Revocation Rule were in violation of the (69 FR 9242, February 27, 2004) needs APA. The court vacated and remanded [Docket No. 031124287–4060–02; I.D. to be supplemented from the non- the Permit Revocation Rule to the 051804B] specified reserve in order to continue Service for further consideration operations and account for prior consistent with section 553 of the APA. Fisheries of the Exclusive Economic harvest. In compliance with the court’s order, we Zone Off Alaska; Rock Sole in the Therefore, in accordance with therefore withdraw the Permit Bering Sea and Aleutian Islands Area § 679.20(b)(3), NMFS proposes to apportion 3,075 metric tons from the Revocation Rule (50 CFR 17.22(b)(8) and AGENCY: National Marine Fisheries non-specified reserve to the rock sole 17.32(b)(8)). Service (NMFS), National Oceanic and initial TAC in the BSAI. These proposed Atmospheric Administration (NOAA), Effective Date apportionments are consistent with Commerce. In accordance with 5 U.S.C. 553(d)(3), § 679.20(b)(1)(ii) and do not result in ACTION: Apportionment of reserve; overfishing of a target species because we find good cause to make this rule request for comments. effective upon publication. Moreover, in the revised initial TAC is equal to or less than the specification of the accordance with 5 U.S.C. 553(b)(3)(B), SUMMARY: NMFS apportions amounts of acceptable biological catch (69 FR 9242, we find good cause that notice and the non-specified reserve of groundfish February 27, 2004). public procedure for this rulemaking in the Bering Sea and Aleutian Islands action are impracticable, unnecessary, management area (BSAI) to rock sole. Classification or contrary to the public interest. We This action is necessary to account for This action responds to the best must remove the text identified in this previous harvest of the total allowable available information recently obtained rule from 50 CFR 17 because the catch (TAC). It is intended to promote from the fishery. The Assistant December 11, 2003, court order in Spirit the goals and objectives of the Fishery Administrator for Fisheries, NOAA, of the Sage Council v. Norton, Civil Management Plan for the Groundfish (AA) finds good cause to waive the Action No. 98–1873 (D.D.C.) vacated Fishery of the Bering Sea and Aleutian requirement to provide prior notice and this text. Islands Area (FMP). opportunity for public comment List of Subjects in 50 CFR Part 17 DATES: Effective May 25, 2004. pursuant to the authority set forth at 5 Comments must be received no later U.S.C. 553(b)(B) and 679.20 (b)(3)(iii)(A) Endangered and threatened species, than 4:30 p.m., Alaska local time, June as such a requirement is impracticable Exports, Imports, Reporting and 8, 2004. and contrary to the public interest. This recordkeeping requirements, ADDRESSES: Send comments to Sue requirement is impracticable and Transportation. Salveson, Assistant Regional contrary to the public interest as it Regulation Promulgation Administrator, Sustainable Fisheries would prevent the agency from Division, Alaska Region, NMFS, Attn: responding to the most recent fisheries I For the reasons set out in the preamble, Lori Durall. Comments may be data in a timely fashion and would we amend title 50, chapter I, subchapter submitted by: delay the apportionment of the reserves B of the Code of Federal Regulations, as ∑ Mail: P.O. Box 21668, Juneau, AK to the rock sole fishery, thus preventing set forth below. 99802–1668; full utilization of the TAC of rock sole,

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cause disruption to the industry and The AA also finds good cause to This action is required by 50 CFR potential economic harm through waive the 30–day delay in the effective 679.20 and is exempt from review under unnecessary discards. This action will date of this action under 5 U.S.C. Executive Order 12866. allow for the orderly conduct and 553(d)(3). This finding is based upon Authority: 16 U.S.C. 1801, et seq. efficient operation of the BSAI the reasons provided above for waiver of Dated: May 19, 2004. groundfish fishery. NMFS was unable to prior notice and opportunity for public Bruce C. Morehead, publish a notice providing time for comment. Under § 679.20(b)(3)(iii), interested Acting Director, Office of Sustainable public comment because the most Fisheries, National Marine Fisheries Service. recent, relevant data only became persons are invited to submit written comments on this action (see [FR Doc. 04–11799 Filed 5–24–04; 8:45 am] available as of May 4, 2004. ADDRESSES) until June 8, 2004. BILLING CODE 3510–22–S

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Proposed Rules Federal Register Vol. 69, No. 101

Tuesday, May 25, 2004

This section of the FEDERAL REGISTER Kelhart, Technical Advisor, Marketing raisin marketing order’s impact on small contains notices to the public of the proposed Order Administration Branch, Fruit and businesses are invited. issuance of rules and regulations. The Vegetable Programs, AMS, USDA, 1400 purpose of these notices is to give interested Dated: May 19, 2004. Independence Avenue, SW., STOP A.J. Yates, persons an opportunity to participate in the 0237, Washington, DC 20250–0237; rule making prior to the adoption of the final Administrator, Agricultural Marketing rules. telephone: (202) 720–2491; Fax: (202) Service. 720–8938; or E-mail: [FR Doc. 04–11742 Filed 5–24–04; 8:45 am] [email protected]. BILLING CODE 3410–02–P DEPARTMENT OF AGRICULTURE SUPPLEMENTARY INFORMATION: Marketing Agricultural Marketing Service Order No. 989, as amended (7 CFR part 989), regulates the handling of raisins DEPARTMENT OF TRANSPORTATION 7 CFR Part 989 produced from grapes grown in California. The marketing order is Federal Aviation Administration [Docket No. FV04–989–610 REVIEW] effective under the Agricultural Marketing Agreement Act of 1937 14 CFR Part 39 Raisins Produced From Grapes Grown (AMAA), as amended (7 U.S.C. 601– in California [Docket Nos. 2002–CE–05–AD and 2002– 674). CE–57–AD] AGENCY: Agricultural Marketing Service, AMS initially published in the RIN 2120–AA64 USDA. Federal Register (63 FR 8014; February ACTION: Notice of regulatory review and 18, 1999), its plan to review certain Airworthiness Directives; Cessna request for comments. regulations, including Marketing Order Aircraft Company Models 401, 401A, No. 989, under criteria contained in 401B, 402, 402A, 402B, 402C, 411, SUMMARY: This document announces section 610 of the Regulatory Flexibility 411A, and 414A Airplanes that the Agricultural Marketing Service Act (RFA; 5 U.S.C. 601–612). Updated (AMS) plans to review Marketing Order plans were published in the Federal AGENCY: Federal Aviation No. 989 for raisins produced from Register on January 4, 2002 (67 FR 525), Administration, DOT. grapes grown in California, under and again on August 14, 2003 (68 FR ACTION: Proposed rules; Withdrawal. criteria contained in section 610 of the 48574). Because many AMS regulations Regulatory Flexibility Act (RFA). impact small entities, AMS has decided, SUMMARY: This document withdraws DATES: Written comments on this notice as a matter of policy, to review certain two notices of proposed rulemaking must be received by July 23, 2004. regulations which, although they may (NPRMs) that would have applied to ADDRESSES: Interested persons are not meet the threshold requirement Cessna Aircraft Company (Cessna) invited to submit written comments under section 610 of the RFA, warrant Models 401, 401A, 401B, 402, 402A, concerning this notice of review. review. 402B, 402C, 411, 411A, and 414A Comments must be sent to the Docket The purpose of the review will be to airplanes. The proposed ADs would Clerk, Marketing Order Administration determine whether the marketing order have superseded existing ADs and Branch, Fruit and Vegetable Programs, for raisins produced from grapes grown would have required you to repetitively AMS, USDA, 1400 Independence in California should be continued inspect the wing spar caps of all Avenue, SW., STOP 0237, Washington, without change, amended, or rescinded airplanes for fatigue cracks and repair or DC 20250–0237; Fax: (202) 720–8938; or (consistent with the objectives of the replace as necessary and incorporate a E-mail: [email protected] or AMAA) to minimize the impacts on spar strap modification on each wing http://www.regulations.gov. All small entities. In conducting this spar on certain airplanes. The FAA has comments should reference the docket review, AMS will consider the decided not to issue the new ADs as number and the date and page number following factors: (1) The continued proposed. We will propose ADs after of this issue of the Federal Register and need for the marketing order; (2) the alternative solutions are developed. will be made available for public nature of complaints or comments ADDRESSES: You may view the AD inspection in the Office of the Docket received from the public concerning the dockets at FAA, Central Region, Office Clerk during regular business hours, or marketing order; (3) the complexity of of the Regional Counsel, Attention: may be viewed at http:// the marketing order; (4) the extent to Rules Docket No. 2002–CE–05–AD or www.ams.usda.gov/fv/moab.html. which the marketing order overlaps, Rules Docket No. 2002–CE–57–AD, 901 FOR FURTHER INFORMATION CONTACT: duplicates, or conflicts with other Locust, Room 506, Kansas City, Martin Engeler, Assistant Regional Federal rules, and, to the extent feasible, Missouri 64106. Office hours are 8 a.m. Manager, or Maureen T. Pello, Senior with State and local governmental rules; to 4 p.m., Monday through Friday, Marketing Specialist, Marketing Order and (5) the length of time since the except Federal holidays. Administration Branch, Fruit and marketing order has been evaluated or FOR FURTHER INFORMATION CONTACT: Paul Vegetable Programs, AMS, USDA, 2202 the degree to which technology, Nguyen, Aerospace Engineer, FAA, Monterey Street, Suite 102B, Fresno, CA economic conditions, or other factors Wichita Aircraft Certification Office, 93721; telephone: (559) 487–5901; Fax: have changed in the area affected by the 1801 Airport Road, Mid-Continent (559) 487–5906; E-mail: marketing order. Airport, Wichita, Kansas 67209; [email protected] or Written comments, views, opinions, telephone: (316) 946–4125; facsimile: [email protected]; or George and other information regarding the (316) 946–4107.

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SUPPLEMENTARY INFORMATION: industry to develop alternative solutions DEPARTMENT OF THE TREASURY to address the unsafe condition. We will Discussion repropose ADs after alternative Internal Revenue Service What action has FAA taken to date? solutions are developed. We issued proposals to amend part 39 26 CFR Part 1 of the Federal Aviation Regulations (14 Future Action [REG–106590–00; REG–138499–02] CFR part 39) to include two ADs that would apply to Cessna Models 401, Does this mean the FAA cannot take RIN 1545–AX95; RIN 1545–BB05 401A, 401B, 402, 402A, 402B, 402C, regulatory action in the future? No. 411, and 411A, 414A airplanes. These Withdrawal of these NPRMs does not Depreciation of MACRS Property That proposals (Docket Nos. 2002–CE–05–AD prevent us from issuing other regulatory Is Acquired in a Like-Kind Exchange or and 2002–CE–57–AD) were published action in the future, and it does not as a Result of an Involuntary in the Federal Register as notices of commit us to any future action. In fact, Conversion; Hearing Cancellation we plan to propose and issue further proposed rulemaking (NPRMs) on May AGENCY: Internal Revenue Service (IRS), rulemaking on this subject after 15, 2003 (68 FR 26239 and 68 FR Treasury. 26244). The NPRMs proposed the alternative solutions are identified and ACTION: following: developed. We fully expect one of the Cancellation of public hearing • Docket No. 2002–CE–05–AD: options in such a proposed action on proposed rulemaking. applies to Cessna Models 401, 401A, would be the incorporation of the SUMMARY: This document relates to a 401B, 402, 402A, 402B, 411, and 411A Cessna service information and cancellation of a public hearing for airplanes and proposed to supersede AD repetitive inspections with appropriate proposed regulations that provide 79–10–15 R2 with a new AD that would compliance schedules. guidance on how to depreciate MACRS require one of the following (depending property acquired in a like-kind on the aircraft configuration): How can I be part of the solution? The FAA, the public, and industry need to exchange under section 1031 or as a —For airplanes that do not incorporate one continue the discussion on this issue. result of an involuntary conversion of the specified Cessna Service Kits: The FAA is planning a second public under section 1033 when both the Repetitively inspect the wing spar caps for acquired and relinquished property are fatigue cracks and repair or replace the meeting. Details of this meeting will be published in the Federal Register and subject to MACRS in the hands of the wing spar caps as necessary and acquiring taxpayer. incorporate a spar strap modification on made available on the Internet. each wing spar; or DATES: The public hearing originally —For airplanes that incorporate one of the Regulatory Impact scheduled for June 3, 2004, at 10 a.m., specified Cessna Service Kits: Repetitively is cancelled. inspect the wing spar caps for fatigue Does this AD involve a significant rule or regulatory action? Since this action FOR FURTHER INFORMATION CONTACT: cracks and repair or replace the wing spar Robin R. Jones of the Publications and caps as necessary. only withdraws two proposed ADs, it is Regulations Branch, Legal Processing • not an AD and, therefore, is not covered Docket No. 2002–CE–57–AD: Division at (202) 622–7180 (not a toll- under Executive Order 12866, the applies to Cessna Models 402C and free number). 414A airplanes and proposed to Regulatory Flexibility Act, or DOT SUPPLEMENTARY INFORMATION: A notice supersede AD 2000–23–01 with a new Regulatory Policies and Procedures (44 FR 11034, February 26, 1979). of proposed rulemaking and notice of AD that would require you to: public hearing that appeared in the —Inspect the wing spar caps for fatigue List of Subjects in 14 CFR Part 39 Federal Register on Monday, March 1, cracks; 2004 (69 FR 9560), announced that a —Repair or replace the wing spar caps Air transportation, Aircraft, Aviation public hearing was scheduled for June as necessary; and safety, Safety. 3, 2004, at 10 a.m., in the auditorium. —Incorporate a spar strap modification The subject of the public hearing is on each wing spar. The Withdrawal proposed regulations under section 168 Was the public invited to comment? Accordingly, FAA withdraws the of the Internal Revenue Code. The The FAA invited interested persons to following notices of proposed public comment period for these participate in the making of these rulemaking: regulations expired on June 1, 2004. The amendments during the original 75-day outlines of oral comments were due on • Docket No. 2002–CE–05–AD, which comment periods. We extended the May 13, 2004. was published in the Federal Register comment periods for another 30 days The notice of proposed rulemaking on May 15, 2003 (68 FR 26239); and and then reopened the comment periods and notice of public hearing instructed for another 60 days. We received • Docket No. 2002–CE–57–AD, which those who are interested in testifying at numerous comments on the NPRMs. was published in the Federal Register the public hearing to submit an outline In addition, we held a public meeting on May 15, 2003 (68 FR 26244). of the topics to be addressed. As of on March 3 and 4, 2004, in Herndon, Wednesday, May 19, 2004, no one has Virginia. The public meeting allowed an Issued in Kansas City, Missouri, on May 18, 2004. requested to speak. Therefore, the open flow of communication among the public hearing scheduled for June 3, James E. Jackson, FAA, the public, and industry on issues 2004, is cancelled. related to the NPRMs. Acting Manager, Small Airplane Directorate, What is FAA’s determination of the Aircraft Certification Service. Cynthia E. Grigsby, best course of action? After analyzing all [FR Doc. 04–11705 Filed 5–24–04; 8:45 am] Acting Chief, Publications and Regulations Branch, Legal Processing Division, Associate information related to this subject, the BILLING CODE 4910–13–P FAA has decided not to issue the ADs Chief Counsel, (Procedure and as proposed. We have determined that Administration). the best way to address the unsafe [FR Doc. 04–11809 Filed 5–24–04; 8:45 am] condition is for FAA, the public, and BILLING CODE 4830–01–P

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ENVIRONMENTAL PROTECTION submit an electronic comment, EPA manufacturers for reformulation or AGENCY recommends that you include your repackaging; (2) any aerosol coating name and other contact information in product; or (3) any architectural coating 40 CFR Part 52 the body of your comment and with any that is sold in a container with a volume disk or CD–ROM you submit. If EPA of one liter (1.057 quarts) or less. The [MD166–3111; FRL–7666–4] cannot read your comment due to rule sets specific VOC content limits, in Approval and Promulgation of Air technical difficulties and cannot contact grams per liter, for AIM coating Quality Implementation Plans; you for clarification, EPA may not be categories with a compliance date of Maryland; Control of VOC Emissions able to consider your comment. January 1, 2005. Manufacturers would From AIM Coatings Electronic files should avoid the use of ensure compliance with the limits by special characters, any form of reformulating coatings and substituting AGENCY: Environmental Protection encryption, and be free of any defects or coatings with compliant coatings that Agency (EPA). viruses. are already in the market. The rule ACTION: Proposed rule. Copies of the documents relevant to contains VOC content requirements for this action are available for public a wide variety of field-applied coatings, SUMMARY: EPA is proposing to approve inspection during normal business including graphic art coatings, lacquers, a State Implementation Plan (SIP) hours at the Air Protection Division, primers and stains. The rule also revision submitted by the State of U.S. Environmental Protection Agency, contains administrative requirements Maryland. This revision pertains to the Region III, 1650 Arch Street, for labeling and reporting. There are a control of volatile organic compound Philadelphia, Pennsylvania 19103; and number of test methods that would be (VOC) emissions from architectural and Maryland Department of the used to demonstrate compliance with industrial maintenance (AIM) coatings. Environment, 1800 Washington this rule. Some of these test methods DATES: Written comments must be Boulevard, Suite 705, Baltimore, include those promulgated by EPA and received on or before June 24, 2004. Maryland 21230. South Coast Air Quality Management District of California. The test methods ADDRESSES: Submit your comments, FOR FURTHER INFORMATION CONTACT: Rose used to test coatings must be the most identified by MD166–3111 by one of the Quinto, (215) 814–2182, or by e-mail at current approved method at the time following methods: [email protected]. testing is performed. In addition, the A. Federal eRulemaking Portal: SUPPLEMENTARY INFORMATION: On March rule includes good faith efforts to be http://www.regulations.gov. Follow the 19, 2004, the Maryland Department of used by a retailer in safeguarding on-line instructions for submitting the Environment (MDE) submitted a against the sale of a non-compliant comments. revision to its State Implementation product, in the course of business, B. E-mail: [email protected]. Plan (SIP). The SIP revision consists of ensure that the products meet the C. Mail: Makeba Morris, Chief, Air COMAR 26.11.33 Architectural Coatings applicable State requirements. Quality Planning Branch, Mailcode which pertains to the control of VOC 3AP21, U.S. Environmental Protection emissions from AIM coatings (the AIM III. Proposed Action Agency, Region III, 1650 Arch Street, Rule). EPA is proposing to approve COMAR Philadelphia, Pennsylvania 19103. I. Background 26.11.33 for the control of VOC D. Hand Delivery: At the previously- emission from AIM Coatings submitted listed EPA Region III address. Such In December 1999, EPA identified on March 19, 2004. EPA is soliciting deliveries are only accepted during the emission reduction shortfalls in several public comments on the issues Docket’s normal hours of operation, and one-hour ozone nonattainment areas in discussed in this document. These special arrangements should be made the Ozone Transport Region (OTR) and comments will be considered before for deliveries of boxed information. required those areas to address the taking final action. Instructions: Direct your comments to shortfalls. The Ozone Transport Docket ID No. MD166–3111. EPA’s Commission (OTC) developed model IV. Statutory and Executive Order policy is that all comments received rules of control measures for a number Reviews will be included in the public docket of source categories. The OTC AIM Under Executive Order 12866 (58 FR without change, including any personal coatings model rule was based on the 51735, October 4, 1993), this proposed information provided, unless the existing rules developed by the action is not a ‘‘significant regulatory comment includes information claimed California Air Resources Board, which action’’ and therefore is not subject to to be Confidential Business Information were analyzed and modified by the OTC review by the Office of Management and (CBI) or other information whose workgroup to address VOC reduction Budget. For this reason, this action is disclosure is restricted by statute. Do needs in the OTR. The standards and also not subject to Executive Order not submit information that you requirements contained in Maryland’s 13211, ‘‘Actions Concerning Regulations consider to be CBI or otherwise AIM coatings rule are consistent with That Significantly Affect Energy Supply, protected through regulations.gov or e- the OTC model rule. Distribution, or Use’’ (66 FR 28355 (May mail. The Federal regulations.gov Web 22, 2001)). This action merely proposes site is an ‘‘anonymous access’’ system, II. Summary of SIP Revision to approve State law as meeting Federal which means EPA will not know your The Maryland AIM Rule applies to requirements and imposes no additional identity or contact information unless any person who supplies, sells, offers requirements beyond those imposed by you provide it in the body of your for sale, or manufactures any AIM State law. Accordingly, the comment. If you send an e-mail coating for the use in Maryland; as well Administrator certifies that this comment directly to EPA without going as a person who applies or solicits the proposed rule will not have a significant through regulations.gov, your e-mail application of any AIM coating within economic impact on a substantial address will be automatically captured Maryland. The rule does not apply to number of small entities under the and included as part of the comment the following: (1) Any AIM coating that Regulatory Flexibility Act (5 U.S.C. 601 that is placed in the public docket and is sold or manufactured for use outside et seq.). Because this rule proposes to made available on the Internet. If you of Maryland, or for shipment to other approve pre-existing requirements

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under State law and does not impose This proposed rule pertaining to addressed in a subsequent final rule any additional enforceable duty beyond Maryland’s AIM rule does not impose based on this proposed rule. EPA will that required by State law, it does not an information collection burden under not institute a second comment period. contain any unfunded mandate or the provisions of the Paperwork Any parties interested in commenting significantly or uniquely affect small Reduction Act of 1995 (44 U.S.C. 3501 on this action should do so at this time. governments, as described in the et seq.). DATES: Comments must be received in Unfunded Mandates Reform Act of 1995 List of Subjects in 40 CFR Part 52 writing by June 24, 2004. (Pub. L. 104–4). This proposed rule also ADDRESSES: Submit your comments, Environmental protection, does not have a substantial direct effect identified by VA141–5075 by one of the Intergovernmental relations, Ozone, on one or more Indian tribes, on the following methods: relationship between the Federal Reporting and recordkeeping A. Federal eRulemaking Portal: Government and Indian tribes, or on the requirements, Volatile organic http://www.regulations.gov. Follow the distribution of power and compounds. on-line instructions for submitting responsibilities between the Federal Authority: 42 U.S.C. 7401 et seq. comments. Government and Indian tribes, as Dated: May 18, 2004. B. E-mail: [email protected]. specified by Executive Order 13175 (65 C. Mail: Walter Wilkie, Chief, Air FR 67249, November 9, 2000), nor will Richard J. Kampf, Acting Regional Administrator, Region III. Quality Analysis Branch, Mailcode it have substantial direct effects on the 3AP22, U.S. Environmental Protection [FR Doc. 04–11773 Filed 5–24–04; 8:45 am] States, on the relationship between the Agency, Region III, 1650 Arch Street, national government and the States, or BILLING CODE 6560–50–P Philadelphia, Pennsylvania 19103. on the distribution of power and D. Hand Delivery: At the previously- responsibilities among the various listed EPA Region III address. Such levels of government, as specified in ENVIRONMENTAL PROTECTION AGENCY deliveries are only accepted during the Executive Order 13132 (64 FR 43255, Docket’s normal hours of operation, and August 10, 1999), because it merely 40 CFR Part 62 special arrangements should be made proposes to approve a State rule for deliveries of boxed information. implementing a Federal standard, and [VA141–5075b; FRL–7666–6] Instructions: Direct your comments to does not alter the relationship or the Docket ID No. VA141–5075. EPA’s Approval and Promulgation of State distribution of power and policy is that all comments received Air Quality Plans for Designated responsibilities established in the Clean will be included in the public docket Facilities and Pollutants; Air Act. This proposed rule also is not without change, including any personal Commonwealth of Virginia; Control of subject to Executive Order 13045 (62 FR information provided, unless the Emissions From Existing Commercial/ 19885, April 23, 1997), because it is not comment includes information claimed Industrial Incineration (CISWI) Units economically significant. to be Confidential Business Information In reviewing SIP submissions, EPA’s AGENCY: Environmental Protection (CBI) or other information whose role is to approve State choices, Agency (EPA). disclosure is restricted by statute. Do provided that they meet the criteria of ACTION: Proposed rule. not submit information that you the Clean Air Act. In this context, in the consider to be CBI or otherwise absence of a prior existing requirement SUMMARY: EPA proposes to approve the protected through regulations.gov or e- for the State to use voluntary consensus commercial and industrial solid waste mail. The Federal regulations.gov standards (VCS), EPA has no authority incinerator 111(d)/129 plan (the ‘‘plan’’) website is an ‘‘anonymous access’’ to disapprove a SIP submission for submitted by the Virginia Department or system, which means EPA will not failure to use VCS. It would thus be Environmental Quality (DEQ). The plan know your identity or contact inconsistent with applicable law for was submitted to EPA by the DEQ on information unless you provide it in the EPA, when it reviews a SIP submission, September 8, 2003, and supplemental body of your comment. If you send an to use VCS in place of a SIP submission information on August 11, and e-mail comment directly to EPA without that otherwise satisfies the provisions of September 30, 2003, and April 6, 2004. going through regulations.gov, your e- the Clean Air Act. Thus, the In the ‘‘Final Rules’’ section of this mail address will be automatically requirements of section 12(d) of the Federal Register, EPA is approving the captured and included as part of the National Technology Transfer and Commonwealth of Virginia’s CISWI comment that is placed in the public Advancement Act of 1995 (15 U.S.C. plan submittal as a direct final rule docket and made available on the 272 note) do not apply. As required by without prior proposal because the Internet. If you submit an electronic section 3 of Executive Order 12988 (61 Agency views this as a noncontroversial comment, EPA recommends that you FR 4729, February 7, 1996), in issuing action and anticipate no adverse include your name and other contact this proposed rule, EPA has taken the comments. A more detailed description information in the body of your necessary steps to eliminate drafting of the state submittal and EPA’s comment and with any disk or CD–ROM errors and ambiguity, minimize evaluation are included in a Technical you submit. If EPA cannot read your potential litigation, and provide a clear Support Document (TSD) prepared in comment due to technical difficulties legal standard for affected conduct. EPA support of this rulemaking action. A and cannot contact you for clarification, has complied with Executive Order copy of the TSD is available, upon EPA may not be able to consider your 12630 (53 FR 8859, March 15, 1988) by request, from the EPA Regional Office comment. Electronic files should avoid examining the takings implications of listed in the ADDRESSES section of this the use of special characters, any form the rule in accordance with the document. If no adverse comments are of encryption, and be free of any defects ‘‘Attorney General’s Supplemental received in response to this action, no or viruses. Guidelines for the Evaluation of Risk further activity is contemplated. If EPA Copies of the documents relevant to and Avoidance of Unanticipated receives adverse comments, the direct this action are available for public Takings’’ issued under the executive final rule will be withdrawn and all inspection during normal business order. public comments received will be hours at the Air Protection Division,

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U.S. Environmental Protection Agency, Division, International Bureau, (202) international telecommunications Region III, 1650 Arch Street, 418–1460. For information concerning carriers to file annual circuit-status Philadelphia, Pennsylvania 19103; and the information collection(s) contained reports that detail, as of December 31st the Virginia Department of in this document, contact Judith B. each year, the number of circuits they Environmental Quality, 629 East Main Herman at 202–418–0214, or via the own or lease to each country they serve Street, Richmond, Virginia, 23219. Internet at [email protected]. and the services for which they use each FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: This is a such circuit. The NPRM seeks comment James B. Topsale, P.E., at (215) 814– summary of the Commission’s Notice of on whether to retain the § 43.53 2190, or by e-mail at Proposed Rulemaking in IB Docket No. telegraph carrier report. [email protected]. 04–112, FCC 04–70, adopted March 24, The NPRM tentatively concludes that the § 43.61 traffic and revenue reports SUPPLEMENTARY INFORMATION: For 2004. The full text of this Commission decision is available for inspection and and the § 43.82 circuit-status reports further information, please see the continue to be needed and proposes to information provided in the direct final copying during normal business hours in the FCC Reference Center (Room CY– retain them. The NPRM, however, action, with the same title, that is proposes certain simplifications to A257), 445 12th Street, SW. located in the ‘‘Rules and Regulations’’ lessen the burden on the carries of filing Washington, DC 20554. The document section of this Federal Register the reports and, in a few cases, proposes is also available for download over the publication. Please note that if EPA to expand the information carriers are Internet at http://hraunfoss.fcc.gov/ receives adverse comment on an required to file to make the reports more edocs_public/attachmatch/FCC–04– amendment, paragraph, or section of useful under current conditions in the 70.pdf. The complete text may also be this rule and if that provision may be international telecommunications purchased from the Commission’s copy severed from the remainder of the rule, market. EPA may adopt as final those provisions contractor, Qualex International, in The NPRM proposes a number of of the rule that are not the subject of an person at 445 12th Street, SW., Room ways to simplify the § 43.61 traffic and adverse comment. CY–B402, Washington, DC. 20554, via revenue reports and § 43.82 circuit- telephone at (202) 863–2893, via status report. For example, the NPRM Dated: May 18, 2004. facsimile at (202) 863–2898, or via e- Richard J. Kampf, proposes to eliminate the current mail at [email protected]. This Notice requirement in the annual traffic and Acting Regional Administrator, Region III. of Proposed Rulemaking (NPRM) revenue report that carriers file the [FR Doc. 04–11772 Filed 5–24–04; 8:45 am] contains proposed new or modified number of messages they carry to and BILLING CODE 6560–50–P information collections subject to the from the foreign countries they serve, Paperwork Reduction Act of 1995 requiring only that they continue to (PRA), Public Law 104–3. It will be report the number of minutes they FEDERAL COMMUNICATIONS submitted to the Office of Management handle and the amount of revenues COMMISSION and Budget (OMB) for review under associated with those minutes. Second, section 3507(d) of the PRA. OMB, the the NPRM proposes to eliminate the 47 CFR Parts 1, 43 and 63 general public, and other Federal current requirement that carriers file [IB Docket No. 04–112; FCC No. 04-70] agencies are invited to comment on the traffic and revenue information or modified information collections circuit-status information for services Reporting Requirements for U.S. contained in this proceeding. they offer between the U.S. Mainland Providers of International Summary of Notice of Proposed and offshore U.S. points such as Hawaii Telecommunications Services Rulemaking and Puerto Rico or traffic carried between two such offshore U.S. points. AGENCY: Federal Communications On March 24, 2004, the Commission Third, the NPRM proposes to establish Commission. adopted a Notice of Proposed a $5 million annual revenue threshold ACTION: Notice of proposed rulemaking. Rulemaking in the Matter of Reporting for reporting U.S. international resale Requirements for U.S. Providers of telephone services. That is, U.S. carriers SUMMARY: This document is a summary International Telecommunications that provide international telephone of the Notice of Proposed Rulemaking Services; Amendment of Part 43 of the service on a resale basis do not have to adopted by the Commission in this Commission’s Rule (NPRM). In the file an annual traffic and revenue report proceeding. The Commission seeks NPRM, the Commission undertakes a unless their annual resale revenues comment on the continued need for comprehensive review of the reporting exceed $5 million. Similarly, the NPRM traffic and revenue reports and requirements to which carriers proposes to implement a $5 million facilities-use reports and on proposals providing U.S. international services are annual revenue threshold also for that simplify and the reports that subject under part 43 of the rules. The ‘‘miscellaneous’’ international services, carriers must file. The Commission also NPRM seeks comment on changes to i.e., services other than international seeks comment of the elimination of simplify the reporting requirements and telephone service. The NPRM includes requirement that international telegraph to ensure the usefulness of the data a staff proposal that recommends a carriers file their contracts with their collected by the Commission. number of ways to simplify the foreign correspondents. The NPRM seeks comment on information that international carriers DATES: Comments are due to be filed by whether to retain the annual traffic and must report on covered services. The July 26, 2004, and reply comments are revenue reporting requirements. staff proposal is available for download due to be filed by August 23, 2004. Currently, § 43.61(a) requires over the Internet at http:// OMB, the general public, and other international telecommunications hraunfoss.fcc.gov/edocs_public/ Federal agencies are invited to comment carriers to file annual reports setting attachmatch/FCC–04–70A1.pdf. on the information collection forth their traffic and revenues for each The NPRM also seeks comment on the requirements on or before July 26, 2004. international service they provide. need to retain the § 43.61(b) and FOR FURTHER INFORMATION CONTACT: Section 43.82 of the Commission’s rules § 43.61(c) quarterly traffic and revenue David Krech or John Copes, Policy requires facilities-based U.S. reports. If the Commission ultimately

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concludes that it should retain the Form No.: Not Applicable. Written public comments are quarterly reports, the simplifications Type of Review: Revision of a requested on this IRFA. Comments must proposed for the annual traffic and currently approved collection. be identified as responses to the IRFA revenue reports would apply to the Respondents: Businesses or other for- and must be filed by the deadlines for retained quarterly reports as well. profit entities. comments on the Notice July 26, 2004. The NPRM proposes to require all Number of Respondents: 134. The Commission will send a copy of the carriers that own international Estimated Time Per Response: 18 Notice, including this IRFA, to the Chief transmission facilities to file the annual hours. Counsel for Advocacy of the Small circuit-status reports. At present, only Frequency of Response: Quarterly, Business Administration. In addition, common-carrier service providers are Annual, on occasion. the Notice and IRFA will be published required to file circuit-status Total Annual Burden: 2412 hours. in the Federal Register information. The NPRM proposes to Total Annual Costs: $216,524. Needs and Uses: The information will A. Need for, and Objectives of, the require owners of non-common-carrier Proposed Rules international transmission facilities also be used by the Commission staff for to file. Since the circuit-status report international planning, facility The Commission initiated this was adopted, the mix of common-carrier authorization, monitoring emerging comprehensive review of the reporting and non-common-carrier international developments in communications requirements imposed on U.S. carriers transmission facilities has shifted so services, analyzing market structures, providing international that currently common-carrier facilities tracking the balance of payments in telecommunications services. The represent less than 10 percent of all international communications services, Commission believes that the proposals international transmission facilities. To and market analysis purposes. The contained in the NPRM will make it keep the Commission informed about reported data enables the Commission easier for carriers, both small and large, the availability and usage of to fulfill its regulatory responsibilities. to provide the information required by international transmission facilities, it OMB Control Number: 3060–0572. the rules. In addition, section 11 of the will be necessary for it to have Title: Filing Manual for Annual Telecommunications Act of 1996 directs information on both common-carrier International Circuit Status Reports. the Commission to undertake, in every and non-common-carrier facilities. Form No.: Not Applicable. even-numbered year beginning in 1998, The NPRM also proposes to eliminate Type of Review: Revision of a a review of all regulations issued under the § 43.53 telegraph carriers reporting currently approved collection. the Communications Act of 1934, as requirement. The NPRM notes that Respondents: Business and other for- amended. The objective of this proceeding is to international telegraph services have profit entities. improve the reporting requirements of sharply declined in importance and that Number of Respondents: 138. Estimated Time Per Response: 11 §§ 43.61 and 43.82 imposed on carriers no useful purpose would be served by hours. providing international requiring such carriers to file their Frequency of Response: Annual telecommunications services. overseas contracts. reporting requirement. Specifically, the NPRM proposes to Procedural Matters Total Annual Burden: 1,540 hours. simplify, consolidate, and revise the Total Annual Costs: $42,600. annual traffic and revenue reporting Initial Paperwork Reduction Act Needs and Uses: The information will requirements and the circuit-status Analysis enable the Commission to discharge its reporting requirements. Also, the NPRM This NPRM contained proposed new obligation to authorize the construction proposes to eliminate several reporting information collections. The and use of international common carrier requirements. Commission, as part of its continuing transmission facilities. The information Currently, § 43.61 requires that all effort to reduce paperwork burdens, will be used by the Commission and the international telecommunications invites the general public and the Office industry as to whether an international carriers file an annual report of their of Management and Budget (OMB) to common carrier is providing direct or traffic and revenues. In addition, § 43.61 comment on the information indirect service to countries and to sets forth additional reporting collection(s) contained in this NPRM, as assess industry trends in the use of requirements for specific carriers that required by the Paperwork Reduction international transmission facilities. The meet the criteria set forth in the rule. Act (PRA) of 1995, Public Law 104–13. information is extremely valuable Under § 43.82, facilities-based common Public and agency comments are due because it is not available from any carriers providing international July 26, 2004. PRA comments should other source. telecommunications services must file address: (a) Whether the proposed an annual report on the status of their collection of information is necessary Final Regulatory Flexibility Act circuits. The information derived from for the proper performance of the Analysis the international revenue and traffic functions of the Commission, including As required by the Regulatory report and circuit-status report is critical whether the information shall have Flexibility Act (RFA), as amended, the in understanding the international practical utility; (b) the accuracy of the Commission has prepared this Initial telecommunications market. These Commission’s burden estimates; (c) Regulatory Flexibility Analysis (IRFA) reports are the only source of publicly ways to enhance the quality, utility, and of the possible significant economic available information of this nature. clarity of the information collected; and impact on a substantial number of small The information obtained from these (d) ways to minimize the burden of the entities by the policies and rules reports is used extensively by the collection of information on the proposed in this Notice of Proposed Commission, the industry, other respondents, including the use of Rulemaking (NPRM). (See 5 U.S.C. 603. government agencies, and the public. automated collection techniques or The RFA, see 5 U.S.C. 601–612, has The Commission uses the information to other forms of information technology. been amended by the Small Business evaluate applications for international OMB Control Number: 3060–0106. Regulatory Enforcement Fairness Act of facilities, track market developments Title: Section 43.61—Reports of 1996 (SBREFA), Pub. L. 104–121, Title and the competitiveness of each service Overseas Telecommunications Traffic. II, 110 Stat. 857 (1996).) and geographical market to formulate

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rules and policies consistent with the section 214 of the Communications Act; international message telephone service public interest, monitor compliance entities providing domestic or (IMTS) on a pure resale basis. (See FCC, with those rules and policies, and gauge international wireless common carrier Wireline Competition Bureau, Industry the competitive effect of its decisions on services under section 309 of the Act; Analysis and Technology Division, the market. The information is used to entities providing common carrier or ‘‘2001 International ensure compliance with the non-common carrier satellite services Telecommunications Data’’ at page 1, Commission’s international rules and under section 309 of the Act; and Statistical Findings (January 2003). FCC policies. The information enables the entities licensed to construct and Web site location http://www.fcc.gov/ Commission to tailor policies to respond operate submarine cables under the wcb/iatd/intl.html.) Pure resale to the market developments on a Cable Landing License Act on a providers resell the services of particular route. The Commission also common carrier or non-common carrier underlying U.S. facilities-based and uses the information to identify those basis. The Commission has not facilities-resale carriers. Pure resale routes for which settlement rates are at developed a definition of small entities service is primarily provided by small a level low enough to permit relief from applicable to these entities. Therefore, businesses. For example, of the 625 certain regulatory requirements, the applicable definition of small entity carriers, 277 carriers had revenues less including the prohibition on the use of is the definition under the SBA rules than $10,000; 482 had revenues less private lines for the provision of applicable to Telecommunications than $500,000; and 513 had revenues switched, basic services (‘‘ISR’’). Services (see 13 CFR 121.201, NAICS less than $1 million. The report also Carriers use the information to track the Code.) According to the SBA definition, shows that 52 U.S. facilities-based and balance of payments in international wired telecommunications carriers, facilities-resale carriers reported that communications services and for market cellular and other wireless providers, they billed $10.8 billion for IMTS analysis purposes. Carriers and and telecommunications resellers would service, $1.4 billion for private line potential entrants use the information be considered small entities if they services, and $0.2 billion for for, among other things, assessment of employ 1,500 employees or less. The international telex, telegraph, and other market opportunities and to monitor definition also considers satellite or miscellaneous services. These carriers competition in markets. The other telecommunications providers as would be considered large entities Commission, along with other small entities if they have $12.5 million under the SBA definition. (See 13 CFR government agencies, uses the or less in annual receipts. (See 13 CFR 121.201, NAICS Code at Subsector information in merger analyses and 121.201, NAICS Code at Subsector 517—Telecommunications.) According negotiations with foreign countries. In 517—Telecommunications.) to the 2002 Circuit-Status Report, 79 addition, the information contained in We have included small incumbent U.S. international facility-based carriers the circuit-stateus report allows the local exchange carriers in this present filed information pursuant to § 43.82. Commission to comply with the RFA analysis. As noted above, a ‘‘small (See International Bureau Releases 2002 statutory requirements of the Omnibus business’’ under the RFA is one that, Year-End Circuit Status Report for U.S. Budget Reconciliation Act of 1993. inter alia, meets the pertinent small Facilities-Based International Carriers; business size standard (e.g., a telephone Capacity Use Shows Modest Growth, rel. B. Legal Basis communications business having 1,500 Dec. 24, 2003. The report is available on The NPRM is adopted pursuant to or fewer employees), and ‘‘is not the FCC Web site at http://www.fcc.gov/ sections 1, 4(i) and (j), 11, 201–205, 211, dominant in its field of operation.’’ The ib/pd/pf/csmanual.html.) 214, 219, 220, 330(r), 309, and 403 of SBA’s Office of Advocacy contends that, The report does not yield employee or the Communications Act of 1934 as for RFA purposes, small incumbent revenue statistics, so it is impossible for amended, 47 U.S.C. 151, 154(i), 154(j), local exchange carriers are not dominant use to determine how many carriers 161, 201–205, 211, 214, 219, 220, 303(r), in their field of operation because any could be considered small entities. 309, and 403. such dominance is not ‘‘national’’ in Although it is quite possible that a scope. (See Letter from Jere W. Glover, carrier could report a small amount of C. Description and Estimate of the Chief Counsel for Advocacy, SBA, to capacity and have significant revenues, Number of Small Entities to Which the William E. Kennard, Chairman, FCC we will consider those carriers small Proposals Will Apply (May 27, 1999). The Small Business Act entities at this time. Thus, of the 79 The RFA directs agencies to provide contains a definition of ‘‘small-business carriers filing the annual circuit-status a description of, and, where feasible, an concern,’’ which the RFA incorporates report for 2002, there were at least 8 estimate of the number of small entities into its own definition of ‘‘small carriers that could be considered small that may be affected by the proposals, if business.’’ 15 U.S.C. 632(a) (Small entities because they did not have any adopted. The RFA generally defines the Business Act); 5 U.S.C. 601(3) (RFA). circuits in 2002. term ‘‘small entity’’ as having the same SBA regulations interpret ‘‘small D. Description of Projected Reporting, meaning as the terms ‘‘small business,’’ business concern’’ to include the Recordkeeping, and Other Compliance ‘‘small organization,’’ and ‘‘small concept of dominance on a national Requirements governmental jurisdiction.’’ In addition, basis. 13 CFR 121.102(b). We have the term ‘‘small business’’ has the same therefore included small incumbent The NPRM proposes to retain the meaning as the term ‘‘small business local exchange carriers in this RFA annual traffic and revenue reporting concern’’ under the Small Business Act. analysis, although we emphasize that requirements and the circuit-status A small business concern is one that: (1) this RFA action has no effect on reporting requirements because the Is independently owned and operated; Commission analysis and collection and public reporting of this (2) is not dominant in its field of determinations in other, non-RFA information continues to be necessary in operation; and (3) satisfies any contexts. the public interest. The NPRM, additional criteria established by the The carriers required to file the traffic however, proposes to simplify and Small Business Administration (SBA). and revenue and circuit-status reports clarify the reporting requirements to The proposals in the NPRM apply are both large and small entities. In the reduce the burdens for both small and only to entities providing international 2001 annual traffic and revenue report, large carriers. Because carriers currently common carrier services pursuant to 625 carriers reported that they provided are required to file annual traffic and

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revenue and circuit-status reports, the minutes of IMTS carriers receive from E. Steps Taken To Minimize Significant proposals contained in the NPRM will their overseas correspondents and the Economic Impact on Small Entities, and not impose any significant economic dollar amounts they receive for Significant Alternatives Considered burden on small carriers. The terminating that traffic. Also, carriers The RFA requires an agency to information contained in the proposed would be required to continue to describe any significant, specifically reporting requirements is the same separate the inbound traffic they receive small business, alternatives that it has information that the carriers collect and under the traditional settlement considered in reaching its proposed maintain during the routine course of arrangements from inbound traffic they approach, which may include the business. The NPRM contains a staff receive under all other arrangements, following four alternatives (among recommendation on the proposed such as ISR, hubbing, etc. others): ‘‘(1) The establishment of reporting requirements, including eight Proposed Schedule 4 would require differing compliance or reporting proposed schedules that show the carries to provide additional detail on a requirements or timetables that take into specific information that carries would world total basis for the IMTS minutes account the resources available to small be required to report and how they and revenues for traffic billed to U.S. entities; (2) the clarification, would report it. The proposed reporting customers and for traffic billed to consolidation, or simplification of requirements are described below. others. Carriers would be required to compliance and reporting requirements However, because the Commission may report the minutes of collect calls, under the rule for small entities; (3) the change the reporting proposed in the international toll-free calls, country- use of performance, rather than design, NPRM based on comments received in beyond calls, and country-direct calls standards; and (4) an exemption from this proceeding, consequently, the they handle. When reporting this coverage or the rule, or any part thereof, schedules would also change. information, carriers would be required Schedule 1 contains a proposed for small entities.’’ to provide separate data for the minutes The NPRM seeks comment on a summary report that applies to all they receive from foreign carriers for entities, both small and large. This number of proposals to simplify and traditional IMTS transit traffic, refilled consolidate the reporting requirements report would be a one-page form that traffic, and traffic received from spot international section 214 authorization for carriers providing international markets. telecommunications services. The holders would be required to file Proposed Schedule 5 would require annually. The generic form would proposals in the NPRM are designed to pure resale carriers with over $5 million reduce the regulatory requirements for require a carrier to provide basic in revenue from international services to information about its international both small and large carriers, while report their U.S.-customer minutes and maintaining and enhancing the goals the section 214 authorization. Specifically, revenues separately for U.S. end-user the carrier would be required to provide reports serve. The Commission will also traffic, traffic handled for other U.S. its name, its Form 499–A identification consider other additional significant carriers, and traffic re-originated for number, its Commission Registration alternatives developed in the record. foreign carriers. System (CORES) identification number, The possible change to the reporting Proposed Schedule 6 would require and a list of the international section requirements with the most significant carriers to provide country-by-country 214 authorizations that it holds. In impact on small carriers is the proposal addition, the carrier would provide information on their international to exempt pure resale carriers with less basic information about the services that private-line services. Carriers would be then $5 million in revenues from it provided the previous year. Based on required to report separately service international services the preceding year the services the responding carriers provided over facilities they own and from filing reports. Based on the number reported, the schedule would inform the service provided over resold circuits. of carriers filing the annual traffic and carrier which other schedules, if any, Proposed Schedule 6 includes a new revenue report in 2001, the majority of the carrier would be required to category called ‘‘Data Services’’ to carriers would be considered small complete. The schedule would provide ensure proper reporting of several new carriers. (See FCC, Wireline the carriers with information on which services that carriers have begun to offer Competition Bureau, Industry Analysis of its entities are required to file, in recent years. and Technology Divison, ‘‘2001 including subsidiaries of the Proposed Schedule 7 would require International Telecommunications authorization holder that might need to carriers to provide information Data’’ at page 1, Statistical Findings file separately. regarding miscellaneous services. (January 2003). FCC Web site location Proposed Schedules 2 and 3 would Services other than IMTS and private- http://www.fcc.gov/wcb/iatd/intl.html.) require carriers to submit information line service would be considered This proposal would benefit a on IMTS and seek country-by-country miscellaneous services. Carriers would substantial number of small entities by traffic and revenue information. be required to provide a minimal relieving them from certain reporting Schedule 2 will require carriers to amount of information on the new requirements. provide the information on ‘‘outbound’’ services, such as the name of each The NPRM proposes to simplify the IMTS traffic, whereas Schedule 3 will service and the total annual revenues information that the carriers, both small require carriers to provide the the carriers derived from the service. and large, must submit for any traffic information on ‘‘inbound’’ IMTS traffic. Proposed Schedule 8 would require and revenue reports. First, the NPRM Under Schedule 2, carriers would carriers to provide a snapshot of their proposes to eliminate the requirement report, their minutes and revenues/ active and idle circuits as of December that carriers provide information on the payouts if the ‘‘source of traffic’’ is from 31st of each year. Carriers would be number of messages that they carried end users or another U.S. carrier and the required to report their circuit capacity the previous year. Second, the NPRM carrier terminates those minutes with a on the basis of the type of facilities they proposes to eliminate the requirement foreign carrier, on the spot marked, or use to provide service—submarine that carriers use the billing codes set out self terminates in the foreign country. cables, satellites, and terrestrial links. in the § 43.61 Filing Manual and the Proposed Schedule 3 would require Carriers would be required to report Public Notices. Currently, carriers report carriers to report, on a country-by- their circuit use in units of 64 Kilobit international telephone traffic under 12 country basis, the number of inbound per second (Kbps) equivalent circuits. different billing codes, and the various

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billing codes have presented recurring mandate carriers to submit their data § 1.789 [Removed] problems for carriers filing the reports electronically. Electronic filing would 2. Remove § 1.789. as well as those who review the reports. lessen the burden of filing the reports Third, the NPRM proposes a set of for both small and large carriers. PART 43—REPORTS OF schedules for the reporting of the traffic Because carriers maintain the data COMMUNICATION COMMON and revenue and circuit-status electronically, it would be practicable CARRIERS AND CERTAIN AFFILIATES information in lieu of the two filing for carriers to submit the data in the 3. The authority citation for part 43 manuals that are currently used. The same format rather than convert the data continues to read as follows: Notice proposes to streamline some of into a different format. the reporting categories, which will The NPRM proposes a general report Authority: 47 U.S.C. 154; reduce the reporting requirements on Telecommunications Act of 1996, Pub. that will make it very simple for a L.104–104, secs. 402(b)(2)(B), (c), 110 Stat. 56 both small and large entities. carrier to determine which, if any, (1996) as amended unless otherwise noted. The NPRM proposes to consolidate reporting requirements are applicable to 47 U.S.C. 211, 219, 220 as amended. § 43.61 (traffic and revenue reporting the carrier. In addition, this proposal requirement) and § 43.82 (circuit-status will simplify a carrier’s compliance § 43.53 [Removed] reporting requirement) into one rule. with other reporting requirements, such 4. Remove § 43.53. Consolidating the rules will eliminate as the Form 499–A. 5. Section 43.61 is revised to read as the requirement that carriers file two follows: separate reports—one for traffic and F. Federal Rules That May Duplicate, revenue data and one for circuit-status Overlap, or Conflict With the Proposed § 43.61 Reporting requirements for U.S. data. The Notice proposes that one filing Rules international carriers. (a) Annual traffic and revenue reports. manual be developed that will satisfy None. the reporting requirements of the new Each carrier engaged in providing rule. One consolidated filing manual for Ordering Clauses international telecommunications both reports would be less confusing service between the area comprising the Accordingly, pursuant to the continental United States, Alaska, and less time-consuming for both small authority contained in sections 1, 4(i), and large carriers. Hawaii, and off-shore U.S. points and 4(j), 11, 201–205, 211, 214, 219, 220, any country or point outside that area The NPRM also proposes to require 303(r), 309, and 403 of the carriers to file the report earlier than shall file a report with the Commissions Communications Act of 1934, as not later than May 1, of each year currently required in order to improve amended, 47 U.S.C. Sections 151, 154(i), the timeliness of the resulting report. In showing traffic and revenue fro 154(j), 161, 201–205, 211, 214, 219, 220, selecting a proposed filing date, the international services provided in the 303(r), 309 and 403, this notice of Commission tried to balance the need preceding calendar year. proposed rulemaking is hereby adopted for more expeditious filing with any (b) Quarterly traffic reports for and comments are requested as burden an earlier filing would place on facilities-based carriers. (1) Each described above. carriers. In addition, with more timely- common carrier engaged in providing filed data, it would be unnecessary for The Commission’s Consumer and international telecommunications carriers to file corrected traffic and Governmental Affairs Bureau, Reference service between the area comprising the revenue data. The proposed new filing Information Center, shall send a copy of continental United States, Alaska, date minimizes any burden on the this notice of proposed rulemaking, Hawaii, and off-shore U.S. points and carriers because it does not coincide including the Initial Regulatory any country or point outside that area with any other reporting requirements. Flexibility Act Analysis, to the Chief shall file with the Commission, in Also, carriers will not be burdened with Counsel for Advocacy of the Small addition to the report required by filing another report with corrected Business Administration in accordance paragraph (a) of this section, actual data. with section 603(a) of the Regulatory traffic and revenue data for each The NPRM proposes changes in the Flexibility Act, 5 U.S.C. 601 et seq. calendar quarter in which the carrier’s format under which the carriers file the List of Subjects in 47 CFR Parts 1, 43 quarterly minutes exceed the reports. The NPRM proposes replacing and 63 corresponding minutes for all carriers the current DOS-based filing procedures by one or more of the following tests: with spreadsheet-based reporting Communications common carriers, (i) The carrier’s aggregate minutes of thereby allowing carriers to file their Reporting and recordkeeping facilities-based or private-line resale data using a commercial spread sheet requirements, Telecommunications. switched telephone traffic for service program. This proposal should Federal Communications Commission. billed in the United States are greater substantially reduce the burden on all Marlene H. Dortch, than 1.0 percent of the total of such carriers, both small and large, in Secretary. minutes of international traffic for all preparing their data submissions. Also, U.S. carriers published in the carriers filing schedules that do not Rule Changes Commission’s most recent § 43.61 require country-by-country data could For the reasons discussed in the annual report of international easily prepare and submit such preamble, the Federal Communications telecommunications traffic; information online. This, too, would Commission proposes to amend 47 CFR (ii) The carrier’s aggregate minutes of substantially reduce the burden on the parts 1, 43 and 63 as follows: facilities-based or private-line resale filing carrier, facilitate interactive edit switched telephone traffic for service checks, and allow data to be PART 1—PRACTICE AND billed outside the United States are automatically loaded into the PROCEDURE greater than 1.0 percent of the total of Commission’s database programs. such minutes of international traffic for The NPRM seeks comment on 1. The authority citation for part 1 all U.S. carriers published in the whether it would significantly speed continues to read as follows: Commission’s most recent § 43.61 and facilitate the submission of data if Authority: 47 U.S.C. 151, 154(i), 154(j), annual report of international the Commission were to encourage or 155, 225, 303(r), 309 and 325(e). telecommunications traffic;

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(iii) The carrier’s aggregate minutes of outside that area shall file a circuit Authority: Sections 1, 4(i), 4(j), 10, 11, 201, facilities-based or private-line resale status report with the Commission not 205, 214, 218, 403 and 651 of the switched telephone traffic for service later than May 1, each year showing the Communications Act of 1934, as amended, billed in the United States for any status of its circuits used to provide 47 U.S.C. 151, 154(i), 154(j), 160, 201, 205, foreign country are greater than 2.5 international services as of December 214, 218, 403, and 571, unless otherwise noted. percent of the total of such minutes of 31, of the preceding calendar year. international traffic for that country for (e) Filing manual. The information § 63.23 [Amended] all U.S. carriers published in the required under this section shall be 8. Section 63.23 is amended by Commission’s most recent § 43.61 furnished in conformance with the removing paragraph (e) and annual report of international instructions and reporting requirements redesignating paragraph (f) as paragraph telecommunications traffic; or prepared under the direction of the (e). (iv) The carrier’s aggregate minutes of Chief, International Bureau, prepared facilities-based or private-line resale and published as a filing manual. [FR Doc. 04–10837 Filed 5–24–04; 8:45 am] switched telephone traffic for service (f) Definitions. (1) Two entities are BILLING CODE 6712–01–M billed outside the United States for any affiliated with each other if one of them, foreign country are greater than 2.5 or any entity that controls one of them, percent of the total of such minutes of directly or indirectly owns more than 25 DEPARTMENT OF THE INTERIOR international traffic for that country for percent of the capital stock of, or all U.S. carriers published in the controls, the other one, Also, a U.S. Fish and Wildlife Service Commission’s most recent § 43.61 carrier is affiliated with two or more annual report of international foreign carriers if the foreign carriers, or 50 CFR Part 17 telecommunications traffic. entities that control them, together (2) Except as provided in this directly or indirectly own more than 25 RIN 1018–AT64 paragraph, the quarterly reports percent of the capital stock of, or Endangered Species Act Incidental required by paragraph (b)(1) of this control, the U.S. carrier and those Take Permit Revocation Regulations section shall be filed in the same format foreign carriers are parties to, or the as, and in conformance with, the filing beneficiaries of, a contractual relation AGENCY: Fish and Wildlife Service, procedures for the annual reports (e.g., a joint venture or market alliance) Interior. required by paragraph (a) of this section. affecting the provision or marketing of ACTION: Proposed rule. (i) Carriers filing quarterly reports international basic telecommunications shall include in those reports only their services in the United States. SUMMARY: We, the U.S. Fish and provision of switched, facilities-based (2) Facilities-based carrier means a Wildlife Service (Service), propose to telephone service and switched, private- carrier that holds an ownership, amend part 17 of title 50 of the Code of line resale telephone service. indefeasible-right-of-user, or leasehold Federal Regulations (CFR) to add (ii) The quarterly reports required by interest in bare capacity in the U.S. end regulations that describe circumstances paragraph (b)(1) of this section shall be of an international facility, regardless of in which the Service may revoke filed with the Commission no later than whether the underlying facility is a incidental take permits issued under the April 30 for the prior January through common carrier or non-common carrier authority of the Endangered Species Act March quarter; no later than July 31 for submarine cable or a satellite system. (ESA). On December 11, 2003, the U.S. the prior April through June quarter; no (3) Foreign carrier is defined as any District Court for the District of later than October 31 for the prior July entity that is authorized within a foreign Columbia in Spirit of the Sage Council through September quarter; and no later country to engage in the provision of v. Norton, Civil Action No. 98–1873 (D. than January 31 for the prior October international telecommunications D.C.), invalidated 50 CFR 17.22(b)(8) through December period. services offered to the public in that and 17.32(b)(8), the regulations (c) Quarterly Traffic Reports for resale country within the meaning of the addressing Service authority to revoke carriers. Each common carrier engaged International Telecommunication incidental take permits under certain in the resale of international switched Regulations, see Final Acts of the World circumstances. The court ruled that we services that is affiliated with a foreign Administrative Telegraph and had adopted these regulations without carrier that has sufficient market power Telephone Conference, Melbourne, 1988 adequately complying with the public on the foreign end of an international (WATTC–88), Art. 1, which includes notice and comment procedures route to affect competition adversely in entities authorized to engage in the required by the Administrative the U.S. market and that collects provision of domestic Procedure Act (APA) and remanded the settlement payments from U.S. carriers telecommunications services if such regulations to us for further proceedings shall file a quarterly version of the carriers have the ability to originate or consistent with the APA. In the Rules report required in paragraph (a) of this terminate telecommunications services and Regulations section of today’s section for its switched resale services to or from points outside their country. Federal Register is a final rule on the dominant route within 90 days § 43.82 [Removed] withdrawing the permit revocations from the end of each calendar quarter. 6. Remove § 43.82. regulations in 50 CFR 17 vacated by the Commercial Mobile Radio Service court order. In this document, we are (CMRS) carriers, as defined in § 20.9 of PART 63—EXTENSION OF LINES, NEW requesting public comments on our this chapter, are not required to file LINES AND DISCONTINUANCE, proposal to reestablish the permit reports pursuant to this paragraph. REDUCTION, OUTAGE AND revocation regulations vacated by the (d) Circuit status reports. Each IMPAIRMENT OF SERVICE BY court. facilities-based carrier engaged in COMMON CARRIERS; AND GRANTS providing international DATES: Comments must be received by OF RECOGNIZED PRIVATE July 26, 2004. telecommunications service between the OPERATING AGENCY STATUS area comprising the continental United ADDRESSES: You may submit comments, States, Alaska, Hawaii, and off-shore 7. The authority citation for part 63 identified by RIN number 1018–AT64, U.S. points and any country or point continues to read as follows: by any of the following methods: (1)

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Mail or hand delivery to the Chief, Flora (CITES). The regulations in these Interior/Department of Commerce Division of Consultation, Habitat parts contain their own specific regulations implementing section 7 of Conservation Planning, Recovery and permitting requirements that the ESA (50 CFR 402.02). In essence, the State Grants, U.S. Fish and Wildlife supplement the general permitting Permit Revocation Rule authorizes the Service, 4401 North Fairfax Drive, Room provisions of part 13. Service to revoke an incidental take 420, Arlington, VA 22203; (2) FAX: 703/ With respect to the ESA, the permit if continuation of the permitted 358–2229; (3) E-mail: [email protected]; or combination of the general permitting activity would jeopardize the continued (4) through the Federal eRulemaking provisions in part 13 and the specific existence of a listed species and the Portal: http://www.regulations.gov. All permitting provisions in part 17 has jeopardy situation is not remedied in a submissions must include the worked well in most instances. timely fashion. identification number RIN 1018–AT64. However, the Service has found that, in On February 11, 2000 (65 FR 6916), The complete file for this proposed rule, some areas of permitting policy under we published a request for additional including public comments, is available, the Act, the ‘‘one size fits all’’ approach public comment on several specific by appointment, during normal business of part 13 has been inappropriately regulatory changes included in the June hours at the same address. You may call constraining and narrow. These areas 17, 1999 (64 FR 32706), final rule, 703/358–2171 to make an appointment include specifically the Habitat including the Permit Revocation Rule. to view the files. Conservation Planning, Safe Harbor Based on our review of the comments FOR FURTHER INFORMATION CONTACT: Rick Agreement, and Candidate Conservation we received in response to the February Sayers, Chief, Branch of Consultation Agreement with Assurances programs. 11, 2000, request for comments, we and Habitat Conservation Planning, at Incidental take permitting under section published a notice on January 22, 2001 the above address (Telephone 703/358– 10(a)(1)(B) of the ESA is one such area. (66 FR 6483), that affirmed the 2171, Facsimile 703/358–1735). On June 12, 1997 (62 FR 32189), we provisions of the June 17, 1999 (64 FR published proposed revisions to our SUPPLEMENTARY INFORMATION: This 32706), final rule, including the Permit general permitting regulations in 50 CFR notice of proposed rulemaking applies Revocation Rule. part 13 to identify, among other things, to the U.S. Fish and Wildlife Service the situations in which the permit The ‘‘No Surprises’’ Rule Litigation and only. Therefore, the use of the terms provisions in part 13 would not apply the Order To Vacate the Permit ‘‘Service’’ and ‘‘we’’ in this notice refers to individual incidental take permits. Revocation Rule exclusively to the U.S. Fish and Wildlife On June 17, 1999 (64 FR 32706), we On February 23, 1998 (63 FR 8859), Service. the Service and the National Marine This proposed rule applies only to 50 published a final set of regulations that Fisheries Service jointly promulgated CFR 17.22(b) and 17.32(b), which included two provisions that relate to revocation of incidental take permits. the so-called No Surprises Rule, which pertain to incidental take permits. The first provides that the general provides certainty to holders of Regulations in 50 CFR 17.22(c) and revocation standard in 50 CFR incidental take permits by placing limits 17.32(c) that pertain to Safe Harbor 13.28(a)(5) will not apply to several on the agencies’ ability to require Agreements (SHAs) and in 50 CFR types of ESA permits, including additional mitigation after an incidental 17.22(d) and 17.32(d) that pertain to incidental take permits. The second take permit has been issued. The No Candidate Conservation Agreements provision, hereafter referred to as the Surprises Rule is codified by the Service with Assurances (CCAAs) are not Permit Revocation Rule, described at 50 CFR 17.22(b)(5) (endangered affected by this proposed rule. circumstances under which incidental species) and 17.32(b)(5) (threatened Background take permits could be revoked. On species) and by the National Marine September 30, 1999 (64 FR 52676), we Fisheries Service at 50 CFR 222.307(g). Promulgation of the ‘‘Permit Revocation published a correction to the regulations For both agencies, the No Surprises Rule Rule’’ promulgated in our June 17, 1999 (64 FR was added to pre-existing regulations The Service administers a variety of 32706), final rule; however, the pertaining to incidental take permits. conservation laws that authorize the correction was not associated with In July 1998, a group of issuance of permits for otherwise permit revocation. environmental plaintiffs challenged the prohibited activities. In 1974, we The Permit Revocation Rule, which No Surprises Rule in Spirit of the Sage published 50 CFR part 13 to consolidate was codified at 50 CFR 17.22(b)(8) Council v. Norton, Civil Action No. 98– the administration of various permitting (endangered species) and 17.32(b)(8) 1873 (D. D.C.). After the Service programs. Part 13 established a uniform (threatened species), provided that an promulgated the Permit Revocation Rule framework of general administrative incidental take permit ‘‘may not be on June 17, 1999 (64 FR 32706), the conditions and procedures that would revoked * * * unless continuation of government referred to that rule in its govern the application, processing, and the permitted activity would be briefs in the No Surprises Rule case to issuance of all Service permits. We inconsistent with the criterion set forth demonstrate that the agencies retained intended the general part 13 permitting in 16 U.S.C. 1539(a)(2)(B)(iv) and the the ability to revoke incidental take provisions to be in addition to, and not inconsistency has not been remedied in permits notwithstanding the assurances in lieu of, other more specific permitting a timely fashion.’’ The criterion in in the No Surprises Rule. The plaintiffs requirements of Federal wildlife laws. section 10(a)(2)(B)(iv) of the ESA (16 subsequently amended their complaint We subsequently added many wildlife U.S.C. 1539(a)(2)(B)(iv)) that ‘‘the taking to challenge the Permit Revocation Rule. regulatory programs to title 50 of the will not appreciably reduce the On December 11, 2003, the court CFR. For example, we added part 18 in likelihood of the survival and recovery ruled that the public notice and 1974 to implement the Marine Mammal of the species in the wild’’ is one of the comment procedures followed by the Protection Act; modified and expanded statutory criteria that incidental take Service when promulgating the Permit part 17 in 1975 to implement the permit applicants must meet in order to Revocation Rule were in violation of the Endangered Species Act of 1973; and obtain a permit. The criterion is APA. The court vacated and remanded added part 23 in 1977 to implement the substantively identical to the definition the Permit Revocation Rule to the Convention on International Trade in of ‘‘jeopardize the continued existence Service for further consideration Endangered Species of Wild Fauna and of’’ in the joint Department of the consistent with section 553 of the APA.

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The court did not rule on the validity commenters strongly opposed any (5) Is the description of the rule in the of the No Surprises Rule, but found that further expansion of the revocation SUPPLEMENTARY INFORMATION section of the Permit Revocation Rule is relevant provision and suggested further the preamble helpful in understanding to the court’s review of the No Surprises expansion would be contrary to the rule? Rule. The court, therefore, ordered the congressional intent. A number of (6) What else could we do to make the Service to consider the No Surprises commenters requested that the Service rule easier to understand? Rule together with the Permit reaffirm the principles of No Surprises Send a copy of any comments that Revocation Rule in any new rulemaking and noted that revocation should be ‘‘an concern how we could make this rule proceedings concerning revocation of action of last resort.’’ Another easier to understand to: Office of incidental take permits containing No commenter requested that we limit Regulatory Affairs, Department of the Surprises assurances. revocation to instances where the Interior, Room 7229, 1849 C Street, We are taking two rulemaking actions permittee is not in compliance with the NW., Washington, DC 20240. in response to the court order. First, in permit or, at a minimum, add to the Regulatory Planning and Review the Rules and Regulations section of revocation provision a statement to today’s Federal Register is a final rule indicate that the burden is on the In accordance with Executive Order withdrawing the permit revocation agency to establish that the conditions 12866, this document is a significant regulations, 50 CFR 17.22(b)(8) and for revocation exist. proposed rule because it may raise 17.32(b)(8), vacated by the court order. novel legal or policy issues, and was Second, in this notice we request public Request for Public Comments reviewed by the Office of Management comments on our proposal to reestablish This notice seeks public comment on and Budget (OMB) in accordance with the permit revocation regulations the our proposal to reestablish the Permit the four criteria discussed below. court vacated. Revocation Rule as originally (a) This proposed rule will not have promulgated in June 1999. We an annual economic effect of $100 Summary of Previously Received specifically invite public comment on million or more or adversely affect an Comments the following issues: economic sector, productivity, jobs, the The following are comments we 1. The proposal to reestablish the environment, or other units of previously received on the Permit Permit Revocation Rule. This rule government. Revocation Rule; we will address these would allow the Service to revoke an (b) This proposed rule is not expected and other relevant issues in our final incidental take permit as a last resort in to create inconsistencies with other decision regarding this proposal. We the unexpected and unlikely situation agencies’ actions. These regulations received numerous comments on the in which continuation of the permitted would amend potentially conflicting provisions addressing permit activities would likely jeopardize the permitting regulations established for a revocation. The comments ranged continued existence of a species covered voluntary program, Habitat widely, but generally fell into two by the permit and the Service is not able Conservation Planning, for non-Federal categories: The agency did not go far to remedy the situation through other property owners and would not create enough with the revocation provision means in a timely fashion. inconsistencies with the actions of non- and the agency went too far with the 2. The interrelationship of the Permit Federal agencies. revocation provision. With respect to Revocation Rule and the No Surprises (c) This regulation is not expected to comments that the revocation provision Rule, including whether the revocation significantly affect entitlements, grants, did not go far enough, many of the standard in the Permit Revocation Rule user fees, loan programs, or the rights commenters stated that they did not see is appropriate in light of the regulatory and obligations of their recipients. any reason why the old provision in assurances contained in the No (d) OMB has determined that this rule § 13.28(a) should be replaced with a Surprises Rule. may raise novel legal or policy issues standard they viewed as less protective. 3. Whether the revocation standard in and, as a result, this rule has undergone These commenters also stated that the 50 CFR 13.28(a)(5) or some other OMB review. The proposed rule is a revocation provision should have revocation standard would be more direct response to a previous legal mandatory language like the word appropriate for incidental take permits challenge. ‘‘shall’’ to indicate that revocation is not with No Surprises assurances. Regulatory Flexibility Act discretionary. Many commenters Required Determinations questioned why the Service should have Under the Regulatory Flexibility Act to step in at public expense to remedy Executive Order 12866 (5 U.S.C. 601 et seq., as amended by the jeopardy situations before a permit can Executive Order 12866 requires each Small Business Regulatory Enforcement be revoked. Some questioned what the agency to write regulations that are easy Fairness Act (SBREFA) of 1996), standard ‘‘in a timely fashion’’ means. to understand. We invite your whenever an agency is required to One commenter suggested that the comments on how to make this rule publish a notice of rulemaking for any revocation provision should also easier to understand, including answers proposed or final rule, it must prepare contain a reference to adverse to questions such as the following: and make available for public comment modification of critical habitat, while (1) Are the requirements in the rule a regulatory flexibility analysis that another commenter recommended that clearly stated? describes the effect of the rule on small the word ‘‘jeopardy’’ be used instead of (2) Does the rule contain technical entities (i.e., small businesses, small ‘‘appreciable reduction in the likelihood language or jargon that interferes with organizations, and small government of survival and recovery’’ because the its clarity? jurisdictions), unless the agency commenter viewed ‘‘jeopardy’’ to be a (3) Does the format of the rule certifies that the rule will not have a higher standard. (grouping and order of sections, use of significant economic impact on a With respect to comments expressing headings, paragraphing, etc.,) aid or substantial number of small entities. concern that the Service has gone too reduce its clarity? The Regulatory Flexibility Act requires far, a number of commenters stated that (4) Would the rule be easier to Federal agencies to provide a statement the revocation provision undermined understand if it were divided into more of the factual basis for certifying that a the No Surprises Rule. These (but shorter) sections? rule will not have a significant

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economic impact on a substantial additional information will be required under the Department’s NEPA number of small entities. from a non-Federal entity solely as a procedures in 516 DM 2, Appendix Pursuant to the Regulatory Flexibility result of the proposed rule. These 1.10. Act, we certified to the Small Business regulations implement a voluntary Government-to-Government Administration that these regulations program; no incremental costs are being Relationship With Indian Tribes would not have a significant economic imposed on non-Federal landowners. impact on a substantial number of small (b) These regulations will not produce In accordance with the Secretarial entities. The proposed changes clarify a Federal mandate of $100 million or Order 3206, ‘‘American Indian Tribal the circumstances under which an greater in any year; that is, this rule is Rights, Federal-Tribal Trust incidental take permit issued under the not a ‘‘significant regulatory action’’ Responsibilities, and the Endangered authority of section 10(a)(1)(B) of the under the Unfunded Mandates Reform Species Act’’ (June 5, 1997); the Endangered Species Act might be Act. President’s memorandum of April 29, subject to revocation. As of February 29, Takings 1994, ‘‘Government-to-Government 2004, the Service has issued 327 Relations with Native American Tribal incidental take permits, and none have In accordance with Executive Order Governments’’ (59 FR 22951); E.O. required revocation. As identified in the 12630, these regulations do not have 13175; and the Department of the preamble, the specific circumstances significant takings implications Interior’s Manual at 512 DM 2, we under which the proposed regulations concerning taking of private property by understand that we must relate to would provide for revocation are the Federal Government. These recognized Federal Indian Tribes on a expected to be extraordinarily rare. regulations pertain to a voluntary Government-to-Government basis. program that does not require However, these regulations pertain to Small Business Regulatory Enforcement individuals to participate unless they Fairness Act voluntary agreements, Habitat volunteer to do so. Therefore, these Conservation Plans, in which Tribes and This regulation will not be a major regulations have no impact on personal individuals are not required to rule under 5 U.S.C. 801 et seq., the property rights. participate unless they volunteer to do Small Business Regulatory Enforcement Federalism so. Therefore, these regulations may Fairness Act. have effects on Tribal resources and (a) This regulation would not produce These regulations will not have Native American Tribes, but solely at an annual economic effect of $100 substantial direct effects on the States, their discretion, should those Tribes or million. in the relationship between the Federal individuals choose to participate in the (b) This regulation would not cause a Government and the States, or on the voluntary program. major increase in costs or prices for distribution of power and consumers, individual industries, responsibilities among various levels of List of Subjects in 50 CFR Part 17 Federal, State, or local government government. Therefore, in accordance Endangered and threatened species, agencies, or geographic regions. with Executive Order 13132, the Service Exports, Imports, Reporting and (c) This regulation would not have a has determined that this rule does not recordkeeping requirements, significant adverse effect on have sufficient federalism implications Transportation. competition, employment, investment, to warrant a Federalism Assessment. productivity, innovation, or the ability Proposed Regulation Promulgation of U.S.-based enterprises to compete Civil Justice Reform For the reasons set out in the with foreign-based enterprises. In accordance with Executive Order 12988, the Department of the Interior preamble, we propose to amend title 50, Executive Order 13211 has determined that this proposed rule chapter I, subchapter B of the Code of On May 18, 2001, the President issued does not unduly burden the judicial Federal Regulations, as set forth below. an Executive Order (E.O. 13211) on system and meets the applicable PART 17—[AMENDED] regulations that significantly affect standards provided in sections 3(a) and energy supply, distribution, and use. 3(b)(2) of the Order. 1. The authority citation for part 17 Executive Order 13211 requires agencies continues to read as follows: to prepare Statements of Energy Effects Paperwork Reduction Act when undertaking certain actions. This rule would not impose any new Authority: 16 U.S.C. 1361–1407; 16 U.S.C. Although this rule is a significant action requirements for collection of 1531–1544; 16 U.S.C. 4201–4245; Pub. L. 99– 625, 100 Stat. 3500; unless otherwise noted. under Executive Order 12866, it is not information associated with incidental expected to significantly affect energy take permits other than those already 2. Amend § 17.22 by adding a new supplies, distribution, or use. Therefore, approved for incidental take permits paragraph (b)(8) to read as follows: this action is not a significant energy under the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). This rule will not § 17.22 Permits for scientific purposes, action and no Statement of Energy enhancement of propagation or survival, or Effects is required. impose new recordkeeping or reporting for incidental taking. requirements on State or local Unfunded Mandates Reform Act governments, individuals, businesses, or * * * * * In accordance with the Unfunded organizations. We may not conduct or (b) * * * Mandates Reform Act (2 U.S.C. 1501 et sponsor, and a person is not required to (8) Criteria for revocation. A permit seq.): respond to, a collection of information issued under paragraph (b) of this (a) The Service has determined and unless it displays a currently valid OMB section may not be revoked for any certifies pursuant to the Unfunded Control Number. reason except those set forth in Mandates Reform Act, 2 U.S.C. 1502 et § 13.28(a)(1) through (4) of this seq., that this proposed rulemaking will National Environmental Policy Act subchapter or unless continuation of the not impose a cost of $100 million or The Department of the Interior has permitted activity would be inconsistent more in any given year on local or State determined that the issuance of the with the criterion set forth in 16 U.S.C. governments or private entities. No proposed rule is categorically excluded 1539(a)(2)(B)(iv) and the inconsistency

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has not been remedied in a timely (8) Criteria for revocation. A permit has not been remedied in a timely fashion. issued under paragraph (b) of this fashion. * * * * * section may not be revoked for any * * * * * reason except those set forth in 3. Amend § 17.32 by adding a new Dated: April 12, 2004. § 13.28(a)(1) through (4) of this paragraph (b)(8) to read as follows: Craig Manson, subchapter or unless continuation of the Assistant Secretary for Fish and Wildlife and § 17.32 Permits—general. permitted activity would be inconsistent Parks. * * * * * with the criterion set forth in 16 U.S.C. 1539(a)(2)(B)(iv) and the inconsistency [FR Doc. 04–11741 Filed 5–24–04; 8:45 am] (b) * * * BILLING CODE 4310–55–P

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Notices Federal Register Vol. 69, No. 101

Tuesday, May 25, 2004

This section of the FEDERAL REGISTER wild fires that occurred in southern allowed period set out in this notice are contains documents other than rules or California. received, and the available funds are proposed rules that are applicable to the DATES: Applications by eligible persons less than the eligible claims, a proration public. Notices of hearings and investigations, will be made. Claims are limited to the committee meetings, agency decisions and may be submitted April 19, 2004 rulings, delegations of authority, filing of through May 28, 2004, or such other lesser of the established practice rates or petitions and applications and agency date as announced by the Deputy 75 percent of actual costs for eligible statements of organization and functions are Administrator for Farm Programs of the replantings after adjusting for normal examples of documents appearing in this Farm Service Agency (FSA). mortality. Reimbursement for those section. FOR FURTHER INFORMATION CONTACT: plantings cannot exceed the reasonable Eloise Taylor, Chief, Compliance cost of those replantings as determined Branch, Production, Emergencies and by FSA. In addition, under current law, AGENCY FOR INTERNATIONAL Compliance Divisions, FSA/USDA, Stop no ‘‘person’’ as defined by reference to DEVELOPMENT 0517, 1400 Independence Avenue SW., program regulations can receive, Advisory Committee on Voluntary Washington, DC 20250–0517; telephone cumulatively, for all TAP claims over Foreign Aid; Notice of Meeting (202) 720–9882; e-mail: the life of the program as administered [email protected]. and http:/ pursuant to the general authority of the Pursuant to the Federal Advisory /www.regulations.gov. Persons with 2002 Act, a total of $75,000. Also, and Committee Act, notice is hereby given of disabilities who require alternative cumulatively, no person for all TAP a meeting of the Advisory Committee on means for communication of regulatory claims for all commodities over the life Voluntary Foreign Aid (ACVFA). information, (Braille, large print, of the administration of the program audiotape, etc. should contact USDA’s Date: June 23, 2004 (8:30 a.m. to 1 p.m.). can, under current law, receive benefits Location: The Hilton Washington, 1919 TARGET Center at (202) 720–2600 for losses on more than 500 acres. All (voice and TDD). Connecticut Avenue, NW., Washington, DC other restrictions of the TAP regulations 20009. SUPPLEMENTARY INFORMATION: and statute apply as well. Other This meeting will feature discussion on requirements may also apply. development and humanitarian assistance Background lessons learned in post-conflict and TAP was authorized but not funded Applications reconstruction. A session with Millennium by section 10201 of the Farm Security Challenge Corporation CEO Paul Applegarth and Rural Investment Act of 2002 (Pub. Applications will be accepted until will also take place. Participants will have an L. 107–171) (7 U.S.C. 8201) to provide May 28, 2004, or such other date as opportunity to ask questions of the speakers assistance to eligible orchardists to announced by the Deputy Administrator and participate in the discussion. The meeting is free and open to the public. replant trees, bushes and vines that for Farm Programs of FSA. Only Persons wishing to attend the meeting can were grown for the production of an producers with losses in eligible register online at http://www.ACVFA.com or annual crop and were lost due to a counties in California may file an e-mail their name to Ashley Mattison at natural disaster. This notice sets out a application. The counties are Los [email protected]. special program within TAP for certain Angeles, Riverside, San Diego, and San Dated: May 13, 2004. fruit tree losses due to wild fires in Bernardino for 2003 wild fire losses. California. Section 102(e) of Division H Adele Liskov, of the Consolidated Appropriations Act, Application forms are available for Acting Executive Director, Advisory 2004 (Pub. L. 108–199) appropriated TAP at FSA county offices or on the Committee on Voluntary Foreign Aid Internet at www.fsa.usda.gov. A (ACVFA). $12,500,000 to provide assistance under TAP to compensate tree-fruit growers in complete application for TAP benefits [FR Doc. 04–11794 Filed 5–24–04; 8:45 am] those counties that suffered losses due and related supporting documentation BILLING CODE 6116–01–P to the wild fires that occurred in must be submitted to the county office southern California in the fall of 2003. before the deadline. Consistent with other subsections of the A complete application will include DEPARTMENT OF AGRICULTURE same legislation and what is understood all of the following: to be Congressional intent, assistance (1) A form provided by FSA; Farm Service Agency will be limited to four counties. (2) A written estimate of the number Notice of Funds Availability; Tree Assistance will be provided subject to regulations and restrictions governing of fruit trees lost or damaged which is Assistance Program for California Tree prepared by the owner or someone who Losses Due to Wild Fires the new TAP provided for in the 2002 Act. Those regulations were published is a qualified expert, as determined by AGENCY: Farm Service Agency, USDA. March 2, 2004 (69FR9744) and are the FSA county committee; ACTION: Notice. found at 7 CFR part 783. Also, the (3) The number of acres on which the restrictions of the statute apply. They loss was suffered; and SUMMARY: This notice announces the include a requirement of replanting, a availability of $12,500,000 for the Tree limitation on payments by ‘‘person’’, a (4) Sufficient evidence of the loss to Assistance Program (TAP) to limitation on acres for which relief can allow the county committee to calculate compensate tree-fruit growers in be claimed, a requirement that the loss whether an eligible loss occurred. disaster counties in California who had be tied to a natural disaster, and others. (5) Other information as requested or fruit tree losses as a result of the 2003 If after the claims filed during the required by regulation.

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Signed at Washington, DC April 27, 2004. Dated: May 20, 2004. Cooperative Forestry, Mail Stop Code Michael W. Yost, Raoul W. Gagne, 1123, 1400 Independence Avenue, SW., Acting Administrator, Farm Service Agency. Designated Federal Official, Davy Crockett Washington, DC 20250–0003; via National Forest RAC. [FR Doc. 04–11743 Filed 5–24–04; 8:45 am] electronic mail to [email protected]; or [FR Doc. 04–11808 Filed 5–24–04; 8:45 am] via facsimile to (202) 205–1271. BILLING CODE 3410–05–P BILLING CODE 3410–11–M Comments also may be submitted via the World Wide Web/Internet at http:/ DEPARTMENT OF AGRICULTURE /www.regulations.gov. The agency DEPARTMENT OF AGRICULTURE cannot confirm receipt of comments. All Forest Service comments, including names and Forest Service addresses when provided, are placed in Notice of Public Meeting, Davy RIN 0596–AC19 the record and are available for public Crockett National Forest Resource inspection and copying. The public may Advisory Committee Meeting Tribal Watershed Forestry Assistance inspect comments during regular Program business hours at the office of the Cooperative Forestry Staff, 4th Floor AGENCY: Forest Service, Agriculture. AGENCY: Forest Service, USDA. SE., Yates Building, 201 14th Street, ACTION: ACTION: Notice of public meeting. Advanced notice of interim final SW., Washington, DC. Visitors are guideline; request for comment. encouraged to call ahead to (202) 205– SUMMARY: In accordance with the Secure SUMMARY: The Forest Service is 1389 to facilitate entry into the building. Rural Schools and Community Self announcing its intent to prepare an FOR FURTHER INFORMATION CONTACT: Determination Act of 2000 (Pub. L. 106– interim final guideline, in cooperation Karen Solari, USDA Forest Service, 393) and the Federal Advisory with Indian tribes, for the Tribal Cooperative Forestry, (202) 205–1274, or Committee Act of 1972 (FACA), the U.S. Watershed Forestry Assistance Program, Susan Johnson, USDA Forest Service, Department of Agriculture, Forest as authorized by Title III, Section 303, Office of Tribal Relations, Service, Davy Crockett National Forest of the Healthy Forests Restoration Act of [email protected], (303)275–5760. Resource Advisory Committee (RAC) 2003 (Pub. L. 108–148). The Tribal SUPPLEMENTARY INFORMATION: The Tribal will meet as indicated below. Watershed Forestry Assistance Program Watershed Forestry Assistance Program (TWFAP) is administered by the Forest DATES: The Davy Crockett National (TWFAP) is established in the Healthy Service and implemented by Forest RAC meeting will be held June Forests Restoration Act of 2003 to participating Indian tribes. The purpose 24, 2004. provide technical, financial, and related of the TWFAP is to build and strengthen assistance to Indian tribes for the ADDRESSES: The Davy Crockett National watershed partnerships that focus on purpose of expanding tribal stewardship Forest RAC meeting will be held at the forested landscapes at the State, capacities and activities through tribal Davy Crockett Ranger Station located on regional, tribal, and local levels; to forestry best-management practices and State Highway 7, approximately one provide tribal forestry best-management other means at the tribal level to address quarter mile west of FM 227 in Houston practices and water quality technical watershed issues on land under the County, Texas. The meeting will begin assistance directly to Indian tribes; to jurisdiction of or administered by the at 6 p.m. and adjourn at approximately provide technical guidance to tribal Indian tribes. A copy of the Healthy 9 p.m. A public comment period will be land managers and policy makers for Forests Restoration Act of 2003, Title III, at 8:45 p.m. water quality protection through forest and other information on the watershed management; to complement tribal forestry program can be found at: http:/ FOR FURTHER INFORMATION CONTACT: efforts to protect water quality and /www.fs.fed.us/cooperativeforestry/ Raoul Gagne, District Ranger, Davy provide enhanced opportunities for programs/wfa/. The TWFAP provides Crockett National Forest, Rt. 1, Box 55 consultation and cooperation among for (1) Development a program of FS, Kennard, Texas 75847: Telephone: Federal agencies and tribal entities technical assistance; (2) Annual awards 936–655–2299 or e-mail at: charged with responsibility for water to participating tribes for watershed [email protected]. and watershed management; and to forestry projects; (3) Selection of priority provide enhanced forest resource data watersheds to target watershed forestry SUPPLEMENTARY INFORMATION: The Davy and support for improved projects for funding; and (4) An Crockett National Forest RAC proposes implementation and monitoring of tribal opportunity to create tribal watershed projects and funding to the Secretary of forestry best-management practices. In forester positions. At a minimum, the Agriculture under section 203 of the accordance with Forest Service policy, TWFAP interim final guideline will Secure Rural Schools and Community formal consultation is ongoing with address these provisions. Self Determination Act of 2000. The Indian tribes on development of this In addition, the TWFAP interim final purpose of the June 24, 2004 meeting is new program. This notice supplements guideline will establish the criteria that to introduce the RAC members, discuss the consultation process. Comments are Indian tribes should follow in the operational requirements of the invited and will be considered in the implementing the TWFAP. These will RAC, and elect a chairperson. These development of the interim final include criteria for priority watershed meetings are open to the public. The guideline. Additional direction on the selection, acceptable watershed forest public may present written comments to implementation of TWFAP will be projects, and best management practice the RAC. Each formal RAC meeting will issued to the Forest Service Manual programs. The guideline also will also have time, as identified above, Chapter 3500, Cooperative Watershed establish monitoring and allocated for hearing public comments. Management. accomplishment reporting Depending on the number of persons DATES: Comments must be received by requirements. The guideline will, to the wishing to comment and time available, July 26, 2004. extent consistent with Federal the time for individual oral comments ADDRESSES: Send written comments to accountability and oversight may be limited. Karen Solari, USDA Forest Service, responsibility, allow flexibility to the

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tribes to implement the program in a to forest management, protection, and allocation procedures and monitoring manner consistent with local needs and conservation. Public comment is invited and accomplishment reporting opportunities. Comments are solicited and will be considered in the requirements. The guideline will, to the on these provisions and other issues development of the interim final extent consistent with Federal that should be included in the interim guideline. Additional direction on the accountability and oversight final guideline. implementation of WFAP will be issued responsibility, allow flexibility to the The interim final guideline and to the Forest Service Manual Chapter States to implement the program in a additional direction issued to Forest 3500, Cooperative Watershed manner consistent with local needs and Service Manual 3500 will be developed Management. opportunities. Comments are solicited by a workgroup of representatives from DATES: Comments must be received by on these provisions and other issues Indian tribes, and regional and national July 26, 2004. that should be included in the interim Forest Service State and Private ADDRESSES: Send written comments to final guideline. Forestry. Karen Solari, USDA Forest Service, The interim final guideline and The agency goal is to publish a notice Cooperative Forestry, Mail Stop Code additional direction issued to Forest of issuance of the interim final guideline 1123, 1400 Independence Avenue, SW., Service Manual 3500 will be developed with request for further comment in the Washington, DC 20250–0003; via by a workgroup of representatives from Federal Register by October, 2004. A electronic mail to [email protected]; or State forestry agencies and regional and separate advance notice of an interim via facsimile to (202) 205–1271. national Forest Service State and Private final guideline for the Watershed Comments also may be submitted via Forestry offices and USDA Cooperative Forestry Assistance Program, to be the World Wide Web/Internet at http:/ State Research Education and Extension developed in cooperation with State /www.regulations.gov. The agency Service. Foresters, has been published in today’s cannot confirm receipt of comments. All The agency goal is to publish a notice Federal Register. comments, including names and of issuance of the interim final guideline Dated: May 6, 2004. addresses when provided, are placed in with request for further comment in the Sally D. Collins, the record and are available for public Federal Register by October 2004. A separate notice of an interim final Associate Chief. inspection and copying. The public may guideline for the Tribal Watershed [FR Doc. 04–11735 Filed 5–24–04; 8:45 am] inspect comments during regular business hours at the office of the Forestry Assistance Program, to be BILLING CODE 3410–11–P Cooperative Forestry Staff, 4th Floor developed in cooperation with Indian SE., Yates Building, 201 14th Street, tribes, has been published in today’s Federal Register. DEPARTMENT OF AGRICULTURE SW., Washington, DC. Visitors are encouraged to call ahead to (202) 205– Dated: May 6, 2004. Forest Service 1389 to facilitate entry into the building. Sally Collins, FOR FURTHER INFORMATION CONTACT: RIN 0596–AC18 Associate Chief. Karen Solari, USDA Forest Service, [FR Doc. 04–11734 Filed 5–24–04; 8:45 am] Cooperative Forestry, (202) 205–1274. Watershed Forestry Assistance BILLING CODE 3410–11–P Program SUPPLEMENTARY INFORMATION: The Watershed Forestry Assistance Program AGENCY: Forest Service, USDA. (WFAP) is established in the Healthy COMMISSION ON CIVIL RIGHTS ACTION: Advanced notice of interim final Forests Restoration Act of 2003 to guideline; request for comment. address watershed issues on nonfederal Agenda and Notice of Public Meeting forested and potentially forested land. A of the Pennsylvania Advisory SUMMARY: The Forest Service is copy of the Healthy Forests Restoration Committee announcing its intent to prepare an Act of 2003, Title III, and other interim final guideline, in cooperation information on the watershed forestry Notice is hereby given, pursuant to with the State Foresters and with program can be found at: http:// the provisions of the rules and involvement of the public, for the www.fs.fed.us/cooperativeforestry/ regulations of the U.S. Commission on implementation of the Watershed programs/wfa/. The WFAP provides for Civil Rights that a conference call of the Forestry Assistance Program, as (1) development of a program of Pennsylvania Advisory Committee will authorized by Title III, section 302, of technical assistance; (2) establishment convene at 1 p.m. and adjourn at 2 p.m. the Healthy Forests Restoration Act of of a watershed forestry cost-share on May 26, 2004. The purpose of the 2003 (Pub. L. 108–148). The Watershed program; (3) creation of State watershed conference call is to discuss future Forestry Assistance Program (WFAP) is forester positions; and (4) selection of projects. administered by the Forest Service and priority watersheds by the state forest This conference call is available to the implemented by the State Foresters, or stewardship coordinating committees. public through the following call-in an equivalent State official. The purpose At a minimum, the WFAP interim final number: 1–800–659–1088, access code: of the WFAP is to improve public guideline will address these provisions. 23863133. Any interested member of the understanding of the connection In addition, the WFAP interim final public may call this number and listen between forest management and guideline will establish the criteria that to the meeting. Callers can expect to watershed health; encourage property State Foresters and communities, incur charges for calls not initiated owners to maintain tree cover and use nonprofit groups, and owners of using the supplied call-in number or tree plantings and vegetative treatments nonindustrial private forest land should over wireless lines, and the Commission as creative solutions to watershed follow in implementing the WFAP. will not refund any incurred charges. problems; enhance forest management These will include criteria for priority Callers will incur no charge for calls and riparian buffer use in watersheds, watershed selection, acceptable using the call-in number over land-line with an emphasis on community watershed forest projects, and best connections. Persons with hearing watersheds; and establish partnerships management practice programs. The impairments may also follow the and collaborative watershed approaches guideline also will establish budget proceedings by first calling the Federal

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Relay Service at 1–800–977–8339 and Dated at Washington, DC, May 14, 2004. ACTION: Notice of consideration and providing the Service with the Ivy L. Davis, request for comments. conference call number and access code Chief, Regional Programs Coordination Unit. number. [FR Doc. 04–11713 Filed 5–24–04; 8:45 am] SUMMARY: The Bureau of the Census (Census Bureau) plans to reduce the To ensure that the Commission BILLING CODE 6335–01–P number of individual 6-digit North secures an appropriate number of lines American Industry Classification for the public, persons are asked to COMMISSION ON CIVIL RIGHTS System (NAICS) industries for which register by contacting Barbara de La the Annual Survey of Manufacturers Viez of the Eastern Regional Office, Agenda and Notice of Public Meeting (ASM) estimates are published. We will 202–376–7533 (TTY 202–375–8116), by of the Alabama, Arkansas, Louisiana continue to publish estimates for all 4 p.m. on Monday May 24, 2004. and Mississippi Advisory Committees manufacturing industries at higher The meeting will be conducted levels of industry aggregation. By doing pursuant to the provisions of the rules Notice is hereby given, pursuant to this, we hope to improve the timeliness and regulations of the Commission. the provisions of the rules and of the estimates we produce as well as regulations of the U.S. Commission on Dated at Washington, DC, May 14, 2004. enhance the reliability and relevance of Civil Rights, that a conference call of the variables we collect. Ivy L. Davis, Alabama, Arkansas, Louisiana and We are replacing the current 473 6- Chief, Regional Programs Coordination Unit. Mississippi Advisory Committees will digit NAICS industries with a new list [FR Doc. 04–11712 Filed 5–24–04; 8:45 am] convene at 1:30 p.m. and adjourn at 3 of 318 ASM industries, which will p.m. (CDT) on Thursday, June 10, 2004. BILLING CODE 6335–01–P include selected 6-digit NAICS The purpose of the conference call is to industries and other industries defined discuss and plan future SAC activities as groups of the 6-digit NAICS COMMISSION ON CIVIL RIGHTS and conduct a public briefing meeting. industries. Six-digit industries are the This conference call is available to the most detailed defined by the NAICS. Agenda and Notice of Public Meeting public through the following call-in The lists of present and proposed of the Rhode Island Advisory number: 1–888–777–0937, access code industries along with the concordance Committee #23714062. Any interested member of are available on our Web site at http:/ the public may call this number and /www.census.gov/mcd/asmchange/. Notice is hereby given, pursuant to listen to the meeting. Callers can expect DATES: the provisions of the rules and to incur charges for calls not initiated Written comments on this notice regulations of the U.S. Commission on using the supplied call-in number or must be submitted on or before June 24, 2004. Civil Rights, that a conference call of the over wireless lines and the Commission Rhode Island Advisory Committee will will not refund any incurred charges. ADDRESSES: Direct all written comments convene at 1 p.m. and adjourn at 2 p.m. Callers will incur no charge for calls to the Director, U.S. Census Bureau, on Thursday, June 3, 2004. The purpose using the call-in number over land-line Room 2049, Federal Building 3, of the conference call is to discuss and connections. Persons with hearing Washington, DC 20233. plan future projects. impairments may also follow the FOR FURTHER INFORMATION CONTACT: Judy proceedings by first calling the Federal M. Dodds, Assistant Division Chief, This conference call is available to the Relay Service at 1–800–977–8339 and public through the following call-in Census and Related Programs, providing the Service with the Manufacturing and Construction number: 1–800–659–1081, access code conference call number and access code. number: 23626539. Any interested Division, on (301) 763–4587 or by e- To ensure that the Commission mail at [email protected]. member of the public may call this secures an appropriate number of lines SUPPLEMENTARY INFORMATION: number and listen to the meeting. for the public, persons are asked to The Callers can expect to incur charges for register by contacting Corrine Sanders of Census Bureau is authorized to conduct calls not initiated using the supplied the Central Regional Office 913–551– surveys necessary to furnish current call-in number or over wireless lines, 1400 (TDD 913–551–1414), by 3 p.m. on data on subjects covered by the major and the Commission will not refund any Friday, June 4, 2004. censuses authorized by title 13, United incurred charges. Callers will incur no The meeting will be conducted States Code (U.S.C.), sections 182, 224, charge for calls using the call-in number pursuant to the provisions of the rules and 225. Reporting by ASM over land-line connections. Persons and regulations of the Commission. establishments will continue to be with hearing impairments may also mandatory and provide continuing and Dated at Washington, DC, May 14, 2004. follow the proceedings by first calling timely national statistical data on the Ivy L. Davis, the Federal Relay Service at 1–800–977– manufacturing sector. Data collected in 8339 and providing the Service with the Chief, Regional Programs Coordination Unit. this survey will be within the general conference call number and access code [FR Doc. 04–11711 Filed 5–24–04; 8:45 am] scope, type, and character of those number. BILLING CODE 6335–01–P inquiries covered in the Economic Census. To ensure that the Commission The ASM collects industry statistics, secures an appropriate number of lines DEPARTMENT OF COMMERCE such as total value of shipments, for the public, persons are asked to employment, payroll, workers’ hours, register by contacting Barbara de La Bureau of the Census capital expenditures, cost of materials Viez of the Eastern Regional Office, consumed, supplemental labor costs, 202–376–7533 (TTY 202–375–8116), by [Docket Number 040510146–4146–01] and so forth. This survey, conducted on 4 p.m. on Wednesday, June 2, 2004. Annual Survey of Manufacturers a sample basis, covers all manufacturing The meeting will be conducted industries, including data on plants pursuant to the provisions of the rules AGENCY: Bureau of the Census, under construction, but not yet in and regulations of the Commission. Commerce. operation.

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Beginning with the survey year 2003, DEPARTMENT OF COMMERCE vacuum, with high and low energy the Census Bureau plans to reduce the electrons, (2) ability to work with both number of detailed industries for which International Trade Administration thick and thin samples and (3) laser the ASM estimates are published. interferometer capability. Advice Case Western Reserve University, et Reducing the level of detail for which received from: Sandia National al.; Notice of Consolidated Decision on characteristics are estimated will allow Laboratories, February 12, 2004 Applications for Duty-Free Entry of (comparable case). the Census Bureau to focus resources on Scientific Instruments improving other aspects of the ASM Docket Number: 04–009. Applicant: program. We believe that this reduction This is a decision consolidated University of Colorado, Boulder, CO 80303. Instrument: Cryogenic Fabry- in ASM detail will not have a pursuant to section 6(c) of the Perot Etalon Controller (accessory). substantial adverse impact upon the Educational, Scientific, and Cultural Manufacturer: IC Optical Systems Ltd., public. While some industry detail will Materials Importation Act of 1966 (Pub. L. 89–651, 80 Stat. 897; 15 CFR part United Kingdom. Reasons: This is a be lost for ASM, similar data for some compatible accessory for an existing of the variables are available from other 301). Related records can be viewed between 8:30 a.m. and 5 p.m. in Suite instrument purchased for use by the sources, such as County Business applicant. It is pertinent to the intended Patterns or programs of the Bureau of 4100W, Franklin Court Building, U.S. Department of Commerce, 1099 14th uses and we know of no domestic Labor Statistics. The ASM is conducted accessory which can be readily adapted as a mail-out/mail-back survey. No Street, NW., Washington, DC. Comments: None received. Decision: to the previously imported foreign changes in the collection of information Approved. No instrument of equivalent instrument. are planned as a result of this proposal. scientific value to the foreign The capabilities of each of the foreign Published estimates from the ASM are instruments described below, for such instruments described above are used by a variety of private business and purposes as each is intended to be used, pertinent to each applicant’s intended trade associations. They provide various is being manufactured in the United purposes and we know of no other governmental agencies with a tool to States. instrument or apparatus being evaluate economic policy and to Docket Number: 03–053. Applicant: manufactured in the United States which is of equivalent scientific value to measure progress toward established Case Western Reserve University, any of the foreign instruments. goals. For example, Bureau of Economic Cleveland, OH 44106. Instrument: Analysis staff use data to develop Scanning Near-Field Optical Gerald A. Zerdy, nonresidential fixed investment Microscope, Model ALPHASNOM. Program Manager, Statutory Import Programs components of gross private domestic Manufacturer: WITEC, Germany. Staff. investment in the gross domestic Intended Use: See notice at 69 FR [FR Doc. 04–11806 Filed 5–24–04; 8:45 am] product. The Federal Reserve Board 26074, May 11, 2004. Reasons: The BILLING CODE 3510–DS–P uses the data to estimate indexes of foreign instrument provides: (1) The production, which are presented to the ability to perform tapping mode AFM Board of Governors and have an impact imaging simultaneously with near field DEPARTMENT OF COMMERCE on monetary policy. imaging, (2) > 200 nm bandwidth in the illuminating light source without having International Trade Administration Paperwork Reduction Act to change the near-field aperture and (3) performance of reflection mode confocal The Jackson Laboratory; Notice of Notwithstanding any other provision microscopy using a range of upper Decision on Application for Duty-Free of law, no person is required to respond objectives. Advice received from: The Entry of Electron Microscope to, nor shall a person be subject to a National Institutes of Health, May 12, This decision is made pursuant to penalty for failure to comply with, a 2004. section 6(c) of the Educational, collection of information subject to Docket Number: 04–007. Applicant: Scientific, and Cultural Materials requirements of the Paperwork Argonne National Laboratory, Argonne, Importation Act of 1966 (Pub. L. 89– Reduction Act (PRA), unless that IL 60439. Instrument: UHV STM 651, 80 Stat. 897; 15 CFR part 301). collection of information displays a Microscope with cryostat. Related records can be viewed between current valid Office of Management and Manufacturer: Unisoku Scientific 8:30 a.m. and 5 p.m. in Suite 4100W, Budget (OMB) control number. In Instruments, Japan. Intended Use: See Franklin Court Building, U.S. accordance with the PRA, 44 U.S.C. notice at 69 FR 26074, May 11, 2004. Department of Commerce, 1099 14th chapter 35, the OMB approved the Reasons: The foreign instrument Street, NW., Washington, DC. current ASM under OMB Control provides: (1) An operating temperature Docket Number: 04–006. Applicant: ° Number 0607–0449. The total burden of 1.8 K, (2) in situ surface cleaving, (3) The Jackson Laboratory, Bar Harbor, ME hours associated with OMB Control double stage mechanical damping and 04609. Instrument: Electron Microscope, Number 0607–0449 are 187,000 hours. (4) a magnetic field to 7.0 Tesla. Advice Model JEM–1230 (HC). Manufacturer: We will provide copies of each form received from: The National Institute of JEOL Ltd., Japan. Intended use: See upon written request to the Director, Standards and Technology, May 17, notice at 69 FR 26074, May 11, 2004. 2004. U.S. Census Bureau, Washington, DC Order Date: December 30, 2003. Docket Number: 04–008. Applicant: Comments: None received. Decision: 20233–0001. California Institute of Technology, Approved. No instrument of equivalent Dated: May 19, 2004. Pasadena, CA 91125. Instrument: Dual scientific value to the foreign Charles Louis Kincannon, Beam SEM/FIB System, Model Nova instrument, for such purposes as the Director, Bureau of the Census. 600 Nanolab. Manufacturer: FEI instrument is intended to be used, was [FR Doc. 04–11763 Filed 5–24–04; 8:45 am] Company, the Netherlands. Intended being manufactured in the United States Use: See notice at 69 FR 26074, May 11, at the time the instrument was ordered. BILLING CODE 3510–07–P 2004. Reasons: The foreign instrument Reasons: The foreign instrument is a provides: (1) Operation in high and low conventional transmission electron

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microscope (CTEM) and is intended for potential impacts must be received on National Science Foundation Ocean research or scientific educational uses or before June 24, 2004. Two public Observatories Initiative. NEPTUNE is a requiring a CTEM. We know of no scoping meetings to inform interested regional scale cabled observatory that CTEM, or any other instrument suited to parties of the proposed action and to the NSF plans to construct in 2006 off these purposes, which was being receive public comments on the scope the coast of Washington. MARS will manufactured in the United States of the EIS are scheduled as follows: provide an advance opportunity to look either at the time of order of the Wednesday, June 9, 2004—4 p.m. at the operations, management, outreach instrument or at the time of receipt of Wednesday, June 9, 2004—6:30 p.m. activities, and costs involved with the application by U.S. Customs and ADDRESSES: Submit written comments NEPTUNE on a smaller scale, and allow Border Protection. to Deirdre Hall, Monterey Bay National adjustments where necessary. Marine Sanctuary, 299 Foam Street, Specific Project Objectives are to: Gerald A. Zerdy, • Monterey, CA 93940. Comments may be Test aspects of the regional cabled Program Manager, Statutory Import Programs observatory (NEPTUNE) technology, Staff. submitted by fax at (831) 647–4250 or both for the initial design of the system [FR Doc. 04–11807 Filed 5–24–04; 8:45 am] by e-mail at: [email protected]. Comments received will be available for and during the lifetime of the project. BILLING CODE 3510–DS-M • public inspection at the above address. Test methods for education and Copies of the application materials outreach in partnership with the Monterey Bay Aquarium, which enjoys DEPARTMENT OF COMMERCE may be obtained by writing to the above address, or by contacting Deirdre Hall at a world-class reputation for its National Oceanic and Atmospheric (831) 647–4207. For directions to the innovative programs in public education. Administration public scoping meeting, contact the • MBNMS office at (831) 647–4201. Test deep-water remotely operated Environmental Impact Statement for The public meetings will be held at vehicle (ROV) procedures that will later the Monterey Bay Aquarium Institute the Moss Landing Marine Laboratory, be used for installing and servicing Application To Install a Cabled instruments on NEPTUNE. 8272 Moss Landing Road, Moss • Observatory Within the Monterey Bay Landing, California. Serve as an instrument test bed to National Marine Sanctuary and Notice verify the performance of new FOR FURTHER INFORMATION CONTACT: of Scoping Meeting instrumentation under development William J. Douros, MBNMS prior to being deployed on NEPTUNE. AGENCY: National Marine Sanctuary Superintendent at (831) 647–4201 or by • Provide power and high bandwidth Program (NMSP), National Ocean e-mail at [email protected]. real time communications to a Service (NOS), National Oceanic and SUPPLEMENTARY INFORMATION: broadband seismic observatory located Atmospheric Administration (NOAA), I. Proposed Action on the west side of the San Gregorio Department of Commerce (DOC). fault line. ACTION: Notice of Intent to prepare an The proposed action is MBARI’s • Provide power and high bandwidth EIS; notice of public scoping meeting; installation of approximately 51 communications to instrumentation that request for public comments. kilometers of 28 mm wide submarine will (a) allow long term in situ studies cable and a science node at the end of of chemosynthetic biological SUMMARY: NOAA announces its the cable, all within the boundaries of communities on Smooth Ridge, (b) be intention to prepare an environmental the MBNMS. The Federal action at issue located in the active upper canyon impact statement (EIS) in accordance would be the NMSP’s issuance of a enabling better understanding of canyon with the National Environmental Policy MBNMS permit to authorize the mass wasting events, (c) enable long Act of 1969 (NEPA) for the proposed conduct of this activity. The cable route term monitoring of spatial and temporal Monterey Bay Aquarium Research extends from Moss Landing (Monterey variability in parameters such as Institute (MBARI) installation of an Bay, California) towards the northwest, temperature and chlorophyll associated advanced cabled observatory on the to the north of the Monterey Canyon, with phenomena such as El Nin˜ o that seafloor within the Monterey Bay and along the continental margin to the can significantly affect fishery stocks, National Marine Sanctuary (MBNMS). southeastern part of the Smooth Ridge. and (d) enable studies of carbon The proposed scientific research project, The applicant, Monterey Aquarium transport from the region of primary known as the Monterey Accelerated Research Institute (MBARI), proposes production in the upper ocean to Research System (MARS), is comprised this scientific research project under the benthic communities. of one science node on 51 kilometers title of Monterey Accelerated Research (km) of submarine cable. The Federal System (MARS) cabled observatory. Need for Project Location action at issue would be the NMSP’s MARS would be located in Monterey Project Objectives issuance of a MBNMS permit to Bay offshore the MBARI facilities at authorize the conduct of this activity. The purpose of the MARS project is Moss Landing, Monterey County, The EIS will be prepared in to design and install an advanced- California. MBARI has indicated that cooperation with the California State technology cabled observatory that will Monterey Bay is needed because: Lands Commission, which issued a provide power and high-bandwidth • Moss Landing is within easy year Notice of Preparation on May 21, 2004, communications to instruments sited at round access to deep water due to its regarding its internet to prepare an critical areas of science interest in State location at the head of Monterey Environmental Impact Report (EIR) and federal waters of Monterey Bay. The Canyon, and its mild climate. The pursuant to the California site chosen in Monterey Bay’s Smooth MARS observatory must be located in Environmental Quality Act (CEQA). The Ridge will enable important science deep water to test both the NEPTUNE EIS prepared under this notice will be experiments and science observations to technology and to develop the ROV combined with the EIR and a joint EIR/ be undertaken, as well as serve as the procedures needed to operate deep- EIS will be published. test bed for a state-of-the-art regional water cabled observatories. DATES: Written comments on the scope scale cabled observatory (NEPTUNE), • MBARI has two ships equipped of the EIS, suggested alternatives and currently one component of the with ROVs berthed at Moss Landing,

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one of which is nearly always deployed The installation, maintenance, and minimum, consider the following as a day boat. These ROVs are the only eventual decommissioning and removal project alternatives: ones located on the west coast of the of the cable pose potentially significant • No Project/No-Action Alternative: U.S. operated by an oceanographic impacts upon Sanctuary resources and The EIS will examine the impacts of not institute. qualities. The EIR/EIS will address approving the proposed action. • One of MBARI’s joint projects with onshore and offshore environmental the Monterey Bay Aquarium, Education, effects of cable construction, operation, • Alternative Offshore Locations: The and Research: Testing Hypothesis maintenance, repair and removal. EIS will consider alternative routing and (EARTH) provides wide public and A preliminary listing of issues to be landing locations in the vicinity of the educational benefits. discussed in the EIS is provided below. project within Monterey Bay and in • Smooth Ridge is located on the west Additional issues may be identified at proximity to the MBARI facilities. side of the San Gregorio fault line, the public scoping meeting and in • Alternative Means of Obtaining critical for seismic studies, and is close written comments. Data: The EIS will examine the to several well established • Air Quality—short-term air quality feasibility of utilizing buoys and other chemosynthetic biological communities. effects from construction equipment, means to accomplish the project It is also provides a location that is vehicle, and vessel emissions. objectives. within easy reach of the active upper • Biological Resources—effects on section on Monterey Canyon. benthic communities, rocky hard- IV. Comments Project Installation bottom communities, plankton, fish, MBNMS would like public comments marine birds, marine mammals, and The proposed science node, located on the following: marine turtles from construction approximately 891 meters below the disturbances (e.g., cable laying, boat 1. Comments about the scope of issues ocean surface, will provide eight science anchoring, increased turbidity), release that should be evaluated in the EIS ports for oceanographic instruments. of contaminants, or entanglement; direct concerning this proposal; Extension cable can be plugged into any or indirect effects on sensitive species 2. Comments regarding the expected science port to provide power and and habitats. impacts of this project on the communications up to 3.5 km away • environment of the NBNMS and the from the original node. By supplying Commercial and Recreational overall significance of those impacts; both data links and electrical power, the Fishing—effects on fisheries and network will allow real-time, fisheries operations, including 3. Recommendations on mitigation continuous, and long-term monitoring construction interference with fishing measures and permit conditions that of conditions beneath the surface of the activities, potential loss of catch, would eliminate or minimize the bay. potential accidents (e.g., fishing net impacts of this project on the MBNMS The applicant proposes to bury the entanglement), and long-term or the environment generally should the cable along most of the route to a depth preemption of fishing grounds. permit be issued; • Cultural Resources—potential for of one meter, where feasible, using a 4. Recommendations for specific impacts on cultural resources that may hydraulically operated plow that is monitoring programs or plans that be buried along the proposed cable towed by a cable installation vessel. The would allow the MBNMS route. plow would cut a narrow trench for the Superintendent to know the • Environmental Justice—potential to cable and bury the cable. In areas where effectiveness of mitigation measures and cause disproportionate effects on the cable cannot be buried with this conditions; and method, the cable would be laid on the minority and/or low-income 5. Comments on other alternatives or sea bottom and would be post lay buried populations within the project impact technologies that meet the research by jetting, where feasible. Some portions area. Such populations may include, but objectives. of the cable would remain unburied due not be limited to, those in the local to potentially hard seafloor substrate fishing industry. • V. Future Public Involvement and exposed rocks. In the nearshore Geology and Soils—geologic area, the cable would be installed in an hazards and physical effects on the Additional opportunities for public existing pipeline that extends from 153 cable (e.g., submarine landslides and review will be provided when the Draft meters offshore to the proposed landing erosion). EIR/EIS is completed. A notice of • site located in Moss Landing and owned Marine Water Quality—trenching availability (NOA) of the Draft EIR/EIS by Duke Energy. effects on the water column (e.g., will be published in the Federal The applicant anticipates the cable sediment plume, benthic disruption, Register. and siltation) or contamination from would operate for a minimum of 25 VI. Special Accommodations years. The scope of the EIS will address accidental spills. • the offshore area from shore to the end Noise—increased noise levels from The scoping meeting is physically of the cable. construction and maintenance accessible to people with disabilities. operations. Requests for sign language II. Summary of Environmental Issues • Marine Vessel Traffic—cable interpretation or other auxiliary aids MBNMS has made a determination installation vessel interference with should be directed to Deirdre Hall, at that the issuance of a permit for this commercial and recreational vessel the MBNMS, (831) 647–4207, at least activity would require the preparation navigation. five (5) days prior to the meeting date. of an EIS pursuant to NEPA, the Council • Strumming—lateral movement of on Environmental Quality (CEQ) the cable along the seafloor, which may Richard W. Spinrad, implementing regulations (40 CFR Parts impact the marine environment. Assistant Administrator, Ocean Services and 1500 through 1508), and NOAA’s Coastal Zone Management, National Oceanic implementing guidelines on NEPA III. Alternatives and Atmospheric Administration. codified in NOAA Administrative Order In addition to the applicant’s [FR Doc. 04–11738 Filed 5–24–04; 8:45 am] 216–6. proposed action, the EIS will, at a BILLING CODE 3510–NK–M

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DEPARTMENT OF COMMERCE and identify EFH for the fishery; (2) SUMMARY: NMFS has received a request identify other actions to encourage the from the U.S. Army Corps of Engineers- National Oceanic and Atmospheric conservation and enhancement of such Jacksonville District (Corps) for Administration EFH; and (3) identify measures to authorizations to take marine mammals, [I.D. 051304A] minimize, to the extent practicable, the by harassment, incidental to expanding adverse effects of fishing on such EFH. and deepening the Alafia River Fisheries of the Caribbean, Gulf of The FEIS contains the methods and data Navigation Channel in Tampa Harbor, Mexico, and South Atlantic; Final used in the analyses, background FL (Alafia River project). Under the Environmental Impact Statement information on the physical, biological, Marine Mammal Protection Act Addressing Essential Fish Habitat human, and administrative (MMPA), NMFS is requesting comments Requirements of the Fishery environments, and a description of the on its proposal to issue a 1–year Management Plans of the U.S. fishing and non-fishing threats to EFH. Incidental Harassment Authorization Caribbean The notice of availability of the FEIS (IHA) to the Corps to incidentally take, was published on April 23, 2004 (69 FR by harassment, bottlenose dolphins AGENCY: National Marine Fisheries 22025). (Tursiops truncatus) as a result of Service (NMFS), National Oceanic and The ROD documents NMFS’ decision conducting this activity and the Corps’ Atmospheric Administration (NOAA), to proceed, in cooperation with the application for regulations. Commerce. Caribbean Fishery Management Council DATES: Comments and information must ACTION: Notice of availability of a (Council), with amending the spiny be received no later than June 24, 2004. Record of Decision. lobster, queen conch, reef fish, and coral ADDRESSES: Comments on the fishery management plans for the U.S. SUMMARY: In compliance with the application should be addressed to Caribbean to implement the Council’s National Environmental Policy Act of Michael Payne, Chief, Marine Mammal preferred alternatives for identifying 1969, NMFS announces the availability Conservation Division, Office of EFH, identifying habitat areas of of a Record of Decision (ROD) regarding Protected Resources, NMFS, 1315 East- particular concern, and preventing, a final environmental impact statement West Highway, Silver Spring, MD mitigating, or minimizing the adverse (FEIS) that was prepared to determine 20910–3225. The mailbox address for effects of fishing on EFH. The ROD whether to amend the fishery providing e-mail comments on this identifies all alternatives considered in management plans of the Caribbean action is [email protected] reaching the decision, specifies the Fishery Management Council to address Include in the subject line of the e-mail alternatives which were considered to essential fish habitat (EFH) comment the following document be environmentally preferable, and requirements of the Magnuson-Stevens identifier: ID#031604B. Comments sent identifies and discusses relevant factors Fishery Conservation and Management via email, including all attachments, which were balanced by NMFS in Act (Magnuson-Stevens Act). This ROD must not exceed a 10–megabyte file size. making its decision. A copy of the ROD documents the decision by NMFS to A copy of the application containing a will be mailed to individuals, agencies, proceed with such an amendment to: list of references used in this document or companies that commented on the describe and identify EFH for each may be obtained by writing to the draft and final EISs. In addition, copies fishery; identify other actions to address provided or by telephoning the of the ROD and FEIS are available from encourage the conservation and contact listed under the heading FOR NMFS (see ADDRESSES). enhancement of such EFH; and identify FURTHER INFORMATION CONTACT. measures to prevent, mitigate or Authority: 16 U.S.C. 1801 et seq. Publications referenced in this minimize to the extent practicable the Dated: May 20, 2004. document are available for viewing, by appointment during regular business adverse effects of fishing on such EFH. John Oliver, hours, at the address provided here ADDRESSES: Copies of the ROD and the Deputy Assistant Administrator for during this comment period. FEIS can be obtained from NMFS, Operations, National Marine Fisheries Southeast Regional Office, 9721 Service. FOR FURTHER INFORMATION CONTACT: Executive Center Drive North, St. [FR Doc. 04–11802 Filed 5–24–04; 8:45 am] Kenneth R. Hollingshead, NMFS, (301) 713–2322, ext 128. Petersburg, FL 33702; telephone: 727– BILLING CODE 3510–22–S 570–5317. SUPPLEMENTARY INFORMATION: FOR FURTHER INFORMATION CONTACT: Background DEPARTMENT OF COMMERCE David Dale, Fishery Biologist, 727–570– Sections 101(a)(5)(A) and (D) of the 5317, fax: 727–570–5300; email: National Oceanic and Atmospheric MMPA (16 U.S.C. 1361 et seq.) direct [email protected]. Administration the Secretary of Commerce to allow, SUPPLEMENTARY INFORMATION: NMFS upon request, the incidental, but not Southeast Region was the lead agency [I.D. 031604B] intentional, taking of marine mammals responsible for preparing, under third by U.S. citizens who engage in a Taking Marine Mammals Incidental to party contract, an FEIS for the Generic specified activity (other than Specified Activities; Alafia River Essential Fish Habitat Amendment (EFH commercial fishing) within a specified Navigation Channel, Tampa, FL Amendment) for the spiny lobster, geographical region if certain findings queen conch, reef fish, and coral fishery AGENCY: National Marine Fisheries are made and either regulations are management plans for the U.S. Service (NMFS), National Oceanic and issued or, if the taking is limited to Caribbean. The FEIS evaluates Atmospheric Administration (NOAA), harassment, a notice of a proposed alternatives for bringing the EFH Commerce. authorization is provided to the public Amendment into compliance with the ACTION: Notice of receipt of application for review. EFH mandates of the Magnuson-Stevens Permission may be granted if NMFS and proposed authorization for an Act. For each of the four Caribbean finds that the taking will have a incidental take authorization; request fisheries, the FEIS analyzes a range of negligible impact on the species or for comments. potential alternatives to: (1) describe stock(s) and will not have an

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unmitigable adverse impact on the Dredged Material Disposal Site and at will be required to protect marine availability of the species or stock(s) for two ‘‘beneficial use of dredged material’’ mammals. subsistence uses and that the sites located near the project area. The Summary of Request for Regulations permissible methods of taking and project is proposed to start in February requirements pertaining to the 2005 and is estimated to last for 24 While the Corps was coordinating monitoring and reporting of such months. with NMFS on the application and takings are set forth. NMFS has defined The Corps expects the contractor to issuance of an IHA for the Miami ‘‘negligible impact’’ in 50 CFR 216.103 employ underwater confined blasting Turning Basin in early 2003 (see 68 FR as ‘‘an impact resulting from the and dredging to construct the project. 32016, May 29, 2003 and 69 FR 2899, specified activity that cannot be Blasting may have adverse impacts on January 21, 2004), the Corps identified reasonably expected to, and is not bottlenose dolphins and manatees at least 6 additional Federal navigation reasonably likely to, adversely affect the (Trichechus manatus latirostris) projects that might need similar MMPA species or stock through effects on inhabiting near or utilizing the Alafia authorizations within the next few annual rates of recruitment or survival.’’ River channel in the northern portion of years, if confined blasting is used as a Subsection 101(a)(5)(D) of the MMPA Tampa Bay. Dolphins and other marine construction technique. To ensure established an expedited process by mammals have not been documented as consistency across MMPA which citizens of the United States can being directly affected by dredging authorizations for these dredging apply for an authorization to activities other than blasting. projects, and efficiency for both agencies, NMFS recommended that the incidentally take small numbers of While the Corps does not presently marine mammals by harassment. The Corps apply for these authorizations have a blasting plan from the contractor, under section 101(a)(5)(A) of the MMPA defines ‘‘harassment’’ as: which will specifically identify the any act of pursuit, torment, or annoyance MMPA, instead of individually under which (i) has the potential to injure a marine number of holes that will be drilled, the section 101(a)(5)(D) of the MMPA. This mammal or marine mammal stock in the wild amount of explosives that will be used request was received on December 1, [Level A harassment]; or (ii) has the potential for each hole, the number of blasts per 2003. At this time only the Miami to disturb a marine mammal or marine day (usually no more than 3/day), or the Turning Basin and this Alafia River mammal stock in the wild by causing number of days the construction is disruption of behavioral patterns, including, project are proposed to be covered by anticipated to take to complete, the the section 101(a)(5)(A) rulemaking. but not limited to, migration, breathing, Corps submitted a description of a nursing, breeding, feeding, or sheltering This rule, if implemented, and Letters of [Level B harassment]. completed project in San Juan Harbor, Authorization (LOA) issued under that Subsection 101(a)(5)(D) establishes a Puerto Rico as an example. For that rule, would replace the IHA process for 45–day time limit for NMFS review of project, the maximum weight of the these activities in the Jacksonville an application followed by a 30–day explosives used for each event was 375 District. Each application for an LOA for public notice and comment period on lbs (170 kg) and the contractors additional projects within the any proposed authorizations for the detonated explosives once or twice Jacksonville District for confined incidental harassment of small numbers daily from July 16 to September 9, for blasting within the District would of marine mammals. Within 45 days of a total of 38 individual detonations. require separate public review and the close of the comment period, NMFS Normal practice is for each charge to be comment, prior to issuance of an LOA. must either issue or deny issuance of placed approximately 5 - 10 ft (1.5 - 3 NMFS expects to start this rulemaking the authorization. m) deep within the rock substrate, shortly. depending on how much rock needs to Summary of Request be broken and how deep a channel Description of the Marine Mammals On February 26, 2004, NMFS received depth is authorized. The charges are Affected by the Activity a request from the Corps for an placed in the holes and tamped with General information on marine authorization to take bottlenose rock. Therefore, if the total explosive mammal species found off the dolphins incidental to using blasting weight needed is 375 lbs (170 kg) and east coast of the United States can be during expansion of the Alafia River they have 10 holes, they would average found in Waring et al. (2001, 2002). Navigation Channel by widening the 37.5 lbs (17.0 kgs)/hole. However, a These reports are available on the channel to 250 ft (76.2 m) and more likely weight for this project may Internet at the following location: http:/ deepening the channel to 42 ft (12.8 m) be only 90 lbs (41 kgs) and, therefore, /www.nmfs.noaa.gov/protlres/PR2/ at mean low low water (mllw). The 9 lbs (4.1 kg)/hole. Charge weight and StocklAssessmentlProgram/sars.html existing turning basin would be other determinations are expected to be Bottlenose dolphins and West Indian enlarged to a diameter of 1200 ft (365.8 made by the Corps and the contractor manatees are the only marine mammal m) with a depth of 42 ft (12.8 m) at approximately 30–60 days prior to species expected in the activity area. mllw. The specific geographic area of commencement of the construction However, take authorizations for the construction will be within the project. Because the charge weight and manatees are issued by the U.S. Fish boundaries of the Alafia River other information is not presently and Wildlife Service (USFWS) and are Navigation Channel, part of the Tampa available, NMFS will require the Corps not covered by this proposed IHA or any harbor navigation project. The Alafia to provide this information to NMFS, future rulemaking for LOAs issued by River is located in northern Tampa Bay, including calculations for impact/ NMFS. Wang et al. (2002) provides the Hillsborough County, Florida. mitigation zones (for the protection of following minimum population Completion of the dredging project marine mammals from injury), prior to estimates for the Gulf of Mexico may employ a clamshell dredge, commencing work. However, as bottlenose dolphin stocks: outer shelf, cutterhead dredge and/or blasting. The described later in this document, 43,233; shelf and slope, 4,530; western dredging will remove 5.5 million cubic mitigation measures will require the Gulf, 2,938; northern Gulf, 3,518; yards of material from the existing Corps to limit detonations to the eastern Gulf, 8,953; and Bay, Sound & navigation channel and turning basin. minimum level necessary to accomplish Estuarine waters, 3,933. Material removed from the dredging the task and the larger the charge The best estimate is that the Tampa will be placed in the Tampa Ocean weight, the greater the safety zone that Bay bottlenose dolphin population

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(which includes any dolphins within harassment) harassment from equations have been proposed by the the Alafia River) consists of 559 underwater explosions (see 66 FR Corps for blasting projects to determine individuals (Wang et al., 2002). 22450, May 4, 2001). For non-lethal zones for injury or mortality from an Previous population estimates for injury from explosives the criteria are open water explosion and to assist the Tampa Bay include Wells et al. (1996), established as the peak pressure that Corps in establishing mitigation to Weigle (1990), Scott et al. (1989) Wells will result in: (1) the onset of slight lung reduce impacts to the lowest level (1986), Thompson (1981), and O’Dell hemorrhage, or (2) a 50–percent practicable. These equations are and Reynolds (1980). A monitoring probability level for a rupture of the conservative because they are based on study of bottlenose dolphins in Tampa tympanic membrane. These are injuries humans, which are more sensitive to the Bay was conducted from 1988–1993. from which animals would be expected effects from the pressure wave of the The results of that study were published to recover on their own. detonation than are dolphins and in Wells et al. (1996). It is the most Although each of the tamped charges because they are based on unconfined recent study of those animals currently are fairly small (probably less than the charges while the proposed blasts in the available (R. Wells, pers. comm. to T. 37 lbs (16.8 kg) per drilled hole used in Alafia River will be confined or Jordan, Corps, 2004). The study Puerto Rico) and detonation staggered to stemmed charges (i.e., placed in a hole identified a population size ranging reduce total pressure, the maximum drilled in rock and tamped with rock). between 437 and 728 individuals horizontal extent for mortality/lethal Studies (e.g., Nedwell and utilizing three different survey and injury and non-lethal injury (Level A Thandavamoorthy 1992) have shown population estimation techniques. Some harassment), estimated based on the that stemmed/confined blasts have a of these animals have been shown to be total charge weight (375 lbs in the case greater than 90 percent decrease in the in the vicinity of the Alafia River of Puerto Rico) would be less than 1875 strength of the pressure wave released channel. In a subsequent examination of ft (571 m) and 3750 ft (1143 m) as compared to an open water blast. the data, Urian (2002) identified five respectively. As these distances are The equations, based on Young populations of bottlenose dolphins in based on an open-water charge (1991), are: Tampa Bay. Two of these populations calculation, and as stemmed/confined 1 Caution Zone radius = 260 (lbs/delay) ⁄3 utilize the area adjacent to the Alafia blasts result in a significant decrease in Safety Zone radius = 520 (lbs/delay)1⁄3 the strength of the pressure wave River channel. Specific population with R = 260 times or 520 times the released as compared to an open water levels for these two groups were not cube root of the weight of the explosive blast, the zones for mortality and non- provided in the study. charge in pounds where R = radius of serious injury would be significantly the safety zone in ft and W = weight of Potential Effects on Marine Mammals less than these distances. As a result of the explosive charge in lbs. The Caution According to the Corps, bottlenose these small impact zones, the relatively Zone represents the radius from the dolphins and other marine mammals shallow waters for blasting, and the point of detonation beyond which have not been documented as being nature of bottlenose dolphins to remain directly affected by dredging activities in surface waters, the biological mortality would not be expected from and therefore the Corps does not monitoring (aerial- and vessel-based) is an open-water blast. The Safety Zone is anticipate any incidental harassment of expected to be effective in locating all the approximate distance beyond which bottlenose dolphins by dredging. marine mammals prior to them entering non-serious injury (Level A harassment) Potential impacts to marine mammals an area where injury or mortality might would be unlikely from an open-water from explosive detonations include both result and thereby preventing any takes explosion. These zones will be used for lethal and non-lethal injury, as well as by injury or mortality. implementing mitigation measures to Level B harassment. Marine mammals NMFS has also established dual protect both marine mammals and sea may be killed or injured as a result of criteria for what constitutes Level B turtles, although the activity area is an explosive detonation due to the acoustic harassment for all marine apparently not good habitat for sea response of air cavities in the body, mammals: (1) an energy-based turtles. such as the lungs and bubbles in the temporary threshold shift (TTS) from In the area where explosives are intestines. Effects are likely to be most received sound levels of 182 dB re 1 required to obtain channel design depth severe in near-surface waters where the microPa2–sec cumulative energy flux in for each explosive charge, the Corps reflected shock wave creates a region of any 1/3 octave band above 100 Hz for proposes that detonation will not occur negative pressure called ‘‘cavitation.’’ odontocetes (derived from experiments if a marine mammal is sighted within This is a region of near total physical with bottlenose dolphins (Ridgway et the Safety Zone by a member of the trauma within which no animals would al., 1997; Schlundt et al., 2000); and (2) marine mammal observer program. be expected to survive. A second 12 psi peak pressure (cited by Ketten Although the Caution Zone is possible cause of mortality or lethal (1995) as associated with a safe outer considered to be an area for potential injury is the onset of extensive lung limit for minimal, recoverable auditory mortality, the Corps and NMFS believe hemorrhage. Extensive lung hemorrhage trauma (i.e., TTS)). that because all explosive charges will is considered debilitating and be stemmed, the true areas for potential potentially fatal. Suffocation caused by Mitigation mortality and injury will be lung hemorrhage is likely to be the The Corps proposes to implement significantly smaller than this area and, major cause of marine mammal death mitigation measures that will establish therefore, for reasons mentioned from underwater shock waves. The both caution- and safety-zone radii to previously, it is unlikely that even non- onset of extensive lung hemorrhage for ensure that bottlenose dolphins will not serious injury will occur. This is marine mammals will vary depending be injured or killed during blasting and particularly true in this case, since upon the animal’s weight, with the that impacts will be at the lowest level bottlenose dolphins are commonly smallest mammals having the greatest practicable. In the absence of acoustic found on the surface of the water and potential hazard range. measurements of the shock and pressure implementation of a mitigation/ NMFS has also established criteria for waves emanating from the detonations monitoring program is unlikely to miss determining non-lethal injury (Level A (due to the high cost and complex bottlenose dolphins in such a small harassment) and non-injurious (Level B instrumentation needed), the following area.

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Additional mitigation measures that immediately notify the NMFS Regional harassment and this is expected to have will significantly lower potential Office. only a negligible impact on the affected impacts to marine mammals (and sea species or stocks of bottlenose dolphins. Endangered Species Act turtles) include: (1) confining the In addition, no take by injury and/or explosives in a hole with drill patterns Under section 7 of the ESA, the Corps death is anticipated, and harassment restricted to a minimum of 8 ft (2.44 m) completed consultation with the takes will be at the lowest level separation from any other loaded hole; USFWS on December 14, 1998 for this practicable due to incorporation of the (2) restricting the hours of detonation project. The USFWS concluded that the mitigation measures described in this from 2 hours after sunrise to 1 hour work would not likely jeopardize the document. before sunset to ensure adequate continued existence of the manatee, if Proposed Authorization observation of marine mammals in the standard manatee protection conditions safety zone; (3) staggering the were implemented. The Corps NMFS proposes to issue an IHA to the detonation for each explosive hole in reinitiated consultation with the Corps for the harassment of small order to spread the explosive’s total USFWS by letter dated July 5, 2000, numbers of bottlenose dolphins overpressure over time, which in turn because blasting was identified as a incidental to expanding and deepening will reduce the radius of the caution component of the project. On July 24, the Alafia River Navigation Channel in zone; (4) capping the hole containing 2000 and September 5, 2000, the Tampa Harbor, FL, provided the explosives with rock in order to reduce USFWS provided the Corps with previously mentioned mitigation, the outward potential of the blast, recommendations for protecting monitoring, and reporting requirements thereby reducing the chance of injuring manatees while conducting blasting are incorporated. NMFS has a dolphin or manatee; (5) matching, to operations. These recommendations preliminarily determined that the the extent possible, the energy needed have been incorporated into the project. proposed activity would result in the in the ‘‘work effort’’ of the borehole to Because the proposed issuance of this harassment of only small numbers of the rock mass to minimize excess energy IHA to the Corps is a federal action bottlenose dolphins and will have no vented into the water column; and (6) under section 7 of the ESA that might more than a negligible impact on this conducting a marine mammal watch affect sea turtles (a listed species under marine mammal stock. NMFS’ jurisdiction), NMFS has begun with no less than two qualified Information Solicited observers from a small water craft and/ consultation on the proposed issuance or an elevated platform on the of an IHA under section 101(a)(5)(D) of NMFS requests interested persons to explosives barge, at least 30 minutes the MMPA for this activity. submit comments and information before and continue for 30 minutes after Consultation will be concluded prior to concerning this proposed IHA and the each detonation to ensure that there are a determination on whether or not to application for regulations request (see no dolphins, manatees or sea turtles in issue an IHA. ADDRESSES). the area at the time of detonation. National Environmental Policy Act Dated: May 18, 2004. Monitoring Program The Corps prepared an Environmental Laurie K. Allen, Assessment (EA) on the Navigation Director, Office of Protected Resources, The Corps proposes to implement a Study for Tampa Harbor-Alafia River, National Marine Fisheries Service. aerial and vessel-based observer Florida in September 2000 and made a [FR Doc. 04–11800 Filed 5–24–04; 8:45 am] monitoring programs. The vessel-based finding of no significant impact on BILLING CODE 3510–22–S observer program will take place in a October 11, 2000. A copy of this circular area at least three times the document is available for viewing (see radius of the above described Caution ADDRESSES). NMFS is reviewing this EA DEPARTMENT OF COMMERCE Zone (called the watch zone). in relation to the Corps’ application and Detonation will not occur if a marine will determine the appropriate action to National Oceanic and Atmospheric mammal or sea turtle is sighted within take under NEPA prior to making a Administration the safety zone and will be delayed until determination on the issuance of an [I.D. 032904C] the animal(s) move(s) out of the safety IHA. zone on its own volition. The aerial and vessel-based marine mammal watch is Preliminary Conclusions Small Takes of Marine Mammals Incidental to Specified Activities; proposed to be conducted for at least a NMFS has preliminarily determined half hour before and after the time of Harbor Activities at Vandenberg Air that the Corps’ proposed action, Force Base, CA each detonation. including mitigation measures to protect Reporting marine mammals, should result, at AGENCY: National Marine Fisheries worst, in the temporary modification in Service (NMFS), National Oceanic and NMFS proposes to require the Corps behavior by bottlenose dolphins Atmospheric Administration (NOAA), to submit a report of activities 120 days resulting from temporary hearing Commerce. before the expiration of the proposed impairment (TTS), but may also include ACTION: Notice of issuance of an IHA if the proposed work has started. temporarily vacating the Alafia River incidental take authorization. This report will include the status of the area to avoid the blasting activity and work being undertaken, marine the potential for minor visual and SUMMARY: In accordance with provisions mammals sighted during the monitoring acoustic disturbance from dredging and of the Marine Mammal Protection Act period, any behavioral observations detonations. Because this project will (MMPA) as amended, notification is made on bottlenose dolphins and any affect at most a few dolphins due to its hereby given that NMFS has issued an delays in detonation due to marine local impact, short time duration, and Incidental Harassment Authorization mammals being within the safety zone. implementation of effective vessel-based (IHA) to The Boeing Company (Boeing) In the unlikely event a marine and aerial monitoring programs, NMFS to take marine mammals by harassment mammal or sea turtle is injured or killed believes that only a small number of incidental to harbor activities related to during blasting, the Contractor shall dolphins may be taken by Level B the Delta IV/Evolved Expendable

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Launch Vehicle (EELV) at south mammal or marine mammal stock in the wild Response: NMFS appreciates the Vandenberg Air Force Base, CA (VAFB). [‘‘Level A harassment’’]; or (ii) has the Commission’s comment and is requiring potential to disturb a marine mammal or DATES: Effective from May 20, 2004, all mitigation and monitoring activities marine mammal stock in the wild by causing through May 19, 2005. described in Boeing’s application. disruption of behavioral patterns, including, NMFS is also requiring Boeing to take ADDRESSES: A copy of the IHA and the but not limited to, migration, breathing, application are available by writing to nursing, breeding, feeding, or sheltering all reasonable measures to ensure the Mr. P. Michael Payne, Chief, Marine [‘‘Level B harassment’’]. least practicable impact on the species, Mammal Conservation Division, Office such as turning on lighting before dusk of Protected Resources, NMFS, 1315 Subsection 101(a)(5)(D) establishes a and initiating activities before dusk if East-West Highway, Silver Spring, MD 45–day time limit for NMFS review of Boeing will be conducting harbor 20910–3225, or by telephoning the an application followed by a 30–day activities at night. contact listed here. A copy of the public notice and comment period on Comment 2: An individual stated that application containing a list of the any proposed authorizations for the they oppose the proposal for harbor references used in this document may incidental harassment of small numbers activities on Vandenberg Air Force Base be obtained by writing to this address or of marine mammals. Within 45 days of because there is no explanation of reef by telephoning the contact listed here the close of the comment period, NMFS enhancement in the Federal Register and is also available at: http:// must either issue or deny issuance of notice. www.nmfs.noaa.gov/protlres/PR2/ the authorization. Response: To mitigate the unavoidable removal of kelp habitat SmalllTake/ Summary of Request smalltakelinfo.htm#applications. within the dredge footprint, Boeing, the On December 12, 2003, NMFS U.S. Air Force, and regulatory agencies FOR FURTHER INFORMATION CONTACT: received an application from Boeing have agreed that 150 tons (136.08) Kimberly Skrupky, (301) 713–2322, ext. requesting an authorization for the metric tons) of rocky substrate will be 163 or Monica DeAngelis, (562) 980– harassment of small numbers of Pacific placed in a sandy area between the 3232. harbor seals (Phoca vitulina richardsi) breakwater and the mooring dolphins to SUPPLEMENTARY INFORMATION: and California sea lions (Zalophus enhance an existing artificial reef. This type of mitigation was implemented by Background californianus) incidental to harbor activities related to the Delta IV/EELV, the U.S. Army Corps of Engineers Sections 101(a)(5)(A) and (D) of the including: transport vessel operations, following the 1984 and 1989 dredgings MMPA (16 U.S.C. 1361 et seq.) direct cargo movement activities, harbor and has resulted in the growth of a lush the Secretary of Commerce to allow, maintenance dredging, and kelp habitat kept bed adjacent to this sandy area. upon request, the incidental, but not mitigation operations. In addition, The location is outside of the dredge intentional taking of small numbers of northern elephant seals (Mirounga footprint and navigation channel in a marine mammals by U.S. citizens who angustirostris)and northern fur seals protected environment. The breakwater engage in a specified activity (other than (Callorhinus ursinus) may also be will help protect the kept from storms commercial fishing) within a specified incidentally harassed but in even and surges that might tear young kelp geographical region if certain findings smaller numbers. Incidental Harassment plants from the substrate. The substrate are made and either regulations are Authorizations (IHAs) were issued to will be in the form of approximately 150 issued or, if the taking is limited to Boeing on May 15, 2002 (67 FR 36151, sharp-faced boulders, each with a harassment, notice of a proposed May 23, 2002) and on May 20, 2003 (68 diameter of approximately 2 ft (0.61 m) authorization is provided to the public FR 36540, June 18, 2003) each for a one- and a weight of approximately 1 ton for review. (0.91 metric ton). The boulders will be year period. The harbor where activities Permission for incidental takings may brought in by truck from an off-site will take place is on south VAFB be granted if NMFS finds that the taking quarry, loaded by crane onto a small approximately 2.5 mi (4.02 km) south of will have no more than a negligible barge at the wharf, and pushed by Point Arguello, CA and approximately 1 impact on the species or stock(s) and tugboat to a location along the mooring mi (1.61 km) north of the nearest marine will not have an unmitigable adverse dolphins from which a small barge- mammal pupping site (i.e., Rocky impact on the availability of the species mounted crane can place them Point). or stock(s) for subsistence uses and that randomly into the sandy area. This the permissible methods of taking and Comments and Responses information is also contained in the requirements pertaining to the Boeing application, which could be monitoring and reporting of such taking A notice of receipt of the Boeing found at:http://www.nmfs.noaa.gov/ are set forth. application and proposed IHA was protlres/PR2/SmalllTake/ NMFS has defined ‘‘negligible published in the Federal Register on smalltakelinfo.htm#applications impact’’ in 50 CFR 216.103 as: April 7, 2004 (69 FR 18353). During the Comment 3: The individual also states an impact resulting from the specified comment period, NMFS received that many population estimates are activity that cannot be reasonably expected comments from the Marine Mammal unreliable and untruthful and are to, and is not reasonably likely to, adversely Commission (Commission) and from political estimates made to support affect the species or stock through effects on one individual. something that humans want to do. annual rates of recruitment or survival. Comment 1: The Commission states Response: Monitoring is conducted by Subsection 101(a)(5)(D) of the MMPA that NMFS’ preliminary determinations biologically trained, on-site individuals, established an expedited process by are reasonable provided that all approved by the NMFS Southwest which citizens of the United States can reasonable measures will be taken to Regional Office. Baseline observations apply for an authorization to ensure the least practicable impact on are made prior to each day’s activities, incidentally take small numbers of the subject species and the require recording the species present, numbers, marine mammals by harassment. The mitigation and monitoring activities be location(s), and behavior of the marine MMPA defines ‘‘harassment’’ as: carried out as described in the April 7, mammals in the area. Observations are any act of pursuit, torment, or annoyance 2004 Federal Register notice and the also conducted during and after each which (i) has the potential to injure a marine subject application. day’s activities. NMFS does not believe

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that past data reporting the species and Vandenberg Air Force Base (ENSR thermoregulatory stress. During pupping numbers have ever been doctored to International, 2001). and molting season, harbor seals at the justify conducting any activities. south VAFB sites expand into haul-out Habitat and Marine Mammals Affected areas that are not used the rest of the Specified Activities by the Activity year. The number of seals hauled out Delta Mariner off-loading operations Pacific Harbor Seals begins to decrease in August after the and associated cargo movements will The marine mammal species most molt is complete and reaches the lowest occur a maximum of three times per likely to be harassed incidental to number in late fall and early winter. year. The Delta Mariner is a 95.1–m harbor activities at south VAFB are the California Sea Lions (312–ft) long, 25.6–m (84–ft) wide steel Pacific harbor seal and the California During the wharf modification hull ocean-going vessel capable of sea lion. The most recent estimate of the operating at a 2.4–m (8–ft) draft. For the activity in June-July 2002, California sea Pacific harbor seal population in lions were observed hauling out in first few visits to the south VAFB California is 30,293 seals (Forney et al., harbor, tug boats will accompany the small numbers. Although this is 2000). From 1979 to 1995, the California considered to be an unusual occurrence Delta Mariner. Sources of noise from the population increased at an estimated Delta Mariner include ventilating and is possibly related to fish schooling annual rate of 5.6 percent. The total in the area, Boeing has included sea propellers used for maneuvering into population of harbor seals on VAFB is position and the cargo bay door when it lions in their IHA request. now estimated to be 1,118 (500 hauled- California sea lions range from British becomes disengaged. Removal of the out on south VAFB) based on sighting Columbia to Mexico. The minimum U.S. common booster core (CBC) from the surveys and telemetry data (SRS population estimate for California sea Delta Mariner requires use of an Technologies, 2001). lions is 109,854 individuals. Since 1983, elevating platform transporter. An The daily haul-out behavior of harbor the population has grown at a rate of 6.2 additional source of noise with sound seals along the south VAFB coastline is percent annually. A 1985–1987 levels measured at a maximum of 82 dB primarily dependent on time of day. population survey indicated that most A-weighted (re 20 microPascals at 1 m) The highest number of seals haul-out at individuals on the Northern Channel 6.1 m (20 ft) comes from the engine south VAFB between 1100 through 1700 Islands were on San Miguel Island, with exhaust (Acentech, 1998). Procedures hours. In addition, haul-out behavior at the population ranging from 2,235 to require two short (approximately 1/3 all sites seems to be influenced by over 17,000. The largest numbers of second) beeps of the horn prior to environmental factors such as high California sea lions in the VAFB vicinity starting the ignition. At 60.9 m (200 ft) swell, tide height, and wind. The occur at Lion Rock, 0.4 mi (0.64 km) away, the sound level of the EPT horn combination of all three may prevent southeast of Point Sal. This area is ranged from 62–70 dB A-weighted. seals from hauling out at most sites. The approximately 1.5 mi (2.41 km) north of Containers containing flight hardware number of seals hauled out at any site the VAFB boundary. At least 100 sea items will be towed off the Delta can vary greatly from day to day based lions can be observed during any season Mariner by a tractor tug that generates on environmental conditions. Harbor at this site. The Point Arguello beaches a sound level of approximately 87 dB A- seals occasionally haul out at a beach and the rocky ledges of South Rocky weighted at 15.2 m (50 ft) while in 76.2 m (250 ft) west of the south VAFB Point on south VAFB are haulout areas operational mode. Total time of Delta harbor and on rocks outside the harbor that may be used by California sea lions. Mariner docking and cargo movement breakwater where Boeing will be In 2003, at least 145 sea lions were activities is estimated at between 14 and conducting Delta Mariner operations, observed at Rocky Point, including five 18 hours in good weather. cargo loading, dredging activities, and pups that did not survive due to To accommodate the Delta Mariner, reef enhancement activities. The abandonment shortly after birth. This the harbor will need to be dredged, maximum number of seals present was thought to be an El Nino effect, as removing up to 5,000 cubic yards of during past dredging of the harbor was there have never been any reported sea sediment per dredging. Dredging will 23, with an average of seven seals lion births at VAB previously involve the use of heavy equipment, sighted per observation. The harbor seal (Thomson, 2003). Each year, small including a clamshell dredge, dredging pupping site closest to south VAFB groups of sea lions have been observed crane, a small tug, dredging barge, dump harbor is at Rocky Point, approximately heading south along the VAFB coastline trucks, and a skip loader. Measured 1.6 km (1 mi) north of the harbor. in April and May (Tetra Tech, 1997). sound levels from this equipment are Several factors affect the seasonal Starting in August, large groups of sea roughly equivalent to those estimated haul-out behavior of harbor seals lions can be seen moving north, in for the wharf modification equipment: including environmental conditions, groups varying in size from 25 to more 43 to 81 dB A-weighted at 76.2 m (250 reproduction, and molting. Harbor seal than 300 (Roest, 1995). This concurs ft). Dredge operations, from set-up to numbers at VAFB begin to increase in with established migration patterns tear-down, would continue 24 hours a March during the pupping season (Reeves et al., 1992; Roest, 1995). day for 3 to 5 weeks. Sedimentation (March to June) as females spend more Juvenile sea lions can be observed surveys have shown that initial time on shore nursing pups. The hauled-out with harbor seals along the dredging indicates that maintenance number of hauled-out seals is at its South Base sites from July through dredging should be required annually or highest during the molt which occurs September (Tetra Tech, 1997). Starving twice per year, depending on the from May through July. During the and exhausted subadult sea lions are hardware delivery schedule.A more molting season, tagged harbor seals at fairly common on central California detailed description of the work VAFB increased their time spent on beaches during the months of July and proposed for 2004 is contained in the shore by 22.4 percent; however, all seals August (Roest, 1995). application which is available upon continued to make daily trips to sea to During the breeding season, most of request (see ADDRESSES) and in the Final forage. Molting harbor seals entering the California sea lions inhabit southern US Air Force Environmental water because of a disturbance are not California and Mexico. Rookery sites in Assessment for Harbor Activities adversely affected in their ability to southern California are limited to San Associated with the Delta IV Program at molt and do not endure Miguel Island and to the southerly

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Channel Islands of San Nicolas, Santa Based on the measured sounds of water, may rise to the level of level B Barbara, and San Clemente. Breeding construction equipment, such as might harassment and could even result in season begins in mid-May, occurring be used during Boeing’s activities, injury of individuals. In addition, such within 10 days of arrival at the sound level intensity decreases large-scale movements by dense rookeries. Molting occurs gradually over proportional to the square root of the aggregations of marine mammals or on several months in the late summer and distance from the source. A dredging pupping sites could potentially lead to fall. Because the molt is not crane at the end of the dock producing takes by serious injury or death. catastrophic, the sea lions can enter the 88 dBA of noise would still be noisy However, there is no potential for large- water to feed. (approximately 72 dBA) at the nearest scale movements leading to serious Male California sea lions migrate beach or the end of the breakwater, injury or mortality near the south VAFB annually. In the spring they migrate roughly 250 ft (76.2 m) away. The harbor, because on average the number southward to breeding rookeries in the Elevating Platform Transporter (EPT) of harbor seals hauled out near the site Channel Islands and Mexico, then produces approximately 85 dBA, is less than 30 and there is no pupping migrate northward in the late summer measured less than 20 ft (6 m) from the at nearby sites. The effects of the harbor following breeding season. Females engine exhaust, when the engine is activities are expected to be limited to appear to remain near the breeding running at mid speed. The EPT short-term startle responses and rookeries. The greatest population on operation procedure requires two short localized behavioral changes. land occurs in September and October beeps of the horn (approximately 1/3 of According to the June 2002 dock during the post-breeding dispersal and a second each) prior to starting the modification construction report (ENSR although many of the sea lions, ignition. Sound level measurements for 2002), the maximum number of harbor particularly juveniles and sub-adult and the horn ranged from 84 to 112 dBA at seals hauled out each day ranged from adult males, may move north away from 25 ft (7.6 m) away and 62 to 70 dBA at 23 to 25 animals. There were 15 the Channel Islands. 200 ft (61 m) away. The highest occasions in which construction noise, Other Marine Mammals measurement was taken from the side of vehicle noise, or noise from a fishing the vehicle where the horn is mounted. boat caused the seals to lift their heads. Other marine mammal species are Pinnipeds sometimes show startle Flushing only occurred due to fishing rare to infrequent along the south VAFB reactions when exposed to sudden brief coast during certain times of the year activities which were unrelated to the sounds. An acoustic stimulus with construction activities. The sea lions and, therefore, are unlikely to be sudden onset (such as a sonic boom) harassed by Boeing’s activities. These were less reactive to the construction may be analogous to a ‘‘looming’’ visual noise than the harbor seals. None of the two species are: the Guadalupe fur seal stimulus (Hayes and Saif, 1967), which (Arctocephalus townsendi), and Steller construction activities caused any of the may elicit flight away from the source sea lions to leave the jetty rocks and sea lions (Eumetopias jubatus). (Berrens et al., 1988). The onset of Northern elephant seals and northern there was only one incident of a head operations by a loud sound source, such alert reaction. fur seals may occur on VAFB but do not as the elevating platform transporter The report from the December 2002 haul out in the harbor area. Guadalupe during CBC off-loading procedures, may dredging activities show that the fur seals, and Steller sea lions occur elicit such a reaction. In addition, the number of Pacific harbor seals ranged along the California coast and Northern movements of cranes and dredges may from 0 to 19 and that California sea Channel Islands but are not likely to be represent a ‘‘looming’’ visual stimulus found on VAFB. Descriptions of the to seals hauled out in close proximity. lions did not haul out during the biology and local distribution of these Seals and sea lions exposed to such monitoring period. On 10 occasions, species can be found in the application acoustic and visual stimuli may either harbor seals showed head alerts as well as other sources such as Stewart exhibit a startle response and/or leave although two of the alerts were for and Yochem (1994, 1984), Forney et al. the haul-out site. disturbances that were not related to the (2000), Koski et al. (1998), Barlow et al. Under the MMPA, if harbor activities project. No harbor seals flushed during (1993), Stewart and DeLong (1995), and disrupt the behavioral patterns of harbor the activities on the dock. Lowry et al. (1992). NMFS Stock seals, these activities would take marine For a further discussion of the Assessments can be viewed at: http:// mammals by Level B harassment. In anticipated effects of the planned www.NMFS.noaa.gov/pr/PR2/ general, if the received level of the noise activities on harbor seals in the area, StocklAssessmentlProgram/ stimulus exceeds both the background please refer to the application and Final sars.html. Please refer to those (ambient) noise level and the auditory Environmental Assessment. Information documents for information on these threshold of the animals, and especially in the application and referenced species. if the stimulus is novel to them, there sources is adopted by NMFS as the best may be a behavioral response. The information available on this subject. Potential Effects of Activities on Marine probability and degree of response will Mitigation Mammals also depend on the season, the group Acoustic and visual stimuli generated composition of the pinnipeds, and the To reduce the potential for by the use of heavy equipment during type of activity in which they are disturbance from visual and acoustic the Delta Mariner off-loading engaged. Minor and brief responses, stimuli associated with the activities operations, dredging, and kelp habitat such as short-duration startle or alert Boeing will undertake the following mitigation, as well as the increased reactions, are not likely to result in marine mammal mitigating measures: presence of personnel, may cause short- disruption of behavioral patterns, such (1) If activities occur during nighttime term disturbance to harbor seals and as migration, nursing, breeding, feeding, hours, lighting will be turned on before California sea lions hauled out along the or sheltering (i.e., Level B harassment) dusk and left on the entire night to beach and rocks in the vicinity of the and would not cause serious injury or avoid startling harbor seals at night. south VAFB harbor. This disturbance mortality to marine mammals. (2) Activities will be initiated before from acoustic and visual stimuli is the On the other hand, startle and alert dusk. principal means of marine mammal reactions accompanied by large-scale (3) Construction noises must be kept taking associated with these activities. movements, such as stampedes into the constant (i.e., not interrupted by periods

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of quiet in excess of 30 minutes) while other ways. In addition, the report will diameter of about 2 ft (0.61 m) and each harbor seals are present. include information on the weather, the weighing about 1 ton (907 kg). The (4) If activities cease for longer than tidal state, the horizontal visibility, and boulders will be brought in by truck 30 minutes and harbor seals are in the the composition (species, gender, and from an off-site quarry and loaded by area, start-up of activities will include a age class) and locations of haul-out crane onto a small barge at the wharf. gradual increase in noise levels. group(s). In the unanticipated event that The barge is towed by a tugboat to a (5) A NMFS-approved marine any cases of pinniped injury or location along the mooring dolphins mammal observer will visually monitor mortality are judged to result from these from which a small barge-mounted the harbor seals on the beach adjacent activities, this will be reported to NMFS crane can place them into the sandy to the harbor and on rocks for any immediately. area. Boeing plans to perform the reef flushing or other behaviors as a result of enhancement in conjunction with the Numbers of Marine Mammals Expected Boeing’s activities (see Monitoring). next maintenance dredging event in to Be Harassed (6) The Delta Mariner and order to minimize cost and disturbances accompanying vessels will enter the Boeing estimates that a maximum of to animals. Noise will be generated by harbor only when the tide is too high for 43 harbor seals per day may be hauled the trucks delivering the boulders to the harbor seals to haul-out on the rocks out near the south VAFB harbor, with a harbor and during the operation of and the vessel will reduce speed 1.5 to daily average of 21 seals sighted when unloading the boulders onto the barges 2 knots (1.5–2.0 nm/hr; 2.8–3.7 km/hr) tidal conditions were favorable during and into the water. once the vessel is within 3 mi (4.83 km) previous dredging operations in the Possible Effects of Activities on of the harbor. The vessel will enter the harbor. Considering the maximum and Subsistence Needs harbor stern first, approaching the wharf average number of seals hauled out per and dolphins at less than 0.75 knot (1.4 day, assuming that the seals may be There are no subsistence uses for km/hr). seen more than once, and using a Pacific harbor seals in California waters, (7) As alternate dredge methods are maximum total of 83 operating days in and, thus, there are no anticipated explored, the dredge contractor may 2004–2005, NMFS estimates that 145 to effects on subsistence needs. 623 Pacific harbor seals may be subject introduce quieter techniques and Conclusions equipment. to Level B harassment. During wharf modification activities, NMFS has determined that the impact Monitoring a maximum of 6 California sea lions of conducting harbor activities related to As part of its 2002 application, Boeing were seen hauling out in a single day, the Delta IV/EELV at VAFB, including provided a proposed monitoring plan averaging between 1 and 6 sea lions transport vessel operations, cargo for assessing impacts to harbor seals each day. Based on its own calculations, movement activities, harbor from the activities at south VAFB harbor NMFS believes that a total of 100 maintenance dredging, and kelp habitat and for determining when mitigation California sea lions, 10 northern mitigation will result in the harassment measures should be employed. NMFS elephant seals, and 5 northern fur seals of small numbers of Pacific harbor seals, adopts the same plan for this IHA. may be subject to Level B harassment, California sea lions, northern elephant A NMFS-approved and VAFB- because they may be in nearby waters. seals, and northern fur seals; would designated biologically trained observer have a negligible impact on these Possible Effects of Activities on Marine marine mammal stocks; and would not will monitor the area for pinnipeds Mammal Habitat during all harbor activities. During have an unmitigable adverse impact on nighttime activities, the harbor area will Boeing anticipates no loss or the availability of marine mammal be illuminated, and the monitor will use modification to the habitat used by stocks for subsistence uses. Guadalupe a night vision scope. Monitoring Pacific harbor seals or California sea fur seals and Steller sea lions are activities will consist of: lions that haul out near the south VAFB unlikely to be found in the area and, (1) Conducting baseline observation of harbor. The harbor seal and sea lion therefore, will not be affected. While pinnipeds in the project area prior to haul-out sites near south VAFB harbor behavioral modifications may be made initiating project activities. are not used as breeding, molting, or by the affected species to avoid the (2) Conducting and recording mating sites; therefore, it is not expected resultant acoustic and visual stimuli, observations on pinnipeds in the that the activities in the harbor will there is no potential for large-scale vicinity of the harbor for the duration of have any impact on the ability of Pacific movements, such as stampedes, since the activity occurring when tides are harbor seals or California sea lions in harbor seals and California sea lions low enough for pinnipeds to haul out the area to reproduce. haul out in small numbers near the site (2 ft (0.61 m) or less). Boeing does anticipate unavoidable and northern elephant seals and (3) Conducting post-construction kelp removal during dredging. This northern fur seals do not haul out in the observations of pinniped haul-outs in habitat modification will not affect the harbor area. The effects of Boeing’s the project area to determine whether marine mammal habitat. However, harbor activities are expected to be animals disturbed by the project Boeing will mitigate for the removal of limited to short-term and localized activities return to the haul-out. kelp habitat by placing 150 tons (136.08 behavioral changes. metric tons) of rocky substrate in a Due to the localized nature of these Reporting sandy area between the breakwater and activities, the number of marine Boeing will notify NMFS 2 weeks the mooring dolphins to enhance an mammals potentially taken by prior to initiation of each activity. After existing artificial reef. This type of harassment are estimated to be small. In each activity is completed, Boeing will mitigation was implemented by the addition, no take by injury and/or death provide a report to NMFS within 90 Army Corps of Engineers following the is anticipated, and the potential for days. This report will provide dates and 1984 and 1989 dredging. A lush kelp temporary or permanent hearing locations of specific activities, details of bed adjacent to the sandy area has impairment is unlikely given the low seal behavioral observations, and developed from the efforts. The noise levels expected at the site. No estimates of the amount and nature of substrate will consist of approximately rookeries, mating grounds, areas of all takes of seals by harassment or in 150 sharp-faced boulders, each with a concentrated feeding, or other areas of

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special significance for marine 1506.3 and has made its own FONSI. A Statement. Related data collection mammals occur within or near south copy of the ENSRI EA and the NMFS issues will also be discussed. A panel of VAFB harbor. This activity is expected FONSI for this activity is available upon independent advisors has been invited to result in no more than a negligible request (see ADDRESSES). to work with the TIQ Analytical Team impact on the affected species or stocks. on these issues during the meeting. Authorization Although non-emergency issues not Endangered Species Act (ESA) NMFS has issued an IHA to take contained in the TIQ Analytical Team This action will not affect species marine mammals, by harassment, meeting agenda may come before the listed under the Endangered Species Act incidental to conducting harbor group for discussion, those issues may (ESA) that are under the jurisdiction of activities at VAFB to Boeing for a 1–year not be the subject of formal committee NMFS. VAFB formally consulted with period, provided the mitigation, action during these meetings. TIQ U.S. Fish and Wildlife Service (FWS) in monitoring, and reporting requirements Analytical Team action will be 1998 on the possible take of southern are undertaken. restricted to those issues specifically sea otters during Boeing’s harbor Dated: May 19, 2004. listed in this notice and to any issues activities at south VAFB. A Biological arising after publication of this notice Stephen L. Leathery, Opinion was issued in August 2001. requiring emergency action under FWS recognized that Boeing will restore Acting Director, Office of Protected Resources, Section 305(c) of the Magnuson-Stevens National Marine Fisheries Service. sea otter habitat (i.e., kelp beds) in the Fishery Conservation and Management vicinity of the harbor to replace kelp [FR Doc. 04–11801 Filed 5–24–04; 8:45 am] Act, provided the public has been destroyed during dredging and stated BILLING CODE 3510–22–S notified of the group’s intent to take that there would not be takes of final action to address the emergency. southern sea otters. In addition, the FWS noting that VAFB has committed DEPARTMENT OF COMMERCE Special Accommodations to a southern sea otter monitoring National Oceanic and Atmospheric The meeting is physically accessible program designed to detect the presence Administration to people with disabilities. Requests for and possible disturbance at the VAFB sign language interpretation or other harbor area during dredging activities [I.D. 051904A] auxiliary aids should be directed to Ms. (see 68 FR 36540, June 18, 2003). Carolyn Porter at (503) 820–2280 at least Pacific Fishery Management Council; 5 days prior to the meeting date. National Environmental Protection Act Public Meeting (NEPA) Dated: May 20, 2004. AGENCY: National Marine Fisheries ENSR International (ENSRI) made a Matteo J. Milazzo, Service (NMFS), National Oceanic and Finding of No Significant Impact Acting Director, Office of Sustainable Atmospheric Administration (NOAA), (FONSI) determination on August 15, Fisheries, National Marine Fisheries Service. Commerce. 2001, based on information contained [FR Doc. 04–11803 Filed 5–24–04; 8:45 am] within its Environmental Assessment ACTION: Notice of public meeting. BILLING CODE 3510–22–S (EA), that implementation of the subject SUMMARY: The Pacific Fishery action is not a major Federal action Management Council’s (Council) Ad DEPARTMENT OF COMMERCE having significant effects on the Hoc Groundfish Trawl Individual Quota environment within the meaning of Analytical Team (TIQ Analytical Team) National Oceanic and Atmospheric Executive Order 12114. ENSRI will hold a working meeting, which is Administration determined therefore, that an open to the public. environmental impact statement would [I. D. 052004C] DATES: not be prepared. On April 7, 2004 (69 The TIQ Analytical Team FR 18353), NMFS noted that ENSRI had working meeting will begin Tuesday, Fisheries of the Exclusive Economic prepared an EA for the VAFB harbor June 8, 2004 at 8:30 a.m. and may go Zone Off Alaska; Application for an activities and made this EA available into the evening until business for the Exempted Fishing Permit upon request. In accordance with day is completed. The meeting will reconvene from 8 a.m. and continue AGENCY: National Marine Fisheries NOAA Administrative Order 216–6 Service (NMFS), National Oceanic and (Environmental Review Procedures for until business for the day is complete on Wednesday, June 9, 2004. Atmospheric Administration (NOAA), Implementing the National Commerce. ADDRESSES: The meeting will be held at Environmental Policy Act, May 20, ACTION: Notice of receipt of an 1999), NMFS has reviewed the The University Inn, Orcus Room, 4140 Roosevelt Way NE, Seattle, WA 98105; application for an exempted fishing information contained in ENSRI’s EA permit. and determined that the ENSRI EA telephone: (206) 632–5055. accurately and completely describes the Council address: Pacific Fishery SUMMARY: NMFS has received an proposed action alternative, reasonable Management Council, 7700 NE application for an exempted fishing additional alternatives, and the Ambassador Place, Suite 200, Portland, permit (EFP) from the Washington Sea potential impacts on marine mammals, OR 97220–1384. Grant Program (WSGP). If granted, this endangered species, and other marine FOR FURTHER INFORMATION CONTACT: Mr. EFP would authorize the applicant to life that could be impacted by the Jim Seger, Staff Officer (Economist); conduct an experiment to evaluate the preferred alternative and the other telephone: (503) 820–2280. integrated weight groundline as a alternatives. Therefore, it is not SUPPLEMENTARY INFORMATION: The potential seabird avoidance measure in necessary to issue a new EA, purpose of the TIQ Analytical Team the fall 2004 Pacific cod hook-and-line supplemental EA or an environmental meeting is to conduct preliminary fishery in the Bering Sea and Aleutian impact statement for the issuance of an scoping on the types impacts to be Islands Management Area (BSAI). The IHA to Boeing for this activity. Based on considered and analytical methods used project is intended to promote the this review and analysis, NMFS is in a groundfish trawl dedicated access objectives of the Fishery Management adopting the ENSRI EA under 40 CFR privilege Environmental Impact Plan for the Groundfish Fishery of the

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Bering Sea and Aleutian Islands Area experiment would fulfill such a on the EFP, once they have been (FMP) by reducing fishery interactions recommendation. selected for the project. The NMFS with the endangered short-tailed The goal of the experiment is to Regional Administrator may consider albatross (Phoebastria albatrus) and reduce the incidental catch of the and attach additional terms and other seabird species. endangered short-tailed albatross and conditions to the EFP that are consistent ADDRESSES: Copies of the EFP other seabird species in ways that are with the purpose of the experiment. application may be requested from Sue consistent with Magnuson-Stevens Act Public comment may help determine Salveson, Assistant Regional National Standard 9 which requires such conditions. Administrator for Sustainable Fisheries, conservation and management measures A copy of the application is available Alaska Region, NMFS, Attn: Lori Durall to minimize bycatch and bycatch for review from NMFS (see ADDRESSES). by: mail to P. O. Box 21668, Juneau, AK mortality and that the effects on birds Authority: 16 U.S.C. 1801 et seq. 99802; fax to 907–586–7557; or email to should be considered when selecting [email protected]. these measures. A preliminary WSGP Dated: May 20, 2004. Tracey L. Thompson, FOR FURTHER INFORMATION CONTACT: Kim investigation in 2002 evaluated four Rivera, 907–586–7424 or weightings of integrated weight Acting Director, Office of Sustainable [email protected]. groundline (25, 50, 75, and 100 g/m). Fisheries, National Marine Fisheries Service. The four weighting treatments were [FR Doc. E4–1208 Filed 5–24–04; 8:45 am] SUPPLEMENTARY INFORMATION: NMFS compared to a control of unweighted BILLING CODE 3510–22–S manages the domestic groundfish groundline in the sablefish fishery in fisheries in the BSAI under the FMP. the Aleutian Islands and the Pacific cod The North Pacific Fishery Management fishery in the Gulf of Alaska. DEPARTMENT OF DEFENSE Council (Council) prepared the FMP Preliminary results strongly suggest that under the Magnuson-Stevens Fishery 50 g/m line was the optimal weighting. Department of the Army Conservation and Management Act It was the most practical gear in terms (Magnuson-Stevens Act). Regulations of operational performance in Notice of Availability (NOA) for the governing the groundfish fisheries of the mechanical baiting (auto-bait) longline Final Environmental Impact Statement BSAI appear at 50 CFR parts 600 and systems and it sank quickly beyond the (EIS) for the Transformation of the 2nd 679. The FMP and the implementing range of seabirds. Brigade, 25th Infantry Division (Light) regulations at §§ 679.6 and 600.745(b) Based on these initial results, WSGP to a Stryker Brigade Combat Team authorize the issuance of EFPs to allow proposes to continue this work by (SBCT) in Hawaii fishing that would otherwise be comparing the catch rates of all species, AGENCY: Department of the Army, DoD. prohibited. Procedures for issuing EFPs the abundance and behavior of seabirds, are contained in the implementing and the sink rate of groundlines under ACTION: Notice of Availability. regulations. three scenarios: 50 g/m integrated NMFS received an application for an SUMMARY: The Proposed Action includes weight groundline, and un-weighted training to be conducted at Schofield EFP from the WSGP. The purpose of groundlines with and without paired this EFP is to authorize experimental Barracks Military Reservation (SBMR), streamer lines. Regulations at 50 CFR Dillingham Military Reservation, fishing using integrated weight § 679.24(e)(4)(ii)(c) require the use of groundline to evaluate its effectiveness Kahuku Training Area and Kawailoa paired streamer lines by vessels greater Training Area on the island of Oahu and as a potential new seabird avoidance than 55 ft (16.8 m) length overall. Thus, measure. The application calls for at Po¯hakuloa Training Area on the an EFP is necessary to conduct the island of Hawaii. Twenty-eight projects testing integrated weight groundlines experimental control treatments that are proposed that would improve the against unweighted groundlines, with call for the experimental gear to be existing support structure and facilities and without paired streamer lines. This deployed in the absence of paired to provide the necessary field training proposed effort follows up on work that streamer lines, to allow fishing in a way required for an SBCT. These projects was completed in Alaska in 2002, and that would otherwise be prohibited. include construction of ranges, airfield compliments efforts taking place in Work will take place on two freezer- upgrades, land acquisition, and new other fisheries. Information from this longliner vessels using auto-bait systems equipment such as new and modernized experiment could ultimately result in in the Pacific cod fishery in the BSAI vehicles (namely the Stryker, an eight- better and more effective seabird during the fall of 2004, and during 2005, wheeled, 20-ton combat vehicle) and avoidance measures. The hook-and-line if unforeseen circumstances prohibit weapons systems (105mm cannon, 155 fishing industry appears especially completion of the work in 2004. interested in this experiment, because it In accordance with § 679.6, NMFS has mm howitzer, and 120mm mortar). The may provide them a better tool with determined that the application number of soldiers and vehicles which to avoid the incidental catch of warrants further consideration and has stationed at SBMR also would increase. the endangered short-tailed albatross initiated consultation with the Council The Army would acquire land on the and other seabird species. In addition, by forwarding the application to the island of Oahu (approximately 1,400 potential exists for improved fishing Council for consultation. The Council acres) and on the island of Hawaii. efficiency with better gear handling will consider the application during its (approximately 23,000 acres) for characteristics and increased target June 9–15, 2004, meeting which will be training areas and road construction. catch rates resulting from getting baited held at the Benson Hotel in Portland, DATES: The waiting period for the Final hooks down more quickly. The U.S. Oregon. While the applicant has been EIS will end 30 days after publication of Fish and Wildlife Service issued a invited to appear in support of the the NOA in the Federal Register by the Biological Opinion (September 2003) application, all interested parties may U.S. Environmental Protection Agency. that includes a conservation comment on the application at the ADDRESSES: Direct questions and/or recommendation for NMFS to support meeting during public testimony. written comments regarding the Final research efforts to develop new and The vessels that would conduct the EIS to, or a request for a copy of the novel deterrent technologies such as experimental fishing were not identified document from, Ms. Cindy Barger, U.S. integrated weight groundlines. This on the application, but will be identified Army Corps of Engineers, Honolulu

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Engineer District, Program and Project DEPARTMENT OF DEFENSE CATEGORIES OF INDIVIDUALS COVERED BY THE Management, Attention: CEPOH–PP–E SYSTEM: Department of the Navy (Barger), Building 230, Room 306, Fort All aeronautically designated Shafter, Hawaii 96858–5540. Privacy Act of 1974; System of commissioned Navy and U.S. Marine FOR FURTHER INFORMATION CONTACT: Ms. Records Corps officers and enlisted members Cindy Barger at (808) 438–4812; by assigned as aircrew members in the facsimile at (808) 438–7801; or by e-mail AGENCY: Department of the Navy operation of an aircraft. at [email protected]. ACTION: Notice to add systems of records. CATEGORIES OF RECORDS IN THE SYSTEM: SUPPLEMENTARY INFORMATION: The SBCT Final EIS analyzes three alternative SUMMARY: The Department of the Navy OPNAV Forms 3710/2, 3710/7, 3760/ courses of action with respect to the proposes to add two systems of records 32–32I, and NAVMED 6410/1 or 6410/ transformation of the 2nd Brigade, 25th notices to its inventory of record 2; containing name and Social Security Infantry Division in Hawaii: (1) The systems subject to the Privacy Act of Number of aircrew member; general transformation of the 2nd Brigade, 25th 1974 (5 U.S.C. 552a), as amended. flight-related information, including Infantry Division (Light) to an SBCT DATES: This action will be effective on jacket review and certification record; a with a range of supporting activities June 24, 2004, unless comments are copy of the most recent PCS orders; including new, additional, or modified received that would result in a contrary recent aero-medical clearance or ranges, facilities and infrastructure and determination. grounding notice; and the flight acquisition of approximately 1,400 acres ADDRESSES: Send comments to the equipment issue record. Flight of additional training lands on the Department of the Navy, PA/FOIA qualifications and achievements island of Oahu and 23,000 acres on the Policy Branch, Chief of Naval information, including a flight island of Hawaii (preferred alternative); Operations (DNS–36), 2000 Navy personnel designation record and a (2) the transformation of the 2nd Pentagon, Washington, DC 20350–2000. mission qualification record. Flight Brigade, 25th Infantry Division (Light) FOR FURTHER INFORMATION CONTACT: Mrs. training information, including schools to an SBCT with a range of supporting and courses attendance records, activities including new, additional, or Doris Lama at (202) 685–6545 or DSN 325–6545. operational physiology and survival modified ranges, facilities and training record, NATOPS examinations SUPPLEMENTARY INFORMATION: The infrastructure, and acquisition of record, NATOPS evaluation reports, and Department of the Navy’s record system approximately 100 acres of additional instrument rating reports. Flight notices for records systems subject to training lands on the island of Oahu and records, including copies of Monthly 23,000 acres on the island of Hawaii; (3) the Privacy Act of 1974 (5 U.S.C. 552a), as amended, have been published in the Individual flight Activity Reports and the no action alternative, under which aircrft mishap/violation record. no transformation would occur in the Federal Register and are available from the address above. near term and training would continue AUTHORITY FOR MAINTENANCE OF THE SYSTEM: as currently exists. The proposed system reports, as required by 5 U.S.C. 552a(r) of the 10 U.S.C. 5013, Secretary of the Navy; Copies of the SBCT Final EIS are Privacy Act, were submitted on May 17, 10 U.S.C. 5041, Headquarters, Marine available for review at the following 2004, to the House Committee on Corps; OPNAVINST 3710.7, NATOPS libraries: Hilo Public Library, 300 Government Reform, the Senate General Flight and Operating Waianuenue Avenue, Hilo; Kailua-Kona Committee on Governmental Affairs, Instructions; and E.O. 9397 (SSN). Public Library, 75–138 Hualalai Road, and the Office of Management and Kailua-Kona; Thelma Parker Memorial Budget (OMB) pursuant to paragraph 4c PURPOSE(S): Public and School Library, 96767–1209 of Appendix I to OMB Circular No. A– Mamalahoa Highway, Kamuela; Kahuku 130, Federal Agency Responsibilities for To provide a consolidated record of Public and School Library, 56–490 Maintaining Records About Individuals, the training status and readiness of an Kamehameha Highway, Kahuku; dated February 8, 1996, (61 FR 6427, air crewman and serve as a repository Mililani Public Library, 95–450 February 20, 1996). for certain aviation records accumulated Makaimoimo Street, Mililani; Hawaii during active aviation tours, and to State Library, 478 South King Street, Dated: May 18, 2004. prove commanding officers with Honolulu; Wahiawa Public Library, 820 L.M. Bynum, pertinent data to assist in assignment, California Avenue, Wahiawa; Waianae Alternate OSD Federal Register Liaison utilization, and training of an air Public Library, 85–625 Farrington Officer, Department of Defense. crewman. Highway., Waianae; Waialua Public NM03760–3 Library, 67–068 Kealohanui Street, ROUTINE USES OF RECORDS MAINTAINED IN THE Waialua; UH Environmental Center, SYSTEM NAME: SYSTEM, INCLUDING CATEGORIES OF USERS AND Krauss Annex 19, 2500 Dole Road, NATOPS Flight Personnel Training/ THE PURPOSES OF SUCH USES: Honolulu. Qualification Jacket. In addition to those disclosures The Final EIS also may be reviewed SYSTEM LOCATION: generally permitted under 5 U.S.C. at the SBCT Web Site http:// The NATOPS Flight Personnel 552(b) of the Privacy Act, these records www.SBCTEIS.com. Training and Qualification Jacket or information contained therein may Dated: May 18, 2004. accompanies the individual aircrew specifically be disclosed outside the Raymond J. Fatz, member throughout his career in the DoD as a routine use pursuant to 5 Deputy Assistant Secretary of the Army, Navy or U.S. Marine Corps. Upon U.S.C. 552(b)(3) as follows: (Environment, Safety and Occupational completion of service, the jacket will be The DoD ‘Blanket Routine Uses’ that Health), OASA(I&E). given to the individual. For a deceased, appear at the beginning of the Navy’s [FR Doc. 04–11752 Filed 5–24–04; 8:45 am] missing, or captured air crewman, the compilation of systems and records BILLING CODE 3710–08–M jacket will be treated as personal effects. notices apply to the system.

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POLICIES AND PRACTICES FOR STORING, dates assigned, and be signed by the PURPOSE(S): RETRIEVING, ACCESSING, RETAINING, AND requester. To provide a personal flight record for DISPOSING OF RECORDS IN THE SYSTEM: the individual aircrew member, to serve CONTESTING RECORD PROCEDURES: STORAGE: as a record of certain aviation The Navy’s rules for accessing Paper and automated records. information developed during active records, and for contesting contents and aviation tours, and to provide appealing initial agency determinations RETRIEVABILITY: commanding officers with pertinent are published in the Secretary of the Name and Social Security Number. data to assist in assignment, utilization, Navy Instruction 5211.5; 32 CFR part and training of the air crewman. SAFEGUARDS: 701; or may be obtained from the system Physical access in restricted to the manager. ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND individual and those who maintain RECORD SOURCE CATEGORIES: THE PURPOSES OF SUCH USES: training records, or those who are Individual aeronautically designated directly involved with individual’s In addition to those disclosures Navy and Marine Corps officer or generally permitted under 5 U.S.C. training or evaluation. The aviation enlisted aircrew member; aviation unit unit’s file cabinets containing the 552(b) of the Privacy Act, these records personnel; academic tests support flight of information contained therein may jackets are in command areas under training, flight performance evaluations, normal military 24-hour security specifically be disclosed outside the check flight evaluations, aviation DoD as a routine use pursuant to 5 measures. May also be resident in a physiology training and Individual U.S.C. 552(b) of the Privacy Act, these password controlled system with file Flight Activity Reporting System data records or information contained and element access based on predefined extracts. need-to-know. Physical access to therein may specifically be disclosed terminals, terminal rooms, buildings EXEMPTIONS CLAIMED FOR THE SYSTEM: outside the DoD as a routine use and activities’ grounds are controlled by None. pursuant to 5 U.S.C. 552(b)(3) as follows: locked terminals and room, guards, NM03760–4 personnel screening and visitor The DoD ‘Blanket Routine Uses’ that registers. SYSTEM NAME: appears at the beginning of the Navy’s Aviator’s Flight Log Book System. compilation of systems and records RETENTION AND DISPOSAL: notices apply to this system. SYSTEM LOCATION: Upon detachment from a squadron/ POLICIES AND PRACTICES FOR STORING, Aviation unit to which the individual command or from active duty service, RETRIEVING, ACCESSING, RETAINING, AND the jacket will be reviewed, certified by aircrew member is assigned. When not DISPOSING OF RECORDS IN THE SYSTEM: the commanding officer or designated assigned to an aviation unit, the STORAGE: representative, and given to the individual maintains custody of the log individual. For a deceased, missing, or book. Paper and automated records. captured air crewman, the jacket will be CATEGORIES OF INDIVIDUALS COVERED BY THE RETRIEVABILITY: treated as personal effects. SYSTEM: Name and Social Security Number. SYSTEM MANAGER AND ADDRESS: All aeronautically designated commissioned Navy and U.S. Marine SAFEGUARDS: Commander Naval Air Force, U.S. Corps officers and enlisted members Access is restricted to the individual Pacific Fleet, Code N32, NAS North assigned as aircrew members in the and those who maintain training Island, P.O. Box 357051, San Diego, CA operation of an aircraft. Possession and records, or those who are directly 92135–7051. maintenance of the log book is involved with the individual’s training NOTIFICATION PROCEDURE: mandatory for all Naval Aviators, or evaluation. The file cabinets or Individuals seeking to determine Student Naval Aviators, Naval Flight bookshelves containing the log books whether information about themselves Officer, and Student Naval Flight are in command areas under normal is contained in this system should Officers. Possession and maintenance of military 24-hour security measures. address written inquiries to Commander the log book is optional for other Automated systems are password Naval Air Force, U.S. Pacific Fleet, Code personnel on duty involving flying. protected and accessible only by individuals having an official need to N32, NAS North Island, P.O. Box CATEGORIES OF RECORDS IN THE SYSTEM: know. 357051, San Diego, CA 92135–7051. OPNAV Form 3760/31 (Aviators The request should contain the full Flight Log Book), containing name and RETENTION AND DISPOSAL: name and Social Security Number of the Social Security Number of aircrew Upon detachment from squadron/ individual, the squadron assigned and member, contains sections for the command or from active duty service, dates assigned, and be signed by the aviator’s qualifications and the log book will be given to the requester. achievements, personal changes, individual. For a deceased, missing, or summary of total flight record, flight RECORD ACCESS PROCEDURE: captured air crewman, the log book will record summary, summary of pilot time, be treated as personal effects. Individuals seeking access to record of individual flights, flight information about themselves contained clothing record, accident and flight rule SYSTEM MANAGER AND ADDRESS: in this system should address written violation record, and mishap record. Commander Naval Air Forces (N32), inquiries to the Commander Naval Air NAS North Island, P.O. Box 357051, San Force, U.S. Pacific Fleet, Code N32, AUTHORITY FOR MAINTENANCE OF THE SYSTEM: Diego, CA 92135–7051. NAS North Island, P.O. Box 357051, San 10 U.S.C. 5013, Secretary of the Navy; Diego, CA 92135–7051. 10 U.S.C. 5041, Headquarters, Marine NOTIFICATION PROCEDURE: The request should contain the full Corps; OPNAVINST 3710.7, NATOPS Individuals seeking to determine name and Social Security Number of the General Flight and Operating whether information about themselves individual, the squadron assigned and Instructions; and E.O. 9397 (SSN). is contained in this system should

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address written inquiries to the ADDRESSES: Send comments to Commander, U.S. Joint Forces Commander Naval Air Forces (N32), Department of the Navy, PA/FOIA Command, 1562 Mitscher Avenue, Suite NAS North Island, P.O. Box 357051, San Policy Branch, Chief of Naval 200, Norfolk, VA 23551–2488. Diego, CA 92135–7051. Operations, (DNS–36), 2000 Navy Commander, U.S. Pacific Command, The request should contain the full Pentagon, Washington, DC 20350–2000. P.O. Box 64028, Camp H.M. Smith, HI name and Social Security Number of the FOR FURTHER INFORMATION CONTACT: Mrs. 96861–4028. individual, the squadron assigned and Doris Lama at (202) 685–6545 or DSN CATEGORIES OF INDIVIDUALS COVERED BY THE dates assigned, and be signed by the 325–6545. SYSTEM: requester. SUPPLEMENTARY INFORMATION: The Military and civilian personnel. Department of the Navy systems of RECORD ACCESS PROCEDURE: records notices subject to the Privacy CATEGORIES OF RECORDS IN THE SYSTEM: Individuals seeking access to Act of 1974, (5 U.S.C. 552a), as Record contains such information as information about themselves contained amended, have been published in the name, grade/rate, Social Security in this system should address written Federal Register and are available from Number, organizational code, work inquiries to the Commander Naval Air the address above. center code, grade code, pay rate, labor Forces (N32), NAS North Island, P.O. The specific changes to the records code, type transaction, hours assigned. Box 357051, San Diego, CA 92135–7051. systems being amended are set forth Database includes scheduling and The request should contain the full below followed by the notices, as assignment of work; skill level; tools name and Social Security Number of the amended, published in their entirety. issued; leave; temporary assignments to individual, the squadron assigned and The proposed amendments are not other areas. dates assigned, and be signed by the within the purview of subsection (r) of requester. the Privacy Act of 1974, (5 U.S.C. 552a), AUTHORITY FOR MAINTENANCE OF THE SYSTEM: as amended, which requires the 10 U.S.C. 5013, Secretary of the Navy; CONTESTING RECORD PROCEDURES: submission of a new or altered system 10 U.S.C. 5041, Headquarters, Marine The Navy’s rules for accessing report. Corps; and E.O. 9397 (SSN). records, and for contesting contents and Dated: May 18,2004. appealing initial agency determinations PURPOSE(S): are published in the Secretary of the L.M. Bynum, To effectively manage the work force. Navy Instruction 5211.5; 32 CFR part Alternate OSD Federal Register Liaison Officer, Department of Defense. ROUTINE USES OF RECORDS MAINTAINED IN THE 701; or may be obtained from the system SYSTEM, INCLUDING CATEGORIES OF USERS AND manager. N12610–1 THE PURPOSES OF SUCH USES:

RECORD SOURCE CATEGORIES: SYSTEM NAME: In addition to those disclosures Individual aeronautically designated Hours of Duty Records (May 9, 2003, generally permitted under 5 U.S.C. Navy or Marine Corps officer or enlisted 68 FR 24959). 552a(b) of the Privacy Act, these records crewmember, academic tests supporting or information contained therein may CHANGES: flight training, flight performance specifically be disclosed outside the evaluations, flight check evaluations, SYSTEM IDENTIFIER: DoD as a routine use pursuant to 5 aviation physiology training, and Replace entry with ‘NM12610’ 1. U.S.C. 552a(b)(3) as follows: The DoD ‘Blanket Routine Uses’ that transcribed Individual Flight Activity * * * * * appear at the beginning of the Navy’s Reporting System data. SYSTEM LOCATION: compilation of systems of records EXEMPTIONS CLAIMED FOR THE SYSTEM: Delete first paragraph and replace notices apply to this system. None. with ‘Organizational elements of the POLICIES AND PRACTICES FOR STORING, Department of the Navy. Official [FR Doc. 04–11688 Filed 5–24–04; 8:45 am] RETRIEVING, ACCESSING, RETAINING, AND mailing addresses are published in the DISPOSING OF RECORDS IN THE SYSTEM: BILLING CODE 5001–06–M Standard Navy Distribution List that is STORAGE: available at http://neds.nebt.daps.mil/ Paper and computerized records. DEPARTMENT OF DEFENSE sndl.htm.’ * * * * * RETRIEVABILITY: Department of the Navy AUTHORITY FOR MAINTENANCE OF THE SYSTEM: Name, organization code, Social Security Number, and work center. Privacy Act of 1974; System of Delete entry and replace with ‘10 Records U.S.C. 5013, Secretary of the Navy; 10 SAFEGUARDS: U.S.C. 5041, Headquarters, Marine Access is provided on need-to-know AGENCY: Department of the Navy, DoD. Corps; and E.O. 9397 (SSN).’ basis only. Manual records are ACTION: Notice to amend a system of * * * * * maintained in file cabinets under the records. NM12610–1 control of authorized personnel during working hours. The office space in SUMMARY: The Department of the Navy SYSTEM NAME: which the file cabinets are located is is amending a system of records notice locked outside of official working hours. in its existing inventory of records Hours of Duty Records Computer terminals are located in systems subject to the Privacy Act of SYSTEM LOCATION: supervised areas. Access to 1974, (5 U.S.C. 552a), as amended. Organizational elements of the computerized data is controlled by DATES: This proposed action will be Department of the Navy. Official password or other user code system. effective without further notice on June mailing addresses are published in the 24, 2004, unless comments are received Standard Navy Distribution List that is RETENTION AND DISPOSAL: which result in a contrary available at http://neds.nebt.daps.mil/ Records are destroyed when three determination. sndl.htm. years old.

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SYSTEM MANGER(S) AND ADDRESS: completion of the Water Resources Plan County, Pennsylvania. Following The commanding officer of the for the Delaware River Basin; a tertiary treatment, the effluent will be activity in question. Official mailing proposed resolution amending the discharged to an unnamed tributary of addresses are published in the Standard Water Quality Regulations, Water Code, the Little Neshaminy Creek in the Navy Distribution List that is available and Comprehensive Plan by authorizing Neshaminy Creek Watershed. the Commission to require waste at http://neds.nebt.daps.mil/sndl.htm. The Commission’s 1 p.m. business minimization plans for point and non- NOTIFICATION PROCEDURE: point dischargers; and a proposed meeting also will include consideration Individuals seeking to determine resolution amending the Water Code of a resolution to initiate a notice and whether this system of records contains and Comprehensive Plan relating to comment rulemaking process to amend information about themselves should basin reservoir operations during the Water Quality Regulations, Water address written inquiries to the drought. Code, and Comprehensive Plan by commanding officer of the naval activity The subjects of the public hearing to authorizing the Commission to require where currently employed. Official be held during the 1 p.m. business waste minimization plans for point and mailing addresses are published in the meeting include the dockets listed non-point dischargers; a resolution to Standard Navy Distribution List that is below: initiate a notice and comment available at http://neds.nebt.daps.mil/ 1. Borough of Catasauqua D–87–60 CP rulemaking process to amend the Water sndl.htm. RENEWAL 2. An application for the Code and Comprehensive Plan relating renewal of a ground water withdrawal to basin reservoir operations during RECORD ACCESS PROCEDURES: project to continue withdrawal of 40mg/ drought, for purposes of clarification; a Individuals seeking access to records 30 days to supply the applicant’s public resolution authorizing the executive about themselves contained in this water supply distribution system from director to enter into agreements with existing Wells Nos. 1, 2, 4, and 5 in the system of records should address the U.S. Army Corps of Engineers, PPL written inquiries to the commanding Epler formation. The project is located Holtwood, LLC and others as officer of the naval activity where in Catasauqua Borough, Lehigh County, appropriate to fund a study to determine currently employed. Official mailing Pennsylvania. flow needs of the dwarf wedgemussel in addresses are published in the Standard 2. Northampton Borough Municipal Navy Distribution List that is available Authority D–2004–6 CP. An application the upper basin; a resolution at http://neds.nebt.daps.mil/sndl.htm. to increase the surface water withdrawal authorizing the executive director to from 6 million gallons per day (mgd) to enter into a contract for analytical CONTESTING RECORDS PROCEDURES: 8 mgd from the applicant’s existing services to support the Lower Delaware The Navy’s rules for accessing intakes on the Lehigh River, which are monitoring program; a resolution records, and for contesting contents and located at the northern tip of Whitehall providing for election of the appealing determinations are published Township, Lehigh County, Commission Chair, Vice Chair and in Secretary of the Navy Instruction Pennsylvania. The water will continue Second Vice Chair for the year 2004– 5211.5; 32 CFR part 701; or may be to supply the applicant’s distribution 2005, commencing July 1, 2004. In obtained from the system manager. system which serves the Boroughs of addition, the meeting will include: Northampton and North Catasauqua in adoption of the Minutes of the April 21, RECORD SOURCE CATEGORIES: Northampton County; and the Borough 2004, business meeting; Individual, correspondence, and of Coplay plus a portion of Whitehall announcements; a report on Basin personnel records. Township in Lehigh County. The hydrologic conditions; a report by the project requires only the upgrade of two EXEMPTIONS CLAIMED FOR THE SYSTEM: executive director; and a report by the raw water pumping stations with new Commission’s general counsel. None. pumping facilities. [FR Doc. 04–11689 Filed 5–24–04; 8:45 am] 3. Stony Creek Anglers, Inc. D–2004– Draft dockets scheduled for public BILLING CODE 5001–06–M 12. An application for approval of a hearing on June 2, 2004, are posted on ground water withdrawal project to the Commission’s Web site, http:// supply up to 5.2 million gallons (mg)/ www.drbc.net, where they can be 30 days of water to the applicant’s trout DELAWARE RIVER BASIN accessed through the Notice of nursery from Well No. 2 in the Stockton COMMISSION Commission Meeting and Public Formation, and to retain the existing Hearing. Additional documents relating Notice of Commission Meeting and withdrawal from all wells to 5.2 mg/30 to the dockets and other items may be Public Hearing days. The project well is located in the examined at the Commission’s offices. Stony Creek Watershed in West Please contact William Muszynski at Notice is hereby given that the Norriton Township, Montgomery 609–883–9500 ext. 221 with any docket- Delaware River Basin Commission will County, Pennsylvania and is located in related questions. hold an informal conference followed the Southeastern Pennsylvania Ground by a public hearing on Wednesday, June Water Protected Area. Individuals in need of an 2, 2004. The hearing will be part of the 4. Warminster Municipal Authority D– accommodation as provided for in the Commission’s regular business meeting. 2004–21 CP. An application to construct Americans with Disabilities Act who Both the conference session and a 1.2 million gallon per day (mgd) wish to attend the informational business meeting are open to the public Sewage Treatment Plant (STP) to meeting, conference session or hearings and will be held at the Delaware River provide tertiary treatment of wastewater should contact the Commission Basin Commission, 25 State Police from the proposed commercial secretary directly at 609–883–9500 ext. Drive, West Trenton, New Jersey. redevelopment of the Naval Air Warfare 203 or through the Telecommunications The conference among the Center (NAWC) Site. The project is Relay Services (TRS) at 711, to discuss commissioners and staff will begin at 10 located on Jacksonville Road, near the how the Commission may accommodate a.m. Topics of discussion will include: intersection of Street Road at the NAWC your needs. An update on the development and in Warminster Township, Bucks

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Dated: May 18, 2004. respondents, including through the use opportunity to comment on information Pamela M. Bush, of information technology. collection requests. OMB may amend or Commission Secretary. Dated: May 18, 2004. waive the requirement for public [FR Doc. 04–11695 Filed 5–24–04; 8:45 am] Angela C. Arrington, consultation to the extent that public participation in the approval process BILLING CODE 6360–01–P Leader, Regulatory Information Management, Office of the Chief Information Officer. would defeat the purpose of the information collection, violate State or Office of Postsecondary Education Federal law, or substantially interfere DEPARTMENT OF EDUCATION Type of Review: Revision. with any agency’s ability to perform its Title: Student Aid Report (SAR). statutory obligations. The Leader, Notice of Proposed Information Frequency: Annually. Regulatory Information Management Collection Requests Affected Public: Individuals or Group, Office of the Chief Information households. Officer, publishes that notice containing AGENCY: Department of Education. Reporting and Recordkeeping Hour proposed information collection SUMMARY: The Leader, Regulatory Burden: requests prior to submission of these Information Management Group, Office Responses: 24,521,978. requests to OMB. Each proposed of the Chief Information Officer, invites Burden Hours: 5,402,415. information collection, grouped by comments on the proposed information Abstract: The Student Aid Report office, contains the following: (1) Type collection requests as required by the (SAR) is used to notify all applicants of of review requested, e.g. new, revision, Paperwork Reduction Act of 1995. their eligibility to receive Federal extension, existing or reinstatement; (2) DATES: Interested persons are invited to student aid for postsecondary Title; (3) Summary of the collection; (4) submit comments on or before July 19, education. Description of the need for, and 2004. Requests for copies of the proposed proposed use of, the information; (5) SUPPLEMENTARY INFORMATION: Section information collection request may be Respondents and frequency of 3506 of the Paperwork Reduction Act of accessed from http://edicsweb.ed.gov, or collection; and (6) Reporting and/or 1995 (44 U.S.C. Chapter 35) requires should be addressed to Department of Recordkeeping burden. OMB invites that the Office of Management and Education, 400 Maryland Avenue, SW., public comment. The Department of Budget (OMB) provide interested Potomac Center, 9th Floor, Washington, Education is especially interested in Federal agencies and the public an early DC 20202–4700. Requests may also be public comment addressing the opportunity to comment on information electronically mailed to the Internet following issues: (1) Is this collection collection requests. OMB may amend or address [email protected] or necessary to the proper functions of the waive the requirement for public faxed to 202–245–6623. Please specify Department; (2) will this information be consultation to the extent that public the complete title of the information processed and used in a timely manner; participation in the approval process collection when making your request. (3) is the estimate of burden accurate; would defeat the purpose of the Comments regarding burden and/or the (4) how might the Department enhance information collection, violate State or collection activity requirements should the quality, utility, and clarity of the Federal law, or substantially interfere be directed to Joseph Schubart at (202) information to be collected; and (5) how with any agency’s ability to perform its 245–6566, or via his Internet address might the Department minimize the statutory obligations. The Leader, [email protected]. Individuals who burden of this collection on the Regulatory Information Management use a telecommunications device for the respondents, including through the use Group, Office of the Chief Information deaf (TDD) may call the Federal of information technology. Officer, publishes that notice containing Information Relay Service (FIRS) at 1– Dated: May 19, 2004. proposed information collection 800–877–8339. Angela C. Arrington, requests prior to submission of these [FR Doc. 04–11605 Filed 5–24–04; 8:45 am] Leader, Regulatory Information Management requests to OMB. Each proposed BILLING CODE 4000–01–P Group, Office of the Chief Information Officer. information collection, grouped by office, contains the following: (1) Type Institute of Education Sciences of review requested, e.g., new, revision, DEPARTMENT OF EDUCATION Type of Review: New. extension, existing or reinstatement; (2) Title: Reading First Impact Study. title; (3) summary of the collection; (4) Notice of Proposed Information Frequency: Annually. description of the need for, and Collection Requests Affected Public: State, Local, or Tribal proposed use of, the information; (5) Gov’t, SEAs or LEAs; Individuals or AGENCY: respondents and frequency of Department of Education. household. SUMMARY: collection; and (6) reporting and/or The Leader, Regulatory Reporting and Recordkeeping Hour Recordkeeping burden. OMB invites Information Management Group, Office Burden: public comment. The Department of of the Chief Information Officer, invites Responses: 75,347 Education is especially interested in comments on the proposed information Burden Hours: 110,320. public comment addressing the collection requests as required by the Abstract: The Reading First Impact following issues: (1) Is this collection Paperwork Reduction Act of 1995. Study is a five-year evaluation of the necessary to the proper functions of the DATES: Interested persons are invited to effectiveness of the Reading First Department; (2) will this information be submit comments on or before July 26, Program. This study will estimate the processed and used in a timely manner; 2004. impact of the program on student (3) is the estimate of burden accurate; SUPPLEMENTARY INFORMATION: Section reading achievement through the use of (4) how might the Department enhance 3506 of the Paperwork Reduction Act of a regression discontinuity design that the quality, utility, and clarity of the 1995 (44 U.S.C. Chapter 35) requires compares Reading First schools with information to be collected; and (5) how that the Office of Management and non-Reading First schools. might the Department minimize the Budget (OMB) provide interested Requests for copies of the proposed burden of this collection on the Federal agencies and the public an early information collection request may be

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accessed from http://edicsweb.ed.gov, meeting mandated Federal energy implementing the new interim by selecting the ‘‘Browse Pending management goals. generation market power analysis and Collections’’ link and by clicking on Tentative Agenda: Agenda will mitigation policy announced in the link number 2556. When you access the include discussions on the following Commission’s April 14, 2004 Order in information collection, click on topics: AEP Power Marketing, Inc., et al., 107 ‘‘Download Attachments’’ to view. • Review of FEMP activities. FERC ¶ 61,018 (2004), reh’g pending • Written requests for information should Report on FEMAC Working Groups. (SMA Rehearing Order). This order • Discussion on FEMAC priorities. be addressed to Department of • benefits customers by implementing the Education, 400 Maryland Avenue, SW., Votes on Working Group reports policies adopted in the SMA Rehearing Potomac Center, 9th Floor, Washington, and recommendations. Order, which improve the assessment Public Participation: In keeping with DC 20202–4700. Requests may also be and mitigation of generation market procedures, members of the public are electronically mailed to the Internet power in wholesale markets, thus better _ welcome to observe the business of the ensuring that prices charged for address OCIO [email protected] or faxed to Federal Energy Management Advisory 202–245–6623. Please specify the jurisdictional sales are just and Committee. If you would like to file a reasonable. complete title of the information written statement with the committee, collection when making your request. you may do so either before or after the Background Comments regarding burden and/or meeting. If you would like to make oral the collection activity requirements 2. In an order issued on November 20, statements regarding any of these items 1 should be directed to Kathy Axt at her 2001, the Commission announced a on the agenda, you should contact Rick new generation market power test, the e-mail address Kathy [email protected]. Klimkos at (202) 586–8287 or Individuals who use a Supply Margin Assessment (SMA), to be [email protected] (e-mail). You applied to market-based rate telecommunications device for the deaf must make your request for an oral (TDD) may call the Federal Information applications on an interim basis statement at least 5 business days before pending a generic review of new Relay Service (FIRS) at 1–800–877– the meeting. Members of the public will 8339. methods for analyzing market power. It be heard in the order in which they sign also established mitigation measures [FR Doc. 04–11748 Filed 5–24–04; 8:45 am] up at the beginning of the meeting. applicable to entities that fail the BILLING CODE 4000–01–P Reasonable provision will be made to interim generation market power test. include the scheduled oral statements 3. In the SMA Rehearing Order, the on the agenda. The chair of the Commission granted rehearing of the DEPARTMENT OF ENERGY committee will make every effort to hear SMA Order to the extent that it replaced the views of all interested parties. The the SMA generation market power test Office of Energy Efficiency and chair will conduct the meeting to with two ‘‘indicative screens’’ for Renewable Energy facilitate the orderly conduct of assessing generation market power and business. modified the mitigation announced in Federal Energy Management Advisory Minutes: The minutes of the meeting the SMA Order. Concurrently with the Committee will be available for public review and SMA Rehearing Order, the Commission copying within 30 days at the Freedom AGENCY: Department of Energy. issued a notice establishing a generic of Information Public Reading Room, rulemaking docket to initiate a ACTION: Notice of open meeting. Room 1E–190, Forrestal Building, 1000 comprehensive review of the Independence Avenue, SW., SUMMARY: This notice announces an appropriate analysis for granting open meeting of the Federal Energy Washington, DC, between 9 a.m. and 4 market-based rate authority, in Management Advisory Committee p.m., Monday through Friday, except particular, the analysis of generation (FEMAC). The Federal Advisory Federal holidays. market power, transmission market Committee Act (Pub. L. 92–463, 86 Stat. Issued in Washington, DC on May 20, power, other barriers to entry, and 770) requires that these meetings be 2004. affiliate abuse and reciprocal dealing.2 announced in the Federal Register to Rachel M. Samuel, In the interim, the Commission allow for public participation. This Deputy Committee Management Officer. indicated that the policies it was notice announces the eighth meeting of [FR Doc. 04–11783 Filed 5–24–04; 8:45 am] adopting in the SMA Rehearing Order FEMAC, an advisory committee BILLING CODE 6450–01–P (which deal with the generation market established under Executive Order power part of the analysis) would apply 13123—Greening the Government to all pending and future market-based through Efficient Energy Management.’’ DEPARTMENT OF ENERGY rate applications, including three-year market-based rate reviews, pending the DATES: Wednesday, June 9, 2004; 9 a.m. Federal Energy Regulatory completion of the market-based rate to 12 p.m. Commission rulemaking. The Commission stated that ADDRESSES: U.S. Department of Energy, [Docket No. ER02–1406–001, et al.] it intended to issue a subsequent order 1000 Independence Avenue, SW., Room addressing the implementation process Number 8E–089, Washington, DC Acadia Power Partners, LLC, et al.; for pending three-year market-based rate 20585–0121. Order Implementing New Generation reviews as well as pending applications FOR FURTHER INFORMATION CONTACT: Rick Market Power Analysis and Mitigation for initial market-based rate authority. Klimkos, Designated Federal Officer, Procedures 4. In the SMA Rehearing Order, the Office of Federal Energy Management Commission stated it was not making Programs, U.S. Department of Energy, Issued May 13, 2004. 1000 Independence Avenue, SW., Before Commissioners: Pat Wood, III, 1 See AEP Power Marketing, Inc., et al., 97 FERC Washington, DC 20585; (202) 586–8287. Chairman; Nora Mead Brownell, and ¶ 61,219 (2001) (SMA Order). 2 SUPPLEMENTARY INFORMATION: Joseph T. Kelliher See Initiation of Rulemaking Proceeding on Purpose of Market-Based Rates and Notice of Technical the Meeting: To provide advice and 1. In this order, the Commission Conference, Docket No. RM04–7–000, 107 FERC guidance on a range of issues critical to addresses the procedures for ¶ 61,109 (2004).

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any findings at that time in connection Pending Three-Year Market-Based Rate NYISO, and CAISO). Acting on these with the three-year market-based rate Reviews types of filings will provide other review filings of the three applicants 7. Consistent with the procedures set applicants seeking to obtain or retain that were the subject of the rehearing, forth in the SMA Rehearing Order, all market-based rate authority with needed nor was it imposing in that order applicants with three-year market-based market information that will facilitate mitigation on those applicants. Instead, rate reviews pending before the the completion of their studies. each applicant was directed, within 60 Commission on or before the date of 11. The timing for processing of the days from the date of issuance of the issuance of this order are directed to remaining filings is generally based on SMA Rehearing Order, to make a filing make a filing with the Commission to the age of the filings. We will consider with the Commission submitting revised revise the generation market power the revised applications directed herein generation market power analyses portion of their three-year reviews to to be the next required three-year pursuant to the two indicative screens address the two interim indicative market-based rate review for the (pivotal supplier and market share) generation market power screens applicants listed in Appendix A. In the adopted in the order. As the adopted in the SMA Rehearing Order.5 event that a public utility with a three- Commission explained, each of these The revised filings will be treated as year market-based rate review pending revised filings will be noticed in the amendments to the pending filings, and before the Commission is not listed in Federal Register, with an opportunity all pleadings on the pending filings will Appendix A (and, accordingly, has not for comment by interested parties. The remain in the record. been assigned a date for submitting its Commission stated that, following its 8. In order to facilitate the processing revised generation market power review of these analyses, it would issue of the pending three-year market-based analysis pursuant to the two indicative an order addressing the filings on the rate reviews, however, we have decided screens), such omission is inadvertent. indicative screens. We further stated to stagger the time periods within which Any such omitted public utility is that applicants that do not pass the two such revised filings must be made. In directed, within 30 days of the date of indicative screens (and thus are doing so, we have attempted to take into issuance of this order, to identify itself rebuttably presumed to possess consideration resource issues from the and the pending docket number. generation market power) will have the standpoint of both the industry and the 12. We remind applicants that they option of presenting a more thorough Commission. A schedule listing the time may provide streamlined applications, analysis using the Delivered Price Test. period within which each applicant’s where appropriate, to show that they In the alternative, the applicants may revised three-year market-based rate pass both screens.6 For example, if an proceed directly to mitigation. Should review filing must be made is set forth applicant would pass both screens they choose this route, we explained in Appendix A. Each applicant’s revised without considering competing supplies that each company will have the option filing will be noticed in the Federal imported from adjacent control areas, of proposing specific mitigation tailored Register, with an opportunity for the applicant need not include such to its particular circumstances sufficient comment by interested parties. imports. Likewise, an applicant need to alleviate any market power concerns, 9. We believe it is appropriate to start only account for the minimum amount or adopting default rates, as set forth in with transmission-providing utilities of capacity that would result in the the SMA Rehearing Order.3 because these utilities are required by applicant passing both screens. the SMA Rehearing Order to undertake Accordingly, an applicant may not need Discussion simultaneous import capability studies to consider the capacity of all 5. The purpose of this order is to for their home control areas and for each competitors within the relevant market. provide a framework for applying the of their interconnected first-tier control For example, if there are seven substantive and procedural areas. As other utilities may need such competitors in the relevant market and requirements of the SMA Rehearing simultaneous import capability the applicant passes both screens when Order to other applicants with: (1) information in order to perform their considering only three of those Pending three-year market-based rate own generation market power analyses, competitors, the applicant need not reviews; (2) pending filings for initial as a practical matter it is necessary to account for the other four competitors, market-based rate authority; or (3) future require that the public utilities with the nor consider competing supplies applications for initial market-based rate access to such simultaneous import imported from adjacent control areas. authority or future three-year market- information (the transmission-providing Further, utilities meeting the criteria of based rate reviews. public utilities) be among the first section 35.27 of our regulations,7 as 6. Because the Commission has directed to revise their pending three- clarified in LG&E Capital Trimble adopted a new interim approach for year market-based rate reviews County LLC, 98 FERC ¶ 61,261 at analyzing generation market power, we consistent with the interim screens 62,034–35 (2002) (dealing with sales for will require that the generation market adopted in the SMA Rehearing Order. resale from capacity for which power portion of all pending and future 10. Similarly, because of the construction commenced on or after three-year reviews, as well as all importance of information accessibility, July 9, 1996), may provide evidence pending and future initial applications we will address early on the three-year demonstrating that they satisfy our for market-based rate authority, address market-based rate reviews of public regulations rather than submit a the indicative screens (pivotal supplier utilities located in ISO/RTOs with a generation market power analysis.8 and market share) adopted in the SMA single energy market under the control 4 Rehearing Order. of the ISO/RTO (e.g., PJM, ISO NE, 6 See SMA Rehearing Order, 107 FERC ¶ 61,018 at P 38, 113–117. 3 SMA Rehearing Order, 107 FERC ¶ 61,018 at P 5 Moreover, to the extent that the factual 7 18 CFR 35.27 (2003). 206, 207. circumstances have changed from those described 8 As we explained in the SMA Rehearing Order, 4 As we stated in the SMA Rehearing Order, we in the pending filing regarding the other three parts however, if an applicant sites generation in an area will apply this approach on an interim basis, of our four-part analysis (i.e., transmission market where it or its affiliates own or control other pending a comprehensive generic review of the power, barriers to entry, and affiliate abuse and/or generation assets, the applicant must address appropriate analysis for granting market-based rate reciprocal dealing), such applicants should provide whether its new capacity, when added to existing authority in the market-based rate rulemaking updated information regarding those parts of the capacity, raises generation market power concerns. proceeding. Id. at P 2. test. 107 FERC ¶ 61,018 at P 38, 116.

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13. In addition, consistent with the the SMA Rehearing Order, the market-based rate authority, as well as procedures set forth in the SMA generation market power studies applicants filing three-year market- Rehearing Order, applicants may forgo submitted in connection with these based rate reviews, can forgo submitting submitting a generation market power pending applications have been a generation market power analysis and analysis and go directly to mitigation by rendered deficient. Accordingly, the go directly to mitigation by proposing proposing case-specific mitigation that utilities listed in Appendix B are case-specific mitigation that eliminates eliminates the ability to exercise market directed to revise their filings within 60 the ability to exercise market power, or power, or agreeing to the default rates.9 days from the date of issuance of this agreeing to the default rates. 14. Finally, we understand that there order to reflect the new interim The Commission orders: may be a number of utilities whose generation market power screens. In the (A) The applicants listed in Appendix three-year market-based rate reviews are alternative, these utilities can revise A are directed to file, within the time due to be filed with the Commission their filings to indicate that they will period set forth in Appendix A, revised within the next 60 days. In order to forgo submitting a generation market applications, as discussed in the body of provide such utilities an opportunity to power analysis and go directly to this order. incorporate the two indicative screens mitigation by proposing case-specific (B) The applicants listed in Appendix adopted in the SMA Rehearing Order mitigation that eliminates the ability to B are directed to revise their into the generation market power exercise market power, or agreeing to applications for initial market-based rate portion of their three-year reviews, we the default rates. authority, as discussed in the body of will grant these utilities an extension of this order. Future Initial Market-Based Rate time of 60 days from the date of (C) Applicants with three-year Applications and Future Three-Year issuance of this order to submit their market-based rate reviews due to be Reviews three-year market-based rate reviews. filed within the next 60 days are hereby 16. All future applications for initial granted an extension of time of 60 days Pending Applications for Initial market-based rate authority and future from the date of issuance of this order, Market-Based Rate Authority three-year market-based rate reviews as discussed in the body of this order. 15. A number of utilities have (i.e., those not currently pending and (D) The Secretary is hereby directed to applications for initial market-based rate that are filed after the date of issuance promptly publish this order in the authority pending before the of this order) should include generation Federal Register. Commission, which were filed on or market power analyses pursuant to the By the Commission. Commissioner Kelly before the date of issuance of this order. two indicative screens (pivotal supplier not participating. These utilities are listed in Appendix B. and market share) described in the SMA Linda Mitry, In light of the Commission’s decision to Rehearing Order, as well as the other Acting Secretary. analyze generation market power based three parts of our four-part analysis. In on the two indicative screens adopted in the alternative, new applicants for Appendix A

Group I (due within 90 days of the date of this order)

Alliant Energy Corporate Services ...... ER99–230–002 APS Energy Services, Inc ...... ER99–4122–004 Arizona Public Service Company ...... ER99–4124–001 Pinnacle West Capital Corporation ...... ER00–2268–003 Pinnacle West Energy Corporation ...... ER00–3312–002 CMS Generation Michigan Power LLC ...... ER99–3677–001 Consumers Energy Company ...... ER98–4421–002 Consolidated Water Power Company ...... ER98–4512–002 El Paso Electric Company ...... ER99–2416–001 Dayton Power & Light Company ...... ER96–2602–004 DPL Energy LLC ...... ER96–2601–015 Duke Energy Morro Bay, LLC ...... ER98–2681–002 Duke Energy Moss Landing, LLC ...... ER98–2680–002 Duke Energy Oakland, LLC ...... ER98–2682–002 Duke Energy South Bay, LLC ...... ER99–1785–001 Duke Power Co...... ER96–110–007 Duke Solutions, Inc ...... ER98–3813–007 Kansas City Power & Light Company ...... ER99–1005–001 Public Service Company of New Mexico ...... ER96–1551–006 ER01–615–003 Puget Sound Energy, Inc ...... ER99–845–003

Group II (due within 135 days of the date of this order)

Avista Energy Inc ...... ER96–2408–018 Empire District Electric Company ...... ER99–1757–002 ER99–1757–003 ER99–1757–004 AG-Energy, LP ...... ER98–2782–002 Amergen Energy Company, LLC ...... ER99–754–008 Commonwealth Edison Company ...... ER98–1734–006 Exelon Edgar LLC ...... ER01–513–005 Exelon Energy Company ...... ER97–3954–016

9 Id. at P 39, 148.

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Exelon Fore River Development, LLC ...... ER01–41–004 Exelon Framingham LLC ...... ER01–513–005 Exelon Generation Company, LLC ...... ER00–3251–005 Exelon New Boston LLC ...... ER01–513–005 Exelon New England Power Marketing, L.P ...... ER99–2404–001 ER99–2404–004 Exelon Mystic Development, LLC ...... ER01–42–005 Exelon West Medway LLC ...... ER01–513–005 Exelon Wyman LLC ...... ER01–513–005 PECO Energy Company ...... ER99–1872–005 Power City Partners, L.P ...... ER98–2782–002 Seneca Power Partners, L.P ...... ER98–2782–002 Sithe Edgar LLC ...... ER98–1943–002 Sithe New Boston LLC ...... ER98–1943–002 Sithe Framingham LLC ...... ER98–1943–002 Sithe West Medway LLC ...... ER98–1943–002 Sithe Wyman LLC ...... ER98–1943–002 Sithe Mystic LLC ...... ER98–1943–002 Sithe Power Marketing, L.P ...... ER98–107–011 Unicom Power Marketing, Inc ...... ER01–1919–002 Sterling Power Partners, L.P ...... ER98–2782–002 Idaho Power Company ...... ER97–1481–003 Northeast Generation Company ...... ER99–4463–001 Northeast Utilities Service Company ...... ER96–496–010 Select Energy, Inc ...... ER99–14–007 Athens Generating Company, L.P ...... ER99–4282–002 Attala Generating Company, LLC ...... ER01–747–002 Badger Generating Company, LLC ...... ER00–3457–001 Covert Generating Company, LLC ...... ER01–520–002 Harquahala Generating Company, LLC ...... ER01–748–002 La Paloma Generating Company, LLC ...... ER00–107–001 Lake Road Generating Company, L.P ...... ER99–1714–002 Liberty Generating Company, LLC ...... ER00–1792–001 Logan Generating Company, L.P ...... ER95–1007–014 Madison Windpower LLC ...... ER00–1742–001 Mantua Creek Generating Company, L.P ...... ER99–4162–002 Millennium Power Partners, L.P ...... ER98–830–006 Mountain View Power Partners, LLC ...... ER01–751–001 ER01–751–005 Mountain View Power Partners II, LLC ...... ER01–1336–002 Okeechobee Generating Company, LLC ...... ER99–3643–001 PG&E Dispersed Generating Company, LLC ...... ER00–2134–001 PG&E Energy Trading Power, L.P ...... ER95–1625–024 Pittsfield Generating Company, L.P ...... ER98–4400–003 Plains End, LLC ...... ER01–2741–002 USGen New England, Inc ...... ER98–6–008 Western Resources, Inc ...... ER98–2157–002 Griffin Energy Marketing, LLC ...... ER97–4168–012 Wisconsin Electric Power Company ...... ER98–855–002 ER98–855–003 Wisconsin Public Service Corporation ...... ER95–1528–006 WPS Energy Services, Inc ...... ER96–1088–031 WPS Power Development, Inc ...... ER96–1088–031

Group III (due within 180 days of the date of this order)

AES Alamitos, LLC ...... ER98–2185–006 AES Huntington Beach, LLC ...... ER98–2184–006 AES Placerita, Inc ...... ER00–33–003 AES Redondo Beach, LLC ...... ER98–2186–006 Indianapolis Power & Light Company ...... ER00–1026–006 Citizens Power Sales ...... ER94–1685–031 CPL Power Sales One, LLC ...... ER95–892–055 CPL Power Sales Two, LLC ...... ER95–892–055 CPL Power Sales Five, LLC ...... ER95–892–055 CPL Power Sales Six, LLC ...... ER96–2652–049 CPL Power Sales Seven, LLC ...... ER96–2652–049 CPL Power Sales Eight, LLC ...... ER96–2652–049 CPL Power Sales Nine, LLC ...... ER96–2652–049 CPL Power Sales Ten, LLC ...... ER96–2652–049 CPL Power Sales Twelve, LLC ...... ER99–893–007 CPL Power Sales Thirteen, LLC ...... ER99–892–008 CPL Power Sales Fourteen, LLC ...... ER99–891–008 CPL Power Sales Fifteen, LLC ...... ER99–890–008 CPL Power Sales Seventeen, LLC ...... ER99–4229–005 CPL Power Sales Eighteen, LLC ...... ER99–4230–004

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CPL Power Sales Nineteen, LLC ...... ER99–4228–005 CPL Power Sales Twenty, LLC ...... ER99–4231–004 Edison Mission Marketing & Trading, Inc ...... ER99–852–006 EME Homer City Generation, L.P ...... ER99–666–002 Midwest Generation, LLC ...... ER99–3693–001 Sunrise Power Co ...... ER01–2217–002 LG&E Energy Marketing, Inc ...... ER94–1188–033 Louisville Gas & Electric Company ...... ER98–4540–002 Kentucky Utilities Company ...... ER99–1623–001 WKE Station 2, Inc ...... ER98–1278–008 Western Kentucky Energy Corporation ...... ER98–1279–004 Madison Gas & Electric Company ...... ER00–586–002 Mirant Americas Energy Marketing, LP ...... ER01–1265–002 Mirant Bowline, LLC ...... ER01–1266–002 Mirant California, LLC ...... ER01–1267–002 ER01–1267–003 Mirant Canal, LLC ...... ER01–1268–003 Mirant Chalk Point, LLC ...... ER01–1269–002 Mirant Delta, LLC ...... ER01–1270–002 ER01–1270–003 Mirant Energy Trading, LLC ...... ER02–1213–001 Mirant Kendall, LLC ...... ER01–1271–003 Mirant Las Vegas, LLC ...... ER03–160–001 Mirant Lovett, LLC ...... ER01–1272–002 Mirant Mid-Atlantic, LLC ...... ER01–1273–002 Mirant NY-Gen, LLC ...... ER01–1275–002 Mirant New England, LLC ...... ER01–1274–003 Mirant Oregon, LLC ...... ER02–1331–002 Mirant Peaker, LLC ...... ER01–1276–002 Mirant Potomac River, LLC ...... ER01–1277–002 Mirant Potrero, LLC ...... ER01–1278–002 ER01–1278–003 Mirant Sugar Creek, LLC ...... ER02–900–001 Mirant Zeeland, LLC ...... ER01–1263–002 Shady Hills Power Company, LLC ...... ER02–537–002 West Georgia Generating Company, LLC ...... ER02–1052–001 Wrightsville Power Facility, LLC ...... ER02–1028–001 Minnesota Power ...... ER01–2636–001 Split Rock Energy, LLC ...... ER00–1857–002 PPL Brunner Island, LLC ...... ER00–744–001 PPL Colstrip I, LLC ...... ER99–3491–002 PPL Colstrip II, LLC ...... ER99–3491–002 PPL Electric Utilities Corp ...... ER00–1712–003 PPL EnergyPlus, LLC ...... ER98–4608–005 PPL Holtwood, LLC ...... ER00–744–001 PPL Martins Creek, LLC ...... ER00–744–001 PPL Montana, LLC ...... ER99–3491–002 PPL Montour, LLC ...... ER00–744–001 PPL Susquehanna, LLC ...... ER00–744–001 Reliant Energy Coolwater, LLC ...... ER99–2082–002 Reliant Energy Ellwood, LLC ...... ER99–2081–002 Reliant Energy Etiwanda, LLC ...... ER99–2083–002 Reliant Energy Mandalay, LLC ...... ER99–2080–002 Reliant Energy Ormond Beach, LLC ...... ER99–2079–002 Reliant Energy Services, Inc ...... ER99–1801–005 Sempra Energy Solutions ...... ER00–3444–002 Hardee Power Partners Limited ...... ER99–2341–001 Panda Gila River, L.P ...... ER01–931–004 Tampa Electric Company ...... ER99–2342–001 TECO Energy Source, Inc ...... ER96–1563–017 Union Power Partners, L.P ...... ER01–930–004

Group IV (due within 225 days of the date of this order)

Ameren Energy Development Co ...... ER01–294–002 Ameren Energy Generating Co ...... ER00–3412–003 Ameren Energy Marketing Co ...... ER00–816–001 AmerenEnergy Medina Valley Cogen, LLC ...... ER04–8–002 ER98–2440–003 AmerenEnergy Resources Generating Co ...... ER04–53–002 Central Illinois Light Co ...... ER98–2440–002 Union Electric Co ...... ER00–2687–002 Aquila, Inc ...... ER03–1079–002 Aquila Merchant Services, Inc ...... ER94–216–001 MEP Investments, LLC ...... ER99–2322–001 MEP Pleasant Hill, LLC ...... ER99–2858–002

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MEP Pleasant Hill Operating, LLC ...... ER01–905–001 Pleasant Hill Marketing, LLC ...... ER00–1851–001 Adirondack Hydro Development Corporation ...... ER00–3109–001 Adirondack Hydro Fourth Branch, LLC ...... ER00–3774–001 Black Hills Colorado, LLC ...... ER00–1952–001 Black Hills Generation, Inc ...... ER01–1844–001 Black Hills Pepperell Power Associates, Inc...... ER96–1635–008 Black Hills Power, Inc ...... ER99–2287–001 Fountain Valley Power, LLC ...... ER01–1784–004 Harbor Cogeneration Company ...... ER99–1248–002 ER99–1248–003 NYSD LP ...... ER00–3109–001 Sissonville LP ...... ER00–3109–001 Warrensburg Hydro Power LP ...... ER00–3109–001 Acadia Power Partners, LLC ...... ER02–1406–001 Cleco Evangeline, LLC ...... ER99–2928–001 Cleco Marketing & Trading, LLC ...... ER99–2300–004 Cleco Power, LLC ...... ER99–3855–002 Perryville Energy Partners, LLC ...... ER01–1397–002 Delmarva Power & Light Company ...... ER99–2781–002 Crete Energy Venture, LLC ...... ER02–963–002 The Detroit Edison Company ...... ER97–324–004 DTE Edison America, Inc ...... ER98–3026–007 DTE Energy Marketing, Inc ...... ER99–3368–003 DTE Energy Trading, Inc ...... ER97–3834–010 DTE Georgetown, LLC ...... ER00–1746–001 DTE River Rouge No. 1, LLC ...... ER00–1816–002 Armstrong Limited Energy Partnership, LLP ...... ER02–24–002 Dominion Energy Marketing, Inc ...... ER01–468–001 Dominion Nuclear Connecticut, Inc ...... ER00–3621–002 Dominion Nuclear Marketing I, Inc ...... ER00–3620–002 Dominion Nuclear Marketing II, Inc ...... ER00–3619–002 Dominion Nuclear Marketing III, Inc ...... ER00–3746–003 Dresden Energy, LLC ...... ER02–22–002 Elwood Energy, LLC ...... ER99–1695–002 Fairless Energy, LLC ...... ER02–23–002 Kincaid Generation, LLC ...... ER99–1432–002 Pleasants Energy, LLC ...... ER02–26–002 State Line Energy, LLC ...... ER96–2869–005 Troy Energy, LLC ...... ER02–25–002 Virginia Electric & Power Company ...... ER00–1737–004 Backbone Windpower Holdings, LLC ...... ER02–2559–001 Badger Windpower, LLC ...... ER01–1071–002 Bayswater Peaking Facility, LLC ...... ER02–669–002 Blythe Energy, LLC ...... ER02–2018–002 Calhoun Power Company I, LLC ...... ER01–2074–002 Doswell Limited Partnership ...... ER90–80–001 ESI Vansycle Partners, L.P ...... ER98–2494–004 Florida Power & Light Company ...... ER97–3359–005 FPL Energy Cape, LLC ...... ER00–3068–002 FPL Energy Hancock County Wind, LLC ...... ER03–34–001 FPL Energy Maine Hydro, Inc ...... ER98–3511–006 FPL Energy Marcus Hook, L.P ...... ER02–1903–001 FPL Energy Mason, LLC ...... ER98–3562–006 FPL Energy MH 50, L.P ...... ER99–2917–003 FPL Energy New Mexico Wind, LLC ...... ER03–179–002 FPL Energy Pennsylvania Wind, LLC ...... ER02–2166–001 FPL Energy Power Marketing, Inc ...... ER98–3566–009 FPL Energy Rhode Island Energy, L.P ...... ER02–2120–001 FPL Energy Seabrook, LLC ...... ER02–1838–001 FPL Energy Vansycle, LLC ...... ER01–838–002 FPL Energy Wyman, LLC ...... ER98–3563–006 FPL Energy Wyman IV, LLC ...... ER98–3564–006 Gray County Wind Energy, LLC ...... ER01–1972–002 Hawkeye Power Partners, LLC ...... ER98–2076–005 High Winds, LLC ...... ER03–155–001 Jamaica Bay Peaking Facility, LLC ...... ER03–623–002 Lake Benton Power Partners II, LLC ...... ER98–4222–001 Mill Run Windpower, LLC ...... ER01–1710–002 Somerset Windpower, LLC ...... ER01–2139–003 West Texas Wind Energy Partners, LP ...... ER98–1965–002 Florida Power Corporation ...... ER97–2846–003

Group V (due within 270 days of the date of this order)

The Cleveland Electric Illuminating Company ...... ER99–2330–001

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FirstEnergy Generation Corp ...... ER01–845–001 FirstEnergy Solutions Corp ...... ER01–2968–002 Jersey Central Power & Light Company ...... ER99–2330–001 Metropolitan Edison Company ...... ER99–2330–001 Ohio Edison Company ...... ER99–2330–001 Pennsylvania Electric Company ...... ER99–2330–001 Pennsylvania Power Company ...... ER99–2330–001 The Toledo Edison Company ...... ER99–2330–001 Bluegrass Generation Company, LLC ...... ER02–506–002 Cabrillo Power I LLC ...... ER99–1115–005 Cabrillo Power II LLC ...... ER99–1116–005 Calcasieu Power, LLC ...... ER00–1049–003 Dynegy Danskammer, LLC ...... ER01–140–002 Dynegy Midwest Generation, Inc ...... ER00–1895–002 Dynegy Power Marketing, Inc ...... ER99–4160–003 Dynegy Power Services, Inc ...... ER94–1612–026 Dynegy Roseton, LLC ...... ER01–141–002 El Segundo Power, LLC ...... ER98–1127–005 Foothills Generating, LLC ...... ER02–554–001 Heard County Power, LLC ...... ER01–943–002 Illinova Energy Partners, Inc ...... ER94–1475–021 Long Beach Generation LLC ...... ER98–1796–004 Nicor Energy, LLC ...... ER01–1169–002 Renaissance Power, LLC ...... ER01–3109–002 Riverside Generating Company, LLC ...... ER01–1044–002 Rockingham Power, LLC ...... ER99–1567–002 Rocky Road Power, LLC ...... ER99–2157–002 Rolling Hills Generating, LLC ...... ER02–553–001 Energy USA–TPC Corp ...... ER01–1300–003 Northern Indiana Public Service Company ...... ER00–2173–002 Whiting Clean Energy, Inc ...... ER00–3219–002 OGE Energy Resources, Inc ...... ER98–511–002 Oklahoma Gas and Electric Company ...... ER97–4345–014 Pepco Energy Services, Inc ...... ER98–3096–008 Potomac Power Resources, LLC ...... ER01–202–001 Portland General Electric Company ...... ER98–1643–006 South Carolina Electric & Gas Company ...... ER96–1085–006 Tucson Electric Power Company ...... ER98–1150–002 Northern States Power Company ...... ER98–2640–004 Northern States Power Company (Wisconsin) ...... ER98–2640–004 Public Service Company of Colorado ...... ER98–4590–002 Southwestern Public Service Company ...... ER99–1610–008 Xcel Energy Services Inc ...... ER01–205–004

Group VI (due within 315 days of the date of this order)

Astoria Gas Turbine Power LLC ...... ER99–3000–001 CPN Pleasant Hill, LLC ...... ER01–915–002 CPN Pleasant Hill Operating, LLC ...... ER01–915–002 De Pere Energy LLC ...... ER97–1432–011 Mobile Energy LLC ...... ER01–480–003 Elkem Metals Company—Alloy L.P ...... ER00–2093–001 Fresno Cogeneration Partners, L.P ...... ER00–2392–001 HQ Energy Services (US) Inc ...... ER97–851–012 ER97–851–013 Morgan Stanley Capital Group Inc ...... ER94–1384–030 MS Retail Development Corp ...... ER03–1315–001 Power Contract Finance, LLC ...... ER02–1485–003 Power Contract Financing II, LLC ...... ER03–1108–002 Power Contract Financing II, Inc ...... ER03–1109–002 South Eastern Electric Development Corporation ...... ER99–2329–002 South Eastern Generating Corporation ...... ER00–1803–001 Louisiana Generating, LLC ...... ER00–1259–001 NRG Energy Center Dover LLC ...... ER00–3160–001 NRG Energy Center Paxton LLC ...... ER00–2313–001 Onondaga Cogeneration Limited Partnership ...... ER00–895–001 Otter Tail Corporation ...... ER00–3080–001 Redbud Energy, LP ...... ER01–1011–002 South Jersey Energy Company ...... ER97–1397–010 WFEC GENCO, LLC ...... ER01–388–002 Williams Energy Marketing & Trading Company ...... ER99–1722–004 Williams Flexible Generation, LLC ...... ER00–2469–001 Williams Generation Company—Hazelton ...... ER97–4587–004 Williams Power Company, Inc ...... ER03–1331–003

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Appendix B

Duquesne Power, L.P ...... ER04–268–000 Hartford Steam Company ...... ER04–582–000 ER04–582–001 ER04–582–002 PPL Distributed Generation, LLC ...... ER04–671–000 Tor Power, Inc ...... ER04–698–000

[FR Doc. 04–11744 Filed 5–24–04; 8:45 am] OMITTED ER03–984, 004, New York Independent BILLING CODE 6717–01–P E–3. System Operator, Inc. DOCKET# ER04–691, 000, Midwest ER03–984, 005, New York Independent Independent Transmission System System Operator, Inc. DEPARTMENT OF ENERGY Operator, Inc. ER03–984, 006, New York Independent E–4. System Operator, Inc. Federal Energy Regulatory OMITTED E–22. E–5. DOCKET# ER02–320, 007, Michigan Commission DOCKET# ER04–714, 000, Florida Power & Electric Transmission Company, LLC Light Company-New England Division E–23. Sunshine Act Meeting E–6. DOCKET# EL99–14, 005, Southwestern DOCKET# ER04–697, 000, New England Electric Cooperative, Inc. v. Soyland May 19, 2004. Power Pool Power Cooperative, Inc. The following notice of meeting is E–7. E–24. published pursuant to section 3(a) of the DOCKET# ER04–677, 000, New England DOCKET# EL01–50, 003, New York Government in the Sunshine Act (Pub. Power Pool Independent System Operator, Inc. L. 94–409), 5 U.S.C 552b: E–8. E–25. AGENCY HOLDING MEETING: Federal DOCKET# ER04–641, 000, Duke Energy DOCKET# ER97–1523, 065, Central Energy Regulatory Commission. Lee, LLC Hudson Gas & Electric Corporation, OTHER#S ER04–641, 001, Duke Energy Consolidated Edison Company of New DATE AND TIME: May 26, 2004, 10 a.m. Lee, LLC York, Inc., Long Island Lighting PLACE: Room 2C, 888 First Street, NE., E–9. Company, New York State Electric & Gas Washington, DC 20426. DOCKET# ER04–658, 000, Southwest Corporation, Niagara Mohawk Power STATUS: Open. Power Pool, Inc. Corporation, Orange and Rockland MATTERS TO BE CONSIDERED: Agenda. E–10. Utilities, Inc., Rochester Gas and Electric DOCKET# ER04–589, 000, Commonwealth Corporation and New York Power Pool * Note: Items listed on the Agenda may be Edison Company OTHER#S OA97–470, 060, Central Hudson deleted without further notice. OTHER#S ER04–589, 001 Commonwealth Gas & Electric Corporation, Consolidated Edison Company Edison Company of New York, Inc., Long FOR FURTHER INFORMATION CONTACT: ER04–594, 000, Commonwealth Edison Island Lighting Company, New York Magalie R. Salas, Secretary, Telephone Company State Electric & Gas Corporation, Niagara (202) 502–8400. For a recording listing E–11. Mohawk Power Corporation, Orange and items stricken from or added to the OMITTED Rockland Utilities, Inc., Rochester Gas meeting, call (202) 502–8627. E–12. and Electric Corporation and New York This is a list of matters to be OMITTED Power Pool considerd by the Commission. It does E–13. OA97–470, 062, Central Hudson Gas & not include a listing of all papers DOCKET# ER04–742, 000, PJM Electric Corporation, Consolidated relevant to the items on the Agenda; Interconnection, L.L.C. Edison Company of New York, Inc., Long however, all public documents may be E–14. Island Lighting Company, New York OMITTED State Electric & Gas Corporation, Niagara examined in the Reference and E–15. Mohawk Power Corporation, Orange and Information Center. OMITTED Rockland Utilities, Inc., Rochester Gas 860th—Meeting May 26, 2004, Regular E–16. and Electric Corporation and New York Meeting, 10 a.m. DOCKET# ER03–861, 000, Entergy Power Pool Services, Inc. ER97–1523, 067, Central Hudson Gas & Administrative Agenda E–17. Electric Corporation, Consolidated A–1. DOCKET# ER03–1396, 000, Troy Energy, Edison Company of New York, Inc., Long DOCKET# AD02–1, 000, Agency LLC Island Lighting Company, New York Administrative Matters E–18. State Electric & Gas Corporation, Niagara A–2. OMITTED Mohawk Power Corporation, Orange and DOCKET# AD02–7, 000, Customer Matters, E–19. Rockland Utilities, Inc., Rochester Gas Reliability, Security and Market DOCKET# ER04–680, 000, Tenaska and Electric Corporation and New York Operations Virginia Partners, LP Power Pool OTHER#S ER04–680, 001, Tenaska ER97–4234, 058, Central Hudson Gas & Markets, Tariffs and Rates—Electric Virginia Partners, LP Electric Corporation, Consolidated E–1. E–20. Edison Company of New York, Inc., Long DOCKET# ER03–563, 030, Devon Power DOCKET# OA96–194, 010, Niagara Island Lighting Company, New York LLC, Middletown Power LLC, Montville Mohawk Power Corporation State Electric & Gas Corporation, Niagara Power LLC, Norwalk Power LLC and E–21. Mohawk Power Corporation, Orange and NRG Power Marketing Inc. DOCKET# ER03–552, 006, New York Rockland Utilities, Inc., Rochester Gas OTHER#S EL04–102,000, Devon Power Independent System Operator, Inc. and Electric Corporation and New York LLC, Middletown Power LLC, Montville OTHER#S ER03–552, 007, New York Power Pool Power LLC, Norwalk Power LLC and Independent System Operator, Inc. ER97–4234, 060, Central Hudson Gas & NRG Power Marketing Inc. ER03–552, 008, New York Independent Electric Corporation, Consolidated E–2. System Operator, Inc. Edison Company of New York, Inc., Long

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Island Lighting Company, New York OMITTED PR04–7,001, Raptor Natural Pipeline, LLC State Electric & Gas Corporation, Niagara E–42. G–6. Mohawk Power Corporation, Orange and OMITTED DOCKET# RP03–292, 001, Viking Gas Rockland Utilities, Inc., Rochester Gas E–43. Transmission Company and Electric Corporation and New York DOCKET# ER03–766, 003, New York G–7. Power Pool Independent System Operator, Inc. DOCKET# RP04–76, 000, Southern Star E–26. E–44. Central Gas Pipeline, Inc. DOCKET# QF86–159, 001, Zond DOCKET# EL04–92, 000, Northeast G–8. Windsystem Partners, Ltd., Series 85–C Utilities Service Company OMITTED OTHER#S EL03–47, 001, Investigation of E–45. G–9. Certain Enron-Affiliated QF’s DOCKET# EL04–91, 000, Patrick C. Lynch, DOCKET# RP98–40, 000, Panhandle E–27. Attorney General of the State of Rhode Eastern Pipe Line Company DOCKET# EC04–88, 000, American Island v. ISO New England, Inc. G–10. Electric Power Service Corporation, E–46. DOCKET# RP03–542, 001, Texas Eastern Oklaunion Electric Generating OMITTED Transmission, LP Cooperative, Inc., and Golden Spread E–47. G–11. Electric Cooperative, Inc. OMITTED DOCKET# RP03–492, 001, Columbia Gulf E–28. E–48. Transmission Company DOCKET# EC04–66, 000, Entergy Asset OMITTED G–12. Management, Inc., Entergy Power E–49. DOCKET# RP03–552, 001, Dominion Cove Ventures, L.P., Warren Power, LLC, and DOCKET# EL04–82, 000, NRG Power Point LNG, LP East Texas Electric Cooperative, Inc. Marketing, Inc., Connecticut Jet Power G–13. E–29. LLC, Middletown Power LLC, Montville DOCKET# RP04–36, 000, Enbridge DOCKET# ER01–2905, 002, Xcel Energy Power LLC, and Norwalk Power, LLC v. Pipelines (KPC) Services, Inc. ISO New England, Inc. G–14. OTHER#S ER01–2905, 000, Xcel Energy E–50. DOCKET# RP03–491, 001, Columbia Gas Services, Inc. DOCKET# ER98–1438, 020 Midwest Transmission Corporation ER01–2905,001, Xcel Energy Services, Inc. Independent Transmission System G–15. E–30. Operator, Inc. DOCKET# RP03–123, 002, Southern OMITTED OTHER#S EC98–24, 012, Midwest Natural Gas Company E–31. Independent Transmission System OTHER#S RP02–86, 002, Southern Natural DOCKET# ER04–23, 001, ISO New England Operator, Inc. Gas Company Inc. E–51. RP04–79, 001, Southern Natural Gas OTHER#S ER04–23, 004, ISO New England DOCKET# ER03–1206, 000, DTE East Company Inc. China, LLC and DTE Energy Trading, G–16. E–32. Inc. DOCKET# RP04–155, 002, Northern OMITTED E–52. Natural Gas Company E–33. DOCKET# EL03–47, 001, Investigation of OTHER#S RP03–398, 007, Northern DOCKET# ER04–35, 001, Entergy Services, Certain Enron-Affiliated QF’s Natural Gas Company Inc. OTHER#S QF84–422, 002, Zond-PanAero G–17. OTHER#S ER04–35, 002, Entergy Services, Windsystem Partners I (ZP I) OMITTED Inc. QF85–263,002, Zond-PanAero Windsystem G–18. E–34. Partners II (ZP II) DOCKET# RP93–109, 020, Southern Star DOCKET# EL04–2, 001, Sacramento E–53. Central Gas Pipeline, Inc. DOCKET# EL02–123, 002, Boston Edison G–19. Municipal Utility District v. Pacific Gas Company DOCKET# RP03–398, 005, Northern and Electric Company, Southern E–54. Natural Gas Company California Edison Company and San DOCKET# ER03–1091, 000, Pacific Gas and OTHER#S RP03–398, 004, Northern Diego Gas & Electric Company Electric Company Natural Gas Company E–35. OTHER#S ER03–1091, 001, Pacific Gas and G–20. DOCKET# EL04–11, 001, Californians for Electric Company DOCKET# RP02–361, 025 Gulfstream Renewable Energy, Inc. v. Calpine ER03–1091,004, Pacific Gas and Electric Natural Gas System, L.L.C. Energy Services, L.P. and the California Company G–21. Department of Water Resource E–55. DOCKET# RP04–267, 000, E–36. DOCKET# ER04–717, 000, Orion Power Transcontinental Gas Pipe Line OMITTED MidWest, L.P. Corporation E–37. DOCKET# ER04–77, 003, Dayton Power Miscellaneous Agenda Energy Projects—Hydro and Light Company M–1. H–1. OTHER#S ER04–77, 002, Dayton Power DOCKET# RM03–8, 001, Quarterly DOCKET# P–77, 120, Pacific Gas and and Light Company Financial Reporting and Revisions to the Electric Company E–38. Annual Reports H–2. OMITTED DOCKET# P–2009, 031, Virginia Electric E–39. Markets, Tariffs and Rates—Gas and Power Company, dba Dominion DOCKET# ER04–335, 001, New England G–1. Virginia Power/Dominion North Carolina Power Pool DOCKET# RP00–463, 006, Williston Basin Power OTHER#S ER04–335, 002, New England Interstate Pipeline Company H–3. Power Pool G–2. DOCKET# P–516, 380, South Carolina E–40. OMITTED Electric & Gas Company DOCKET# EL04–43, 001, Tenaska Power G–3. H–4. Services Company v. Midwest OMITTED OMITTED Independent Transmission System G–4. H–5. Operator, Inc. DOCKET# RP04–264, 000, ANR Pipeline DOCKET# P–1494, 244, Grand River Dam OTHER#S EL04–46, 001, Cargill Power Company Authority Markets, LLC v. Midwest Independent G–5. Transmission System Operator, Inc. DOCKET# PR04–7, 000, Raptor Natural Energy Projects—Certificates E–41. Pipeline, LLC C–1.

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DOCKET# CP04–1, 000, ANR Pipeline Protection Agency, Mailcode 5305T, official docket, information claimed as Company 1200 Pennsylvania Ave., NW., CBI, or whose disclosure is otherwise C–2. Washington, DC 20460, and (2) OMB at: restricted by statute, is not included in DOCKET# CP04–67, 000, Algonquin Gas Office of Information and Regulatory the official public docket, and will not Transmission Company be available for public viewing in C–3. Affairs, Office of Management and DOCKET# CP01–49, 004, Northwest Budget (OMB), Attention: Desk Officer EDOCKET. For further information Pipeline Corporation for EPA, 725 17th Street, NW., about the electronic docket, see EPA’s Washington, DC 20503. Federal Register notice describing the The Capitol Connection offers the electronic docket at 67 FR 38102 (May opportunity for remote listening and FOR FURTHER INFORMATION CONTACT: Charles Heizenroth, Office of Solid 31, 2002), or go to http://www.epa.gov/ viewing of the meeting. It is available edocket. for a fee, live over the Internet, via C- Waste, 5306W, Environmental Protection Agency, 1200 Pennsylvania Title: Reporting and Recordkeeping Band Satellite. Persons interested in Requirements Under EPA’s WasteWise receiving the broadcast, or who need Ave., NW., Washington, DC 20460; telephone number: (703) 308–0154; fax Program (Renewal). information on making arrangements Abstract: EPA’s voluntary WasteWise should contact David Reininger or Julia number: (703) 308–8686; e-mail address: [email protected]. program encourages businesses and Morelli at the Capitol Connection (703– other organizations to reduce solid 993–3100) as soon as possible or visit SUPPLEMENTARY INFORMATION: EPA has waste through waste prevention, the Capitol Connection Web site at submitted the following ICR to OMB for recycling, and the purchase or http://www.capitolconnection.gmu.edu review and approval according to the manufacture of recycled-content and click on ‘‘FERC’’. procedures prescribed in 5 CFR 1320.12. products. WasteWise participants On January 13, 2004 (69 FR 1977), EPA Magalie R. Salas, include partners, which commit to sought comments on this ICR pursuant implementing waste reduction activities Secretary. to 5 CFR 1320.8(d). EPA received no of their choice, and endorsers which [FR Doc. 04–11885 Filed 5–21–04; 11:16 am] comments. promote the WasteWise program and BILLING CODE 6717–01–P EPA has established a public docket waste reduction to their members. for this ICR under Docket ID No. RCRA– The Partner Registration Form 2000–0066, which is available for public identifies an organization and its ENVIRONMENTAL PROTECTION viewing at the RCRA Docket in the EPA facilities registering to participate in AGENCY Docket Center (EPA/DC), EPA West, WasteWise, and requires the signature Room B102, 1301 Constitution Ave., [RCRA–2000–0066; FRL–7666–8] of a senior official that can commit the NW., Washington, DC. The EPA Docket organization to the program. (This form Agency Information Collection Center Public Reading Room is open can be submitted either electronically or Activities; Submission to OMB for from 8:30 a.m. to 4:30 p.m., Monday in hard copy.) Within six months of Review and Approval; Comment through Friday, excluding legal registering, each partner is asked to Request; Reporting and holidays. The telephone number for the conduct a waste assessment and submit Recordkeeping Requirements Under Reading Room is (202) 566–1744, and baseline data and waste reduction goals EPA’s WasteWise Program (Renewal), the telephone number for the RCRA to EPA via the Annual Assessment EPA ICR Number 1698.05, OMB Docket is (202) 566–0270. An electronic Form. (This form can also be submitted Control Number 2050–0139 version of the public docket is available either electronically or in hard copy.) through EPA Dockets (EDOCKET) at On an annual basis partners are asked AGENCY: Environmental Protection http://www.epa.gov/edocket. Use to report, via the Annual Assessment Agency (EPA). EDOCKET to submit or view public Form, on their progress toward ACTION: Notice. comments, access the index listing of achieving their waste reduction goals by the contents of the public docket, and to estimating amounts of waste prevented SUMMARY: In compliance with the access those documents in the public and recyclables collected, and Paperwork Reduction Act (44 U.S.C. docket that are available electronically. describing buying or manufacturing 3501 et seq.), this document announces Once in the system, select ‘‘search,’’ recycled-content products. They can that an Information Collection Request then key in the docket ID number also provide WasteWise with (ICR) has been forwarded to the Office identified above. information on total waste prevention of Management and Budget (OMB) for Any comments related to this ICR revenue, total recycling revenue, total review and approval. This is a request should be submitted to EPA and OMB avoided purchasing costs due to waste to renew an existing approved within 30 days of this notice. EPA’s prevention, and total avoided disposal collection. This ICR is scheduled to policy is that public comments, whether costs due to recycling and waste expire on May 31, 2004. Under OMB submitted electronically or in paper, prevention. Additionally, they are asked regulations, the Agency may continue to will be made available for public to submit new waste reduction goals. conduct or sponsor the collection of viewing in EDOCKET as EPA receives Endorsers, which are typically trade information while this submission is them and without change, unless the associations or state/local governments, pending at OMB. This ICR describes the comment contains copyrighted material, submit the Endorser Registration Form nature of the information collection and CBI, or other information whose public once during their endorser relationship its estimated burden and cost. disclosure is restricted by statute. When with WasteWise. (This form can be DATES: Additional comments may be EPA identifies a comment containing submitted either electronically or in submitted on or before June 24, 2004. copyrighted material, EPA will provide hard copy.) The Endorser Registration ADDRESSES: Submit your comments, a reference to that material in the Form identifies the organization, the referencing docket ID number RCRA– version of the comment that is placed in principal contact, and the activities to 2000–0066, to (1) EPA online using EDOCKET. The entire printed comment, which the Endorser commits. EDOCKET (our preferred method), by e- including the copyrighted material, will EPA’s WasteWise program uses the mail to [email protected], or by mail be available in the public docket. submitted information to (1) identify to: EPA Docket Center, Environmental Although identified as an item in the and recognize outstanding waste

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reduction achievements by individual groups, the program is open to all purpose of renewing the ICRs. Before organizations, (2) compile aggregate companies, trade associations, nonprofit submitting the ICRs to OMB for review results that indicate overall organizations, schools, colleges, and approval, EPA is soliciting accomplishments of WasteWise universities, and federal/state/local/ comments on specific aspects of the partners, (3) identify cost-effective waste tribal governments. Due to the broad information collections as described at reduction strategies to share with other universe of eligible WasteWise partners, the beginning of SUPPLEMENTARY organizations, and (4) identify topics on a relevant list of NAICS codes would INFORMATION. which to develop assistance and include virtually every business area DATES: Comments must be submitted on information efforts. contained in the NAICS code manual. or before July 26, 2004. An agency may not conduct or Therefore, it is not practical to include ADDRESSES: sponsor, and a person is not required to such a comprehensive list of affected Comments may be respond to, a collection of information organizations. The WasteWise Endorser submitted electronically, by mail, or unless it displays a currently valid OMB Program initially targeted more than 100 through hand delivery/courier service. control number. The OMB control trade associations across numerous Follow the detailed instructions as SUPPLEMENTARY numbers for EPA’s regulations in 40 industry sectors. The program is, provided under CFR are listed in 40 CFR part 9 and are however, open to all trade associations, INFORMATION, Section I.B. identified on the form and/or membership organizations, and federal/ FOR FURTHER INFORMATION CONTACT: The instrument, if applicable. state/local/tribal organizations. contact individuals for each ICR are Burden Statement: The respondent Estimated Number of Respondents: listed under SUPPLEMENTARY burden for this collection is estimated to 1,425. INFORMATION, section II. C. average 1 hour per response for the Frequency of Response: Once when SUPPLEMENTARY INFORMATION: Partner Registration Form, 40 hours per registering for the program, then yearly I. General Information response for the Annual Assessment to report progress. Form, and 10 hours per response for the Estimated Total Annual Hour Burden: A. How Can I Get Copies of the ICR Endorser Registration Form. This results 56,350. Supporting Statement and Other in an estimated annual partner Estimated Total Annual Cost: Related Information? respondent burden of 41 hours for new $3,527,000, includes $0 annual capital/ 1. Docket. EPA has established official partners, 40 hours for established startup costs, $0 annual O&M and partners, and a one-time respondent public dockets for these ICRs as follows: $3,527,000 annual labor costs. (1) NSPS for Incinerators (40 CFR part burden of 10 hours for endorsers. Changes in the Estimates: There is a The estimated number of respondents 50, subpart E), Docket ID Number decrease of 7,910 hours in the total is 1,325 in Year 1; 1,425 in Year 2; and OECA–2004–0009. estimated burden currently identified in 1,525 in Year 3. Estimated total annual (2) NSPS for Small Industrial- the OMB Inventory of Approved ICR burden on all respondents is 52,350 Commercial-Industrial Steam Burdens. This decrease is due to a hours in Year 1; 56,350 hours in Year 2; Generating Units (40 CFR part 60, and 60,350 hours in Year 3. Burden change in program requirements. The subpart Dc), Docket ID Number OECA– means the total time, effort, or financial goals identification form was eliminated 2004–0010. resources expended by persons to and the new annual assessment form is (3) NSPS for Rubber Tire generate, maintain, retain, or disclose or easier for respondents to complete. Manufacturing (40 CFR part 60, subpart provide information to or for a Federal Dated: May 18, 2004. BBB), Docket ID Number OECA–2004– agency. This includes the time needed Oscar Morales, 0014. to review instructions; develop, acquire, Director, Collection Strategies Division. (4) NSPS for the Graphic Arts install, and utilize technology and [FR Doc. 04–11776 Filed 5–24–04; 8:45 am] Industry (40 CFR part 60, subpart QQ), Docket ID Number OECA–2004–0012. systems for the purposes of collecting, BILLING CODE 6560–50–P validating, and verifying information, (5) NSPS for Onshore Natural Gas processing and maintaining Processing Plants (40 CFR part 60, information, and disclosing and ENVIRONMENTAL PROTECTION subparts KKK and LLL), Docket ID providing information; adjust the AGENCY Number OECA–2004–0005. existing ways to comply with any (6) NSPS for Phosphate Rock Plants previously applicable instructions and [Docket ID Numbers OECA–2004–0004 to (40 CFR part 60, subpart NN); Docket ID requirements; train personnel to be able 0016, OECA–2004–0018 to 0022, FRL–7667– Number OECA–2004–0021. to respond to a collection of 4] (7) NESHAP for Pesticide Active information; search data sources; Agency Information Collection Ingredient Production (40 CFR part 63, complete and review the collection of Activities: Request for Comments on subpart MMM), Docket ID Number information; and transmit or otherwise Eighteen Proposed Information OECA–2004–0007. disclose the information. Collection Requests (ICRs) (8) NSPS for Hospital/Medical/ Respondents/Affected Entities: The Infectious Waste Incinerators (40 CFR WasteWise program was initially AGENCY: Environmental Protection part 60, subpart Ec), Docket ID Number targeted to the Fortune 500 Agency (EPA). OECA–2004–0015. manufacturing companies and the ACTION: Notice. (9) NESHAP for Vinyl Chloride (40 Fortune 500 service companies. During CFR part 61, subpart F), Docket ID the period covered by this ICR, SUMMARY: In compliance with the Number OECA–2004–0011. however, WasteWise will continue to Paperwork Reduction Act (44 U.S.C. (10) NSPS for Portland Cement Plants focus its marketing efforts on a broader 3501 et seq.), this document announces (40 CFR Part 60, Subpart F), Docket ID audience, including medium to large that EPA is planning to submit the Number OECA–2004–0022. size businesses, universities, and following eighteen existing, approved, (11) NSPS for Asphalt Processing and federal/state/local/tribal governments. continuing Information Collection Roofing Manufacture (40 CFR Part 60, While WasteWise actively promotes the Requests (ICR) to the Office of Subpart UU), Docket ID Number OECA– program to a smaller subset of these Management and Budget (OMB) for the 2004–0013.

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(12) NESHAP for Pulp and Paper Certain types of information will not B. How and to Whom Do I Submit Production (40 CFR part 63, subpart S), be placed in the EPA Dockets. Comments? Docket ID Number OECA–2004–0019. Information claimed as CBI, and other You may submit comments (13) NESHAP for Beryllium Rocket information whose disclosure is electronically, by mail, or through hand Motor Fuel Firing (40 CFR part 61, restricted by statute, which is not delivery/courier service. To ensure subpart D), Docket ID Number OECA– included in the official public docket, proper receipt by EPA, identify the 2004–0006. will not be available for public viewing appropriate docket identification (14) NESHAP for Petroleum Refineries in EPA’s electronic public docket. EPA’s (40 CFR part 63, subpart CC), Docket ID number in the subject line on the first policy is that copyrighted material will Number OECA–2004–0016. page of your comment. Please ensure (15) NESHAP for Chemical Recovery not be placed in EPA’s electronic public that your comments are submitted Combustion Sources at Kraft, Soda, docket but will be available only in within the specified comment period. Sulfite, and Stand-Alone Semichemical printed, paper form in the official public Comments received after the close of the Pulp Mills (40 CFR part 63, subpart docket. To the extent feasible, publicly comment period will be marked ‘‘late.’’ MM), Docket ID Number OECA–2004– available docket materials will be made EPA is not required to consider late 0020. available in EPA’s electronic public comments in formulating a final (16) NESHAP for Ferroalloys docket. When a document is selected decision. If you wish to submit CBI or Production: Ferromaganese and from the index list in EPA Dockets, the information that is otherwise protected Silconmaganese (40 CFR part 63, system will identify whether the by statute, please follow the instructions subpart XXX), Docket ID Number document is available for viewing in in section I.C. Do not use EPA Dockets OECA–2004–0004. EPA’s electronic public docket. or e-mail to submit CBI or information protected by statute. (17) NSPS for Polymeric Coating of Although not all docket materials may Supporting Substrates Facilities (40 CFR 1. Electronically. If you submit an be available electronically, you may still electronic comment as prescribed part 60, subpart VVV), Docket ID access any of the publicly available Number OECA–2004–0018. below, EPA recommends that you (18) NESHAP for Solvent Extraction docket materials through the docket include your name, mailing address, for Vegetable Oil Production (40 CFR facility identified in section I.A.1. EPA and an e-mail address or other contact part 63, subpart GGGG), Docket ID intends to work towards providing information in the body of your Number OECA–2004–0008. electronic access to all of the publicly comment. Also include this contact The official public docket for each available docket materials through information on the outside of any disk ICR consists of the documents EPA’s electronic public docket. or CD ROM you submit, and in any specifically referenced in the ICR, any For public commenters, it is cover letter accompanying the disk or public comments received, and other important to note that EPA’s policy is CD ROM. This ensures that you can be information related to each ICR. that public comments, whether identified as the submitter of the Although a part of the official docket, submitted electronically or in paper, comment and allows EPA to contact you the public docket does not include will be made available for public in case EPA cannot read your comment Confidential Business Information (CBI) viewing in EPA’s electronic public due to technical difficulties or needs or other information whose disclosure is docket as EPA receives them and further information on the substance of your comment. EPA’s policy is that EPA restricted by statute. The official public without change, unless the comment docket for each ICR is the collection of will not edit your comment, and any contains copyrighted material, CBI, or materials that is available for public identifying or contact information other information whose disclosure is viewing at the Enforcement and provided in the body of a comment will Compliance Docket and Information restricted by statute. When EPA be included as part of the comment that Center in the EPA Docket Center (EPA/ identifies a comment containing is placed in the official public docket, DC), EPA West, Room B102, 1301 copyrighted material, EPA will provide and made available in EPA’s electronic Constitution Avenue, NW., Washington, a reference to that material in the public docket. If EPA cannot read your DC. The EPA Docket Center Public version of the comment that is placed in comment due to technical difficulties Reading Room is open from 8:30 a.m. to EPA’s electronic public docket. The and cannot contact you for clarification, 4:30 p.m., Monday through Friday, entire printed comment, including the EPA may not be able to consider your excluding legal holidays. The telephone copyrighted material, will be available comment. number for the Reading Room is (202) in the public docket. i. EPA Dockets. Your use of EPA’s 566–1744, and the telephone number for Public comments submitted on electronic public docket to submit the Enforcement and Compliance computer disks that are mailed or comments to EPA electronically is Docket and Information Center Docket is delivered to the docket will be EPA’s preferred method for receiving (202) 566–1514. transferred to EPA’s electronic public comments. Go directly to EPA Dockets 2. Electronic Access. You may access docket. Public comments that are at http://www.epa.gov/edocket, and this document electronically through mailed or delivered to the Docket will follow the online instructions for the EPA Internet under the ‘‘Federal be scanned and placed in EPA’s submitting comments. To access EPA’s Register’’ listings at http:// electronic public docket. Where electronic public docket from the EPA www.epa.gov/fedrgstr. You may use Internet Home Page, select ‘‘Information practical, physical objects will be EPA Dockets at http://www.epa.gov/ Sources,’’ ‘‘Dockets,’’ and ‘‘EPA photographed, and the photograph will edocket to submit or view public Dockets.’’ After entering the system, be placed in EPA’s electronic public comments, access the index listing of select ‘‘search,’’ and then key in Docket the contents of the official public docket along with a brief description ID Number. The system is an docket, and to access those documents written by the docket staff. ‘‘anonymous access’’ system, which in the public docket that are available For additional information about means EPA will not know your identity, electronically. After entering the system, EPA’s electronic public docket, visit e-mail address, or other contact select ‘‘search,’’ then key in the docket EPA Dockets online or see 67 FR 38102, information unless you provide it in the identification number. May 31, 2002. body of your comment.

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ii. E-mail. Comments may be sent by mark the outside of the disk or CD ROM or provide information to or for a electronic mail (e-mail) to clearly that it does not contain CBI. Federal agency. This includes the time [email protected]. Provide the Information not marked as CBI will be needed to review instructions; develop, Docket ID Number when submitting included in the public docket and EPA’s acquire, install, and utilize technology your comments. In contrast to EPA’s electronic public docket without prior and systems for the purposes of electronic public docket, EPA’s e-mail notice. If you have any questions about collecting, validating, and verifying system is not an ‘‘anonymous access’’ CBI or the procedures for claiming CBI, information, processing and system. If you send an e-mail comment please consult the person identified maintaining information, and disclosing directly to the Docket without going under the section titled FOR FURTHER and providing information; adjust the through EPA’s electronic public docket, INFORMATION CONTACT. existing ways to comply with any EPA’s e-mail system automatically previously applicable instructions and D. What Should I Consider as I Prepare captures your e-mail address. E-mail requirements; train personnel to be able My Comments for EPA? addresses that are automatically to respond to a collection of captured by EPA’s e-mail system are You may find the following information; search data sources; included as part of the comment that is suggestions helpful for preparing your complete and review the collection of placed in the official public docket, and comments: information; and transmit or otherwise made available in EPA’s electronic (1) Explain your views as clearly as disclose the information. public docket. possible. iii. Disk or CD ROM. You may submit (2) Describe any assumptions that you II. ICRs To Be Renewed comments on a disk or CD ROM that used. A. For All ICRs you mail to the mailing address (3) Provide any technical information identified in section I.A.1. These and/or data you used that support your An Agency may not conduct or electronic submissions will be accepted views. sponsor, and a person is not required to in WordPerfect or ASCII file format. (4) If you estimate potential burden or respond to, a collection of information Avoid the use of special characters and costs, explain how you arrived at your unless it displays a currently valid OMB any form of encryption. estimate. control number. The OMB control 2. By Mail. Send your comments to (5) Provide specific examples to numbers for EPA’s standards are the EPA Docket Center using the illustrate your concerns. displayed in 40 CFR Part 9. address provided in section I.A.1.; (6) Offer alternatives. These information collection Attention: Docket ID Number (provide (7) Make sure to submit your requirements are mandatory. number). comments by the comment period Furthermore, the records required by 3. By Hand Delivery or Courier deadline identified. New Source Performance Standards Service. Deliver your comments to the (8) To ensure proper receipt by EPA, (NSPS) must be retained by the owner address provided in section I.A.1.; identify the appropriate docket or operator for at least two years and Attention: Docket ID Number (provide identification number in the subject line records required by the National number). Such deliveries are only on the first page of your response. It Emission Standards for Hazardous Air accepted during the Docket’s normal would also be helpful if you provided Pollutants (NESHAP) must be retained hours of operation as identified in the name, date, and Federal Register by the owner or operator for at least five section I.A.1. citation related to your comments. years. In general, the required information consists of emissions data C. How Should I Submit CBI to the E. In What Information Is EPA and other information deemed not to be Agency? Particularly Interested? private. Do not submit information that you Pursuant to section 3506(c)(2)(A) of In the absence of such information consider to be CBI electronically the PRA, EPA specifically solicits collection requirements, enforcement through EPA’s electronic public docket comments and information to enable it personnel would be unable to determine or by e-mail. Send or deliver to: whether the standards are being met on information identified as CBI only to the (1) Evaluate whether the proposed a continuous basis, as required by the contact individuals listed in section collections of information are necessary Clean Air Act. II.C.; Attention: Docket ID Number for the proper performance of the The Agency computed the burden for (provide number). You may claim functions of the Agency, including each of the recordkeeping and reporting information that you submit to EPA as whether the information will have requirements applicable to the industry CBI by marking any part or all of that practical utility; for the currently approved Information information as CBI. If you submit CBI on (2) Evaluate the accuracy of the Collection Requests (ICRs) listed in this disk or CD ROM, mark the outside of the Agency’s estimates of the burdens of the notice. Where applicable, the Agency disk or CD ROM as CBI, and then proposed collections of information; identified specific tasks and made identify within the disk or CD ROM the (3) Enhance the quality, utility, and assumptions, while being consistent specific information that is CBI. clarity of the information to be with the concept of the Paperwork Information so marked will not be collected; Reduction Act. disclosed except in accordance with (4) Minimize the burden of the B. List of ICRs Planned To Be Submitted procedures set forth in 40 CFR part 2. collections of information on those who In addition to one complete version of are to respond, including through the In compliance with the Paperwork the comment that includes any use of appropriate automated or Reduction Act (44 U.S.C. 3501 et seq.), information claimed as CBI, a copy of electronic collection technologies or this notice announces that EPA is the comment that does not contain the other forms of information technology, planning to submit the following information claimed as CBI must be e.g., permitting electronic submission of eighteen Information Collection submitted for inclusion in the public responses. Requests (ICR) to the Office of docket and EPA’s electronic public Burden means the total time, effort, or Management and Budget (OMB): docket. If you submit the copy that does financial resources expended by persons (1) NSPS for Incinerators (40 CFR part not contain CBI on disk or CD ROM, to generate, maintain, retain, or disclose 50, subpart E), Docket ID Number

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OECA–2004–0009; EPA Preliminary ICR 2060–0002; expiration date November Number 2060–0202; expiration date Number 1058.08; OMB Control Number 30, 2004. October 31, 2004. 2060–0040; expiration date October 31, (12) NESHAP for Pulp and Paper (3) NSPS for Rubber Tire 2004. Production (40 CFR part 63, subpart S); Manufacturing (40 CFR part 60, subpart (2) NSPS for Small Industrial- Docket ID Number OECA–2004–0019; BBB); Marı´a Malave´ of the Office of Commercial-Industrial Steam EPA Preliminary ICR Number 1657.05; Compliance at (202) 564–7027 or via e- Generating Units (40 CFR part 60, OMB Control Number 2060–0387; mail at [email protected]; EPA ICR subpart Dc), Docket ID Number OECA– expiration date November 30, 2004. Number 1158.08; OMB Control Number 2004–0010; EPA Preliminary ICR (13) NESHAP for Beryllium Rocket 2060–0156; expiration date is October Number 1564.06; OMB Control Number Motor Fuel Firing (40 CFR part 61, 31, 2004. 2060–0202; expiration date October 31, subpart D); Docket ID Number OECA– (4) NSPS for the Graphic Arts 2004. 2004–0006; EPA Preliminary ICR Industry (40 CFR part 60, subpart QQ); (3) NSPS for Rubber Tire Number 1125.04; OMB Control Number Learia Williams of the Office of Manufacturing (40 CFR part 60, subpart 2060–0394; expiration date November Compliance at (202) 564–4113 or via e- BBB); Docket ID Number OECA–2004– 30, 2004. mail at [email protected]; EPA 0014; EPA ICR Number 1158.08; OMB (14) NESHAP for Petroleum Refineries ICR Number 0657.08; OMB Control Control Number 2060–0156; expiration (40 CFR part 63, subpart CC); Docket ID Number 2060–0105; expiration date date is October 31, 2004. Number OECA; EPA ICR Number October 31, 2004. (4) NSPS for the Graphic Arts 1692.05, OMB Control Number 2060– (5) NSPS for Onshore Natural Gas Industry (40 CFR part 60, subpart QQ), 0340; expiration date is December 31, Processing Plants (40 CFR part 60, Docket ID Number OECA–2004–0012; 2004. subparts KKK and LLL); Dan Chadwick of the Office of Compliance at (202) EPA Preliminary ICR Number 0657.08; (15) NESHAP for Chemical Recovery 564–7054, or via e-mail at OMB Control Number 2060–0105; Combustion Sources at Kraft, Soda, [email protected]; EPA ICR expiration date October 31, 2004. Sulfite, and Stand-Alone Semichemical Number 1086.07; OMB Control Number (5) NSPS for Onshore Natural Gas Pulp Mills (40 CFR part 63, subpart 2060–0120; expiration date October 31, Processing Plants (40 CFR part 60, MM); Docket ID Number OECA–2004– subparts KKK and LLL); Docket ID 2004. 0020; EPA Preliminary ICR Number (6) NSPS for Phosphate Rock Plants Number OECA–2004–0005; EPA 1805.04; OMB Control Number 2060– (40 CFR part 60, subpart NN); Gregory Preliminary ICR Number 1086.07; OMB 0377; expiration date December 31, Fried of the Office of Compliance at Control Number 2060–0120; expiration 2004. (202) 564–7016 or via e-mail at date October 31, 2004. (16) NESHAP for Ferroalloys [email protected]; EPA ICR Number (6) NSPS for Phosphate Rock Plants Production: Ferromaganese and 1078.07; OMB Control Number 2060– (40 CFR Part 60, Subpart NN); Docket ID Silconmaganese (40 CFR part 63, 0111; expiration date October 31, 2004. Number OECA–2004–0021; EPA subpart XXX); Docket ID Number (7) NESHAP for Pesticide Active Preliminary ICR Number 1078.07; OMB OECA–2004–0004; EPA ICR Number Ingredient Production (40 CFR part 63, Control Number 2060–0111; expiration 1831.03; OMB Control Number 2060– subpart MMM); Learia Williams of the date October 31, 2004. 0391; expiration date is December 31, Office of Compliance at (202) 564–4113 (7) NESHAP for Pesticide Active 2004. or via e-mail at [email protected]; Ingredient Production (40 CFR part 63, (17) NSPS for Polymeric Coating of EPA ICR Number 1807.03; OMB Control subpart MMM), Docket ID Number Supporting Substrates Facilities (40 CFR Number 2060–0370; expiration date OECA–2004–0007; EPA Preliminary ICR part 60, subpart VVV); Docket ID October 31, 2004. Number 1807.03; OMB Control Number Number OECA–2004–0018; EPA (8) NSPS for Hospital/Medical/ 2060–0370; expiration date October 31, Preliminary ICR Number 1284.07; OMB Infectious Waste Incinerators (40 CFR 2004. Control Number 2060–0181; expiration part 60, subpart Ec); Learia Williams of (8) NSPS for Hospital/Medical/ date January 31, 2005. the Office of Compliance at (202) 564– Infectious Waste Incinerators (40 CFR (18) NESHAP for Solvent Extraction 4113 or via e-mail at part 60, subpart Ec), Docket ID Number for Vegetable Oil Production (40 CFR [email protected]; EPA ICR OECA–2004–0015; EPA Preliminary ICR part 63, Subpart GGGG), Docket ID Number 1730.04; OMB Control Number Number 1730.04; OMB Control Number Number OECA–2004–0008; EPA 2060–0363; expiration date November 2060–0363; expiration date November Preliminary ICR Number 1947.03; OMB 30, 2004. 30, 2004. Control Number 2060–0471; expiration (9) NESHAP for Vinyl Chloride (40 (9) NESHAP for Vinyl Chloride (40 date January 31, 2005. CFR part 61, subpart F); Learia Williams CFR part 61, subpart F), Docket ID C. Contact Individuals for ICRs of the Office of Compliance at (202) Number OECA–2004–0011; EPA 564–4113 or via e-mail at Preliminary ICR Number 0186.10; OMB (1) NSPS for Incinerators (40 CFR part [email protected]; EPA ICR Control Number 2060–0071; expiration 50, subpart E); Learia Williams of the Number 0186.10; OMB Control Number date November 30, 2004. Office of Compliance at (202) 564–4113 2060–0071; expiration date November (10) NSPS for Portland Cement Plants or via e-mail at [email protected]; 30, 2004. (40 CFR part 60, subpart F); Docket ID EPA ICR Number 1058.08; OMB Control (10) NSPS for Portland Cement Plants Number OECA–2004–0022; EPA Number 2060–0040; expiration date (40 CFR part 60, subpart F); Gregory Preliminary ICR Number 1051.09; OMB October 31, 2004. Fried of the Office of Compliance at Control Number 2060–0025; expiration (2) NSPS for Small Industrial- (202) 564–7016 or via e-mail at date November 30, 2004. Commercial-Industrial Steam [email protected]; EPA ICR Number (11) NSPS for Asphalt Processing and Generating Units (40 CFR part 60, 1051.09; OMB Control Number 2060– Roofing Manufacture (40 CFR part 60, subpart Dc); Dan Chadwick of the Office 0025; expiration date November 30, subpart UU); Docket ID Number OECA– of Compliance at (202) 564–7054, or via 2004. 2004–0013; EPA Preliminary ICR e-mail at [email protected]; EPA (11) NSPS for Asphalt Processing and Number 0661.08; OMB Control Number ICR Number 1564.06; OMB Control Roofing (40 CFR part 60, subpart UU);

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Gregory Fried of the Office of D. Information for Individual ICRs less than 29 megawatt (MW) (100 Compliance at (202) 564–7016 or via e- (1) NSPS for Incinerators (40 CFR part million Btu/hr), but greater than or mail at [email protected]; EPA ICR 60, subpart E); EPA Preliminary ICR equal to 2.9 MW (10 million Btu/hr). Abstract: The New Source Number 0661.08; OMB Control Number Number 1058.08; OMB Control Number Performance Standard (NSPS) for small 2060–0002; expiration date November 2060–0040; expiration date October 31, industrial-commercial-institutional 30, 2004. 2004. steam generation units was promulgated (12) NESHAP for Pulp and Paper Affected Entities: Sources potentially Production (40 CFR part 63, subpart S); on September 12, 1990. affected by this action are incinerators The affected sources are subject to the Leonard Lazarus of the Office of that charge more than 45 megagrams per Compliance at (202) 564–6369 or via e- General Provisions of the NSPS at 40 day (50 tons per day) of solid waste. CFR part 60, subpart A and any changes mail at [email protected]; EPA Abstract: The New Source Preliminary ICR Number 1657.05; OMB or additions to the General Provisions Performance Standard (NSPS) for specified at 40 CFR part 60, subpart Dc. Control Number 2060–0387; expiration incinerators was promulgated on date November 30, 2004. Owners/operators must make one-time- December 23, 1971. only notifications of construction, (13) NESHAP for Beryllium Rocket The affected sources are subject to the Motor Fuel Firing (40 CFR part 61, reconstruction, or startup, the initial General Provisions of the NSPS at 40 performance test, and physical or subpart D); Dan Chadwick of the Office CFR part 60, subpart A and any changes of Compliance at (202) 564–7054, or via operational changes. They must also or additions to the General Provisions demonstrate a continuous monitoring e-mail at [email protected]; EPA specified at 40 CFR part 60, subpart E. Preliminary ICR Number 1125.04; OMB system that meets the requirements of Owners/operators of the affected the standard, and submit reports on the Control Number 2060–0394; expiration sources described must make one-time- date November 30, 2004. performance test results, monitoring only notifications including: (1) results and excess emissions. (14) NESHAP for Petroleum Refineries Notification of any physical or Burden Statement: In the previously (40 CFR part 63, subpart CC); Docket ID operational change to an existing facility approved ICR, the estimated number of Number OECA–2003–0016; Dan which may increase the regulated respondents for this information Chadwick of the Office of Compliance at pollutant emission rate; (2) notification collection was 708 with 1,696 responses (202) 564–7054, or via e-mail at of the initial performance test, including per year. The annual industry reporting [email protected]; EPA ICR information necessary to determine the and recordkeeping burden for this Number 1692.05; OMB Control Number conditions of the performance test; and collection of information was 432,767 2060–0340; expiration date is December (3) performance test measurements and hours. On average, each respondent 31, 2004. results. Owners or operators are also reported 2.4 times per year, and 255 (15) NESHAP for Chemical Recovery required to maintain records of the hours were spent preparing each Combustion Sources at Kraft, Soda, occurrence and duration of any startup, response. The total annualized cost for Sulfite, and Stand-Alone Semichemical shutdown, or malfunction in the this ICR is $13,185,000 which is Pulp Mills (40 CFR part 63, subpart operation of an affected facility, or any comprised of capital/startup costs of MM); Leonard Lazarus of the Office of period during which the monitoring $8,400,000 and operation and Compliance at (202) 564–6369 or via e- system is inoperative. Monitoring maintenance costs of $4,785,000. mail at [email protected]; EPA requirements specific to the standard (3) NSPS for Rubber Tire Preliminary ICR Number 1805.04; OMB provide information on daily charging Manufacturing (40 CFR part 60, subpart Control Number 2060–0377; expiration rates and hours of operation. BBB); EPA ICR Number 1158.08; OMB date December 31, 2004. Burden Statement: In the previously Control Number 2060–0156; expiration (16) NESHAP for Ferroalloys approved ICR, the estimated number of date is October 31, 2004. Production: Ferromaganese and respondents for this information Affected Entities: Sources potentially Silconmaganese (40 CFR part 63, collection was 96 with 96 responses per affected by this action are rubber tire subpart XXX); Maria Malave´ of the year. The annual industry reporting and manufacturing plants. Office of Compliance at (202) 564–7027 recordkeeping burden for this collection Abstract: The New Source or via e-mail at [email protected]; of information was 8,544 hours. On Performance Standard (NSPS) for rubber EPA ICR Number 1831.03; OMB Control average, each respondent reported one tire manufacturing at 40 CFR part 60, Number 2060–0391; expiration date is time per year, and 89 hours were spent subpart BBB was promulgated on December 31, 2004. preparing each response. The total September 15, 1987, and revised most (17) NSPS for Polymeric Coating of annualized costs associated with the recently on September 19, 1989. Supporting Substrates Facilities (40 CFR continuous monitoring equipment in The affected sources are subject to the part 60, subpart VVV); Leonard Lazarus the previous ICR were $240,000. There General Provisions of the NSPS at 40 of the Office of Compliance at (202) were no capital/startup costs. However, CFR part 60, subpart A and any changes 564–6369 or via e-mail at there were operation and maintenance or additions to the General Provisions [email protected]; EPA costs in the previous ICR of $240,000. specified at 40 CFR part 60, subpart Preliminary ICR Number 1284.07; OMB (2) NSPS for Small Industrial- BBB. The standards require the Control Number 2060–0181; expiration Commercial-Industrial Steam submission of notifications when date January 31, 2005. Generating Units (40 CFR part 60, conducting performance tests and (18) NESHAP for Solvent Extraction subpart Dc); EPA Preliminary ICR during periods of excess emissions. for Vegetable Oil Production (40 CFR Number 1564.06; OMB Control Number Owners/operators are also required to part 63, subpart GGGG); Learia Williams 2060–0202; expiration date October 31, maintain records of the occurrence and of the Office of Compliance at (202) 2004. duration of any startup, shutdown, or 564–4113 or via e-mail at Affected Entities: Sources potentially malfunction, or any period during [email protected]; EPA ICR affected by this action are small which the monitoring system is Number 1947.03; OMB Control Number industrial-commercial-institutional inoperative. Additional monitoring 2060–0471; expiration date January 31, steam generating units having a requirements specific to rubber tire 2005. maximum design heat input capacity of manufacturing plants provide

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information on the operation of the subparts KKK and LLL), EPA ICR sources described must make the emissions control device and Number 1086.07; OMB Control Number following one-time-only reports: compliance with the volatile organic 2060–0120; expiration date October 31, Notification of the date of construction compounds emission limitation. 2004. or reconstruction; notification of the Semiannual reports are also required. Affected Entities: Sources potentially actual dates of startup; notification of Burden Statement: In the previously affected by this action are onshore any physical or operational change to an approved ICR, the estimated number of natural gas processing plants. existing facility which may increase the respondents for this information Abstract: The New Source regulated pollutant emission rate; collection was 43 with 79 responses per Performance Standards (NSPS) for notification of demonstration of the year. The annual industry reporting and onshore natural gas processing plants continuous monitoring system (CMS); recordkeeping burden for this collection were promulgated on June 24, 1985 notification of the date of the initial of information was 13,151 hours. On (subpart KKK) and October 1, 1985 performance test; and the results of the average, each respondent reported 1.8 (subpart LLL). initial performance test. times per year and 167 hours were spent The affected sources are subject to the Owners or operators are also required preparing each response. There were no General Provisions of the NSPS at 40 to maintain records of the occurrence capital/startup costs since no new CFR part 60, subpart A and any changes, and duration of any startup, shutdown, sources were expected over the three- or additions to the General Provisions or malfunction in the operation of an year period of the ICR. The total annual specified at 40 CFR part 60, subparts affected facility, or any period during operations and maintenance (O&M) cost KKK and LLL. The standards require which the monitoring is inoperative. for this ICR is estimated to be $17,200 performance tests, notifications, reports, Burden Statement: In the previously dollars. This estimate was based on the recordkeeping, and monitoring of approved ICR, the estimated number of assumption that 10 percent of the emissions. The standards also require respondents for this information existing plants have a temperature that the owners/operators of onshore collection was 31. In addition, it is monitor with a continuous recorder per natural gas processing plants must estimated that each respondent will combustion control device for volatile notify EPA of construction, submit one response per year for a total organic compound (VOC) emission modification, startup, shutdowns, of 31 responses. The annual industry reduction (e.g., an incinerator). malfunctions, and the results of the reporting and recordkeeping burden in (4) NSPS for the Graphic Arts initial performance test. the previous ICR was 3,002 hours or Industry (40 CFR part 60, subpart QQ); Owners/operators of onshore natural approximately 97 hours per response. EPA Preliminary ICR Number 0657.08; gas processing plants that are potential The annualized capital/startup costs for OMB Control Number 2060–0105; volatile organic compound emitters installation of compliance monitors is expiration date October 31, 2004. must also keep records of leaks from estimated to be $74,000 based on two Affected Entities: Sources potentially pressure relief devices, the date of leak new plants per year at $37,000 per affected by this action are publication detection, repair method used, and plant. The annualized operation and rotogravure printing presses. other pertinent details. maintenance costs for the monitoring Abstract: The New Source Burden Statement: In the previously systems is estimated to be $253,000. Performance Standard (NSPS) for the approved ICR, the estimated number of Therefore, the total annualized cost on graphic arts industry was promulgated respondents for this information the industry is estimated to be $327,000. on November 8, 1982. collection was 558 with 1,116 responses (7) NESHAP for Pesticide Active The affect sources are subject to the per year. The annual industry reporting Ingredient Production (40 CFR part 63, General Provisions of the NSPS at 40 and recordkeeping burden for this subpart MMM); EPA Preliminary ICR CFR part 60, subpart A and any changes, collection of information was 114,036 Number 1807.03; OMB Control Number or additions to the General Provisions hours. On average, each respondent 2060–0370; expiration date October 31, specified at 40 CFR part 60, subpart QQ. reported two times per year, and 102 2004. The General Provisions are comprised of hours were spent preparing each Affected Entities: Sources potentially notification, reporting, and response. There were no annualized affected by this action are pesticide recordkeeping requirements including a capital/startup costs in the previous active ingredient manufacturing one-time-only notifications of the ICR, and the total operation and processing units. startup date, a report on the initial maintenance costs associated with Abstract: The National Emission performance test, semiannual reports continuous emission monitoring were Standards for Hazardous Air Pollutants and reports of excess emissions. In estimated to be $74,000 per year. for pesticide active ingredient addition, certain weekly and monthly (6) NSPS for Phosphate Rock Plants production were promulgated on June records are needed for this industry in (40 CFR part 60, subpart NN); EPA ICR 23, 1999. order to ensure continuous compliance. Number 1078.07; OMB Control Number The affected sources are subject to the Burden Statement: In the previously 2060–0111; expiration date October 31, General Provisions of the NESHAP at 40 approved ICR, the estimated number of 2004. CFR part 63, subpart A and any changes respondents for this information Affected Entities: Entities potentially or additions to the General Provisions collection was 31 with 60 responses per affected by this action are phosphate specified at 40 CFR part 63, subpart year. The annual industry reporting and rock plants. MMM. These reporting requirements recordkeeping burden for this collection Abstract: The New Source include: A notification by the source of information was 3,871 hours. On Performance Standards (NSPS) for (i.e., self-reporting) that the facility is average, each respondent reported twice phosphate rock plants were subject to the rule; a notification of per year and 65 hours were spent promulgated on April 16, 1982. emission testing (control device preparing each response.There were no The affected entities are subject to the performance test and continuous capital/startup costs or operation and General Provisions of the NSPS at 40 monitoring system (CMS) performance maintenance costs associated with the CFR part 60, subpart A and any changes evaluation); submission of the results of previous ICR. or additions to the General Provisions performance testing and CMS (5) NSPS for Onshore Natural Gas specified at 40 CFR part 60, subpart NN. performance evaluations; startup, Processing Plants (40 CFR part 60, Owners/operators of the affected shutdown, and malfunction reports;

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semiannual/quarterly reports; and CMS September 15, 1997.The standards Control Number 2060–0071; expiration performance reports. In addition to the apply to HMIWIs for which construction date November 30, 2004. requirements of subpart A, respondents commenced after June 20, 1996 or for Affected Entities: Sources potentially are required to submit a precompliance which modification commenced after affected by this action are ethylene plan, and plants that wish to implement the date of promulgation. dichloride plants, vinyl chloride the emission averaging provisions in the The source are subject to the General monomer plants, and polyvinyl chloride standard must submit an emissions Provisions of the NSPS at 40 CFR part plants. averaging plan. 60, subpart A and any changes or Abstract: The National Emissions Respondents electing to comply with additions to the General Provisions Standard for Hazardous Air Pollutants the emission limit or emission reduction specified at 40 CFR part 60, subpart Ec. (NESHAP) from Vinyl Chloride (VC) requirements for process vents, storage As such, the reporting and was promulgated on October 21, 1976, tanks, or wastewater must also record recordkeeping requirements differ and amended on June 7, 1977, certain equipment operating parameters. somewhat for incinerators burning September 30, 1986, September 23, 1988 If the owner/operator identifies any hospital waste or medical/infectious and December 23, 1992. deviation resulting from a known cause waste and for co-fired combustors The affected sources are subject to the for which no exemption from an incinerators burning only pathological, General Provisions of the NESHAP at 40 emission limitation or standard applies, low-level radioactive, and/or CFR part 61, subpart A and any changes, the compliance report will also include chemotherapeutic waste. Notification or additions to the General Provisions all records that the affected source is reports are required for all sources specified at 40 CFR part 63, subpart F. required to maintain that pertain to the constructing, reconstructing, or The standard applies to exhaust gases and oxychlorination vents at ethylene periods during which such deviation modifying an HMIWI. Also, required are dichloride plants; exhaust gases at vinyl occurred, as well as the following: The one-time-only reports related to initial chloride monomer plants; and exhaust magnitude of each deviation; the reason performance tests and continuous gases, reactors opening losses, manual for each deviation; a description of the measurements of site-specific operating vent valves, and stripping residuals at corrective action taken for each parameters. Annual compliance reports polyvinyl chloride plants. The deviation, including action taken to are required for site-specific operating standards also apply to relief valves and minimize each deviation and action parameters, including exceedance of fugitive emission sources at all three taken to prevent recurrence; and a copy applicable limits. Semiannual reports types of plants. of all quality assurance activities are also required. performed on any element of the In order to ensure compliance with Co-fired combustors and incinerators the standard, the owner/operator must monitoring protocol. burning only pathological, low-level Since many of the facilities make the following one-time-only radioactive, and/or chemotherapeutic potentially affected by the NESHAP reports; application for approval of waste are required to submit notification standard are also subject to a similar construction or modification; new source performance standard of any exemption claim, and an estimate notification of startup; application of a (NSPS), the standard includes an of the relative amounts of waste and waiver of testing (if desired by source); exemption from the NSPS for such fuels to be combusted. These co-fired and an initial compliance report. The sources. The exemption eliminates a combustors and incinerators are also initial compliance report includes a list duplication of information collection required to maintain records on a of the control equipment installed, a requirements. calendar quarter basis of the weight of description of the physical and Burden Statement: In the previously hospital waste combusted, the weight of functional characteristics of each piece approved ICR, the estimated number of medical/infectious waste combusted, of equipment, a description of the respondents for this information and the weight of fuels combusted. methods which have been incorporated collection was 84 with 375 responses Owners/operators are required to into the standard operation procedures per year. The annual industry reporting maintain records of the occurrence and at the source to measure and calculate and recordkeeping burden for this duration of any startup, shutdown, or emissions, and a statement that the collection of information was 53,752 malfunction, or any period during equipment and procedures are in-place hours. On average, each respondent which the monitoring system is and are being used. Initial reports also reported 4.5 times per year, and 143 inoperative. These notifications, reports, include an application for approval of hours were spent preparing each and records are essential in determining construction or modification, and response. The total annualized costs of compliance and are required of all notification of startup. The standards this ICR are estimated to be $2,268,000 sources subject to NSPS. require quarterly reporting of vinyl of which the capital/startup costs are Burden Statement: In the previously chloride emissions from stripping, $2,210,000, and the operation and approved ICR, the estimated number of reactor openings, and exhausts. Reports maintenance costs are $58,000. respondents was six with 2,349 must be submitted within 10 days of (8) NSPS for Hospital/Medical/ responses per year. The annual industry each valve discharge and manual vent Infectious Waste Incinerators (40 CFR reporting and recordkeeping burden for valve discharge. Semiannual and excess part 60, subpart Ec); EPA Preliminary this collection of information was 4,541 emission reports are also required. ICR Number 1730.04; OMB Control hours. On average, each respondent Burden Statement: In the previously Number 2060–0363; expiration date reported 391.5 times per year,and 1.9 approved ICR, the estimated number of November 30, 2004. hours were spent preparing each respondents for this information Affected Entities: Sources potentially response. The total annualized costs for collection was 44 with 308 responses affected by this action are hospital/ this ICR are estimated to be $19,000 per year. The annual industry reporting medical/infectious waste incinerators. which is comprised of capital/startup and recordkeeping burden for this Abstract: The New Source costs of $2,000 and operation and collection of information was 16,159 Performance Standards (NSPS) for maintenance costs of $17,000. hours. On average, each respondent Hospital/Medical/Infectious Waste (9) NESHAP for Vinyl Chloride (40 reported seven times per year, and 52 Incinerators (HMIWI), 40 CFR part 60, CFR part 61, subpart F); EPA hours were spent preparing each subpart Ec were promulgated on Preliminary ICR Number 0186.10; OMB response. The total annualized cost of

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this ICR is estimated to be $1,980,000. performance test. Excess emission hours were spent preparing each In the previous ICR, there were no reports are also required. response. The annual reporting and capital/startup costs and the annualized Burden Statement: In the previously recordkeeping cost burden was operation and maintenance costs were approved ICR, the estimated number of estimated to be $370,000 in the previous $1,980,000. respondents for this information ICR. The capital/startup cost was (10) NSPS for Portland Cement Plants collection was 83 with ten responses per $370,000 with no expected operation (40 CFR part 60, subpart F); EPA ICR year. The annual industry reporting and and maintenance cost. Number 1051.09; OMB Control Number recordkeeping burden for this collection (13) NESHAP for Beryllium Rocket 2060–0025; expiration date November of information was 15,089 hours or Motor Fuel Firing (40 CFR part 61, 30, 2004. approximately 1,509 hours per subpart D), EPA ICR Number 1125.04; Affected Entities: Entities potentially response. The total annualized capital/ OMB Control Number 2060–0394; affected by this action are portland startup for installation of temperature expiration date November 31, 2004. cement plants. monitors is estimated to be Affected Entities: Sources potentially Abstract: The New Source approximately $200,000 based on two affected by this action are beryllium Performance Standards (NSPS) for new plants annually at $100,000 per rocket motor testing facilities. portland cement plants were plant. The total annualized operation Abstract: The National Emission promulgated on July 25, 1977. and maintenance costs for the Standards for Hazardous Air Pollutants The affected entities are subject to the monitoring systems is estimated at (NESHAP) for beryllium rocket motor General Provisions of the NSPS at 40 $2,905,000. Therefore, the total firing were promulgated on April 6, CFR part 60, subpart A and any changes annualized cost to the industry is 1973. or additions to the General Provisions estimated to be $3,105,000. The affected sources are subject to the specified at 40 CFR part 60, subpart F. (12) NESHAP for Pulp and Paper General Provisions of the NESHAP at 40 Owners/operators of portland cement Production (40 CFR part 63, subpart S); CFR part 61, subpart A and any changes plants must notify EPA of construction, EPA Preliminary ICR Number 1657.05; or additions to the General Provisions modification, startups, shut downs, date OMB Control Number 2060–0387; specified at 40 CFR part 63, subpart D. and results of initial performance test expiration date November 31, 2004. The standard requires source to test the and excess emissions. Affected Entities: Sources potentially ambient air for beryllium during and Burden Statement: In the previously affected by this action are pulp and after firing of a rocket motor. Sampling approved ICR, the estimated number of paper mills. techniques are approved by the respondents for this information Abstract: The National Emission Administrator. Samples are analyzed collection was 113. In addition, it is Standards for Hazardous Air Pollutants within 30 days and results are reported estimated that each existing respondent (NESHAP) for pulp and paper to the EPA Region by registered letter by will submit approximately four production was promulgated on April the business day following the responses per year, or a total of 448 15, 1998. compliance determination (see 40 CFR responses per year. The annual industry The affected sources are subject to the 61.43). In addition, stack sampling reporting and recordkeeping burden in General Provisions of the NESHAP at 40 required at 40 CFR 61.41, requires the previous ICR was 7,968 hours or CFR part 63, subpart A and any changes continuous sampling of beryllium approximately 18 hours per response. or additions to the General Provisions combustion products, analysis and The capital/startup for installation of specified at 40 CFR part 63, subpart S. reporting within 30 days. The results are continuous monitoring systems was Pulp mill owners/operators are reported to EPA the day following the estimated to be $139,200 based on four required to submit initial notifications, compliance determination. new plants per year at $34,800 per maintain records of the occurrence and Burden Statement: In the previously plant. The operation and maintenance duration of any startup, shutdown, or approved ICR, the estimated number of costs for the monitoring systems was malfunction in the operation of an respondents for this information estimated at $848,000. Therefore, the affected source, or any period during collection was 1 with 1⁄3 response per total annualized cost to the industry in which the emission monitoring system year (Once per test firing, one test firing the previous ICR was $987,200. is inoperative. Respondents are required in three years). The annual industry (11) NSPS for Asphalt Processing and to monitor and keep records of specific reporting and recordkeeping burden for Roofing (40 CFR part 60, subpart UU); operating parameters for each control this collection of information was eight EPA ICR Number 0661.08; OMB Control device and to perform and document hours. On average, each respondent Number 2060–0002; expiration date periodic inspections of the closed vent reported one time every two years and November 30, 2004. and wastewater conveyance systems. 8 hours were spent preparing each Affected Entities: Entities potentially All respondents must submit response. The responses were prepared affected by this action are asphalt semiannual reports of the monitored biannually. In the previously approved storage facilities, asphalt processing parameters, and they must submit an ICR, there were no capital/startup costs plants and petroleum refineries. additional monitoring report during and the total operation and maintenance Abstract: The New Source each quarter in which monitored costs associated with continuous Performance Standards (NSPS) for parameters were outside the ranges emission monitoring in the previous ICR asphalt processing and roofing were established in the standard or during were estimated to be $453 per year. promulgated on August 6, 1982. initial performance tests. (14) NESHAP for Petroleum Refineries The affected sources are subject to the Burden Statement: In the previously (40 CFR part 63, subpart CC); EPA ICR General Provisions of the NSPS at 40 approved ICR, the estimated number of Number 1692.05; OMB Control Number CFR part 60, subpart A and any changes respondents for this information 2060–0340; expiration date December or additions to the General Provisions collection was 162 with 500 responses 31, 2004. specified at 40 CFR part 60, subpart UU. per year. The annual industry reporting Affected Entities: Sources potentially Owners/operators of the regulated and recordkeeping burden for this affected by this action are petroleum sources must notify EPA of collection of information was 50,232 refineries. construction, modification, startups, hours. On average, each respondent Abstract: The National Emission shut downs, date and results of initial reported three times per year, and 100 Standards for Hazardous Air Pollutants

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(NESHAP) for petroleum refineries (40 combustion sources at kraft, soda, reports. In addition, sources are CFR part 63, subpart CC) were sulfite, and stand-alone semichemical required to maintain records of the promulgated on August 18, 1995, and pulp mills. occurrence and duration of any startup, technically corrected and amended Abstract: The National Emission shutdown, or malfunction in the several times with the most recent Standards for Hazardous Air Pollutants operation of an affected facility; any correction made on May 25, 2001, and (NESHAP) for chemical recovery period during which the monitoring the most recent revision made on combustion sources at kraft, soda, system is inoperative; bag leak detection August 18, 1998. sulfite, and stand-alone semichemical system alarms, including corrective The affected sources are subject to the pulp mills at 40 CFR part 63, subpart actions; parametric monitoring data; General Provisions of the NESHAP at 40 MM were promulgated on January 12, system maintenance and calibration; CFR part 63, subpart A and any changes 2001. and opacity and visible emissions or additions to the General Provisions The subject sources are subject to the observations to demonstrate initial and specified at 40 CFR part 63, subpart CC. General Provisions of the NESHAP at 40 on-going compliance with the This standard requires sources to CFR part 63, subpart A and any changes regulation. comply with the recordkeeping and or additions to the General Provisions Burden Statement: In the previously reporting requirements contained in specified at 40 CFR part 63, subpart approved ICR, the estimated number of either 40 CFR part 61 subpart VV or 40 MM. These requirements include initial respondents for this information CFR part 63, subpart H for equipment notifications; notifications of collection was one with 31 responses leaks (which include an initial report performance tests; notifications of per year. The annual industry reporting and semiannual summaries of leak performance evaluations; notifications and recordkeeping burden for this detection and repair) and 40 CFR part of compliance status, including the collection of information was 746 hours. 61, subpart FF or 40 CFR part 63, results of performance tests; startup, On average, the respondent spent 24 subpart H for wastewater operations. shutdown, and malfunction reports; and hours preparing each response. There This rule also requires sources to semiannual compliance reports. were no capital/startup costs or submit initial notifications, conduct Burden Statement: In the previously operation and maintenance costs performance tests, and submit periodic approved ICR, the estimated number of associated with continuous emission reports. In addition, sources are respondents for this information monitoring in the previous ICR. required to: Maintain records of the collection was 136 with 125 responses (17) NSPS for Polymeric Coating of occurrence and duration of any startup, per year. The annual industry reporting Supporting Substrates Facilities (40 CFR shutdown, or malfunction in the and recordkeeping burden for this part 60, subpart VVV); EPA Preliminary operation of an affected facility; any collection of information was 21,528 ICR Number 1284.07; OMB Control period during which the monitoring hours. On average, each respondent Number 2060–0181; expiration date system is inoperative; bag leak detection reported 0.9 times per year, and 172 January 31, 2005. system alarms and corrective actions; hours were spent preparing each Affected Entities: Sources potentially parametric monitoring data; and system response. The annual reporting and affected by this action are of polymeric maintenance and calibration data. recordkeeping cost burden in the coating plants. Burden Statement: In the previously previous ICR was $5,000. The total Abstract: The New Source approved ICR, the estimated number of annualized capital/startup costs were Performance Standard (NSPS) respondents for this information $2,000, and the total operation and polymeric coating of supporting collection was 157 with 314 responses maintenance costs were $3,000. substrates facilities at 40 CFR part 60, per year. The annual industry reporting (16) NESHAP for Ferroalloys subpart VVV were promulgated on and recordkeeping burden for this Production: Ferromaganese and September 15, 1987, and revised most collection of information was 469,430 Silconmaganese (40 CFR part 63, recently on September 19, 1989. hours. On the average each respondent subpart XXX); EPA ICR Number The affected sources are subject to the reported twice per year and 1,495 hours 1831.03; OMB Control Number 2060– General Provisions of the NSPS at 40 were spent preparing each response. 0391; expiration date is December 31, CFR part 60, subpart A and any changes, The annualized capital/startup costs for 2004. or additions to the General Provisions this ICR was estimated to be $542,173. Affected Entities: Sources potentially specified at 40 CFR part 60, subpart This estimate was based on the affected by this action are affected VVV. Sources must: maintain records of assumptions that all refineries facilities at ferromanganese and startups, shutdowns, malfunctions; (‘‘respondents’’) will hire a contractor to silicomanganese production facilities periods where the continuous provide sampling and analytical that are major sources or are co-located monitoring system is inoperative; all services during the initial performance at major sources. measurements including performance tests. There are no operation and Abstract: The National Emission tests; operating parameters of maintenance costs since this rule does Standards for Hazardous Air Pollutants monitoring device results for catalytic or not require any additional monitoring (NESHAP) for ferroalloys production: thermal incinerators, carbon adsorption equipment and any related costs are ferromaganese and silconmaganese at 40 system, condensation system, vapor assumed to be negligible. CFR part 63, subpart XXX were capture system and/or total enclosure; (15) NESHAP for Chemical Recovery promulgated on May 20, 1999, and monitor the annual use of volatile Combustion Sources at Kraft, Soda, amended most recently on March 22, organic compounds (VOC); and make Sulfite, and Stand-Alone Semichemical 2001. semiannual estimates of projected VOC Pulp Mills (40 CFR part 63, subpart The affected sources are subject to the use, if affected facility uses less than 95 MM); EPA Preliminary ICR Number General Provisions of the NESHAP at 40 Mg/year of volatile organic compounds 1805.04; OMB Control Number 2060– CFR part 63, subpart A and any changes or is subject to provisions specified at 0377; expiration date December 31, or additions to the General Provisions § 60.742(c)(3). 2004. specified at 40 CFR part 63, subpart Burden Statement: In the previously Affected Entities: Sources potentially XXX. This rule requires sources to approved ICR, the estimated number of affected by this action are owners and submit initial notifications, conduct respondents for this information operators of chemical recovery performance tests, and submit periodic collection was 56 with 173 responses

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per year. The annual industry reporting Burden Statement: In the previously access to Agency documents for and recordkeeping burden for this approved ICR, the estimated number of purposes of document processing, filing, collection of information was 14,366 respondents for this information abstracting, analyzing, inventorying, hours. On average, each respondent collection was 75 with 75 responses per retrieving, tracking, etc. The documents reported 3.1 times per year, and 83 year. The annual industry reporting and to which these contractors and hours were spent preparing each recordkeeping burden for this collection subcontractors will have access response. The annual reporting and of information was 10,092 hours. On potentially include all document recordkeeping cost burden in the average, each respondent reported once submitted under the CERCLA. Some of previous ICR was $564,000, which was per year and 135 hours per spent these documents may contain comprised of capital/startup costs of preparing each response. There were no information claimed as CBI. $43,000 and operation and maintenance capital/startup costs or operation and Pursuant to EPA regulations at 40 CFR costs of $521,000. maintenance costs associated with part 2, subpart B, EPA has determined (18) NESHAP for Solvent Extraction continuous emission monitoring in the that these contractors and for Vegetable Oil Production (40 CFR previous ICR. subcontractors require access to CBI to part 63, subpart GGGG); EPA Dated: May 18, 2004. perform the work required under the Preliminary ICR Number 1947.03; OMB Michael M. Stahl, contracts and subcontracts. These Control Number 2060–0471; expiration Director, Office of Compliance. regulations provide for five days notice before contractors are given CBI. This date January 31, 2005. [FR Doc. 04–11777 Filed 5–24–04; 8:45 am] Affected Entities: Sources potentially notice is intended to provide notice of BILLING CODE 6560–50–P affected by this action are vegetable oil all disclosures of such information by production plants. EPA Region III to the contractors and Abstract: The National Emission ENVIRONMENTAL PROTECTION subcontractors listed below. Standards for Hazardous Air Pollutants AGENCY All of the listed contractors and (NESHAP) for vegetable oil production subcontractors are required by contract at 40 CFR part 63, subpart GGGG for [FRL–7667–2] to protect confidential information. When the contractors’ and vegetable oil production were EPA Region III Comprehensive promulgated on April 12, 2001. subcontractors’ need for the documents Environmental Response, is completed, the contractors and This standard applies to any Compensation and Liability Act reconstructed, or new vegetable oil subcontractors will return them to EPA. Program; Transfer of Information to The contractors and subcontractors to production process, which is defined as Contractors and Subcontractors a group of continuous process which this notice applies are as follows: equipment used to remove an oil from AGENCY: Environmental Protection List of Contractors That May Review Your oilseeds through direct contact with an Agency (EPA). Response organic solvent such as n-hexane. The ACTION: Notice. Chenega Technical Products term oilseed refers to the following • SUMMARY: EPA Region III intends to Contract # EP–S3–04–01 agricultural products: corn germ, • Tetra Tech EM, Inc.— cottonseed, flax, peanut, rapeseed (for authorize certain contractors and • subcontractors access to information Contract #68S3–0002 example, canola), safflower, soybean, Subcontractor to Tetra Tech EM, Inc. is: and sunflower. A vegetable oil submitted to EPA under the Eagle Instruments, Inc. Comprehensive Environmental production process is only subject to the • Ecology and Environment, Inc.— regulation if it is a major source of Response, Compensation, and Liability • Contract #68–S3–001 hazardous air pollutant (HAP) Act (‘‘CERCLA’’). Some of this Subcontractor to Ecology and Environment, emissions, or is collocated with other information may be claimed or Inc. is: sources that are individually or determined to be confidential business S & S Engineers, Inc. collectively a major source of HAP information (CBI). • IT Corporation— emissions. DATES: Contractor access to this • Contract #68–S3–00–06 The source are subject to the General information will occur June 24, 2004. Subcontracts to IT Corporation are: Provisions of the NESHAP at 40 CFR Comments concerning CBI access will Weavertown Environmental Group Environmental Restoration Company part 63, subpart A and any changes, or be accepted for thirty days from May 25, 2004. • Earth Tech, Inc.— additions to the General Provisions • FOR FURTHER INFORMATION CONTACT: Ben Contract #68–S3–00–07 specified at 40 CFR part 63, subpart Subcontractors to Earth Tech, Inc. are: GGGG. The solvent extraction for Mykijewycz (3HS42), Chief Contracts, Industrial Marine Services, Inc. vegetable oil production standard ADP and State Support Section, EPA Cline Oil requires each source to develop a plan Region III (215) 814–3351. Hertz Equipment Rental for demonstrating compliance. On a SUPPLEMENTARY INFORMATION: The • Tetra Tech NUS Inc.— monthly basis, sources must measure/ contractor and subcontractors listed Contract #68–S6–3003 record extraction solvent, and record the below will provide certain services to Subcontractors to Tetra Tech NUS Inc. are: HAP content of the extraction solvent EPA Region III, including; (1) Gannett Fleming, Inc. and oilseed inventories. Sources also information management support Dynamic Corporation develop a startup, shutdown, and services for the operation of a file room C.C. Johnson & Malhotra, P.C. malfunction plan to be followed during and an administrative records room in • CDM—Federal Programs Corporation— noncompliance events. Each source Philadelphia, Pennsylvania; (2) Contract #68–S7–3003 must submit initial and startup compilation and organization of Subcontractors to CDM—Federal Programs Corporation are: notifications. Sources must submit a documents and information; and (3) Tetra Tech EM, Inc. compliance status notification 12 review and analysis of documents and Robert Kimball & Associates months after the compliance date and information. In performing these tasks, PMA & Associates an annual compliance certification employees of the contractors and Horne Engineering every subsequent 12 months. subcontractors listed below will have Pacific Environmental Services

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• Black and Veatch Waste Science and docket as described below under Litigation Technology Corporation/Tetra Tech, ADDRESSES. Inc.— On July 17, 2002, EPA published a final rule (67 FR 47042), amending the Contract #68–S7–3002 ADDRESSES: EPA has established a Subcontractor: docket for this action under Docket: SPCC regulation. Several members of the regulated community filed legal Enviro Consultants Group OPA–2004–0002. All documents in the • challenges to certain aspects of the rule. Tech Law, Inc.— docket are listed in the EDOCKET index See American Petroleum Institute v. Contract #68–W–00–108 at http://www.epa.gov/edocket. • Leavitt et al., No. 1;102CV02247 PLF WRS Infrastructure & Environment, Inc.— Although listed in the index, some Contract #68–S3–03–02 and consolidated cases (D.D.C. filed information is not publicly available, 1 • Kemron Environmental Services— November 14, 2002). i.e., CBI or other information whose Settlement discussions between EPA Contract #68–S3–03–05 disclosure is restricted by statute. • ASRC Aerospace Corp.— and the plaintiffs have led to an Certain other material, such as agreement on all issues except one. In Contract #68–W–01–02 copyrighted material, is not placed on • Industrial Marine Services, Inc. this notice, we are publishing the Internet and will be publicly clarifications developed by the Agency Contract #68–S3–03–03 available only in hard copy form. • during the course of settlement Guardian Environmental Services, Inc. Publicly available docket materials are 68–S3–03–04 proceedings (and which provided the available either electronically in basis for the settlement agreement) List of Inter-Agency Agreements EDOCKET or in hard copy at the EPA regarding the SPCC regulation to the • General Services Administration Docket Center EPA West, Room B102, regulated community and other CERCLA File Room 1301 Constitution Ave., NW., interested parties. We are also notifying Contractor: Booz-Allen & Hamilton Washington, DC. The Public Reading the public of the availability of • General Services Administration Room is open from 8:30 a.m. and 4:30 OSWER’s letter to PMAA referenced Spectron Superfund Site p.m., Monday through Friday, excluding above, on our Web site, http://epa.gov/ Contractor: Booz-Allen & Hamilton legal holidays. The telephone number oilspill, and through the docket, as • General Services Administration for the Public Reading Room is (202) described above. Breslube Penn Superfund Site 566–1744, and the telephone number for Contractor: Booz-Allen & Hamilton the EPA Docket is (202) 566–0276. III. Clarifications ‘‘Loading Racks’’ List of Cooperative Agreements FOR FURTHER INFORMATION CONTACT: • National Association of Hispanic Elderly Hugo Paul Fleischman, Oil Program Plaintiffs challenged certain (Senior Environmental Employment)– Staff, U.S. EPA, at 703–603–8769 statements made in the preamble to the #CQ–822511 July 2002 SPCC amendments (and the • ([email protected]); or the AARP Foundation (Senior Environmental response-to-comment document) Employment)—#823952 RCRA/Superfund Hotline at 800–424– 9346 (in the Washington, DC concerning the ‘‘loading/unloading Dated: May 14, 2004. metropolitan area, 703–412–9810) rack’’ requirements under 40 CFR Peter W. Schaul, ([email protected]). The 112.7(h). That provision addresses Acting Division Director, Hazardous Site Telecommunications Device for the Deaf specific SPCC requirements for tank car Cleanup Division. (TDD) Hotline number is 800–553–7672 and tank truck loading and unloading [FR Doc. 04–11774 Filed 5–24–04; 8:45 am] (in the Washington, DC metropolitan racks, including requirements for BILLING CODE 6560–50–M area, 703–412–3323). You may wish to secondary containment. The preamble visit the Oil Program’s Internet site at language at issue, which appears at 67 http://www.epa.gov/oilspill. FR 47110 (July 17, 2002), stated the ENVIRONMENTAL PROTECTION following: SUPPLEMENTARY INFORMATION: AGENCY This section is applicable to any non- transportation-related or terminal facility [FRL–7666–7] I. General where oil is loaded or unloaded from or to How Can I Get Copies of the Notice Concerning Certain Issues a tank car or tank truck. It applies to Background Materials Supporting containers which are aboveground (including Pertaining to the July 2002 Spill Today’s Notice or Other Related partially buried tanks, bunkered tanks, or Prevention, Control, and Information? vaulted tanks) or completely buried (except Countermeasure (SPCC) Rule those exempted by this rule), and to all EPA will publish this document, as facilities, large or small. All of these facilities AGENCY: Environmental Protection well as the letter from OSWER to PMAA have a risk of discharge from transfers. Agency. described more fully below, on its Web (Emphasis added.) ACTION: Notice. site, http://epa.gov/oilspill, and has The Agency did not intend with the already posted the settlement agreement emphasized language to interpret the SUMMARY: The Environmental Protection on that Web site. Alternatively, contact term ‘‘loading/unloading rack.’’ Instead, Agency (EPA) has partially settled the Agency was responding generally to litigation over the Spill Prevention, the docket as described above under ADDRESSES. You may access this Federal a variety of comments each asking that Control, and Countermeasure (SPCC) their specific situation not be subject to rule. This notice provides clarifications Register document electronically through the EPA Internet under the the 40 CFR 112.7(h) requirements. The developed by the Agency during the reasoning of these commenters did not course of settlement proceedings. It also ‘‘Federal Register’’ listings at http:// www.epa.gov/fedrgstr. focus specifically on the contours of announces the availability of a letter what might be considered a loading/ issued by EPA’s Office of Solid Waste II. Background unloading rack, but instead focused on and Emergency Response (OSWER) to the Petroleum Marketers Association of Authority: 33 U.S.C. 1251 et seq.; 33 U.S.C. 1 Lead plaintiffs in the cases were the American America (PMAA) on our website, i.e., 2720; E.O. 12777 (October 18, 1991), 3 CFR, Petroleum Institute, Marathon Oil Co., and the epa.gov/oilspill, or by contacting the 1991 Comp., p. 351. Petroleum Marketers Association of America.

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a variety of other factors relevant to language approaches to rule writing). conclusion is different than that reached their facilities. See, e.g., 67 FR 47110 Previously, the rule stated that a facility with respect to purely economic (July 17, 2002) (‘‘Another commenter must compensate for lack of specified considerations in determining whether asked that we clarify that only facilities drainage systems at the ‘‘rack area’’ with to meet other rule requirements subject routinely used for loading or unloading ‘‘a quick drainage system for tank car or to deviation under § 112.7(a)(2). Under of tanker trucks from or into tank truck loading and unloading that section, as stated above, facilities aboveground bulk storage tanks are areas.’’ Obviously, the scope of these may choose environmentally equivalent subject to this provision.’’) Thus, the two emphasized terms was always approaches (selected in accordance with emphasized language above was meant meant to be identical, and the good engineering practices) for any to be a rejection of pleas for exclusions challenged language change only makes reason, including because they are of specific facilities, not an that clearer. cheaper. interpretation of the term ‘‘loading/ In addition, with respect to the unloading rack.’’ ‘‘Impracticability’’ emphasized language enumerating In the response-to-comments Plaintiffs challenged statements made considerations for determinations of document for the rule, EPA stated that in the preamble to the SPCC impracticability, the Agency did not ‘‘[w]e intend § 112.7(h) to apply to all amendments concerning the meaning of intend to foreclose the consideration of facilities, including production ‘‘impracticability’’ under 40 CFR other pertinent factors. In fact, in the facilities.’’ As discussed more fully 112.7(d). As you know, that section response-to-comment document for the below, we interpret § 112.7(h) only to provides that where secondary SPCC amendments rulemaking, the apply to loading and unloading ‘‘racks.’’ containment is ‘‘not practicable,’’ a ‘‘Agency stated that ’’* * * for certain Under this interpretation, if a facility facility may use a contingency plan facilities, secondary containment may does not have a loading or unloading instead. The preamble language at issue, not be practicable because of geographic ‘‘rack,’’ § 112.7(h) does not apply. Thus, which appears at 67 FR 47104 (July 17, limitations, local zoning ordinances, fire in stating that section 112.7(h) applies 2002), stated the following: prevention standards, or other good to ‘‘all facilities, including production engineering practice reasons.’’ For more We believe that it may be appropriate for facilities,’’ the Agency only meant that an owner or operator to consider costs or examples of situations that may rise to the provision applies if a ‘‘facility’’ economic impacts in determining whether he the level of impracticability, see, e.g. 67 happens to have a loading or unloading can meet a specific requirement that falls FR 47102 (July 17, 2002) and 67 FR rack present. The Agency did not mean within the general deviation provision of 47078 (July 17, 2002) (pertaining to flow to imply that any particular category of § 112.7(a)(2). We believe so because under and gathering lines). facilities, such as production facilities, this section, the owner or operator will still Produced Water are likely to have loading or unloading have to utilize good engineering practices racks present. and come up with an alternative that The Agency has been asked whether Plaintiffs also challenged a change in provides ‘‘equivalent environmental produced water tanks at dry gas the language of § 112.7(h) (formerly protection.’’ However, we believe that the facilities are eligible for the SPCC rule’s codified as § 112.7(e)(4)). Specifically, secondary containment requirement in wastewater treatment exemption at 40 § 112.7(d) is an important component in CFR 112.7(d)(6). A dry gas production EPA substituted the phrase ‘‘loading/ preventing discharges as described in unloading area drainage’’ for the phrase § 112.1(b) and is environmentally preferable facility is a facility that produces natural ‘‘rack area drainage’’ in paragraph to a contingency plan prepared under 40 CFR gas from a well (or wells) from which § 112.7(h)(1). The Agency does not part 109. Thus, we do not believe it is it does not also produce condensate or interpret this change as expanding the appropriate to allow an owner or operator to crude oil that can be drawn off the requirements of that section beyond consider costs or economic impacts in any tanks, containers or other production activities associated with tank car and determination as to whether he can satisfy equipment at the facility. tank truck loading/unloading racks. the secondary containment requirement. The SPCC rule’s wastewater treatment After all, the title of § 112.7(h) remains Instead, the owner or operator may only exemption excludes from 40 CFR part ‘‘facility tank car and tank truck provide a contingency Plan in his SPCC Plan 112 ‘‘any facility or part thereof used and otherwise comply with § 112.7(d). exclusively for wastewater treatment loading/unloading rack.’’ In addition, Therefore, the purpose of a determination of the record for the rulemaking reflects impracticability is to examine whether space and not used to satisfy any requirement that the Agency specifically rejected the or other geographic limitations of the facility of this part.’’ However, for the purposes idea of enlarging the scope of that would accommodate secondary containment; of the exemption, the ‘‘production, section to apply beyond ‘‘racks.’’ (See or, if local zoning ordinances or fire recovery, or recycling of oil is not response-to-comment document, p. 212, prevention standards or safety considerations wastewater treatment.’’ In interpreting rejecting a comment on the proposed would not allow secondary containment; or, this provision, the preamble to the final rule suggesting that we change the title if installing secondary containment would rule states that the Agency does ‘‘not of § 112.7(h) from ‘‘loading/unloading defeat the overall goal of the regulation to consider wastewater treatment facilities rack’’ to ‘‘loading/unloading area’’ prevent discharges as described in § 112.1(b). or parts thereof at an oil production, oil (Emphasis added.) because the Agency had not proposed recovery, or oil recycling facility to be such a change.) The Agency did not intend with the wastewater treatment for purposes of Like other editorial changes to the language emphasized above to opine this paragraph.’’ rule, many of which were not broadly on the role of costs in It is our view that a dry gas accompanied by specific explanations, determinations of impracticability. production facility (as described above) the Agency believes the change simply Instead, the Agency intended to make would not be excluded from the serves to make the rule easier to the narrower point that secondary wastewater treatment exemption based understand. See, 67 FR 47051 containment may not be considered on the view that it constitutes an ‘‘oil (describing the Agency’s use of a ‘‘plain impracticable solely because a production, oil recovery, or oil recycling language’’ approach in the rule). In this contingency plan is cheaper. (This was facility.’’ As discussed in the preamble case, the change in language made the the concern that was presented by the to the July 2002 rulemaking, ‘‘the goal terminology used in the sentence commenter to whom the Agency was of an oil production, oil recovery, or oil uniform (a basic principle of plain responding.) As discussed above, this recycling facility is to maximize the

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production or recovery of oil. * * *’’ 67 DEPARTMENT OF HEALTH AND ASTPHND the only national FR 47068. A dry gas facility does not HUMAN SERVICES organization representing 5 A Day meet this description. Coordinators from each State, district, Centers for Disease Control and In verifying that a particular gas and territory. ASTPHND is the only Prevention organization positioned to provide facility is not an ‘‘oil production, oil training and promote the translation of recovery, or oil recycling facility,’’ the [Program Announcement 04130] public health nutrition research to Agency plans to consider, as National Organizations for Nutrition practice that is critical to CDC efforts to appropriate, evidence at the facility and Physical Activity Programs; Notice build State capacity to implement pertaining to the presence or absence of of Intent To Fund Single Eligibility effective nutrition programs. All State condensate or crude oil that can be Award nutrition directors and 5 A Day drawn off the tanks, containers or other coordinators are members of ASTPHND, production equipment at the facility, as A. Purpose therefore it is the only national well as pertinent facility test data and The Centers for Disease Control and organization with a membership reports (e.g., flow tests, daily gauge Prevention (CDC) announces the intent representing State nutrition directors reports, royalty reports or other to fund fiscal year (FY) 2004 funds for and 5 A Day coordinators from all 50 production reports required by state or a cooperative agreement program to States, the District of Columbia, and five federal regulatory bodies). enhance nutrition, 5 a day, and physical territories. ‘‘Facility’’ activity efforts by: C. Funding • Providing annual training Approximately $200,000 is available In the July 2002 SPCC amendments, opportunities and professional in FY 2004 to fund this award. It is the Agency promulgated definitions of development. • expected that the award will begin on or ‘‘facility’’ and ‘‘production facility.’’ Coordinating training activities and before September 1, 2004, and will be These definitions, which appear in 40 programs between health departments made for a 12-month budget period CFR 112.2, apply ‘‘for the purposes of’’ that have nutrition and physical activity within a project period of up to 5 years. part 112. The Agency has been asked components and the State Nutrition and Funding estimates may change. which of these definitions governs the Physical Activity Programs to Prevent term ‘‘facility’’ as it is used in 40 CFR Obesity and Chronic Diseases. D. Where To Obtain Additional • 112.20(f)(1) when applied to oil Establishing a National 5 A Day Information production facilities. 40 CFR Council to provide leadership on For general comments or questions 112.20(f)(1) sets criteria for determining policies and programs to increase fruit about this announcement, contact: and vegetable consumption. Technical Information Management, whether a ‘‘facility could, because of its • location, reasonably be expected to Conducting State or community- CDC Procurement and Grants Office, cause substantial harm to the based special projects. The Catalog of 2920 Brandywine Road, Atlanta, GA Federal Domestic Assistance number for environment’’ (emphasis added). It is 30341–4146. Telephone: 770–488–2700. this program is 93.945. the Agency’s view that, because, among For technical questions about this other things, that section consistently B. Eligible Applicant program, contact: Diane Thompson, M.P.H., RD, Project Officer, Division of uses the term ‘‘facility,’’ not Assistance will be provided only to Nutrition and Physical Activity, ‘‘production facility,’’ it is the definition the Association of State and Territorial National Center for Chronic Disease of ‘‘facility’’ in 40 CFR 112.2 that Public Health Nutrition Directors Prevention and Health Promotion, governs the meaning of ‘‘facility’’ as it (ASTPHND). No other applications are Centers for Disease Control and is used in 40 CFR 112.20(f)(1), solicited. Prevention, 4770 Buford Highway, NE., regardless of the specific type of facility ASTPHND is the only organization MS K–25, Atlanta, GA 30341. at issue. with State nutrition directors or designees and nutrition-related staff Dated: May 19, 2004. Notice of Availability uniquely positioned in State health William P. Nichols, Acting Director, Procurement and Grants With this notice, EPA is announcing departments to provide statewide leadership for nutrition, 5 A Day, Office, Centers for Disease Control and the availability of a letter issued by the Prevention. Assistant Administrator for OSWER to physical activity, and obesity and chronic disease prevention efforts. [FR Doc. 04–11754 Filed 5–24–04; 8:45 am] PMAA addressing certain matters BILLING CODE 4163–18–P pertaining to the SPCC rule’s ASTPHND’s members direct the requirements for integrity testing, nutrition and 5 A Day programs in the State health departments or public security, and loading racks. This letter DEPARTMENT OF HEALTH AND health agencies of fifty States, the is available on EPA’s website at epa.gov/ HUMAN SERVICES District of Columbia, and five oilspill or by contacting the docket as Territories. ASTPHND has established a described above. Centers for Disease Control and unique network of public health Prevention Dated: May 17, 2004. nutritionists working to improve the [Program Announcement 04145] Marianne Lamont Horinko, health of the American population Assistant Administrator, Office of Solid Waste through statewide and local community Enhancing State Capacity To Address and Emergency Response. efforts. The group is committed to Child and Adolescent Health Through [FR Doc. 04–11775 Filed 5–24–04; 8:45 am] addressing nutrition and physical Violence Prevention; Notice of activity related to the prevention of Availability of Funds—Amendment BILLING CODE 6560–50–P obesity. ASTPHND has experience conducting training and professional A notice announcing the availability development related to nutrition, 5 A of fiscal year (FY) 2004 funds for a Day, and physical activity. cooperative agreement entitled,

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‘‘Enhancing State Capacity to Address Dated: May 19, 2004. OMB No. 0970–0196. Child and Adolescent Health Through William P. Nichols, Description: Section 466(a)(17) of the Violence Prevention’’ was published in Acting Director, Procurement and Grants Social Security Act (the Act), requires the Federal Register Friday, May 14, Office, Centers for Disease Control and states to establish procedures under Prevention. 2004, Volume 69, Number 94, pages which the state child support [FR Doc. 04–11751 Filed 5–24–04; 8:45 am] 26829–26833. The notice is amended as enforcement (IV–D) agency shall enter follows: BILLING CODE 4163–18–P into agreements with financial • Page 26829, first column, change institutions doing business in the state Application Deadline Date to June 23, DEPARTMENT OF HEALTH AND for the purpose of securing information 2004. HUMAN SERVICES leading to the enforcement of child support orders. Under 452(1) of the Act, • Page 26830, second column, change Administration for Children and financial institutions doing business in Anticipated Award Date to September 1, Families multiple states may comply by centrally 2004. matching through the Federal Parent • Proposed Information Collection Page 26831, first column, section, Locator Service rather than matching in Activity; Comment Request ‘‘IV.3. Submission Dates and Times,’’ each state in which the financial change Application Deadline Date to Proposed Projects institution conducts business. June 23, 2004. Title: Financial Institution Data Respondents: Financial institutions Match. doing business in two or more states.

ANNUAL BURDEN ESTIMATES

Number of Average burden Instrument Number of responses per hours per Total burden respondents respondent response hours

Financial Data Match Tape ...... 4501 4 .5 9002 Election Form ...... 333 1 .5 166.5

Estimated Total Annual Burden of automated collection techniques or homeless youth. Organizations funded Hours: 9168.5. other forms of information technology. under the Runaway and Homeless In compliance with the requirements Consideration will be given to Youth (RHY) program are required by of section 3506(c)(2)(A) of the comments and suggestions submitted section 312(b)(7) of the statute to meet Paperwork Reduction Act of 1995, the within 60 days of this publication. several data collection and reporting Administration for Children and Dated: May 19, 2004. requirements. These requirements Families is soliciting public comment Bob Sargis, include maintenance of client statistical on the specific aspects of the records and submission of annual Reports Clearance Officer. information collection described above. program reports profiling the Copies of the proposed collection of [FR Doc. 04–11814 Filed 5–24–04; 8:45 am] characteristics of the youth and families information can be obtained and BILLING CODE 4184–01–M served and the services provided to comments may be forwarded by writing them. The October 2003 reauthorization to the Administration for Children and of the Act maintained the requirements DEPARTMENT OF HEALTH AND Families, Office of Information Services, as described in the standing legislation. HUMAN SERVICES 370 L’Enfant Promenade, SW., Data from the National Extranet Washington, DC 20447, Attn: ACF Administration for Children and Optimized Runaway and Homeless Reports Clearance Officer. All requests Families Youth Management Information System should be identified by the title of the (NEORHYMIS) support grantee information collection. E-mail address: Submission for OMB Review; organizations as they carry out a variety [email protected]. Comment Request of integrated, ongoing responsibilities The Department specifically requests and projects. These include meeting comments on: (a) Whether the proposed Title: National Extranet Optimized statutory and regulatory reporting collection of information is necessary Runaway and Homeless Youth requirements, maintaining program for the proper performance of the Management Information System service and management information for functions of the agency, including (NEORHYMIS) internal uses, tracking youth in their whether the information shall have OMB No.: 0970–0123. programs, accountability monitoring, practical utility; (b) the accuracy of the Description: The Runaway and management improvement, research, agency’s estimate of the burden of the Homeless Youth Act (RHYA), as and evaluation. proposed collection of information; (c) amended by Public Law 106–71 (42 Respondents: Recipients of grants the quality, utility, and clarity of the U.S.C. 5701 et seq.), mandates that the from the HHS/ACF/Family and Youth information to be collected; and (d) Department of Health and Human Services Bureau to operate emergency ways to minimize the burden of the Services (HHS) report regularly to shelters for runaway youth, transitional collection of information on Congress on the status of HHS-funded programs for homeless youth, and street respondents, including through the use programs serving runaway and outreach programs.

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ANNUAL BURDEN ESTIMATES

Number of Average burden Instrument Number of responses per hours per Total burden respondents respondent response hours

Youth Profile ...... 535 153 0.25 20,464 Street Outreach Report ...... 147 4211 0.02 12,380 Brief Contacts ...... 535 305 0.15 24,476 Turnaways ...... 535 13 0.1 696 Data Transfer ...... 535 2 0.5 535

Estimated Total Annual Burden DATES: Due Date for Applications: The 2. Child Care Bureau’s Research Agenda Hours: due date for receipt of applications is Since 2000, Congress has Additional Information: Copies of the July 26, 2004. appropriated approximately $10 million proposed collection may be obtained by Due Date for Letters of Intent: If you per year to be used for child care writing to the Administration for intend to submit an application, please research and evaluation. The Child Care Children and Families, Office of e-mail the ACYF Operations Center and Bureau’s research agenda supports Administration, Office of Information include the following information: the activities likely to help decision makers Services, 370 L’Enfant Promenade, SW., number and title of this announcement, in crafting effective child care policies Washington, DC 20447, Attn: ACF your organization’s name and address, and practices that promote positive Reports Clearance Officer. All requests and your contact person’s name, title, outcomes for children and families. It is should be identified by the title of the phone number, fax number, and e-mail also intended to increase the capacity information collection. E-mail address: address. This notice is not required but for child care research at the national, [email protected]. is strongly encouraged. The information State, and local levels and to promote OMB Comment: OMB is required to will be used to determine the number of better linkages among research, policy, make a decision concerning the expert reviewers needed to evaluate and practice. collection of information between 30 applications and to update the mailing The Bureau’s capacity to further child and 60 days after publication of this list for future program announcements. care-related research is enhanced by the Child Care Policy Research Consortium, document in the Federal Register. I. Funding Opportunity Description Therefore, a comment is best assured of which is an alliance of research projects having its full effect if OMB receives it 1. Child Care Bureau sponsored by the CCB. The consortium within 30 days of publication. Written is comprised of researchers and their Since its establishment in 1995, the partners in States, local communities comments and recommendations for the Child Care Bureau (CCB) has been proposed information collection should and other organizations who join in dedicated to enhancing the quality, linking research, policy, and practice. be sent directly to the following: Office affordability, and supply of child care of Management and Budget, Paperwork The research projects of consortium available for all families. The Child Care members cover a broad range of issues. Reduction Project, Attn: Desk Officer for Bureau administers the Child Care and ACF, E-mail address: katherine_ For example, some projects describe _ Development Fund (CCDF), a $4.8 State and local child care populations, t. [email protected]. billion child care program that includes Dated: May 19, 2004. services, and programs, while others funding for child care subsidies and focus on child care subsidy policies and Robert Sargis, activities to improve child care quality market dynamics. In addition, some Reports Clearance Officer. and availability. Combined with related projects examine issues that deal with [FR Doc. 04–11815 Filed 5–24–04; 8:45 am] State and Federal funding, CCDF the professional development and provides more than $11 billion a year to BILLING CODE 4184–01–M training of child care providers. The States, territories, and tribes. Most of consortium meets annually in these funds are used to assist low- Washington, DC. DEPARTMENT OF HEALTH AND income, working families in paying for In order to synthesize the broad array HUMAN SERVICES child care. of child care information being The Bureau works closely with ACF generated, the Bureau has created the Administration for Children and Regions, States, territories, and tribes to Child Care and Early Education Families facilitate, oversee, and document the Research Collaboration and Archive implementation of policies and Field Initiated Child Care Research (CCEERCA), which serves as the Child programs that support State, local, and Projects Care Bureau’s national research private sector administration of child knowledge management system for the AGENCY: Administration for Children care services and systems. In addition, child care field. The CCEERCA consists and Families (ACF), Administration on the Bureau collaborates extensively with of an interactive Web site, an archive of Children, Youth, and Families (ACYF), other offices throughout the Federal data sets and reports, and a technical Child Care Bureau (CCB). government to promote integrated assistance support system to assist approaches, family-focused services, Funding Opportunity Title: Field researchers and facilitate collaboration. and coordinated child care delivery Initiated Child Care Research Projects. systems. In all of these activities, the 3. Purpose and Goals Announcement Type: Competitive Bureau strives to support children’s The purpose of these grants is to Grant-Initial. healthy growth and development, support researchers in investigating Funding Opportunity Number: HHS– family self-sufficiency, parental choice child care issues that are consistent with 2004–ACF–ACYF–YE–0020. and involvement, and linkage of child the Child Care Bureau’s research agenda CFDA Number: 93.575. care with other community services. and to improve the overall quality of

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child care research. They are funded and provides examples of research child care quality? Do partnerships under the authority of the Child Care questions under each area. among child care and nutrition and Development Block Grant Act of A. Child Care Subsidy Policies. Under programs result in an effective system 1990, as amended. the Child Care and Development Fund, for the delivery of training for informal The goals of this program area are as States have the flexibility to establish caregivers? How does participation in follows: child care policies and practices that other types of support relate to the To address issues of current relevance respond to State and local needs. quality of care provided by this group of to decision makers at the local, State, Existing research demonstrates that caregivers? and national levels. Research and significant variations exist across • What proportion of child care evaluation are critical to understanding jurisdictions. Relatively little is known providers take advantage of State and child care issues and their implications about how these variations influence community systems of tiered for children and families. In fiscal year which families and children are being reimbursement? Does tiered 2004 (FY 2004), the Bureau is served, the types and amounts of child reimbursement result in increased particularly concerned with outcomes care being used, continuity of care for participation in accreditation, that relate to alternative child care children, and employment and school certification, or other mechanisms subsidy policies and practices, readiness outcomes. For example: through which providers can investments in child care quality • What family and child outcomes are demonstrate that they offer higher including provider training and associated with receipt of subsidies? quality care? How do variations across professional development, the school How do outcomes differ for different systems of tiered reimbursement, readiness of young children cared for in population groups and types of care? including incentive amounts, influence a variety of care settings, and • How do child care policies and provider participation? Are there coordination across child care and other administrative practices affect the child differences in participation in tiered programs that serve children and care decisions parents make, including reimbursement and responses to families. the selection of faith-based providers? licensing incentives among types of To increase the capacity for child care • How do alternatives to on-site providers (including faith-based research at the national, State, and local application and eligibility re- organizations)? Is it possible to levels. Once completed and released, determination processes, and the demonstrate improvements in the studies funded through this frequency of these activities, relate to quality of care? Do such systems announcement must be prepared and characteristics of families served, the influence the child care choices parents archived according to the specifications duration of arrangements, continuity of make? supplied by the Child Care and Early care, and outcomes for families and • Do strategies such as putting Education Research Collaboration and children? licensing information on the web or Archive. These public-use data files will • How do alternative approaches to monitoring child care facilities based on be the property of the Federal parental co-payments influence the risk factors improve the health, safety government and will remain in the number of families that can be served, and quality of child care facilities? Do public domain for secondary analysis by the types of care parents use, the such strategies result in better informed other researchers. affordability of care, continuity of care, consumers? To encourage the active and the willingness of providers to serve C. Professional Development and communication, networking, and subsidized families? Training. In connection with the collaboration among prominent child • How well do market rate surveys administration’s early learning care researchers, and policy makers. In assess the price of care in various types initiative, Good Start, Grow Smart, the order to facilitate networking with of communities? What methods can be Child Care Bureau has been working policy makers, researchers are required used to validate the findings from with States on the development of to participate in the Child Care Bureau’s market rate surveys? voluntary guidelines for early learning. Annual Meeting of the Child Care Policy • What are the effects of child care States are being encouraged to link their Research Consortium and invited to subsidies on the larger child care market professional development and provider attend the State Administrators’ (e.g., does an infusion of public funding training strategies to the outcomes they Meeting. result in higher community child care hope to achieve for children. In support 4. Fiscal Year 2004 Field Initiated Child prices or is there displacement between of these efforts, the Bureau is interested Care Research Priorities subsidized and non-subsidized in research projects that can provide children)? greater insight into the effectiveness of In FY 2004, the Child Care Bureau is • How do child care subsidy policies, alternative approaches to professional seeking to fund Field Initiated Child financing strategies, and delivery development and training in improving Care Research Projects that address systems affect the role of child care in the quality of care and outcomes for questions that are highly relevant to the community economic development? children across the range of child care issues faced by Federal, State, and local B. Quality Investments. In FY 02, settings. For example: community policy makers. These States spent 11 percent of the funds they • What characteristics of caregivers include: The effects of alternative child received through the Child Care and are associated with choosing child care care subsidy policies and practices; the Development Fund on activities to as a long-term profession and staying in relative effectiveness of child care improve child care quality. The Child the field? quality investments; issues and Care Bureau seeks projects that will • What levels of compensation and outcomes related to the professional provide sound information about the benefits are necessary to motivate development and training of caregivers; cost-effectiveness of alternative caregivers to participate in quality the school readiness of young children investments in improving child care improvement initiatives such as in a range of care settings; and issues quality. For example: incentives for earning professional and approaches in coordinating between • Does giving informal caregivers, credentials or degrees and specialized child care and other services for such as relatives, friends and neighbors, training? children and families. The following access to USDA adult and child • Are States implementing policies describes each of these areas in detail nutrition programs result in improved (such as tax incentives, loan programs

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and training) that encourage individuals including health, assistance for children additional projects from among the to work in child care or establish child with special needs, TANF, child care, applications received under this care businesses? How effective are these Head Start, pre-kindergarten, and K–12 announcement. strategies? services with respect to service delivery III. Eligibility Information • What characteristics of professional and funding? How well do these development systems provide an strategies work? 1. Eligible Applicants • effective vehicle for the pursuit of career What are the barriers and Universities and colleges, public paths in child care and early childhood facilitators to collaboration and agencies, non-profit organizations, for- education? How well do articulation integration across programs? profit organizations agreeing to waive • What are the effects of universal agreements and systems of training their fees are eligible applicants, faith- pre-kindergarten programs on the larger approval and registry work for based and community organizations are child care market? individual caregivers? also eligible to apply. • Do professional development Applicants should propose sound Institutions serving minority systems support the workforce in all research methodologies and analyses populations, including but not limited sectors and levels of development that are appropriate to the study. to Tribally Controlled Land Grant including caregivers working in family Projects may also involve secondary Colleges and Universities (TCUs) and child care and informal settings as well analyses of completed data sets. Within Historically Black Colleges and as center-based programs (including the maximum funding level available Universities (HBCUs), are also eligible faith-based)? ($400,000), applicants are expected to applicants. • How effective are alternative develop a budget that is reasonable • TCUs are those institutions cited in training strategies such as distance given the nature and scope of the section 532 of the Equity in Educational learning, mentoring, and coaching in proposed study. Projects may include Land Grant Status Act of 1994 (7 U.S.C. improving the skills of caregivers with multiple sites, propose linkages with 301 note), any other institution that limited education and access to the other studies, or otherwise leverage qualifies for funding under the Tribally formal system? resources and knowledge. D. School Readiness. Young children Applicants are encouraged to form Controlled Community College are spending increasing numbers of research partnerships if the result will Assistance Act of 1978 (25 U.S.C. 1801 hours in child care and other early be a more comprehensive, policy- et seq.), and Navajo Community College, education settings. More needs to be relevant, and rigorous study than could authorized in the Navajo Community known about how the school readiness be accomplished by a single College Assistance Act of 1978, Pub. L. of young children is influenced across organization. Funding partnerships to 95–471, title II (25 U.S.C. 640a note). types of child care as well as how enhance the scope or quality of research Those TCUs that are not accredited are school readiness can be promoted across activities are also encouraged. not eligible to apply under this announcement. settings. For example: • • How do school readiness outcomes II. Award Information HBCUs are defined in the amended differ among early childhood education Funding Instrument Type: Grant. version of the Higher Education Act of settings? What are the characteristics of Category of Funding Activity: ISS 1965, codified at 20 U.S.C. 1061(2), as settings that make a difference in school Income Security and Social Services. institutions established prior to 1964 readiness outcomes for children? How Anticipated Total Program Funding: whose principle mission was, and is, does this vary by racial, ethnic, or $2 million in FY 2004. the education of Black Americans, and language differences among children? Anticipated Number of Awards: Five must satisfy section 322 of the Higher • How do hours in child care and to eight awards will be funded. Education Act of 1965, as amended. early education relate to child Ceiling on Amount of Individual Institutions which meet the definition of outcomes? Awards: $400,000 per budget period. ‘‘Part B institution’’ in section 322 of the • Does subsidy receipt impact the Applications that exceed this ceiling Higher Education Act of 1965, as probability that low-income children will be considered non-responsive and amended, 20 U.S.C. 1061(2), shall be will be in settings that support school will not be eligible for funding under eligible for assistance under this readiness? this announcement. announcement. • What factors promote children’s Floor on Amount of Individual Additional Information on Eligibility: early learning and school readiness in Awards: None. Non-profit organizations applying for child care centers, family child care Average Anticipated Award: funding are required to submit proof of homes, and in informal arrangements $200,000–$400,000 per budget period. their non-profit status. Proof of non- among families, friends and neighbors? Project Period for Awards: This profit status is any one of the following: E. Coordination. With growth in child announcement invites applications for (a) A reference to the applicant care subsidies, Head Start, State pre- project periods up to three years. organization’s listing in the Internal kindergarten programs, services for Awards, on a competitive basis, will be Revenue Service’s (IRS) most recent list children with special needs, and a range for a one-year budget period, although of tax-exempt organizations described in of other programs targeted toward low- project periods may be for three years. the IRS code. income families and children, it is Applications for continuation of grants (b) A copy of a currently valid IRS tax critical that services be coordinated. beyond the one-year budget period will exemption certificate. This is necessary to maximize the be entertained in subsequent years on a (c) A statement from a State taxing resources that are available and to non-competitive basis, subject to the body, State Attorney General, or other ensure that services make sense and are availability of funds from future appropriate State official certifying that effective in supporting positive appropriations, satisfactory progress of the applicant organization has a non- outcomes for families and children. the grantee, and a determination that profit status and that none of the net Examples of research questions include: continued funding is in the best interest earnings accrue to any private • What are States and communities of the government. Should additional shareholders or individuals. doing to coordinate across early funds be available in FY 2005 or 2006, (d) A certified copy of the childhood and school-age programs, ACF reserves the right to fund organization’s certificate of

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incorporation or similar document that IV.2 below will be considered non- typically included on the SF 424 and all clearly establishes non-profit status. responsive and will not be eligible for necessary assurances and certifications. (e) Any of the items in the funding under this announcement. • Your application must comply with subparagraphs immediately above for a Applications that exceed the funding any page limitation requirements State or national parent organization ceiling will be considered non- described in this program and a statement signed by the parent responsive and will not be eligible for announcement. organization that the applicant funding under this announcement. • After you electronically submit organization is a local non-profit Applications that fail to include the your application, you will receive an affiliate. required amount of cost-sharing will be automatic acknowledgment from 2. Cost-Sharing or Matching considered non-responsive and will not Grants.gov that contains a Grants.gov be eligible for funding under this tracking number. The Administration Grantees must provide at least 20 announcement. for Children and Families will retrieve percent of the total approved cost of the your application from Grants.gov and project. The total approved cost of the IV. Application and Submission send you a second confirmation, which project is the sum of the ACF share and Information will include an ACF tracking number. the non-federal share. The non-federal 1. Address To Request Application • We may request that you provide share may be met by cash or in-kind Package original signatures on forms at a later contributions, although applicants are date. encouraged to meet their match This full announcement can be • You may access the electronic requirements through cash obtained via the following link: http:// application for this program on http:// contributions. For example, in order to www.acf.hhs.gov/programs/ccb. www.Grants.gov. meet the match requirements, a project If you are unable to download the Format and Organization. An original with a total approved cost of $375,000, complete announcement, requests for and two copies of the application must requesting $300,000 in ACF funds, must applications may be sent to: ACYF be submitted. Applicants should limit provide a non-federal share of at least Operations Center, c/o The Dixon their application to 100 pages, double- $75,000 (20% of total approved project Group, Inc., Child Care Bureau, Field spaced, with standard one-inch margins cost of $375,000). Grantees will be held Initiated Child Care Research Grants, and 12 point fonts. This page limit accountable for commitments of non- 118 Q Street, NE., Washington, DC applies to both narrative text and federal resources even if over the 20002–2132, phone: 866–796–1591, e- supporting materials. In addition, amount of the required match. Failure to mail: [email protected]. applicants should number the pages of provide the amount will result in 2. Content and Format of Application their application and include a table of disallowance of Federal funds. Submission contents. Applications that fail to include the Applicants are advised to include all required amount of cost-sharing will be Electronic Submission. You may required forms and materials and to considered non-responsive and will not submit your application to us in either organize these materials according to be eligible for funding under this electronic or paper format. To submit an the format presented below: announcement. application electronically, please use a. Cover letter. the http://www.Grants.gov apply site. If 3. Other b. Required standard forms: you use Grants.gov, you will be able to • Standard Application for Federal On June 27, 2003, the Office of download a copy of the application Assistance (forms 424 and 424A). Management and Budget published in package, complete it off-line, and then • Applicants requesting financial the Federal Register a new Federal upload and submit the application via assistance for a non-construction project policy applicable to all Federal grant the Grants.gov site. You may not email must sign and return Standard Form applicants. The policy requires all an electronic copy of a grant 424B, Assurances: Non-construction Federal grant applicants to provide a application. Please note the following if Programs, with their applications. Dun and Bradstreet Data Universal you plan to submit your application • Applicants must provide a Numbering System (DUNS) number electronically via Grants.gov: Certification Regarding Lobbying. Prior when applying for Federal grants or • Electronic submission is voluntary. to receiving an award in excess of cooperative agreements on or after • When you enter the Grants.gov site, $100,000, applicants shall furnish an October 1, 2003. The DUNS number will you will find information about executed copy of the lobbying be required whether an applicant is submitting an application electronically certification. Applicants must sign and submitting a paper application or using through the site, as well as the hours of return the certification with their the government-wide electronic portal operation. We strongly recommend that application. (http://www.Grants.gov). A DUNS you do not wait until the application • Applicants must make the number will be required for every deadline date to begin the application appropriate certification of compliance application for a new award or renewal/ process through Grants.gov. with all Federal statues relation to continuation of an award, including • To use Grants.gov, you, as the nondiscrimination. By signing and applications or plans under formula, applicant, must have a DUNS Number submitting the application, applicants entitlement and block grant programs, and register in the Central Contractor are providing the certification and need submitted on or after October 1, 2003. Registry (CCR). You should allow a not mail back a certification form. Please ensure that your organization minimum of five days to complete the • Applicants must make the has a DUNS number. You may acquire CCR registration. appropriate certification of their a DUNS number at no cost by calling the • You will not receive additional compliance with the requirements of the dedicated toll-free DUNS number point value because you submit a grant Pro-Children Act of 1994 as outlined in request line at 1–866–705–5711 or you application in electronic format, nor Certification Regarding Environment may request a number on-line at http:/ will we penalize you if you submit an Tobacco Smoke. /www.dnb.com. application in paper format. c. Table of contents. Applications that fail to follow the • You may submit all documents d. Project narrative statement. required format described in Section electronically, including all information e. Appendix:

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Complete Contact Information for title of this announcement, your Late Applications: Mailed Principle Investigators; organization’s name and address, and applications will be considered as Curriculum Vitae for Principle your contact person’s name, title, phone meeting the deadline if they are Investigators. number, fax number, and e-mail postmarked on or before the closing date Content of Project Narrative address. This notice is not required but and received by ACYF in time for the Statement: The project narrative is strongly encouraged. The information independent review. Applications hand statement contains most of the will be used to determine the number of carried by applicants, couriers, other information on which applications will expert reviewers needed to evaluate representatives of the applicant, will be be competitively reviewed. The project applications and to update the mailing considered as meeting the deadline if narrative should be carefully developed list for future program announcements. they are received at the ACYF in accordance with the Bureau’s Mailing and Delivery Instructions. Operations Center on the closing date research goals and agenda, the Applications may be sent through the between the hours of 8 a.m. and 4:30 requirements listed in the Uniform U.S. Postal Service, delivered by private p.m., e.t., Monday through Friday Project Description and the evaluation courier, or hand delivered to the ACYF (excluding Federal holidays). criteria. Operations Center. Applications must Applications that do not meet the Omission of Salary Rate: Applicants be mailed or delivered to: ACYF criteria stated above will be considered have the option of omitting from the Operations Center, The Dixon Group, late. The Administration for Children application copies (not the original) Inc., Child Care Bureau, Field Initiated and Families (ACF) will notify each late specific salary rates or amounts for applicant that his/her application will individuals specified in the application Child Care Research Program, 118 Q Street, NE., Washington, DC 20002– not be considered in the current budget. competition. Applications from Non-profit 2132, phone: 866–796–1591, e-mail: Organizations: Private, non-profit [email protected]. Applications Extension of Deadline: ACF may organizations are encouraged to submit delivered by a private courier or by extend an application deadline for with their applications the survey under hand must be received no later than applicants affected by acts of God (such ‘‘Grant Related Documents and Forms’’ 4:30 p.m., eastern time (e.t.), on the as floods and hurricanes), when there is titled ‘‘Survey for Private, Non-Profit closing date. ACYF cannot accept widespread disruption of mail service, Grant Applicants’’ at http:// applications by fax or through other or for other disruption of services that www.acf.hhs.gov/programs/ofs/ electronic media. Applicants will affect the public at large (such as forms.htm. receive a confirmation postcard upon prolonged electrical blackout). receipt of applications. Authority to waive or extend deadline 3. Submission Dates and Times Closing Date: The closing date for requirements rests with the Chief Grants Notice of Intent to Submit receipt of applications is 4:30 p.m. Management Officer. Application: If you intend to submit an eastern time (e.t.) on July 26, 2004. The table below details when the application, please e-mail the ACYF Mailed or handcarried applications materials need to be submitted and Operations Center and include the received after 4:30 p.m. on the closing where these forms or formatting following information: the number and date will be classified as late. descriptions can be found.

What to submit Required content Required form or format When to submit

Standard Application for Per required form...... May be found at http://acf.hhs.gov/programs/ofs/ By application due date. Federal Assistance (forms forms.htm. SF 424, 424A, and 424B). Certification regarding Lob- Per required form...... May be found at http://acf.hhs.gov/programs/ofs/ By application due date. bying and associated Dis- forms.htm. closure of Lobbying Activi- ties (SF LLL). Environmental Tobacco Per required form...... May be found at http://acf.hhs.gov/programs/ofs/ By application due date. Smoke Certification. forms.htm. Protection of Human Sub- Per required form...... May be found at http://acf.hhs.gov/programs/ofs/ By application due date. jects. forms.htm. Proof of Non-Profit Status ... See Section III.1...... May be found at http://acf.hhs.gov/programs/ofs/ By application due date. forms.htm. Project Narrative Statement See Section IV.2 and Sec- Format described in Section V.1 and V.2 ...... By application due date. tion V.1 and V.2. Contact Information, Vita, See Section and IV.2 ...... Format described in Section IV.2 ...... By Application due date. Letter of Support, Tran- script.

Additional Forms applications the survey located under Grant Applicants’’ at http:// Private, non-profit organizations are ‘‘Grant Related Documents and Forms’’ www.acf.hhs.gov/programs/ofs/ encouraged to submit with their titled ‘‘Survey for Private, Non-Profit forms.htm.

What to submit Required content Required form or format When to submit

Survey for Private, Non- Per Required Form ...... http://www.acf.hhs.gov/programs/ofs/form.htm ...... By application due date. Profit Grant Applicants.

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4. Intergovernmental Review 5. Funding Restrictions Instruction: ACF Uniform Project Description (UPD) State Single Point of Contact (SPOC) Grants awarded as a result of this competition are not transferable to The following are instructions and This program is covered under another institution. No individual guidelines on how to prepare the Executive Order 12372, ‘‘Project Summary/Abstract’’ and ‘‘Full institution will be funded for more than ‘‘Intergovernmental Review of Federal Project Description’’ sections of the one award unless applications from Programs,’’ and 45 CFR part 100, application. The UPD was approved by different institutions do not qualify for ‘‘Intergovernmental Review of the Office of Management and Budget support. Department of Health and Human (OMB) Control No. 0970–0139. Services Programs and Activities.’’ 6. Other Submission Requirements The Project Description Overview. The Under the Order, States may design project description provides a major their own processes for reviewing and Submission by Mail: Mailed means by which an application is commenting on proposed Federal applications shall be considered as evaluated and ranked to compete with assistance under covered programs. meeting an announced deadline if they other applications for available are received on or before the deadline All States and territories except assistance. The project description time and date at the ACYF Operations Alabama, Alaska, Arizona, Colorado, should be concise and complete and Center, The Dixon Group, Inc., Child Connecticut, Hawaii, Idaho, Indiana, should address the activity for which Care Bureau, Field Initiated Child Care Kansas, Louisiana, Massachusetts, Federal funds are being requested. Research Grants, 118 Q Street, NE., Minnesota, Montana, Nebraska, New Supporting documents should be Washington, DC 20002–2132. Jersey, Ohio, Oklahoma, Oregon, included where they can present Applicants are responsible for mailing Pennsylvania, South Dakota, Tennessee, information clearly and succinctly. In applications well in advance, when Vermont, Virginia, Washington, preparing your project description, all using all mail services, to ensure that Wyoming, and Palau have elected to information requested through each the applications are received on or participate in the Executive Order specific evaluation criteria should be before the deadline time and date. process and have established Single provided. Awarding offices use this and Points of Contact (SPOCs). Applicants Hand Delivery: Applications other information in making their from these twenty-six jurisdictions need handcarried by applicants, applicant funding recommendations. It is take no action regarding E.O. 12372. couriers, other representatives of the important, therefore, that this Applicants for projects to be applicant, or by overnight/express mail information be included in the administered by federally-recognized couriers shall be considered as meeting application. Indian tribes are also exempt from the an announced deadline if they are General Instructions. ACF is requirements of E.O. 12372. Otherwise, received on or before the deadline date, particularly interested in specific factual applicants should contact their SPOCs between the hours of 8 a.m. and 4:30 information and statements of as soon as possible to alert them of the p.m. eastern time at the ACYF measurable goals in quantitative terms. prospective applications and receive Operations Center, c/o The Dixon Project descriptions are evaluated on the any necessary instructions. Applicants Group, Inc., 118 Q Street, NE., basis of substance, not length. Extensive must submit any required material to Washington, DC 20002–2132, between exhibits are not required. Cross the SPOCs as soon as possible so that Monday and Friday (excluding Federal referencing should be used rather than the program office can obtain and holidays). This address must appear on repetition. Supporting information review SPOC comments as part of the the envelope/package containing the concerning activities that will not be award process. It is imperative that the application with the note ‘‘Attention directly funded by the grant or applicant submit all required materials, Field Initiated Child Care Research information that does not directly if any, to the SPOC and indicate the date Grants.’’ Applicants are cautioned that pertain to an integral part of the grant of this submittal (or the date of contact express/overnight courier services do funded activity should be placed in an if no submittal is required) on the not always deliver as agreed. appendix. Pages should be numbered Standard Form 424, item 16a. Under 45 and a table of contents should be ACF cannot accommodate included for easy reference. CFR 100.8(a)(2), a SPOC has 60 days transmission of applications by fax. from the application deadline to Instructions for Preparing a Full Project comment on proposed new or V. Application Review Information Description competing continuation awards. 1. Criteria 1. Project Summary Abstract SPOCs are encouraged to eliminate Provide a summary of the project the submission of routine endorsements Paperwork Reduction Act of 1995 description (a page or less) with as official recommendations. (Pub. L. 104–13): Public reporting for reference to the funding request. Additionally, SPOCs are requested to this collection of information is clearly differentiate between mere estimated to average 15 hours for the 2. Objectives and Need for Assistance Field Initiated Child Care Research advisory comments and those official Clearly identify the physical, State process recommendations which Grants, including time for reviewing instructions, gathering and maintaining economic, social, financial, may trigger the ‘‘accommodate or institutional, and/or other problem(s) explain’’ rule. the data needed, and reviewing the collection of information. requiring a solution. The need for When comments are submitted assistance must be demonstrated and directly to ACF, they should be The project description is approved the principal and subordinate objectives addressed to: Department of Health and under OMB Control No. 0970–0139. of the project must be clearly stated; Human Services, Administration for An agency may not conduct or supporting documentation, such as Children and Families, Division of sponsor, and a person is not required to letters of support and testimonials from Discretionary Grants, 370 L’Enfant respond to, a collection of information concerned interests other than the Promenade, SW., Washington, DC unless it displays a currently valid OMB applicant, may be included. Any 20447. control number. relevant data based on planning studies

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should be included or referred to in the include estimation methods, quantities, vehicles will be used, and other endnotes/footnotes. Incorporate unit costs, and other similar quantitative transportation costs and subsistence demographic data and participant/ detail sufficient for the calculation to be allowances. Travel costs for key staff to beneficiary information, as needed. duplicated. The detailed budget must attend ACF-sponsored workshops In developing the project description, also include a breakout by the funding should be detailed in the budget. the applicant may volunteer or be sources identified in Block 15 of the SF– d. Equipment requested to provide information on the 424. total range of projects currently being Provide a narrative budget Description: ‘‘Equipment’’ means an conducted and supported (or to be justification that describes how the article of nonexpendable, tangible initiated), some of which may be categorical costs are derived. Discuss personal property having a useful life of outside the scope of the program the necessity, reasonableness, and more than one year and an acquisition announcement. allocability of the proposed costs. cost which equals or exceeds the lesser of (a) the capitalization level established 3. Approach 5. General by the organization for the financial Outline a plan of action which The following guidelines are for statement purposes, or (b) $5,000. describes the scope and detail of how preparing the budget and budget Note: Acquisition cost means the net the proposed work will be justification. Both Federal and non- invoice unit price of an item of equipment, accomplished. Account for all functions Federal resources shall be detailed and including the cost of any modifications, or activities identified in the justified in the budget and narrative attachments, accessories, or auxiliary application. Cite factors which might justification. For purposes of preparing apparatus necessary to make it usable for the accelerate or decelerate the work and the budget and budget justification, purpose for which it is acquired. Ancillary state your reason for taking the ‘‘Federal resources’’ refers only to the charges, such as taxes, duty, protective in- proposed approach rather than others. ACF grant for which you are applying. transit insurance, freight, and installation Describe any unusual features of the Non-Federal resources are all other shall be included in or excluded from acquisition cost in accordance with the project such as design or technological Federal and non-Federal resources. It is organization’s regular written accounting innovations, reductions in cost or time, suggested that budget amounts and practices. or extraordinary social and community computations be presented in a involvement. columnar format: First column, object Justification: For each type of Provide quantitative monthly or class categories; second column, Federal equipment requested, provide a quarterly projections of the budget; next column(s), non-Federal description of the equipment, the cost accomplishments to be achieved for budget(s), and last column, total budget. per unit, the number of units, the total each function or activity in such terms The budget justification should be a cost, and a plan for use on the project, as the number of people to be served narrative. as well as use or disposal of the and the number of activities equipment after the project ends. An a. Personnel accomplished. When accomplishments applicant organization that uses its own cannot be quantified by activity or Description: Costs of employee definition for equipment should provide function, list them in chronological salaries and wages. a copy of its policy or section of its order to show the schedule of Justification: Identify the project policy which includes the equipment accomplishments and their target dates. director or principal investigator, if definition. If any data is to be collected, known. For each staff person, provide e. Supplies maintained, and/or disseminated, the title, time commitment to the project clearance may be required from the U.S. (in months), time commitment to the Description: Costs of all tangible Office of Management and Budget project (as a percentage or full-time personal property other than that (OMB). This clearance pertains to any equivalent), annual salary, grant salary, included under the Equipment category. ‘‘collection of information that is wage rates, etc. Do not include the costs Justification: Specify general conducted or sponsored by ACF.’’ of consultants or personnel costs of categories of supplies and their costs. List organizations, cooperating delegate agencies or of specific Show computations and provide other entities, consultants, or other key project(s) or businesses to be financed information which supports the amount individuals who will work on the by the applicant. requested. project, along with a short description of b. Fringe Benefits f. Other the nature of their effort or contribution. Description: Costs of employee fringe Description: Enter the total of all other 4. Additional Information benefits unless treated as part of an costs. Such costs, where applicable and Following are requests for additional approved indirect cost rate. appropriate, may include but are not information that need to be included in Justification: Provide a breakdown of limited to insurance, food, medical and the application: the amounts and percentages that dental costs (non-contractual), comprise fringe benefit costs such as professional services costs, space and a. Staff and Position Data health insurance, FICA, retirement equipment rentals, printing and Provide a biographical sketch for each insurance, taxes, etc. publication, computer use, training key person appointed and a job costs, such as tuition and stipends, staff c. Travel description for each vacant key position. development costs, and administrative A biographical sketch will also be Description: Costs of project-related costs. required for new key staff as appointed. travel by employees of the applicant Justification: Provide computations, a organization (does not include costs of narrative description and a justification b. Budget and Budget Justification consultant travel). for each cost under this category. Provide line item detail and detailed Justification: For each trip, show the calculations for each budget object class total number of traveler(s), travel g. Indirect Charges identified on the Budget Information destination, duration of trip, per diem, Description: Total amount of indirect form. Detailed calculations must mileage allowances, if privately owned costs. This category should be used only

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when the applicant currently has an ethical issues that may arise and (b) and sources; (c) provides evidence that the indirect cost rate approved by the includes realistic strategies for the applicant and its partners, if any, have Department of Health and Human resolution of difficulties; the expertise, resources and Services (HHS) or another cognizant The extent to which the researchers commitment to solve problems that may Federal agency. assure adequate protection of human arise in carrying out the project; and (d) Justification: An applicant that will subjects, confidentiality of data, and provides detailed project management charge indirect costs to the grant must consent procedures, as appropriate; charts showing tasks and sub tasks, enclose a copy of the current rate The extent to which the research milestones, staff allocation, and costs. agreement. If the applicant organization design (a) specifies the measures to be The extent to which (a) the scope of is in the process of initially developing used and their psychometric properties; the project is reasonable for the funds or renegotiating a rate, it should (b) describes how these measures have available and feasible for the project immediately upon notification that an been used to address the proposed time frame; (b) includes an effective award will be made, develop a tentative research questions; and (c) describes plan for the dissemination and indirect cost rate proposal based on its how these measures have been used utilization of information by most recently completed fiscal year in with the low-income, diverse researchers, policy-makers, and accordance with the principles set forth population to be studied. practitioners in the field; and (c) in the cognizant agency’s guidelines for Criterion 2: Objectives and Need for includes assurances and plans for establishing indirect cost rates, and Assistance (25 Point Maximum) working with the Child Care Bureau’s submit it to the cognizant agency. Child Care Research Collaboration and Applicants awaiting approval of their The extent to which the application Archive to archive final data sets, indirect cost proposals may also request responds to the Child Care Bureau’s reports, and other research products. indirect costs. It should be noted that priorities and proposes research likely when an indirect cost rate is requested, to yield findings that will help decision Criterion 4: Organizational Profile (10 those costs included in the indirect cost makers in crafting effective child care Point Maximum) pool should not also be charged as policies and strategies. The extent to which the application: direct costs to the grant. Also, if the Identifies the results and benefits of (a) Demonstrates organizational applicant is requesting a rate which is the project and describes how these will competence and expertise in the areas less than what is allowed under the inform child care policies and services, addressed by the proposed research, program, the authorized representative improve practice, and advance including relevant background, of the applicant organization must understanding of the contexts that experience, and training on related submit a signed acknowledgement that promote healthy development and well- research or similar projects; (b) the applicant is accepting a lower rate being in families and children. demonstrates expertise in research The extent to which the application than allowed. design, sampling, field work, data demonstrates a sound understanding of processing, statistical analysis, 2. Evaluation Criteria the critical issues and research needs in reporting, and information child care. This should include Eligible applications will be scored dissemination to academic and policy particular emphasis on the issues competitively against the evaluation communities; (c) demonstrates an addressed by the proposed study. criteria. These criteria will be used in understanding of the child care subsidy conjunction with the other expectations The extent to which the application provides a literature review that is system and the child care needs of low- and requirements set forth in this income families. announcement to evaluate how well current and comprehensive, identifies The extent to which the application: each proposal addresses the bureau’s other research that has addressed (a) Provides evidence of an effective research agenda and the program goals. similar issues, and supports the need for the proposed study. Describes how the organizational structure and Criterion 1: Approach—Research Design proposed study will help address gaps collaborative relationships, if and Methodology (30 Point Maximum) in the research literature and appropriate; (b) provides evidence that The extent to which the application unanswered questions. the project will be effectively managed provides a theoretical framework and a The extent to which the conceptual by the lead organization to ensure that review of empirical evidence supporting model, objectives and hypotheses are: all participants in the study operate as the proposed project. (a) Well formulated and appropriately a cohesive research team; (c) includes a The extent to which the proposed linked; (b) reflect the Bureau’s research detailed organizational chart showing research design (a) appropriately links agenda and goals; and (c) will contribute relationships and responsibilities of research issues, questions, variables, new knowledge to the field. participating organizations; (d) data sources, samples, and analyses; (b) The extent to which the application demonstrates and documents specific provides a logic model that illustrates describes a project framework that is organizational and staff experience in the expected linkages; and (c) employs appropriate, feasible and contributes to developing, implementing, and technically sound and appropriate the importance, comprehensiveness, maintaining a research project of the approaches, design elements and and quality of the proposed research. nature and scope proposed; and (e) procedures, and sampling techniques. provides information on the skills, The extent to which the application Criterion 3: Approach—Management experience, and capabilities of the provides a detailed analysis plan that Plan (25 Point Maximum) project director and key project staff shows how the measures and analyses The extent to which the application including the principal investigators relate to the proposed hypotheses or includes a management plan that (a) and other key staff at each site. research questions and demonstrates presents a sound framework for The extent to which the application their appropriateness for the questions maintaining quality control over the describes the management plan for under consideration. implementation and ongoing operations achieving the objectives of the proposed The extent to which the proposed of the study; (b) demonstrates how the project on time and within budget, design (a) reflects sensitivity to applicant will gain access to necessary including clearly defined technical, logistical, cultural, and organizations, participants, and data responsibilities, timelines, and

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milestones for accomplishing project they would be able to provide effective 4. Reporting Requirements tasks and ensuring quality. services. Programmatic Reports: Semi-annually Criterion 5: Budget (10 Points) Approved but Unfunded Applications and a final report is due 90 days after The extent to which the proposed the end of the grant period. In cases where more applications are Financial Reports: Semi-annually and project costs are reasonable and justified approved for funding than ACF can a final report due 90 days after the end in terms of scope, approach, staff time fund with the money available, the of the grant period. commitment, and anticipated results. Grants Officer shall fund applications in Refers to the budget information their order of approval until funds run VII. Agency Contacts presented on Standard Forms 424 and out. In this case, ACF has the option of Program Office Contacts: 424 A and the applicant’s budget carrying over the approved applications justification. Dr. Ivelisse Martinez-Beck, Program The extent to which the application up to a year for funding consideration Area Manager, 330 C Street, SW., describes the fiscal control and in a later competition of the same Room 2046, Washington, DC 20447; accounting procedures that will be used program. These applications need not be (202) 690–7885, imartinez- to ensure prudent use, proper and reviewed and scored again if the [email protected]. timely disbursement, and accurate program’s evaluation criteria have not Ms. Karen Tvedt, Director, Policy and accounting of funds received under this changed. However, they must then be Research Division, 330 C Street, SW., announcement. placed in rank order along with other Room 2046, Washington, DC 20447; applications in the later competition. (202) 401–5130, [email protected]. 3. Review and Selection Process VI. Award Administration Information Grants Management Office Contact: Initial Screening for Eligibility and William Wilson, Grants Officer, 330 C Conformance 1. Award Notices Street, SW., Room 2070, Washington, Review and Selection Process: Each Successful applicants will be notified DC 20447; (202) 205–8913, application will undergo an eligibility through the issuance of a Financial [email protected]. and conformance review by Federal Assistance Award document, which sets VIII. Other Information Child Care Bureau staff. Applications forth the amount of funds granted, the None. that pass the eligibility and terms and conditions of the grant, the conformance review will be evaluated effective date of the grant, the budget Dated: May 18, 2004. on a competitive basis according to the period for which initial support will be Joan E. Ohl, specified evaluation criteria. given, the non-Federal share to be Commissioner, Administration on Children, Youth and Families. Competitive Review Process provided, and the total project period for which support is contemplated. The [FR Doc. 04–11816 Filed 5–24–04; 8:45 am] The competitive review will be Financial Assistance Award will be BILLING CODE 4184–01–P conducted in the Washington, DC signed by the Grants Officer and metropolitan area by panels of Federal transmitted via postal mail. and non-Federal experts knowledgeable DEPARTMENT OF HEALTH AND Organizations whose applications will in the areas of literacy, early learning, HUMAN SERVICES child care, early childhood education, not be funded will be notified in and other relevant program areas. writing. Food and Drug Administration Application review panels will assign 2. Administrative and National Policy [Docket No. 2001D–0357] a score to each application and identify Requirements its strengths and weaknesses. International Cooperation on Conference Attendance. The grantee Harmonisation of Technical Application Consideration and must attend and present a poster at the Selection Requirements for Approval of Annual Meeting of the Child Care Policy Veterinary Medicinal Products; The Child Care Bureau will conduct Research Consortium each year of the Guidance for Industry on Studies to an administrative review of the grant. This conference is typically Evaluate the Safety of Residues of applications and results of the scheduled during the spring. In Veterinary Drugs in Human Food: competitive review panels and make addition, the applicant may be asked to Carcinogenicity Testing; Availability recommendations for funding to the attend and present at the annual State Commissioner, ACYF. Administrators’ Meeting typically held AGENCY: Food and Drug Administration, Subject to the recommendation of the each summer in Washington, DC. The HHS. Child Care Bureau’s Associate budget should reflect travel funds for ACTION: Notice. Commissioner, the Commissioner, both conferences. Grantees with ACYF, will make the final selection of graduate students are encouraged to SUMMARY: The Food and Drug the applications to be funded. bring at least one student to these Administration (FDA) is announcing the Application may be funded in whole or meetings. availability of a final guidance for in part depending on: (1) The ranked industry (#141) entitled ‘‘Studies to Archiving and Publishing. The order of applicants resulting from the Evaluate the Safety of Residues of grantee must agree to archive final data competitive review; (2) staff review and Veterinary Drugs in Human Food: sets, reports and other research products consultations; (3) the combination of Carcinogenicity Testing’’ (VICH GL28). with the Child Care Research and projects that best meets the Bureau’s This guidance has been adapted for Collaboration Archive (CCRCA). objectives; (4) the funds available; and veterinary use by the International (6) other relevant considerations. The 45 CFR part 74 and 45 CFR part 92. Cooperation on Harmonisation of Commissioner may also elect not to 3. Special Terms and Conditions of Technical Requirements for Registration fund any applicants with known Award of Veterinary Medicinal Products management, fiscal, reporting, program, (VICH) from a guidance regarding or other problems that make it unlikely None. pharmaceuticals for human use, which

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was adopted by the International States. The VICH is a parallel initiative Carcinogenicity of Pharmaceuticals.’’ Conference on Harmonisation of for veterinary medicinal products. The Notices of availability for these Technical Requirements for Approval of VICH is concerned with developing guidances published in the Federal Pharmaceuticals for Human Use (ICH). harmonized technical requirements for Register of March 1, 1996, (61 FR 8153) The objective of this VICH guidance the approval of veterinary medicinal and February 23, 1998, (63 FR 8983) document is to help ensure that the products in the European Union, Japan, respectively. The guidance has been assessment of carcinogenic potential is and the United States, and includes adapted for veterinary use by the VICH appropriate to human exposure to input from both regulatory and industry from the aforementioned guidances residues of veterinary drugs in human representatives. regarding pharmaceuticals for human food in the European Union, Japan, and The VICH Steering Committee is use. VICH also took into account the the United States. composed of member representatives Organisation for Economic Cooperation DATES: Submit written or electronic from the European Commission, and Development methodological comments at any time. European Medicines Evaluation Agency; guidances and the current practices for European Federation of Animal Health; ADDRESSES: Submit written requests for evaluating the safety of veterinary drug Committee on Veterinary Medicinal single copies of the guidance to the residues in human food in the European Products; the U.S. FDA; the U.S. Communications Staff (HFV–12), Center Union, Japan, the United States of Department of Agriculture; the Animal for Veterinary Medicine, Food and Drug America, Australia and New Zealand. Health Institute; the Japanese Veterinary Administration, 7519 Standish Pl., (Information collection for new animal Pharmaceutical Association; the Rockville, MD 20855. Send one self- drug applications is covered under OMB Japanese Association of Veterinary addressed adhesive label to assist that control number 0910–0032.) Biologics; and the Japanese Ministry of office in processing your requests. See Agriculture, Forestry and Fisheries. III. Significance of Guidance the SUPPLEMENTARY INFORMATION section Four observers are eligible to This document, developed under the for electronic access to the guidance participate in the VICH Steering VICH process, has been revised to document. Committee: One representative from the conform to FDA’s good guidance Submit electronic or written government of Australia/New Zealand, practices regulation (21 CFR 10.115). comments at any time on the guidance one representative from the industry in For example, the document has been to the Division of Dockets Management Australia/New Zealand, one designated ‘‘guidance’’ rather than (HFA–305), Food and Drug representative from the government in ‘‘guideline.’’ Because guidance Administration, 5630 Fishers Lane, rm. Canada, and one representative from the documents are not binding unless 1061, Rockville, MD 20852. Submit industry in Canada. The VICH specifically supported by statute or electronic comments to http:// Secretariat, which coordinates the regulation, mandatory words such as www.fda.gov/dockets/ecomments. preparation of documentation, is ‘‘must,’’ ‘‘shall,’’ and ‘‘will’’ in the Comments should be identified with the provided by the International original VICH documents have been full title of the guidance and the docket Federation for Animal Health (IFAH). substituted with ‘‘should’’ or ‘‘it is number found in brackets in the An IFAH representative also recommended.’’ heading of this document. participates in the VICH Steering This guidance document represents FOR FURTHER INFORMATION CONTACT: Committee meetings. the agency’s current thinking on Louis T. Mulligan, Center for Veterinary carcinogenicity testing for veterinary Medicine (HFV–153), Food and Drug II. Guidance on Carcinogenicity Testing drug residues in human food. This Administration, 7500 Standish Pl., In the Federal Register of August 28, guidance does not create or confer any Rockville, MD 20855, 301–827–6984, e- 2001 (66 FR 45319), FDA published the rights for or on any person and will not mail: [email protected]. notice of availability of the VICH draft operate to bind FDA or the public. An SUPPLEMENTARY INFORMATION: guidance, giving interested persons alternative method may be used as long until September 28, 2001 to submit as it satisfies the requirements of I. Background comments. No comments were received. applicable statutes and regulations. In recent years, many important At a meeting held on October 10–11, initiatives have been undertaken by 2002, the VICH Steering Committee IV. Comments regulatory authorities and industry endorsed the guidance for industry, As with all of FDA’s guidances, the associations to promote the VICH GL28. public is encouraged to submit written international harmonization of This guidance is one of a series of or electronic comments pertinent to this regulatory requirements. FDA has VICH guidances developed to facilitate guidance. FDA will periodically review participated in efforts to enhance the mutual acceptance of safety data the comments in the docket and, where harmonization and has expressed its necessary for the establishment of appropriate, will amend the guidance. commitment to seek scientifically based acceptable daily intakes for veterinary The agency will notify the public of any harmonized technical procedures for the drug residues in human food by the such amendments through a notice in development of pharmaceutical relevant regulatory authorities. The the Federal Register. products. One of the goals of guidance on the overall strategy for the Interested persons may, at any time, harmonization is to identify and then evaluation of veterinary drug residues in submit written comments to the reduce differences in technical human food (‘‘VICH Guidance on Division of Dockets Management (see requirements for drug development General Testing Approach’’) will be ADDRESSES) regarding this guidance among regulatory agencies in different made available at a later time. document. Two copies of any comments countries. VICH developed this guidance after are to be submitted, except individuals FDA has actively participated in the consideration of the existing ICH may submit one copy. Comments ICH for several years to develop guidances for pharmaceuticals for should be identified with the docket harmonized technical requirements for human use: ‘‘Final Guideline on the number found in the brackets in the the approval of human pharmaceutical Need for Long-Term Rodent heading of this document. A copy of the and biological products among the Carcinogenicity Studies of document and received comments are European Union, Japan, and the United Pharmaceuticals’’; and ‘‘S1B Testing for available for public examination in the

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Division of Dockets Management and to relinquish rights to a research best assured of having their full effect if between 9 a.m. and 4 p.m., Monday grant. Frequency of response: received within 30-days of the date of through Friday. Applicants may submit applications for this publication. published receipt dates. If awarded, V. Electronic Access Dated: May 13, 2004. annual progress is reported and trainees Dr. Charles Mackay, Copies of the guidance document may be appointed or reappointed. entitled ‘‘Studies to Evaluate the Safety Affected Public: Individuals or Chief, Project Clearance Branch, OPERA, OER, National Institutes of Health. of Residues of Veterinary Drugs in Households; Business or other for-profit, Human Food: Carcinogenicity Testing’’ Not-for-profit institutions; Federal [FR Doc. 04–11708 Filed 5–24–04; 8:45 am] (VICH GL28) may be obtained on the Government;l and State, Local or Tribal BILLING CODE 4140–01–M Internet from the CVM home page at Government. Type of Respondents: http://www.fda.gov/cvm. Adult scientific professionals. The DEPARTMENT OF THE INTERIOR Dated: May 18, 2004. annual reporting burden is as follows: Estimated Number of Respondents: Jeffrey Shuren, Bureau of Land Management Assistant Commissioner for Policy. 122,000; Estimated Number of Responses per Respondent: 1; Average [NV–025–1232–EA); Special Recreation [FR Doc. 04–11781 Filed 5–24–04; 8:45 am] Burden Hours Per Response: 8.5; and Permit # NV–025–04–01] BILLING CODE 4160–01–S Estimates Total Annual Burden Hours Requested: 1,032,439. The estimated Notice of Temporary Closure of Public operating cost to respondents is Lands: Pershing, Washoe, & Humboldt DEPARTMENT OF HEALTH AND Counties, NV HUMAN SERVICES $500,000. Request for Comments: Written AGENCY: Bureau of Land Management, comments and/or suggestions from the National Institutes of Health Interior. public and affected agencies are invited ACTION: Proposed Collection: Comment on one or more of the following points: Notice to the public of Request; Revision of OMB No. 0925– (1) Whether the proposed collection of temporary closures on public lands 0001 exp. 05/31/04, ‘‘Research and information is necessary for the proper administered by the Bureau of Land Research Training Grant Applications performance of the function of the Management, Winnemucca Field Office, and Related Forms’’ agency, including whether the Nevada. information will have practical utility; SUMMARY: Pursuant to 43 CFR 8364.1, SUMMARY: In compliance with the (2) The accuracy of the agency’s notice is hereby given that certain requirement section 3507(a)(1)(D) of the estimate of the burden of the proposed public lands will be temporarily closed Paperwork Reduction Act of 1995, the collection of information, including the to all public use in and around the Office of the Director (OD), Office of validity of the methodology and Paragon Astronautics rocket launch site, Extramural Research (OER), the assumptions used; (3) Ways to enhance located in Pershing, Washoe and National Institutes of Health (NIH) has the quality, utility, and clarity of the Humboldt counties, Nevada, from 0700 submitted to the Office of Management information to be collected; and (4) to 1200 hours, June 7th through June 11 and Budget (OMB) a request for review Ways to minimize the burden of the and approval of the information collection of information on those who and June 14 through June 18, 2004. collection listed below. This proposed are to respond, including the use of These closures are being made in the information collection was previously appropriate automatted, electronic, interest of public safety at and around published in the Federal Register on mechanical, or other technological the location of an amateur high-altitude February 19, 2004, Volume 69, No. 33, collection techniques or other forms of rocket launch site. This event is page 7763 and allowed 60 days for information technology. expected to attract approximately 50 public comment. No public comments Direct Comments to OMB: Written participants. The public lands involved were received. The purpose of this comments and/or suggestions regarding with the event are located northeast of notice is to allow an additional 30 days the item(s) contained in this notice, Gerlach, Nevada in the Mount Diablo for public comment. The National especially regarding the estimated Meridian. Institutes of Health may not conduct or public burden and associated response DATES: Closure to all public use from sponsor, and the respondent is not time should be directed to the Office of 0700–1200 hours, June 7 through June required to respond to, an information Management and Budget, Office of 11 and June 14 through June 18, 2004 collection that has been extended, Regulatory Affairs, New executive with the exception of BLM personnel, revised, or implemented on or after Office Building, Room 10235, law enforcement, emergency medical October 1, 1995, unless it displays a Washington, DC 20503, Attention: Desk services, and Paragon Astronautics staff currently valid OMB control number. Officer for NIH. To request more as designated by the BLM authorized information on the propose project or to officer. Proposed Collection: obtain a copy of the data collection ADDRESSES: Title: Research and Training Grant plans and instruments, contact Mr. A map showing these Applications and Related Forms. Type Mikia Currie, Division of Grants Policy, temporary closures, restrictions and of Information Collection Request: Office the Policy for Extramural prohibitions is available from the Revision, OMB 0925–0001, Expiration Research Administration, NIH, following BLM offices: Date 5/31/04. Form Numbers: PHS 398, Rockledge 1 Building, Room 3505, 6705 BLM-Winnemucca Field Office, 5100 2590, 2271, 3734 and HHS 568. Need Rockledge Drive, Bethesda, MD 20892– East Winnemucca Blvd, Winnemucca, and Use of Information Collection: The 7974, or call non-toll-free number (301) Nevada 89445–2921. application is used by applicants to 435–0941, or E-mail your request, BLM-State Office, 1340 Financial Blvd., request Federal assistance for research including your address to: Reno, Nevada 89520–0006. and research-related training. The other [[email protected]]. The map may also be viewed on the related forms are used for trainee Comments Due Date: Comments Winnemucca Field Office website at: appointment, final invention reporting, regarding this informaiton collection are www.nv.blm.gov/winnemucca. In

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addition, notice of this closure will be ACTION: Notice to the public of DEPARTMENT OF THE INTERIOR posted at the primary access points temporary closure on public lands within the area to which the closure administered by the Bureau of Land Bureau of Land Management applies. Management, Carson City Field Office, [CO–921–04–1320–EL; COC 67011] FOR FURTHER INFORMATION CONTACT: Nevada. Dave Lefevre, National Conservation Notice of Coal Lease Offering by Area Outdoor Recreation Planner, SUMMARY: Pursuant to 43 CFR 8364.1 Sealed Bid; COC 67011 Bureau of Land Management, notice is hereby given that certain AGENCY: Bureau of Land Management, Winnemucca Field Office, 5100 E public lands will be temporarily closed Interior. Winnemucca Blvd, Winnemucca, NV to all public use located in Washoe ACTION: Notice of competitive coal lease 89445, telephone: (775) 623–1500 or e- County, Nevada. This action is being sale. mail at [email protected]. taken to provide for public safety during SUPPLEMENTARY INFORMATION: The the 2004 Pylon Racing Seminar and SUMMARY: Bureau of Land Management, following Public Lands are closed to 2004 Reno National Championship Air Colorado State Office, Lakewood, public use: Public land areas north of Races. Colorado, hereby gives notice that the Union Pacific Railroad tracks, and certain coal resources in the lands DATES: Closure to all public use from east of State Highway 34 and County hereinafter described in Gunnison Road 200, and west of the Pahute Peak June 17 through June 20, 2004, and County, Colorado, will be offered for and Black Rock Desert wilderness September 12 through September 19, competitive lease by sealed bid in boundaries within the following legally 2004 (24 hrs. a day). accordance with the provisions of the described areas are included in the ADDRESSES: A map showing these Mineral Leasing Act of 1920, as closure: temporary closures, restrictions, and amended (30 U.S.C. 181 et seq.). T33.5N, R24E sec. 25–28, 32–36; prohibitions is available from the DATES: The lease sale will be held at 11 T33N R24E secs., 1–5, 8–22, 23 ,27–30; following BLM office: a.m., Thursday, July 1, 2004. Sealed T33N, R25E sec. 2,3,4,9; T34N, R24E Carson City Field Office, 5665 Morgan bids must be submitted no later than 10 sec. 1–3, 10–15, 21–27, 34–36; T34N, a.m., Thursday, July 1, 2004. Mill Road, Carson City, Nevada 89701. R25E sec.1–4, 9–16, 21–28, 33–36; ADDRESSES: The lease sale will be held T34N, R26E sec. 1–24, 28–33; T34N, FOR FURTHER INFORMATION CONTACT: in the Conference Room, Fourth Floor, R27E sec. 1–18; T35.5N, R25E sec. 27– Charles P. Pope, Assistant Manager, Colorado State Office, 2850 Youngfield 34; T35.5N, R26E sec. 25–36; T35N, Nonrenewable Resources, Carson City Street, Lakewood, Colorado. Sealed bids R24E sec. 6,13, 22–27, 34–36; T35N, Field Office, 5665 Morgan Mill Road, must be submitted to the Cashier, R25E sec. 1–4,9–16, 21–28, 33–36; All of Carson City, Nevada 89701. Telephone Colorado State Office, 2850 Youngfield T35N, R26E; All of T35N R27E; T36N (775) 885–6000. Street, Lakewood, Colorado 80215. R23.5E sec. 1; T36N, R24E sec. 5, 6, 8, FOR FURTHER INFORMATION CONTACT: 17, 30; T36N, R25E sec. 1–5, 8–18, 21– SUPPLEMENTARY INFORMATION: This 36; All of T36N, R26E; T36N, R27E sec. closure applies to all public use, Karen Purvis at 303–239–3795. 4–9, 16–21, 28–33; T37N, R23.5E sec. including pedestrian use and vehicles. SUPPLEMENTARY INFORMATION: The tract 36; T37N, R24E sec. 11, 14, 23, 24, 30; will be leased to the qualified bidder The public lands affected by this submitting the highest offer, provided T37N, R25E sec. 7, 22–27, 34–36; T37N, closure are described as follows: R26E sec. 19–36; T37N, R27E sec. 19– that the high bid meets the fair market value determination of the coal 21, 28–33; T38N, R23E sec. 22. Mt. Diablo Meridian resource. The minimum bid for this Penalty T. 21 N., R. 19 E., tract is $100 per acre or fraction thereof. Sec. 8, N1⁄2NE1⁄4, SE1⁄4NE1⁄4 and E1⁄2SE1⁄4; No bid less than $100 per acre or Any person failing to comply with the 1 1 closure orders may be subject to Sec. 16, N ⁄2 and SW ⁄4. fraction thereof will be considered. The imprisonment for not more than 12 Aggregating approximately 680 acres. minimum bid is not intended to months, or a fine in accordance with the represent fair market value. applicable provisions of 18 U.S.C. 3571, The above restrictions do not apply to Sealed bids received after the time or both. emergency or law enforcement specified above will not be considered. personnel or event officials. Persons In the event identical high sealed bids Authority: 43 CFR 8364.1. who violate this closure order are are received, the tying high bidders will Terry A. Reed, subject to arrest and, upon conviction, be requested to submit follow-up bids Field Manager. may be fined not more than $1,000 and/ until a high bid is received. All tie- [FR Doc. 04–11718 Filed 5–24–04; 8:45 am] or imprisoned for not more than 12 breaking sealed bids must be submitted BILLING CODE 4310–HC–P months. within 15 minutes following the Sale Official’s announcement at the sale that Authority: 43 CFR 8364.1. identical high bids have been received. DEPARTMENT OF THE INTERIOR Dated: April 6, 2004. Fair market value will be determined Bryant Smith, by the authorized officer after the sale. Bureau of Land Management Acting Assistant Manager, Nonrenewable Coal Offered: The coal resource Resources, Carson City Field Office. offered is limited to coal recoverable by [NV–030–5700–BX; Closure Notice No. NV– underground mining methods in the B 030–04–002] [FR Doc. 04–11728 Filed 5–24–04; 8:45 am] seam in the following lands: BILLING CODE 4310–HC–P Notice of Temporary Closure of Public T. 13 S., R. 90 W., 6th P.M. Lands: Washoe County, NV Sec. 12, lots 8 to 10, inclusive; Sec. 13, lots 2 to 7, inclusive, and lots 10 AGENCY: Bureau of Land Management, to 15, inclusive. Interior. Sec. 24, lots 4 and 5.

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Contains approximately 690.95 acres. attention of the following persons and familiarize interested publics with the Total recoverable reserves are must be received by June 24, 2004. project and to identify issues and estimated to be 2.3 million tons. The ADDRESSES: Karen Purvis, CO–921, concerns to be addressed in the EIS. The underground minable coal in the B seam Solid Minerals Staff, Division of Energy, scoping meeting will be announced is ranked as high volatile B bituminous Lands and Minerals, Colorado State through the local news media, coal. The estimated coal quality on an Office, Bureau of Land Management, newsletters, and the BLM Web site at as-received basis is as follows: 2850 Youngfield Street, Lakewood, www.nv.blm.gov/Elko at least 15 days Btu—12,136 Btu/lb. Colorado 80215; and Juan Garcia, prior to the event. Any additional public Moisture—5.52% Project Manager, Colowyo Coal meetings, if necessary, will be Sulfur Content—0.60% Company L.P., 5731 State Highway 13, announced similarly. Comments on Ash Content—12.20% Meeker, Colorado 81641. issues can also be submitted in writing Rental and Royalty: The lease issued SUPPLEMENTARY INFORMATION: The to the address listed below and for 30 as a result of this offering will provide application for coal exploration license days after publication of this Notice in for payment of an annual rental of $3.00 is available for public inspection during the Federal Register. In addition to the per acre or fraction thereof and a royalty normal business hours under serial ongoing public participation process, payable to the United States of 8 percent number COC 67664 at the Bureau of formal opportunities for public participation will be provided upon of the value of coal mined by Land Management, Colorado State publication of the BLM Draft EIS. underground methods. The value of the Office, 2850 Youngfield Street, coal will be determined in accordance Lakewood, Colorado 80215, and at the ADDRESSES: You may submit comments with 30 CFR 206. Little Snake Field Office, 455 Emerson by any of the following methods: Notice of Availability: Bidding St., Craig, Colorado 81625. Any party —E-mail: [email protected]. instructions for the offered tract are electing to participate in this program —Fax: (775) 753–0255. included in the Detailed Statement of must share all costs on a pro rata basis —Mail: Send to the attention of the Coal Lease Sale. Copies of the statement with Colowyo Coal Company L.P. and Emigrant Mine Project Manager, BLM and the proposed coal lease are with any other party or parties who Elko Field Office, 3900 East Idaho available upon request in person or by elect to participate. Street, Elko, NV 89801. mail from the Colorado State Office at Comments, including names and Dated: April 14, 2004. street addresses of respondents, will be the address given above. The case file is Karen Purvis, available for inspection in the Public available for public review at the above Solid Minerals Staff, Division of Energy, address during regular business hours Room, Colorado State Office, during Lands and Minerals. normal business hours at the address 7:30 a.m. to 4:30 p.m., Monday through [FR Doc. 04–11724 Filed 5–24–04; 8:45 am] given above. Friday, except holidays, and may be BILLING CODE 4310–JB–P published as part of the EIS. Individual Dated: March 24, 2004. respondents may request Karen Purvis, confidentiality. If you wish to withhold Solid Minerals Staff, Division of Energy, DEPARTMENT OF THE INTERIOR your name or street address from public Lands and Minerals. review or from disclosure under the Bureau of Land Management [FR Doc. 04–11723 Filed 5–24–04; 8:45 am] Freedom of Information Act, you must BILLING CODE 4310–JB–P [NV–910–04–1990–EX] state this prominently at the beginning of your written comment. However, we Notice of Intent To Prepare an will not consider anonymous DEPARTMENT OF THE INTERIOR Environmental Impact Statement on a comments. Such requests will be Plan of Operations for the Newmont honored to the extent allowed by law. Bureau of Land Management Mining Corporation Emigrant Mine All submissions from organizations or [CO–921–04–1320–EL; COC 67664] Project in Elko County, NV; and Notice businesses, and from individuals of Scoping Period and Public Meeting identifying themselves as Notice of Invitation for Coal representatives or officials of Exploration License Application, AGENCY: Bureau of Land Management, Interior. organizations or businesses, will be Colowyo Coal Company L.P. COC available for public inspection in their ACTION: Notice of Intent. 67664; Colorado entirety. AGENCY: Bureau of Land Management, SUMMARY: In accordance with section FOR FURTHER INFORMATION CONTACT: Tom Interior. 102(2)(c) of the National Environmental Schmidt, Project Manager at the Elko ACTION: Notice of invitation for coal Policy Act of 1969 and 43 CFR part Field Office, 3900 E. Idaho Street, Elko, exploration license application. 3809, the Bureau of Land Management NV 89801. Telephone: (775) 753–0200. Elko Field Office will be directing the Email: [email protected]. SUMMARY: Pursuant to the Mineral preparation of an EIS by a third-party SUPPLEMENTARY INFORMATION: The Leasing Act of February 25, 1920, as contractor on the potential impacts of a Newmont Mining Corporation has amended, and to Title 43, Code of proposed Plan of Operations for gold submitted a Plan of Operations to open Federal Regulations, Subpart 3410, mining by Newmont Mining the Emigrant Mine about ten miles members of the public are hereby Corporation in Elko County, Nevada. south of Carlin, Nevada. The mine and invited to participate with Colowyo The project encompasses approximately associated facilities would be located in Coal Company L.P. in a program for the 1,172 acres of public land. portions of Sections 24, 26, 34, 36 of T. exploration of unleased coal deposits DATES: This Notice initiates the 30-day 32 N., R. 53 E.; and Sections 1, 2, 3, 11, owned by the United States of America public scoping period. Within 30 days 12, T. 31 N., R 53 E. The proposed containing approximately 4,509.89 acres of the publication of this Notice, a Emigrant Mine would include in Moffat County, Colorado. public scoping meeting will be held at developing and operating an open pit DATES: Written Notice of Intent to the BLM Elko Field Office, 3900 East mine; constructing a waste rock disposal Participate should be addressed to the Idaho Street, Elko, Nevada, to facility, storing oxide waste in mined

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out areas of the pit; developing an oxide Committee Act of 1972, the U.S. suitable for lease/disposal pursuant to heap leach pad; constructing ancillary Department of the Interior, Bureau of the Recreation and Public Purposes Act facilities; temporarily rerouting Land Management (BLM) Central of June 14, 1926 (44 Stat. 741), as intermittent stream and flows in the pit Montana Resource Advisory Council amended, and opens 20.00 acres of land area; and concurrent reclamation. (RAC) will meet as indicated below. to surface entry, and mining, subject to Proposed mining operations would last DATES: The meeting will be held June 16 the existing laws, rules, and regulations for approximately 9 years through the & 17, 2004, at the Great Northern Hotel applicable to public lands administered year 2013. Approximately 1172 acres of in Malta, Montana. The June 16 meeting by the Bureau of Land Management. The public land and 260 acres of private will begin at 1 p.m. with a 60-minute land has been and will remain open to land would be disturbed. public comment period and will mineral leasing. The issues expected to be analyzed in adjourn at 6 p.m. The June 17 meeting DATES: Effective Date: May 25, 2004. will begin at 8 a.m. with a 30-minute the EIS include potential impacts to FOR FURTHER INFORMATION CONTACT: public comment period and will wildlife and cultural resources; the Phyllis Gregory, BLM, Oregon/ adjourn at 3 p.m. potential for waste rock, heap leach, and Washington State Office, P.O. Box 2965, pit walls to produce acid rock drainage SUPPLEMENTARY INFORMATION: This 15- Portland, OR 97208, 503–808–6188. or heavy metals; and diversion of an member council advises the Secretary of unnamed drainage. Cumulative impacts the Interior on a variety of management SUPPLEMENTARY INFORMATION: On April will also be addressed. In addition, the issues associated with public lands in 23, 1987, 20.00 acres of public land following resources will be analyzed: Montana. At this meeting the council under the jurisdiction of the Bureau of geology and minerals, Native American will discuss: Land Management were classified as religious concerns, air quality, The Blackleaf EIS scoping meetings; suitable for lease pursuant to the paleontology, lands and realty, fisheries The visitor use services category in Recreation and Public Purposes Act of and aquatic resources, range the Monument RMP; June 14, 1926 (44 Stat. 741), as management, vegetation, soils, visual The definition of a road used in the amended, and the regulations at 43 CFR resources, recreation and wilderness, Monument RMP; part 2400. Upon classification the land weeds, social and economic values, The recent joint RAC meeting held in was leased to the LaPine Rodeo environmental justice, and threatened, Phoenix; Association for the construction, endangered, candidate, and sensitive The Region 6 prairie dog management operation, and maintenance of rodeo resources. guidelines; and grounds and facilities for a term of 10 A range of alternatives (including, but Field manager updates (time years under BLM Serial Number OR not limited to, alternative reclamation permitting). 40119. On June 25, 1997, this lease measures and the no-action alternative) All meetings are open to the public. expired. will be developed to address the issues. The public may present written The formerly leased land is described Mitigating measures will be considered comments to the RAC. Each formal RAC as follows: to minimize environmental impacts and meeting will also have time allocated for to assure the proposed action does not hearing public comments (as detailed Willamette Meridian, Oregon result in undue or unnecessary above). Depending on the number of T. 23 S., R. 10 E., degradation of public lands. Federal, persons wishing to comment and time Sec. 3, SE1⁄4 SE1⁄4. state and local agencies and other available, the time for individual oral The area described contains 20.00 acres in individuals or organizations who may comments may be limited. Klamath County, Oregon. be interested in or affected by BLM’s FOR FURTHER INFORMATION CONTACT: At 8:30 a.m., on June 24, 2004, the decision on Emigrant Mine Plan of Dave Mari, Lewistown Field Manager, land will be opened to operation of the Operations are invited to participate in Lewistown Field Office, Airport Road, public land laws generally, but not to the scoping process with respect to this Lewistown, Montana 59457, 406/538– location or entry, subject to valid EIS. 7461. existing rights, the provisions of existing Authority: 43 CFR Part 3809. Dated: May 19, 2004. withdrawals, and the requirements of applicable law. All valid existing David L. Mari, Dated: March 9, 2004. applications received at or prior to 8:30 Helen Hankins, Lewistown Field Manager. a.m., on June 24, 2004, will be Field Office Manager. [FR Doc. 04–11812 Filed 5–24–04; 8:45 am] considered as simultaneously filed at [FR Doc. 04–11720 Filed 5–24–04; 8:45 am] BILLING CODE 4310–$$–P that time. Those received thereafter will BILLING CODE 4310–HC–P be considered in the order of filing. At 8:30 a.m., on July 9, 2004, the land DEPARTMENT OF THE INTERIOR will be opened to location and entry DEPARTMENT OF THE INTERIOR Bureau of Land Management under the United States mining laws. Appropriation under the general mining Bureau of Land Management [OR–056–04–1430–ES; GP4–0151] laws prior to the date and time of [MT–060–01–1020–PG] restoration is unauthorized. Any such Termination of Classification and attempted appropriation, including Order Providing for Opening of Land, Notice of Public Meeting; Central attempted adverse possession under 30 OR 40119 Montana Resource Advisory Council U.S.C. Sec. 38, shall vest no rights AGENCY: Bureau of Land Management, AGENCY: Bureau of Land Management against the United States. Acts required Interior. (BLM), Interior. to establish a location and to initiate a ACTION: Notice of Public Meeting. ACTION: Notice. right of possession are governed by State law where not in conflict with Federal SUMMARY: In accordance with the SUMMARY: This notice terminates the law. The Bureau of Land Management Federal Land Policy and Management existing classification in its entirety for will not intervene in disputes between Act and the Federal Advisory public lands that were classified as rival locators over possessory rights

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since Congress has provided for such rebar stamped LS 2335, said aluminum Dated: April 22, 2004. determination in local courts. capped rebar being the true point of Melvin Schlagel, beginning; thence N. 89°58′15″ E. a distance Dated: April 9, 2004. Realty Officer. of 331.71 feet to an aluminum capped rebar Sherrie L. Reid, [FR Doc. 04–11726 Filed 5–24–04; 8:45 am] stamped LS 2335; thence S. 18°59′05″ E. a BILLING CODE 4210–33–P Acting Chief, Branch of Realty and Records distance of 181.79 feet to an aluminum Services. capped rebar stamped LS 2335; thence S. [FR Doc. 04–11727 Filed 5–24–04; 8:45 am] 79°29′04″ E. a distance of 122.52 feet to an DEPARTMENT OF THE INTERIOR BILLING CODE 4310–33–P aluminum capped rebar stamped LS 2335; thence S. 00°28′00″ E. a distance of 328.52 Bureau of Land Management feet to an existing iron pipe; thence S. [NM–070–1430–ES; NMNM111110] DEPARTMENT OF THE INTERIOR 89°01′06″ W. a distance of 209.65 feet to an existing iron pipe; thence S. 89°04′17″ W. a Bureau of Land Management Notice of Realty Action—Recreation distance of 300.09 feet to an existing iron ° ′ ″ and Public Purpose (R&PP) Lease/ [WYW 88021] pipe; thence N. 00 28 00 W. a distance of Patent of Public Land in San Juan 531.06 feet to the true point of beginning. Notice of Proposed Extension of County, NM; Act Classification, New Mexico Public Land Order No. 6581; For a period of 90 days from the date Opportunity for Public Meeting; of publication of this notice, all persons AGENCY: Bureau of Land Management, Wyoming who wish to submit comments, Interior. suggestions, or objections in connection ACTION: AGENCY: Bureau of Land Management, Notice of realty action. with the proposed extension may Interior. present their views in writing to the SUMMARY: The following described ACTION: Notice. undersigned officer of the BLM. public land is determined suitable for classification for leasing and patenting SUMMARY: As required by 43 CFR Comments, including names and to the City of Bloomfield, Bloomfield, 2310.3–1, notice is hereby given that the street addresses of respondents, will be New Mexico under the provisions of the Department of Housing and Urban available for public review at the BLM R&PP Act, as amended (43 U.S.C. 869 et Development (HUD) has filed an Wyoming State Office, 5353 seq.). The City of Bloomfield proposes application to extend Public Land Order Yellowstone Rd., Cheyenne, Wyoming, to use the land for a fire station/water (PLO) No. 6581 for a 20-year period. during regular business hours 9 a.m. to loading facility and park facilities. This notice also gives an opportunity to 4 p.m. Monday through Friday, except New Mexico Principal Meridian comment on the proposed action and to holidays. Individual respondents may request a public meeting. PLO No. 6581 request confidentiality. If you wish to T. 29 N., R. 11 W., will expire on January 5, 2005. Sec. 3: (S1⁄2S1⁄2NW1⁄4NE1⁄4, withhold your name or address from 1 1 1 1 1 S ⁄2S ⁄2SW ⁄4NE ⁄4NE ⁄4;) portion of lot 5; DATES: Comments and requests for a public review or from disclosure under Containing 12.5 acres, more or less. public meeting must be received by the Freedom of Information Act, you August 23, 2004. must state this prominently at the Comment Dates: On or before July 9, ADDRESSES: Comments and meeting beginning of your comments. Such 2004, interested parties may submit comments regarding the proposed requests should be sent to the BLM requests will be honored to the extent leasing and conveyance, or Wyoming State Director, P.O. Box 1828, allowed by law. BLM will not consider classification of the lands to the Bureau Cheyenne, Wyoming 82003–1828. anonymous comments. All submissions FOR FURTHER INFORMATION CONTACT: of Land Management (BLM) at the from organizations or businesses, and following address. Any adverse Janet Booth, BLM Wyoming State Office, from individuals identifying themselves 307–775–6124. comments will be reviewed by the BLM, as representatives or officials of Farmington Field Manager, 1235 La SUPPLEMENTARY INFORMATION: On April organizations or businesses, will be 14, 2004, HUD filed an application to Plata Highway, Suite A, Farmington, made available for public inspection in NM 87401, who may sustain, vacate, or extend PLO No. 6581. This order their entirety. withdrew non-public land in which the modify this realty action. In the absence United States may hereafter acquire Notice is hereby given that an of any adverse comments, this realty interests from settlement, sale, location, opportunity for a public meeting is action becomes the final determination or entry under the public land laws, but afforded in connection with the of the Department of the Interior and not the mining laws, for the purpose of proposed extension. All interested effective on July 26, 2004. protecting the equity of HUD in the persons who desire a public meeting for FOR FURTHER INFORMATION CONTACT: development of public housing. The the purpose of being heard on the Information related to this action, mineral estate of the land is owned by proposed extension should submit a including the environmental the State of Wyoming. The withdrawal written request to the BLM Wyoming assessment, is available for review at the comprises approximately 5.55 acres as State Director within 90 days from the BLM, Farmington Field Office, 1235 La described below: date of publication of this notice. If the Plata Highway, Suite A, Farmington, NM 87401. Sixth Principal Meridian authorized officer determines that a public meeting will be held, a notice of SUPPLEMENTARY INFORMATION: A tract of land, being a portion of Parcel Publication of this notice segregates the A, Township 50 and 51 North, Range 82 the time and place will be published in the Federal Register at least 30 days public land described above from all West, 6th P.M., Johnson County, Wyoming, other forms of appropriation under the being further described as follows: before the scheduled date of the public land laws, including the general Commencing at an existing brass cap which meeting. marks the center of Section 34, Township 51 mining laws, except for leasing and North, Range 82 West, 6th P.M., in Johnson This extension will be processed in conveyance under the R&PP Act and County, Wyoming; thence S. 00°28′00″ E. a accordance with the regulations set leasing under the mineral leasing laws distance of 79.03 feet to an aluminum capped forth in 43 CFR 2310.4. for a period of two (2) years from the

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date of this publication in the Federal DEPARTMENT OF THE INTERIOR constructed by the authority of the Register. The segregative affect will United States. Act of August 30, 1890 terminate upon issuance of the lease Bureau of Land Management (43 U.S.C. 945). and patent to the City of Bloomfield, or [OR–102–04–5870–EU; HAG4–0099] 2. The Deed would also include a two (2) years from the date of this notice and indemnification statement publication, whichever occurs first. The Direct Sale of Public Lands, OR 59372 under the Comprehensive lease, when issued, will be subject to Environmental Response, Compensation the following terms: AGENCY: Bureau of Land Management and Liability Act (42 U.S.C. 9620) 1. Provisions of the R&PP Act and to (BLM), Roseburg District. holding the United States harmless from all applicable regulations of the ACTION: Notice of realty action. any release of hazardous materials that may have occurred as a result of the Secretary of the Interior. SUMMARY: A 0.08-acre parcel in Douglas unauthorized use of the property by 2. Provisions of the Resource County, Oregon, is being considered for Conservation and Recovery Act of 1976 other parties. direct sale to Douglas County as part of The mineral interests being offered for (RCAA) as amended, 42 U.S.C. 6901– the road widening project for State 6987 and the Comprehensive conveyance have no known value. Highway 99. The parcel is the minimum Acceptance of the direct sale offer Environmental Response, Compensation size possible which still ensures that the and Liability Act of 1980 (CERCLA) as constitutes an application for County has all the land it needs to conveyance of the mineral interests also amended, 42 U.S.C. 9601 and all complete its project. The parcel applicable regulations. being offered under the authority of proposed for sale is identified as Section 209(b) of the Federal Land 3. Provisions of Title VI of the Civil suitable for disposal in the Roseburg Policy and Management Act of 1976 (43 Rights Act of 1964. District Resource Management Plan, U.S.C. 1719). In addition to the full 4. Provisions that the lease be June 2, 1995. purchase price, a nonrefundable fee of operated in compliance with the DATES: Submit comments on or before $50 will be required for purchase of the approved Development Plan. July 9, 2004. mineral interests to be conveyed The patent, when issued, will be ADDRESSES: Address all written simultaneously with the sale of the subject to the following terms: comments concerning this notice to land. 1. Reservation to the United States of Glenn W. Lahti, Acting Field Manager, The land described is segregated from a right-of-way for ditches and canals in Swiftwater Field Office, 777 NW. appropriation under the public land accordance with 43 U.S.C. 945. Garden Valley Blvd., Roseburg, Oregon laws, including the mining laws, 2. Reservation to the United States of 97470. pending disposition of this action or 270 all minerals. FOR FURTHER INFORMATION CONTACT: days from the date of publication of this 3. All valid existing rights, e.g. rights- Mary Johnson, District Realty Specialist notice, whichever occurs first. of-way and leases of record. at (541) 464–3276. Detailed information concerning this 4. Provisions that if the patentee or its SUPPLEMENTARY INFORMATION: The land sale, including the reservations, successor attempts to transfer title to or following described public land in sale procedures and conditions, control over the land to another or the Douglas County, Oregon, has been planning and environmental land is devoted to a use other than that examined and found suitable for sale documents, and mineral report is for which the land was conveyed, under sections 203 and 209 of the available for review at the Roseburg without the consent of the Secretary of Federal Land Policy and Management District Office, Bureau of Land the Interior or his delegate, or prohibits Act of 1976 (90 Stat. 2750, 43 U.S.C. Management, 777 NW. Garden Valley or restricts, directly or indirectly, or 1713 and 1719). The parcel proposed for Blvd., Roseburg, Oregon 97470. In the absence of any objections, this permits its agents, employees, sale is identified as follows: contractors, or subcontractors, including proposal will become the final without limitation, lessees sub-lessees Willamette Meridian, Oregon determination of the Department of the and permittees, to prohibit or restrict, T. 25 S., R. 5 W., Interior. directly or indirectly, the use of any part Parcel B, in DLC 52. Comments, including names, street of the patented lands or any of the The area described contains 0.08 acre, addresses, and other contact facilities whereon by any person more or less. Said legal description is information of respondents, will be because of such person’s race, creed, subject to final approval and acceptance available for public review. Individual color, or national origin, title shall of a Cadastral Survey. This parcel will respondents may request revert to the United States. be sold at no less than the appraised confidentiality. If you wish to request The lands are not needed for Federal market value, which has been that BLM consider withholding your purposes. Leasing and later patenting is determined to be $7,254. name, street address and other contact consistent with current Bureau of Land In accordance with 43 CFR 2710.0– information (such as: Internet address, Management policies and land use 6(c)(3)(iii) direct sale procedures are fax or phone number) from public planning. The estimated intended time appropriate since the land is needed for review or from disclosure under the of lease issuance is August 15, 2004, a public purpose. Freedom of Information Act, you must with the patent being issued upon Douglas County will be allowed 30 state this prominently at the beginning substantial development taking place. days from receipt of a written offer to of your written comment. BLM will The proposal serves the public interest submit a deposit of at least 20 percent honor requests for confidentiality on a since it would provide a fire station/ of the appraised market value of the case-by-case basis to the extent allowed water loading facility and park facilities. parcel, and within 180 days thereafter to by law. BLM will make available for submit the balance. public inspection in their entirety all Dated: May 11, 2004. The following rights, reservations, submissions from organizations and Ray Sanchez, and conditions will be included in the businesses, and from individuals Acting Assistant Field Manager. Deed conveying the land: identifying themselves as [FR Doc. 04–11721 Filed 5–24–04; 8:45 am] 1. A reservation to the United States representatives or officials of BILLING CODE 4310–VB–P for a right-of-way for ditches and canals organizations or businesses.

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(Authority: 43 CFR 2711.1–2 (a)). appraised market value for this parcel geothermal interests, which will be Dated: March 12, 2004. has been determined to be $3,600.00. reserved to the United States in Glenn W. Lahti, The land is being considered for a accordance with Section 209 of the modified competitive sale. There is no Acting Field Manager, Swiftwater Field Office. Federal Land Policy and Management legal access for BLM or members of the Act of 1976 (43 U.S.C. 1719). In addition [FR Doc. 04–11732 Filed 5–24–04; 8:45 am] public. This land is difficult and to the full purchase price, a BILLING CODE 4310–33–P uneconomic to manage as a part of the nonrefundable fee of $50 will be public lands and is not suitable for required for purchase of the mineral management by another Federal agency. DEPARTMENT OF THE INTERIOR interests to be conveyed simultaneously No significant resource values will be with the sale of the land. Bureau of Land Management affected by this disposal. The land described is segregated from In accordance with 43 CFR 2711.3–2, appropriation under the public land [OR–014–01–1430–EU; GP–04–0066] Public lands may be offered for sale laws, including the mining laws, with utilizing modified competitive bidding Realty Action: Modified Competitive the exception of sales under the above procedures when the authorized officer cited statues, pending disposition of this Sale of Public Lands in Klamath determines it is necessary in order to County, OR action or 270 days from the date of assure equitable distribution of land publication of this notice, whichever AGENCY: Bureau of Land Management among purchasers or to recognize occurs first. (BLM), Interior. equitable considerations or public Comments, including names, street policies. Modified competitive bidding ACTION: Notice of realty action. addresses, and other contact includes but is not limited to: Offering information of respondents, will be SUMMARY: The following described to designated bidder (Mr. Al Bruner of available for public review. Individual public land in Klamath County, Oregon A.L. Bruner enterprises) the right to respondents may request has been examined and found suitable meet the highest bid. Mr. Bruner is the confidentiality. If you wish to request for sale under Sections 203 and 209 of adjacent land owner and his land that BLM consider withholding your the Federal Land Policy and completely surrounds the 40-acre parcel name, street address, and other contact Management Act of 1976 (90 Stat. 2750, on all four sides. Refusal or failure to information (such as: Internet address, 43 U.S.C. 1713 and 1719, at not less meet the highest bid shall constitute a FAX or phone number) from public than the appraised market value. The waiver of such bidding provisions. review or from disclosure under the parcel proposed for sale is identified as The winning bidder will be allowed Freedom of Information Act, you must suitable for disposal in the Klamath 30 days from receipt of a written offer state this prominently at the beginning Falls Resource Area Resource to submit a deposit of at least 20 percent of your comment. BLM will honor Management Plan, June 2, 1995. of the appraised market value of the requests for confidentiality on a case-by- The parcel proposed for sale is parcel, and 180 days thereafter to case basis to the extent allowed by law. identified as follows: submit the balance. Anonymous comments will not be The following rights, reservations, accepted. BLM will make available for Willamette Meridian, and conditions will be included in the public inspection in their entirety all T. 41 S., R. 13 E. patent conveying the land: submissions from organizations or 1. A reservation to the United States Sec. 14, NE1/4NW1/4. businesses, and from individuals for a right-of-way for ditches and canals The area described contains 40 acres. identifying themselves as constructed by the authority of the representatives or officials of United States. Act of August 30, 1890 DATES: On or before July 9, 2004, organizations or businesses. interested persons may submit written (43 U.S.C. 945). comments. Objections will be reviewed 2. A reservation to the United States Dated: February 4, 2004. by the Lakeview District Manager who for all oil, gas and geothermal resources Jon Raby, may sustain, vacate, or modify this in the land in accordance with Section Field Manager, Klamath Falls Resource Area. realty action. In the absence of any 209 of the Federal Land Policy and [FR Doc. 04–11733 Filed 5–24–04; 8:45 am] objections, this proposal will become Management Act of 1976 (43 U.S.C. BILLING CODE 4310–33–P the final determination of the 1719). Department of the Interior. 3. Patents will be issued subject to all valid existing rights and reservations of ADDRESSES: Written comments should DEPARTMENT OF THE INTERIOR be submitted to Jon Raby, Klamath Falls record. 4. The patent would also include a Bureau of Land Management Resource Area Field Manager, Klamath notice and indemnification statement Falls Field Office, 2795 Anderson Ave. under the Comprehensive [WY–100–22; WYW–158906] Building 25, Klamath Falls, Oregon Environmental Response, Compensation 97603. Electronic format submittal is Notice of Realty Action; Agricultural and Liability Act (42 U.S.C. 9620) not acceptable. Lease of Public Lands, Wyoming holding the United States harmless from FOR FURTHER INFORMATION CONTACT: any release of hazardous materials that AGENCY: Bureau of Land Management, Detailed information concerning this may have occurred as a result of the Interior. land sale, including the reservations, unauthorized use of the property by ACTION: Notice of Realty Action, sale procedures and conditions, other parties. Agricultural Lease of Public Lands in appraisal, planning and environmental The mineral interests being offered for Sublette County. documents, is available from Linda conveyance have no known value. The Younger, Realty Specialist, at the above successful bidder of modified SUMMARY: The Bureau of Land address, phone (541) 883–6916. competitive sale offer constitutes an Management has determined that the SUPPLEMENTARY INFORMATION: The area application for conveyance of the land described below is suitable for described contains 40 acres, more or mineral interest, with the exception of agricultural lease under Section 302 of less, in Klamath County, Oregon. The all leaseables, including oil, gas and the Federal Land Policy and

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Management Act of 1976, 43 U.S.C. affected by this closure are all lands as the Services), the Bureau of Land 1732. administered by the BLM within Management (BLM) and Forest Service Section 08 of Township 15 South, Range (FS) have approved Alternative Sixth Principal Meridian 24 East, Boise Meridian. This area is Consultation Agreements pursuant to T.30 N., R. 112 W., section 18, NE1⁄4SE1⁄4. known as Castle Rocks State Park and the joint counterpart regulations for These lands contain 6.90 acres. Castle Rocks Inter-Agency Recreation consultation under section 7 of the Area. The area covers approximately Endangered Species Act (ESA) to FOR FURTHER INFORMATION CONTACT: 320 acres of BLM land. A closure notice streamline consultation on proposed Priscilla Mecham, Field Manager, including time periods will be posted projects that support the National Fire Bureau of Land Management, Pinedale near the entry point at the Castle Rocks Plan (NFP). Resource Area, P.O. Box 768, Pinedale, Ranch House. DATES: The BLM and FS Alternative WY 82941, 307–367–5300. The casefile Exceptions To this Order are Granted Consultation Agreements with U.S. Fish may be reviewed at the Pinedale To the Following: No exceptions. and Wildlife Service and National Resource Area office. EFFECTIVE DATE: This closure is effective Marine Fisheries Service are available SUPPLEMENTARY INFORMATION: The June 1, 2004 and shall remain effective on the BLM and FS Web sites. Bureau of Land Management proposes until June 1, 2005. ADDRESSES: Information on the to lease the above described land for FOR FURTHER INFORMATION, CONTACT: Alternative Consultation Agreements is haying purposes for a 3-year period on Dennis Thompson, Burley Field Office, available electronically through the a non-competitive land use permit. 200 South 15 East, Burley, ID. 83318. Internet sites (http://www.blm.gov or Interested parties may submit Telephone (208) 677–6641. A Map of http://www.fs.fed.us. ), or from the BLM, comments to the Bureau of Land the closure area is available from the 1849 C Street, NW., LSB–204, Management, Field Manager, Pinedale, Burley BLM Office. Washington, DC 20240 or from the FS, P.O. Box 768, Pinedale, Wyoming 82941 SUPPLEMENTARY INFORMATION: Mail Stop 1121, 1400 Independence until [July 9, 2004.] Any adverse The authority for this closure is found under Avenue, Washington, DC 20250. comments will be evaluated by the State FOR FURTHER INFORMATION CONTACT: Director who may sustain, vacate, or 43 CFR 8364.1. Any person who violates this closure may be subject to the Peggy Olwell, Bureau of Land modify this realty action. In the absence Management, Endangered Species of any objections, this proposed realty penalties provided in Sec. 8360.0–7 of this title. Any person who violates this Program Lead, 202–452–7764, or action will become effective on [July 26, [email protected] or Marc Bosch, 2004.] closure may be tried before a United States Magistrate and fined no more U.S. Forest Service, Endangered Species Authority: 43 U.S.C. 1712(f) and 43 CFR than $1,000 or imprisoned for no more Program Leader, 202–205–1220, or 2920.4(c) than 12 months, or both. Such [email protected]. Dated: February 4, 2004. violations may also be subject to the SUPPLEMENTARY INFORMATION: The Priscilla Mecham, enhanced fines provided for by 18 counterpart regulations, authorized by Field Manager. U.S.C. 3571. 50 CFR 402.04, complement the [FR Doc. 04–11722 Filed 5–24–04; 8:45 am] Dated: April 5, 2004. consultation process by providing an BILLING CODE 4310–22–M Wendy Reynolds, alternative process for completing section 7 consultation for projects that Burley Field Manager. authorize, fund, or carry out actions that [FR Doc. 04–11729 Filed 5–24–04; 8:45 am] DEPARTMENT OF THE INTERIOR support the NFP. The Counterpart BILLING CODE 4310–66–P Regulations eliminate the need to Bureau of Land Management conduct informal consultations and [ID–077–1220–MA] DEPARTMENT OF THE INTERIOR obtain written concurrence from the Services for those NFP actions that the Notice of Temporary Restriction of the Bureau of Land Management BLM or FS determines are ‘‘not likely to Use of Public Lands in the Area Known adversely affect’’ (NLAA) listed species as Castle Rocks State Park and Castle DEPARTMENT OF AGRICULTURE or designated critical habitat. Rocks Inter-Agency Recreation Area The final rule for the counterpart Near Almo, ID Forest Service regulations was published in the Federal Register on December 8, 2003, AGENCY: Bureau of Land Management, [WO–230–04–1150–PG] and became effective on January 7, Interior. 2004. Implementation of the counterpart Joint Counterpart Endangered Species ACTION: Notice of temporary restriction. regulations requires BLM and FS to Act Section 7 Consultation develop and sign an Alternative SUMMARY: The Bureau of Land Regulations; Bureau of Land Consultation Agreement (ACA) with the Management announces temporary Management and Forest Service Services, and to jointly develop a restriction of use of certain public lands Alternative Consultation Agreements training program, based on the needs of in Cassia County. This closure will With U.S. Fish and Wildlife Service and the agency. The BLM and the FS signed prohibit bolting and placement of fixed National Oceanic and Atmospheric separate ACAs with the Services on anchors to rocks, and overnight Administration Fisheries March 3, 2004. The interagency training camping. The BLM intends to take this AGENCY: Bureau of Land Management, program is being developed by BLM, FS, action to allow time for analysis of a Interior. Forest Service, Agriculture. FWS, and NOAA and will be available fixed anchor management plan. ACTION: Notice of availability. for agency staff by May, 2004. DATES: This closure will take effect on The regulations require that the ACA June 1, 2004 and shall remain in effect SUMMARY: The U.S. Fish and Wildlife and related oversight or monitoring until June 1, 2005. Service (FWS) and National Oceanic reports be made available to the public The Legal Land Descriptions for the and Atmospheric Administration through a Federal Register notice of Closure are as Follows: The public lands Fisheries (NOAA Fisheries) (referred to availability. The ACA for the Bureau of

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Land Management is available on BLM’s planning process, but to be most SUPPLEMENTARY INFORMATION: Web site at: http://www.blm.gov/nhp/ beneficial comments on the preliminary Preliminary issues and management text/index.html. The Forest Service issues and suggestions for potential concerns have been identified by BLM ACA is available on the Forest Service’s planning criteria should be submitted in personnel in consultation with other Web site at http://www.fs.fed.us. writing to the address listed below and agencies, individuals and organizations, Dated: April 8, 2004. will be accepted for 30 days following and include: Management of special Jim Gladen, the publication of this notice in the areas, health and resilience of wetland, Federal Register. Public meetings will riparian and upland ecosystems, Director, Watershed, Fisheries and Wildlife Staff, USDA Forest Service. be held throughout the plan scoping and management and protection of sensitive, preparation period. In order to ensure rare, threatened or endangered species, Dated: April 21, 2004. local community participation and community protection, firefighter safety, Thomas H. Dyer, input, public meetings will be held in invasive plants, visual resources Deputy Assistant Director, Renewable locations most closely affiliated with the management, Native American Resources and Planning, Bureau of Land public lands in the planning area. traditions and practices, and protection Management. Probable locations include Bridgeport of cultural resource sites. [FR Doc. 04–11730 Filed 5–24–04; 8:45 am] and Bishop, California. These public Disciplines involved in the planning BILLING CODE 4310–84–P meetings are scheduled to be held the process include specialists with month of May 2004. Specific dates and expertise in wildlife and fisheries meeting locations will be announced by management, forestry, botany and DEPARTMENT OF THE INTERIOR BLM through news releases, direct vegetation community ecology, fire/ mailings or other applicable means of fuels management and ecology, Bureau of Land Management public notification within 15 days of the hydrology and watershed management, [CA–170] event. archeology, lands and realty, minerals and geology, grazing management and ADDRESSES: Notice of Intent To Prepare a Proposed Scoping comments should recreation management. be sent to Bill Dunkelberger, Field Resource Management Plan Authority: 43 CFR 1610.5–5. Amendment and Associated Office Manager, BLM—Bishop Field Environmental Assessment for the Office, 351 Pacu Lane, Suite 100, Dated: April 2, 2004. Bureau of Land Management (BLM), Bishop, California 93514. Comments Bill Dunkelberger, Bishop Field Office, Located in Eastern will also be received via Fax at (760) Field Office Manager, Bishop Field Office. California 872–5050 or e-mail at [FR Doc. 04–11731 Filed 5–24–04; 8:45 am] [email protected]. BILLING CODE 4310–40–P AGENCY: Bureau of Land Management, The BLM will maintain a record of Interior. public documents related to the ACTION: Notice of intent. development of the RMP amendment at DEPARTMENT OF THE INTERIOR the Bishop Field Office at the address SUMMARY: This document provides Bureau of Land Management notice that the BLM intends to prepare listed above. Comments, including a Proposed Resource Management Plan names and street addresses of [UT 040–1150–CB, 1430–ES, 1220–BA] respondents will be available for public (RMP) Amendment and associated AGENCY: Bureau of Land Management, review at the Bishop Field Office in Environmental Assessment for the Interior. Bishop, California during regular Bishop Field Office, located in eastern ACTION: business hours, 8 a.m. to 4 p.m., Notice of intent and notice of California. The Bishop Field Office realty action. manages approximately 750,000 acres of Monday through Friday, excluding public lands, with its headquarters Federal holidays, and may be published SUMMARY: This notice is to advise the located in Bishop, California. An as part of the EA. Individual public that the Bureau of Land amendment to the existing 1993 RMP is respondents may request Management (BLM) is proposing to needed to update Land Use Plan confidentiality. Individuals who wish to amend the Cedar/Beaver/Garfield/ decisions to comply with new national withhold their name or street address Antimony (CBGA) Resource direction for the National Fire Plan/ from public review or from disclosure Management Plan (RMP) affecting Comprehensive Strategy and BLM under the Freedom of Information Act public lands located in the Three Peaks directives. must state this prominently at the Area of Iron County, Utah, to create a The Proposed RMP Amendment and beginning of their written comment. Special Recreation Management Area EA would fulfill the needs and Such requests will be honored to the (SRMA) comprising 4,966 acres. The obligations set forth by the National extent allowed by law. BLM will not BLM also proposes to lease or convey Environmental Policy Act (NEPA), the consider anonymous comments. All under the provisions of the Recreation Federal Land Policy and Management submissions from organizations and & Public Purposes (R&PP) Act forty-five Act (FLPMA), and BLM management businesses, and from individuals (45) acres of public land described policies. The BLM will work identifying themselves as herein to Iron County, Utah, for collaboratively with interested parties to representatives or officials of recreational use purposes. identify management decisions that best organizations or businesses, will be DATES: The comment period for the address local, regional, and national available for public inspection in their proposed plan amendment and R&PP needs and concerns. The public scoping entirety. classification/application will process will identify wildland fire and FOR FURTHER INFORMATION CONTACT: Dale commence with publication of this hazardous fuels management planning Johnson, Fuels Specialist, BLM—Bishop notice. Comments must be submitted on issues and develop planning criteria. Field Office, 351 Pacu Lane, Suite 100, or before July 9, 2004. DATES: This notice initiates the public Bishop, California 93514, (760) 872– ADDRESSES: All comments addressing scoping process. Public comments will 5055 or via e-mail at the actions proposed in this notice be accepted throughout the entire [email protected]. should be sent to Todd S. Christensen,

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Field Office Manager, Cedar City Field GTPSRMA, delineating certain trails in will be effective, and the process to Office, 176 East DL Sargent Drive, Cedar the GTPSRMA for non-motorized use lease or convey the public lands may be City, Utah, 84720. only, limiting mechanized and completed. Iron County proposes to use FOR FURTHER INFORMATION CONTACT: equestrian use to designated roads and the land for the development of a Todd S. Christensen, Field Office trails, and prohibiting of the use of motocross track, an ATV trail head, Manager, Cedar City Field Office, 176 firearms within the GTPSRMA, except parking lots, and camping and East DL Sargent Drive, Cedar City, Utah, in a designated shooting range. The picnicking facilities. The patent, when 84720. Existing planning documents CBGA RMP would be amended to allow issued, would be subject to the and information are available at the for these changes. following terms, conditions, and above address or telephone (435) 586– The land being considered for reservations: (1) Provisions of the R&PP 2401. inclusion in the GTPSRMA includes Act and applicable regulations of the public, state, county and any acquired SUPPLEMENTARY INFORMATION: Interested Secretary of the Interior. (2) A right-of- private land within the established parties may submit comments way for ditches and canals constructed boundaries of the GTPSRMA. The concerning the following actions: by the authority of the United States. (3) public land being considered comprises proposed plan amendment to the Cedar/ All valid existing rights documented on 4,966 acres described as follows: Salt Beaver/Garfield/Antimony RMP; the official public land records at the Lake Meridian, Utah, Township 35 specific proposed use in the R&PP time of patent issuance. (4) All minerals South, Range 12 West, Section 1, All application and plans of development shall be reserved to the United States, except the SE1⁄4NE1⁄4; Section 2, Lot 3, and management, anticipated impacts of together with the right to prospect for, N1⁄2; Sections 3 and 10, All except the proposal, and the BLM’s mine, and remove the minerals. Upon patented mining claims; Sections 4 and administrative procedure used in publication of this Notice in the Federal 9, All except the Iron County Shooting reaching a decision on the lease or Register, the public lands described Range; Sections 11 and 12, All; Section above are segregated from all forms of conveyance of the public lands; and 1 1 1 1 1 1 14, NW ⁄4, N ⁄2SW ⁄4, N ⁄2S ⁄2SW ⁄4; appropriation under the public land suitability of the lands identified for 1 1 1 Section 15, All except the S ⁄2S ⁄2SE ⁄4 laws, including the mining laws, except R&PP lease or conveyance for the stated and patented mining claims; and recreational purposes. Comments on the for conveyance under the R&PP Act and Section 16, Lots 2, 3, and 8 except for leasing under the Mineral Leasing Act. classification of lands are restricted to patented mining claims. whether the lands are physically suited State and private lands located in the Gene R. Terland, for the use, whether the use will sections mentioned above would be Associate State Director. maximize the use or future uses, incorporated into the recreation area [FR Doc. 04–11719 Filed 5–24–04; 8:45 am] whether the use is consistent with local should they be acquired in the future by BILLING CODE 4310–DQ–P planning and zoning, or whether the use the BLM or Iron County, in accordance is consistent with State or Federal with the SRMA objectives. All existing programs. All comments submitted from federal land and any land acquired by DEPARTMENT OF THE INTERIOR organizations or businesses will be the federal government within the made available for public inspection in GTPSRMA would be retained in federal Bureau of Land Management their entirety. Individuals may request ownership, except for the R&PP lease confidentiality with respect to their [ES–960–1420–BJ–TRST; ES–052303, noted above and described below. These Group No. 16, Maine] name, address, and phone number. If lands would be managed in accordance you wish to have your name or street with the SRMA goals and objectives and Eastern States: Filing of Plat of Survey address withheld from public review, or the proposed management plan for the from disclosure under the Freedom of area. AGENCY: Bureau of Land Management, Information Act, the first line of the This action also constitutes a Notice Interior. comment should start with the words of Realty Action for the Classification ACTION: Notice of filing of plat of survey; ‘‘CONFIDENTIALITY REQUESTED’’ in and Lease or Conveyance (Patent) of Maine. uppercase letters in order for BLM to Public Lands for Recreation Purposes comply with your request. Such (EA# UT–040–04–24). BLM proposes to SUMMARY: The Bureau of Land requests will be honored to the extent lease or convey the following public Management (BLM) will file the plat of allowed by law. Comment contents will lands in Iron County under the survey of the lands described below in not be kept confidential. BLM will not provision of the R&PP Act, as amended, the BLM-Eastern States, Springfield, consider anonymous comments. (43 U.S.C. 869 et. seq.) to Iron County Virginia, 30 calender days from the date The proposed amendment to the for public recreational purposes (UTU– of publication in the Federal Register. CBGA RMP would designate land about 54574). The R&PP area would be used FOR FURTHER INFORMATION CONTACT: nine miles northwest of Cedar City, for a motocross track and supporting Bureau of Land Management, 7450 Utah as the Greater Three Peaks Special amenities and would support the Boston Boulevard, Springfield, Virginia Recreation Management Area recreation objectives of the area. The 22153. Attn: Cadastral Survey. (GTPSRMA). The current land use plan land to be leased and or conveyed is SUPPLEMENTARY INFORMATION: This designates these lands for unstructured described as follows: survey was requested by the Bureau of recreation, but increased use of the area Salt Lake Meridian, Utah, Township Indian Affairs. has resulted in user conflicts and public 35 South, Range 12 West, Section 11, The lands we surveyed are: safety concerns. The proposed S1⁄2 SE1⁄4 SW1⁄4 SW1⁄4; and Section 14, North of Bingham’s Kennebec Purchase, recreation area would be designated and NE1⁄4 NW1⁄4 NW1⁄4, S1⁄2 NW1⁄4 NW1⁄4, Somerset County, Maine an associated recreation management N1⁄2 N1⁄2 SW1⁄4 NW1⁄4, containing 45 plan implemented to mitigate these acres. Following completion of an T. 2, R. 3 (Soldiertown) and T. 2, R. 4 concerns and increase user satisfaction environmental assessment and upon (Pittston Academy Grant) in the area. Actions being proposed signature of a decision record, the The plat of survey represents the which are not in conformance with the classification of the public lands, if dependent resurvey and survey of lands CBGA RMP are: designating the found suitable for lease or conveyance, held in trust for the Passamaquoddy

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Tribe in Township 2, Range 3 available to the public as a matter of Further information concerning this (Soldiertown) and Township 2, Range 4 information. meeting may be obtained from the (Pittston Academy Grant), North of If BLM receives a protest against this Superintendent, Acadia National Park, Bingham’s Kennebec Purchase, survey, as shown on the plat, prior to P.O. Box 177, Bar Harbor, Maine 04609, Somerset County, in the state of Maine, the date of the official filing, we will tel: (207) 288–3338. and was accepted May 18, 2004. stay the filing pending our Dated: April 8, 2004. consideration of the protest. We will place a copy of the plat we Len Bobinchock, described in the open files. It will be We will not officially file the plat until the day after we have accepted or Acting Superintendent, Acadia National available to the public as a matter of Park. information. dismissed all protests and they have [FR Doc. 04–11716 Filed 5–24–04; 8:45 am] If BLM receives a protest against this become final, including decisions on survey, as shown on the plat, prior to appeals. BILLING CODE 4312–52–M the date of the official filing, we will Dated: May 18, 2004. stay the filing pending our Stephen D. Douglas, DEPARTMENT OF THE INTERIOR consideration of the protest. Chief Cadastral Surveyor. We will not officially file the plat [FR Doc. 04–11750 Filed 5–24–04; 8:45 am] National Park Service until the day after we have accepted or dismissed all protests and they have BILLING CODE 4310–GJ–P Cape Cod National Seashore, South become final, including decisions on Wellfleet, MA, Cape Cod National appeals. DEPARTMENT OF THE INTERIOR Seashore Advisory Commission Two Dated: May 18, 2004. Hundred Forty-eighth; Notice of Stephen D. Douglas, National Park Service Meeting Chief Cadastral Surveyor. Acadia National Park, Bar Harbor, ME, Notice is hereby given in accordance [FR Doc. 04–11749 Filed 5–24–04; 8:45 am] Acadia National Park Advisory with the Federal Advisory Committee BILLING CODE 4310–GJ–P Commission; Notice of Meeting Act (Pub. L. 92–463, 86 Stat. 770, 5 U.S.C. App 1, section 10), that a meeting Notice is hereby given in accordance of the Cape Cod National Seashore DEPARTMENT OF THE INTERIOR with the Federal Advisory Committee Advisory Commission will be held on Act (Pub. L. 92–463, 86 Stat. 770, 5 June 21, 2004. Bureau of Land Management U.S.C. App. 1, Sec. 10), that the Acadia The Commission was reestablished [ES–960–1420–BJ–TRST; ES–052302, National Park Advisory Commission pursuant to Public Law 87–126 as Group No. 15, Maine] will hold a meeting on Monday, June 7, amended by Public Law 105–280. The 2004. purpose of the Commission is to consult Eastern States: Filing of Plat of Survey The Commission was established with the Secretary of the Interior, or his pursuant to Public Law 99–420, Sec. designee, with respect to matters AGENCY: Bureau of Land Management, 103. The purpose of the commission is relating to the development of Cape Cod Interior. to consult with the Secretary of the National Seashore, and with respect to ACTION: Notice of filing of plat of survey; Interior, or his designee, on matters carrying out the provisions of sections 4 Maine. relating to the management and and 5 of the Act establishing the development of the park, including but Seashore. SUMMARY: The Bureau of Land not limited to the acquisition of lands The Commission members will meet Management (BLM) will file the plat of and interests in lands (including at 1 p.m. at Headquarters, Marconi survey of the lands described below in conservation easements on islands) and Station, Wellfleet, Massachusetts for the the BLM-Eastern States, Springfield, termination of rights of use and regular business meeting to discuss the Virginia, 30 calender days from the date occupancy. following: of publication in the Federal Register. The meeting will convene at Acadia 1. Adoption of Agenda FOR FURTHER INFORMATION CONTACT: National Park, Schoodic Education and 2. Approval of Minutes of Previous Bureau of Land Management, 7450 Research Center, Winter Harbor, Maine, Meeting (May 3, 2004) Boston Boulevard, Springfield, Virginia at 1 p.m. to consider the following 3. Reports of Officers 22153. Attn: Cadastral Survey. agenda: 4. Reports of Subcommittees SUPPLEMENTARY INFORMATION: This 1. Review and approval of minutes from 5. Superintendent’s Report survey was requested by the Bureau of the meeting held February 2, 2004 News from Washington Indian Affairs. 2. Committee reports: 6. Old Business The lands we surveyed are: —Lands Conservation 7. New Business Surf Side Colony, Commercial North of Bingham’s Kennebec Purchase, —Park Use Somerset County, Maine —Science Certificate of Suspension of 3. Old business Condemnation T. 3, R. 3 (Alder Brook) 4. Superintendent’s report 8. Date and agenda for next meeting The plat of survey represents the 5. Public comments 9. Public comment and dependent resurvey and survey of lands 6. Proposed agenda for next 10. Adjournment held in trust for the Passamaquoddy Commission meeting, September The meeting is open to the public. It Tribe in Township 3, Range 3 (Alder 13, 2004. is expected that 15 persons will be able Brook), North of Bingham’s Kennebec The meeting is open to the public. to attend the meeting in addition to Purchase, Somerset County, in the state Interested persons may make oral/ Commission members. of Maine, and was accepted May 18, written presentations to the Commission Interested persons may make oral/ 2004. or file written statements. Such requests written presentations to the Commission We will place a copy of the plat we should be made to the Superintendent during the business meeting or file described in the open files. It will be at least seven days prior to the meeting. written statements. Such requests

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should be made to the park concerning agenda items. The statement MICHIGAN superintendent at least seven days prior should be Addressed to the Gettysburg Kent County to the meeting. Further information National Military Park Advisory concerning the meeting may be obtained Commission, 97 Taneytown Road, Grand Rapids Cycle Company Factory, 514 Butterworth St. SW., Grand Rapids, from the Superintendent, Cape Cod Gettysburg, Pennsylvania 17325. 04000600 National Seashore, 99 Marconi Site Dated: April 26, 2004. Road, Wellfleet, MA 02667. Tuscola County John A. Latschar, Hart, Jr., Lovira and Esther Maria Parker, Dated: May 6, 2004. Superintendent, Gettysburg NMP/Eisenhower Farm, 9491 W. Frankenmuth Rd., Tuscola, Michael B. Murray, NHS. 04000599 Deputy Superintendent. [FR Doc. 04–11715 Filed 5–24–04; 8:45 am] [FR Doc. 04–11714 Filed 5–24–04; 8:45 am] BILLING CODE 4312–52–P Wayne County BILLING CODE 4312–52–P Jeffferson—Chalmers Historic Business District, E. Jefferson bet. Eastlawn and DEPARTMENT OF THE INTERIOR Alter, Detroit, 04000598 DEPARTMENT OF THE INTERIOR National Park Service Piquette Avenue Industrial Historic District, National Park Service Roughly bounded by Woodward, Harper, National Register of Historic Places; Hastings and the Grand Trunk Western Gettysburg National Military Park Notification of Pending Nominations Railroad Line, Detroit, 04000601 Advisory Commission MISSOURI Nominations for the following AGENCY: National Park Service, Interior. properties being considered for listing Montgomery County ACTION: Notice of two meetings to be in the National Register were received Farmers Mercantile Co. Building, 872 held on June 17, 2004 and October 21, by the National Park Service before May Boone’s Lick Rd., High Hill, 04000604 2004. 8, 2004. Reynolds County SUMMARY: This notices sets forth the Pursuant to § 60.13 of 36 CFR Part 60 Buford—Carty Farmstead, 0.75 mi. S of Hwy dates of June 17, 2004 and October 21, written comments concerning the J on Cty Rd. 814, Black, 04000603 2004 of the Gettysburg National Military significance of these properties under Park Advisory Commission. the National Register criteria for St. Louis Independent City DATES: The public meetings will be held evaluation may be forwarded by United Weisert, John, Tobacco Company, 1120 S. on June 17, 2004 and October 21, 2004 States Postal Service, to the National Sitxth St., St. Louis (Independent City), from 7 p.m. to 9 p.m. Register of Historic Places, National 04000602 LOCATION: The meeting will be held at Park Service, 1849 C St. NW., 2280, NORTH CAROLINA the Cyclorama Auditorium, 125 Washington, DC 20240; by all other Northampton County Taneytown Road, Gettysburg, carriers, National Register of Historic Pennsylvania 17325. Places, National Park Service, 1201 Eye Jackson Historic District, Roughly bounded by Atherton St., Picard St., Buxton St., and AGENDA: The June 19, 2004 and October St. NW., 8th floor, Washington, DC 20005; or by fax, 202–371–6447. Written northern town limit line, Jackson, 21, 2004 meetings will consist of The 04000606 Sub-Committee Reports from the or faxed comments should be submitted Historical, Executive, and Interpretive by June 9, 2004. Yancey County Committees; Federal Consistency Beth M. Boland, Chase—Coletta House, 108 Town Sq., Reports Within the Gettysburg Acting Keeper of the National Register of Burnsville, 04000605 Battlefield Historic District; Operational Historic Places. OHIO Updates on Park Activities, which consists of an update on the Gettysburg ALASKA Cuyahoga County National Battlefield Museum Van Rooy Coffee Company Building, 2900 Kodiak Island Borough-Census Area Foundation and National Park Service Detroit Ave., Cleveland, 04000608 SS ALEUTIAN (Shipwreck), Address activities related to the new Visitor Franklin County Center/Museum Complex, updates on Restricted, Larsen Bay, 04000593 Zion’s Evangelical Lutheran Church, 4501 the Wills House and the Train Station; CALIFORNIA Transportation which consists of the Groveport Rd., Obetz, 04000609 Alameda County National Park Service and the Greene County Green Shutter Hotel, 22650 Main St., Gettysburg Borough working on the Carnegie Library (Old Wilberforce University Hayward, 04000594 Shuttle System; Update on Land Campus), 1400 Brush Row Rd., Acquisition within the park boundary or Madera County Wilberforce, 04000610 in the historic District; and the Citizens Young’s Market Company Building, 1610 W. Lake County Open Forum where the public can make Seventh St., Los Angeles, 04000595 Comments and ask questions on any Foster, Claud, House, 30333 Lake Shore park activity. COLORADO Blvd., Willowick, 04000611 FOR FURTHER INFORMATION CONTACT: John Morgan County Warren County A. Latschar, Superintendent, Gettysburg Fort Morgan State Armory, 528 State St., Fort Hunt—Forman Farm, 2945 N OH 741, National Military Park, 97 Taneytown Morgan, 04000596 Franklin, 04000607 Road, Gettysburg, Pennsylvania 17325. IOWA OREGON SUPPLEMENTARY INFORMATION: The meeting will be open to the public. Any Bremer County Benton County member of the public may file with the Sumner High School, 300 West 4th, Sumner, Crystal Lake Cemetery, 1945 SE., Crystal Commission a written statement 04000597 Lake Dr., Corvallis, 04000613

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Deschutes County The Final EIS evaluates two the Federal Columbia River Power Nerdrum—Conrad House, 979 S. Fifth St., alternatives. The Action Alternative System. The BiOp’s Reasonable and Coos Bay, 04000616 describes the resource conditions that Prudent Alternative (RPA) included would occur with Banks Lake water Jackson County Action 31 that advised Reclamation to surface elevations between 1570 feet ‘‘assess the likely environmental effects Medford Plaza Apartments, 235 S. Oakdale and 1560 feet, while the No Action of operation of Banks Lake up to 10 feet Ave., Medford, 04000614 Alternative describes the conditions that down from full pool during August.’’ Multnomah County would occur without the action, with Reclamation has completed RPA Action Sweeney, Straub and Dimm Printing Plant, surface elevation between 1570 feet and 31 by preparing the Banks Lake 535 NW., 16th Ave., Portland, 04000615 1565 feet. Both the No Action and Drawdown Environmental Impact Action Alternatives include four PENNSYLVANIA Statement which describes and analyzes possible operational scenarios that the environmental effects of lowering Bradford County could occur within their respective the August surface elevation of Banks Athens Historic District, Roughly bounded by ranges, depending upon the hydrology Lake annually to elevation 1560 feet, Elm and Locust Sts., 772 S. Main St., and of each year. The Action Alternative which is 10 feet below full pool. the Chemung and Susquehanna River, refills the reservoir to elevation 1565 by Copies of the Final EIS are available Athens, 04000612 September 10 and to 1570 feet by for public review and inspection at the SOUTH CAROLINA September 22. The No Action following locations: Alternative also refills to 1570 feet • Bureau of Reclamation, U.S. Newberry County elevation by September 22. Department of the Interior, Room 7455, Newberry Historic District (Boundary The Final EIS includes the comment 18th and C Streets, NW., Washington, Increase), (Newberry MRA) Along sections letters received on the Draft EIS and DC 20240. of Main, Lindsay and Wilson Sts., Reclamation’s responses to those • Bureau of Reclamation, Denver Newberry, 04000617 comments, as well as a summary of Office Library, Denver Federal Center, Oconee County comments from the public hearings. Building 67, Room 167, Denver, Oconee State Park Historic District, (South Changes from the Draft EIS include Colorado 80225. Carolina State Parks MPS) 624 State Park minor revisions and additions to the • Bureau of Reclamation, Pacific Rd., Mountain Rest, 04000618 analysis as a result of review comments. Northwest Regional Office, 1150 North Sumter County The No Action Alternative is identified Curtis Road, Suite 100, Boise, Idaho as the preferred alternative in the Final 83706–1234. Sumter County Courthouse, (Courthouses in EIS. • Bureau of Reclamation, Upper South Carolina Designed by William A Record of Decision (ROD) Augustus Edwards TR) 141 N. Main St., Columbia Area Office, 1917 Marsh identifying the alternative chosen for Road, Yakima, Washington 98901. Sumter, 04000619 • A request for a Move has been made for the implementation, and discussing factors Bureau of Reclamation, Ephrata following resource: for its selection, is anticipated by June, Field Office, 32 C Street, Ephrata, 2004. Washington 98823. NORTH DAKOTA ADDRESSES: Copies of the Final EIS are Libraries Grand Forks County available for public review and • Campbell, Thomas D., House 2405 Belmont inspection at the locations listed in the Bridgeport Community Library, Rd. Grand Forks, 87002010 Supplementary Information Section. Douglas County, 1206 Columbia St., FOR FURTHER INFORMATION CONTACT: Mr. Bridgeport, WA (509) 686–7281. [FR Doc. 04–11717 Filed 5–24–04; 8:45 am] • Coulee City Community Library, BILLING CODE 4312–51–P Jim Blanchard, Special Projects Officer, at (509) 754–0226 (relay users may dial 405 W. Main St., Coulee City, WA (509) 711). Those wishing to obtain a copy of 674–2313. • Des Moines Library, 21620 11th DEPARTMENT OF THE INTERIOR the Final EIS in the form of a printed document or a compact disk (CD–ROM Ave. S, Des Moines, WA (206) 824– Bureau of Reclamation with reader included), or a summary of 6066. • East Wenatchee Community the Final EIS may contact Mr. Library, Douglas County, 271 9th St, [INT–FES–04–09] Blanchard. NE., East Wenatchee, WA (509) 886– Banks Lake Drawdown, Columbia SUPPLEMENTARY INFORMATION: Since its 7404. Basin Project, Washington creation in the early 1950s, Banks Lake • Ephrata Public Library, 45 Alder has been operated and maintained for NW., Ephrata, WA (509) 754–3971. AGENCY: Bureau of Reclamation, the storage and delivery of irrigation • Grand Coulee Community Library, Interior. water drawn from the Columbia River to 225 Federal, Grand Coulee, WA (509) ACTION: Notice of availability of the Columbia Basin Project (CBP) lands. 633–0972. Banks Lake Drawdown final Reclamation operates the reservoir • Moses Lake Public Library, 418 E. environmental impact statement. within established constraints on water 5th Ave., Moses Lake, WA (509) 765– surface elevation to meet contractual 3489. SUMMARY: Pursuant to section 102(2)(C) obligations, ensure public safety, and • Quincy Community Library, 108 B of the National Environmental Policy protect property. Reclamation considers St., SW., Quincy, WA (509) 787–2359. Act of 1969, as amended, the other resource needs as feasible within • Royal City Community Library, 356 Department of the Interior, Bureau of existing operational constraints. Camelia, Royal City, WA (509) 346– Reclamation (Reclamation), has In December of 2000, the National 9281. prepared a final environmental impact Marine Fisheries Service issued a • Seattle Public Library, 800 Pike St., statement (Final EIS) that examines the Biological Opinion (BiOp) to the Bureau Seattle, WA (206) 386–4636. impacts of annually lowering the water of Reclamation, Bonneville Power • Soap Lake Community Library, 32 surface elevation of Banks Lake in Administration and the U.S. Army E. Main, Soap Lake, WA (509) 246– August. Corps of Engineers for the operation of 1313.

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• Warden Community Library, 305 S. —Evaluate the accuracy of the agencies DEPARTMENT OF JUSTICE Main, Warden, WA (509) 349–2226. estimate of the burden of the • Wenatchee Public Library, Chelan proposed collection of information, Antitrust Division County, 310 Douglas St., Wenatchee, including the validity of the WA (509) 662–5021. methodology and assumptions used; Notice Pursuant to The National —Enhance the quality, utility, and Cooperative Research and Production Internet clarity of the information to be Act of 1993—National Electronics æ The DEIS is also available on the collected; and Manufacturing Initiative, Inc. (‘‘NEMI’’ Internet at www.usbr.gov/pn. —Minimize the burden of the collection Notice is hereby given that, on April Dated: March 11, 2004. of information on those who are to 23, 2004, pursuant to Section 6(a) of the J. William McDonald, respond, including through the use of National Cooperative Research and appropriate automated, electronic, Regional Director, Pacific Northwest Region. Production Act of 1993, 15 U.S.C. 4301 mechanical, or other technological et seq. (‘‘the Act’’), National Electronics [FR Doc. 04–11797 Filed 5–24–04; 8:45 am] collection techniques or other forms BILLING CODE 4310–MN–P Manufacturing Initiative, Inc. (‘‘NEMI’’) of information technology, e.g., has filed written notifications permitting electronic submission of simultaneously with the Attorney responses. General and the Federal Trade DEPARTMENT OF JUSTICE Overview of this information Commission disclosing changes in its collection: membership status. The notifications Bureau of Alcohol, Tobacco, Firearms (1) Type of Information Collection: and Explosives were filed for the purpose of extending Extension of a currently approved the Act’s provisions limiting the collection. Agency Information Collection recovery of antitrust plaintiffs to actual (2) Title of the Form/Collection: Activities: Proposed Collection; damages under specified circumstances. Application for Tax-Exempt Transfer of Comments Requested Specifically, Centor Software, Irvine, Firearm and Registration to Special CA; Cisco Systems Inc., San Jose, CA; ACTION: 60-day notice of information (Occupational) Taxpayer. Dell, Inc., Round Rock, TX; Endicott collection under review: Application for (3) Agency form number, if any, and Interconnect Technologies (E.I.T.), Tax-Exempt Transfer of Firearm and the applicable component of the Endicott, NY; Foxconn, Houston TX; Registration to Special (Occupational) Department of Justice sponsoring the Massachusetts Institute of Technology Taxpayer collection: Form Number: ATF F 3 (M.I.T.), Cambridge, MA; MatrixOne, (5320.3). Bureau of Alcohol, Tobacco, Inc., Westford, MA; Microsoft, The Department of Justice (DOJ), Firearms and Explosives. Redmond, WA; Senju Comtek (4) Affected public who will be asked Bureau of Alcohol, Tobacco, Firearms Corporation, San Jose, CA; Speedline or required to respond, as well as a brief and Explosives (ATF), has submitted the Technologies, Foxboro, MA; and Tyco abstract: Primary: Business or other for- following information collection request Corporation, Middletown, PA have been profit. Other: None. The form is to the Office of Management and Budget added as parties to this venture. submitted and approved by ATF prior to (OMB) for review and approval in Also, 3SAE Technologies, Inc., the transfer of a National Firearms Act accordance with the Paperwork Nashville, TN; Aerotech World Trade; weapon from one Special Occupational Reduction Act of 1995. The proposed Ltd., Westlake Village, CA; ChipPAC, Tax paying Federal firearms licensee to information collection is published to Fremont, CA; Cimetrix, Inc., Salt Lake another special taxpaying licensee. The obtain comments from the public and City, UT; CTS Corporation, Elkhart, IN; form is required whenever such a affected agencies. Comments are GSI Lumonics, Northville, MI; iManage, transfer is to be made. encouraged and will be accepted for Inc., San Mateo, CA; IONA (5) An estimate of the total number of ‘‘sixty days’’ until July 26, 2004. This Technologies, Santa Clara, CA; Kasaria respondents and the amount of time process is conducted in accordance with Corporation, Wilmington, MA; KIC estimated for an average respondent to 5 CFR 1320.10. Thermal Profiling, San Diego, CA; respond: It is estimated that 2,521 If you have comments especially on Henkel Loctite Corporation, Rocky Hill, respondents will complete a 30 minute the estimated public burden or CT; Peregrine Systems, Inc., Belmont, associated response time, suggestions, form. (6) An estimate of the total public CA; and Tecnomatrix Unicam, Inc., or need a copy of the proposed Portsmouth, NH have been dropped as information collection instrument with burden (in hours) associated with the collection: There are an estimated parties to this venture. The following instructions or additional information, members have changed their names: please contact Gary Schaible, National 11,144 annual total burden hours associated with this collection. Delphi Corporation to Delphi Firearms Act Branch, Room 5100, 650 Electronics & Safety, Kokomo, IN; and Massachusetts Avenue, NW., If additional information is required contact: Brenda E. Dyer, Deputy Shipley Company to Rohm and Haas Washington, DC 20226. Electronics Materials, Freeport, NY. Written comments and suggestions Department Clearance Officer, United States Department of Justice, Justice No other changes have been made in from the public and affected agencies either the membership or planned concerning the proposed collection of Management Division, Policy and Planning Staff, Patrick Henry Building, activity of the group research project. information are encouraged. Your Membership in this group research comments should address one or more Suite 1600, 601 D Street, NW., Washington, DC 20530. project remains open, and National of the following four points: Electronics Manufacturing Initiatives, —Evaluate whether the proposed Dated: May 19, 2004. Inc. (‘‘NEMI’’) intends to file additional collection of information is necessary Brenda E. Dyer, written notification disclosing all for the proper performance of the Department Deputy Clearance Officer, PRA, changes in membership. functions of the agency, including Department of Justice. On June 6, 1996, National Electronics whether the information will have [FR Doc. 04–11766 Filed 5–24–04; 8:45 am] Manufacturing Initiative, Inc. (‘‘MENI’’) practical utility; BILLING CODE 4410–FY–P filed its original notification pursuant to

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Section 6(a) of the Act. The Department Register pursuant to Section 6(b) of the a fiduciary with respect to a plan from of Justice published a notice in the Act on August 15, 2003 (68 FR 48942). causing the plan to engage in the direct Federal Register pursuant to Section or indirect lending of money or other Dorothy B. Fountain, 6(b) of the Act on June 28, 1996 (61 FR extension of credit between the plan 33774). Deputy Director of Operations Antitrust and a party in interest. ERISA section Division. The last notification was filed with 408(b)(1) exempts loans made by a plan the Department on December 30, 2002. [FR Doc. 04–11805 Filed 5–24–04; 8:45 am] to parties in interest who are A notice was published in the Federal BILLING CODE 4410–11–M participants and beneficiaries of the Register pursuant to Section 6(b) of the plan from this prohibition provided that Act on January 23, 2003 (68 FR 3273). certain requirements are satisfied. In DEPARTMENT OF LABOR Dorothy B. Fountain, final regulations published in the Federal Register on July 20, 1989 (54 FR Deputy Director of Operations Antitrust Employee Benefits and Security 30520), the Department of Labor Division. Administration provided additional guidance on section [FR Doc. 04–11804 Filed 5–24–04; 8:45 am] 408(b)(1)(C), which requires that loans BILLING CODE 4410–11–M Proposed Extension of Information Collection Request; Comment must be made in accordance with Request; 29 CFR 2550.408b–1 specific provisions set forth in the plan. DEPARTMENT OF JUSTICE This ICR relates to the specific AGENCY: Employee Benefits Security provisions that must be included in Antitrust Division Administration, Labor. plan documents for those plans that ACTION: Notice. permit loans to participants. Notice Pursuant to the National Cooperative Research and Production SUMMARY: The Department of Labor, as II. Review Focus Act of 1993—Petrotechnical Open part of its continuing effort to reduce The Department of Labor is Standards Consortium, Inc. (‘‘POSC’’) paperwork and respondent burden, particularly interested in comments provides the general public and Federal that: Notice is hereby given that, on April agencies with an opportunity to • Evaluate whether the proposed 13, 2004, pursuant to section 6(a) of the comment on proposed and/or collection of information is necessary National Cooperative Research and continuing collections of information in for the proper performance of the Production Act of 1993, 15 U.S.C. 4301 accordance with the Paperwork functions of the agency, including et seq. (‘‘the Act’’), Petrotechnical Open Reduction Act of 1995 (PRA 95) 44 whether the information will have Standards Consortium, Inc. (‘‘POSC’’) U.S.C. 3506(c)(2)(A). This program practical utility; has filed written notifications helps to ensure that requested data can • Evaluate the accuracy of the simultaneously with the Attorney be provided in the desired format, General and the Federal Trade agency’s estimate of the burden of the reporting burden (time and financial proposed collection of information, Commission disclosing changes in its resources) is minimized, collection membership status. The notifications including the validity of the instruments are clearly understood, and methodology and assumptions used; were filed for the purpose of extending the impact of collection requirements on • the Act’s provisions limiting the Enhance the quality, utility, and respondents can be properly assessed. clarify the information to be collected; recovery of antitrust plaintiffs to actual Currently, the Employee Benefits damages under specified circumstances. and Security Administration is soliciting • Minimize the burden of the Specifically, Anadarko Petroleum comments concerning the proposed Corporation, The Woodlands, TX; U.S. collection of information on those who extension of the information collection are to respond, including through the Department of the Interior, Washington, provisions of the regulation relating to DC; OpenSpirit Corporation, Sugar use of appropriate automated, loans to plan participants and electronic, mechanical, or other Land, TX; MetaCarta, Inc., Cambridge, beneficiaries that are parties in interest MA; and Fugro-Jason, Rotterdam, technological collection techniques or with respect to the plan (29 CFR other forms of information technology, Netherlands have been added as parties 2550.408b–1). to this venture. e.g., permitting electronic submissions A copy of the proposed information of responses. No other changes have been made in collection request (ICR) can be obtained either the membership or planned by contacting the individual listed in III. Current Actions activity of the group research project. the ADDRESSES section of this notice. Membership in this group research This notice requests comments on the DATES: Written comments must be project remains open, and extension of the ICR included in 29 CFR submitted to the office shown in the Petrotechnical Open Standards 2550.408b–1. The ICR ensures that ADDRESSES section on or before July 26, Consortium, Inc. (‘‘POSC’’) intends to participants and beneficiaries are 2004. file additional written notification provided with adequate information disclosing all changes in membership. ADDRESSES: Gerald B. Lindrew, with respect to matters affecting their On January 14, 1991, Petrotechnical Department of Labor, Employee Benefits benefits. The Department is not Open Standards Consortium, Inc. Security Administration, 200 proposing or implementing changes to (‘‘POSC’’) filed its original notification Constitution Avenue, NW., Washington, the existing ICR at this time. pursuant to Section 6(a) of the Act. The DC 20210, (202) 693–8410, FAX (202) Type of Review: Extension. Department of Justice published a notice 219–5333. (These are not toll-free Agency: Employee Benefits Security in the Federal Register pursuant to numbers.) Administration, Department of Labor. Section 6(b) of the Act on February 7, SUPPLEMENTARY INFORMATION: Title: Regulation Relating to Loans to 1991 (56 FR 5021). Plan Participants and Beneficiaries who The last notification was filed with I. Background are Parties in Interest with Respect to the Department on July 17, 2003. A The Employee Retirement Income the Plan. notice was published in the Federal Security Act of 1974 (ERISA) prohibits OMB Number: 1210–0076.

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Affected Public: Business or other for- on March 2, 2004 (69 FR 9854 and SUMMARY: The National Science profit, not-for-profit institutions, 9855). No comments were received. Foundation (NSF) has submitted the individuals. NARA has submitted the described following information collection Total Respondents: 1,400. information collection to OMB for requirement to OMB for review and Frequency: On occasion. approval. clearance under the Paperwork Total Responses: 1,400. In response to this notice, comments Reduction Act of 1995, Public Law 104– Average Time Per Response: 3 hours. and suggestions should address one or 13. This is the second notice for public Estimated Total Burden Hours: 0. more of the following points: (a) comment; the first was published in the Total Burden Cost (operating/ Whether the proposed information Federal Register at 69 FR 9386, and no maintenance): $348,600. collection is necessary for the proper comments were received. NSF is Comments submitted in response to performance of the functions of NARA; forwarding the proposed renewal this notice will be summarized and/or (b) the accuracy of NARA’s estimate of submission to the Office of Management included in the request for Office of the burden of the proposed information and Budget (OMB) for clearance Management and Budget approval of the collection; (c) ways to enhance the simultaneously with the publication of information collection request; they will quality, utility, and clarity of the this second notice. Comments regarding also become a matter of public record. information to be collected; and (d) (a) whether the collection of information Dated: May 19, 2004. ways to minimize the burden of the is necessary for the proper performance Gerald B. Lindrew, collection of information on of the functions of the agency, including Deputy Director, Office of Policy and respondents, including the use of whether the information will have Research, Employee Benefits Security information technology. In this notice, practical utility; (b) the accuracy of the Administration. NARA is soliciting comments agency’s estimate of burden including [FR Doc. 04–11795 Filed 5–24–04; 8:45 am] concerning the following information the validity of the methodology and BILLING CODE 4910–29–P collection: assumptions used; (c) ways to enhance Title: Microfilm Rental Order Form. the quality, utility and clarity of the OMB number: 3095–NEW. information to be collected; (d) ways to NATIONAL ARCHIVES AND RECORDS Agency form number: NA Form minimize the burden of the collection of ADMINISTRATION 14127. information on those who are to Type of review: Regular. respond, including through the use of Agency Information Collection Affected public: Individuals or appropriate automated, electronic, Activities: Submission for OMB households. mechanical, or other technological Review; Comment Request Estimated number of respondents: collection techniques or other forms of 5,200. information technology should be AGENCY: National Archives and Records Estimated time per response: 10 addressed to: Office of Information and Administration (NARA). minutes. Regulatory Affairs of OMB, Attention: ACTION: Notice. Frequency of response: On occasion. Desk Officer for National Science Estimated total annual burden hours: Foundation, 725—17th Street, NW., SUMMARY: NARA is giving public notice 867 hours. Room 10235, Washington, DC 20503, that the agency has submitted to OMB Abstract: The NARA microfilm and to Suzanne H. Plimpton, Reports for approval the information collection publications provides ready access to Clearance Officer, National Science described in this notice. The public is records for research in a variety of fields Foundation, 4201 Wilson Boulevard, invited to comment on the proposed including history, economics, political Suite 295, Arlington, Virginia 22230 or information collection pursuant to the science, law, and genealogy. NARA send e-mail to [email protected]. Paperwork Reduction Act of 1995. emphasizes microfilming groups of Comments regarding these information DATES: records relating to the same general Written comments must be collections are best assured of having subject or to a specific geographic area. submitted to OMB at the address below their full effect if received within 30 For example, the decennial population on or before June 24, 2004 to be assured days of this notification. Copies of the censuses from 1790 to 1930 and their of consideration. submission(s) may be obtained by related indexes are available on ADDRESSES: Comments should be calling 703–292–7556. microfilm. Census records constitute the electronically mailed to: NSF may not conduct or sponsor a _ _ vast majority of microfilmed records Jonathan P. [email protected]; or collection of information unless the available currently through the rental faxed to 202–395–5806, Attn: Mr. collection of information displays a program. Jonathan Womer, Desk Officer for currently valid OMB control number NARA. Dated: May 17, 2004. and the agency informs potential FOR FURTHER INFORMATION CONTACT: L. Reynolds Cahoon, persons who are to respond to the Requests for additional information or Assistant Archivist for Human Resources and collection of information that such copies of the proposed information Information Services. persons are not required to respond to collection and supporting statement [FR Doc. 04–11703 Filed 5–24–04; 8:45 am] the collection of information unless it should be directed to Tamee Fechhelm BILLING CODE 7515–01–P displays a currently valid OMB control at telephone number 301–837–1694 or number. Under OMB regulations, NSF fax number 301–837–3213. may continue to conduct or sponsor the SUPPLEMENTARY INFORMATION: Pursuant NATIONAL SCIENCE FOUNDATION collection of information while this to the Paperwork Reduction Act of 1995 submission is pending at OMB. (Pub. L. 104–13), NARA invites the Agency Information Collection SUPPLEMENTARY INFORMATION: Title: general public and other Federal Activities: Comment Request Antarctic Conservation Act Application agencies to comment on proposed AGENCY: National Science Foundation. and Permit Form. information collections. NARA OMB Control Number: 3145–0034. ACTION: Submission for OMB review; published a notice of proposed Proposed Project: The current comment request. collection for this information collection Antarctic Conservation Act Application

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Permit Form (NSF 1078) has been in use NATIONAL SCIENCE FOUNDATION species offers a unique opportunity to for several years. The form requests model the biochemistry and physiology general information, such as name, Notice of Permit Applications Received of nutrient utilization in a large affiliation, location, etc., and more Under the Antarctic Conservation Act carnivore that may not be possible in specific information as to the type of of 1978 (Pub. L. 95–541) any other system. The applicant plans to object to be taken (plant, native AGENCY: National Science Foundation. capture up to 8 adult female seals, attach diving recorders and blood mammal, or native bird). ACTION: Notice of Permit Applications sampling lines, then transport the seals Use of the Information: The purpose Received under the Antarctic to a diving hut where they will be of the regulations (45 CFR part 670) is Conservation Act of 1978, Public Law observed for several days and blood to conserve and protect the native 95–541. samples taken. Blood samples will also mammals, birds, plants, and SUMMARY: be taken from about 6 pups less than 5 invertebrates of Antarctica and the The National Science Foundation (NSF) is required to publish weeks old. All seals will be returned to ecosystem upon which they depend and notice of permit applications received to the tide crack areas. to implement the Antarctic conduct activities regulated under the Conservation Act of 1978, Public Law Location Antarctic Conservation Act of 1978. 95–541, as amended by the Antarctic NSF has published regulations under McMurdo Sound, Antarctica. Science, Tourism, and Conservation Act the Antarctic Conservation Act at Title of 1996, Public Law 104–227. 45 Part 670 of the Code of Federal Dates Burden on the Public: The Foundation Regulations. This is the required notice October 5, 2004 to December 31, 2004. estimates about 25 responses annually of permit applications received. at 1⁄2 hour per response; this computes DATES: Interested parties are invited to 2. Applicant to approximately 12.5 hours annually. submit written data, comments, or Arthur L. DeVries, Department of Dated: May 19, 2004. views with respect to this permit application by June 24,2004. This Animal Biology, 524 Burrill Hall, Suzanne H. Plimpton, application may be inspected by University of Illinois, Urbana, IL 61801. Reports Clearance Officer, National Science interested parties at the Permit Office, Permit Application No. 2005–003 Foundation. address below. [FR Doc. 04–11747 Filed 5–24–04; 8:45 am] ADDRESSES: Comments should be Activity for Which Permit Is Requested BILLING CODE 7555–01–M addressed to Permit Office, Room 755, Introduce non-indigenous species to Office of Polar Programs, National Antarctica. The applicant plans to Science Foundation, 4201 Wilson NATIONAL SCIENCE FOUNDATION import algal cells (Nanochloropsis) to be Boulevard, Arlington, Virginia 22230. fed to imported marine rotifers Notice of Permits Issued Under the FOR FURTHER INFORMATION CONTACT: (Brachionus calyciflorus) after they Antarctic Conservation Act of 1978 Nadene G. Kennedy at the above hatch. After 5 days the rotifers will be address or (703) 292–7405. harvested by filtering out the algae, and AGENCY: National Science Foundation. SUPPLEMENTARY INFORMATION: The concentrating the rotifers into a thick National Science Foundation, as slurry. The slurry will be flash-frozen ACTION: Notice of permits issued under directed by the Antarctic Conservation and aliquots of the thawed rotifers will the Antarctic Conservation of 1978, Act of 1978 (Pub. L. 95–541), as be fed daily to the larval stages of the Public Law 95–541. amended by the Antarctic Science, naked dragon fish, Gymnodraco Tourism and Conservation Act of 1996, acuticeps. The naked dragon fish SUMMARY: The National Science has developed regulations for the spawns in mid-October on rocks in the Foundation (NSF) is required to publish establishment of a permit system for shallow waters of McMurdo Sound. notice of permits issued under the various activities in Antarctica and Their eggs hatch some 10 months later, Antarctic Conservation Act of 1978. designation of certain animals and the full-terms eggs will be collected, the This is the required notice. certain geographic areas a requiring larva hatched in aquarium tanks, and special protection. The regulations FOR FURTHER INFORMATION CONTACT: reared in seawater tanks in the Crary establish such a permit system to Science and Engineering Center at Nadene G. Kennedy, Permit Office, designate Antarctic Specially Protected Office of Polar Programs, Rm. 755, McMurdo Station. The fish will be Areas. raised to juvenile stage to follow their National Science Foundation, 4201 The applications received are as Wilson Boulevard, Arlington, VA 22230. elaboration of blood antifreeze follows: glycoproteins. The rotifers and algae SUPPLEMENTARY INFORMATION: On March 1. Applicant will be autoclaved and disposed of as 26, 2004, the National Science dry biological waste. Michael Castellini, Director, Institute Foundation published a notice in the of Marine Science, University of Alaska, Location Federal Register of a permit application Fairbanks, Fairbanks, AK 99775. received. A permit was issued on may McMurdo Station, Ross Island 18, 2004 to: Stacy Kim Permit No. 2005– Permit Application No. 2005–002 Antarctica. 001. Activity for Which Permit Is Requested Dates Nadene G. Kennedy, Taking. The applicant proposes to Permit Officer. study Weddell seals to quantify the August 20, 2004 to February 15, 2005. [FR Doc. 04–11701 Filed 5–24–04; 8:45 am] dynamics of lipid uptake and utilization Applicant BILLING CODE 7555–01–M in a naturally foraging mammalian carnivore by examining freely diving Lawrence J. Conrad, 845 17th Street, Weddell seals in Antarctica. This Washougal, WA 98761.

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Permit Application No. 2005–004 DEPARTMENT OF NATIONAL Federal Register, pages 23823–23824, SCIENCE FOUNDATION April 30, 2004 Activity for Which Permit Is Requested Previously Announced Date and Time: Enter Antarctic Specially Protected Proposal Review; Notice of Meetings Monday, May 3, 2004. Areas. The applicant proposes take In accordance with the Federal Additional Concurrent Session photographs of named geographic Advisory Committee Act (Pub. L. 92– features throughout the McMurdo 463, as amended), the National Science Open Sound region. The photographs will Foundation (NSF) announces its intent National Science Board, ad hoc Task illustrate a geographically arranged to hold proposal review meetings Group on High Risk Research (11:00— gazetteer or ‘‘field guide’’ to the features. throughout the year. The purpose of 11:30 a.m.), Room 1295. The applicant proposes to enter the these meetings is to provide advice and Place: The National Science Barwick Valley, Victoria Land (ASPA recommendations concerning proposals Foundation, 4201 Wilson Boulevard, #123) to fully document the Barwick submitted to the NSF for financial Arlington, VA 22230, www.nsf.gov/ Valley features which will benefit the support. The agenda for each of these nsb. scientific community in current and meetings is to review and evaluate Contact for Information: National future work. Delineating data proposals as part of the selection Science Board Office (703) 202–7000 accompanying each photograph will process for awards. The review and Status: Open. include latitude, longitude, altitude, evaluation may also include assessment Changes in the Meeting: A half-hour date, time, elevation, look direction, of the progress of awarded proposals. open meeting was added to the agenda focal length and associated camera The majority of these meetings will take after the schedule was published in the settings. The photographs and place as NSF, 4201 Wilson, Blvd., Federal Register. Public announcement accompanying data will provide the Arlington, Virginia 22230. of this additional session was made on potential for contemporary and future These meetings will be closed to the the National Science Board Web site comparative studies of landscape public. The proposals being reviewed ahead of the meeting. The following include information of a proprietary or change, thereby reducing need for topic was discussed. confidential nature, including technical access to the ASPA. The applicant Discussion: Discussion of Workshop information; financial data, such as and White Paper. proposes approximately 5-days work in salaries; and personal information the Barwick Valley and will fully concerning individuals associated with Michael P. Crosby, comply with the designated the proposals. These matters are exempt Executive Officer, NSB. management plan for the site. under 5 U.S.C. 552b(c), (4) and (6) of the [FR Doc. 04–11939 Filed 5–21–04; 2:58 pm] Furthermore, the applicant will visit Government in the Sunshine Act. NSF BILLING CODE 7555–01–M Cape Crozier (ASPA #124) to film will continue to review the agenda and Wilson’s Stone Igloo and The Knoll, merits of each meeting for overall avoiding the penguin and skua compliance of the Federal Advisory NUCLEAR REGULATORY rookeries. Committee Act. COMMISSION In addition, the applicant proposes to These closed proposal review [Docket No. 50–336 and 50–423 ASLBP No. enter Discovery Hut (ASPA #157), Cape meetings will not be announced on an 04–824–01–LR] Evans Historic Site (ASPA #154), and individual basis in the Federal Register. Hut and Associated Artifacts, Backdoor NSF intends to publish a notice similar Dominion Nuclear Connecticut; Bay, Cape Royds (ASPA #156) for the to this on a quarterly basis. For an Establishment of Atomic Safety and purpose of reproducing historic photos advance listing of the closed proposed Licensing Board review meetings that include the names of the area for use in the described Pursuant to delegation by the gazetteer. of the proposal review panel and the time, date, place, and any information Commission dated December 29, 1972, Location on changes, corrections, or published in the Federal Register, 37 FR cancellations, please visit the NSF Web- 28,710 (1972), and the Commission’s ASPA #123—Barwick Valley, Victoria site: http://www.nsf.gov/home/pubinfo/ regulations, see 10 CFR 2.104, 2.300, Land advisory.htm. This information may also 2.303, 2.309, 2.311, 2.318, and 2.321, notice is hereby given that an Atomic ASPA #124—Cape Crozier, Ross Island be requested by telephone (703) 292– 8182. Safety and Licensing Board is being ASPA #154—Cape Evans Historic Site established to preside over the following ASPA #156—Hut and associated Dated: May 19, 2004. proceeding: artifacts, Backdoor Bay, Cape Susanne Bolton, Committee Management Officer. Dominion Nuclear Connecticut Royds, Ross Island (Millstone Nuclear Power Station, Units [FR Doc. 04–11700 Filed 5–24–04; 8:45 am] ASPA #157—Discovery Hut, Hut Point, 2 and 3) BILLING CODE 7555–01–M Ross Island Pursuant to a March 8, 2004 notice of Dates opportunity for hearing published in the NATIONAL SCIENCE FOUNDATION Federal Register (69 FR 11,897 (Mar. 12, August 22, 2004 to February 15, 2006. 2004)), and a May 4, 2004 Commission Sunshine Act Meeting memorandum and order, CLI–04–12, 59 Nadene G. Kennedy, NRCl(May 4, 2004), a Licensing Board Permit Officer, Office of Polar Programs. Agency Holding Meeting: National is being established to conduct a [FR Doc. 04–11702 Filed 5–24–04; 8:45 am] Science Foundation, National Science proceeding on the March 22, 2004 BILLING CODE 7555–01–M Board and its Subdivisions. hearing petition of Connecticut Federal Register Citation of Previous Coalition Against Millstone (CCAM) Announcement: Volume 69, Number 84, regarding the January 22, 2004

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Dominion Nuclear Connecticut requirements of 10 CFR part 51. Based contact the NRC PDR Reference staff by applications for renewal of the on the EA, the NRC has concluded that telephone at 1–800–397–4209 or (301) Millstone Units 2 and 3 operating a Finding of No Significant Impact 415–4737, of by e-mail to [email protected]. licenses. (FONSI) is appropriate. The amendment For the Nuclear Regulatory Commission. will be issued following the publication The Board is comprised of the Dated at King of Prussia, Pennsylvania this following administrative judges: of this Notice. 18th day of May, 2004. Dr. Paul B. Abramson, Chair, Atomic II. EA Summary Safety and Licensing Board Panel, John D. Kinneman, U.S. Nuclear Regulatory Commission, The purpose of the proposed action is Chief, Nuclear Materials Safety Branch 2, Washington, DC 20555–0001. to authorize the release of the licensee’s Division of Nuclear Materials Safety Region Ann Marshall Young, Atomic Safety and Malvern, Pennsylvania facility for I Licensing Board Panel, U.S. Nuclear unrestricted use. Message [FR Doc. 04–11758 Filed 5–24–04; 8:45 am] Regulatory Commission, Washington, Pharmaceuticals, Inc., was authorized BILLING CODE 7590–01–P DC 20555–0001. by NRC from July 29, 1998, to use Dr. Richard F. Cole, Atomic Safety and radioactive materials for research and Licensing Board Panel, U.S. Nuclear development purposes at the site. On NUCLEAR REGULATORY Regulatory Commission, Washington, January 5, 2004, Message COMMISSION DC 20555–0001. Pharmaceuticals, Inc., requested that [Docket Nos. 050–00135 (Retired) and 030– All correspondence, documents, and NRC release the facility for unrestricted 01317] other materials shall be filed with the use. Message Pharmaceuticals, Inc., has administrative judges in accordance conducted surveys of the facility and Notice of Availability of Environmental with 10 CFR 2.302. determined that the facility meets the Assessment and Finding of No license termination criteria in Subpart E Significant Impact for License Issued at Rockville, Maryland, this 19th of 10 CFR part 20. The NRC staff has Amendement for Department of the day of May 2004. prepared an EA in support of the Army, Walter Reed Army Medical G. Paul Bollwerk, III, proposed license amendment. Center Washington, DC Chief Administrative Judge, Atomic Safety and Licensing Board Panel. III. Finding of No Significant Impact AGENCY: Nuclear Regulatory [FR Doc. 04–11755 Filed 5–24–04; 8:45 am] The staff has prepared the EA Commission. BILLING CODE 7590–01–P (summarized above) in support of the ACTION: Notice of Availability of proposed license amendment to Environmental Assessment and Finding terminate the license and release the of No Significant Impact. NUCLEAR REGULATORY facility for unrestricted use. The NRC COMMISSION staff has evaluated Message FOR FURTHER INFORMATION CONTACT: [Docket No. 030–34781] Pharmaceuticals, Inc.’s request and the Laurie Peluso, Decommissioning results of the surveys and has concluded Branch, Division of Nuclear Materials Notice of Availability of Environmental that the completed action complies with Safety, Region I, 475 Allendale Road, Assessment and Finding of No the criteria in Subpart E of 10 CFR part King of Prussia, Pennsylvania, 19406, Significant Impact for License 20. The staff has found that the telephone (610) 337–5323, fax (610) Amendment for Message environmental impacts from the 337–5269; or by email: [email protected]. Pharmaceuticals, Inc.’s Facility in proposed action are bounded by the SUPPLEMENTARY INFORMATION: Malvern, PA impacts evaluated by the ‘‘Generic Environmental Impact Statement in I. Introduction AGENCY: Nuclear Regulatory Support of Rulemaking on Radiological The Nuclear Regulatory Commission Commission. Criteria for License Termination of NRC- (NRC) is considering the issuance of a ACTION: Notice of Availability of Licensed Facilities’’ (NUREG–1496). On license amendment to Department of Environmental Assessment and Finding the basis of the EA, the NRC has Army, Walter Reed Medical Center for of No Significant Impact. concluded that the environmental Materials License No. 08–01738–02, to impacts from the proposed action are authorize release of Building 40 of the FOR FURTHER INFORMATION CONTACT: expected to be insignificant and has Washington, DC site for unrestricted Sattar Lodhi, Nuclear Materials Safety determined not to prepare an use. NRC has prepared an Branch 2, Division of Nuclear Materials environmental impact statement for the Environmental Assessment (EA) in Safety, Region I, 475 Allendale Road, proposed action. support of this action in accordance King of Prussia, Pennsylvania, 19406, with the requirements of 10 CFR part IV. Further Information telephone (610) 337–5364 fax (610) 337– 51. Based on the EA, the NRC has 5269; or by e-mail: [email protected]. The EA and the documents related to concluded that a Finding of No SUPPLEMENTARY INFORMATION: this proposed action, including the Significant Impact (FONSI) is application for the license amendment appropriate. The amendment will be I. Introduction and supporting documentation, are issued following the publication of this The Nuclear Regulatory Commission available for inspection at NRC’s Public Notice. (NRC) is considering the issuance of a Electronic Reading Room at http:// license amendment to Message www.nrc.gov/reading-rm/adams.html II. EA Summary Pharmaceuticals, Inc.’s Materials (ADAMS Accession Nos. ML040250011 The purpose of the proposed action is License No. 37–30462–01, to authorize and ML041040862). These documents to authorize the release of the licensee’s release of its facility in Malvern, are also available for inspection and Building 40 of the Washington, DC Pennsylvania for unrestricted use. NRC copying for a fee at the Region I Office, facility for unrestricted use. WRAMC has prepared an Environmental 475 Allendale Road, King of Prussia, was authorized by the U.S. Atomic Assessment (EA) in support of this Pennsylvania, 19406. Persons who do Energy Commission (AEC) from action in accordance with the not have access to ADAMS, should February 18, 1959 to use radioactive

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materials for medical research, For the Nuclear Regulatory Commission. Contact person for more information: diagnosis, and therapy purposes and on Ronald R. Bellamy, Dave Gamberoni, (301) 415–1651. August 17, 1962 to operate a research Chief, Decommissioning Branch, Division of * * * * * reactor in Building 40 at the site. On Nuclear Materials Safety, Region I. Additional Information March 9, 2004, WRAMC requested that [FR Doc. 04–11756 Filed 5–24–04; 8:45 am] NRC release the facility for unrestricted BILLING CODE 7590–01–P By a vote of 3–0 on May 14 and 18, use. WRAMC has conducted surveys of the Commission determined pursuant to the facility and determined that the U.S.C. 552b(e) and § 9.107(a) of the facility meets the license termination NUCLEAR REGULATORY Commission’s rules that ‘‘Discussion of criteria in Subpart E of 10 CFR part 20. COMMISSION Security Issues (Closed—Ex. 1)’’ be held The NRC staff has prepared an EA in May 20, and on less than one week’s Sunshine Act Meeting notice to the public. support of the proposed license By a vote of 3–0 on May 19 and 20, amendment. AGENCY HOLDING THE MEETING: Nuclear the Commission determined pursuant to III. Finding of No Significant Impact Regulatory Commission. U.S.C 552b(e) and § 9.107(a) of the DATE: Weeks of May 24, 31, June 7, 14, Commission’s rules that ‘‘Affirmation of The staff has prepared the EA 21, 28, 2004. (1) Nuclear Fuel Services, Inc. (Erwin, (summarized above) in support of the PLACE: Commissioners’ Conference Tennessee); Appeal of LBP–04–05, the proposed license amendment to release Room, 11555 Rockville Pike, Rockville, Presiding Officer’s Ruling on Hearing Building 40 in its entirety of the Maryland. Requests; (2) Hydro Resources, Inc. (Rio Rancho, New Mexico) Petitions for WRAMC facility at 6900 Georgia STATUS: Public and closed. Avenue, NW., Washington, DC for Review of LBP–04–03 (Financial MATTERS TO BE CONSIDERED: unrestricted use. The NRC staff has Assurance); (3) Louisiana Energy evaluated WRAMC’s request and the Week of May 24, 2004 Services, L.P. (National Enrichment Center); and (4) Final Rule to amend 10 results of the surveys, performed Tuesday, May 25, 2004 independent measurements to confirm CFR Part 2, Subpart J, in Regard to the 2 p.m. Discussion of Management Licensing Support Network’’ be held on the results, and has concluded that the Issues (Closed—Ex. 2) completed action complies with the May 20, and on less than one week’s Wednesday, May 26, 2004 notice to the public. criteria in Subpart E of 10 CFR part 20. 10:30 a.m. All Employees Meeting The staff has found that the (Public Meeting) * * * * * The NRC Commission Meeting environmental impacts from the All Employees Meeting (Public Schedule can be found on the Internet proposed action are bounded by the Meeting) impacts evaluated by the ‘‘Generic at: www.nrc.gov/what-we-do/policy- making/schedule.html. Environmental Impact Statement in Week of May 31, 2004—Tentative Support of Rulemaking on Radiological Wednesday, June 2, 2004 * * * * * This notice is distributed by mail to Criteria for License Termination of NRC- 9:30 a.m. Briefing on Equal several hundred subscribers; if you no Licensed Facilities’’ (NUREG–1496). On Employment Opportunity Program longer wish to receive it, or would like the basis of the EA, the NRC has (Public Meeting) (Contact: Corenthis Kelley, 301–415–7380) to be added to the distribution, please concluded that the environmental contact the Office of the Secretary, impacts from the proposed action are This meeting will be webcast live at the Web address—www.nrc.gov Washington, DC 20555 (301–415–1969). expected to be insignificant and has In addition, distribution of this meeting determined not to prepare an 1:30 p.m. Meeting with Advisory Committee on Reactor Safeguards notice over the Internet system is environmental impact statement for the available. If you are interested in proposed action. (ACRS) (Public Meeting) (Contact: John Larkins, 301–415–7360) receiving this Commission meeting IV. Further Information This meting will be webcast live at schedule electronically, please send an the Web address—www.nrc.gov electronic message to [email protected]. The EA and the documents related to Dated: May 20, 2004. this proposed action, including the Week of June 7, 2004—Tentative Dave Gamberoni, application for the license amendment Thursday, June 10, 2004 Office of the Secretary. and supporting documentation, are 1:30 p.m. Discussion of Security [FR Doc. 04–11852 Filed 5–21–04; 9:35 am] available for inspection at NRC’s Public Issues (Closed—Ex. 1) BILLING CODE 7590–01–M Electronic Reading Room at http:// www.nrc.gov/reading-rm/adams.html Week of June 14, 2004—Tentative (ADAMS Accession No. ML041380084). There are no meetings scheduled for NUCLEAR REGULATORY These documents are also available for the Week of June 14, 2004. COMMISSION inspection and copying for a fee at the Week of June 21, 2004—Tentative Region I Office, 475 Allendale Road, Biweekly Notice; Applications and King of Prussia, Pennsylvania, 19406. There are no meetings scheduled for Amendments To Facility Operating Persons who do not have access to the Week of June 21, 2004. Licenses Involving No Significant Hazards Considerations ADAMS, should contact the NRC PDR Week of June 28, 2004—Tentative Reference staff by telephone at 1–800– There are no meetings scheduled for I. Background 397–4209 or (301) 415–4737, or by e- the Week of June 28, 2004. Pursuant to section 189a. (2) of the mail to [email protected]. *The schedule for Commission Atomic Energy Act of 1954, as amended Dated at King of Prussia, Pennsylvania this meetings is subject to change on short (the Act), the U.S. Nuclear Regulatory 18th day of May, 2004. notice. To verify the status of meetings Commission (the Commission or NRC call (recording)—(301) 215–1292. staff) is publishing this regular biweekly

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notice. The Act requires the Commission may issue the amendment days, the Commission or a presiding Commission publish notice of any prior to the expiration of the 30-day officer designated by the Commission or amendments issued, or proposed to be comment period should circumstances by the Chief Administrative Judge of the issued and grants the Commission the change during the 30-day comment Atomic Safety and Licensing Board authority to issue and make period such that failure to act in a Panel, will rule on the request and/or immediately effective any amendment timely way would result, for example in petition; and the Secretary or the Chief to an operating license upon a derating or shutdown of the facility. Administrative Judge of the Atomic determination by the Commission that Should the Commission take action Safety and Licensing Board will issue a such amendment involves no significant prior to the expiration of either the notice of a hearing or an appropriate hazards consideration, notwithstanding comment period or the notice period, it order. the pendency before the Commission of will publish in the Federal Register a As required by 10 CFR 2.309, a a request for a hearing from any person. notice of issuance. Should the petition for leave to intervene shall set This biweekly notice includes all Commission make a final No Significant forth with particularity the interest of notices of amendments issued, or Hazards Consideration Determination, the petitioner in the proceeding, and proposed to be issued from, April 30, any hearing will take place after how that interest may be affected by the through May 13, 2004. The last issuance. The Commission expects that results of the proceeding. The petition biweekly notice was published on May the need to take this action will occur should specifically explain the reasons 11, 2004 (69 FR 26184). very infrequently. why intervention should be permitted Written comments may be submitted with particular reference to the Notice of Consideration of Issuance of by mail to the Chief, Rules and following general requirements: (1) The Amendments To Facility Operating Directives Branch, Division of name, address and telephone number of Licenses, Proposed No Significant Administrative Services, Office of the requestor or petitioner; (2) the Hazards Consideration Determination, Administration, U.S. Nuclear Regulatory nature of the requestor’s/petitioner’s and Opportunity for a Hearing Commission, Washington, DC 20555– right under the Act to be made a party The Commission has made a 0001, and should cite the publication to the proceeding; (3) the nature and proposed determination that the date and page number of this Federal extent of the requestor’s/petitioner’s following amendment requests involve Register notice. Written comments may property, financial, or other interest in 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

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participate fully in the conduct of the For further details with respect to this significant increase in the risk of plant hearing. action, see the application for operation. Given the extremely low failure If a hearing is requested, and the amendment which is available for probabilities for the RCP motor flywheel public inspection at the Commission’s during normal and accident conditions, the Commission has not made a final extremely low probability of a loss-of-coolant determination on the issue of no PDR, located at One White Flint North, accident (LOCA) with loss of offsite power significant hazards consideration, the Public File Area 01F21, 11555 Rockville (LOOP), and assuming a conditional core Commission will make a final Pike (first floor), Rockville, Maryland. damage probability (CCDP) of 1.0 (complete determination on the issue of no Publicly available records will be failure of safety systems), the core damage significant hazards consideration. The accessible from the Agencywide frequency (CDF) and change in risk would final determination will serve to decide Documents Access and Management still not exceed the NRC’s acceptance when the hearing is held. If the final System’s (ADAMS) Public Electronic guidelines [contained] in Regulatory Guide Reading Room on the Internet at the (RG) 1.174 (<1.0E–6 per year). Moreover, determination is that the amendment considering the uncertainties involved in this request involves no significant hazards NRC Web site, http://www.nrc.gov/ evaluation, the risk associated with the consideration, the Commission may reading-rm/adams.html. If you do not postulated failure of an RCP motor flywheel issue the amendment and make it have access to ADAMS or if there are is significantly low. Even if all four RCP immediately effective, notwithstanding problems in accessing the documents motor flywheels are considered in the the request for a hearing. Any hearing located in ADAMS, contact the NRC bounding plant configuration case, the risk is held would take place after issuance of PDR Reference staff at 1–800–397–4209, still acceptably low. the amendment. If the final 301–415–4737 or by e-mail to The proposed change does not adversely determination is that the amendment [email protected]. affect accident initiators or precursors, nor alter the design assumptions, conditions, or request involves a significant hazards Duke Energy Corporation, et al., Docket configuration of the facility, or the manner in consideration, any hearing held would Nos. 50–369 and 50–370, McGuire which the plant is operated and maintained; take place before the issuance of any Nuclear Station, Units 1 and 2, alter or prevent the ability of structures, amendment. Mecklenburg County, North Carolina systems, components (SSCs) from performing their intended function to mitigate the A request for a hearing or a petition Docket Nos. 50–413 and 50–414, for leave to intervene must be filed by: consequences of an initiating event within Catawba Nuclear Station, Units 1 and 2, the assumed acceptance limits; or affect the (1) First class mail addressed to the York County, South Carolina Office of the Secretary of the source term, containment isolation, or Date of amendment request: March radiological release assumptions used in Commission, U.S. Nuclear Regulatory evaluating the radiological consequences of Commission, Washington, DC 20555– 23, 2004. Description of amendment request: an accident previously evaluated. Further, 0001, Attention: Rulemaking and the proposed change does not increase the Adjudications Staff; (2) courier, express The amendments would revise type or amount of radioactive effluent that mail, and expedited delivery services: Technical Specification 5.5.7, ‘‘Reactor may be released offsite, nor significantly Office of the Secretary, Sixteenth Floor, Coolant Pump Flywheel Inspection increase individual or cumulative One White Flint North, 11555 Rockville Program,’’ to extend the allowable occupational/public radiation exposure. The Pike, Rockville, Maryland, 20852, inspection interval to 20 years. proposed change is consistent with the safety Attention: Rulemaking and The NRC staff issued a notice of analysis assumptions and resultant consequences. Therefore, the proposed Adjudications Staff; (3) E-mail opportunity for comment in the Federal Register on June 24, 2003 (68 FR 37590), change does not involve a significant addressed to the Office of the Secretary, increase in the probability or consequences U.S. Nuclear Regulatory Commission, on possible amendments to extend the inspection interval for reactor coolant of an accident previously evaluated. [email protected]; or (4) facsimile Criterion 2—The proposed change does not transmission addressed to the Office of pump (RCP) flywheels, including a create the possibility of a new or different the Secretary, U.S. Nuclear Regulatory model safety evaluation and model no kind of accident from any accident Commission, Washington, DC, significant hazards consideration previously evaluated. Attention: Rulemakings and (NSHC) determination, using the The proposed change in flywheel Adjudications Staff at (301) 415–1101, consolidated line-item improvement inspection frequency does not involve any change in the design or operation of the RCP. verification number is (301) 415–1966. process. The NRC staff subsequently issued a notice of availability of the Nor does the change to examination A copy of the request for hearing and frequency affect any existing accident petition for leave to intervene should models for referencing in license amendment applications in the Federal scenarios, or create any new or different also be sent to the Office of the General accident scenarios. Further, the change does Counsel, U.S. Nuclear Regulatory Register on October 22, 2003 (68 FR not involve a physical alteration of the plant Commission, Washington, DC 20555– 60422). The licensee affirmed the (i.e., no new or different type of equipment 0001, and it is requested that copies be applicability of the model NSHC will be installed) or alter the methods transmitted either by means of facsimile determination in its application dated governing normal plant operation. In transmission to 301–415–3725 or by e- March 23, 2004. addition, the change does not impose any new or different requirements or eliminate mail to [email protected]. A copy Basis for proposed no significant hazards consideration determination: any existing requirements, and does not alter of the request for hearing and petition any assumptions made in the safety analysis. for leave to intervene should also be As required by 10 CFR 50.91(a), an analysis of the issue of NSHC is The proposed change is consistent with the sent to the attorney for the licensee. safety analysis assumptions and current plant presented below: Nontimely requests and/or petitions operating practice. Therefore, the proposed and contentions will not be entertained Criterion 1—The proposed change does not change does not create the possibility of a absent a determination by the involve a significant increase in the new or different kind of accident from any Commission or the presiding officer of probability or consequences of an accident accident previously evaluated. previously evaluated. Criterion 3—The proposed change does not the Atomic Safety and Licensing Board The proposed change to the RCP flywheel involve a significant reduction in a margin of that the petition, request and/or the examination frequency does not change the safety. contentions should be granted based on response of the plant to any accidents. The The proposed change does not alter the a balancing of the factors specified in 10 RCP will remain highly reliable and the manner in which safety limits, limiting safety CFR 2.309(a)(1)(i)–(viii). proposed change will not result in a system settings, or limiting conditions for

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operation are determined. The safety analysis 19. These compensatory measures will serve Entergy Gulf States, Inc., and Entergy acceptance criteria are not impacted by this to minimize the consequences of an open Operations, Inc., Docket No. 50–458, change. The proposed change will not result control room boundary and ensure the CREF River Bend Station (RBS), Unit 1, West in plant operation in a configuration outside system can continue to perform its function. Feliciana Parish, Louisiana of the design basis. The calculated impact on As such, these changes will not affect the risk is insignificant and meets the acceptance function or operation of any other systems, Date of amendment request: October criteria contained in RG 1.174. There are no structures or components. Therefore, the 21, 2003, as supplemented February 10, significant mechanisms for inservice proposed TS change does not involve a 2004. degradation of the RCP flywheel. Therefore, significant increase in the probability or Description of amendment request: the proposed change does not involve a consequences of an accident previously The amendment would modify the significant reduction in a margin of safety. evaluated. Technical Specifications (TSs) to delete The NRC staff proposes to determine 2. The proposed change does not create the TS 3.6.4.4, ‘‘Shield Building Annulus possibility of a new or different kind of that the amendment request involves accident from any accident previously Mixing System,’’ in its entirety, revise NSHC. evaluated. the Main Steam Isolation Valve (MSIV) Attorney for licensee: Ms. Lisa F. The proposed change adds a Note to LCO leakage limits contained within TS Vaughn, Legal Department (PB05E), 3.7.3 that allows the control room boundary Surveillance Requirement 3.6.1.3.10, Duke Energy Corporation, 422 South to be opened intermittently under and delete reference to TS 3.6.4.4 within Church Street, Charlotte, North Carolina administrative controls. A new Condition B TS 3.10.1, ‘‘Inservice Leak and 28201–1006. is also added to LCO 3.7.3 to specify a Hydrostatic Testing Operation.’’ NRC Section Chief: Stephanie M. Completion Time of 24 hours to restore an Basis for proposed no significant Coffin, Acting. inoperable control room boundary to hazards consideration determination: OPERABLE status before requiring the plant As required by 10 CFR 50.91(a), the Energy Northwest, Docket No. 50–397, to perform an orderly shutdown. The CREF licensee has provided its analysis of the Columbia Generating Station, Benton system and the control room boundary are issue of no significant hazards County, Washington designed to protect the habitability of the control room. The CREF system and the consideration, which is presented Date of amendment request: April 19, control room boundary are not accident below: 2004. initiators and do not affect the probability of 1. Does the proposed change involve a Description of amendment request: accidents. This change is administrative in significant increase in the probability or The proposed change revises Limiting nature and does not involve any physical consequences of an accident previously Condition for Operation (LCO) 3.7.3, changes to the plant. Therefore, the proposed evaluated? ‘‘Control Room Emergency Filtration TS change does not create the possibility of Response: No. System,’’ to provide specific conditions a new or different kind of accident from any As discussed above, the proposed changes and required actions that address previously evaluated. are to delete the annulus mixing function and 3. The proposed change does not involve deletion of the single MSIV leakage rate limit. degraded control room boundary. a significant reduction in a margin of safety. Basis for proposed no significant A review of the safety analysis report The proposed change adds a Note to LCO indicates that operation (or mis-operation) of hazards consideration determination: 3.7.3 that allows the control room boundary the annulus mixing system, or any As required by 10 CFR 50.91(a), the to be opened intermittently under component of the annulus mixing system is licensee has provided its analysis of the administrative controls. A new Condition B not considered an initiator of any accident issue of no significant hazards is also added to LCO 3.7.3 to specify a evaluated in the Updated Safety Analysis consideration, which is presented Completion Time of 24 hours to restore an Report. The deletion of the single MSIV below: inoperable control room boundary to leakage limit of 50 scfh in effect establishes OPERABLE status before requiring the plant a maximum leakage limit of 150 scfh which 1. The proposed change does not involve to perform an orderly shutdown. The 24-hour is the current total MSIV leakage limit. The a significant increase in the probability or Completion Time is reasonable based on the elimination of the single MSIV acceptable consequences of an accident previously low probability of a DBA occurring during leakage rate limit does not impact any event evaluated. this time period and Energy Northwest’s initiator. As the proposed changes do not The proposed Technical Specifications commitment to implement, via involve any accident initiators, there is no (TS) change involves the Control Room administrative controls, appropriate increase in the probability of an accident Emergency Filtration (CREF) System and compensatory measures consistent with the previously evaluated. associated control room boundary, which intent of 10 CFR 50, Appendix A, GDC 19. The annulus mixing system and the main provide a radiological controlled These compensatory measures will serve to steam isolation valves operate following an environment from which the plant can be minimize the consequences of an open LOCA [loss-of-coolant accident] to mitigate operated following a design basis accident control room boundary and assure that the the consequences of an accident. Elimination (DBA). The CREF system and the control CREF system can continue to perform its of the annulus mixing system and the single room boundary are not assumed to be function. Therefore, the proposed TS change MSIV leakage limit will lead to some increase initiators of any analyzed accident and do does not involve a significant reduction in in the dose consequences of a LOCA. The not affect the probability of accidents. The the margin of safety. current LOCA dose consequences evaluation proposed change adds a Note to LCO 3.7.3 for RBS was revised to account for the that allows the control room boundary to be The NRC staff has reviewed the elimination of the annulus mixing system opened intermittently under administrative licensee’s analysis and, based on this and for increasing the single MSIV leakage to controls. A new Condition B is also added to review, it appears that the three 150 scfh (applying the total MS–PLCS LCO 3.7.3 to specify a Completion Time of standards of 10 CFR 50.92(c) are Division limit to the single MSIV). The 24 hours to restore an inoperable control satisfied. Therefore, the NRC staff results of the revised evaluation with the room boundary to OPERABLE status before proposed changes show an increase in the requiring the plant to perform an orderly proposes to determine that the calculated dose consequences, however, the shutdown. The 24-hour Completion Time is amendment request involves no calculated doses were still within the reasonable based on the low probability of a significant hazards consideration. acceptance limits of 10 CFR 50.67. Thus, DBA occurring during this time period and Attorney for licensee: Thomas C. while there is an increase in the dose Energy Northwest’s commitment to Poindexter, Esq., Winston & Strawn, consequences of an accident previously implement, via administrative controls, 1400 L Street, NW., Washington, DC identified, the increase is not deemed to be appropriate compensatory measures significant. consistent with the intent of 10 CFR 50, 20005–3502. Therefore, the proposed change does not Appendix A, General Design Criteria (GDC) NRC Section Chief: Stephen Dembek. involve a significant increase in the

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probability or consequences of an accident consideration, which is presented Attorney for licensee: Mark previously evaluated. below: Wetterhahn, Esq., Winston & Strawn, 2. Does the proposed change create the 1400 L Street, NW., Washington, DC possibility of a new or different kind of 1. Does the proposed change involve a significant increase in the probability or 20005. accident from any accident previously NRC Section Chief: Robert A. Gramm. evaluated? consequences of an accident previously evaluated? Response: No. Entergy Operations Inc., Docket No. 50– The proposed change does not add any Response: No. The proposed amendment to TS SR 382, Waterford Steam Electric Station, equipment, nor is any equipment replaced 3.6.5.1.3 adds a one-time extension to the Unit 3, (Waterford 3) St. Charles Parish, with equipment with different performance current interval for the DWBT. The current Louisiana characteristics. Thus, no new initiators are interval of ten years, based on past added, and therefore, no new accident types Date of amendment request: May 7, performance, would be extended on a one- are created as a result of this change. The time basis to 15-years from the date of the 2004. proposed changes affect performance last test. The proposed extension to the Description of amendment request: characteristics assumed in the LOCA dose DWBT cannot increase the probability of an The proposed changes will revise the consequences evaluation, however, the accident since there are no design or Waterford 3 Technical Specifications nature of the accidents evaluated in the operating changes involved and the test is (TS) to clarify the actions of TS 3.4.5.1, safety analysis report are not changed. not an accident initiator. The proposed Reactor Coolant System (RCS) Leakage; Therefore, the proposed change does not extension of the test interval does not involve create the possibility of a new or different some of the surveillance requirements a significant increase in the consequences (SRs) of TS 3.4.5.2, RCS Operational kind of accident from any previously since analysis has shown that, the proposed evaluated. extension of the DWBT frequency has a Leakage; and delete duplication in TS 3. Does the proposed change involve a minimal impact on plant risk. Therefore, the 3.3.3.1, Radiation Monitoring significant reduction in a margin of safety? proposed change does not involve a Instrumentation. The proposed change Response: No. significant increase in the probability or is based on NUREG–1432, ‘‘Standard With respect to dose consequences for the consequences of an accident previously Technical Specifications Combustion LOCA event, the margin of safety is evaluated. Engineering Plants,’’ Revision 2, dated considered to be that provided by meeting 2. Does the proposed change create the April 30, 2001. Also, the proposed the 10 CFR 50.67 limits. The revised dose possibility of a new or different kind of consequences evaluation, which includes the accident from any accident previously change will delete the containment proposed changes, continues to demonstrate evaluated? atmosphere gaseous radioactivity that the doses at the exclusion area boundary, Response: No. monitoring system from the TS because the low population zone, and the control The proposed extension to the interval for this monitor does not meet the room are within the acceptance limits in 10 the DWBT does not involve any design or requirements of Regulatory Guide 1.45, CFR 50.67. Therefore, there is no reduction operational changes that could lead to a new Revision 0, ‘‘Reactor Coolant Pressure in the margin of safety. or different kind of accident from any Boundary Leakage Detection Systems,’’ Therefore, the proposed change does not accidents previously evaluated. The tests are and Title 10 of the Code of Federal not being modified, but are only being involve a significant reduction in a margin of Regulations (10 CFR), Part 50, Appendix safety. performed after a longer interval. The proposed change does not involve a physical A, General Design Criteria 30, ‘‘Quality The NRC staff has reviewed the alteration of the plant (no new or different of Reactor Coolant System Pressure licensee’s analysis and, based on this type of equipment will be installed) or a Boundary.’’ review, it appears that the three change in the methods governing normal Basis for proposed no significant standards of 10 CFR 50.92(c) are plant operation. Therefore, the proposed hazards consideration determination: satisfied. Therefore, the NRC staff change does not create the possibility of a As required by 10 CFR 50.91(a), the proposes to determine that the new or different kind of accident from any licensee has provided its analysis of the amendment request involves no previously evaluated. 3. Does the proposed change involve a issue of no significant hazards significant hazards consideration. significant reduction in a margin of safety? consideration, which is presented Attorney for licensee: Mark Response: No. below: Wetterhahn, Esq., Winston & Strawn, An evaluation of extending the DWBT 1. Does the proposed change involve a 1400 L Street, NW., Washington, DC surveillance frequency from once in 10 years significant increase in the probability or 20005. to once in 15 years has been performed using consequences of an accident previously NRC Section Chief: Robert A. Gramm. methodologies based on the ILRT [integrated evaluated? leak rate testing] methodologies. This Response: No. Entergy Gulf States, Inc., and Entergy evaluation assumed that the DWBT The proposed revisions do not involve any Operations, Inc., Docket No. 50–458, frequency was being adjusted in conjunction physical change to plant design. The less River Bend Station (RBS), Unit 1, West with the ILRT frequency. This analysis used restrictive changes proposed in this Feliciana Parish, Louisiana realistic, but still conservative, assumptions amendment request include relocation of with regard to developing the frequency of Date of amendment request: February information to the UFSAR [updated final leakage classes associated with the DWBT. safety analysis report], addition of a TS 3.0.4 16, 2004. The results from this conservative analysis exception, utilization of the diversity and Description of amendment request: indicates that the proposed extension of the redundancy of the Waterford 3 leakage The amendment would change DWBT frequency has a minimal impact on detection instrumentation, allowing diversity Technical Specification (TS) 3.6.5.1.3, plant risk and therefore, the proposed change in the contingency actions, deletion of SRs, regarding drywell bypass leakage testing does not involve a significant reduction in a and addition of an allowed outage time when (DWBT). The change would allow for a margin of safety. two of three required leakage detection one-time extension of the interval (from The NRC staff has reviewed the instrumentation is inoperable. The less 10 to 15 years) for performance of the licensee’s analysis and, based on this restrictive changes will not affect the next DWBT. review, it appears that the three capability of Waterford 3 to detect RCS leakage. At least one RCS leakage detection Basis for proposed no significant standards of 10 CFR 50.92(c) are instrumentation is always required to remain hazards consideration determination: satisfied. Therefore, the NRC staff operable, and other leakage detection As required by 10 CFR 50.91(a), the proposes to determine that the indication, while not credited specifically for licensee has provided its analysis of the amendment request involves no RCS leakage detection, is still available and issue of no significant hazards significant hazards consideration. required to be operable per other TS

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requirements (i.e., Containment Temperature probability or consequences of an accident proposes to determine that the and Containment Pressure). Also contingency previously evaluated. amendment request involves no actions are required (i.e., RCS Inventory 2. Does the proposed change create the significant hazards consideration. Balance, containment grab samples, flow possibility of a new or different kind of Attorney for licensee: N. S. Reynolds, switch verification) when any of the RCS accident from any accident previously leakage detection instrumentation is evaluated? Esquire, Winston & Strawn 1400 L inoperable. Performance of the RCS Response: No. Street NW., Washington, DC 20005– inventory balance is the most accurate The aforementioned revisions do not 3502. method of determining and quantifying involve any physical change to plant design. NRC Section Chief: Robert A. Gramm. leakage. The RCS inventory balance is being None of the proposed changes affect[s] the added as a contingency and replacement for accident analyses. The RCS water inventory FirstEnergy Nuclear Operating monitoring instrumentation that has balance is more accurate than normal leak Company, Docket No. 50–346, Davis- continuous indication and alarms in the detection methods in regard to actual RCS Besse Nuclear Power Station, Unit 1, control room. leak rates, and therefore is an excellent Ottawa County, Ohio The more restrictive changes proposed by alternative when other leak detection Date of amendment request: April 29, this revision do not adversely affect the components may become inoperable. The capability of Waterford 3 RCS leakage proposed changes do not prevent acceptable 2004. detection instrumentation to detect RCS detection of RCS leakage by diverse methods. Description of amendment request: leakage. The deletion of the containment The detection of a RCS leak can not cause an The proposed amendment would revise atmosphere gaseous radioactivity monitor is accident. Likewise, detecting a RCS leak, Technical Specification (TS) Section considered a more restrictive change. This while in its beginning stages, does not create 3/4.4.10, ‘‘Reactor Coolant System— monitor does not meet the leakage detection the possibility of a new or different kind of Structural Integrity, ASME Code Class 1, requirements of Regulatory Guide 1.45 and accident than any previously analyzed. 2, and 3 Components,’’ to relocate does not meet the requirements for retention Therefore, a new or different kind of accident specified in 10 CFR 50.36. Deletion of this Surveillance Requirement (SR) than that previously analyzed does not result 4.4.10.1.b which requires that the monitor will reduce the diversity of the due to the proposed changes of this Waterford 3 instrumentation for monitoring submittal. reactor vessel internals vent valves be the containment atmosphere and require the Therefore. the proposed change does not tested and inspected, to the Technical plant to enter an Action statement when the create the possibility of a new or different Requirements Manual (TRM). The containment atmosphere particulate monitor kind of accident from any previously Davis-Besse Nuclear Power Station is inoperable. Requiring performance of an evaluated. RCS inventory balance when the (DBNPS) TRM is a licensee-controlled containment sump monitor is inoperable 3. Does the proposed change involve a document that is incorporated by provides contingency actions when the plant significant reduction in a margin of safety? reference into the DBNPS Updated is in a degraded RCS leakage detection Response: No. Safety Analysis Report (USAR). Changes condition. The aforementioned revisions do not to the DBNPS TRM are performed in involve any physical change to plant design. The administrative changes proposed by accordance with the regulatory this revision do not adversely affect the The proposed changes do not adversely affect the ability of the RCS leakage detection requirements of 10 CFR 50.59. capability of Waterford 3 RCS leakage Basis for proposed no significant detection instrumentation to detect RCS system to detect RCS leakage. The ability of leakage. Relocating the requirements the RCS leakage detection instrumentation to hazards consideration determination: associated with the RCS Leak Detection detect leakage within the requirements of As required by 10 CFR 50.91(a), the System from various TS to Specification Regulatory Guide 1.45 is actually improved. licensees have provided their analysis of 3.4.5.1 and adding requirement to shutdown The containment atmosphere gaseous the issue of no significant hazards when all required RCS leakage detection monitor is being deleted from TS, because, it consideration, which is presented instrumentation are inoperable are does not meet the requirements of Regulatory below: administrative in nature. The relocation of Guide 1.45 to detect a 1.0 gpm [gallon per information from one TS to another minute] RCS leakage within 1 hour. 1. Does the proposed change involve a consolidates information and causes less Extending the AOT [allowed outage time] significant increase in the probability or contusion in the control room by having all when two of three leakage detection systems consequences of an accident previously requirements for the leakage detection is inoperable does not decrease the margin of evaluated? instrumentation in one TS. The addition of safety because one instrument remains Response: No. The proposed surveillance a specific action to shutdown when all three operable, other instrumentation capable of requirement relocation from the Technical leakage detection instrumentation are indicating RCS leakage is available, and an Specifications to the USAR TRM does not inoperable versus an implied requirement to RCS inventory balance is required to be alter the design, operation, or testing of any enter TS 3.0.3 is being performed to be performed on an increased frequency. The structure, system, or component. No similar to the STS [Standard Technical RCS inventory balance is more accurate than preciously analyzed accident scenario is Specifications]. normal leak detection methods in regard to changed. Initiating conditions and None of the above less restrictive, more actual RCS leak rates, and therefore is an assumptions remain as previously analyzed. restrictive, or administrative changes affects excellent alternative when other Ieak Therefore, the proposed changes does not the accident analyses. Since the proposed detection components may become involve a significant increase in the changes only affect the requirements for the inoperable. Maintaining diverse and accurate probability or consequences of an accident detection of RCS leakage, the probability that RCS leak detection methods available and previously evaluated. an accident previously evaluated will occur capable of prompt leakage detection helps to 2. Does the proposed change create the remains unchanged. The proposed changes ensure RCS leaks will be detected within an possibility of a new or different kind of do not prevent nor limit the diversity of acceptable period of time and, therefore, the accident from any accident previously acceptable detection of RCS leakage. These proposed changes do not significantly reduce evaluated? changes also do not affect the mitigation the margin to safety. Response: No. The proposed surveillance capability of any accident previously Therefore, the proposed change does not requirement relocation from the Technical evaluated. The consequences of an accident involve a significant reduction in a margin of Specifications to the USAR TRM does not previously evaluated are not affected since safety. alter the design, operation, or testing of any structure, system or component. The the mitigation of previously evaluated The NRC staff has reviewed the accidents is not affected and leak rate proposed change does not introduce any new information will remain available to station licensee’s analysis and, based on this or different accident initiators. Therefore, the personnel. review, it appears that the three proposed change does not create the Therefore, the proposed change does not standards of 10 CFR 50.92(c) are possibility of a new or different kind of involve a significant increase in the satisfied. Therefore, the NRC staff accident from any previously evaluated.

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3. Does the proposed change involve a analyzed accident scenario is affected by the review, it appears that the three significant reduction in a margin of safety? proposed change. standards of 10 CFR 50.92(c) are Response: No. The proposed surveillance The proposed change does not affect the satisfied. Therefore, the NRC staff requirements relocation from the Technical initiation of any analyzed accident. The proposes to determine that the Specifications to the USAR TRM does not accident mitigation functions for affected affect the capabilities of the Reactor Vessel equipment are maintained. Therefore, the amendment request involves no Internals Vent Valves. Therefore, the proposed change does not involve a significant hazards consideration. proposed change will not affect a margin of significant increase in the probability or Attorney for licensee: Mary E. safety. consequences of an accident previously O’Reilly, Attorney, FirstEnergy evaluated. Corporation, 76 South Main Street, The NRC staff has reviewed the 2. Does the proposed change create the licensee’s analysis and, based on this Akron, OH 44308. possibility of a new or different kind of NRC Section Chief: Anthony J. review, it appears that the three accident from any accident previously standards of 10 CFR 50.92(c) are evaluated? Mendiola. satisfied. Therefore, the NRC staff Response: No. The proposed amendment Florida Power and Light Company, proposes to determine that the affects the USAR requirements for EDG Docket Nos. 50–250 and 50–251, Turkey amendment request involves no voltage and frequency response following a loss of offsite power. The effect of this change Point Plant, Units 3 and 4, Miami-Dade significant hazards consideration. County, Florida Attorney for licensee: Mary E. on the capability of the EDGs, the onsite electric power system, and essentially O’Reilly, Attorney, FirstEnergy Date of amendment request: April 23, powered equipment to perform their required 2004. Corporation, 76 South Main Street, safety functions has been evaluated, and the Akron, OH 44308. proposed change does not significantly Description of amendment request: NRC Section Chief: Anthony J. impact the capability of these systems to The proposed amendments would Mendiola. perform their required safety functions. The revise several Technical Specification assumptions of the current accident analyses (TS) Allowed Outage Times for TS 3.3.3, FirstEnergy Nuclear Operating are maintained and no new or different Accident Monitoring, to be consistent Company, Docket No. 50–346, Davis- accident initiators are created. Therefore, the with the Completion Times in the Besse Nuclear Power Station, Unit 1, proposed change does not create the related Specification in NUREG–1431, Ottawa County, Ohio possibility of a new or different kind of Revision 2, ‘‘Standard Technical accident from any previously evaluated. Date of amendment request: May 3, 3. Does the proposed change involve a Specifications Westinghouse Plants (the 2004. significant reduction in a margin of safety? Improved Standard Technical Description of amendment request: Response: No. The proposed amendment Specifications, or ISTS).’’ The proposed amendment would affects the USAR requirements for EDG Basis for proposed no significant change the facility as described in the voltage and frequency response following a hazards consideration determination: Updated Safety Analysis Report (USAR) loss of offsite power. The effect of this change As required by 10 CFR 50.91(a), the for the emergency diesel generators on the capability of the EDGs, the onsite licensee has provided its analysis of the electric power system, and essentially (EDGs). Specifically, the proposed issue of no significant hazards change would describe a departure from powered equipment to perform their required safety functions has been evaluated, and it is consideration, which is presented Safety Guide 9, ‘‘Selection of Diesel concluded the proposed change does not below: Generator Set Capacity for Standby impact the capability of these systems to 1. Operation of the facility in accordance Power Supplies,’’ for the frequency and perform their required safety functions. with the proposed amendment would not voltage transient during the EDG However, since the proposed change does involve a significant increase in the automatic loading sequence. make changes to the controlling values for probability or consequences of an accident Basis for proposed no significant EDG voltage and frequency transient previously evaluated. hazards consideration determination: response that are less restrictive than those The proposed changes revise the Actions As required by 10 CFR 50.91(a), the presently described in the USAR, this is and allowed outage times of the accident considered a reduction in a margin of safety. licensees have provided their analysis of monitoring instrumentation. The accident The magnitude of voltage and frequency monitoring instrumentation is not an initiator the issue of no significant hazards drops which would result in failure of the consideration, which is presented of any accident previously evaluated. As a EDGs, the onsite power system, or essentially result, the probability of any accident below: powered equipment have not been previously evaluated is not significantly 1. Does the proposed change involve a determined due to the limitations of the increased by these proposed changes. The significant increase in the probability or transient assessment model and the Technical Specifications continue to require consequences of an accident previously nonlinear phenomena associated with that the accident monitoring instrumentation to evaluated? postulated failure. However, based on (1) a be operable. Therefore, the accident Response: No. The proposed amendment computer model and testing of the diesel monitoring instrumentation will continue to alters the design requirements for the engine, engine speed control governor and provide sufficient information on selected actuator, the synchronous generator and Emergency Diesel Generators (EDGs). plant parameters to monitor and assess these excitation system that demonstrate the EDGs Specifically, the proposed amendment affects variables following an accident. The are capable of starting, accelerating, and the requirements for EDG voltage and consequences of an accident during the carrying the required loads, (2) a frequency response following a loss of offsite extended allowed outage time are the same comprehensive evaluation of the impact of power. The EDGs function to mitigate the as the consequences during the current the transient voltage and frequency response consequences of accidents when offsite allowed outage time. As a result, the on plant equipment and safety functions, (3) power is not available. The EDGs are not an consequences of any accident previously the momentary duration of the voltage and initiator of any analyzed accident. evaluated are not significantly increased by frequency dips, and (4) based on engineering The effect of this change on the capability these proposed changes. Therefore, the judgement, the proposed change is not proposed amendments do not involve a of the EDGs, the onsite electric power system, considered to have a significant effect on the and essentially powered equipment to margin of safety. Therefore, the proposed significant increase in the probability or perform their required safety functions has change does not involve a significant consequences of any accident previously been evaluated, and the proposed change reduction in a margin of safety. evaluated. does not significantly impact the capability 2. Operation of the facility in accordance of these systems to perform their required The NRC staff has reviewed the with the proposed amendments would not accident mitigation functions. No previous licensee’s analysis and, based on this create the possibility of a new or different

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kind of accident from any previously and final status survey results for the systems, structures and components will evaluated. Spray Building and Spray Pipe with the have been removed from the land. The The proposed changes do not alter the amendment request, and proposes to requested release of the land does not create design, physical configuration, or mode of submit dismantlement and survey the possibility of a new or different kind of operation of the plant. The accident accident that could affect the ISFSI that has monitoring instrumentation is not an initiator information for the remaining land area not been considered in the design, of any accident previously evaluated. No in four additional submittals. Maine installation or operation of the ISFSI. As changes are being made to the plant that Yankee is seeking review and approval noted above, Maine Yankee will retain would introduce any new accident causal of the amendment; however, Maine control over activities performed in the mechanisms. The proposed changes do not Yankee is requesting that the NRC Owner Controlled Area for the ISFSI to affect any other plant equipment. Therefore, condition the effective date of the assure that no new hazards are introduced operation of the facility in accordance with license amendment to correspond with that could create the potential for a new or the proposed amendments does not create the NRC’s approval of the final different kind of accident. Therefore, the the possibility of a new or different kind of information submittal. proposed amendment does not create the accident from any previously evaluated. Basis for proposed no significant possibility of a new or different kind of 3. Operation of the facility in accordance accident from any accident previously with the proposed amendments would not hazards consideration determination: evaluated. involve a significant reduction in a margin of As required by 10 CFR 50.91(a), the 3. Does the proposed amendment involve safety. licensee has provided its analysis of the a significant reduction in a margin of safety? The proposed changes do not change the issue of no significant hazards Response: No. operation, function, or modes of the plant or consideration, which is presented The margin of safety defined in the equipment operation. The proposed changes below: statements of consideration for the final rule do not change the level of assurance that the on the Radiological Criteria for License 1. Does the proposed amendment involve accident monitoring instrumentation will be Termination is described as the margin a significant increase in the probability or available to perform its function. The between the 100 mrem/yr public dose limit consequences of an accident previously proposed changes provide a more established in 10 CFR 20.1301 for licensed evaluated? appropriate time to restore the inoperable operation and the 25 mrem/yr dose limit to Response: No. the average member of the critical group at channel(s) to operable status, and only apply The requested license amendment involves when one or more channels of a required release of land presently considered part of a site considered acceptable for unrestricted instrument are inoperable. The additional the Maine Yankee plant site under license use. This margin of safety accounts for the time to restore an inoperable channel to DPR–36. The release of this land will occur potential effect of multiple sources of operable status is appropriate based on the after all demolition activities are completed radiation exposure to the critical group. low probability of an event requiring an and final status surveys have been performed Additionally, the State of Maine, through accident monitoring instrument during the to document the final radiological conditions legislation, has imposed a 10 mrem/yr all interval, providing a reasonable time for of the land. When the release occurs, the only pathways dose limit, with no more than 4 repair, and other means which may be remaining radiological hazard at the site will mrem/yr attributable to drinking water available to obtain the required information. be contained in the Independent Spent Fuel sources. Therefore, operation of the facility in Storage Installation (ISFSI). Therefore, the The License Termination Plan (LTP) accordance with the proposed amendments focus of the analysis is on the potential prepared by Maine Yankee establishes would not involve a significant reduction in impact on the probability and consequences conservative criteria for residual radiation the margin of safety. of accidents associated with the ISFSI. levels following completion of demolition activities at the site. The LTP demonstrates The NRC staff has reviewed the The accident conditions evaluated for the spent fuel storage casks include the that when these conservative criteria are met, licensee’s analysis and, based on this following: accident pressurization, mis- the dose to the average member of the critical review, it appears that the three loading of fuel canisters, drop of the vertical group will be below the regulatory criteria standards of 50.92(c) are satisfied. concrete casks, explosion, fires, maximum established by the State of Maine, and, Therefore, the NRC staff proposes to anticipated heat load, earthquakes, floods, therefore, well below the dose limits determine that the amendment request lightening strikes, tornado and tornado established by the NRC. The proposed release involves no significant hazards driven missiles, tip over of vertical concrete of the site lands, once the criteria established consideration. cask, and full blockage of vertical concrete in the LTP have been met will, therefore, not Attorney for licensee: M.S. Ross, cask air inlets and outlets. The release of the result in any reduction in the margin of safety. Attorney, Florida Power & Light, P.O. non-ISFSI land from the license will not affect the probability of any of these Conclusion Box 14000, Juno Beach, Florida 33408– accidents. Maine Yankee will retain 0420. sufficient control over activities performed Based on the above, Maine Yankee NRC Section Chief: William F. Burton, on the Owner Controlled Area through rights concludes that the proposed amendment Acting. granted in the legal land conveyance presents no significant hazards consideration documents to ensure that there is no impact under the standards set forth in 10 CFR Maine Yankee Atomic Power Company, on consequences from postulated accidents. 50.92(c), and, accordingly, a finding of ‘‘no Docket No. 50–309, Maine Yankee Therefore, the proposed release of the land significant hazards consideration’’ is Atomic Power Station, Lincoln County, will not affect the consequences of any of justified. Maine these postulated accidents. The NRC staff has reviewed the The proposed action, therefore, does not licensee’s analysis and, based on this Date of amendment request: March increase either the probability or the 15, 2004. consequences of any accidents that have been review, it appears that the three Description of amendment request: considered. standards of 10 CFR 50.92(c) are Maine Yankee Atomic Power Company 2. Does the proposed amendment create satisfied. Therefore, the NRC staff (Maine Yankee) is requesting that the the possibility of a new or different kind of proposes to determine that the U.S. Nuclear Regulatory Commission accident from any accident previously requested amendment involves no (NRC) release the remaining land under evaluated? significant hazards consideration. License No. DPR–36, with the exception Response: No. Attorney for licensee: Joe Fay, Esquire, The requested amendment involves release of land where the Independent Spent of land presently considered part of the Maine Yankee Atomic Power Company, Fuel Storage Installation is located. Maine Yankee plant site under license DPR– 321 Old Ferry Road, Wiscasset, Maine Maine Yankee submitted detailed 36. When the amendment becomes effective, 04578 information on dismantlement activities demolition activities will be complete and all NRC Section Chief: Claudia M. Craig.

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Nine Mile Point Nuclear Station, LLC, instrumentation requirements to the UFSAR. (LAR) proposes selective scope Docket No. 50–220, Nine Mile Point As such, the proposed changes do not application of the alternate source term Nuclear Station Unit No. 1, Oswego eliminate any requirements or impose any (AST) for the fuel handling accident County, New York new requirements, and adequate controls of (FHA) in accordance with the existing requirements are maintained. Date of amendment request: April 19, Furthermore, since the proposed changes do provisions of 10 CFR 50.67. Nuclear 2004. not make any physical changes to the plant, Management Company requests the Description of amendment request: no new accident initiators or failure Nuclear Regulatory Commission (NRC) The licensee proposed to revise the mechanisms are introduced, and the accident review and approval of the AST FHA Technical Specifications (TSs) to assumptions and initial conditions will methodology for application to the establish an operating cycle (24-month) remain unchanged. Therefore, the proposed Prairie Island Nuclear Generating Plant. calibration surveillance frequency for changes do not create the possibility of a new This LAR also proposes revisions to or different kind of accident from any the Intermediate Range Monitor (IRM) Technical Specifications (TS) associated accident [previously] evaluated. with ensuring that safety analyses instrumentation, which would replace 3. Does the proposed change involve a the current ‘‘prior to startup and normal significant reduction in a margin of safety? assumptions are met for a postulated shutdown’’ Surveillance Requirement Response: No. FHA in containment. Based on the AST (SR). The proposed changes also The proposed changes establish a 24- FHA analyses, this LAR proposes to included associated conforming month IRM calibration frequency in lieu of modify TS 3.9.4, ‘‘Containment changes. In addition, the licensee the current ‘‘prior to startup and normal Penetrations,’’ to apply during the proposed to relocate the Limiting shutdown’’ requirement and relocate certain handling of recently irradiated fuel and Conditions for Operation (LCOs) and instrumentation requirements to the UFSAR. require all containment penetrations to Although the proposed changes result in SRs for selected control rod withdrawal be closed during handling of recently changes to surveillance intervals, the impact, irradiated fuel; and also proposes to block instrumentation to the Updated if any, on system availability is small based Final Safety Analysis Report (UFSAR), a on (1) other more frequent testing that is remove the requirements of TS 3.3.5, licensee-controlled document. performed, (2) the existence of redundant ‘‘Containment Ventilation Isolation Basis for proposed no significant equipment, and (3) overall system reliability. Instrumentation’’ relating to movement hazards consideration determination: Consistent with the findings of previous of irradiated fuel assemblies. As required by 10 CFR 50.91(a), the industry evaluations, the NMP1 [Nine Mile Basis for proposed no significant licensee has provided its analysis of the Point Nuclear Station, Unit No. 1] plant- hazards consideration determination: issue of no significant hazards specific analyses have shown no evidence of As required by 10 CFR 50.91(a), the consideration, which is presented time-dependent failures that would impact licensee has provided its analysis of the the availability of the affected systems. below: issue of no significant hazards Furthermore, plant-specific evaluations and consideration, which is presented 1. Does the proposed change involve a the adoption of the calculated IRM setpoint significant increase in the probability or Allowable Values ensure that the setpoint below: consequences of an accident previously margins are maintained for a 24-month (30- 1. Do the proposed changes involve a evaluated? month maximum) calibration frequency. The significant increase in the probability or Response: No. proposed relocated requirements are consequences of an accident previously The proposed changes are limited to: (1) consistent with the Improved Standard TSs evaluated? establishing a 24-month calibration (NUREG–1433 and NUREG–1434) and 10 Response: No. frequency for the IRM instrumentation in lieu CFR 50.36, and will be maintained in The proposed Technical Specification of the current ‘‘prior to startup and normal accordance with 10 CFR 50.59. Accordingly, changes require containment integrity during shutdown’’ requirement and incorporating the proposed changes will have no movement of recently irradiated fuel. With the associated conforming changes, and (2) significant impact on the condition or this change, the Technical Specifications the relocation of certain instrumentation performance of structures, systems, and selectively implement 10 CFR 50.67 requirements from the TSs that do not satisfy components relied upon for accident alternative source term methodologies for a the screening criteria for retention in the TSs. mitigation. Therefore, the proposed changes fuel handling accident and implement The proposed changes do not introduce any do not involve a significant reduction in a portions of the approved industry improved new modes of plant operation, make any margin of safety. Standard Technical Specification traveler, physical changes to the plant, or alter any TSTF–51, ‘‘Revise containment requirements operational setpoints in a manner which The NRC staff has reviewed the during handling irradiated fuel and core could degrade the performance of, or increase licensee’s analysis and, based on this alterations’ as it applies to TS 3.9.4, the challenges to, any safety system assumed review, it appears that the three ‘‘Containment Penetrations.’’ This change to function in the accident analysis. In standards of 10 CFR 50.92(c) are also removes requirements for containment addition, evaluations of the proposed satisfied. Therefore, the NRC staff ventilation isolation instrumentation during changes pursuant to NRC and industry proposes to determine that the handling irradiated fuel from TS 3.3.5, guidance demonstrate that the availability amendment request involves no ‘‘Containment Ventilation Isolation and reliability of equipment and systems Instrumentation’’ since the containment required to prevent or mitigate the significant hazards consideration. purge and inservice purge system radiological consequences of an accident are Attorney for licensee: Mark J. penetrations which are isolated by this not significantly affected. Therefore, the Wetterhahn, Esquire, Winston & Strawn, instrumentation will be required to be proposed changes do not involve a 1400 L Street, NW., Washington, DC isolated during movement of recently significant increase in the probability or 20005–3502. irradiated fuel. With the proposed 10 CFR consequences of an accident previously NRC Section Chief: Richard J. Laufer. 50.67 alternative source term methodologies, evaluated. these filtration systems are not assumed to 2. Does the proposed change create the Nuclear Management Company, LLC, function during a fuel handling accident possibility of a new or different kind of Docket Nos. 50–282 and 50–306, Prairie involving fuel which is not recently accident from any accident previously Island Nuclear Generating Plant, Units irradiated. evaluated? 1 and 2, Goodhue County, Minnesota This amendment does not alter the Response: No. methodology or equipment used directly in The proposed changes establish a 24- Date of amendment request: January fuel handling operations. None of the month IRM calibration frequency in lieu of 20, 2004. containment integrity features including the the current ‘‘prior to startup and normal Description of amendment request: containment equipment hatch, personnel air shutdown’’ requirement and relocate certain This License Amendment Request locks or any other containment penetration

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are used to handle fuel. Therefore, hardware, system operation, or procedures The NRC staff has reviewed the containment integrity and ventilation involved with actual handling of irradiated licensee’s analysis and, based on this systems, and spent fuel pool ventilation fuel. The proposed changes include review, it appears that the three systems are not accident initiators and application of new methodology for fuel standards of 10 CFR 50.92(c) are therefore these changes do not increase the handling accident analysis and revises probability of a previously evaluated requirements for equipment operability satisfied. Therefore, the NRC staff accident. during movement of irradiated fuel proposes to determine that the The total effective dose equivalent (TEDE) assemblies. These changes do not create the amendment requests involve no doses from the analysis supporting this possibility for a new or different kind of significant hazards consideration. amendment request have been compared to accident. Attorney for licensee: Jonathan Rogoff, equivalent total effective dose equivalent Therefore, the proposed changes do not Esquire, Vice President, Counsel & (TEDE) doses estimated with the guidelines create the possibility of a new or different Secretary, Nuclear Management of Regulatory Guide 1.183 Footnote 7. The kind of accident from any previously Company, LLC, 700 First Street, new values are shown to be comparable to evaluated. 3. Do the proposed changes involve a Hudson, WI 54016. the results of the previous analysis. NRC Section Chief: L. Raghavan. A fuel handling accident analysis utilizing significant reduction in a margin of safety? alternative source term methodologies Response: No. Notice of Issuance of Amendments to allowed by 10 CFR 50.67 demonstrated that The proposed Technical Specification Facility Operating Licenses the dose consequences of a postulated fuel changes require containment integrity during handling accident remain within the limits of movement of recently irradiated fuel. With During the period since publication of 10 CFR 50.67 without taking credit for this change, the Technical Specifications the last biweekly notice, the containment closure or ventilation systems selectively implement 10 CFR 50.67 Commission has issued the following assuming the fuel has not recently been in a alternative source term methodologies for a amendments. The Commission has critical reactor. The alternative source term fuel handling accident and implement determined for each of these fuel handling accident analysis also portions of the approved industry improved amendments that the application Standard Technical Specification traveler, demonstrated that the more restrictive dose complies with the standards and guidelines of Regulatory Guide 1.183 are also TSTF–51, ‘‘Revise containment requirements during handling irradiated fuel and core requirements of the Atomic Energy Act met without taking credit for these mitigation of 1954, as amended (the Act), and the features. Since the alternative source term alterations’ as it applies to TS 3.9.4, fuel handling accident analysis results are ‘‘Containment Penetrations.’’ This change Commission’s rules and regulations. within the regulatory limits and regulatory also removes requirements for containment The Commission has made appropriate ventilation isolation instrumentation during guidelines without taking credit for these findings as required by the Act and the handling irradiated fuel from TS 3.3.5, mitigation features, revising this Technical Commission’s rules and regulations in ‘‘Containment Ventilation Isolation Specification for containment closure does Instrumentation’’ since the containment 10 CFR Chapter I, which are set forth in not involve a significant increase in the purge and inservice purge system the license amendment. consequences of a previously evaluated penetrations which are isolated by this Notice of Consideration of Issuance of accident. instrumentation will be required to be Amendment to Facility Operating Therefore, the proposed changes do not isolated during movement of recently License, Proposed No Significant involve a significant increase in the irradiated fuel. With the proposed 10 CFR Hazards Consideration Determination, probability or consequences of an accident 50.67 alternative source term methodologies, and Opportunity for A Hearing in previously evaluated. these filtration systems are not assumed to 2. Do the proposed changes create the connection with these actions was function during a fuel handling accident published in the Federal Register as possibility of a new or different kind of involving fuel which is not recently accident from any accident previously irradiated. indicated. evaluated? The assumptions and input used in the Unless otherwise indicated, the Response: No. fuel handling accident analysis are Commission has determined that these The proposed Technical Specification conservative. The design basis fuel handling amendments satisfy the criteria for changes require containment integrity during accident has been defined to identify categorical exclusion in accordance movement of recently irradiated fuel. With conservative conditions. The source term and with 10 CFR 51.22. Therefore, pursuant this change, the Technical Specifications radioactivity releases have been calculated to 10 CFR 51.22(b), no environmental selectively implement 10 CFR 50.67 pursuant to Regulatory Guide 1.183, alternative source term methodologies for a impact statement or environmental Appendix B and with conservative assessment need be prepared for these fuel handling accident and implement assumptions concerning prior reactor portions of the approved industry improved operations. The control room atmospheric amendments. If the Commission has Standard Technical Specification traveler, dispersion factor has been calculated with prepared an environmental assessment TSTF–51, ‘‘Revise containment requirements conservative assumptions associated with the under the special circumstances during handling irradiated fuel and core release. These conservative assumptions and provision in 10 CFR 51.12(b) and has alterations’’ as it applies to TS 3.9.4, input ensure that the radiation doses cited in made a determination based on that ‘‘Containment Penetrations.’’ This change this license amendment request are the upper assessment, it is so indicated. also removes requirements for containment bounds to radiological consequences of a fuel For further details with respect to the ventilation isolation instrumentation during handling accident in containment or the handling irradiated fuel from TS 3.3.5, action see (1) the applications for spent fuel pool. The analysis shows that amendment, (2) the amendment, and (3) ‘‘Containment Ventilation Isolation there is a significant margin between the Instrumentation’’ since the containment offsite radiation doses calculated for the the Commission’s related letter, Safety purge and inservice purge system postulated fuel handling accident using the Evaluation and/or Environmental penetrations which are isolated by this alternate source term and the dose limits of Assessment as indicated. All of these instrumentation will be required to be 10 CFR 50.67 and acceptance criteria of items are available for public inspection isolated during movement of recently Regulatory Guide 1.183. The proposed at the Commission’s Public Document irradiated fuel. With the proposed 10 CFR changes will not degrade the plant protective Room, located at One White Flint North, 50.67 alternative source term methodologies, boundaries, will not cause a release of fission Public File Area 01F21, 11555 Rockville these filtration systems are not assumed to products to the public, and will not degrade Pike (first floor), Rockville, Maryland. function during a fuel handling accident the performance of any structures, systems, involving fuel which is not recently and components important to safety. Publicly available records will be irradiated. Therefore, the proposed changes do not accessible from the Agencywide The proposed Technical Specification involve a significant reduction in a margin of Documents Access and Management changes do not involve plant design, safety. Systems (ADAMS) Public Electronic

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Reading Room on the Internet at the Date of initial notice in Federal No significant hazards consideration NRC Web site, http://www.nrc.gov/ Register: February 17, 2004 (69 FR 7520) comments received: No. reading-rm/adams.html. If you do not The Commission’s related evaluation Florida Power and Light Company, et have access to ADAMS or if there are of the amendments is contained in a al., Docket Nos. 50–335 and 50–389, St. problems in accessing the documents Safety Evaluation dated April 29, 2004. Lucie Plant, Units Nos. 1 and 2, St. located in ADAMS, contact the NRC No significant hazards consideration Lucie County, Florida Public Document Room (PDR) Reference comments received: No. Date of application for amendments: staff at 1–800–397–4209, 301–415–4737 Duke Energy Corporation, Docket Nos. or by e-mail to [email protected]. July 18, 2002, as supplemented 50–369 and 50–370, McGuire Nuclear November 14, 2002, and December 11, Calvert Cliffs Nuclear Power Plant, Inc., Station, Units 1 and 2, Mecklenburg 2003. Docket Nos. 50–317 and 50–318, Calvert County, North Carolina Brief description of amendments: The Cliffs Nuclear Power Plant, Unit Nos. 1 Date of application for amendments: amendments relocate Technical and 2, Calvert County, Maryland November 5, 2003. Specification (TS) 3/4 9.7 regarding the Date of application for amendments: Brief description of amendments: The Spent Fuel Storage Pool Building cranes April 17, 2003, as supplemented July amendments revised the Technical and TS 3/4 9.13 (Unit 1) and TS 3/4 9.12 29, 2003. Specifications to adopt the provisions of (Unit 2) regarding spent fuel cask cranes Brief description of amendments: Industry/Technical Specification Task to the respective units’ Updated Final These amendments revise the Required Force change TSTF–359, ‘‘Increase Safety Analysis Report. Actions requiring suspension of Flexibility in Mode Restraints.’’ Date of Issuance: April 28, 2004 operations involving positive reactivity Date of issuance: April 29, 2004. Effective Date: As of the date of additions and various notes that Effective date: As of the date of issuance and shall be implemented preclude reduction of boron issuance and shall be implemented within 60 days of issuance. concentration. within 120 days from the date of Amendment Nos.: 190 and 134 Date of issuance: May 6, 2004. issuance. Facility Operating License Nos. DPR– Effective date: As of the date of Amendment Nos.: 221, 203. 67 and NPF–16: Amendments revised issuance to be implemented within 30 Renewed Facility Operating License the Technical Specifications. days. Nos. NPF–9 and NPF–17: Amendments Date of initial notice in Federal Amendment Nos.: 266 and 243. revised the Technical Specifications. Register: August 6, 2002 (67 FR 50954). Renewed Facility Operating License Date of initial notice in Federal The November 14, 2002, and December Nos. DPR–53 and DPR–69: Amendments Register: February 17, 2004 (69 FR 7520) 11, 2003, supplements did not affect the revised the Technical Specifications. The Commission’s related evaluation original proposed no significant hazards Date of initial notice in Federal of the amendments is contained in a determination, or expand the scope of Register: May 27, 2003 (68 FR 28841). Safety Evaluation dated April 29, 2004. the request as noticed in the Federal The July 29, 2003, letter clarified the No significant hazards consideration Register. application, did not expand the scope of comments received: No. The Commission’s related evaluation the application as originally noticed, of the amendments is contained in a Entergy Operations, Inc., Docket No. 50– and did not change the staff’s original Safety Evaluation dated April 28, 2004. 368, Arkansas Nuclear One, Unit No. 2, proposed no significant hazards No significant hazards consideration Pope County, Arkansas consideration determination as comments received: No. published in the Federal Register on Date of application for amendment: Florida Power and Light Company, May 27, 2003 (68 FR 28841). February 9, 2004, as supplemented by Docket No. 50–335, St. Lucie Plant, Unit The Commission’s related evaluation letter dated March 2, 2004. No. 1, St. Lucie County, Florida of these amendments is contained in a Brief description of amendment: The Safety Evaluation dated May 6, 2004. amendment removed the pressurizer Date of application for amendment: No significant hazards consideration heatup and cooldown limits, and the May 22, 2002, as supplemented by comments received: No. associated action and surveillance letters dated December 5, 2002, and requirements, from the Technical February 11, 2004. Duke Energy Corporation, et al., Docket Specifications and placed them in the Brief description of amendment: The Nos. 50–413 and 50–414, Catawba Technical Requirements Manual. amendment revised Technical Nuclear Station, Units 1 and 2, York Date of issuance: May 4, 2004. Specification 6.9.1.11.b to add two NRC- County, South Carolina Effective date: As of the date of approved topical reports to the Core Date of application for amendments: issuance to be implemented within 60 Operating Limits Report methodology November 5, 2003. days from the date of issuance. list, and delete superseded reports. Brief description of amendments: The Amendment No.: 253. Also, the method of listing topical amendments revised the Technical Facility Operating License No. NPF–6: reports was revised to be consistent Specifications to adopt the provisions of Amendment revised the Technical with Technical Specifications Task Industry/Technical Specification Task Specifications. Force 363, which has been approved by Force change TSTF–359, ‘‘Increase Date of initial notice in Federal the NRC. Flexibility in Mode Restraints.’’ Register: March 2, 2004 (69 FR 9860). Date of Issuance: May 6, 2004. Date of issuance: April 29, 2004. The March 2, 2004, supplemental Effective Date: As of the date of Effective date: As of the date of letter provided clarifying information issuance and shall be implemented issuance and shall be implemented that did not change the scope of the within 60 days of issuance. within 120 days from the date of original Federal Register notice or the Amendment No.: 191. issuance. original no significant hazards Facility Operating License No. DPR– Amendment Nos.: 213, 207. consideration determination. 67: Amendment revised the Technical Renewed Facility Operating License The Commission’s related evaluation Specifications. Nos. NPF–35 and NPF–52: Amendments of the amendment is contained in a Date of initial notice in Federal revised the Technical Specifications. Safety Evaluation dated May 4, 2004. Register: June 25, 2002 (67 FR 42827).

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The supplemental letters provided Date of initial notice in Federal Facility Operating License Nos. DPR– clarifying information that was within Register: March 2, 2004 (69 FR 9862). 80 and DPR–82: The amendments the scope of the initial notice and did The Commission’s related evaluation revised the Technical Specifications. not change the initial proposed no of the amendment is contained in a Date of initial notice in Federal significant hazards consideration Safety Evaluation dated May 13, 2004. Register: March 2, 2004 (69 FR 9864). determination. No significant hazards consideration The March 11, 2004, supplemental The Commission’s related evaluation comments received: No. letter provided additional information of the amendment is contained in a Omaha Public Power District, Docket that clarified the application, did not Safety Evaluation dated May 6, 2004. No. 50–285, Fort Calhoun Station, Unit expand the scope of the application as No significant hazards consideration No. 1, Washington County, Nebraska originally noticed, and did not change comments received: No. the staff’s original proposed no Date of amendment request: July 25, significant hazards consideration Nine Mile Point Nuclear Station, LLC, 2003, as supplemented on December 5, Docket No. 50–410, Nine Mile Point determination as published in the 2003 Federal Register. Nuclear Station, Unit 2, Oswego County, Brief description of amendment: The New York The Commission’s related evaluation amendment modifies Technical of the amendments is contained in a Date of application for amendment: Specification (TS) 2.1.4, ‘‘Reactor Safety Evaluation dated May 4, 2004. August 22, 2003, as supplemented by Coolant System (RCS) Leakage Limits,’’ No significant hazards consideration letters dated January 12 and March 11, by (1) adding a requirement for no RCS comments received: No. 2004. pressure boundary leakage, (2) Brief description of amendment: The combining the existing RCS leakage Dated at Rockville, Maryland, this 14th amendment revised Section 3.7.1, limits into a format similar to the May 2004. ‘‘Service Water (SW) System and Improved Standard TS (ISTS), and (3) For the Nuclear Regulatory Commission. Ultimate Heat Sink (UHS),’’ by adding a replacing the existing basis associated Eric J. Leeds, new Condition G to allow continued with this TS with a basis similar in Acting Director, Division of Licensing Project operation with short-term elevated UHS format and content to the ISTS. Management, Office of Nuclear Reactor temperatures. Date of issuance: May 7, 2004. Regulation. Date of issuance: May 7, 2004. Effective date: As of the date of [FR Doc. 04–11507 Filed 5–24–04; 8:45 am] Effective date: As of the date of issuance, to be implemented within 90 BILLING CODE 7590–01–P issuance to be implemented within 60 days from issuance. days. Amendment No.: 226. Amendment No.: 113. Renewed Facility Operating License NUCLEAR REGULATORY Facility Operating License No. NPF– No. DPR–40: The amendment revised COMMISSION 69: Amendment revises the Technical the Technical Specifications. 10 CFR Part 52 Construction Specifications. Date of initial notice in Federal Date of initial notice in Federal Register: August 19, 2003 (68 FR 49818). Inspection Program Framework Register: September 30, 2003 (68 FR The December 5, 2003, supplemental Document; Availability of NUREG 56344). letter provided additional information AGENCY: U.S. Nuclear Regulatory The January 12 and March 11, 2004, that clarified the application, did not Commission. letters provided clarifying information expand the scope of the application as ACTION: within the scope of the original originally noticed, and did not change Notice of availability. application, and did not change the the staff’s original proposed no SUMMARY: The Nuclear Regulatory staff’s initial proposed no significant significant hazards consideration Commission is announcing the hazards consideration determination. determination. completion and availability of NUREG– The staff’s related evaluation of the The Commission’s related evaluation 1789, ‘‘10 CFR Part 52 Construction amendment is contained in a Safety of the amendment is contained in a Inspection Program Framework Evaluation dated May 7, 2004. Safety Evaluation dated May 7, 2004. Document,’’ dated April 2004. No significant hazards consideration No significant hazards consideration comments received: No. comments received: No. ADDRESSES: Copies of NUREG–1789 may be purchased from the Nuclear Management Company, LLC, Pacific Gas and Electric Company, Superintendent of Documents, U.S. Docket No. 50–305, Kewaunee Nuclear Docket Nos. 50–275 and 50–323, Diablo Government Printing Office, P.O. Box Power Plant, Kewaunee County, Canyon Nuclear Power Plant, Unit Nos. 37082, Washington, DC 20402–9328; Wisconsin 1 and 2, San Luis Obispo County, http://www.access.gpo.gov/su_docs; Date of application for amendment: California 202–512–1800 or The National January 30, 2004. Date of application for amendments: Technical Information Service, Brief description of amendment: The December 30, 2003, and its supplement Springfield, Virginia 22161–0002; amendment relocates the requirements dated March 11, 2004. http://www.ntis.gov; 1–800–533–6847 for hydrogen monitors from the Brief description of amendments: The or, locally, 703–805–6000. Technical Specifications to the amendments eliminate the requirements A copy of the document is also Technical Requirements Manual. in the technical specifications available for inspection and/or copying Date of issuance: May 13, 2004. associated with hydrogen recombiners for a fee in the NRC Public Document Effective date: As of the date of and hydrogen monitors. Room, 11555 Rockville Pike, Rockville, issuance and shall be implemented Date of issuance: May 4, 2004. Maryland. As of November 1, 1999, you within 120 days. Effective date: May 4, 2004, and shall may also electronically access NUREG- Amendment No.: 174. be implemented within 60 days from series publications and other NRC Facility Operating License No. DPR– the date of issuance. records at NRC’s Public Electronic 43: Amendment revised the Technical Amendment Nos.: Unit 1—168; Unit Reading Room at http://www.nrc.gov/ Specifications. 2—169. reading-rm.html.

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Some publications in the NUREG PRESIDIO TRUST • Battery Caulfield Alternative series that are posted at NRC’s Web site (Alternative 4)—Rehabilitates the address http://www.nrc.gov are updated Public Health Service Hospital, The historic buildings for residential use, regularly and may differ from the last Presidio of San Francisco (Presidio), removes the hospital’s non-historic printed version. CA; Notice of Intent To Prepare a wings as well as other non-historic Supplemental Environmental Impact buildings and additions, and provides FOR FURTHER INFORMATION, CONTACT: Ms. Statement and Conduct Public for new construction on Battery Mary Ann M. Ashley, Inspection Scoping Caulfield. Program Branch, U.S. Nuclear AGENCY: The Presidio Trust. Regulatory Commission, Washington, A complete description of DC 20555–0001. Ms. Ashley may be ACTION: The Presidio Trust (Trust) Alternatives 1 through 4 is provided in reached at (301) 415–1073 or by e-mail announces, in accordance with the the EA, which may be viewed at or provisions of the National at [email protected]. downloaded from the Trust’s Web site at Environmental Policy Act (NEPA) (42 http://www.presidio.gov following the SUPPLEMENTARY INFORMATION: On May U.S.C. 4321 et seq.), that it is link from the home page. A printed 30, 2003, the NRC staff issued the ‘‘Draft commencing preparation of a copy may be requested at no charge at Supplemental Environmental Impact 10 CFR Part 52 Construction Inspection 415/561–5414 or Statement (SEIS) regarding the Program Framework Document’’ for [email protected], or by writing to public comment. The framework rehabilitation and reuse of historic buildings in the Public Health Service the Presidio Trust, P.O. Box 29052, San document set forth the proposed basis Francisco, CA 94129–0052. The EA may for the construction inspection program Hospital (PHSH) district of the Presidio, and that the Trust is inviting the also be reviewed in the Trust’s library for reactors built under 10 CFR Part 52. on the Presidio at 34 Graham Street, San A public workshop was held on August participation of the public and interested agencies in the scoping Francisco, CA. 27, 2003 to discuss the scope and the process. The SEIS tiers from the Final types of inspections which are planned The Trust encourages all interested EIS for the Presidio Trust Management individuals, organizations and agencies during the new reactor construction Plan, the Trust’s comprehensive land project. to provide comments on the scope of the use plan and policy framework for Area SEIS. As part of the scoping process, The NRC has considered the B of the Presidio, adopted in August oral comments will be accepted from comments received from stakeholders 2002. the public on the issues and choice of and has incorporated them, as SUMMARY: alternatives to be considered in the SEIS appropriate, into a final revision of the The Trust prepared and made available to the public an at a Trust public meeting on June 29, construction inspection program Environmental Assessment (EA) for the 2004, beginning at 6 p.m., at the framework document and is issuing the PHSH in February 2004 (69 FR 96591). Officers’ Club, 50 Moraga Avenue, on framework as NUREG–1789. A detailed Based on the impact analysis in the EA the Main Post in the Presidio. Written resolution of comments submitted about and a review of public comments comments may be submitted to John the draft framework document has been received on the document, the Trust has Pelka, NEPA Compliance Coordinator at incorporated into NUREG–1789. The determined that the proposed Federal 415/561–2790 (fax), NUREG details the audits and action has the potential to cause [email protected], or the Trust inspections that will be conducted by significant effects on the human Post Office address specified above, and the NRC during the Early Site Permit environment, and that a SEIS would must be received no later than July 7, (ESP) and Combined License (COL) best achieve NEPA’s goals. The EA will 2004. Comments previously received phases. The document also discusses be used to help facilitate preparation of regarding the EA need not be repeated; how the NRC staff will verify the SEIS, which will include new these comments will inform the Trust’s substantive environmental analyses and satisfactory completion of the preparation of the Supplemental EIS. information in response to public inspections, tests, analyses, and Please be aware that all written acceptance criteria (ITAAC) and review comment. The SEIS will evaluate the following comments and information submitted operational programs. NRC staff will use will be made available to the public, the inspection program descriptions alternatives: • No-Action Alternative—Continues including, without limitation, any contained in the framework NUREG to recent and existing activities in the postal address, e-mail address, phone guide the development of internal PHSH district with no building number or other information contained inspection documents including rehabilitation, new construction or in each submission. Inspection Manual Chapters and demolition. Inspection Procedures. • The Trust will provide information PTMP Alternative (Alternative 1)— updates and notices concerning the Rehabilitates existing buildings for Dated at Rockville, Maryland, this 12th day project through postings on its Web site educational and residential uses with no of May 2004. or through its bi-monthly publication, For the Nuclear Regulatory Commission. new construction or demolition. • the Presidio Post. The Trust will Stuart A. Richards, Infill Alternative (Alternative 2)— Rehabilitates the historic buildings as announce the release of the SEIS by Chief, Inspection Program Branch, Division well as the non-historic wings of the notice in the Federal Register and of Inspection Program Management, Office hospital for residential use with limited Presidio Post, as well as via direct of Nuclear Reactor Regulation. demolition and new construction. mailing and other means. [FR Doc. 04–11757 Filed 5–24–04; 8:45 am] • No Infill Alterative (Alternative 3)— FOR FURTHER INFORMATION CONTACT: John BILLING CODE 7590–01–P Rehabilitates the historic buildings for Pelka, NEPA Compliance Coordinator, residential use and removes the hospital’s non-historic wings as well as the Presidio Trust, 34 Graham Street, other non-historic buildings and P.O. Box 29052, San Francisco, CA additions. 94129–0052, 415/561–5300.

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Dated: May 19, 2004. proposed rule change and discussed any 19(b)(3)(A)(iii) of the Act 8 and Rule Karen A. Cook, comments it received on the proposed 19b–4(f)(3) thereunder 9 in that it is General Counsel. rule change. The text of these statements concerned solely with the [FR Doc. 04–11753 Filed 5–24–04; 8:45 am] may be examined at the places specified administration of the self-regulatory BILLING CODE 4310–4R–P in Item IV below. Nasdaq has prepared organization. At any time within 60 summaries, set forth in Sections A, B, days of the filing of such proposed rule and C below, of the most significant change, the Commission may summarily SECURITIES AND EXCHANGE aspects of such statements. abrogate the rule change if it appears to COMMISSION A. Self-Regulatory Organization’s the Commission that such action is Statement of the Purpose of, and necessary or appropriate in the public [Release No. 34–49732; File No. SR–NASD– interest, for the protection of investors, 2004–069] Statutory Basis for, the Proposed Rule Change or otherwise in furtherance of the Self-Regulatory Organizations; Notice purposes of the Act. 1. Purpose of Filing and Immediate Effectiveness IV. Solicitation of Comments of Proposed Rule Change by the On November 4, 2003, the Interested persons are invited to National Association of Securities Commission approved a number of rule submit written data, views, and Dealers, Inc. To Redesignate Rules changes to the rules relating to the arguments concerning the foregoing, 4200A and 4350A corporate governance of companies listed on Nasdaq,5 including the including whether the proposed rule May 19, 2004. adoption of Rules 4200A and 4350A. change is consistent with the Act. Pursuant to section 19(b)(1) of the Nasdaq seeks to redesignate Rules Comments may be submitted by any of Securities Exchange Act of 1934 4200A and 4350A as 4200–1 and 4350– the following methods: 1 2 (‘‘Act’’) and Rule 19b–4 thereunder, 1, respectively, to avoid any confusion Electronic Comments notice is hereby given that on April 23, with previously existing NASD Rule • 2004, the National Association of 4200A. In addition, Nasdaq seeks to Use the Commission’s Internet Securities Dealers, Inc. (‘‘NASD’’), conform references to Rules 4200A and comment form (http://www.sec.gov/ rules/sro.shtml); or through its subsidiary, The Nasdaq 4350A in other rules. • Stock Market, Inc. (‘‘Nasdaq’’), filed Send an e-mail to rule- 2. Statutory Basis with the Securities and Exchange [email protected]. Please include File Commission (‘‘Commission’’) the Nasdaq believes that the proposed No. SR–NASD–2004–069 on the subject proposed rule change as described in rule change is consistent with the line. Items I, II, and III below, which Items provisions of Section 15A of the Act,6 in Paper Comments have been prepared by Nasdaq. general, and with Section 15A(b)(6) of • the Act,7 in particular, in that it is Send paper comments in triplicate Pursuant to section 19(b)(3)(A)(iii) of the to Jonathan G. Katz, Secretary, 3 4 designed to prevent fraudulent and Act and Rule 19b–4(f)(3) thereunder, Securities and Exchange Commission, Nasdaq has designated this proposal as manipulative acts and practices, to promote just and equitable principles of 450 Fifth Street, NW., Washington, DC one concerned solely with the 20549–0609. administration of the self-regulatory trade, remove impediments to a free and open market and a national market All submissions should refer to File organization, which renders the No. SR–NASD–2004–069. This file proposal effective upon filing with the system, and, in general, to protect investors and the public interest. number should be included on the Commission. The Commission is subject line if e-mail is used. To help the publishing this notice to solicit Nasdaq believes that clarifying the new rules helps investors and issuers. Commission process and review your comments on the proposed rule change comments more efficiently, please use from interested persons. B. Self-Regulatory Organization’s only one method. The Commission will I. Self-Regulatory Organization’s Statement on Burden on Competition post all comments on the Commission’s Statement of the Terms of Substance of Nasdaq does not believe that the Internet Web site (http://www.sec.gov/ the Proposed Rule Change proposed rule change will impose any rules/sro.shtml). Copies of the submission, all subsequent Nasdaq is filing a proposed rule burden on competition that is not amendments, all written statements change to redesignate Rules 4200A and necessary or appropriate in furtherance with respect to the proposed rule 4350A as 4200–1 and 4350–1 of the purposes of the Act. change that are filed with the respectively, and to make conforming C. Self-Regulatory Organization’s Commission, and all written changes. Statement on Comments on the The text of the proposed rule change communications relating to the Proposed Rule Change Received from proposed rule change between the is available at Nasdaq and at the Members, Participants, or Others Commission. Commission and any person, other than Written comments were neither those that may be withheld from the II. Self-Regulatory Organization’s solicited nor received. public in accordance with the Statement of the Purpose of, and III. Date of Effectiveness of the provisions of 5 U.S.C. 552, will be Statutory Basis for, the Proposed Rule Proposed Rule Change and Timing for available for inspection and copying in Change Commission Action the Commission’s Public Reference In its filing with the Commission, Section, 450 Fifth Street, NW., The foregoing rule change has become Nasdaq included statements concerning Washington, DC 20549. Copies of such effective pursuant to section the purpose of and basis for the filing also will be available for inspection and copying at the principal 5 See Securities Exchange Act Release No. 48475 1 15 U.S.C. 78s(b)(1). (November 4, 2003), 68 FR 64154 (November 12, office of the NASD. All comments 2 17 CFR 240.19b–4. 2003). 3 15 U.S.C. 78s(b)(3)(A)(iii). 6 15 U.S.C. 78o–3. 8 15 U.S.C. 78s(b)(3)(A)(iii). 4 17 CFR 240.19b–4(f)(3). 7 15 U.S.C. 78o–3(b)(6). 9 17 CFR 240.19–4(f)(3).

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received will be posted without change; DATES: Comments must be received on Issued in Washington, DC, on May 18, the Commission does not edit personal or before July 26, 2004. 2004. identifying information from Judith D. Street, ADDRESSES: Comments may be mailed submissions. You should submit only FAA Information Collection Clearance or delivered to the FAA at the following information that you wish to make Officer, APF–100. address: Ms. Judy Street, Room 613, available publicly. All submissions [FR Doc. 04–11792 Filed 5–24–04; 8:45 am] Federal Aviation Administration, should refer to File No. SR–NASD– BILLING CODE 4910–13–M Standards and Information Division, 2004–069 and should be submitted on APF–100, 800 Independence Ave., SW., or before June 15, 2004. Washington, DC 20591. For the Commission, by the Division of DEPARTMENT OF TRANSPORTATION Market Regulation, pursuant to delegated FOR FURTHER INFORMATION CONTACT: Ms. authority.10 Judy Street at the above address or on Federal Aviation Administration Margaret H. McFarland, (202) 267–9895. [Summary Notice No. PE–2004–33] Deputy Secretary. SUPPLEMENTARY INFORMATION: In Petitions for Exemption; Dispositions [FR Doc. 04–11764 Filed 5–24–04; 8:45 am] accordance with the Paperwork of Petitions Issued BILLING CODE 8010–01–P Reduction Act of 1995, an agency may not conduct or sponsor, and a person is AGENCY: Federal Aviation not required to respond to a collection Administration (FAA), DOT. SMALL BUSINESS ADMINISTRATION of information unless it displays a ACTION: Notice of dispositions of prior currently valid OMB control number. petitions. Advisory Committee on Veterans Therefore, the FAA solicits comments Business Affairs; Public Meeting on the following current collections of SUMMARY: Pursuant to FAA’s rulemaking information in order to evaluate the provisions governing the application, The U.S. Small Business necessity of the collection, the accuracy processing, and disposition of petitions Administration (SBA), pursuant to the of the agency’s estimate of the burden, for exemption part 11 of Title 14, Code Veterans Entrepreneurship and Small the quality, utility, and clarity of the of Federal Regulations (14 CFR), this Business Development Act of 1999 (Pub. information to be collected, and notice contains a summary of certain L. 106–50), will host its second meeting possible ways to minimize the burden of dispositions of certain petitions of the Advisory Committee on Veterans the collection in preparation for previously received. The purpose of this Business Affairs for fiscal year 2004. submission to renew the clearances of notice is to improve the public’s The meeting will be held on June 1–2, the following information collections. awareness of, and participation in, this 2004, from 9 a.m.–5 p.m. in the 1. 2120–0020, Maintenance, aspect of FAA’s regulatory activities. Eisenhower conference room, located on Preventive Maintenance, Rebuilding, FOR FURTHER INFORMATION CONTACT: the 2nd floor, side B at the SBA, 409 3rd Tim and Alternation. FAR Part 43 prescribes Street, SW., Washington, DC, 20416. If Adams (202) 267–8033, or Sandy the rules governing maintenance, you have any questions or concerns Buchanan-Sumter (202) 267–7271, rebuilding, and alteration of aircraft and regarding this meeting, please contact Office of Rulemaking (ARM–1), Federal aircraft components, and is necessary to Ms. Cheryl Clark in The Office of Aviation Administration, 800 ensure this work is performed by Veterans Business Development (OVBD) Independence Avenue, SW., qualified persons, and at proper at (202) 619–1697. Washington, DC 20591. intervals. This work is done by certified This notice is published pursuant to Matthew K. Becker, mechanics, repair stations, and air 14 CFR 11.85 and 11.91. Committee Manager Officer, Office of the carriers authorized to perform Issued in Washington, DC, on May 19, Administrator. maintenance. The current estimated 2004. [FR Doc. 04–11759 Filed 5–24–04; 8:45 am] annual reporting burden is 1,43,784 Donald P. Byrne, BILLING CODE 8025–01–P hours. Assistant Chief Counsel for Regulations. 2. 2120–0101, Psychological Training. This report is necessary to establish Dispositions of Petitions DEPARTMENT OF TRANSPORTATION qualifications of eligibility to receive Docket No.: FAA–2002–13275. voluntary psychological training and Petitioner: Frankfort Flight Service, Federal Aviation Administration will be used as proper evidence of Inc. training. The form is completed by Section of 14 CFR Affected: 14 CFR Notice of Intent To Request Renewal pilots and crewmembers for application 135.143(c)(2). From the Office of Management and to receive voluntary training. The Description of Relief Sought/ Budget (OMB) of Three Current Public current estimated annual reporting Disposition: To permit Frankfort Flight Collections of Information burden is 733 hours. Service, Inc., to operate certain aircraft AGENCY: Federal Aviation 3. 2120–0524, High Density Airports, under part 135 without a TSO–C112 Administration (FAA), DOT. Slot Allocation and Transfer Methods. (Mode S) transponder installed on those aircraft. ACTION: Notice. The FAA needs this information to allocate slots and maintain accurate Grant, 5/5/2004, Exemption No. SUMMARY: In compliance with the records of slot transfers at the High 7888A Paperwork Reduction Act (44 U.S.C. Density Traffic Airports. The Docket No.: FAA–2001–9502. 3501 et seq.), the FAA invites public information will be provided by air Petitioner: AMI Jet Charter, Inc./TAG comment on three currently approved carriers and commuter operators or Aviation d/b/a. Section of 14 CFR public information collections which other persons holding a slot at High Affected: 14 CFR 135.152(i)(1). will be submitted to OMB for renewal. Density Traffic Airports. The current Description of Relief Sought/ estimated annual reporting burden is Disposition: To permit AMI Jet Charter, 10 17 CFR 200.30–3(a)(12). 3,064 hours. Inc./TAG Aviation d/b/a, to operate a

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Dassault Falcon 50–900EX aircraft qualified and authorized check airman Docket No.: FAA–2004–17632. without meeting the digital flight data in place of a Federal Aviation Petitioner: Alaska Air Transit. recorder requirements established by Administration inspector to observe a Section of 14 CFR Affected: 14 CFR the Federal Aviation Administration. qualifying pilot in command who is 135.143(c)(2). Denial, 5/4/2004, Exemption No. 8310 completing the initial or upgrade Description of Relief Sought/ Docket No.: FAA–2001–10955. training specified in § 121.424 during at Disposition: To permit Alaska Air Petitioner: LC Busre E.I.R.L. least one flight leg that includes a Transit to operate certain aircraft under Section of 14 CFR Affected: 14 CFR takeoff and a landing, subject to certain part 135 without a TSO–C112 (Mode S) 135.152. conditions and limitations. transponder installed on those aircraft. Description of Relief Sought/ Grant, 5/4/2004, Exemption No. Grant, 5/3/2004, Exemption No. 8301 Disposition: To permit LC Busre E.I.R.L., 6473D Docket No.: FAA–2001–9331. to operate a Fairchild Metroliner III SA– Docket No.: FAA–2002–12728. Petitioner: Pratt & Whitney. 227–AC airplane, registration No. Petitioner: National Business Aviation Section of 14 CFR Affected: 14 CFR N139LC, in a 19-passenger configuration Association, Inc. 21.325(b)(3). under part 135, without the airplane Section of 14 CFR Affected: 14 CFR Description of Relief Sought/ being equipped with one or more digital 91.409(e) and 91.501(a). Disposition: To permit authorized flight data recorders. Description of Relief Sought/ representatives employed by Pratt & Denial, 5/4/2004, Exemption No. 8311 Disposition: To permit National Whitney ODAR to issue export Docket No.: FAA–2004–17409. Business Aviation Association, Inc., airworthiness approvals for Class II and Petitioner: United Parcel Service. members to operate small civil airplanes Class II products manufactured and Section of 14 CFR Affected: 14 CFR and helicopters of U.S. registry under located at Pratt & Whitney suppliers 121.434(c)(1) and (2). the operating rules of §§ 91.503 through located in Germany, Italy, Japan, and Description of Relief Sought/ 91.535 and to select an inspection Sweden. Disposition: To permit a United Parcel program as described in § 91.409(f), Grant, 4/28/2004, Exemption No. Service check airman to take a rest subject to certain conditions and 7915A period during the cruise portion of a limitations. Docket No.: FAA–2002–11799. flight leg in which the check airman is Grant, 5/3/2004, Exemption No. Petitioner: Matsushita Avionics observing the operating experience of a 7897A Systems Corporation. qualifying crewmember. Docket No.: FAA–2004–17609. Section of 14 CFR Affected: 14 CFR Denial, 5/4/2004, Exemption No. 8308 Petitioner: Rugby Aviation, LLC. 21.325(b)(3). Docket No.: FAA–2004–17514. Section of 14 CFR Affected: 14 CFR Description of Relief Sought/ Petitioner: Mr. Adrian A. Eichhorn. 135.143(c)(2). Disposition: To permit Matsushita Section of 14 CFR Affected: 14 CFR Description of Relief Sought/ Avionics Systems Corporation (MAS) 91.109(a) and (b)(3). Disposition: To permit Rugby Aviation, airworthiness representatives, reporting Description of Relief Sought/ LLC, to operate certain aircraft under to an ODAR at MAS Bothell, to issue Disposition: To permit Mr. Adrian A. part 135 without a TSO–C112 (Mode S) export airworthiness approvals for Class Eichhorn to conduct certain flight transponder installed on those aircraft. III products manufactured by MAS training and to provide simulated Grant, 5/3/2004, Exemption No. 8305 Osaka. instrument flight experience in certain Docket No.: FAA–2004–17631. Grant, 4/28/2004, Exemption No. Beech airplanes that are equipped with Petitioner: JIM Air, Inc. 7925A a functioning throwover control wheel. Section of 14 CFR Affected: 14 CFR Docket No.: FAA–2002–11900. Grant, 5/4/2004, Exemption No. 8307 135.143(c)(2). Petitioner: AM–SAFE Aviation, Inc. Docket No.: FAA–2004–17600. Description of Relief Sought/ Section of 14 CFR Affected: 14 CFR Petitioner: Barth’s Aviation. Disposition: To permit JIM Air, Inc., to 21.325(b)(3). Section of 14 CFR Affected: 14 CFR operate certain aircraft under part 135 Description of Relief Sought/ 61.89(a)(5) and 61.111(b). without a TSO–C112 (Mode S) Disposition: To permit AM–SAFE Description of Relief Sought/ transponder installed on those aircraft. Aviation, Inc., (AMSAFE) to issue Disposition: To permit Mr. Maxime Grant, 5/3/2004, Exemption No. 8304 export airworthiness approvals for Class Desouches’ student pilots of Barth’s Docket No.: FAA–2004–17663. II and Class III products manufactured Aviation, to conduct solo flights Petitioner: Excel Aviation, LLC. by AMSAFE Aviation UK in the United between the French islands of Saint Section of 14 CFR Affected: 14 CFR Kingdom under AMSAFE’s technical Bathelemy, Saint Martin and 135.143(c)(2). standard order authorizations. Guadeloupe, the Dutch islands of Sint Description of Relief Sought/ Grant, 4/28/2004, Exemption No. Maarten, Sint Eustatius in the Disposition: To permit Excel Aviation, 7354B Netherlands Antilles and the islands of LLC, to operate certain aircraft under Docket No.: FAA–2004–16911. the Federation of St. Kitts and Nevis in part 135 without a TSO–C112 (Mode S) Petitioner: American Airlines, Inc. the eastern Carribbean while fulfilling transponder installed on those aircraft. Section of 14 CFR Affected: 14 CFR the cross-country requirements for a Grant, 5/3/2004, Exemption No. 8303 121.434(c)(1) and (2). private pilot certificate. Docket No.: FAA–2004–17633. Description of Relief Sought/ Grant, 5/4/2004, Exemption No. 8309 Petitioner: Moore Quality Flying. Disposition: To permit an American Docket No.: FAA–2002–12343. Section of 14 CFR Affected: 14 CFR Airlines, Inc., (AAL) check airman to Petitioner: Federal Express 135.143(c)(2). take a rest period during the cruise Corporation. Description of Relief Sought/ portion of a flight leg in which the Section of 14 CFR Affected: 14 CFR Disposition: To permit Moore Quality check airman is required to supervise 121.434(c)(1)(ii). Flying to operate certain aircraft under the operating experience of a qualifying Description of Relief Sought/ part 135 without a TSO–C112 (Mode S) AAL pilot in command or a qualifying Disposition: To permit the Federal transponder installed on those aircraft. AAL second in command. Express Corporation to substitute a Grant, 5/3/2004, Exemption No. 8302 Denial, 5/1/2004, Exemption No. 8300

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Docket No.: FAA–2002–13134. Docket No.: FAA–2002–12097. type certificate * * *’’ to read Petitioner: Ram Air Freight, Inc. Petitioner: Mirabella Aviation. ‘‘Description of Relief sought: To permit Section of 14 CFR Affected: 14 CFR Section of 14 CFR Affected: 14 CFR the Eagle 150B–23 aircraft, which will 135.143(c)(2). 135.143(c)(2). be issued a 14 CFR 21.21 type certificate Description of Relief Sought/ Description of Relief Sought/ ***’’. Disposition: To permit Ram Air Freight, Disposition: To permit Mirabella Inc., to operate certain aircraft under Aviation to operate certain aircraft Issued in Washington, DC, on May 19, part 135 without a TSO–C112 (Mode S) under part 135 without a TSO–C112 2004. transponder installed on those aircraft. (Mode S) transponder installed on those Donald P. Byrne, Grant, 5/3/2004, Exemption No. aircraft. Assistant Chief Counsel for Regulations. 7876A Grant, 4/29/2004, Exemption No. [FR Doc. 04–11786 Filed 5–24–04; 8:45 am] Docket No.: FAA–2002–13178. 7178B BILLING CODE 4910–13–P Petitioner: Cedar Valley Air Charter. Docket No.: FAA–2002–11498. Section of 14 CFR Affected: 14 CFR Petitioner: Air Tractor, Inc. 135.143(c)(2). Section of 14 CFR Affected: 14 CFR DEPARTMENT OF TRANSPORTATION Description of Relief Sought/ 61.31(a)(1). Disposition: To permit Cedar Valley Air Description of Relief Sought/ Federal Aviation Administration Charter to operate certain aircraft under Disposition: To permit Air Tractor, Inc., part 135 without a TSO–C112 (Mode S) and pilots of Air Tractor AT–802 and RTCA Government/Industry Air Traffic transponder installed on those aircraft. AT–802A airplanes to operate those Management Advisory Committee Grant, 5/3/2004, Exemption No. airplanes without holding a type rating, (Successor of RTCA Government/ 7880A although the maximum gross weight of Industry Free Flight Steering Docket No.: FAA–2001–11080. the airplanes exceeds 12,500 pounds. Committee) Petitioner: Experimental Aircraft Grant, 4/27/2004, Exemption No. 5651H Association, Small Aircraft AGENCY: Federal Aviation Manufacturers Association, and [FR Doc. 04–11785 Filed 5–24–04; 8:45 am] Administration (FAA), DOT. National Association of Flight BILLING CODE 4910–13–P Instructors. ACTION: Notice of RTCA/Industry Air Section of 14 CFR Affected: 14 CFR Traffic Management Advisory 91.319(a)(1) and (2). DEPARTMENT OF TRANSPORTATION Committee. Description of Relief Sought/ Disposition: To permit the members of Federal Aviation Administration SUMMARY: The FAA is issuing this notice the Experimental Aircraft Association, [Summary Notice No. PE–2004–32] to advise the public of a meeting of the Small Aircraft Manufacturers RTCA Government/Industry Air Traffic Association, and the National Petitions for Exemption; Summary of Management Advisory Committee. Association of Flight Instructors who Petitions Received; Correction own certain amateur-and kit-built DATES: The meeting will be held June 2, aircraft certificated in the experimental AGENCY: Federal Aviation 2004, 1–3 p.m. Administration (FAA), DOT. category, to receive compensation for ADDRESSES: The meeting will be held at the use of the aircraft for the purpose of ACTION: Notice of petitions for Aerospace Building, 901 D Street, SW., conducting aircraft-specific flight exemption received; correction. Andrews/BWI Conference Rooms (Suite training and flight reviews under 14 850) Washington, DC, 20024. CFR 61.56. SUMMARY: This document makes a Grant, 5/2/2004, Exemption No. correction to the summary of petitions FOR FURTHER INFORMATION CONTACT: (1) 7162C received published in the Federal RTCA Secretariat, 1828 L Street, NW., Docket No.: FAA–2002–13346. Register on March 23, 2004 (69 FR Suite 805, Washington, DC, 20036; Petitioner: Westjet Air Center, Inc. 13615). That notice contained a telephone (202) 833–9339; fax (202) Section of 14 CFR Affected: 14 CFR summary of certain petitions seeking 833–9434; Web site http://www.rtca.org. 135.143(c)(2). relief from specified requirements of 14 Description of Relief Sought/ CFR. SUPPLEMENTARY INFORMATION: Pursuant Disposition: To permit Westjet Air FOR FURTHER INFORMATION CONTACT: John to section 10(a)(2) of the Federal Center, Inc., to operate certain aircraft Linsenmeyer (202) 267–5174, Tim Advisory Committee (Pub. L. 92–463, 5 under part 135 without a TSO–C112 Adams (202) 267–8033, or Sandy U.S.C., Appendix 2), notice is hereby (Mode S) transponder installed on those Buchanan-Sumter (202) 267–7271, given for the Air Traffic Management aircraft. Office of Rulemaking (ARM–1), Federal Advisory Committee meeting. Grant, 4/30/2004, Exemption No. Aviation Administration, 800 7881A Independence Avenue, SW., Note: Non-Government attendees to the meeting must go through security and be Docket No.: FAA–2003–15969. Washington, DC 20591. Petitioner: Northern Air Cargo, Inc. escorted to and from the conference room. Correction Section of 14 CFR Affected: 14 CFR Issued in Washington, DC, on May 17, In notice of petitions for exemption 121.345(c)(2). 2004. Description of Relief Sought/ FR Doc. 04–6384, published on March Disposition: To permit Northern Air 23, 2004 (69 FR 13615), make the Natalie Olgetree, Cargo, Inc., to operate certain aircraft following correction: FAA General Engineer, RTCA Advisory under part 121 without a TSO–C112 1. On page 13615, in column 2, under Committee. (Mode S) transponder installed on those the heading ‘‘Petition for Exemption,’’ [FR Doc. 04–11793 Filed 5–24–04; 8:45 am] aircraft. correct ‘‘Description of Relief sought: To BILLING CODE 4910–13–M Grant, 4/30/2004, Exemption No. permit the Eagle 150B–23 aircraft, 8121A which will be issued a 14 CFR 21.29

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DEPARTMENT OF TRANSPORTATION holidays by making an appointment in with State funds. No federal funds or advance with the person listed under federal action will be required for the Federal Aviation Administration FOR FURTHER INFORMATION CONTACT. project. The UDOT will prepare a State Environmental Study for the project. Background Proposed Policy Statement on Comments or questions concerning this Establishing Supplemental Type Policy statement PS–ACE100–2004– action should be directed to FHWA at Certificate (STC) Project Workload 10028, Establishing Supplemental Type the address provided above. Priorities; PS–ACE100–2004–10028 Certificate (STC) Project Workload (Catalog of Federal and Domestic Assistance AGENCY: Federal Aviation Priorities, has been drafted to aid both Program Number 20.205, Highway Research, Administration (FAA), DOT. the applicant and the Aircraft Planning and Construction. The regulations Certification Offices in evaluating the ACTION: Notice of availability of implementing Executive Order 12372 priorities for STC projects. The FAA proposed policy statement and request regarding intergovernmental consultation on will give priority to projects that contain Federal programs and activities apply to this for comments. an application, a certification plan, and program.) SUMMARY: This notice announces the information about the intended use of Issued on: May 19, 2004. availability of, and requests comments FAA designees. Further details of the Gregory S. Punske, on, proposed policy statement PS– plan are contained in the proposed Environmental Program Manager, Utah ACE100–2004–10028, which establishes policy statement. Division, Federal Highway Administration, workload priorities for incoming Issued in Kansas City, Missouri on May 12, Salt Lake City, Utah. supplemental type certificate projects 2004. [FR Doc. 04–11813 Filed 5–24–04; 8:45 am] (STC). When new STC projects arrive, David R. Showers, BILLING CODE 4910–22–M the Aircraft Certification Office engineer Acting Manager, Small Airplane Directorate, or supervisor must prioritize these Aircraft Certification Service. projects. To avoid devoting excessive [FR Doc. 04–11784 Filed 5–24–04; 8:45 am] DEPARTMENT OF TRANSPORTATION FAA resources to incomplete data BILLING CODE 4910–13–P packages, we are establishing a policy Federal Railroad Administration that will minimize delays to applicants Petition for Waiver of Compliance who submit complete packages. DEPARTMENT OF TRANSPORTATION DATES: Comments must be received on In accordance with part 211 of title 49 or before July 26, 2004. Federal Highway Administration Code of Federal Regulations (CFR), ADDRESSES: Send all comments on the Environmental Impact Statement: Salt notice is hereby given that the Federal proposed policy statement to: Federal Lake County, UT railroad Administration (FRA) has Aviation Administration, Small received a request for a waiver of Airplane Directorate, Aircraft AGENCY: Federal Highway compliance of certain requirements of Certification Service, Regulations and Administration (FHWA), DOT. its safety regulations. The individual Policy (ACE–111), 901 Locust Street, ACTION: Withdrawal of Notice of Intent. petition is described below, including Kansas City, Missouri 64106. the party seeking relief, the regulatory FOR FURTHER INFORMATION CONTACT: Mr. SUMMARY: The FHWA is issuing this provisions involved, the nature of the Taylor Martin, Standards Office, Small notice to advise the public that the effort relief being requested, and the Airplane Directorate, Aircraft to prepare an Environmental Impact petitioner’s arguments in favor of relief. Statement (EIS) will be terminated for Certification Service, Kansas City, Norfolk Southern Corporation Missouri 64106, telephone (816) 329– transportation improvements in the 4138, fax (816) 329–4090. corridor of Redwood Road (SR–68) in [Docket Number FRA–2003–16203] Salt Lake County, Utah. SUPPLEMENTARY INFORMATION: Any Norfolk Southern Corporation (NS) person may obtain a copy of this FOR FURTHER INFORMATION CONTACT: seeks to modify existing waiver FRA– proposed policy statement by contacting Sandra Garcia-Aline, Environmental 2002–11896, which is a conditional the person named above under FOR Engineer, FHWA, Utah Division, 2520 waiver of compliance from certain FURTHER INFORMATION CONTACT. A copy West 4700 South, Suite 9A, Salt Lake provisions of the Safety Appliances of the policy statement will also be City, UT 84118, Telephone (801) 963– Standards, 49 CFR part 231, and Power available on the internet at http:// 0182; or Rob Wight, Utah Department of Brakes and Drawbars regulations, 49 www.airweb.faa.gov within a few days. Transportation (UDOT), 2010 South CFR part 232, concerning the operation 2760 West, Salt Lake City, UT 84104, of RoadRailer equipment in Triple Comments Invited Telephone (801) 887–3438. Crown Service over their railroad We invite interested parties to submit SUPPLEMENTARY INFORMATION: The system. Specifically, NS requests that comments on the proposed policy FHWA is cooperation with the UDOT FRA modify the existing waiver to statement. Commenters must identify have elected to terminate efforts to incorporate the use of ‘‘Railrunner’’ PS–ACE100–2004–10028 and submit prepare an EIS for transportation equipment in its RoadRailer operations. comments to the address specified improvements in the corridor of The ‘‘Railrunner’’ equipment is above. The FAA will consider all Redwood Road (SR–68) from 10400 essentially a set of highway trailer communications received on or before South in the city of South Jordan to chassis and intermediate and transition the closing date for comments before Bangerter Highway (SR–172) in the city rail bogies that allows the transport of issuing the final policy statement. The of Bluffdale, Salt Lake County, Utah. ship containers by both highway and proposed policy statement and The original Notice of Intent was rail modes. The ship containers are comments received may be inspected at published on May 29, 2003, anticipating placed on a highway ‘‘Railrunner’’ the Standards Office (ACE–110), 901 Utah Department of Transportation chassis at the shipping terminal where Locust, Room 301, Kansas City, (UDOT) would request Federal funding they can be transported by highway to Missouri, between the hours of 8:30 and for project construction. The UDOT has a rail terminal. Upon arrival at a rail 4 p.m. weekdays, except Federal recently elected to fully fund the project terminal, the chassis and container

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combinations are coupled to and made submitted on behalf of an association, 5. At no time shall the train length an integral part of a ‘‘Railrunner’’ rail business, labor union, etc.). You may exceed the equivalent of 150 Mark V bogie combination. Once the highway review DOT’s complete Privacy Act RoadRailer units. ‘‘Railrunner’’ chassis has been Statement in the Federal Register 6. An adapter unit (couplermate converted to rail mode by use of the rail published on April 11, 2000 (Volume bogie) must be used between the bogies, the ‘‘Railrunner’’ units can then 65, Number 70; Pages 19477–78). The hauling locomotive and the first be assembled behind a RoadRailer train Statement may also be found at http:// RoadRailer unit in the train. for shipment to another terminal on the dms.dot.gov. 7. Each adapter unit (couplermate bogie) shall be equipped with a tool box NS system. NS would introduce the Issued in Washington, DC, on May 19, ‘‘Railrunner’’ equipment into their 2004. containing appropriate instructions, job aids, and the necessary tools and service using existing RoadRailer trains Grady C. Cothen, Jr., and routes on its system network. equipment required to address problems Norfolk Southern requests the Acting Associate Administrator for Safety. that may be encountered in route by the following amendments to the existing [FR Doc. 04–11698 Filed 5–24–04; 8:45 am] train crew. RoadRailer waiver: (1) The waiver will BILLING CODE 4910–06–P 8. Trains will only be permitted to apply to Norfolk Southern rail pick-up or set-out RoadRailer units at operations handling RoadRailer and locations specifically designed to Railrunner equipment; (2) Interchange DEPARTMENT OF TRANSPORTATION perform these functions with mechanical personnel that are trained of RoadRailer-Railrunner equipment Federal Railroad Administration will only be permitted with a railroad and on duty for the purpose of assembly that has a comparable waiver to operate Petition for Waiver of Compliance and disassembly of RoadRailer units the RoadRailer-Railrunner equipment; unless a defective condition develops in and (3) RoadRailer-Railrunner In accordance with part 211 of title 49 route that would require a RoadRailer equipment will not be handled with Code of Federal Regulations (CFR), unit to be set-out of the train. conventional railroad rolling equipment notice is hereby given that the Federal 9. Hazardous materials are permitted and will only be operated in trains Railroad Administration (FRA) has to be hauled in RoadRailer units consisting exclusively of RoadRailer- received a request for a waiver of provided: (1) The particular Railrunner units. compliance from certain requirements commodities are limited to those listed Interested parties are invited to of its safety regulations. The individual in Table 2 of 49 CFR 172.504; (2) the participate in these proceedings by petition is described below, including shipment complies with other relevant submitting written views, data, or the party seeking relief, the regulatory provisions of the hazardous materials comments. FRA does not anticipate provisions involved, the nature of the regulations; (3) placarding provisions of scheduling a public hearing in relief being requested, and the 49 CFR subpart F of part 172 shall apply connection with these proceedings since petitioner’s arguments in favor of relief. during rail movements; and (4) cargo the facts do not appear to warrant a tanks, multi-unit tank car tanks, Union Pacific Railroad Company hearing. I f any interested party desires portable tanks and intermodal (1M) an opportunity for oral comment, they [Docket Number FRA–2004–17565] portable tanks handling hazardous should notify the FRA in writing, before Union Pacific Railroad Company (UP) materials are not permitted in this the end of the comment period and seeks to obtain a waiver of certain service. specify the basis for their request. provisions of the Safety Appliance 10. Each RoadRailer-43 adapter unit All communications concerning these Standards, 49 CFR part 231, and Power (couplermate bogie) that does not have proceedings should identify the Brakes and Drawbars regulations, 49 safety appliances that are compliant appropriate docket number (e.g., Waiver CFR part 232, concerning the operation with current federal regulations (with Petition Docket Number FRA–2003– of RoadRailer equipment in Triple the exception of the handbrake), must 16203) and must be submitted in Crown Service over their railroad be stenciled on each side, in clearly triplicate to the Docket Clerk, DOT system. Specifically, the UP requests legible letters not less than 6 inches Central Document Management Facility, that it be allowed to operate RoadRailer high, ‘‘NO SAFETY APPLIANCES’’ and Room PL–401, Washington, DC 20590– trains from Chicago, IL to Minneapolis, ‘‘DO NOT RIDE’’, at a location that is 0001. Communications received within MN and return. The UP requests FRA to visible to a person walking at track level 30 days of the date of this notice will grant approval to operate the Roadrailer beside the unit. be considered by FRA before final equipment to include the following 11. UPRR shall have instructions that action is taken. Comments received after conditions: prohibits anyone from riding RoadRailer that date will be considered as far as 1. This waiver applies only to the equipment unless it is an adapter unit practicable. All written communications UPRR Roadrailer equipment operation. (couplermate bogie) specifically concerning these proceedings are 2. Interchange will only be permitted designed to be ridden and is not available for examination during regular with a railroad that has a comparable stenciled as required in condition #10. business hours (9a.m–5p.m) at DOT waiver to operate RoadRailer Strict enforcement of this rule is Central Docket Management Facility, equipment. required. Room PL–401 (Plaza Level), 400 3. RoadRailer equipment shall not be 12. New terminal facilities for Seventh Street, SW., Washington, DC. commingled with conventional railroad RoadRailer equipment shall, to the All documents in the public docket are rolling equipment. RoadRailer units extent feasible, be designed to limit the also available for inspection and shall only be operated in trains frequency and length of reverse copying on the Internet at the docket consisting exclusively of RoadRailer movements. Reverse movements of facility’s Web site at http://dms.dot.gov. units and locomotives. RoadRailer equipment, with personnel Anyone is able to search the 4. RoadRailer trains shall be limited to riding couplermates equipped with electronic form of all comments a maximum trailing tonnage of 5,200 compliant safety appliances, shall not received into any of our dockets by tons and will be further limited by exceed 10 miles per hour. name of the individual submitting the RoadRailer total gross rail load, track 13. Whenever a shoving move of comment (or signing the comment, if grade and curvatures. RoadRailer equipment is required, the

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movement shall be protected by either; pertaining to the safety of rail operations Issued in Washington, DC on May 19, an individual riding an adapter unit or in the event of non-compliance with 2004. (couplermate bogie) specifically any of the conditions of this waiver. Grady C. Cothen, Jr., designed to be ridden, or by an 22. UPRR requests that this waiver is Acting Associate Administrator for Safety. individual walking with the movements effective for a five-year period from the [FR Doc. 04–11699 Filed 5–24–04; 8:45 am] and the speed of the move shall not date of approval of the requested waiver BILLING CODE 4910–06–P exceed that of the individual walking. 14. Maximum speed of a RoadRailer and FRA will reserve the right to extend train is 60 MPH, unless the RoadRailer the waiver if petition having been made DEPARTMENT OF TRANSPORTATION units are equipped with AAR–1 B and conditions warrant. UPRR will narrow flange profile (#40 taper) and make a written request for an extension Federal Railroad Administration maintained in that condition whereby of the five-year period to the FRA’s the maximum speed shall be 70 MPH. Office of Safety Assurance and Notice of Application for Approval of 15. Piston travel at initial terminal compliance within six months of the Discontinuance or Modification of a shall be 1.25 to 3.5 inches. granted expiration date. Railroad Signal System or Relief From 16. The air brake shall be considered the Requirements of Title 49 Code of Interested parties are invited to ineffective at 3–5/8 inches piston travel. Federal Regulations Part 236 17. UPRR shall ensure that adequate participate in these proceedings by records are maintained to demonstrate submitting written views, data, or Pursuant to title 49 Code of Federal all personnel (including contractors) comments. FRA does not anticipate Regulations (CFR) part 235 and 49 responsible for assembly, inspection, scheduling a public hearing in U.S.C. 20502(a), the following railroad testing, maintenance and operation of connection with these proceedings since has petitioned the Federal Railroad RoadRailer equipment have been the facts do not appear to warrant a Administration (FRA) seeking approval trained and qualified to perform those hearing. If any interested party desires for the discontinuance or modification duties prior to undertaking them, an opportunity for oral comment, they of the signal system or relief from the including instruction in the provisions should notify FRA in writing, before the requirements of 49 CFR part 236 as of this waiver pertinent to their duties. end of the comment period and specify detailed below. Training for railroad operating and the basis for their request. [Docket Number FRA–2004–17688] mechanical personnel, who may All communications concerning these Applicant: Union Pacific Railroad encounter the equipment, shall proceedings should identify the Company, Mr. Phil Abaray, Chief specifically include training necessary appropriate docket number (e.g., Waiver Engineer—Signals, 1416 Dodge Street, to provide for their personal safety Room 1000, Omaha, Nebraska 68179– Petition docket Number FRA–2004– when working on or in proximity to the 1000. 17565) and must be submitted in equipment. Supervisors shall also The Union Pacific Railroad Company possess the knowledge and skills triplicate to the Docket Clerk, DOT (UP) seeks approval of the proposed required of employees subject to their Central Docket Management Facility, modification of the traffic control direct supervision. Effective coincident Room PL–401, Washington, DC 20590– system, on the two main tracks at with compliance dates established for 0001. FRA will consider Endicott, Nebraska, milepost 180.3, on revisions to 49 CFR part 232, all communications received within 30 the Marysville Subdivision, Council personnel required to receive training days of the date of this notice before Bluffs Area. The proposed changes subject to this condition shall have their final action is taken. Comments received consist of the following: qualifications for duties, related to after that date will be considered as far 1. Removal of three power-operated RoadRailer equipment, documented in as practicable. All written switches, No’s. 1A, 1B, and 2; the same manner provided in that part. communications concerning these 2. Removal of five associated 18. UPRR shall ensure that adequate proceedings are available for controlled signals, No’s. 1E, 2E, 1W, records are maintained to demonstrate examination during regular business 2W, and BNSF 1W; the current qualification status of all hours (9 a.m.–5 p.m.) at DOT Central 3. Removal of the Approach ‘‘D’’ personnel assigned to operate, inspect, Docket Management Facility, Room PL– signals on the BNSF track; test, and maintain RoadRailer 401 (Plaza Level), 400 Seventh Street, 4. Conversion of the No. 3 power- equipment. SW., Washington, DC All documents in operated switch to hand operation; 19. UPRR supervisors or their the public docket are also available for 5. Conversion of the eastbound No. 2E signal, to an absolute entrance signal, in representatives shall exercise oversight inspection and copying on the Internet lieu of a switch lock; and or undertake contractual arrangements at the docket facility’s Web site at to ensure that all tasks and 6. Installation of eastbound and http://dms.dot.gov. maintenance/repair practices are westbound back-to-back controlled performed in accordance with the Anyone is able to search th signals on both main tracks. railroad’s written procedures, applicable electronics form of all comments The reason given for the proposed standards and recommended practices received into any of our dockets by changes is that the crossover and of the AAR, current AAR interchange name of the individual submitting the switches were installed to replace a rules, and all applicable Federal comment (or signing the comment, if diamond crossover. The BNSF is taking Regulatory requirements. submitted on behalf of an association, their north connecting track out of 20. UPRR shall immediately report business, labor union, etc.). You may service, so the control point with the any accident, incident or injury review DOT’s Privacy Act Statement in crossover is no longer needed. involving this equipment to FRA’s the Federal Register published on April Any interested party desiring to Office of Safety Assurance and 11, 2000 (Volume 65, Number 70; Pages protest the granting of an application Compliance in Washington, DC. 19477–78). The Statement may also be shall set forth specifically the grounds 21. FRA will reserve the right to found at http://dms.dot.gov. upon which the protest is made, and modify or rescind this waiver at any include a concise statement of the time upon receipt of information interest of the party in the proceeding.

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Additionally, one copy of the protest Competitive Proposals (RFP) for the S4.3(d) and S4.3(e) of 49 CFR 571.109, shall be furnished to the applicant at the construction of up to five new tank Federal Motor Vehicle Safety Standard address listed above. vessels. The RFP is available on the (FMVSS) No. 109, ‘‘New pneumatic All communications concerning this Internet at http://www.fedbizopps.gov tires.’’ Kumho has filed an appropriate proceeding should be identified by the and http://www.marad.dot.gov and hard report pursuant to 49 CFR part 573, docket number and must be submitted copies of the RFP are available in the ‘‘Defect and Noncompliance Reports.’’ to the Docket Clerk, DOT Central Docket Office of the Secretary, Maritime Pursuant to 49 U.S.C. 30118(d) and Management Facility, Room PL–401 Administration. 30120(h), Kumho has petitioned for an (Plaza Level), 400 7th Street, SW., exemption from the notification and FOR FURTHER INFORMATION CONTACT: remedy requirements of 49 U.S.C. Washington, DC 20590–0001. Gregory V. Sparkman or Edmond J. Chapter 301 on the basis that this Communications received within 45 Fitzgerald, Office of Insurance and noncompliance is inconsequential to days of the date of this notice will be Shipping Analysis, Maritime considered by the FRA before final motor vehicle safety. Administration, Room 8117, 400 This notice of receipt of Kumho’s action is taken. Comments received after Seventh Street, SW., Washington, DC that date will be considered as far as petition is published under 49 U.S.C. 20590; Telephone: (202) 366–2400; Fax: 30118 and 30120 and does not represent practicable. All written communications (202) 366–7901. concerning these proceedings are any agency decision or other exercise of available for examination during regular SUPPLEMENTARY INFORMATION: On judgment concerning the merits of the business hours (9 a.m.–5 p.m.) at the February 20, 2004, the Maritime petition. above facility. All documents in the Administration formally solicited A total of approximately 2656 tires are public docket are also available for competitive RFPs for the construction of involved. These include 324 size 255/ inspection and copying on the internet up to five new product tank vessels 50R17 tires and 2332 size 255/45R17 at the docket facility’s Web site at http:/ necessary to meet the commercial and tires. The tires are marked ‘‘Tread: /dms.dot.gov. national security needs of the United Rayon 2 + Steel 2 + Nylon 2, Sidewall: FRA wishes to inform all potential States and to be built with assistance Rayon 2,’’ when the correct stamping commenters that anyone is able to under subtitle D of the Maritime would be ‘‘Tread: Polyester 2 + Steel 2 search the electronic form of all Security Act of 2003. In response to + Nylon 2, Sidewall: Polyester 2.’’ comments received into any of our certain questions raised by industry Paragraph S4.3 of FMVSS No. 109 dockets by the name of the individual representatives, the Maritime requires ‘‘each tire shall have submitting the comment (or signing the Administration has decided to host a permanently molded into or onto both comment, if submitted on behalf of an public conference call to provide sidewalls * * * (d) The generic name of association, business, labor union, etc.). additional information, have further each cord material used in the plies You may review DOT’s complete discussion and answer any outstanding * * * of the tire; and (e) Actual number Privacy Act Statement in the Federal questions related to the new tanker of plies in the sidewall, and the actual Register published on April 11, 2000 program. The conference call is open to number of plies in the tread area if (Volume 65, Number 70; Pages 19477– all interested parties and will be held on different.’’ Kumho states that it uses rayon and 78) or you may visit http://dms.dot.gov. May 26, 2004 in two parts: polyester body ply construction to meet FRA expects to be able to determine • From 3:30 to 4:30 p.m. for vessel the preferences of the North American these matters without an oral hearing. owners/operators and European markets, and that rayon is However, if a specific request for an oral • From 4:30 to 5:30 p.m. for popular in the European market while hearing is accompanied by a showing shipyards polyester is more popular in the North that the party is unable to adequately To participate, contact Edmond American market. Kumho explains that present his or her position by written Fitzgerald or Greg Sparkman at (202) for sizes sold in both markets, either statements, an application may be set 366–2400 for specific instructions. material may be used, and the two sizes for public hearing. Please note that each call is limited to 30 participants. which are the subject of this petition Issued in Washington, DC, on May 19, have North American construction and 2004. Authority: 49 CFR 1.66 European stamping. Grady C. Cothen, Jr., By Order of the Maritime Administrator Kumho states that the tires meet or Acting Associate Administrator for Safety. Dated: May 19, 2004. exceed all performance requirements of [FR Doc. 04–11697 Filed 5–24–04; 8:45 am] Joel C. Richard, FMVSS No. 109 and will have no BILLING CODE 4910–06–P Secretary, Maritime Administration. impact on the operational performance [FR Doc. 04–11746 Filed 5–24–04; 8:45 am] or safety of vehicles on which these tires are mounted. Therefore, Kumho BILLING CODE 4910–81–P DEPARTMENT OF TRANSPORTATION believes that the noncompliance is inconsequential to motor vehicle safety Maritime Administration DEPARTMENT OF TRANSPORTATION and that no corrective action is warranted. Maritime Security Act of 2003, Subtitle National Highway Traffic Safety Interested persons are invited to D—National Defense Tank Vessel Administration submit written data, views, and Construction Assistance arguments on the petition described [Docket No. NHTSA–2004–17903; Notice 1] AGENCY: Maritime Administration, DOT. above. Comments must refer to the ACTION: Notice of conference call. Kumho Tire Co., Inc., Receipt of docket and notice number cited at the Petition for Decision of beginning of this notice and be SUMMARY: The purpose of the notice is Inconsequential Noncompliance submitted by any of the following to advise interested parties of a methods. Mail: Docket Management conference call to be hosted by the Kumho Tire Co., Inc. (Kumho) has Facility, U.S. Department of Maritime Administration to address determined that certain tires it produced Transportation, Nassif Building, Room certain issues regarding the Request for in 2003 and 2004 do not comply with PL–401, 400 Seventh Street, SW.,

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Washington, DC, 20590–0001. Hand government entity acting on behalf of the EA by writing to SEA (Room 500, Delivery: Room PL–401 on the plaza such user) regarding cessation of service Surface Transportation Board, level of the Nassif Building, 400 over the line either is pending with the Washington, DC 20423–0001) or by Seventh Street, SW., Washington, DC. It Surface Transportation Board (Board) or calling SEA, at (202) 565–1539. is requested, but not required, that two with any U.S. District Court or has been [Assistance for the hearing impaired is copies of the comments be provided. decided in favor of complainant within available through the Federal The Docket Section is open on the 2-year period; and (4) the Information Relay Service (FIRS) at 1– weekdays from 10 am to 5 pm except requirements at 49 CFR 1105.7 800–877–8339.] Comments on Federal Holidays. Comments may be (environmental reports), 49 CFR 1105.8 environmental and historic preservation submitted electronically by logging onto (historic reports), 49 CFR 1105.11 matters must be filed within 15 days the Docket Management System Web (transmittal letter), 49 CFR 1105.12 after the EA becomes available to the site at http://dms.dot.gov. Click on (newspaper publication) and 49 CFR public. ‘‘Help’’ to obtain instructions for filing 1105.50(d)(1) (notice to governmental Environmental, historic preservation, the document electronically. Comments agencies) have been met. public use, or trail use/rail banking may be faxed to 1–202–493–2251, or As a condition to this exemption, any conditions will be imposed, where may be submitted to the Federal employee adversely affected by the appropriate, in a subsequent decision. eRulemaking Portal: go to http:// abandonment shall be protected under Pursuant to the provisions of 49 CFR www.regulations.gov. Follow the online Oregon Short Line R. Co.— 1152.29(e)(2), BNSF shall file a notice of instructions for submitting comments. Abandonment—Goshen, 360 I.C.C. 91 consummation with the Board to signify The petition, supporting materials, (1979). To address whether this that it has exercised the authority and all comments received before the condition adequately protects affected granted and fully abandoned the line. If close of business on the closing date employees, a petition for partial consummation has not been effected by indicated below will be filed and will be revocation under 49 U.S.C. 10502(d) BNSF’s filing of a notice of considered. All comments and must be filed. Provided no formal consummation by May 25, 2005, and supporting materials received after the expression of intent to file an offer of there are no legal or regulatory barriers closing date will also be filed and will financial assistance (OFA) has been to consummation, the authority to be considered to the extent possible. received, this exemption will be abandon will automatically expire. When the petition is granted or denied, effective on June 24, 2004, unless stayed Board decisions and notices are notice of the decision will be published pending reconsideration. Petitions to available on our Web site at ‘‘http:// in the Federal Register pursuant to the stay that do not involve environmental www.stb.dot.gov.’’ issues,1 formal expressions of intent to authority indicated below. Decided: May 17, 2004. Comment closing date: June 24, 2004. file an OFA under 49 CFR 1152.27(c)(2),2 and trail use/rail banking By the Board, David M. Konschnik, Authority: (49 U.S.C. 30118, 30120: requests under 49 CFR 1152.29 3 must Director, Office of Proceedings. delegations of authority at 49 CFR 1.50 and be filed by June 4, 2004. Petitions to Vernon A. Williams, 501.) reopen or requests for public use Secretary. Issued on: May 19, 2004. conditions under 49 CFR 1152.28 must [FR Doc. 04–11517 Filed 5–24–04; 8:45 am] Kenneth N. Weinstein, be filed by June 14, 2004, with: Surface BILLING CODE 4915–01–P Associate Administrator for Enforcement. Transportation Board, 1925 K Street, [FR Doc. 04–11791 Filed 5–24–04; 8:45 am] NW., Washington, DC 20423–0001. BILLING CODE 4910–59–P A copy of any petition filed with the DEPARTMENT OF TRANSPORTATION Board should be sent to the applicant’s representative: Michael Smith, Freeborn Surface Transportation Board DEPARTMENT OF TRANSPORTATION & Peters, 311 S. Wacker Dr., Suite 3000, [STB Docket No. AB–6 (Sub–No. 417X)] Chicago, IL 60606–6677. Surface Transportation Board If the verified notice contains false or The Burlington Northern and Santa Fe misleading information, the exemption [STB Docket No AB–6 (Sub–No. 416X)] Railway Company—Abandonment is void ab initio. Exemption-in Clay County, MN The Burlington Northern and Santa Fe BNSF has filed an environmental Railway Company—Abandonment report which addresses the The Burlington Northern and Santa Fe Exemption—-in Bottineau County, ND abandonment’s effects, if any, on the Railway Company (BNSF) has filed a environment and historic resources. notice of exemption under 49 CFR 1152 The Burlington Northern and Santa Fe SEA will issue an environmental Subpart F—Exempt Abandonments to Railway Company (BNSF) has filed a assessment (EA) by May 28, 2004. abandon a 15.91-mile line of railroad notice of exemption under 49 CFR part Interested persons may obtain a copy of between milepost 18.09 near Glyndon 1152 subpart F—Exempt Abandonments and milepost 34.00 near Felton, in Clay to abandon and discontinue service over 1 The Board will grant a stay if an informed County, MN. The line traverses United a 15.50-mile line of railroad between decision on environmental issues (whether raised States Postal Service Zip Codes 56547 by a party or by the Board’s Section of milepost 52.00 near Souris, and Environmental Analysis (SEA) in its independent and 56536. milepost 67.50, near Westhope, in investigation) cannot be made before the BNSF has certified that: (1) No local Bottineau County, ND. The line exemption’s effective date. See Exemption of Out- traffic has moved over the line for at traverses United States Postal Service of-Service Rail Lines, 5I.C.C.2d 377 (1989). Any least 2 years; (2) there is no overhead request for a stay should be filed as soon as possible Zip Codes 58783 and 58793. so that the Board may take appropriate action before traffic to be rerouted; (3) no formal BNSF has certified that: (1) No local the exemption’s effective date. complaint filed by a user of rail service traffic has moved over the line for at 2 Each OFA must be accompanied by the filing on the line (or by a state or local least 2 years; (2) there is no overhead fee, which currently is set at $1,100. See 49 CFR government entity acting on behalf of 1102.2(f)(25). traffic to be rerouted; (3) no formal 3 Each trail use request must be accompanied by such user) regarding cessation of service complaint filed by a user of rail service the filing fee, which is set at $200.00 See 49 CFR over the line either is pending with the on the line (or by a state or local 1002.2(f)(27). Board or with any U.S. District Court or

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has been decided in favor of Information Relay Service (FIRS) at 1– copies of the form and instructions complainant within the 2-year period; 800–877–8339.] Comments on should be directed to Carol Savage at and (4) the requirements at 49 CFR environmental and historic preservation Internal Revenue Service, room 6407, 1105.7 (environmental reports), 49 CFR matters must be filed within 15 days 1111 Constitution Avenue NW., 1105.8 (historic reports), 49 CFR after the EA becomes available to the Washington, DC 20224, or at (202) 622– 1105.11 (transmittal letter), 49 CFR public. 3945, or through the Internet at 1105.12 (newspaper publication), and Environmental, historic preservation, [email protected]. 49 CFR 1152.50(d)(1) (notice to public use, or trail use/rail banking SUPPLEMENTARY INFORMATION: Title: U.S. conditions will be imposed, where governmental agencies) have been met. Individual Income Tax Return. As a condition to this exemption, any appropriate, in a subsequent decision. OMB Number: 1545–0085. employee adversely affected by the Pursuant to the provisions of 49 CFR Form Number: 1040A and Schedules abandonment shall be protected under 1152.29(e)(2), BNSF shall file a notice of 1, 2, 3, and EIC. Oregon Short Line R.Co.— consummation with the Board to signify Abstract: This form is used by Abandonment—Goshen, 360 I.C.C. 91 that it has exercised the authority individuals to report their income (1979). To address whether this granted and fully abandoned the line. If subject to income tax and to compute condition adequately protects affected consummation has not been effected by their correct tax liability. The data are employees, a petition for partial BNSF’s filing of a notice of used to verify that the income reported revocation under 49 U.S.C. 10502(d) consummation by May 25, 2005, and on the form is correct and are also for must be filed. there are no legal or regulatory barriers statistics use. Provided no formal expression of to consummation, the authority to Current Actions: There are no changes intent to file an offer of financial abandon will automatically expire. being made to the form at this time. assistance (OFA) has been received, this Board decisions and notices are Type of Review: Extension of a exemption will be effective on June 24, available on our website at ‘‘http:// currently approved collection. 2004, unless stayed pending www.stb.dot.gov.’’ Affected Public: Individuals or reconsideration. Petitions to stay that do *COM019*Decided: May 18, 2004. households. not involve environmental issues,1 By the Board, David M. Konschnik, Estimated Number of Respondents: formal expressions of intent to file an Director, Office of Proceedings. 28,826,589. 2 Vernon A. Williams, OFA under 49 CFR 1152.27(c)(2), and Estimated Time Per Respondent: Secretary. trail use/rail banking requests under 49 Varies. CFR 1152.29 must be filed by June 4, [FR Doc. 04–11660 Filed 5–24–04; 8:45 am] Estimated Total Annual Burden 2004. Petitions to reopen or requests for BILLING CODE 4915–01–P Hours: 318,019,338. public use conditions under 49 CFR The following paragraph applies to all 1152.28 must be filed by June 14, 2004, of the collections of information covered with the Surface Transportation Board, DEPARTMENT OF THE TREASURY by this notice: 1925 K Street, NW., Washington, DC An agency may not conduct or Internal Revenue Service 20423–0001. sponsor, and a person is not required to A copy of any petition filed with the respond to, a collection of information Board should be sent to BNSF’s Proposed Collection; Comment unless the collection of information representative: Michael Smith, Freeborn Request for Form 1040A and displays a valid OMB control number. & Peters, 311 S. Wacker Dr., Suite 3000, Schedules 1, 2, 3 and EIC Books or records relating to a collection Chicago, IL 60606–6677. AGENCY: Internal Revenue Service (IRS), If the verified notice contains false or of information must be retained as long Treasury. misleading information, the exemption as their contents may become material ACTION: is void ab initio. Notice and request for in the administration of any internal BNSF has filed an environmental comments. revenue law. Generally, tax returns and tax return information are confidential, report which addresses the SUMMARY: The Department of the abandonment’s effects, if any, on the as required by 26 U.S.C. 6103. Treasury, as part of its continuing effort Request for Comments: Comments environment and historic resources. to reduce paperwork and respondent SEA will issue an environmental submitted in response to this notice will burden, invites the general public and be summarized and/or included in the assessment (EA) by May 28, 2004. other Federal agencies to take this Interested persons may obtain a copy of request for OMB approval. All opportunity to comment on proposed comments will become a matter of the EA by writing to SEA (Room 500, and/or continuing information Surface Transportation Board, public record. Comments are invited on: collections, as required by the (a) Whether the collection of Washington, DC 20423–0001) or by Paperwork Reduction Act of 1995, Pub. calling SEA, at (202) 565–1539. information is necessary for the proper L. 104–13 (44 U.S.C. 3506(c)(2)(A)). performance of the functions of the [Assistance for the hearing impaired is Currently, the IRS is soliciting available through the Federal agency, including whether the comments concerning Form 1040A, U.S. information shall have practical utility; Individual Income Tax Return, and 1 (b) the accuracy of the agency’s estimate The Board will grant a stay if an informed Schedules 1, 2, 3 and EIC. decision on environmental issues (whether raised of the burden of the collection of by a party or by the Board’s Section of DATES: Written comments should be information; (c) ways to enhance the Environmental Analysis (SEA) in its independent received on or before July 26, 2004 to be quality, utility, and clarity of the investigation) cannot be made before the assured of consideration. exemption’s effective date. See Exemption of Out- information to be collected; (d) ways to of-Service Rail Lines, 5 I.C.C.2d 377 (1989). Any ADDRESSES: Direct all written comments minimize the burden of the collection of request for a stay should be filed as soon as possible to Glenn P. Kirkland, Internal Revenue information on respondents, including so that the Board may take appropriate action before Service, room 6411, 1111 Constitution through the use of automated collection the exemption’s effective date. Avenue NW., Washington, DC 20224. 2 Each OFA must be accompanied by the filing techniques or other forms of information fee, which currently is set at $1,100. See 49 CFR FOR FURTHER INFORMATION CONTACT: technology; and (e) estimates of capital 1002.2(f)(25). Requests for additional information or or start-up costs and costs of operation,

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maintenance, and purchase of services Dated: May 20, 2004. DEPARTMENT OF VETERANS to provide information. Bernard Coston, AFFAIRS Approved: May 19, 2004. Director, Taxpayer Advocacy Panel. Glenn P. Kirkland, [FR Doc. 04–11811 Filed 5–24–04; 8:45 am] Advisory Committee on Structural Safety of Department of Veterans IRS Reports Clearance Officer. BILLING CODE 4830–01–P Affairs Facilities, Notice of Meeting [FR Doc. 04–11810 Filed 5–24–04; 8:45 am] BILLING CODE 4830–01–P DEPARTMENT OF VETERANS The Department of Veterans Affairs AFFAIRS (VA) gives notice under Public Law 92– DEPARTMENT OF THE TREASURY 463 (Federal Advisory Committee Act) Professional Certification and that a meeting of the Advisory Internal Revenue Service Licensure Advisory Committee; Notice Committee on Structural Safety of of Meeting Department of Veterans Affairs Open meeting of the Wage & The Department of Veterans Affairs Facilities will be held on Thursday, Investment Reducing Taxpayer Burden (VA) gives notice under Public Law 92– June 10, 2004, from 10 a.m. until 5 p.m., (Notices) Issue Committee of the 463 (Federal Advisory Committee Act) and on Friday, June 11, 2004, from 8:30 Taxpayer Advocacy Panel that the Professional Certification and a.m. until 12:30 p.m., in Room 442, Export Import Bank, 811 Vermont AGENCY: Internal Revenue Service (IRS), Licensure Advisory Committee has Avenue, NW., Washington, DC. The Treasury. scheduled a meeting for Wednesday, June 30, 2004, at the Department of meeting is open to the public. ACTION: Notice. Veterans Affairs, Veterans Benefits The purpose of the Committee is to Administration, Conference Room 542, advise the Secretary of Veterans Affairs SUMMARY: An open meeting of the Wage 1800 G Street, NW., Washington, DC, on matters of structural safety in the & Investment Reducing Taxpayer from 8:30 a.m. to 4 p.m. The meeting is construction and remodeling of VA Burden (Notices) Issue Committee of the open to the public. Taxpayer Advocacy Panel will be The purpose of the Committee is to facilities, and to recommend standards conducted (via teleconference). The advise the Secretary of Veterans Affairs for use by VA in the construction and Taxpayer Advocacy Panel is soliciting on the requirements of organizations or alteration of facilities as prescribed public comments, ideas and suggestions entities offering licensing and under section 8105 of title 38, United on improving customer service at the certification tests to individuals for States Code. Internal Revenue Service. which payment for such tests may be On June 10, the Committee will DATES: The meeting will be held made under chapters 30, 32, 34, or 35 review developments in the field of Wednesday, June 23, 2004 from 12 p.m. of title 38, United States Code. structural design as they relate to to 1 p.m. e.d.t. The meeting will begin with opening seismic safety of buildings and fire remarks by Ms. Sandra Winborne, safety issues. On June 11, the Committee FOR FURTHER INFORMATION CONTACT: Committee Chair. During the morning will receive briefings/presentations on Sallie Chavez at 1–888–912–1227, or session, there will be a discussion about current fire and seismic safety issues 954–423–7979. the process of applying for approval of that are particularly relevant to facilities SUPPLEMENTARY INFORMATION: Notice is a test, a presentation on the usage of the license and certification test owned and leased by the Department. hereby given pursuant to section The Committee will also vote on 10(a)(2) of the Federal Advisory reimbursement benefit, and a discussion of helpful links from the VA Education structural and fire safety Committee Act, 5 U.S.C. App. (1988) recommendations for inclusion in VA’s that an open meeting of the Wage & Service Web site. The afternoon session standards. Investment Reducing Taxpayer Burden will include old business, and any new (Notices) Issue Committee of the business. No time will be allocated for receiving Taxpayer Advocacy Panel will be held Interested persons may file written oral presentations from the public. Wednesday, June 23, 2004, from 12 p.m. statements to the Committee before the However, the Committee will accept meeting, or within 10 days after the to 1 p.m. e.d.t. via a telephone written comments. Comments should be meeting, with Mr. Giles Larrabee, conference call. If you would like to sent to Mr. Krishna K. Banga, Senior Designated Federal Officer, Department have the TAP consider a written Structural Engineer, Facilities Quality of Veterans Affairs, Veterans Benefits statement, please call 1–888–912–1227 Service, Office of Facilities Management Administration (225B), 810 Vermont or 954–423–7979, or write Sallie Avenue, NW., Washington, DC 20420. (181A), Department of Veterans Affairs, Chavez, TAP Office, 1000 South Pine Oral statements from the public will be 810 Vermont Avenue, NW., Island Road, Suite 340, Plantation, FL heard at 1 p.m. on June 30. Anyone Washington, DC 20420. Those wishing 33324. Due to limited conference lines, wishing to attend the meeting should to attend should contact Mr. Banga at notification of intent to participate in contact Mr. Giles Larrabee or Mr. (202) 565–9370. the telephone conference call meeting Michael Yunker at (202) 273–7187. must be made with Sallie Chavez. Ms. Dated: May 18, 2004. Chavez can be reached at 1–888–912– Dated: May 13, 2004. By Direction of the Secretary. 1227 or 954–423–7979, or post By Direction of the Secretary. E. Philip Riggin, comments to the Web site: http:// E. Philip Riggin, Committee Management Officer. www.improveirs.org. Committee Management Officer. [FR Doc. 04–11737 Filed 5–24–04; 8:45 am] The agenda will include: Various IRS [FR Doc. 04–11745 Filed 5–24–04; 8:45 am] BILLING CODE 8320–01–M issues. BILLING CODE 8320–01–M

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Part II

Department of Health and Human Services Food and Drug Administration

21 CFR Parts 210, 211, 820, and 1271 Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Final Rule and Notice

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DEPARTMENT OF HEALTH AND Eligibility • Current Good Tissue Practice for HUMAN SERVICES E. Economic Impacts Manufacturers of Human Cellular and IV. Analysis of Economic Impacts Tissue-Based Products; Inspection and Food and Drug Administration A. Objectives and Basis of the Enforcement (the CGTP proposed rule) Proposed Action (66 FR 1508, January 8, 2001). 21 CFR Parts 210, 211, 820, and 1271 B. The Type and Number of Entities We published a final rule entitled Affected ‘‘Human Cells, Tissues, and Cellular [Docket No. 1997N–0484S] C. Nature of Impacts and Tissue-Based Products; [RIN 0910–AB27] D. Benefits of the Final Rule Establishment Registration and Listing,’’ E. Small Entity Impacts and Analysis in the Federal Register on January 19, Eligibility Determination for Donors of of Alternatives 2001 (the registration final rule) (66 FR V. Environmental Impact Human Cells, Tissues, and Cellular and 5447). The registration final rule put Tissue-Based Products VI. Federalism Assessment VII. The Paperwork Reduction Act of into place general provisions pertaining AGENCY: Food and Drug Administration, 1995 to the scope and applicability of part HHS. VIII. References 1271. These provisions are contained in subpart A of part 1271, along with a ACTION: Final rule. I. Introduction section that contains definitions SUMMARY: The Food and Drug This final rule is part of a applicable to all of part 1271 (§ 1271.3). Administration (FDA) is requiring comprehensive new system of The registration final rule requires cell human cell, tissue, and cellular and regulation for HCT/Ps. The goal of the and tissue establishments to register tissue-based product (HCT/P) new approach is to improve protection with us and submit a list of their establishments to screen and test cell of the public health without imposing HCT/Ps; the procedures for registration and tissue donors for risk factors for, unnecessary restrictions on research, and listing are contained in subpart B of and clinical evidence of, relevant development, or the availability of new part 1271. communicable disease agents and products. Consolidating the regulation Some sections of the registration final diseases. The agency is amending the of HCT/Ps into one regulatory program rule became effective on April 4, 2001. current good manufacturing practice is expected to lead to increased Under those provisions, we now receive (CGMP) and quality system (QS) consistency and greater efficiency. registration and listing information from regulations that apply to HCT/Ps Together, these planned improvements establishments that engage in the regulated as drugs, medical devices, will increase the safety of HCT/Ps, and recovery, screening, testing, processing, and/or biological products to clarify the public confidence in their safety. We storage, or distribution of human tissue role of the new donor-eligibility intend to make the good tissue practice intended for transplantation (as described in § 1271.3(d)(1)). The regulations in relation to existing CGMP final rule, which has not yet published effective date for the remaining sections regulations. By preventing the but which FDA intends to issue soon, was January 21, 2003, by which time we transmission of communicable disease effective 1 year after publication of this expected to have completed rulemaking by the wide spectrum of HCT/Ps that are rule. Once both this rule and the good for all of part 1271 (66 FR 5447 at 5448). marketed now or may be marketed in tissue practice regulations are in effect, At that time, the registration and listing the future, the agency’s action will FDA’s comprehensive regulatory requirements would have become improve protection of the public health framework will be complete. effective for all other HCT/Ps (as and increase public confidence in new A. Background described in § 1271.3(d)(2)). However, technologies. In 1997, FDA proposed a new we recognized that unanticipated delays DATES: This rule is effective May 25, approach to the regulation of HCT/Ps in completing the rulemaking for the 2005. This rule is applicable to cells and (62 FR 9721, March 4, 1997). (The term remainder of part 1271 could occur, and tissues recovered on or after May 25, ‘‘HCT/P’’ is defined at § 1271.3(d) (21 we noted that, should the rulemaking 2005. CFR 1271.3(d).) To improve the proceedings be delayed past the 2-year FOR FURTHER INFORMATION CONTACT: regulation of HCT/Ps, we announced timeframe, we would consider whether Paula S. McKeever, Center for Biologics our intention to establish a to maintain the 2-year effective date for Evaluation and Research (HFM–17), comprehensive regulatory program for the HCT/Ps described in § 1271.3(d)(2) Food and Drug Administration, 1401 HCT/Ps, contained in part 1271 (21 CFR or whether to extend that date for some Rockville Pike, suite 200N, Rockville, part 1271). In accordance with the or all of these HCT/Ps (66 FR 5447 at MD 20852–1448, 301–827–6210. tiered, risk-based approach that we 5449). Since the rulemaking SUPPLEMENTARY INFORMATION: proposed, some HCT/Ps would be proceedings were delayed past the regulated only under these new original 2-year effective date of January Table of Contents regulations, while others would also be 21, 2003, we delayed the effective date I. Introduction regulated as drugs, devices, and/or of § 1271.3(d)(2) until January 21, 2004 A. Background biological products. (68 FR 2690, January 21, 2003). After the B. Legal Authority To implement the proposed approach, definition became final on January 21, II. Highlights of the Final Rule we issued three proposed rules: 2004, we issued an interim final rule A. Plain Language • Establishment Registration and excepting human dura mater and B. New Terminology and Definitions Listing for Manufacturers of Human human heart valve allografts from the C. Other Highlights Cellular and Tissue-Based Products (the scope of the definition of ‘‘human cells, III. Comments on the Proposed Rule and registration proposed rule) (63 FR tissues, or cellular or tissue-based FDA’s Responses 26744, May 14, 1998); products (HCT/Ps)’’ (69 FR 3823, A. General • Suitability Determination for Donors January 27, 2004). We took this action B. Amendments to 21 CFR Parts 210, of Human Cellular and Tissue-Based to assure that these products, which 211, and 820 Products (the donor-suitability proposed were subject to the Federal Food, Drug, C. Definitions (§ 1271.3) rule) (64 FR 52696, September 30, and Cosmetic Act (the act) and therefore D. Part 1271, Subpart C—Donor- 1999); and regulated under the current good

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manufacturing practice regulations set June 26 to 27, 2002); the Blood Products viruses, bacteria, fungi, parasites, and out in the quality system regulations in Advisory Committee (BPAC) (December transmissible spongiform part 820 (21 CFR part 820), were not 13 to 14, 2001, and March 14 to 15, encephalopathy agents. released from the scope of those 2002); and the Centers for Disease Certain diseases are transmissible regulations before a more Control and Prevention (CDC) (June 26 through the implantation, comprehensive regulatory framework to 27, 2000). We have placed transplantation, infusion, or transfer of applicable to HCT/Ps, including donor information on these meetings in the HCT/Ps derived from donors infected eligibility requirements, good tissue docket for this rulemaking. with those diseases. To prevent the practice regulations, and appropriate We have used the information introduction, transmission, or spread of enforcement provisions, is fully in obtained at those meetings to develop a such diseases, we consider it necessary place. When that comprehensive draft guidance document on to take appropriate measures to prevent framework is in place, we intend that determining donor eligibility entitled the use of cells or tissues from infected human dura mater and human heart ‘‘Eligibility Determination for Donors of donors. Thus, these regulations require valve allografts will be subject to it. We Human Cells, Tissues, and Cellular and that, before the use of most HCT/Ps, the intend to revoke the interim final rule Tissue-Based Products’’ (the donor- cell or tissue donor must be determined at that time. eligibility draft guidance). Elsewhere in to be eligible to donate, based on the We are now making final the donor- this issue of the Federal Register, we results of screening and testing for suitability proposed rule that was announce the availability of that draft relevant communicable diseases. In proposed on September 30, 1999. (For guidance, and solicit comments on its most cases, a donor who tests reactive reasons discussed in comment 26 of this contents. We have also developed draft for a particular disease, or who document, we refer in this final rule to guidance on screening for Creutzfeldt- possesses clinical evidence of or risk donor ‘‘eligibility’’ rather than Jakob Disease (CJD) and Variant factors for such a disease, would be ‘‘suitability.’’) The comment period for Creutzfeldt-Jakob Disease (vCJD) considered ineligible, and cells and that proposed rule closed on December entitled ‘‘Guidance for Industry: tissues from that donor would not 29, 1999. On April 18, 2000, we Preventive Measures to Reduce the ordinarily be used. reopened the comment period for an Possible Risk of Transmission of In addition to regulations governing additional 90 days. We took this step in Creutzfeldt-Jakob Disease (CJD) and the testing and screening of donors for response to requests for an extension of Variant Creutzfeldt-Jakob Disease (vCJD) relevant communicable disease and the comment period as well as to by Human Cells, Tissues, and Cellular quarantine and storage of HCT/Ps, FDA provide sufficient time for State officials and Tissue-Based Products (HCT/Ps)’’ has also determined that regulations to participate in the rulemaking (65 FR (the CJD draft guidance) (67 FR 42789, requiring establishments to maintain 20774, April 18, 2000). June 25, 2002). We intend to combine certain records related to HCT/Ps and to Because of their nature as derivatives the donor-eligibility draft guidance with establish standard operating procedures of the human body, HCT/Ps pose a risk the CJD draft guidance, and to issue a are necessary to prevent the of transmitting communicable diseases. single final guidance document. introduction, transmission, or spread For this reason, this final rule requires interstate of communicable disease. A that most cell and tissue donors be B. Legal Authority single donor may be the source of a tested and screened for evidence of We are issuing these new regulations large number of HCT/Ps. For example, relevant communicable disease under the authority of section 361 of the it may be discovered, long after the infection. It also contains other related PHS Act (42 U.S.C. 264). Under that donation and transplantations have requirements (e.g., on records, section, by delegation from the Surgeon been completed, that a donor of HCT/Ps quarantine, storage, and labeling). These General and the Secretary of Health and transplanted into a large number of donor-eligibility requirements, which Human Services, FDA may make and recipients had a relevant communicable locate in subpart C of part 1271, are part enforce regulations necessary to prevent disease. Although it might be too late to of the core requirements applicable both the introduction, transmission, or prevent the recipients’ infections, it to HCT/Ps regulated solely under these spread of communicable diseases would not be too late to for the recipient regulations and section 361 (the 361 between the States or from foreign to obtain treatment and take steps to HCT/Ps) of the Public Health Service countries into the States. Intrastate avoid infecting others, such as close Act (the PHS Act) and to those HCT/Ps transactions affecting communicable family members. However, unless also subject to regulation as drugs, disease transmission may also be adequate records were maintained, and devices, and/or biological products. As regulated under section 361 of the PHS maintained for the period of time part of this rulemaking, we are also Act. (See Louisiana v. Mathews, 427 F. throughout which infections may be amending the drug CGMP regulations supp. 174, 176 (E.D. La. 1977).) identified, it would be impossible to and the device QS regulations to clarify It is especially important to recognize identify the recipients potentially the role of the donor-eligibility that HCT/P manufacturing inevitably infected by the donor’s HCTPs. This requirements in the manufacture of has interstate effects. HCT/Ps recovered would be a critical breakdown in the HCT/Ps subject to regulation as drugs, in one State may be sent to another for prevention of disease transmission. devices, and/or biological products. processing, then shipped for use Accordingly, FDA determined that the Since the publication of the donor- throughout the United States, or maintenance and retention of records suitability proposed rule, we have beyond. FDA has been involved in are necessary to prevent the interstate continued to obtain current and many recalls where HCT/Ps processed introduction, transmission, and spread accurate information on the risks of in a single establishment have been of communicable disease. Since some communicable-disease transmission by distributed in many States. diseases, such as transmissible HCT/Ps and the most appropriate Section 361 of the PHS Act authorizes spongiform encephalopathies (TSEs), testing and screening measures. To this FDA to issue regulations necessary to appear to have a long latency period, end, we have met with FDA’s prevent the introduction, transmission, FDA has determined that a 10-year Transmissible Spongiform or spread of communicable diseases. record retention period is necessary. Encephalopathies Advisory Committee Communicable diseases include, but are Similarly, it is necessary for (TSEAC) (January 18 to 19, 2001, and not limited to, those transmitted by establishments to establish, maintain,

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and follow procedures related to the violation or up to $250,000 if death has that is a device under the act, must prevention of communicable disease. resulted. For organizational defendants, comply with the same procedures. The agency has determined that these fines range up to $200,000 and Section 375 of the PHS Act provides provisions are necessary to ensure that $500,000. Individuals and organizations for Federal oversight of the nation’s the important protections created by also face possible alternative fines based Organ Procurement and Transplantation these regulations are actually effected on the amount of gain or loss (18 U.S.C. Network, and section 379 of the PHS and are not simply empty promises. 3559 and 3571(b) through (d)). Federal Act authorizes the National Bone Only manufacturing conducted in District Courts also have jurisdiction to Marrow Donor Registry (42 U.S.C. 274c accordance with established procedures enjoin individuals and organizations and 274k). The Health Resources and can assure that HCT/Ps meet the from violating regulations implementing Services Administration (HRSA) standards in these rules. If standardized section 361 of the PHS Act. (See currently administers both of these processes are not developed and used, Califano v. Yamasaki, 442 U.S. 682, programs. Given HRSA oversight in mistakes, inevitably, are made. 704–05 (1979); United States v. Beatrice these areas, vascularized human organs (to include vascularized subparts of Moreover, review of procedures can be Foods Co., 493 F.2d 1259, 1271–72 (8th human organs) and minimally critical to determining the cause of a Cir. 1974), cert. denied, 420 U.S. 961 manipulated bone marrow (as defined disease transmission. Without that (1975).) Under sections 501(a)(2)(B) and analysis, it would be impossible to in § 1271.3(d)(2)) for unrelated (h), and 520(f)(1) of the Federal Food, prevent a future occurrence, with allogeneic use are specifically excluded Drug, and Cosmetic Act (the act) (21 possibly fatal consequences. from these final regulations. These regulations are intended to U.S.C. 351(a)(2)(B) and (h), and 21 II. Highlights of the Final Rule prevent the transmission of U.S.C. 360j(f)(1)), drugs (including communicable disease through the biological products) and devices This final rule requires establishments implantation, transplantation, infusion, (including biological products) are to make donor-eligibility determinations or transfer of HCT/Ps. However, as subject to CGMP requirements designed for cell and tissue donors, based on noted in the registration and donor- to ensure, among other things, product donor screening and testing for relevant suitability proposed rules, all HCT/Ps safety (21 U.S.C. 351(a)(2)(B) and (h), communicable disease agents and pose some risk of carrying pathogens and 21 U.S.C. 360j(f)(1)). The authorities diseases (§ 1271.45). The regulations that could cause disease in health-care supporting the CGMP and QS cover how to screen and test donors personnel, other handlers of tissue, regulations are also applicable when the (§§ 1271.75, 1271.80, and 1271.85), as recipients, and family members or other CGMP and QS regulations apply to an well as how to make the donor- contacts of recipients (63 FR 26744 and HCT/P regulated as a drug, biological eligibility determination (§ 1271.50). 64 FR 52696 at 52698). This broader product, or device. Currently, the CGMP The term ‘‘relevant communicable concern for the spread of communicable and QS regulations applicable to disease agent or disease’’ is defined at disease is reflected in certain labeling HCT/Ps regulated as drugs or devices do § 1271.3(r). The rule also contains requirements in these regulations and in not delineate testing and screening related requirements pertaining to the criteria for identifying a relevant procedures for communicable diseases. procedures (§ 1271.47); records communicable disease. We recognize (See parts 210, 211, and 820 (21 CFR (§ 1271.55); quarantine (§ 1271.60); and that regulations exist that are parts 210, 211, and 820).) Nevertheless, storage of HCT/Ps from ineligible specifically designed to protect we consider communicable-disease donors (§ 1271.65). Two of these employees who may come in contact testing and screening to be steps in the provisions describe situations where it with infectious materials (see 29 CFR manufacturing process that are crucial is not prohibited to use an HCT/P from 1910.1030, 42 CFR 72.6, and 49 CFR to the safety of such products. As a an ineligible donor or a donor who has 173.196), and we do not consider these result, we are amending the existing not yet been determined eligible regulations to be in conflict with those CGMP regulations for drugs in parts 210 (§§ 1271.60 and 1271.65). Exceptions other regulations currently in effect. and 211 and the QS regulations for from the requirement for making a However, we have made an effort to be devices in part 820, which include donor-eligibility determination appear consistent with the terminology used in CGMP requirements, to make clear that in § 1271.90. The donor-eligibility draft guidance these other regulations; e.g., ‘‘Infectious the testing and screening provisions of that may be found elsewhere in this Substances’’ and the Biohazard legend. part 1271 subpart C apply to HCT/Ps Federal Register is intended to assist Under section 361 of the PHS Act, regulated as drugs, devices, and/or establishments in complying with the FDA is authorized to enforce the biological products. regulations it issues to prevent the requirements of this final rule and introduction, transmission, or spread of Under § 210.1(c), the manufacturer of contains details that are not in the communicable diseases interstate an HCT/P regulated as a drug, including regulation. Although not binding, the through such means as inspection, a biological product that is a drug under draft guidance presents the agency’s disinfection, sanitation, destruction of the act, must comply with the donor- current thinking on the topics covered. animals or articles found to be so eligibility procedures in part 1271, For example, whereas the regulation infected or contaminated as to be subpart C. Failure to follow the CGMP requires an establishment to screen sources of dangerous infection in requirements, including the testing and donors for risk factors, the draft human beings, and other measures that screening procedures in part 1271, guidance specifies what we consider may be necessary. In addition, under would make the product adulterated those risk factors to be. Similarly, the section 368(a) of the PHS Act, any under the act. In issuing this regulation, draft guidance contains person who violates a regulation FDA is relying on the drug CGMP recommendations on which tests to use prescribed under section 361 of the PHS authorities (in particular, section to comply with the testing requirements Act may be punished by imprisonment 501(a)(2)(B) of the act (21 U.S.C. in §§ 1271.80 and 1271.85. The draft for up to 1 year. Individuals may also 351(a)(2)(B)), as well as section 361 of guidance also identifies several be punished for violating such a the PHS Act. Under § 820.1(a)(1), the additional disease agents or diseases regulation by a fine of up to $100,000 manufacturer of an HCT/P regulated as that we believe meet the definition of if death has not resulted from the a device, including a biological product relevant communicable disease agent or

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disease. We welcome comments on the establish and maintain procedures for that final rule we discussed comments draft guidance. As scientific knowledge the steps they perform in determining on dispute resolution (66 FR 5447 at is developed, new tests are introduced, donor eligibility, including testing and 5451); homologous use (66 FR 5447 at and additional relevant communicable screening; 5458); the practice of medicine (66 FR disease agents and diseases are • The requirement for donor retesting 5447 at 5452); minimal manipulation identified, we intend to follow the good 6 months after donation now applies (66 FR 5447 at 5457); the definition of guidance practices set out in § 10.115 to only to anonymous semen donors. In ‘‘family-related allogeneic use’’ (66 FR modify the donor-eligibility guidance so addition, you do not have to obtain a 5447 at 5454); the terms ‘‘human that it remains current. specimen for testing at each donation cellular or tissue-based product’’ and from a repeat anonymous donor, so long ‘‘manufacture’’ (66 FR 5447 at 5455 and A. Plain Language as you do not release the donation 5456); the regulation of bone allografts In the Federal Register of June 10, unless the donor has been retested (at (66 FR 5447 at 5457); establishments not 1998 (63 FR 31885), the Presidential least 6 months post donation). Directed required to comply with part 1271 (66 Memorandum on Plain Language in donations of semen are excepted from FR 5447 at 5460); and the frequency of Government Writing was issued. The the retesting requirement; updates (66 FR 5447 at 5460 and 5461). goal of the plain language initiative is to • Physical separation between HCT/Ps If we considered an issue in the publish government documents that are from ineligible and eligible donors is no registration final rule, we are not easier to understand. longer required; reiterating our response here. In response to this initiative, we have • We have removed the requirement Several comments submitted to the written the donor-eligibility regulation that a physician must consent to the use docket for the CGTP proposed rule in plain language. We have taken the of an HCT/P from an ineligible donor; raised issues that are appropriately following actions: • You must screen all donors for addressed in this final rule. We respond • Written the regulation in question- Treponema pallidum and some donors to those comments in comments 32, 48, and-answer format; for Human T-lymphotropic virus 49, and 59, and in the discussion of • Reorganized some regulatory (HTLV) (in addition to testing); § 1271.47 in section III.D.3 of this sections for greater clarity; and • You must screen donors for document. • Followed other plain-language ‘‘communicable disease risks associated We received two requests for an conventions, such as using ‘‘must’’ with xenotransplantation.’’ Under the extension of the comment period. On instead of ‘‘shall.’’ proposed rule, receipt of a April 18, 2000, a document was The resulting codified language is xenotransplantation product would published in the Federal Register easier to read and understand than the have made a donor ineligible under all reopening the comment period for an proposed regulation. These editorial circumstances. Now, receipt of a additional 90 days (65 FR 20774). changes are for clarity only and do not xenotransplantation product no longer A. General change the substance of the overrides the special circumstances, requirements. listed in § 1271.65(b)(1), under which (Comment 1) We received various use of an HCT/P from an ineligible comments expressing general approval B. New Terminology and Definitions donor is not prohibited; of the proposed rule. One comment In the registration final rule, we • We have modified the requirements applauded us for addressing concerns of discussed our decision to replace the applicable to testing for vital interest to the protection of the term ‘‘human cellular or tissue-based Cytomegalovirus (CMV); public health. Another comment products’’ with ‘‘human cells, tissues, • If the donor is one month of age or expressed continued support for our and cellular and tissue-based products’’ younger, you must test a specimen from efforts to design a comprehensive (abbreviated HCT/Ps) (66 FR 5447 at the birth mother; regulatory program for HCT/Ps, and 5455). For consistency, we have made • The requirements on timing of agreed that screening and testing of the same change in this final rule. specimen collection allow 7 days before donors constitutes a vital component of In response to comments, we have or after recovery, or for donors of such a program. Other comments changed the term ‘‘donor suitability’’ to peripheral blood stem progenitor cells supported our goal of preventing the ‘‘donor eligibility.’’ only, up to 30 days before recovery, if transmission of communicable diseases In addition, we have made several specimen collection at the time of through donor screening and testing. changes to the definition of ‘‘relevant recovery is not feasible; and One comment supported requiring communicable disease agent or disease’’ • Required testing can be performed semen banks to comply with the with respect to prevalence. We intend by a laboratory that has met proposed screening and testing the new language to cover both requirements equivalent to those regulations. intentional and unintentional release of imposed by the Clinical Laboratory We also received comments voicing infectious agents. Improvement Amendments of 1988 general criticism of the proposed rule We have also modified the definition (CLIA), as determined by the Centers for and of our comprehensive regulatory of ‘‘directed donor’’ and changed the Medicare and Medicaid Services (CMS). approach to cells and tissues. Some term to ‘‘directed reproductive donor.’’ comments described the proposed rule We have deleted the definitions of III. Comments on the Proposed Rule as unnecessary or burdensome. One ‘‘xenotransplantation’’ and ‘‘close and FDA’s Responses comment asserted that the regulations contacts.’’ We received over 500 comments on were inconsistent with the the proposed rule. Congressionally supported ‘‘least C. Other Highlights Some comments raised issues relating burdensome’’ practice of regulation. This final rule contains other changes to the general provisions in subpart A of (Response) We acknowledge and from the proposed rule. These changes part 1271 or the registration and listing appreciate the supportive comments. are listed as follows: procedures in subpart B, and we This rule contains important • Provisions in § 1271.47, originally considered those comments in drafting requirements that will help prevent the proposed in the CGTP proposed rule, the registration final rule (66 FR 5447 at transmission of communicable diseases require that HCT/P establishments 5450, January 19, 2001). For example, in by HCT/Ps. Moreover, it forms a vital

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component of the new tiered, risk-based and Drug Administration Modernization within the definition of health care and regulatory program, which will be Act of 1997. the establishments that perform such superior to the patchwork of (Comment 2) Several comments asked activities are not considered health care requirements that it replaces. As that provisions be made for HCT/Ps providers when conducting these discussed in greater detail in section IV collected before the effective date of this functions (65 FR 82462 at 82477, of this document, this rule is consistent regulation and opposed retrospective December 28, 2000). In addition, the with Executive Order 12866, which, in application of the new regulations. Privacy Rule authorizes health care its eleventh Principle of Regulation (Response) This regulation will apply providers who are subject to the Privacy applicable to Federal rulemaking, to cells and tissues recovered on or after Rule to ‘‘disclose protected health requires FDA to ‘‘* * * tailor its the effective date of the regulation. information to organ procurement regulations to impose the least burden (Comment 3) One comment urged us organizations or other entities engaged on society * * * consistent with to coordinate our donor screening in the procurement, banking or obtaining the regulatory objectives.’’ requirements with those of other transplantation of cadaveric organs, FDA has designed this regulatory countries. eyes, or tissue for the purpose of program to impose only appropriate, (Response) We support the long-term facilitating organ, eye or tissue donation and appropriately limited, burdens. goal of international harmonization. In and transplantation’’ (45 CFR For example, the compliance the process of developing this final rule, 164.512(h)). The preamble to the expectations for a small medical we have reviewed standards from other Privacy Rule notes that, when an practice that provides artificial countries and met with representatives individual has not previously insemination are commensurate with from the European Union, Australia, authorized release of protected health the communicable disease risks Japan, and other nations. The information, this provision of the associated with its activities. If the requirements in place in other countries Privacy Rule ‘‘* * * is intended to allow practice is limited to artificial are diverse and rarely static, reflecting covered entities [those subject to the insemination using either semen from the fact that other countries may have privacy rule] to initiate contact with an anonymous or directed reproductive screening needs different from those in organ and tissue donation and donor obtained from a semen bank the United States and different tests transplantation organizations to (§ 1271.15(d)), or semen recovered at the available to them. The challenge of facilitate transplantation of cadaveric practice and immediately used to achieving consistency is underscored by organs, eyes, and tissues’’ (65 FR 82464 inseminate the donor’s sexually the European Commission’s at 82534). The Privacy Rule further intimate partner (§ 1271.15(e)), then the announcement of the need for a new authorizes covered entities to disclose risks are minimal and the practice is not directive on human tissue, intended to protected health information to persons required to comply with part 1271. If replace the current myriad of 15 subject to the jurisdiction of FDA with the semen is not immediately differing—and sometimes nonexistent— respect to an FDA-regulated product or transferred to a donor’s sexually national laws on the subject. On June activity for which that person has intimate partner but instead is stored 19, 2002, the Commission of European responsibility, for the purpose of (raising concerns about possible cross- Communities put forth a ‘‘Proposal for activities related to the quality, safety or contamination during storage), the a Directive of the European Parliament effectiveness of such FDA-regulated practice would not be eligible for the and of the Council on setting standards product or activity (45 CFR exception under § 1271.15(e) and would of quality and safety for the donation, 164.512(b)(1)(iii)). Finally, we further need to comply with the requirements procurement, testing, processing, note that in the event that one of the in part 1271 subpart B (registration and storage, and distribution of human previously mentioned provisions is not listing) and in applicable sections of tissues and cells.’’ Completion of this applicable, covered entities may subpart C (minimal standard operating directive is expected to take several disclose protected health information procedures, minimal recordkeeping, and years. We applaud this effort and will pursuant to an authorization from the specific labeling for stored reproductive continue to follow developments in individual or the individual’s personal cells or tissue from sexually intimate tissue regulation throughout the world. representative (45 CFR 164.502(a)(1)(iv) partners if not screened or tested). However, at this time, our primary goal and (g)(1), and 164.508). For these Additional risks are associated with the is to put into place the basic safeguards reasons, we do not believe that the recovery of semen from an anonymous set out in this rule, an effort that may Privacy Rule conflicts with this final or directed reproductive donor for provide a starting point for further rule. artificial insemination; practitioners harmonization efforts. However, FDA has considered the who perform these services are not (Comment 4) Several comments stated impact of this donor-eligibility final rule eligible for the exception under that the rule would conflict with the on patient privacy. We have deleted the § 1271.15(d) and must comply with both rule concerning privacy of health care requirement that relevant patient subpart B (registration and listing) and information proposed by the records accompany an HCT/P, requiring all of subpart C (donor screening and Department of Health and Human instead a summary of records. We made testing, standard operating procedures, Services (HHS) on November 3, 1999. this change in response to concerns recordkeeping, and labeling) in part The privacy rule was subsequently about privacy. 1271. FDA intends to provide further finalized on December 28, 2000 (65 FR (Comment 5) One comment stated detailed guidance regarding these risk- 82462), and amended on August 14, that, in the proposed rule, FDA based approaches. 2002 (67 FR 53182). improperly ‘‘relied’’ on provisions of the We have striven to establish (Response) The Department registration proposed rule. Another regulations that provide public health regulations on privacy of health care comment objected to the rulemaking protection without imposing an undue information (the Privacy Rule) were process, asserting that we circumvented burden on regulated industry. In this codified at 45 CFR parts 160 and 164. the usual departmental review process sense, they are also entirely consistent The Privacy Rule does not include the before publishing the proposed rule. with the requirement for ‘‘least procurement or banking of organs, blood (Response) We disagree with both burdensome’’ regulation of devices set (including autologous), sperm, eyes or comments. In the proposed rule, the out in section 205(a) and (b) of the Food any other tissue or human product agency did not ‘‘rely’’ on the registration

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proposed rule, but merely described component with a drug or a device, B. Amendments to 21 CFR Parts 210, another ongoing, related, rulemaking. except for a sterilizing, preserving, or 211, and 820 Moreover, we made clear that the storage agent, and then only if the We proposed amending §§ 210.1 and provisions of the registration proposed addition of the agent does not raise new 820.1 to require manufacturers of rule we referenced in the preamble to clinical safety concerns with respect to HCT/Ps regulated as drugs, medical the donor-suitability proposed rule were the HCT/P. Should an additive raise devices, and/or biological products to merely proposals. The agency received new safety concerns or, as in the case of comply with the donor-eligibility comments related to those proposals in glycerol, be for any purpose other than procedures in subpart C and the current the donor suitability docket. When we sterilizing, preserving, or storage, the good tissue practice (CGTP) procedures finalized those provisions in the HCT/P would be subject to regulation in subpart D of part 1271. (We also registration final rule, we considered under the act and/or section 351 of the proposed minor amendments, for comments received in the donor PHS Act, and FDA would consider consistency, to §§ 210.2 and 211.1.) The suitability docket, as well as in the allowable limits of chemical additives donor-eligibility and CGTP procedures registration docket (66 FR 5447 at 5450). in the context of the premarket review would be considered part of CGMP With respect to the second comment, we process. requirements for drugs and the QS disagree that we followed anything requirements for devices. other than our usual review process; (Comment 8) One comment asserted The proposed amendment to § 210.1 however, we note that these procedures that tissue banks should audit their stated that failure to comply with the constitute department practice and are domestic and international tissue donor-eligibility, CGTP, or other CGMP not required by regulation by law or recovery and distribution intermediaries regulations would render adulterated, regulation. to assure accountability to the same (Comment 6) One comment cited a standards that they themselves uphold. under section 501(a)(2)(B) of the act, an potential conflict with the regulation HCT/P regulated as a drug and/or (Response) We agree that biological product, and the HCT/P, as issued by CMS requiring hospitals to documentation of these audits would notify organ procurement organizations well as the person responsible for the help assure our goals of protecting the failure to comply, would be subject to (OPOs) upon patients’ death or public health. Audits and other ways of imminent death (42 CFR 482.45). The regulatory action. The proposed ensuring accountability are addressed in amendments to § 820.1 were comment pointed out that OPOs might, the CGTP proposed rule. in some instances, determine donor comparable, stating in part that the eligibility for tissue donors. The (Comment 9) One comment supported failure to comply with any applicable comment asserted that FDA does not the establishment of a central registry donor-eligibility, CGTP, or QS regulate OPOs and questioned who for tracking all reproductive tissue regulation would render a device would be accountable for compliance donors to locate donors and recipients adulterated under section 501(h) of the with FDA regulations. in an emergency. act. (Response) We disagree that there is a (Response) We encourage interested We received no comments on the conflict between the regulations in part parties to explore methods of tracking proposed amendments. 1271 and CMS’s regulation of OPOs; we donors, donations, and recipients, We are finalizing the proposed also disagree that OPOs are exempt from including the establishment of such a modifications to §§ 211.1(b) and FDA regulations. The determination of central registry. However, we do not 820.1(a), which add a cross-reference to the regulations in part 1271. As donor eligibility is a key function of an propose to require such a registry at this finalized, § 211.1(b) applies to HCT/Ps HCT/P manufacturing establishment. time. Therefore, although human organs are that are also regulated as drugs or excluded from the definition of HCT/P, (Comment 10) One comment asked biological products subject to the drug and thus not covered by the regulations that the regulations clarify the current good manufacturing practice in part 1271, any OPO that performs any responsibilities of reproductive tissue (CGMP) regulations in parts 210 and part of any HCT/P manufacturing banks and client depositors with respect 211, and § 820.1(a) applies to HCT/Ps function, is subject to the regulations in to length of storage of tissue and the that are also regulated as devices subject part 1271. Such an OPO must register right of a bank to destroy tissue of to the QS regulations in part 820. with the agency and comply with all noncompliant depositors. In response to a comment submitted applicable regulations in part 1271; (Response) The requested clarification on the CGTP proposed rule that asserted thus, an OPO that screens tissue donors is beyond the scope of these regulations, that the ‘‘impossible to comply’’ must do so in compliance with the which concern communicable disease language in proposed § 1271.150(c) did regulations in part 1271 on donor transmission and not provisions of not provide useful guidance, we have screening. If an OPO performs no tissue agreements between HCT/P modified this provision by replacing the manufacturing functions, it would not establishments and individual clients ‘‘impossible to comply’’ language with be subject to these regulations. that are unrelated to communicable more specific wording referring to a (Comment 7) One comment disease transmission. conflict between applicable regulations recommended that we set allowable in different parts. In the event of a (Comment 11) One comment limits for additives to allograft tissues, conflict between applicable regulations questioned why these regulations do not such as glycerol. in part 1271 and regulations in parts (Response) We decline to set a address the use of cellular material 210, 211, or 820, the regulations specific limit on such additives in these other than from the patient in in-vitro specifically applicable to the product in regulations. We point out, however, that fertilization. Another comment question will supersede the more one of the criteria in § 1271.10 for supported restrictions on gene, ooplasm, general regulations. Because the regulation of an HCT/P solely under and nuclear transfer. ‘‘impossible to comply’’ language is section 361 of the PHS Act and part (Response) We recognize the contained in related provisions in other 1271 is that the manufacture of the comments’ concerns and are addressing parts we have made the same change to HCT/P does not involve the these issues in contexts outside of this these provisions to ensure consistency. combination of the cell or tissue rulemaking. This new language is intended for

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purposes of clarity. The ‘‘impossible to regulations establishing requirements proposed definition of ‘‘summary of comply’’ language in our current under section 520(f) of the act, the act records’’ into § 1271.55 and so have regulations was not the subject of requires FDA to submit the proposed deleted the definition of that term from complaints by regulated establishments. regulations for review by an advisory the final rule. We received no comments With the revised language, FDA intends committee meeting the criteria on that definition. We also received no to continue to interpret the standard established in section 520(f)(3). comments on the proposed definition of reasonably and does not intend to However, FDA’s advisory committee for ‘‘quarantine,’’ and it remains unchanged impose unreasonable burdens on device GMP regulations has not met in this final rule (§ 1271.3(q)); however, establishments. since April 29, 1997, and only six of the comments on the quarantine provisions We note that the phrase ‘‘impossible required nine seats are currently filled. in § 1271.60 are addressed in section to comply’’ has been used for products Although the agency believes it would III.D.6 of this document. other than HCT/Ps since FDA first be desirable to include a provision such issued the device CGMP regulations in as proposed § 820.1(c), we believe it is 1. Colloid (§ 1271.3(j)) and Crystalloid 1978 (43 FR 31508, July 21, 1978). Two not absolutely necessary to the (§ 1271.3(k)) months later, FDA used the phrase in regulatory scheme. When the device Proposed § 1271.3(k) defined the drug CGMP regulations (43 FR GMP advisory committee has been fully ‘‘colloid,’’ and proposed § 1271.3(l) 45014, September 29, 1978). FDA reconstituted, FDA may consider defined ‘‘crystalloid.’’ Both are terms explained in the preamble to the drug submitting proposed § 820.1(c) for its used in § 1271.80 with respect to plasma regulations that ‘‘impossible to comply’’ consideration. In the meantime, FDA dilution. Although we specifically encompasses situations where intends to enforce violations of part requested comments on the regulations contradict or conflict each 1271, subparts C and D, under the appropriateness of these definitions, no other (43 FR 45014 at 45029). enforcement provisions contained in comments were submitted. The new language on a conflict section 368 of the PHS act (42 U.S.C. For greater accuracy, we have made between applicable regulations replaces 271), and the general equitable powers minor changes to the language of each the phrase ‘‘impossible to comply’’ in of the Federal courts. definition. The final rule contains a two- §§ 210.2(a), 211.1(b), 820.1(a), and Finally, we note that the references to part definition of ‘‘colloid’’ in 820.1(b). (Although a revision to part 1271 in these sections (§§ 210.1, § 1271.3(j). Under the first part, a colloid § 820.1(b) was not proposed, it is now 210.2, 211.1, and 820.1) refer to is a protein or polysaccharide solution, necessary to revise that paragraph for ‘‘applicable’’ provisions of part 1271. In such as albumin, dextran, or hetastarch, consistency with § 820.1(a).) The new the event that the final CGTP rule that can be used to increase or maintain language pertains only to conflicts that provides that any or all provisions in osmotic (oncotic) pressure in the occur between applicable regulations in that rule are not being implemented for intravascular compartment. We have one part (e.g., part 211) and applicable certain HCT/Ps, those CGTP provisions deleted the word ‘‘certain’’ from the regulations in another part (e.g., part would not be ‘‘applicable’’ for those second part of the definition, so that it 1271) and not between regulations HCT/Ps. within one part (e.g., between two now reads: ‘‘Blood components such as regulations in part 211). FDA believes C. Definitions (§ 1271.3) plasma and platelets.’’ that, in the event of such a conflict, the We have grouped all definitions The final rule replaces the word more specifically applicable regulation pertinent to part 1271 in a single ‘‘balanced’’ in the proposed definition would be found in part 1271. definitions section (§ 1271.3), among the of crystalloid with ‘‘isotonic,’’ so that We are also finalizing proposed general provisions of subpart A. the definition now refers to an isotonic § 210.1(c), which would provide that the We received no comments on the salt and/or glucose solution used for failure to comply with any applicable proposed definitions of the following electrolyte replacement or to increase provision in part 1271, subparts C and terms, and those definitions appear in intravascular volume, such as saline D, would render a drug adulterated the final rule either unchanged or with solution, Ringer’s lactate solution, or 5 under section 501(a)(2)(B) of the act. only minor changes for consistency in percent dextrose in water. We have made minor revisions to the terminology (i.e., references to HCT/Ps): 2. Directed Reproductive Donor wording of the proposed amendments to Biohazard legend (§ 1271.3(h)), blood (§ 1271.3(l)) §§ 210.1(c), 210.2, 211.1(b), and component (§ 1271.3(i)), donor 820.1(a). These changes include the (§ 1271.3(m)), plasma dilution The proposed rule contained a addition of a reference to section 361 of (§ 1271.3(p)), responsible person definition of ‘‘directed donor,’’ a term the PHS Act in §§ 210.1(c) and 820.1(a). (§ 1271.3(t)), act (§ 1271.3(v)); PHS Act used in proposed § 1271.65(b) to We have also clarified in § 210.1(c) that (§ 1271.3(w)); and FDA (§ 1271.3(x)). For describe a situation in which the use of screening refers to donor screening and clarity, we have added the phrase ‘‘of a reproductive cells or tissue from an that testing includes donor testing. cadaveric donor’’ to the term ‘‘physical ineligible donor would not be However, we are not finalizing assessment,’’ but have made no other prohibited. In considering the proposed § 820.1(c) in this rule, which change to that definition (§ 1271.3(o)). comments on § 1271.65(b), discussed in would have provided that the failure to We received no comments on the greater detail in section III.C.5 of this comply with any applicable provision proposed definitions of the terms document, we concluded that, for in part 1271, subparts C and D, would ‘‘embryo’’ and ‘‘gamete,’’ but have clarity, we should limit the definition of render a device adulterated under deleted those definitions from this final ‘‘directed donor’’ to donors of section 501(h) of the act. The act rule as unnecessary; ‘‘gamete’’ is not reproductive cells and tissue and requires FDA to follow special used in the codified provisions and change the term to ‘‘directed procedures when issuing regulations ‘‘embryo’’ is generally understood. We reproductive donor.’’ Because the term under the device good manufacturing received no comments on the term ‘‘directed reproductive donor’’ is used practice (GMP) authority; those ‘‘reconstituted blood,’’ but have deleted only in the context of the donation of procedures are not applicable to the term from the final rule because of reproductive cells and tissue, these regulations issued under the CGMP its potential to cause confusion. We changes do not affect the scope of the authority for drugs. Before issuing have incorporated the substance of the exception.

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As proposed, a directed donation for revealing a donor’s identity at a communications with friends and life involved the designation of a specific future time. partners. potential recipient. We have maintained We note that the suggested change to (Response) A donor medical history this part of the definition in the final the screening requirement in § 1271.75 interview means a ‘‘documented rule. would exempt the anonymous donors dialog.’’ You may conduct such a dialog (Comment 12) Our review of described in the comment from in person, by telephone, or through comments indicated that there was screening for risk factors for human written or other forms of some confusion about whether the immunodeficiency virus (HIV), hepatitis communication that allow the exchange designation of a specific recipient could B virus (HBV), hepatitis C virus (HCV), of information between interviewer and take place in the context of anonymous human transmissible spongiform interviewee. The interview method semen donation (i.e., a situation in encephalopathy (TSE), including CJD should allow the interviewer to ask which the donor and recipient do not and vCJD, Treponema pallidum, HTLV, followup questions to collect necessary know each other). Chlamydia trachomatis, and Neisseria information or to clarify responses. In (Response) We did not intend for the gonorrhea. We cannot justify this the case of a living donor, a face-to-face term ‘‘directed donor’’ to refer to exception on public health grounds. interview is generally the most effective anonymous donations. Rather, our Whether or not the identity of an way to conduct a dialog. intention was to respect the existence of anonymous donor may be revealed later We agree that the definition may relationships between people. To has no bearing on the appropriate include communications with friends recognize existing relationships between screening and testing of that donor. For and life partners, if they are donors and recipients, we have added the prevention of the transmission of knowledgeable about the donor’s language to the definition of ‘‘directed communicable disease, the same medical history and relevant social reproductive donor’’ to indicate that, in requirements should apply to all behavior. a directed donation, the donor knows anonymous donors. We have distinguished between We note that the definition of ‘‘donor and is known by the recipient before directed reproductive donors and medical history interview’’ is among the donation. anonymous donors to respect the provisions of this final rule that we have We have also clarified the definition existence of relationships between redrafted for clarity and plain language by noting that directed reproductive people who know each other and have reasons. The meaning of the definition donors do not include sexually intimate made a joint decision for the recipient remains unchanged. donors, who are excepted from to conceive a child. In contrast to the screening and testing requirements 4. Relevant Communicable Disease directed reproductive donor who has an Agent or Disease (§ 1271.3(r)) under § 1271.90. This change is existing relationship with the recipient, intended to make clear that, for the only the potential for a future Proposed § 1271.3(y) contained a 2- purpose of this rule, there are three relationship exists for the anonymous part definition of ‘‘relevant categories of reproductive donors, donors described in the comment. communicable disease or disease subject to three different sets of Under the identification-revealed agent.’’ The first part listed those requirements listed as follows: (1) The donation arrangement described in the disease agents and diseases that are anonymous donor, to whom all the comment, there is no relationship specifically identified in §§ 1271.75 and donor-eligibility requirements apply; (2) between donor and recipient at the time 1271.85 as relevant communicable the directed reproductive donor, whose of donation. The recipient does not even diseases for which screening and testing reproductive cells and tissue may be know the name of the donor at the time would be required. These are as follows: used even if the donor is determined of the donation, and may never learn the HIV, types 1 and 2; HBV; HCV; TSE, ineligible; and (3) the sexually intimate donor’s identity at all. For these reasons, including CJD and vCJD; Treponema partner, for whom testing and screening we decline to add a new definition for pallidum; HTLV, types I and II; CMV; are not required (discussed in section ‘‘identification revealed donor.’’ Chlamydia trachomatis and Neisseria III.D.11 of this document). gonorrhea. The proposed rule noted that (Comment 13) One comment 3. Donor Medical History Interview in some instances, FDA had identified requested that we define an additional (§ 1271.3(n)) a disease agent or disease as relevant for category of anonymous semen donor, The donor medical history interview a particular type of HCT/P and that this the ‘‘Identification Revealed Donor.’’ is one of the relevant medical records distinction was reflected in the Under this kind of donation, the that are reviewed in the donor screening proposed testing and screening identity of an anonymous semen donor process. We proposed to define ‘‘donor requirements in §§ 1271.75 and 1271.85 may be revealed to the child and/or medical history interview’’ as a (64 FR 52696 at 52701). For clarity, we mother at some point after birth. (We documented dialog with the donor, if have reorganized the list of identified also received comments supporting this living, or, if the donor is not living or relevant communicable disease agents type of arrangement.) The comment is unable to participate in the interview, and diseases in the first part of the suggested a related change to proposed with an individual knowledgeable about definition (§ 1271.3(r)(1)) according to § 1271.75 so that screening for risk the donor’s medical history and relevant tissue type. Thus, for example, HIV, factors for relevant communicable social behavior (proposed § 1271.3(o)). types 1 and 2, is listed as relevant for diseases would not be required for The proposed definition provided all cells and tissues; HTLV, types I and donors whose identities may be examples of possible interviewees and II, is listed as a cell-associated disease revealed later. described the questions to be asked agent or disease relevant for viable, (Response) Donor identification is about relevant social behavior leukocyte-rich cells and tissues; and outside our jurisdiction and unrelated to (Comment 14) Several comments Chlamydia trachomatis is listed as a the purpose of this rule, which is to asserted that the proposed definition of disease agent or disease of the prevent the transmission of donor medical history interview implies genitourinary tract relevant for communicable disease. For these that an in-person, face-to-face interview reproductive cells and tissues. This is reasons, this rule does not address any would be required. One comment an organizational change and not agreements that might be entered into assumed that the definition includes substantive.

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The second part of the proposed responsible for the lack of reports of identify communicable disease agents or definition described criteria for other syphilis transmission via organs, diseases for which donor screening and communicable diseases or disease tissues, or cells, including the use of testing should be performed. agents to be considered ‘‘relevant.’’ The antibiotics during tissue processing and We also believe that, by issuing proposed criteria related to prevalence, the storage of tissues at low guidance, the agency will assist small transmission risk, significance of health temperature. (Treponema pallidum does tissue establishments, which may not be risk, and the availability of appropriate not survive when stored at 4 °C for more in a position to track the prevalence of screening and/or testing methods. We than 48 to 72 hours.) However, these emerging diseases and disease agents in have made changes to several aspects of factors might not always be in place; a timely manner. Through guidance, this part of the definition, discussed in i.e., antibiotics might not be used, and FDA will perform an important comments 16 through 19 of this fresh bone grafts might not be stored communications function and assist document. under time and temperature conditions small tissue establishments in meeting ‘‘Relevant communicable disease that would kill the organism, if present. their regulatory obligations to test and agent or disease’’ is defined in the final Because of the potential for screen for relevant communicable rule at § 1271.3(r) transmission by cells and tissue, diseases and disease agents. (Comment 15) One comment stated including cornea, of both CJD and Under the final rule, whether or not that we had not sufficiently syphilis, we are maintaining the a disease or disease agent is ‘‘relevant’’ demonstrated the need to expand screening and testing requirements in under the rule will still be measured by agency oversight to include diseases in the final rule. the factors set out in § 1271.3(r)(2)(i), addition to HIV and hepatitis. Another (Comment 16) Several comments (r)(2)(ii), and (r)(2)(iii), taken together. comment asserted that transmission of asked about the procedure we would We recognize that, due to a variety of CJD and syphilis (Treponema pallidum) use to identify additional relevant circumstances, you may not be aware of via cornea transplants is rare or communicable disease agents and every instance when a disease or disease nonexistent. diseases under the second part of the agent meets these factors. We therefore (Response) When we issued part 1270 definition. Two comments asserted that intend to clarify the application of these as an interim rule in 1993, among other we should specify that procedure, and criteria in guidance. FDA’s role in reasons, we were acting swiftly to that, except in cases of real urgency, the issuing guidance is to provide notice counter the transmission of three agency must afford interested parties that the definitional elements appear to serious disease agents, HIV, HBV, and prior notice and an opportunity to be met. FDA’s notification will take the HCV (64 FR 52696 at 52698). One comment before adding a new disease form of guidance and will not constitute reason for the inclusion of more agent or disease to the list. According to a rule. In an enforcement action diseases and disease agents in the these comments, providing for such involving testing and screening for a proposed rule and this final rule is that input would provide the following new relevant communicable disease or the new rules cover more types of cells results: (1) Reveal scientific disease agent, FDA’s identification in and tissues than were subject to part complexities otherwise unknown to guidance of the disease or disease agent 1270. These additional cells and tissues FDA, (2) allow us to avoid imposing an would not be dispositive of the issue of pose additional risks of transmitting additional testing obligation where no whether it meets the factors set out in communicable disease. For example, we test is available, and (3) help avert the § 1271.3(r)(2)(i), (r)(2)(ii), and (r)(2)(iii). are now requiring you to test donors of unnecessary destruction of tissues in In such an action, FDA would have to viable, leukocyte-rich tissue for HTLV inventory. Some comments stated that establish that the disease met those and CMV; this requirement did not tissue establishments would have a factors. previously exist, because part 1270 did difficult time identifying a new relevant (Comment 17) One comment asserted not cover such viable, leukocyte-rich communicable disease agent or disease that the application of ‘‘relevant’’ is HCT/Ps as semen and hematopoietic under the four factors set out in the subject to FDA’s sole determination, stem/progenitor cells. Similarly, we are proposed rule. In the absence of which is further complicated by FDA’s now requiring that you test donors of guidance by the agency, establishments interpretation of terms such as ‘‘risk’’ reproductive tissue for Neisseria might feel forced to conduct testing that and ‘‘appropriate screening.’’ The gonorrhea and Chlamydia trachomatis, was not supported by the risk, due to comment asserted that these terms are a requirement that did not exist under liability concerns. not sufficiently defined, and that part 1270, which did not cover (Response) We agree that public relevant risk is broadly applied and reproductive tissue. participation in these issues is does not sufficiently address risk by We proposed to add TSE (including important. We intend to issue guidance specific tissue. Another comment stated CJD and vCJD) and syphilis to the list of in accordance with the good guidance that ‘‘relevant disease risk’’ is overly disease agents and diseases for which practices set out in § 10.115 to advise broad and would subject all tissue donors of all types of cells and tissues you when, in the agency’s view, a new entities to unfair malpractice claims, would be required to undergo screening relevant communicable disease agent or leaving the system vulnerable and and/or testing, because these two disease exists. Good guidance practices subject to unnecessary costs. The diseases present significant health risks. provide the public with an opportunity comment further opined that the mere We disagree with the assertion that to comment on guidance before its hypothetical threat of a disease or agent testing is unnecessary due to the implementation, except when the would make it eligible for required infrequency of transmission. With agency determines that prior public screening and testing. respect to CJD, there have been over 100 participation is not feasible or (Response) The rule establishes transmissions of CJD from dura mater appropriate (e.g., in a public health factors that must be met before a disease worldwide (including 3 in the United emergency). When FDA issues guidance agent or disease is ‘‘relevant’’ under this States) and 1 transmission from cornea for immediate implementation, the rule. As explained in comment 16 of (in addition to 2 possible public is invited to comment after this document, we intend to follow good transmissions), and the number of cases publication. In suitable situations, we guidance practices to notify you that the of vCJD is rising. With respect to will hold public meetings or consult agency believes additional relevant syphilis, several factors could be with advisory committees to help us communicable disease agents or

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diseases exist. This will provide the screening for a communicable disease or the agency to be able to respond opportunity for public participation in disease agent; grouping them will promptly by issuing guidance on testing the process. ensure that both factors are considered and screening without awaiting the We disagree with those comments together. accumulation of data on prevalence. that question the terms ‘‘relevant We believe that the factors set out in In response to the second comment, disease risk’’ and ‘‘relevant risk.’’ These § 1271.3(r)(2)(i), (r)(2)(ii), and (r)(2)(iii) which asked at which point and by are not terms that we used in the should be considered as a whole. This whom would a disease be designated proposed definition of relevant approach is useful in explaining the sufficiently prevalent among potential communicable disease agent or disease, concept of prevalence/incidence. On the donors, we discuss in comment 16 of and they do not appear in the final one hand, a highly prevalent but this document, the procedures we will definition. relatively harmless disease agent might follow to communicate the agency’s With respect to the comment on not be considered relevant. For conclusions concerning when a disease requiring testing and screening for a example, some communicable diseases or disease agent meets the definition of disease that poses a ‘‘mere hypothetical (e.g., Ureaplasma urealyticum, a disease relevant communicable disease or threat,’’ screening and testing would be of the genitourinary tract) are prevalent, disease agent. required only when supported by a but their pathogenicity to cell and tissue (Comment 19) One comment asked us sound scientific basis. Identifying a recipients is of questionable clinical to define ‘‘significant’’ health risk. This relevant communicable disease agent or significance. For this reason, we do not comment asserted that the term is vague disease will entail an evaluation of the currently consider Ureaplasma and subject to misinterpretation. risk of the disease based on the criteria urealyticum to be a relevant (Response) In response to this in § 1271.3(r)(2). Establishments would communicable disease agent. On the comment, we have replaced the phrase not be required to determine other hand, testing or screening might with more specific language in independently which disease agents and be required for a less prevalent but § 1271.3(r)(2)(ii). The definition now diseases meet the definition of ‘‘relevant particularly virulent agent. Examples of states that a relevant communicable communicable disease agent or communicable diseases that are less disease agent or disease is one that disease,’’ and could simply follow FDA prevalent, yet pose extremely significant could be fatal or life-threatening, could guidance concerning communicable health risks, are TSE and HIV–2. result in permanent impairment of a diseases or disease agents newly The second change we have made is body function or permanent damage to identified as relevant. Establishments to modify the proposed language on body structure, or could necessitate could also participate in FDA’s prevalence so that it now refers to medical or surgical intervention to identification process, for example by ‘‘sufficient incidence and/or prevalence preclude permanent impairment of body commenting on draft and final to affect the potential donor function or permanent damage to a body guidances. Such FDA guidances would population.’’ Whereas prevalence refers structure. This more specific description identify disease agents or diseases to the number of existing cases over a is modeled on language used in the which, in the agency’s view, meet the period of time, incidence refers to the agency’s regulations on medical device standards for ‘‘relevant communicable number of new cases. Both prevalence reporting (see 21 CFR 803.3(bb)). disease or disease agent.’’ Each guidance and incidence are important indicators 5. Relevant Medical Records would describe effective, and thus of the risk that a potential HCT/P donor ‘‘appropriate,’’ screening practices, and could be infected with a particular (§ 1271.3(s)) would list recommended tests, if there disease or disease agent, and that Donor screening involves the review are available and effective tests that HCT/Ps from that donor could transmit of relevant medical records for risk have been licensed, approved, or the disease. factors for, and clinical evidence of, a cleared by FDA. The third change we have made is to relevant communicable disease agents (Comment 18) One comment asserted identify an alternative to prevalence. and diseases. Proposed § 1271.3(v) that the term ‘‘prevalent’’ is not Under § 1271.3(r)(2)(i)(B), a relevant would define ‘‘relevant medical sufficiently defined. Another comment communicable disease or disease agent records’’ as a collection of documents asked at which point and by whom a is one that ‘‘* * * either (1) has sufficient that includes a current donor medical disease would be designated sufficiently incidence and/or prevalence to affect history interview and a current report of prevalent among potential donors. the potential donor population, or (2) the physical assessment of a cadaveric (Response) We have made several may have been released accidentally or donor or the physical examination of a changes to the definition of ‘‘relevant intentionally in a manner that could living donor. The proposed definition communicable disease agent or disease’’ place donors at risk of infection.’’ listed additional records that would be with respect to prevalence. We intend this new language to cover considered relevant medical records if First, we have made the question of both intentional and unintentional they were available. prevalence and/or incidence part of the release of infectious agents. Although (Comment 20) One comment opposed evaluation of the risk of transmissibility prevalence/incidence remains an including, in the definition of ‘‘relevant of a communicable disease agent or important consideration in determining medical records,’’ a current report of a disease. We have implemented this whether a communicable disease or physical assessment or examination. change by dividing the question of risk disease agent should be considered The comment asserted that these of transmissibility into the following relevant, we recognize that when an evaluations are of minimal utility, two parts: (1) Is the disease or disease infectious agent is released, whether by particularly if the available exam was agent potentially transmissible by an accident or purposefully (e.g., to inflict not performed to look for evidence of HCT/P? and (2) does the disease or harm), we may not immediately have specific disease, and suggested that the disease agent have sufficient incidence adequate information to assess the requirement be moved to the ‘‘if and/or prevalence to affect the potential prevalence of the disease or disease available’’ part of the definition. donor population? This change is agent. In this instance, where we have (Response) We disagree with this reflected in § 1271.3(r)(2)(i). Both information about the release of an comment. There are clear physical questions are important in considering infectious agent, and the other prongs of findings that could indicate that a donor whether to require testing and/or the definition are met, it is important for either has a relevant communicable

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disease or exhibits signs of risk factors medical records, and you must review ‘‘xenotransplantation’’ and ‘‘close for such a disease. Examples include them if they are available at the time of contact’’ in proposed § 1271.3(aa) and jaundice, lymphadenopathy, or needle the donor-eligibility determination. (bb). marks. The donor-eligibility draft (Comment 23) Other comments (Comment 25) Several comments guidance that accompanies this final recommended that the definition of requested clarification of the definitions rule lists physical findings that would ‘‘relevant medical records’’ be limited to of ‘‘xenotransplantation’’ and ‘‘close suggest if a cadaveric or living donor processing records, health histories, and contacts,’’ including the meaning of could have a relevant communicable the infectious disease test results of the ‘‘live cells’’ and ‘‘ex vivo,’’ two terms disease and that should be looked for in donor. These comments expressed used to define xenotransplantation. One the physical assessment or examination. concern that the definition includes the comment preferred the term ‘‘intimate (Comment 21) Five comments donor’s medical records ‘‘if available.’’ contact’’ to ‘‘close contact.’’ We were questioned the need for a physical This comment urged us to make the also asked to provide examples of examination of a cord blood donor. summary of records the sole set of activities that could result in exchanges Three of these recommended that the documents required to accompany the of bodily fluids, a factor in the proposed requirement not apply to cord blood product. definition of close contact. donors, but only to HCT/Ps for which (Response) We agree that the (Response) The final rule does not the physical examination is relevant to summary of records should be the sole contain definitions of the safety of the donor or the HCT/P. set of documents required to accompany ‘‘xenotransplantation’’ or ‘‘close Two comments proposed requiring only an HCT/P, and we have modified contact.’’ These terms are relevant to the a limited physical examination. § 1271.55, as discussed in greater detail determination under § 1271.50, (Response) We disagree with the in comment 29 of this document. concerning whether the donor presents suggestion that it is unnecessary to However, for the purposes of donor communicable disease risks associated conduct a physical examination of a screening, we continue to believe that a with xenotransplantation. We now cord blood donor. A physical larger range of information should be explain our current understanding of examination could reveal risk factors for considered, including the donor’s ‘‘xenotransplantation,’’ or the presence of a relevant medical records, if available. For that ‘‘xenotransplantation product,’’ communicable disease. reason, we have not changed the list of ‘‘xenotransplantation product We note that the purpose of the documents that make up the relevant recipient,’’ and ‘‘intimate contact of a physical examination is to assess for medical records. xenotransplantation product recipient’’ signs of a relevant communicable in the donor-eligibility draft guidance disease and for signs suggestive of any 6. Urgent Medical Need (§ 1271.3(u)) announced elsewhere in this issue of risk factor for a relevant communicable Under proposed § 1271.65(b) and (c), the Federal Register. disease. The donor-eligibility draft an HCT/P from an ineligible donor The terminology used in the guidance announced elsewhere in this could be used in cases of urgent medical accompanying guidance, and the Federal Register provides further need. We proposed to define ‘‘urgent definitions provided, are consistent information on physical evidence of medical need’’ as meaning that no with guidance on xenotransplantation relevant communicable diseases that comparable HCT/P is available and the developed by the Public Health Service may be observed during the physical recipient is likely to suffer serious (PHS) and by FDA (PHS Guideline on examination of a living donor. morbidity without the product. Infectious Disease Issues in (Comment 22) One comment asserted (Comment 24) One comment Xenotransplantation; Availability (66 FR that the scope of medical records should requested that we add to the definition 8120, January 29, 2001); Draft Guidance be limited to information pertaining to of ‘‘urgent medical need’’ the for Industry: Precautionary Measures to relevant communicable diseases. The requirement that the risk of morbidity Reduce the Possible Risk of comment expressed concern that a with use of the product be considerably Transmission of Zoonoses by Blood and potentially significant finding would be less than without the product. Blood Products from lost in the minutiae. The comment cited (Response) We decline to make this Xenotransplantation Product Recipients autopsy results as an example of a change. We expect that doctors will use and Their Intimate Contacts (67 FR record that does not add significant their professional judgment to balance 6266, February 11, 2002). In the value to the donor screening process, the risk of using an HCT/P against the accompanying guidance, we describe noting also that certain products need to risk of not using it. ‘‘xenotransplantation’’ as any procedure be released before coroner and autopsy We have, however, modified the that involves the transplantation, reports are available. definition of ‘‘urgent medical need’’ to implantation, or infusion into a human (Response) We agree that the scope of include the risk of death, in addition to recipient of either of the following: (1) medical records that you review in the risk of serious morbidity. The risk of Live cells, tissue, or organs from a donor screening is limited to death is clearly more urgent than the nonhuman animal source; or (2) Human information pertaining to relevant risk of serious morbidity and should body fluids, cells, tissues, or organs that communicable diseases. We disagree, have been included in the proposed have had ex vivo contact with live however, with the assertion that autopsy definition. nonhuman animal cells, tissues, or results do not provide significant organs. By ‘‘live cells’’ we mean cells information. On the contrary, an 7. Xenotransplantation Product that have the ability to metabolize or autopsy can lead to the discovery of Recipient and Intimate Contact of a divide. By ‘‘ex vivo’’ we mean outside subclinical evidence of relevant Xenotransplantation Product Recipient of an individual’s body. communicable diseases (e.g., liver Proposed § 1271.75(a)(2) would We agree with the comment that the disease may indicate hepatitis). We require you to determine whether a term ‘‘intimate contact’’ is preferable to understand that certain HCT/Ps need to potential donor has received a ‘‘close contact,’’ because it is more be released before autopsy results are xenotransplant (now called a specific. The donor-eligibility draft available (e.g., corneas). However, xenotransplantation product) or has guidance describes ‘‘intimate contact of autopsy results are an important been a close contact of such a recipient. a xenotransplantation product component of a donor’s relevant We proposed to define recipient’’ as a person who has engaged

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in activities that could result in the states that, in the case of an embryo or GTP proposed rule under § 1271.3(ll); intimate exchange of body fluids with a of cells derived from an embryo, a we received no comments on the xenotransplantation product recipient. donor-eligibility determination is proposed definition. Paragraph (b) of Examples of intimate contacts include, required for both the oocyte donor and § 1271.47 requires that a responsible but are not limited to, sexual partners, the semen donor. We have moved this person must review and approve all household members who share razors or requirement from proposed § 1271.50(a). procedures before implementation. toothbrushes, and health care workers We have also extended the proposed Under paragraph (c) of § 1271.47, or laboratory personnel with repeated requirement, which referred only to written procedures must be readily percutaneous, mucosal, or other direct embryos, to cells derived from an available to personnel. Paragraph (d) of exposures. Mere sharing of domicile or embryo. Although this meaning was § 1271.47 contains requirements relating casual contact, such as hugging or implicit in the proposed language, we to departures from established kissing without the exchange of saliva, have made this change for greater procedures. Paragraph (e) of § 1271.47 would not be interpreted as intimate clarity. states that an establishment may adopt contact. Section 1271.45(c) prohibits the current standard procedures, provided implantation, transplantation, infusion, that certain conditions are met. D. Part 1271, Subpart C—Donor or transfer of an HCT/P unless the cell Section 1271.47 reflects the following Eligibility or tissue donor has been determined to changes to proposed § 1271.180, made Subpart C of part 1271 contains the be eligible, except as provided under in response to comments submitted to donor-eligibility requirements for §§ 1271.60(d), 1271.65(b), and 1271.90. the GTP proposed rule docket: HCT/Ps, including donor screening and This was originally proposed in All steps. Proposed § 1271.180 would testing. § 1271.50(a). require procedures for ‘‘all significant Section 1271.45(d) states that, if you steps’’ that an establishment performs. 1. General are an establishment that performs any One comment asked for examples of (Comment 26) We received comments function described in subpart C, you what constitutes a ‘‘significant step’’ urging the use of a term other than must comply with the requirements that and asked how it differs from ‘‘any ‘‘unsuitable’’ to describe a reproductive are applicable to that function. step.’’ tissue donor with risk factors for A ‘‘significant’’ step is not considered 3. What Procedures Must I Establish and relevant communicable disease. different from ‘‘any or all steps,’’ as the (Response) ‘‘Suitability’’ is a term Maintain? (§ 1271.47) latter term is used in the definition of with wide usage in tissue and blood In this final rule, we have added ‘‘manufacture’’ in § 1271.3(e). For this establishments. We understand, § 1271.47 (‘‘What procedures must I reason, we have removed the word however, that when the term establish and maintain?’’). This reflects ‘‘significant,’’ and § 1271.47(a) refers ‘‘unsuitable’’ is applied to a donor, it an organizational change, but is not instead to ‘‘all steps.’’ may take on an unintended meaning. substantive. General requirements for Periodic review. Proposed § 1271.180 For that reason, we have decided to establishing and maintaining would require establishments to review substitute the more neutral terms procedures were proposed as part of the and, if necessary, revise all procedures ‘‘donor eligibility,’’ ‘‘eligible donor,’’ GTP proposed rule (§ 1271.180). These at least once in a 12-month period. One and ‘‘ineligible donor’’ throughout this proposed requirements would apply to comment objected to the specificity of final rule. Like the donor-suitability all significant steps in the manufacture this requirement, citing the more determination in the proposed rule, the of HCT/Ps, including donor screening flexible requirements in the CGMP and donor-eligibility determination will be and testing. However, in finalizing the QS regulations. based on both screening and testing. A donor-eligibility rule, we have decided We agree with this comment and note donor is ‘‘ineligible’’ if either screening that a separate provision on procedures that the comparable requirements in the or testing indicates the presence of a specific to the donor-eligibility CGMP and QS regulations (§§ 211.100 communicable disease or risk factor for requirements of subpart C is warranted. and 820.40) do not require an annual a communicable disease. Throughout To consolidate procedural requirements review of procedures. For this reason, this rule, we refer to the ‘‘donor- within the donor-eligibility we are deleting the proposed suitability proposed rule,’’ but in all requirements, and to remind you that requirement, § 1271.47 does not contain other instances, even references to the you must develop procedures for testing a requirement for an annual review of provisions of that rule, we now refer to and screening, we have added procedures. ‘‘donor eligibility.’’ § 1271.47. Final section § 1271.47 is Departures from procedures. We have based on proposed § 1271.180, but replaced the term ‘‘deviation’’ with 2. What Requirements Does This tailored to be specific to donor- ‘‘departure’’ in this final rule to prevent Subpart Contain? (§ 1271.45) eligibility requirements. (In this final confusion with HCT/P deviation In this final rule, we have added rule, we sometimes refer to procedures reporting in the CGTP proposed rule. § 1271.45 (‘‘What requirements does this as standard operating procedures Several comments objected to the subpart contain?’’). Section 1271.45(a) (SOPs).) proposed requirement that departures states that subpart C sets out For greater clarity and ease of reading, from procedures be authorized in requirements for determining donor we have divided the proposed language advance, because departures are not eligibility, and points out that the into paragraphs. Paragraph (a) of foreseeable and cannot be authorized requirements in subpart C are a § 1271.47 requires that you establish before they occur. One comment component of CGTP requirements. and maintain written procedures for all suggested requiring a justification for Section 1271.45(b) requires a steps that you perform in testing, the departures to be recorded at the time determination of eligibility, based on screening, determining donor eligibility, of the occurrence, and requiring donor screening and testing for relevant and complying with all other approval of the departures by a communicable disease agents and requirements in subpart C. Paragraph (a) responsible person before release of the diseases, for all donors of cells or tissue of § 1271.47 incorporates an explanation tissue. used in HCT/Ps, except as provided of the phrase ‘‘establish and maintain.’’ We agree with these comments and under § 1271.90. Section 1271.45(b) also This definition was proposed in the have modified the requirement in

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accordance with the suggestion. Section donor who is deemed unsuitable, and (Comment 29) Several comments 1271.47(d) now requires an who is covered by proposed § 1271.65, described as burdensome the establishment to record and justify any nevertheless, would be subject to requirement in proposed § 1271.55(a) departure from a procedure relevent to mandatory testing. that a copy of the donor’s relevant preventing risks of communicable (Response) We agree that you must medical records accompany an HCT/P. disease transmission at the time of its base a donor-eligibility determination One comment questioned the occurrence, rather than before. The on both screening and testing. If the confidentiality of information in these provision further states that the screening shows the presence of a risk records, even with the donor’s name establishment must not make available factor, the donor becomes ineligible and redacted. Other comments urged us to for distribution any HCT/P from a donor there is no reason to conduct the testing. require only that a summary of records whose eligibility is determined under Thus, we disagree that testing is accompany an HCT/P, to ensure patient such a deviation unless a responsible mandatory where screening indicates a privacy and the appropriate use of a person has determined that the risk factor for a relevant communicable patient’s medical records. Another departure does not increase the risk of disease and use under § 1271.65 is not comment supported our decision to communicable disease transmission sought. To require testing in the case of require deletion of the donor’s name. through the use of the HCT/P. a donor already determined ineligible (Response) To increase confidentiality Archiving of obsolete procedures. based on screening would impose an protections, we have removed the Proposed § 1271.180 would require unnecessary expense. provision in § 1271.55 for relevant obsolete procedures to be archived for at If the screening does not reveal any medical records to accompany an least 10 years. One comment suggested risk factors, the testing should be HCT/P. The regulation now requires that a longer retention period of 10 years conducted to determine the donor’s only that the summary of records after transplantation would be more eligibility. We also agree that, if donor accompany the HCT/P. We note that appropriate and consistent with record screening indicates a risk factor, and this change affects only the retention requirements in § 1271.270 you wish to use the HCT/P from the documentation that accompanies the (which also appear in proposed ineligible donor under the provisions of HCT/P; it does not affect the § 1271.55). § 1271.65(b), you must complete all requirement in § 1271.75(a) to review We have deleted archiving obsolete relevant medical records. required testing. procedures as a requirement, but we As redrafted, § 1271.55(a) requires recommend that establishments archive (Comment 28) One comment asked that, once a donor-eligibility their obsolete procedures so that they whether a person who has tested determination has been made, the may reference at any time and as needed positive for a treatable communicable HCT/P must be accompanied by: (1) A a specific procedure used for disease could donate reproductive distinct identification code affixed to manufacturing a specific HCT/P that is tissue. the HCT/P container, e.g., still available for use and in storage. (Response) A living donor who tests alphanumeric, that relates the HCT/P to positive for a relevant communicable the donor and to all records pertaining 4. How Do I Determine Whether a Donor disease is ineligible to donate, but could to the HCT/P and, except in the case of Is Eligible? (§ 1271.50) become eligible to donate reproductive autologous or directed reproductive Proposed § 1271.50 sets out basic tissue in the future after successful donations, does not include an requirements with respect to the donor- treatment of the disease. In the donor- individual’s name, social security eligibility determination. Under eligibility draft guidance, we make number, or medical record number; (2) proposed § 1271.50(b), the recommendations concerning the length a statement whether, based on the determination would be required to be of time following treatment of various results of screening and testing, the performed by a responsible person. communicable diseases after which a donor has been determined to be Under proposed § 1271.50(b), the donor could become eligible to donate. eligible or ineligible; and (3) a summary responsible person would determine a 5. What Records Must Accompany an of the records used to make the donor- donor to be eligible if the following HCT/P After the Donor-Eligibility eligibility determination. We have requirements are met: (1) The results of Determination Is Complete? (§ 1271.55) specified that the distinct identification donor screening indicated that the code must be affixed to the HCT/P donor was free from risk factors for, and Proposed § 1271.55(a) would require container (rather than attached by a tie- clinical evidence of, infection due to documentation of the donor-eligibility tag) because it is crucial that this relevant communicable disease agents determination to accompany the HCT/P. information never become separated and diseases and is neither a This documentation would include a from the HCT/P. Instead of defining xenotransplant recipient nor a close copy of the donor’s relevant medical ‘‘summary of records’’ in § 1271.3, as contact of a xenotransplant recipient, records, results of required testing, and proposed, we describe in § 1271.55(b) and (2) the results of donor testing for the name and address of the that the summary of records must relevant communicable disease agents establishment that made the contain the following components: (1) A are negative or nonreactive. determination. Alternatively, the HCT/P statement that the testing was performed Final § 1271.50 reflects changes in could be accompanied by a summary of by a laboratory certified to perform such screening for xenotransplantation made records (defined in proposed testing on human specimens under the in § 1271.75, discussed in comment 48 § 1271.3(x)). In both instances, the Clinical Laboratory Improvement of this document. donor’s name must be deleted from the Amendments of 1988 or that has met (Comment 27) Two comments documentation. Proposed § 1271.55(b) equivalent requirements as determined supported the provision in proposed would require that the establishment by the Centers for Medicare and § 1271.50 that required a determination that generated the records used in the Medicaid Services; (2) a listing and of eligibility to be based on both eligibility determination, and the interpretation of the results of all screening and testing. These comments establishment that made the communicable disease tests performed; further asserted that requiring both determination, maintain the records for and (3) the name and address of the screening and testing for all prospective 10 years and make them available for establishment that made the donor- donors would assure that a prospective FDA inspection. eligibility determination. We have

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removed the requirement for a statement tracking requirements of the CGTP the determination. (No comments were describing the types of records, which proposed rule. received on either of these issues.) may have been reviewed as part of the (Comment 32) One comment We have also incorporated into relevant medical records, because it did supported the requirement in proposed § 1271.55(d) the requirement that not add useful information about the § 1271.55(b) that records regarding information on the identity and relevant particular HCT/P. We note that the gamete donation be kept 10 years. medical records of the donor must be in requirement to list and interpret all (Response) We appreciate this English, or, if in another language, must communicable disease tests refers not comment and have maintained the be translated into English. We received just to those tests required under this requirement, in § 1271.55(d), that donor- two comments on the docket for the rule, but would also include any eligibility records must be maintained GTP rule about the English language nonrequired communicable disease tests for 10 years. requirement in proposed § 1271.270(c). that have been performed. The record retention requirements in One comment stated that the proposed We have added one item to the list of § 1271.55(d) have been reorganized and language implied that the original non- information in the summary of records, clarified. In several instances, we have English record may be destroyed, and in the case of an HCT/P from a donor, modified the requirements for suggested revising the regulation to ineligible based on screening, that is consistency with the more general indicate that the original may be in any released under the provisions of records requirements of the GTP rule. language and should be retained, but § 1271.65(b), the summary of records For example, proposed § 1271.55(b) that a copy translated into English must contain a statement noting the would require records to be retained: should also be kept. Another comment reason or reasons for the determination ‘‘* * * at least 10 years after the date asserted that we should stipulate that of ineligibility. This information will of implantation, transplantation, the English translation requirement greatly assist practitioners in weighing infusion, or transfer of the product, or applies to products distributed within the risks of using an HCT/P from an if the date of implantation, the United States. We disagree that the proposed ineligible donor and in explaining risks transplantation, infusion, or transfer is regulation implies that an original to the recipient. not known, then * * * at least 10 years The final regulation, at § 1271.55(c), record that is not in English can be after the date of the product’s states that the records that accompany destroyed, and for this reason we have distribution, disposition, or expiration, the HCT/P must not include the donor’s added the codified language that the whichever is latest.’’ Three comments name and other personal information information on the identity and relevant submitted to the GTP docket pointed that might identify the donor. medical records of the donor must be (Comment 30) One comment asked out that similar language in proposed retained. You must maintain the whether separate records would be § 1271.270(e) is confusing. original documentation, whether or not required for all batches of HCT/Ps made Accordingly, we have revised the the documentation is in English. These from a single cell bank. relevant language in proposed requirements apply to all HCT/Ps that (Response) If you make multiple § 1271.55(b) by replacing the words are imported into the United States, for batches from a single cell bank, you may ‘‘implantation, transplantation, distribution within the United States, maintain a single set of donor-eligibility infusion, or transfer’’ with and that are shipped under § 1271.60(c) records for the cell bank. However, each ‘‘administration.’’ Section 1271.55(d) into the United States for processing or HCT/P from that cell bank must be now reads ‘‘You must retain the records other manufacture before distribution in accompanied by a copy of the summary pertaining to a particular HCT/P at least another country. of records. 10 years after the date of its (Comment 33) One comment (Comment 31) One comment asserted administration, or if the date of requested that we change proposed that it is important to permit a tissue administration is not known, then at § 1271.55(b) to require that any party bank to qualify a donor as eligible and least 10 years after the date of the involved in the collection, processing, then to certify that eligibility to the HCT/P’s distribution, disposition, or or transplantation of an HCT/P be establishment that further processes the expiration, whichever is latest.’’ allowed access to the donor’s medical cells or tissue without providing We have made several other changes records. specific donor information. This to the record retention requirements that (Response) The purpose of the comment also asserted that a both improve the language and also language, as proposed, was to ensure mechanism should provide traceability increase consistency with the proposed FDA’s access to records supporting a through use of a donor number that can GTP rule. Final § 1271.55(d) requires donor-eligibility determination. Because be used to trace the cells or tissue to the that all records must be accurate, of concerns about maintaining the tissue bank if necessary. indelible, and legible; this language is confidentiality of patient information, (Response) Under § 1271.55, an consistent with the proposed GTP rule we decline to expand the provision to HCT/P must be accompanied by a (proposed § 1271.270(a)). Similarly, require an establishment to make summary of records that indicates the § 1271.55(d) sets out a more specific list medical records available to any party conclusions of the donor-eligibility of required documentation than involved in the collection, processing, determination and that does not contain appeared in the proposed rule; as in or transplantation of the HCT/P. information that could identify the proposed § 1271.270(c), § 1271.55(d) donor. We have added the requirement specifies that you must maintain 6. What Quarantine and Other for a distinct identification code, e.g., documentation of the results and Requirements Apply Before the Donor- alphanumeric, that relates the HCT/P to interpretation of all testing and Eligibility Determination Is Complete? the donor and to all records pertaining screening for relevant communicable (§ 1271.60) to the HCT/P and, except in the case of disease and disease agents; the name Proposed § 1271.60 contained autologous or directed reproductive and address of the testing laboratory or provisions for quarantine of HCT/Ps donation, does not include an laboratories; documentation of the pending the donor-eligibility individual’s name, social security donor-eligibility determination; the determination. Proposed § 1271.60(a) number, or medical record number. This name of the responsible person who stated that, ‘‘* * * [f]or reproductive requirement is consistent with the made the determination; and the date of cells and tissues that can reliably be

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stored, quarantine shall last until HCT/Ps, we have deleted the phrase in conception that would result from completion of the testing required under ‘‘reproductive cells and tissue that can quarantine. Some comments asserted § 1271.85(d).’’ (In § 1271.85(d), we reliably be stored.’’ The 6-month that the proposed provisions would proposed to require retesting of the quarantine requirement in § 1271.60(a) encourage people to perform donor of such reproductive cells or and the retesting requirement in inseminations without medical tissue at least 6 months after the date of § 1271.85(d) applies only to anonymous assistance and safety screening. donation.) semen donors. (Response) On December 14, 2001, we (Comment 34) One comment We disagree with comments that asked the BPAC whether, compared supported the provision in § 1271.60 minimize the communicable disease with fresh semen, the use of that permits, under certain safeguards, risks associated with reproductive cells cryopreserved semen for artificial shipping of material that is in and tissue. Among other things, these insemination reduces pregnancy rates quarantine. comments assert that there have been no per cycle. After a presentation of data, (Response) We have maintained this known transmissions of disease by ova the committee agreed that the practice provision in the final rule. or embryos or that there is no of cryopreserving semen for artificial (Comment 35) Many comments compelling evidence to indicate that insemination does reduce pregnancy opposed any quarantine requirement for human gametes or embryos are capable rates. embryos. These comments disputed the of transmitting infectious disease In light of the comments and the communicable disease risks associated Each cell in the human body has opinion of the BPAC, we have with embryos. They also cited increased receptors for viruses and bacteria and is reconsidered whether to require costs from a quarantine; decreased thus capable of transmitting quarantine and retesting in directed success rates through use of frozen communicable disease. Even avascular semen donation. The requirement to embryos; adverse effects on patients tissue has been known to transmit retest the donor was intended to provide from a quarantine requirement; disease (e.g., corneas have transmitted an important added measure of logistical concerns associated with HBV). Semen is known to have protection by addressing the ‘‘window retesting; and other possible transmitted HBV and HIV. Because period’’ between the time of infection consequences of a quarantine embryos are a result of the combining of and the presence of detectable levels of requirement, including loss of embryos. sperm and ova, they have the potential antigens and/or antibodies to Some comments asserted that current of being contaminated by communicable communicable diseases and agents such screening practices are adequate. Others disease agents transmitted by the sperm. as HIV. However, we recognize that asserted that FDA was interfering with Moreover, bacterial contamination and semen from different donors varies in its the practice of medicine or criticized transmission of HCV has occurred in ability to withstand cryopreservation. our approach as having a potentially assisted reproduction procedures. Two Because of the variability in whether a negative effect on the field of cases have been reported of women in particular donor’s sperm will survive reproductive medicine. Many comments France who were HCV antibody the freeze/thaw process, a requirement suggested alternative approaches, such negative, but seroconverted after for quarantine could defeat the as optional quarantine, mandatory undergoing assisted reproductive intentions of the directed reproductive insurance coverage for infertility, and technology (ART) procedures. The cause donor and intended recipient who have creation of an embryo bank. One of transmission was theorized to be made a joint decision for the recipient comment described a clinically effective cross-contamination by health care to conceive a child. Accordingly, we program using frozen embryos that was workers (Lesourd, F., et al., have modified the regulation to except instituted to help ensure patient ‘‘Transmissions of Hepatitis C Virus directed semen donors from the 6- confidentiality. During the Ancillary Procedures for month retesting requirement in (Response) We also received Assisted Conception,’’ Human § 1271.85(d). Because of this change, the comments opposed to quarantining Reproduction, vol. 15, no. 5 pp. 1083– requirement in § 1271.60(a) that semen oocytes. Some comments distinguished 1085, (2000)). be quarantined until the completion of between oocytes and semen based on Because there is a risk that ova and retesting under § 1271.85(a) no longer differences in communicable disease embryos could transmit disease, this applies to directed semen donations. risk, cryopreservation success, risk should not be ignored. Given the 7. How Do I Store an HCT/P From a availability, cost, and other factors. lack of oversight and reporting Donor Determined to Be Ineligible, and We have considered the many requirements to date, it is difficult to What Uses of the HCT/P Are Not comments received on the retesting and know whether incidents of transmission Prohibited? (§ 1271.65) quarantine requirements and have of disease by ova or embryos have Proposed § 1271.65(a) would require decided to clarify our intentions with occurred. HCT/Ps from ineligible donors to be respect to embryos and oocytes. In the (Comment 36) Many comments kept in quarantine and physically preamble to the proposed rule, we objected to the application of the separate from other HCT/Ps until stated that reproductive cells and quarantine and retesting requirements to destruction or other permissible tissues that can reliably be stored are directed semen donations. These disposition was accomplished. those that maintain function and comments pointed out that, under the Proposed § 1271.65(b) described three integrity during storage. As examples, proposed regulation, semen from a situations in which these regulations we listed spermatozoa and sperm directed donor would have to be would not prohibit the use of an HCT/P progenitor cells (64 FR 52696 at 52706). quarantined for 6 months pending from an ineligible donor, and additional Given technologies at the time, we did retesting of the donor. Comments requirements that would apply in those not assert that embryos or oocytes could asserted that this would effectively bar instances. The three cases were as reliably be stored. Thus, we did not the use of fresh semen in directed follows: (1) Family-related, allogeneic intend the quarantine and retesting donations. Some comments cited use; (2) directed donation of requirement to apply to embryos or problems with sperm cryopreservation reproductive cells or tissue; and (3) oocytes. and noted a higher conception rate with urgent medical need. Under proposed To clarify the provisions for fresh semen than with frozen semen. § 1271.65(c), the use of an HCT/P from quarantine and retesting of reproductive Other comments pointed out the delay a donor for whom the donor-eligibility

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determination had not yet been designation, until destruction of the unrelated donors with respect to completed would not have been HCT/P or other disposition in screening and testing for communicable prohibited in cases of urgent medical accordance with § 1271.65(b) or (c). disease. need. (For organizational consistency, As revised, § 1271.65(a) now provides (Response) Although we recognize we have moved that provision to establishments with flexibility in that the urgent medical need exception § 1271.60 of this final regulation, which achieving the goal of preventing the might apply in some instances of deals with HCT/Ps pending the donor- improper release of HCT/Ps from donations between family members, we eligibility determination.) Finally, ineligible donors. You may choose to decline to make the change requested by proposed § 1271.65(d) would impose keep HCT/Ps from ineligible donors in the first comment. Our intention in special labeling requirements on a physically separate area clearly crafting the exception was to recognize HCT/Ps used under § 1271.65(b). identified for such use. Such physical that, in some situations, a recipient and Proposed § 1271.65(b)(4) would separation may include storage on a his or her physician might weigh the prohibit making available an HCT/P separate shelf in a refrigerator or freezer risks of using an HCT/P from an from a xenotransplantation product that also contains other shelves storing ineligible family member in the absence recipient or an intimate contact of a HCT/Ps in quarantine pending the of an urgent medical need, if such an xenotransplantation product recipient donor-eligibility determination and action were in keeping with the family’s for use in the special circumstances set shelves storing HCT/Ps from eligible wishes; this exception, with its added out elsewhere in paragraph (b) (family- donors. A separate refrigerator or freezer safeguards, would allow them to do so. related, allogeneic use; directed may not be necessary. We agree with the second comment donation of reproductive cells or tissue; Alternatively, § 1271.65(a) allows you that the same screening and testing and urgent medical need). Throughout to use other procedures that prevent requirements should apply to donors of this final rule, we have adopted a more improper release. Such procedures hematopoietic stem/progenitor cells flexible approach to screening for could include automated designation to who are related to the recipient as to xenotransplantation than proposed. prevent improper release. For example, unrelated donors, and the final rule is This new approach is intended to some establishments label HCT/Ps with consistent with this view. However, we recognize that different kinds of bar codes and store the HCT/Ps in have chosen to defer to the family and xenotransplantation may present freezers that maintain a constant physician the decision of whether or not different degrees of risk and to provide temperature. Moving the products to a to use an HCT/P from a related donor us with the ability to respond separate storage area would risk who has been determined to be appropriately to these differences as the transient warming. Instead, the HCT/Ps ineligible. For this reason, the field of xenotransplantation develops. remain in the original storage area and regulations do not prohibit such use. The absolute prohibition in proposed are tracked by a validated computer We have rewritten proposed paragraph (b)(4) is not consistent with system that maintains information on § 1271.65(b)(1) to reflect changes made this new flexibility in approach, and so the results of screening and testing. At in the registration final rule (66 FR 5447 we have deleted it from § 1271.65. the time of release of the HCT/P, the at 5454). The proposed exception for (Comment 37) Several comments establishment activates the computer ‘‘family-related, allogeneic use’’ questioned how to comply with the system to assure identification and extended only to first-degree blood requirement that HCT/Ps from ineligible retrieval of the specific HCT/P for the relatives; as modified, the exception donors be kept physically separate from intended recipient. This is an example now extends to ‘‘allogeneic use in a other HCT/Ps. Some comments asserted of a system of automated designation first-degree or second-degree blood that physical separation would require that could satisfy the requirements of relative.’’ Our decision, expressed in the additional refrigerator storage units, § 1271.65(a). registration final rule, to broaden the presenting an unnecessary cost and The provisions of the CGTP proposed scope of related donors was based on space burden. These comments rule would require you to establish and several factors, which also apply here. questioned the benefit of physically maintain procedures for the control of The likelihood of finding a donor with separate storage, suggested that storage areas to prevent such problems a haplotype identical to that of the quarantine alone should be sufficient, or as cross-contamination and improper recipient is greater among blood-related requested that we delete the physical release (proposed § 1271.260(a)). individuals than among unrelated separation requirement. One comment As for the comment regarding vapor individuals. In addition, for certain asked whether storing in vapor phase phase nitrogen and plastic bags, limited ethnic groups, it is extremely difficult to nitrogen or encasing units in plastic scientific evidence exists to show the find an appropriate unrelated donor. bags is sufficient to prevent cross- effectiveness of measures such as Finally, registry outcome data for some contamination. overwrap bags or storage in the vapor hematologic malignancies suggest that (Response) We have revised phase of liquid nitrogen to reduce the peripheral blood and bone marrow § 1271.65(a) to delete the requirement likelihood of cross-contamination. Such transplant recipients may have a better for physical separation. Section measures could be used if sufficient survival rate when transplanted with 1271.65(a) now incorporates language evidence exists of their ability to hematopoietic stem/progenitor cells from the definition of quarantine; minimize the risk of cross- from related donors (66 FR 5447 at however, the term ‘‘quarantine’’ is no contamination. 5454). longer used in paragraph (a), because we (Comment 38) One comment urged us Parents, children, and siblings are believe it is more appropriately reserved to delete the exception for family- considered first-degree relatives. Aunts, for HCT/Ps awaiting the outcome of the related, allogeneic use, arguing that the uncles, nieces, nephews, first cousins, donor-eligibility determination. Section urgent medical need exception would grandparents, and grandchildren are 1271.65(a) now requires you either to apply for both related and unrelated second-degree relatives. Relations by store or identify HCT/Ps from ineligible stem/progenitor cell donors. Another adoption or marriage are excluded from donors in a physically separate area comment supported the concept that § 1271.65(b)(1), because they are not in clearly identified for such use or to hematopoietic stem/progenitor cell the same genetic pool as blood relatives. follow other procedures that prevent donors who are related to the recipient (Comment 39) We received comments improper release, such as automated should be held to the same standards as on the proposed provision for directed

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donation of HCT/Ps from ineligible the HCT/P. We decline to require a normal donor population will make this donors. Elsewhere in this rule, we written contract between physician and exception widely used. respond to comments on the definition patient. We know that physicians are (Response) We have maintained the of directed reproductive donor and on under legal and ethical restrictions, provisions for urgent medical need, the applicability of retesting requiring them to discuss the risks of although, as noted, the provisions requirements to directed donations of communicable disease transmission governing use pending the donor- reproductive cells and tissues. stemming from the use of HCT/Ps. We eligibility determination have been One comment on proposed § 1271.65 rely on physicians to meet these moved to § 1271.60. (To ensure that the praised the directed donor provision as obligations when obtaining consent to physician receives sufficient appropriate. This comment stated that procedures involving HCT/Ps from information about the risks of the the directed donor provisions should patients and their legal representatives. HCT/P, § 1271.60(d)(2) requires that an also apply when a woman seeks a (Comment 41) One comment on HCT/P from a donor for whom the second child by the same anonymous directed donations of reproductive cells eligibility determination is not complete donor with known high-risk behavior. or tissue praised FDA for adding clarity be accompanied by results of donor (Response) We disagree that the to a process that has created confusion screening and testing that have been directed reproductive donor provisions for donors and patients. This comment completed, as well as a list of any of § 1271.65(b) extend to anonymous endorsed the procedures in proposed screening or testing that has not yet donation. As discussed in comment 13 § 1271.65(b), but objected to the been completed.) of this document, the term ‘‘directed proposed requirement for physician We also note that, under the final reproductive donor’’ does not apply to consent. The comment asserted that the regulation, you are not required to anonymous donations, but to situations patient has the right to make his or her determine a donor ineligible on the where the donor knows, and is known own decisions about medical treatment, basis of a reactive CMV test, but under by, the recipient. Moreover, under this that physician consent is unnecessary § 1271.85(b)(2) you must establish and final rule, all potential anonymous because of other standards of physician maintain an SOP governing the release semen donors must be screened for risk conduct, and that some physicians may of an HCT/P from a donor whose factors for relevant communicable withhold consent for invalid reasons. specimen tests reactive for CMV. Thus, disease, including high-risk behavior; it will be unnecessary to invoke the (Response) In light of this comment, potential donors with a high-risk urgent medical need provisions to use we have reconsidered the necessity of behavior will be determined ineligible. an HCT/P from a donor who has tested requiring documentation of the (Comment 40) One comment positive for CMV. (See the discussion in physician’s authorization of the use of expressed concern about allowing comment 60 of this document.) patients and physicians to decide an HCT/P from an ineligible donor in (Comment 43) One comment asserted whether to use donated gametes from a the directed reproductive donor that labeling tissue ‘‘untested for directed reproductive donor who is situation, as well as in cases of urgent Biohazard’’ might cause transportation found to be ineligible. This comment medical need or use in a first- or issues, because commercial carriers are asserted that it is essential that patients second-degree blood relative. Our reluctant to transport a container be fully informed, and that written decision is not based on an evaluation labeled ‘‘Biohazard.’’ The comment contracts be signed indicating the of patients’ rights, but on the recommended that the proposed possible risks to recipient and baby, so observation that, in each of these regulations clarify that the tissue that there is complete understanding for situations, a physician will be closely container, not necessarily the tissue the risks involved. involved in the decision to use the transport container, be labeled (Response) It is essential that the HCT/P from the ineligible donor. For ‘‘untested for Biohazard.’’ patient who chooses to use a directed this reason, no additional requirement (Response) The labeling requirements donation from an ineligible donor be to obtain physician consent is in this final regulation apply to the fully informed of the risks involved. For necessary. labeling of the HCT/P. (An HCT/P made any use under § 1271.65(b)(1), the For the same reasons, we have also available under § 1271.60(d) must be establishment must notify the physician removed the requirement for physician labeled ‘‘NOT EVALUATED FOR using the HCT/P from the ineligible authorization from the provisions INFECTIOUS SUBSTANCES,’’ and an donor of the results of testing and governing use of an HCT/P for urgent HCT/P made available under screening. Under § 1271.65(b), the medical need before completion of the § 1271.65(b) must bear the Biohazard HCT/P must be labeled prominently donor-eligibility determination legend; in both instances, the label must with the Biohazard legend and must (§ 1271.60(d)). state: ‘‘WARNING: Advise patient of bear the statement ‘‘WARNING: Advise (Comment 42) Several comments communicable disease risks.’’) Other patient of communicable disease risks,’’ strongly supported the urgent medical regulations, e.g., those issued by the and, in the case of reactive test results, need provision in proposed § 1271.65(b) Department of Transportation, may ‘‘WARNING: Reactive test results for and (c). Some comments commended apply to the shipping container. (name of disease agent or disease).’’ In the structuring of the proposed the case of reproductive HCT/Ps, this regulations, noting that the 8. How Do I Screen a Donor? (§ 1271.75) includes risk to the baby. We have transplanting physician and the Proposed § 1271.75(a) would require removed the proposed requirement for informed patient may deem appropriate screening of all donors, except as the establishment to document that the a tissue that is positive for infectious provided in § 1271.90, for risk factors physician agreed to explain the disease when comparing alternatives, for, and clinical evidence of, relevant communicable disease risks associated particularly in a matter of life or death communicable disease agents and with the use of the HCT/P to the or other emergency medical situations. diseases, including, at a minimum, HIV, recipient or the recipient’s legally One comment asserted that the HBV, HCV, and TSE, including CJD and authorized representative and that the transplant physician must be the vCJD. Under proposed § 1271.75(b), physician agreed to obtain from the ultimate authority for the use of tissues donors of reproductive cells or tissue recipient or the recipient’s legally from all donors and noted that the would be screened for genitourinary authorized representative consent to use prevalence of CMV positivity in the diseases that can be transmitted with

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the recovery of reproductive cells or (Response) Given the severity of TSE, medical history interview. Most of these tissues, including at a minimum the lack of an approved test, and the comments came from eye banks. Chlamydia trachomatis and Neisseria lack of information about the tissue Comments from eye banks that gonorrhea. Under proposed distribution of the vCJD agent in supported the proposal described their § 1271.75(c), donors would also be humans, we continue to believe that it positive experiences performing screened for xenotransplantation or is necessary to screen all prospective medical history interviews. One close contact with a xenotransplantation donors for risk factors. In January 2001, comment described a next-of-kin product recipient. And proposed we asked the TSEAC to evaluate the risk interview that revealed the information § 1271.75(d) would allow of transmission of vCJD through the that the potential donor’s sister had died establishments to follow an abbreviated transplantation, implantation, infusion, from CJD, information that would not donor screening procedure when a or transfer of HCT/Ps. The committee have otherwise been obtained. Another complete donor screening had been agreed that, compared to the risk of comment supported the interview as a performed within the previous 6 transmission of vCJD by blood means of detecting high-risk behavior months. transfusion, there is a significant risk of for diseases other than CJD, such as We have deleted the phrase ‘‘at a transmission of vCJD from HCT/Ps. hepatitis and HIV, and said that FDA minimum’’ from § 1271.75(a) and (b), We recognize that the potential for should carefully consider any interview because it might give the impression transmission appears to differ between questions relating to TSE with input that screening is required only for those different types of HCT/Ps, with the from transplant practitioners and other relevant communicable diseases listed greatest risk associated with corneas and experts. Several comments cited the risk in § 1271.75. Although at this time we dura mater. Nevertheless, you must to patients if donors are not screened only require screening for those listed screen all donors for TSE, for the with an interview. One comment from diseases, additional diseases may be previously listed reasons. This the medical director of an Italian eye identified as relevant in the future. As screening would include questions bank described a positive experience discussed in comment 16 of this about risk factors for sporadic CJD and with a recently implemented Italian document, we intend to issue guidance vCJD, and donors would be subject to requirement to obtain medical and that notifies you when we have exclusion based on those factors. We social information through an interview. identified additional relevant also recognize that some TSE symptoms Some comments criticized the communicable diseases that appear to are not specific to TSE. The specific recovery of corneas under legislative meet the definition in § 1271.3(r)(2). symptoms to watch for are discussed in consent, asserting that autopsy reports Section 1271.75, as finalized, requires the CJD draft guidance. are insufficient for assessing high-risk the establishment that performs donor (Comment 45) The proposed behaviors and that donors from medical screening to review the donor’s relevant regulations did not contain an exception examiner’s or coroner’s offices have an medical records for risk factors for, and from the donor medical history increased likelihood of high risk clinical evidence of, relevant interview for corneas procured under behavior. One comment asserted that, communicable disease agents and legislative consent; i.e., in accordance although part of the justification for diseases. For consistency with testing with a State law that allows the medical legislative consent has been that there is requirements, we have added the examiner or coroner to procure corneal a cornea shortage in this country, requirements that you screen all donors tissue without the consent of the current donation rates have enabled for Treponema pallidum donor’s next of kin. The preamble to the most eye banks to become exporters. (§ 1271.75(a)(1)) and that you screen proposed rule stated that requiring a Most comments on this issue opposed donors of viable, leukocyte-rich cells or donor medical history interview for a requirement for a donor medical tissue for relevant cell-associated corneas obtained under legislative history interview for all cornea donors. communicable diseases, including consent is necessary to ensure that the One comment opposed the requirement HTLV (§ 1271.75(b)). These additional risk of communicable disease but appreciated FDA’s efforts to help screening requirements impose only a transmission is appropriately assessed. ensure a safe supply of donor corneal minimal burden. We describe screening We noted that the necessity of adequate tissues. Another comment asserted that factors for these relevant communicable screening for TSE illustrates the the government should stay out of eye diseases in the donor-eligibility draft importance of the donor medical history banking. guidance. interview (64 FR 52696 at 52703). Many comments cited benefits of (Comment 44) Proposed We also noted that the proposed medical examiner laws, and some § 1271.75(a)(1) would require screening definition of donor medical history comments expressed the view that the of all donors for human TSE, including interview would permit the interview to proposed requirement would eliminate CJD. We received several comments on be conducted with an individual the procurement of corneas under this provision. One comment supported knowledgeable about the donor’s legislative consent. Some expressed the proposed screening requirements as medical history and relevant social concern about diminished cornea written. Another comment stated that behavior (e.g., primary treating supplies. Others asserted that the time the agency should make clear whether physician) and would not require an required for screening would detract it intends procurers of human tissue to interview with the next of kin. For this from cornea viability and quality, and apply the policies in the draft guidance reason, we considered that the proposed some comments expressed concern for blood donors issued on November regulation and State laws on legislative about decreased access to healthy young 23, 1999. Other comments argued that consent may coexist and stated that we corneal material from the medical semen and oocytes should be exempt did not intend to preempt those laws. examiner donor pool. Numerous from screening for TSE, or questioned We specifically requested comments on comments cited the added expense of why the screening is applied to all any potential conflicts that might make performing a medical history interview. donors, not just donors of dura mater or it impossible to comply with both this Many comments asserted that cornea. One comment expressed regulation and State laws on legislative additional screening is unnecessary, or concern that particular symptoms of consent. disputed the usefulness of an interview. TSE, such as changes in speech or gait, We received many comments about Two comments asserted that the are not specific to TSE. the proposed requirement for a donor medical/social histories performed on

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all cases obtained under legislative animal products, blood transfusion, screening measures for CJD and vCJD. consent are just as comprehensive as tissue transplantation, and other FDA- This draft guidance was discussed at the those obtained with a next-of-kin regulated products. FDA also wants to TSEAC meeting in June 2002. consent and a medical/social history establish a coordinated education and It would be inconsistent with our questionnaire. Other comments outreach program to the community, level of concern about TSE to fail to expressed doubt that the interview and to expand research in TSE. The require a donor medical history would be effective in screening for CJD plan will enhance regulatory tools, and interview for some corneas, when it is or would increase the safety of corneal help enforce regulations concerning generally agreed that corneas are among tissue. cattle feeding and import restrictions. the tissues most likely to transmit TSE. Many comments disputed the risk of The action plan is posted on the Internet The information needed to screen for CJD transmission via corneas. One at http://www.fda.gov/oc/oca/ TSE (e.g., cognitive changes; travel comment asserted that TSE cases are not roundtable/bse/FDAlactionplan.html. history) is not the sort that can be brought to the medical examiner’s office Another example of FDA’s heightened obtained through an autopsy or through for determination of cause of death. concern with potential TSE a review of investigators’ reports or Another comment asserted that there is transmission is the publication of the hospital charts. no evidence of any increased risk of guidance entitled ‘‘Revised Preventive Moreover, although the preamble to disease transmission through corneas Measures to Reduce the Possible Risk of the proposed rule used TSE to illustrate obtained under legislative consent Transmission of Creutzfeldt-Jakob the need for a medical history interview absent a medical history interview and Disease (CJD) and Variant Creutzfeldt- for all cornea donors, questions that mandating an interview does not Jakob Disease (vCJD) by Blood and pertaining to other relevant appear to have adequate scientific Blood Products (January 2002),’’ communicable diseases would also go substantiation. Another comment stated available on the Internet at http:// unanswered without an interview. We that CJD is not sufficiently prevalent to www.fda.gov/cber/gdlns/cjdvcjd.pdf. agree with the comment that supported warrant testing and screening. This guidance recommends blood donor the interview as a way of screening for The Eye Bank Association of America deferrals for travel to the UK and the diseases other than CJD, such as (EBAA) commissioned a report, which it rest of Europe, for military personnel hepatitis and HIV. submitted to the docket, on the who resided in U.S. military bases in The EBAA report focused on CJD, and occurrence and transmissibility of CJD Europe, and for receipt of blood in the not on other diseases that might be as it relates to cornea transplantation. UK. screened for, including HIV. The report The report concluded, in part, that In January 2001, we asked the TSEAC recommended against requiring a donor screening for symptoms of CJD would to evaluate the risk of transmission of medical history interview in cases of have minimal impact on safety but vCJD through the transplantation, legislative consent. In reaching this would reduce the supply of donor implantation, infusion, or transfer of conclusion, the report’s authors made corneas. One comment objected to the HCT/Ps and to compare this risk to that certain assumptions about the diagnosis, report’s conclusion and supported a of the transfusion of blood and blood course, and prevalence of CJD in the medical/social history interview. On the products, for which precautionary cornea donor population, including the other hand, one comment indicated measures have already been adopted. frequency of misdiagnosis of CJD. As we that, based on the EBAA report, it now We specifically requested advice on discuss in this document, varying these recommended that the regulation permit how information about residence/travel assumptions can lead to very different corneal donation under legislative history could best be obtained and conclusions. Moreover, the report consent without a donor medical history noted the relevance of this question to analyzed the possible effect of interview. corneas procured under legislative supplemental screening applicable to all (Response) We have carefully consent. The committee agreed that, cornea donors, assuming a new considered the many comments on this compared with blood transfusion, there screening requirement where none difficult issue. Since the publication of is a significant risk of transmission of currently exists. However, the the proposed rule, our concerns about vCJD from HCT/Ps, and noted that dura requirement for a donor medical history preventing the spread of TSE, including mater and cornea have the greatest risk. interview is currently in place with vCJD, have increased. We have taken A majority of the committee supported respect to all cornea donations except steps to address those concerns by deferral for donors of dura mater and for the small percentage obtained under developing an agency action plan and cornea who had possibly been exposed legislative consent. (The actual issuing new guidance documents, to the bovine spongiform percentage of cornea donations obtained including guidance specific to HCT/Ps. encephalopathy agent, but the under legislative consent is unknown. In August 2001, HHS also announced a committee did not vote on the question The EBAA report used an unsupported TSE action plan. One of FDA’s of whether an interview should be value of 10 percent.) responsibilities under the departmental required of all donors. In evaluating the proposed regulation, action plan is to review and upgrade our Since that meeting of the TSEAC, we the EBAA report considered the number policies designed to prevent potential have issued a draft guidance document of potential cornea donors who might be exposure to TSE through blood entitled ‘‘Draft Guidance for Industry: deferred for CJD risk because of the transfusion or tissue transplantation or Preventive Measures to Reduce the results of supplemental screening but transmission of TSE through FDA- Possible Risk of Transmission of who in fact do not have CJD (i.e., the regulated products. (You can find Creutzfeldt-Jakob Disease (CJD) and number of all cornea donors who might information about the departmental Variant Creutzfeldt-Jakob Disease (vCJD) be erroneously excluded). Depending on action plan on the Internet at http:// by Human Cells, Tissues, and Cellular the assumptions made, the estimated www.hhs.gov/news/press/2001pres/ and Tissue-Based Products (HCT/Ps)’’ number of cornea donors with CJD and 20010823.html.) dated June 2002, available on the the number of donors erroneously We developed our action plan for TSE Internet at http://www.fda.gov/cber/ excluded by screening could vary in April 2001. The plan has several gdlns/cjdvcjd0602.pdf. This draft tremendously. For instance, the authors focus areas, including prevention of guidance document contains our current of the report assumed that 1 percent of exposure to TSE through human and recommendations on appropriate donor actual CJD cases would be missed, and

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diagnosed as some other neurological of the deceased and/or the deceased’s requirement for a donor medical history disease. They calculated that it would family. Another comment asserted that, interview in the case of corneas take 8.1 years of screening to exclude for the proposed rule not to conflict obtained under legislative consent is not one actual case of CJD, and the numbers with State laws on legislative consent, it justified. of otherwise eligible donors incorrectly would have to allow the medical We disagree with the comment that excluded by screening would range examiner or pathologist who performs urged us to interpret the definition to from 18,415 to 73,362 (depending upon the autopsy to qualify as an ‘‘individual include an interview with the medical the specificity of the screening knowledgeable about the donor’s examiner or pathologist who performs questions). If, instead of 1 percent, we medical history and relevant social the autopsy. Although the medical make the assumption that 10 percent of behavior’’ and to respond to a modified examiner or pathologist will have useful cases of CJD would be misdiagnosed, set of history questions appropriate to clinical information that should bear on then it would take 1.4 years of screening the medical examination. According to the donor-eligibility determination, it is to exclude 1 actual case of CJD, with the comment, other medical and social unlikely that this person will know the 3,219 to 12,876 donors incorrectly history would be obtained through the donor well enough to answer questions excluded. Thus, the assumption made case file containing investigator’s about his or her medical history, travel by the authors resulted in a calculation reports, hospital charts, or other sources history, and/or social behavior. of approximately six times the number of donor history. Therefore, an interview with the of donors incorrectly excluded as under (Response) As discussed in section VI medical examiner or pathologist would another possible scenario. Furthermore, of this document, we contacted the be inadequate to fulfill the interview the EBAA model estimates the numbers States to give them the opportunity to requirements. of incorrectly excluded donors that comment on any possible preemption (Comment 47) In the preamble to the would result assuming that the issues. No States replied to our request. proposed rule, we noted that, together additional screening would apply to all In this final rule, we have defined with CDC, we were reviewing the risk cornea donors. However, the additional ‘‘donor medical history interview’’ as a factors for transmission of relevant screening required under this rule documented dialog about the donor’s communicable diseases in light of would affect only the subset of donors medical history and relevant social current scientific knowledge. Based on from whom an interview is not behavior, including activities, that review, we planned to specifically currently obtained (e.g., corneas behaviors, and descriptions considered describe, in a guidance document, risk obtained under legislative consent). to increase the donor’s relevant factors and screening information to Because the report failed to explicitly communicable disease risk. If the donor assist establishments in complying with consider a variety of uncertainties in the is not living or able to participate in the the regulations (64 FR 52696 at 52703). model assumptions, did not consider interview, the interview must take place Although the proposed rule did not the effect of the donor medical history with an individual or individuals who specify risk factors, we received many interview requirement on the are able to provide the information comments opposed to a screening factor appropriate subset of potential donors, sought in the interview. (This language that would prevent men who have had and did not include diseases other than replaces ‘‘individual knowledgeable sex with men from donating semen CJD in the risk assessment, we decline about the donor’s medical history and anonymously. (Many comments also to follow any recommendation based on relevant social behavior’’ from the focused on the proposed requirement to the results. proposed rule. This change is for quarantine directed donations of We disagree with comments that purposes of clarity and plain language, reproductive cells and tissue. As predict a shortage of corneas resulting and it does not affect the definition’s discussed in comment 36 of this from this rule. At present, meaning.) Examples of these individuals document, we have deleted this approximately 30 percent of corneas who could possibly provide the requirement from this final rule. The recovered in the United States are appropriate information include the final regulations allow the use of fresh exported (2002 Eye Banking Statistical donor’s next-of-kin, the nearest semen from directed reproductive Report, Eye Bank Association of available relative, a member of the donors.) America). Because any estimates of donor’s household, an individual with Some comments disagreed with potential reductions in donations under an affinity relationship, or the primary considering homosexual men to be legislative consent are quite speculative, treating physician. ‘‘high risk donors’’ and disputed the we have not included such estimates in We continue to believe that the scientific basis for excluding these men this response. Even if this final rule led definition of ‘‘donor medical history as donors. Many comments cited the to a reduction in donations under interview’’ provides sufficient flexibility efficacy of the blood test for HIV, with legislative consent, we do not anticipate to allow for the continued recovery of retesting after a 6-month quarantine, that a shortage would result. corneas under legislative consent. although one comment noted that HIV (Comment 46) Although comments However, we recognize that there may antibody testing is imperfect. Many expressed concern about the effect of be some difficulty in communicating comments disputed the public health the proposed requirement for a donor with the primary treating physician benefits of the rule, although some medical history interview on medical without obtaining permission from the applauded the agency for trying to craft examiner laws, we received only a few deceased and/or the family of the safeguards to protect the public. responses to our request for comments deceased, and that therefore this final Other comments asserted that the on any potential conflicts that might rule may have an effect on the ability of regulations would abridge the make it impossible to comply with both medical examiners and coroners to reproductive, civil, or constitutional this regulation and State laws on recover corneas under State legislative rights of both donor and recipient, but legislative consent. One comment consent laws. But, given the known did not provide an explanation of the agreed with requiring a donor medical transmission by corneas of HBV and scope of those rights or a legal analysis history interview, but noted that, given CJD, and the potential for corneas to of how this rule would affect them. privacy considerations, an interview transmit other communicable diseases, Many comments argued that the with a primary treating physician may including TSE, we have concluded that proposed regulations were be difficult to obtain without permission making an exception from the discriminatory. Some comments

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suggested language for the donor- and HCV for specific groups and risk that there have been no reports of the eligibility draft guidance. behaviors; these data were derived spread of zoonoses to close contacts or (Response) In response to the primarily from the literature published household members. The comment comments suggesting that FDA should between 1995 and 2000 and from further recommended use of a allow establishments to rely on HIV test unpublished sources. Data indicated simplified question in donor screening. results alone, or on quarantine and that, compared to the general (Response) This final rule adopts a retesting, without screening for risk population, the incidence and different approach to screening for factors, FDA rejects that approach at this prevalence rates for HIV, HBV, and HCV xenotransplantation than proposed. The time. Although it is reasonable to expect were substantially higher for rule is intended to permit the agency that more sensitive nucleic acid heterosexuals attending sexually added flexibility in responding amplification testing (NAT) will be transmitted disease clinics, men who appropriately to the risks presented by available soon for reproductive tissue have sex with men, commercial sex different kinds of xenotransplantation as donors, even that testing may fail to workers, and injection drug users. this field develops and changes. To this detect early stage HIV and other After the consultation, it was end, we have modified several infections, particularly because the level concluded that there is no new data that provisions of the final rule with respect of viremia may be extremely low in the would warrant revising the 1994 to xenotransplantation, including the early stages of infection (Refs. 1, 2, and guidelines. CDC and others also screening requirements set out in 3). Moreover, even the best test may fail concluded that current data are not § 1271.75. (Changes to the definitions to provide an accurate test result due to sufficient to allow the identification of and to § 1271.65 are discussed in human error in running the test or in lower-risk subsets of currently excluded comment 25 and the text before linking the test result to the correct population groups, and thus, to refine comment 37 of this document.) donor. Accordingly, FDA believes that, the exclusionary criteria. At the The final rule requires screening for based on the current state of testing and consultation, representatives of CDC ‘‘communicable disease risks associated current knowledge about disease encouraged the development of new with xenotransplantation.’’ The donor- transmission, it is necessary to screen data. eligibility draft guidance that for risk factors as well as to test for On December 14, 2001, we asked the accompanies this final rule describes diseases such as HIV. Center for Biologics Evaluation and those risks. Because, at this time, so few Like the proposed rule, this final rule Research’s (CBER) BPAC, whether there xenotransplantations have been does not specify risk factors. Risk factors are existing data that identify subsets of performed, and much is unknown about and other information about screening men who have had sex with other men the actual risks of xenotransplantation, are contained in the donor-eligibility in which the incidence and prevalence the risks for which you must screen may draft guidance announced elsewhere in rates for HIV, HBV, and HCV of the be potential or hypothetical risks. We this Federal Register. We welcome subsets are similar to the population at currently consider both the comments on the guidance document. large. By a 10 to 0 vote, the committee xenotransplantation product recipient In developing the guidance, we have advised that these data do not exist. and the intimate contact of a seriously considered the comments. To We have reviewed relevant legal xenotransplantation product recipient to obtain up-to-date information on risk authorities and disagree that these be at risk for acquiring zoonoses, and, as factors, we have worked with CDC. CDC regulations discriminate or improperly in the proposed rule, these individuals performed a literature search and then, abridge donor or recipient rights. We would be ineligible to donate HCT/Ps. on June 26 and 27, 2000, held a donor further note that, since FDA has tailored However, if requested to do so through suitability consultation to consider the rule’s requirements to take into a request for an exemption from or whether the 1994 ‘‘Guidelines for account an existing relationship alternative to the regulations under Preventing Transmission of Human between a donor and recipient (for proposed § 1271.155 when finalized, we Immunodeficiency Virus Through example, FDA has not required will consider exceptions for certain ex Transplantation of Human Tissue and quarantine and retesting for directed vivo exposures (e.g., exposure to a well- Organs’’ (Morbidity and Mortality reproductive donors, permits the use of characterized cell line, or exposure Weekly Report 1994; 43(RR–8)), should reproductive tissue from ineligible across a physical barrier). be revised with respect to men who directed reproductive donors, and We have considered the comments’ have sex with men. requires no testing for sexually intimate assertion that intimate contacts should Approximately 50 persons were partners), the comments’ remaining be eligible for donation, based on the invited as consultants. They represented objections relate almost exclusively to lack of reports of zoonosis spread, and transfusion and transplant professional anonymous donations of reproductive we disagree. Given the potential risks organizations, public health experts, tissue. We will continue to examine the associated with the spread of diseases donor families, persons receiving data on risk factors and, as new data are from live animal cells, tissues, and transplants, ethicists, and donor rights developed that justify changes to our organs, we believe that the most prudent advocates. Representatives of the guidance, we will make those changes course at this time is to defer intimate Department of Health and Human in accordance with good guidance contacts, and the donor-eligibility draft Services and its component agencies practice. guidance follows this course. As with also participated. Observers at the (Comment 48) Proposed hepatitis and HIV, those individuals meeting were also encouraged to § 1271.75(a)(2) would require screening most likely to be infected by a contribute. a potential donor to determine if he or xenotransplantation product recipient Representatives of CDC presented the she had received a ‘‘xenotransplant’’ or with a zoonosis are the recipient’s scientific literature search prepared as a was a ‘‘close contact’’ of a intimate contacts. Should that background for the consultation. xenotransplant recipient. Two individual become infected with a Presenters compared the comments agreed that zoonosis, then an HCT/P from that transmissibility of infection through xenotransplantation recipients should intimate contact could transmit the blood, organs, tissues, and reproductive be deferred as tissue donors, but zoonosis to the recipient of that HCT/P. tissues. Data were presented on the asserted that close contacts do not need The donor-eligibility draft guidance incidence and prevalence on HIV, HBV, to be deferred. One comment asserted describes the types of questions that can

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elicit information on communicable appropriate because in this timeframe a fetal or neonatal donor, a specimen from disease risks associated with potential donor may develop physical the mother is generally acceptable for xenotransplantation. We welcome signs of a communicable disease that testing. comments on the draft guidance. can be detected by examination. (Comment 51) One comment (Comment 49) One comment said With an abbreviated screening emphasized the importance of that, instead of questioning at the time procedure, a full review of records is not permitting testing of an appropriate of donation, FDA should require that necessary, but you must make sure that specimen from the mother of a fetal or past xenotransplantation product there have been no changes in a donor’s neonatal donor. Another comment recipients and their next of kin be risk factors, including high risk requested that we require maternal tests notified by the medical institution behavior, since the previous donation. to be validated as predictive of performing the clinical trials that they You may accomplish this by having the transmissibility of infection in the fetal are deferred from donating blood and donor read a written list of risk or neonatal tissue. tissues. behaviors and asking whether he or she (Response) We have reexamined the (Response) We agree that a transplant has participated in these behaviors. proposed language on maternal testing institution should tell a With respect to changes in screening and now believe that testing of the xenotransplantation product recipient requirements, we agree with the intent mother is preferable to testing of the not to donate blood and tissues (e.g., as of the comment but disagree that the fetal or neonatal donor. We are part of informed consent). The PHS requested change is necessary. particularly concerned about the Guideline on Infectious Disease Issues Information on screening (e.g., risk possibility that HBV might be in Xenotransplantation (January 19, factors) is contained in guidance that, transmitted at or around the time of 2001) recommends that although not binding, represents our birth, or possibly in utero. In such cases, xenotransplantation product recipients current thinking on the topic. If FDA HBV testing of the fetus or neonate be instructed not to donate blood, blood guidance on screening has changed could lead to a false negative result, but components, tissues, breast milk, ova, since the last donation (for example, if testing of the mother would be positive. sperm, or any other body parts for use a new risk factor has been added), we We have therefore revised § 1271.80(a) in humans. This document further recommend that you screen in to require that, in the case of a donor 1 recommends that the recipient inform accordance with the new guidance at month of age or younger, you must test his contacts (now referred to as the next scheduled donation following a specimen from the birth mother ‘‘intimate contacts’’) not to donate. the implementation date of the guidance instead of from the donor. We note that However, as an added precaution, an (for example, by screening for the new requiring testing of the mother is HCT/P donor, or other person risk factor). consistent with the standards of several interviewed in the donor medical We have made several changes to the professional organizations (see, e.g., history interview, should be questioned regulation for clarity. We have replaced American Association of Blood Banks at the time of HCT/P donation. Unless the phrase ‘‘on subsequent donations’’ (AABB) Standards for Hematopoietic prodded by the question, the donor may with ‘‘on repeat donations’’ to clarify Progenitor Cell and Cellular Product not remember that he or she is not that we intend this abbreviated Services, 3rd edition, 2002; NMDP supposed to donate HCT/Ps. Moreover, procedure to apply in repeat donation Standards, 17th edition, Sept. 1999; another person interviewed in the donor situations (e.g., semen). Foundation for the Accreditation of medical history interview may not We note that while § 1271.75(d) Cellular Therapy (FACT)/Netcord remember the warning against donation addresses abbreviated screening International Standards for Cord Blood, unless specifically asked about procedures for repeat donors, the 2002; FACT Standards for xenotransplantation. requirements for quarantine, testing, Hematopoietic Progenitor Cell (Comment 50) Proposed § 1271.75(d) and retesting applicable to repeat Collection, Processing and would allow an abbreviated donor donations are contained in §§ 1271.60, Transplantation, 2nd edition, 2002). screening procedure for living donors, 1271.80, and 1271.85. In comment 53 of Because it is generally accepted that, in as long as complete donor screening is this document, we discuss changes to most cases, until a month of age the performed every 6 months. One the testing requirements applicable in same IgG antibodies are present in the comment asserted that it is impractical the repeat donor situation. mother’s blood as in the neonate’s, we to conduct abbreviated screening at each decline to add the requested validation donation for anonymous semen donors 9. What Are the General Requirements for Donor Testing? (§ 1271.80) requirement. and that a complete donor-eligibility b. Timing of specimen collection. determination every 6 months is Proposed § 1271.80 would require an Proposed § 1271.80(b) would require unnecessary. Another comment establishment to test donor specimens collection of the donor specimen at the recommended that a complete screening for relevant communicable disease time of recovery of cells or tissue from be recorded with each donation event. agents, to adequately and appropriately the donor or within 48 hours after A third comment asked us to revise the reduce the risk of transmission of recovery, although proposed regulation to indicate that an relevant communicable diseases. § 1271.80(b)(1) through (b)(3) would abbreviated donor screening would not Among other things, proposed § 1271.80 allow specimen collection from a living be acceptable if there has been a change sets out requirements for the timing of donor up to 7 days before recovery in in screening requirements since the last specimen collection; the use of FDA- certain situations. complete screening procedure was licensed, approved, or cleared tests; We received many comments on this performed on the donor. which laboratories could perform the provision. (Response) We decline to make the required tests; exceptions applicable to (Comment 52) One comment changes suggested by the comments. We certain test results for CMV or syphilis; recommended that time constraints for believe that the requirement for a and determining the adequacy of a specimen storage before testing be complete screening procedure (i.e., a specimen where the donor has received consistent with test kit instructions. donor medical history interview), a transfusion or infusion. (Response) We agree. Section review of medical records and physical a. Testing of mother. Proposed 1271.80(c) requires that you follow the examination, every 6 months is § 1271.80(a) stated that, in the case of a manufacturer’s instructions in

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performing testing. This includes prior to recovery, the treatment of the labeled for cadaveric specimens, when instructions with respect to storage time recipient has already started and the applicable and available, instead of before testing. decision to proceed is irreversible. more generally labeled donor screening (Comment 53) Numerous comments Therefore, under § 1271.80(b), for tests. asserted that the proposed rule was too donors of peripheral blood stem/ (Comment 54) Two comments restrictive and requested that we allow progenitor cells only, the establishment suggested that § 1271.80(c) describe the more time between collection of the may collect the donor specimen up to circumstances in which tissue specimen and recovery of the cells or 30 days before recovery of the stem/ establishments may use tests that are tissue. Comments concerned with the progenitor cells. We understand that the not licensed, cleared, or approved. recovery of peripheral blood stem/ current practice of peripheral blood (Response) We decline to make this progenitor cells, where recipient stem/progenitor cell establishments is to change. This section requires the use of conditioning is performed, suggested a take a donor specimen on the day of FDA licensed, approved, or cleared timeframe of 30 days before recovery of recovery for additional testing, and we screening tests. The use of unapproved the HCT/P. Other comments requested encourage these establishments to tests would not meet the requirements that, for cord blood donors, specimen continue this practice, in order to of this regulation. collection be permitted at any time permit appropriate followup and (Comment 55) One comment urged following the donation; another treatment if test results are positive. FDA to work with laboratories and comment requested 7 days. One In response to the comment on semen manufacturers of diagnostic tests to comment requested from 30 to 90 days donation, we have added an exception approve tests for cadaveric specimens. post-donation for specimen collection to § 1271.85(d) that will provide Other comments noted that there were from a sperm donor, citing expense and flexibility for the testing of anonymous, no FDA-licensed screening kits for natural fluctuations in semen sample repeat semen donors. We understand cadaveric blood samples. Another parameters. Another comment asserted that, under current practices, comment expressed doubts that that the proposed time limits were too establishments do not collect a cadaveric blood tests for corneas would restrictive for oocyte donors. Some specimen for testing at each donation by be approved. comments expressed concern that, in a repeat semen donor. As long as a (Response) FDA has encouraged the case of cadaveric donors, the specimen has been taken and tested, manufacturers of in vitro diagnostic regulations would not allow testing of and the donated semen is quarantined products to develop products intended specimens collected before death pending the results of retesting at least for use with cadaveric specimens. Since (premortem specimens). Other 6 months after donation, it is not the publication of the proposed rule, we comments asserted that the necessary for us to restrict this practice have licensed test kits specifically requirements on timing of specimen through these regulations. For this labeled for use with cadaveric blood collection would prohibit the use of reason, we have added an exception to specimens. These test kits must be used, pretransfusion samples. § 1271.85(d) for repeat semen donors if applicable, when testing all cadaveric (Response) We agree that more time from whom a specimen has already HCT/P donors, including cornea donors. should be allowed between collection of been collected and tested, and for whom A list of licensed test kits for use with specimens for testing and HCT/P retesting is required under § 1271.85(d). cadaveric specimens may be found at recovery. The final rule requires a We reiterate that you must collect a new http://www.fda.gov/cber/products/ sample at the time of recovery, when specimen and test it under § 1271.85(d) testkits.htm. feasible. However, if specimen at least 6 months after the donation, and d. CLIA certification. Proposed collection at the time of cell or tissue pending the completion of that retesting § 1271.80(c) stated, in part, that testing recovery is not feasible, you may collect you must quarantine the donated semen must be performed by a laboratory the specimen up to 7 days before or after under § 1271.60(a). certified to perform testing on human recovery. We decline to rely on testing Under the new regulatory language in specimens under the CLIA. for communicable diseases performed § 1271.80(b), which permits the (Comment 56) Two comments later than 7 days before donation, collection of a specimen up to 7 days asserted that we should permit testing because the test results would not before recovery of cells or tissue, you by laboratories that are exempt from accurately reflect the donor’s actual may use a premortem specimen to test CLIA certification. disease exposure at the time of a cadaveric donor, as long as the (Response) We agree with the donation. Moreover, as the time period specimen is collected within that comment that not all laboratories that between donation and specimen timeframe. The use of specimens taken comply with CLIA are certified under collection increases, the chances of mix- pretransfusion or preinfusion will CLIA. We have revised § 1271.80(c) to ups or difficulties with followup also continue to be allowed, subject to the require that required testing must be increase. An establishment may choose same 7-day timeframe; use of these performed by a laboratory that either is to perform testing before initiating specimens is discussed in section certified to perform such testing on preparatory regimens on the donor (e.g., III.C.8.g of this document. human specimens under CLIA and 42 oocyte donors require hormone c. Approved tests. Proposed CFR part 493, or has met equivalent stimulation), but that earlier testing § 1271.80(c) would require the use of requirements as determined by the would not replace the testing required appropriate FDA-licensed, approved, or CMS. Examples of the latter are by this regulation. cleared donor screening tests in Veterans Administration hospital However, we are making an exception accordance with the manufacturer’s laboratories, laboratories in states that for testing donors of peripheral blood instructions (except that, for Chlamydia have received an exemption from CMS, stem/progenitor cells. Since the trachomatis and Neisseria gonorrhea, and laboratories accredited by certain recipient undergoes a myeloablative tests labeled for the detection of those approved accrediting organizations. treatment regiment, i.e., high dose organisms in an asymptomatic, low- (Comment 57) Comments also urged chemotherapy and total body prevalence population must be used us to permit testing by foreign irradiation, it is important to determine until screening tests are available). In laboratories subject to requirements the eligibility of the donor before the addition, proposed § 1271.80(c) would equivalent to or more stringent than recipient’s treatments begin. At 7 days require the use of tests specifically those imposed by CLIA. One comment

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requested that we consider allowing direct you to repeat an initial reactive donors of viable, leukocyte-rich cells or U.S. citizens access to cord blood units test result in duplicate, you must do so. tissue be tested for CMV. Proposed from foreign tissue banks, which would In such cases, the term ‘‘reactive’’ § 1271.80(d)(1)(i) would require you to not follow CLIA standards but would should be understood to mean determine ineligible a donor whose have similarly regulated clinical repeatedly reactive. specimen tests reactive for CMV, unless laboratory testing. Proposed § 1271.80(d)(1) contained additional testing does not show the (Response) We decline to make the two exceptions to the general rule that presence of an active infection. We change requested because it is not a donor whose specimen tests reactive proposed the exception in feasible for us to identify and assess the or positive must be determined § 1271.80(d)(1)(i) because, although a equivalence of other countries’ ineligible. Under the first exception, a donor with active CMV poses a risk of requirements, keep track of any changes reactive test for CMV would not make CMV transmission, a donor’s past to those requirements, and then to a donor unsuitable unless additional infection with the virus does not ascertain that each foreign tissue bank testing showed the presence of an active necessarily present such a risk (64 FR at meets those requirements. In contrast, infection. The second exception was for 52705). We noted that the results of CLIA certification provides a uniform, a donor whose specimen tested CMV testing would accompany the workable mechanism for determining repeatedly reactive on a nontreponemal HCT/P, and we specifically requested laboratory proficiency. Foreign screening test for syphilis and negative comments on this approach (64 FR establishments are not prohibited from on a specific treponemal confirmatory 52705). using domestic CLIA-certified test. (Comment 60) One comment noted laboratories for performing the required (Comment 58) One comment asserted that the proposed rule did not specify a testing, and some firms operating under that FDA should permit confirmatory means for assuring that CMV viral part 1270 send samples ahead to the tests to prevail in all cases, arguing that shedding is not occurring, and United States for testing in CLIA- this is consistent with medical practice suggested that we specify the type of certified laboratories. and would prevent discarding tests to use to determine the presence or When we first issued regulations on transplantable tissue. Another comment absence of viral shedding. human tissue, one major concern was noted that proposed § 1271.80(d)(1) (Response) Considering this comment the distribution in the United States of contained no exception for HBV, has led us to conclude that it would be imported tissue from donors who had although tests for HBV recognize the difficult to comply with the terms of the not been adequately screened and tested validity of confirmatory testing in the exception in proposed § 1271.80(d)(1)(i). to prevent the transmission of infectious manufacturer’s instructions. Therefore, we have made several disease (62 FR 40429 at 40435, July 29, (Response) We disagree that the modifications to the final rule with 1997). The proficiency of the laboratory results of confirmatory tests rather than respect to CMV testing. The effect of performing the required testing is a key the results of screening tests should these changes is to require CMV testing element in assuring the safety of determine donor eligibility. of donors of leukocyte-rich cells or HCT/Ps. Certification under CLIA helps Confirmatory tests may not be as tissue, while allowing the use of HCT/Ps to ensure that the laboratory is sensitive as screening tests in detecting from CMV-reactive donors in some proficient and competent to perform the early infection. Our decision is instances. required tests accurately. Moreover, any consistent with the agency’s policy in First, we have deleted proposed laboratory, foreign or domestic, may blood regulation: For blood donors, § 1271.80(d)(1)(i) from the final rule, apply for certification under CLIA. At supplemental testing is used for donor and we have removed CMV from the list this time, we are aware of 21 foreign reentry or for donor notification and of relevant communicable disease CLIA-certified laboratories. counseling. agents and diseases in § 1271.3(r)(1), as e. Ineligible donors. Proposed Confirmatory testing for HBV, such as well as from § 1271.85(b)(3). We have § 1271.80(d)(1) stated that a donor the hepatitis B surface antigen (HBsAg) made this change because we believe whose specimen tests repeatedly neutralization assay, is valuable for that, as proposed, the rule may have led reactive or positive must be determined confirming the presence of HBsAg in all donors who test reactive for CMV to unsuitable. specimens found to be reactive by a be disqualified, an undesirable result. We have made several changes to the screening assay, and so can be helpful Second, although we have removed wording of this paragraph. As discussed for donor counseling. However, the CMV from the list of relevant earlier in this document, ‘‘unsuitable’’ is neutralization assay may not always communicable disease agents and now ‘‘ineligible.’’ detect all potentially infectious HCT/Ps. diseases in § 1271.3(r)(1), we have not In addition, for consistency with other Therefore, we are not making an removed the requirement for CMV FDA regulations, we have changed exception in this section that would testing from the final rule altogether. An ‘‘repeatedly reactive’’ to ‘‘reactive.’’ As permit a donor-eligibility determination HCT/P from a CMV-antibody-reactive noted in the preamble to the proposed based on HBV confirmatory testing. donor is capable of transmitting CMV to rule, repeatedly reactive means initially (Comment 59) One comment, a recipient who tests negative for CMV reactive, and then reactive in at least submitted to the CGTP docket, asked us antibody, and in some recipients this one of two duplicate tests with the same to allow tissue banks to use the results can have serious consequences. To manufacturer’s test kit (64 FR 52696 at of triplicate testing, performed by prevent these consequences, the final 52705). Deleting the word ‘‘repeatedly’’ laboratories for OPOs, when all three rule, at § 1271.85(b)(2), requires you to from the regulation should allow for tests are negative. test donors of viable leukocyte-rich cells future advancements in testing, when (Response) If you are using test results and tissue for evidence of infection due the process of repeating an initial of an enzyme immunoassay obtained by to CMV. Under § 1271.55(b), results of reactive result in duplicate would no an OPO, and the test was initially run testing (including testing for CMV) must longer be appropriate. This modification in triplicate, you may interpret three accompany an HCT/P. does not affect the requirement that you nonreactive results in a single run as a The third change we have made in the follow the testing protocol set out in the negative test result. final rule is to require, in test kit instructions (§ 1271.80(c)). In f. Testing for CMV. Proposed § 1271.85(b)(2), that you establish and other words, if the test kit instructions § 1271.85(b)(3) would require that maintain an SOP governing the release

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of an HCT/P from a donor whose decisions about the use of an HCT/P in would not be receiving transfusions. specimen tests reactive for CMV. This a particular patient’s situation. What is relevant in this instance is any approach will permit the development g. Plasma dilution. The transfusion or transfusion or infusion within 48 hours of procedures that are specific to infusion of blood, colloids, or of the donor’s death (or one hour, for different situations. SOPs might, for crystalloids may result in plasma crystalloids). example, permit the release of an HCT/P dilution, which can affect the results of As we noted in the guidance from a donor with a CMV-antibody communicable disease testing. Section document that accompanied part 1270, reactive test, depending on the CMV 1271.3(p) defines plasma dilution as a every possible clinical situation cannot status of the recipient. We address the decrease in the concentration of the be predicted, and there may be issue of the use of HCT/Ps from CMV- donor’s plasma proteins and circulating additional circumstances where plasma reactive donors in the donor-eligibility antigens or antibodies. dilution sufficient to affect test results draft guidance, announced elsewhere in Proposed § 1271.80(d)(2) and (d)(3) should be suspected. As restructured, this Federal Register. would set out requirements relating to § 1271.80(d)(2) recognizes that these (Comment 61) Another comment plasma dilution. We have reorganized other situations exist. In the donor- asked whether a semen bank would be those provisions in this final rule, and eligibility draft guidance announced able to use a semen donor who tested they now appear in paragraph (d)(2). elsewhere in this issue of the Federal positive for CMV (IgG) in a CMV The final rule requires you to Register, we list additional positive (IgG) recipient. determine ineligible any donor in whom circumstances in which it may be (Response) Section 1271.85(b)(2), in plasma dilution sufficient to affect the necessary to employ an algorithm. results of communicable disease testing part, requires you to establish and A discussion of plasma dilution and is suspected, unless you: (1) Test a maintain an SOP governing the release algorithms appeared in the final rule specimen taken before transfusion or of an HCT/P from a donor whose ‘‘Human Tissue Intended for infusion (and up to 7 days before specimen tests reactive for CMV. Thus, Transplantation’’ issued in the Federal recovery of cells or tissue), or (2) your SOP would need to address this Register of July 29, 1997 (see 62 FR situation. We discuss the use of semen analyze the extent of plasma dilution, 40429 at 40435 through 40436), and also from a donor who tests reactive to CMV using an established procedure called in a guidance document entitled (IgG) in the donor-eligibility draft an algorithm. If that analysis rules out ‘‘Guidance for Screening and Testing of guidance announced elsewhere in this plasma dilution sufficient to affect test Donors of Human Tissue Intended for Federal Register. results, then you can perform required (Comment 62) One comment testing on a specimen taken after Transplantation’’ dated July 1997. We suggested that we used the term transfusion or infusion. However, if now refer to those documents. We also ‘‘repeatedly positive’’ instead of plasma dilution is sufficient to affect note that the donor-eligibility draft ‘‘repeatedly reactive’’ when describing results, and no specimen taken before guidance announced elsewhere in this results of CMV testing, because the term transfusion or infusion is available, then issue of the Federal Register contains ‘‘repeatedly reactive’’ is not recognized the donor is ineligible to donate. information on appropriate algorithms. as a CMV screening test result. The final rule gives examples of (Comment 64) One comment (Response) As discussed, we have clinical situations in which you must requested clarification of the term changed the wording from ‘‘repeatedly suspect plasma dilution sufficient to ‘‘blood loss.’’ reactive’’ to ‘‘reactive.’’ Although the affect test results. Under (Response) By blood loss, we mean labeling of the devices used to perform § 1271.80(d)(2)(ii)(A), if you know of or bleeding, including internal bleeding. CMV testing describes results as suspect blood loss in a donor over 12 Thus, in considering whether blood loss positive or negative, the terms years of age, transfusions and infusions has occurred in a potential donor, you ‘‘positive’’ and ‘‘reactive’’ are totaling more than 2,000 milliliters (mL) should consider both blood lost within synonymous in this context for the must be suspected of affecting test the body cavity and blood lost outside purposes of this rule. results. Under § 2171.80(d)(2)(ii)(B), any of the body. (Comment 63) One comment asserted transfusion or infusion in a donor 12 (Comment 65) One comment that, for reproductive cells, it is years of age or younger must be questioned how to determine whether to unnecessary to require the CMV status suspected of affecting test results, use an algorithm due to the 2000 mL to accompany the product, because whether or not blood loss has occurred. limit without actually performing the approximately 40 percent of semen These clinical situations were set out in tabulation. donors are CMV antibody (IgG) positive. the proposed regulation and were based (Response) You may need to review The comment noted that it is rare for the closely on § 1270.20(h)(2) and (h)(3). medical records to make a rough physician conducting the insemination However, whereas the proposed rule determination of the total amount of to review this information, and that, for specified the timeframe for these blood, colloids, or crystalloids this reason, the information is provided transfusions or infusions as within 48 administered to a potential donor. This only upon request. hours of specimen collection (or within threshold determination will allow you (Response) We disagree. CMV is the 1 hour in the case of crystalloids), the to decide whether further analysis, most commonly identified cause of final rule sets the timeframe as within using an algorithm, is necessary. In an congenital infection (Krugman S., et al., 48 hours (or one hour, for crystalloids) adult with blood loss, if the total Infectious Diseases in Children, St. before death or specimen collection, exceeds 2,000 mL, and administration Louis, CV Mosby, pp. 8–21, 1985). If a whichever occurred earlier. We have took place within the timeframes set out CMV negative pregnant woman inserted the reference to death to take in § 1271.80(d), then you must suspect contracts CMV, the fetus may acquire into account those situations where the plasma dilution sufficient to affect test congenital CMV infection. We continue specimen is collected after death. For results. Section 1271.80(d)(2) would to believe that information about the example, if the specimen is collected 3 then require you either to test a semen donor’s CMV status should days after death, it does not make sense specimen taken before infusion or appear in materials accompanying the to consider transfusions within the 48 transfusion or to use an appropriate HCT/P, so that physicians may rely on hours before specimen collection, when algorithm to analyze further the this information to make informed the donor would already be dead and possibility of plasma dilution.

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(Comment 66) One comment asserted 10. What Testing Is Required for in the donor-eligibility draft guidance, that including the total volume of whole Different Types of Cells and Tissues? and discuss the HIV p24 antigen test. blood in calculations does not meet (§ 1271.85) (Comment 68) One comment discussed the use of core antibody and scientific principles, because the Proposed § 1271.85(a) would require hepatitis B surface antibody tests to volume of the red blood cells does not you to test donors of all types of cells clarify donor HBV infectivity when the contribute to plasma dilution. and tissues for relevant communicable donor is HBsAg negative and core disease agents including, at a minimum, (Response) The calculations that are antibody positive. The comment HIV, HBV, HCV, and Treponema made to determine if plasma dilution asserted that if the IgM core antibody pallidum. Proposed § 1271.85(b) would has occurred depend upon the category test is negative, and the surface antibody apply to viable, leukocyte-rich cells and of fluids transfused or infused. The test is positive, this indicates that the three categories are blood (e.g., whole tissue and would require testing for donor had a past HBV infection that has blood, red blood cells); colloids (e.g., relevant cell-associated communicable resolved. The comment also asserted dextran, plasma, platelets, albumin, diseases including, at a minimum, that the core antibody (IgG) is not a hetastarch); and crystalloids (e.g., saline, HTLV and CMV. Proposed § 1271.85(c) screening test for HBV infectivity, but is dextrose in water, Ringer’s lactate). If would apply to donors of reproductive a historical test indicating previous the donor has received colloids in the cells and tissues and would require infection with HBV. 48 hours before death or specimen testing for relevant genitourinary (Response) Although we agree that, in collection, and/or crystalloids in the one disease agents, including, at a most cases, a negative IgM core antibody hour before death or specimen minimum, Chlamydia trachomatis and test with a reactive surface antibody test collection, then a comparison of the Neisseria gonorrhea. Proposed indicates a past infection, we disagree total volume of these fluids with the § 1271.85(d) would require retesting for that this combination of results always donor’s plasma volume would be semen donors. Proposed § 1271.85(e) indicates that the infection has resolved. sufficient to determine if plasma would require an assessment to detect Rather, this combination of results does dilution has occurred. However, when evidence of TSE for donors of dura not indicate whether the donor is the fluids transfused are in the ‘‘blood’’ mater. infectious. Under the proposed rule, cells or category (alone, or in combination with In the donor-eligibility draft guidance tissues could be subject to more than colloids and/or crystalloids), a that accompanies this final rule, we one testing requirement. For example, comparison of the total volume of these recommend that you use the total core you would test a donor of leukocyte-rich fluids with the donor’s blood volume antibody (IgG and IgM) test to test for reproductive tissue (e.g., semen) for the should be performed, in addition to a HBV in addition to the HBsAg test. diseases listed in proposed § 1271.85 (Comment 69) One comment noted comparison of the total volume of (a), (b), and (c). that the standard screening test for HCV colloids and/or crystalloids with the The preamble to the proposed rule in Europe is different from the test FDA donor’s plasma volume. listed the tests that, according to our listed in the preamble to the proposed In the situation described in the current thinking, are appropriate to use rule. comment, a comparison of the estimated to test for the disease agents and (Response) This comment referred to volume of plasma contained in whole diseases listed in § 1271.85 (64 FR the use of NAT, which has not yet been blood with the donor’s plasma volume 52696 at 52705 and 52706). Those licensed in this country for the purpose only (without a comparison of the testing recommendations are now of screening cadaveric tissue donors. volume of whole blood with the donor’s contained in the donor-eligibility draft FDA encourages manufacturers of NAT blood volume) would underestimate the guidance. kits licensed for blood donor screening amount of plasma dilution. Thus, a We have deleted the phrase ‘‘at a to validate NAT for use with cadaveric donor might be inappropriately minimum’’ from § 1271.85(a), (b), and blood specimens, and to submit the data determined to be eligible even though (c), because it might give the impression to FDA to obtain a labeling change, to plasma dilution sufficient to affect viral that testing is required only for those include this intended use. marker testing had occurred. communicable diseases listed in (Recommended tests are listed in the The draft guidance that accompanies § 1271.85. Although at this time we only donor-eligibility draft guidance.) this final rule explains which require testing for these diseases, in the (Comment 70) We received several calculations should be performed for future additional diseases may be comments on the requirement for each category of fluids transfused or identified as relevant. As discussed in syphilis testing (Treponema pallidum). comment 16 of this document, we will One comment requested that, if the infused. issue guidance that notifies you when agency eliminates syphilis testing for The proposed rule referred to we believe additional relevant blood donors, it should consider ‘‘reconstituted blood’’ under the communicable diseases meet the eliminating the requirement for tissue category of fluids called ‘‘blood.’’ We definition in § 1271.3(r)(2). donors. Several comments opposed have removed the reference to a. Viable and nonviable cells and requiring syphilis testing for cornea ‘‘reconstituted blood,’’ because we tissue (§ 1271.85(a)). Proposed donors, asserting that transmission is believe it is unnecessary and could lead § 1271.85(a) would require donors of all unlikely or that there is no significant to confusion in performing the types of cells and tissues to be tested for health risk to the corneal transplant necessary calculations (e.g., in which HIV type 1, HIV type 2, HBV, HCV, and recipient. One comment supported the one of the three categories should Treponema pallidum. requirement for cornea donors. reconstituted blood be included?). You (Comment 67) One comment noted (Response) We disagree that syphilis should consider reconstituted blood to that FDA did not require use of the HIV testing should not be required for cell be whole blood for the purpose of p24 antigen test for HIV screening. The and tissue donors, including cornea § 1271.80(d)(2), and you should include comment described the test as easily donors, and note that we have not whole blood in the category of ‘‘blood’’ accessible and inexpensive. eliminated syphilis testing of blood transfused in the 48 hours before death (Response) We recommend the donors. In the final rule on testing of or specimen collection. particular tests to assess HIV infection blood donors, we noted that comments

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did not provide sufficient supporting treated or ‘‘washed’’ sperm do not pose we do not consider them to be data to justify eliminating the the same disease risks. nonviable. Although they do not requirements to test blood and blood (Response) We agree with the proliferate, they are live cells, which components with a serological test for comment requesting a more precise means cells that have the ability to syphilis. Moreover, preliminary results description of those stem cells that are metabolize or divide, and thus ‘‘are from ongoing studies indicate that the rich in leukocytes, and we will refer to viable.’’ infectivity of seroreactive donors those cells as hematopoietic stem/ (Comment 75) One comment asserted remains the subject of scientific debate. progenitor cells. We also agree with the that CMV testing is not necessary for For this reason, we maintained the comments asserting that oocytes and oocyte donors because the virus does syphilis testing requirement for blood embryos are not leukocyte-rich. not appear to infect oocytes or donors (Requirements for Testing However, we disagree that sperm that surrounding cells. Human Blood Donors for Evidence of has been treated or washed should be (Response) We agree that CMV testing Infection Due to Communicable Disease treated differently, for the purposes of is not necessary for oocyte donors. Agents, Final rule (66 FR 31146, June these testing requirements, from semen. Oocytes and embryos are not considered 11, 2001)). The HCT/P initially donated is semen, leukocyte-rich. One comment cited a scientific paper, which is leukocyte-rich; thus, the donor c. Reproductive cells and tissues which we have reviewed (Macsai MS, must be tested for HTLV–I and –II and (§ 1271.85(c)). Proposed § 1271.85(c) Norris SJ, ‘‘OptiSol Corneal Storage CMV. The donated semen poses risks; would list relevant communicable Medium and Transmission of for example, it could transmit disease agents and diseases of the Treponema pallidum,’’ Cornea, vol. communicable disease to those handling genitourinary tract for which you would 14(6), pp. 595–600, November 1995). it, or it could be released improperly test a donor of reproductive cells or The paper reports the results of a rabbit before further processing. Later tissue. The proposal would exclude study on the effects of storage media on processing may decrease or remove the reproductive cells or tissues procured the probability of syphilis transmission. leukocytes from the donated semen, but by a method that ensures freedom from Although the media prevented the would not affect the testing that must be contamination of the cells or tissue by transmission of syphilis by performed on the donor at the time of infectious disease organisms that may contaminated corneas, transmission donation. These testing requirements be present in the genitourinary tract. occurred when the media was not used. apply at the time of donation, regardless (Comment 76) One comment asserted This paper does not support the lack of of how the HCT/P might later be that most oocytes are retrieved through syphilis transmissibility by corneas; processed. vaginal ultrasound techniques, so the indeed, it shows the opposite. For this For the same reason, we decline to exception to testing for chlamydia and reason, we do not believe this study state whether or not cultures of certain gonorrhea would not apply in most provides sufficient evidence to support cell types, such as fibroblasts, are rich cases. eliminating the proposed syphilis in leukocytes. As with semen, the (Response) We agree with this testing requirement. Moreover, we HCT/P initially donated is not the comment that, in most instances, disagree with the comment’s assertion fibroblast, but some other tissue from oocytes are removed transvaginally, and that there is no significant health risk to which fibroblasts are isolated. Thus, the so the exception in § 1271.85(c) would the corneal transplant recipient. applicable testing requirements depend not apply; thus, testing would be Although treatable, syphilis remains a on whether or not the donated cells or required. However, if you use vaginal serious disease. tissue are leukocyte-rich. ultrasound for visualization only, and b. Leukocyte-rich cells and tissues (Comment 72) One comment asserted retrieve the oocytes in a way that (§ 1271.85(b)). Proposed § 1271.85(b) that HTLV–I/II and CMV testing is not ensures freedom from contamination would require testing for HTLV, type I; relevant to corneal transplants. with infectious disease organisms (e.g., HTLV, type II; and Cytomegalovirus for (Response) We agree. As noted in the nonvaginal laparoscopy), then the donors of viable, leukocyte-rich cells preamble to the proposed rule (64 FR exception would apply. and tissue. 52696 at 52705), corneas are not rich in d. Retesting (§ 1271.85(d)). Proposed (Comment 71) We received several leukocytes, so § 1271.85(b) does not § 1271.85(d) would require retesting of comments on our proposal to apply to them. The donor-eligibility donors of ‘‘reproductive cells or tissue distinguish between leukocyte-rich cells draft guidance contains our current that can be reliably stored.’’ and tissue and other cells and tissue, thinking about which cells and tissues We have rewritten this provision to and on our preamble discussion of are leukocyte-rich. apply only to anonymous donors of which cells and tissues we consider (Comment 73) One comment asked semen. We discuss the reasons for this leukocyte-rich (64 FR 52696 at 52705). how to counsel donors of reproductive change elsewhere in this final rule in One comment noted that the tissue who test positive for HTLV. comment 35 of this document. differentiation was helpful. The Another comment noted that diagnosis (Comment 77) Several comments comment suggested adding cultures of of some infections, such as HTLV, expressed concern that retesting would certain cell types, such as fibroblasts, to would lead to serious consequences for be required for all tissues that can be the list of materials that are not those individuals who test positive. reliably stored, not simply reproductive considered to be leukocyte-rich. Two (Response) We recognize that it may cells and tissue. comments asserted that oocytes and be difficult to counsel patients about the (Response) This was not our embryos are not leukocyte-rich. One results of HTLV testing; however, the intention. As noted previously, comment noted that the term ‘‘stem scope of this rule does not extend to § 1271.85(d) requires retesting only for cells,’’ listed in the preamble as an issues of donor notification. semen from anonymous donors. example of leukocyte-rich cells or (Comment 74) One comment asserted (Comment 78) The preamble to the tissue, is too broad, and would apply to that, because leukocyte-rich, nonviable proposal recommended that, where corneal epithelial stem cells, which are lymphocytes may transmit latent HTLV appropriate and feasible, all living not leukocyte-rich. Another comment and CMV, they should be tested. donors of banked tissue be retested 6 agreed that semen can be characterized (Response) We agree that these months after donation (64 FR 52696 at as leukocyte-rich tissue but asserted that lymphocytes must be tested. However, 52706). Several comments objected to

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the recommendation and asserted that is approved. A brain biopsy, although would require special labeling for these retesting donors of nonreproductive less expensive and intrusive, may not HCT/Ps. We have added appropriate cells and tissue would be onerous, provide adequate information on TSE warning label requirements to § 1271.90. costly, and inefficient. changes, because these changes may (Comment 81) Several comments (Response) At the time of initial occur focally in the brain. Moreover, it supported our proposal to recommend testing, a donor may test negative but has not been validated as a predictor of that the requirements for infectious still be in the infectious window period. TSE. For these reasons, we decline to disease testing be applied to HCT/Ps For this reason, retesting living donors change that aspect of our designated for autologous use. Two of banked tissue 6 months after recommendation. comments expressed concern that the donation is an added safeguard for the However, we have reconsidered our recommendations in proposed prevention and spread of communicable proposal that the assessment be § 1271.90(a) pertaining to reproductive diseases. However, in response to the performed by a qualified tissue would have the same effect as comments, we are not adopting this neuropathologist. We recognize that requirements. requirement in this final rule. many institutions do not have a We recognize that a codified e. Dura mater (§ 1271.85(e)). Proposed neuropathologist on staff, and that many recommendation may carry more force § 1271.85(e) would require, for donors pathologists are qualified to do this than we intended. For this reason, of dura mater, an assessment designed assessment. For this reason, we now although we recognize that many to detect evidence of TSE. The preamble recommend that a qualified pathologist establishments will screen and test to the proposed rule described perform the assessment. To be qualified, donors of autologous and reproductive procedures for complying with the the pathologist needs to have the HCT/Ps that fall within the exceptions assessment requirement (see 64 FR appropriate training or experience to in § 1271.90, and we believe there are 52696 at 52706). These procedures perform the appropriate valid reasons for doing so, we have included, after removal of the dura neuropathologic examination. deleted the recommendation from the mater, a full brain autopsy of the donor, We have modified the regulation codified section. including gross and histological slightly to require that the assessment (Comment 82) One comment pointed examination, performed by a qualified performed on donors of dura mater be out that the rules of safe laboratory neuropathologist, to identify evidence of ‘‘adequate.’’ The previous discussion operation dictate that laboratory TSE changes. The preamble also noted provides our current understanding of personnel be informed of the risks in that, although there is no FDA-approved what would constitute an adequate handling autologous donations. Another or validated test for screening TSE in assessment. comment requested that we add to brain tissue, a negative test to detect (Comment 80) The preamble to the § 1271.90(b) the requirement that these protease-resistant prion protein (PrP- proposed rule noted that the type of TSE HCT/Ps be handled as untested in RES), either by immunohistochemistry testing required for donors of dura mater accordance with § 1271.60. or Western Blot, is considered did not appear feasible for cornea Although we agree with the concerns significant in increasing the level of donors, and we requested comments on expressed in the comments, we decline confidence that the brain and the dura this issue (64 FR 52696 at 52706). to amend § 1271.90(b) as suggested by mater are free of TSE. Several comments agreed that TSE the comments. The labeling required in (Comment 79) Several comments testing for corneal tissue donors is not § 1271.90(b) (e.g., ‘‘NOT EVALUATED supported the proposed requirement a feasible option because of the time FOR INFECTIOUS SUBSTANCES’’) and the procedures set out in the required for brain autopsy or biopsy. should alert personnel to the risks of preamble. One comment noted that the The comments also cited concerns about these HCT/Ps. precautions of a full brain autopsy in costs and a potential decrease in (Comment 83) One comment addition to donor screening and medical donation rates. One comment noted that questioned whether proposed history are a necessary step until there the use of all available screening § 1271.90(a)(2) referred to semen, ova, is an approved screening test. One components, including the medical and embryos. comment asserted that a brain autopsy screening interview, would (Response) Semen, ova, and embryos for dura donors is not feasible and satisfactorily substitute for TSE testing. are examples of reproductive cells and recommended a brain biopsy instead. (Response) Under present conditions tissues included in § 1271.90(a)(2). Two comments suggested that we of storage in the United States, corneas (Comment 84) Two comments change our recommendation that the must be transplanted within days of questioned how § 1271.90 would apply autopsy be performed by a qualified procurement to maintain their utility. to individual semen donors who wish to neuropathologist to a qualified For this reason, it is not feasible to test cryopreserve their semen (e.g., cancer pathologist. cornea donors for TSE using current patients). (Response) We based the methodologies, and we are not imposing (Response) If the semen donor intends recommendations in the preamble to the a testing requirement at this time. that the cryopreserved sperm be used proposed rule on conclusions reached However, under § 1271.75(a), screening with a sexually intimate partner, then by FDA’s TSEAC at meetings held on for TSE is required for donors of all § 1271.90 applies. October 6, 1997, and April 16, 1998. types of tissues. After reviewing these comments, we The committee reiterated these 11. Are There Exceptions From the also realized that cryopreserved recommendations at a meeting on Requirement of Determining Donor reproductive cells or tissue for January 18, 2001. The committee Eligibility, and What Labeling autologous use or for use by a sexually recommended a full brain autopsy of the Requirements Apply? (§ 1271.90) intimate partner, originally exempted donor, including gross and histological Proposed § 1271.90 would from the donor screening and testing examination, to identify evidence of recommend, but not require, screening requirements, could be subsequently TSE changes. We agree with comments and testing for banked cells and tissues used for directed donation. Therefore, that a brain autopsy is necessary in the for autologous use and reproductive we have added an exception to the rule absence of an appropriate test, and will cells or tissue donated by a sexually to accommodate individuals whose consider changing the requirement in intimate partner of the recipient for reproductive options have been the future if a sufficiently sensitive test reproductive use. Proposed § 1271.90 restricted due to health or infertility.

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These individuals may not have underestimated the rule’s economic regulations on small business entities is undergone testing at the time of impact and that significant changes in an important consideration under The donation, because their intention at that the SOPs of all eye banks would be Regulatory Flexibility Act, our analysis time was autologous use or use in a required. suggests this final rule will not have a sexually intimate partner. For various (Response) We do not agree. Current significant economic impact. reasons, the donor(s) cannot make industry standards meet or exceed most (Comment 91) One comment objected additional donations (e.g., the woman is of the specifications of this final rule to our estimate of the cost of testing post-menopausal or has her ovaries and and industry consultants have indicated tissue donors for syphilis, suggesting uterus removed; the man has undergone that compliance with these standards is that such testing will cost $15 per donor chemotherapy, which renders him nearly 100 percent. Based on this and that testing 650 donors will increase infertile.) To permit use of such information, we do not believe that costs by approximately $10,000. cryopreserved cells or tissue for directed SOPs will need to be substantively (Response) We do not dispute these donation in situations where subsequent changed as a result of this final rule. figures. However, there is no indication screening and testing is available, we Furthermore, these comments did not given in the comment as to whether this have added § 1271.90(a)(3). provide any data that refute or would is a significant cost impact, and/or for Section 1271.90(a)(3) states that cause us to adjust our estimates of the which types of establishments (i.e., cryopreserved cells or tissue for economic impacts. small versus large). These figures are reproductive use, which were originally (Comment 87) One comment accurate, but would be of greater value intended for autologous use, or use in a suggested that cost increases are not if presented in context, e.g., as a sexually intimate partner (and therefore easily absorbed by the not-for-profit eye percentage of establishment revenues. the donor(s) were not tested at the time banking community, and that a rule (Comment 92) One comment noted of donation) may subsequently be used could negatively affect the availability that there was no discussion of the costs for directed donation, provided that a of and/or access to services. of the forthcoming ‘‘good manufacturing donor cannot make additional donations (Response) We do not agree. Many practices’’ rule. of HCT/Ps due to infertility, or health; similarities exist between the provisions (Response) We believe the comment is and appropriate measures are taken to of this final rule and current industry referring to the compliance costs screen and test the donor(s) before standards. Furthermore, our Analysis of associated with the forthcoming CGTP transfer to the recipient. The agency Economic Impacts suggests only a minor rules, which are not a part of this final intends to address, in guidance, the compliance cost burden, which will not rule. We will include a full economic appropriate methods for screening and significantly affect the availability of analysis of the forthcoming CGTPs testing donors in such circumstances to and/or access to services. when that final rule is published. determine whether the HCT/Ps may (Comment 88) One comment (Comment 93) Four comments carry communicable diseases. suggested that user fees could objected to a quarantine requirement for An example is the situation in which potentially add to the rule’s economic donated oocytes and embryos. These a sexually intimate couple create impact. comments suggested that this embryos, some of which are (Response) A user fee is not a requirement is unnecessary and cryopreserved. The donors were not component of this final rule. unacceptable due to the excessive screened and tested at the time of the (Comment 89) Two comments stated burden placed on reproductive clinics, donation. The woman subsequently has that the rule will impose compliance physicians, and patients. her ovaries and uterus surgically costs of $10,000 to $20,000 per average (Response) The 6-month quarantine removed, due to cancer. The donor tissue and eye bank, and that the effects requirement for reproductive tissues couple wishes to make a directed of the regulation on hospitals may push now applies only to semen from donation of the cryopreserved embryos this figure higher. anonymous donors, and not to oocytes to a recipient who is known to one or We do not agree with these estimates or embryos. both of the donors prior to the donation. of compliance costs. Furthermore, we (Comment 94) One comment Under § 1271.90(a)(3), the embryos are not able to address their validity as suggested that testing and screening of would be eligible for directed donation no information or data were provided to oocyte and embryo donors would need provided the couple can now be support them. We are also unable to to be repeated after a 6-month screened and tested. address the rule’s effects on hospitals as quarantine, resulting in additional costs. (Comment 85) One comment opposed alluded to by the comments, because the (Response) This final rule does not the exception in proposed § 1271.90 for comments did not provide any data that require retesting of oocyte and embryo sexually intimate reproductive tissue would allow us to evaluate the alleged donors. Therefore, there is no need to donors. The comment asserted that all effects. include these costs in the economic reproductive tissue donors should be (Comment 90) One comment objected analysis. screened, because sexually intimate to our $1.23 million estimate of average (Comment 95) One comment partners may have escaped exposure to annual eye bank establishment income suggested that the private sector would each other’s bodily fluids. and noted that ‘‘* * * many U.S. eye have to spend more than $100 million (Response) Although we agree that banks operate within budgets that are per year to comply with this final rule, screening and testing may be <50% of that figure.’’ requiring a cost-benefit analysis. appropriate for sexually intimate (Response) We realize that these (Response) We do not agree. Based on partners, and encourage establishments figures may vary. Our average annual our analysis, the costs of complying to perform screening and testing, we income estimate was intended to with this final rule are far less than $100 believe that this should be the provide insight as to the financial million per year, and therefore a cost- responsibility of the attending burden of this rule for a representative benefit analysis is not required. physician, the donor, and the recipient. establishment. Some establishments Furthermore, no data were provided in would be expected to have income the comment to support its estimate of E. Economic Impacts greater than $1.23 million and others compliance costs. (Comment 86) Five comments less than $1.23 million. While we (Comment 96) Three comments suggested that we significantly recognize that the financial impact of objected to our estimate of the cost of

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screening and testing oocyte donors and Executive Order 12866. The Office of will avoid unnecessary requirements. suggested that the actual cost is much Management and Budget (OMB) has To minimize burdens while maintaining higher. determined that this final rule is a safety, the agency has designed the (Response) We agree that this cost significant regulatory action as defined screening and testing provisions to vary may be higher, and have revised our by the Executive order, and so, is with the specific type and use of each Analysis of Economic Impacts to reflect subject to review. Because the rule does HCT/P. This regulatory action is focused the most recent cost data available. not impose mandates on State, local, or on the prevention of disease (Comment 97) One comment tribal governments, or the private sector, transmission through implantation, suggested that our estimate of the cost that will result in an expenditure in any transplantation, infusion, or transfer of of a donor oocyte cycle is too low. one year of $100 million or more, FDA any HCT/P. For example, FDA will now (Response) We realize that these is not required to perform a cost-benefit require cell and tissue donors to be figures may vary. However, comments analysis according to the Unfunded tested for syphilis and screened for TSE. from another ART facility indicate that Mandates Reform Act. Donors of viable, leukocyte-rich cells or our cost estimate for a donor oocyte The Regulatory Flexibility Act tissue will also be tested for HTLV types cycle (originally obtained from a study requires agencies to prepare a I and II, and CMV. Because published in the journal Fertility and Regulatory Flexibility Analysis for each communicable disease agents can be Sterility) is reasonable (Ref. 26). rule unless the agency certifies that the transmitted by semen and other (Comment 98) One comment rule will not have a significant genitourinary secretions, FDA is suggested that our estimate of the economic impact on a substantial requiring that certain donors of average revenue of ART centers was too number of small entities. As explained reproductive cells and tissue be high. in section IV.C of this document, the screened and tested for sexually (Response) We do not agree. The agency believes that most facilities transmitted diseases. FDA is also comment assumes the cost of an IVF would not be significantly affected by amending the existing CGMP cycle is $10,000, whereas we assume the this final rule because they are already regulations for drugs and QS regulations average cost of an ART cycle is $11,868, performing the infectious disease for medical devices to clarify the scope a more general and somewhat larger screening and testing and recordkeeping of the screening and testing number. Furthermore, the comment that is being required. However, FDA requirements in part 1271, subpart C. presents a net average revenue estimate does not have sufficient data to fully for ART facilities, after subtracting drug FDA’s objectives and authority for characterize the size distribution and issuing this final rule are described in costs and oocyte retrieval fees. In the other relevant features of small entities, detail in section II of this document. proposed rule, we present a gross particularly those involved with FDA is relying on the authority average revenue estimate. It is therefore reproductive HCT/Ps, and the impact on provided by section 361 of the PHS Act unclear that these estimates of average these entities is uncertain. The to issue regulations to prevent the revenue can be meaningfully compared. following analysis, along with this spread of communicable disease, as well preamble, represents FDA’s Final IV. Analysis of Economic Impacts as its authority under the act to issue Regulatory Flexibility Analysis. FDA has examined the impacts of this Based on the following economic CGMP regulations for drugs (21 U.S.C. final rule under Executive Order 12866, analysis, FDA estimates that the total 351(a)(2)(B)). FDA has reviewed related the Regulatory Flexibility Act (5 U.S.C. one-time costs to comply with this final Federal rules and has not identified any 601–612), and the Unfunded Mandates rule will be between $0.4 and $2.1 rules that duplicate, overlap, or conflict Reform Act (Public Law 104–4). million, and the annual or recurring with this final rule. Executive Order 12866 directs agencies costs will be between $1.8 and $3.5 This final rule provides oversight for to assess all costs and benefits of million. These figures imply a total the full spectrum of HCT/Ps that are available regulatory alternatives and, annualized cost estimate of between now marketed and may be marketed in when regulation is necessary, to select $1.9 and $3.8 million. The average the future. This action will improve regulatory approaches that maximize annualized cost per affected entity, protection of the public health and net benefits (including potential expressed as a percentage of average increase public confidence in new economic, environmental, public health annual revenue, ranges from 0.003 to technologies, while imposing a minimal and safety, and other advantages; 0.35 percent. FDA has provided ranges regulatory burden. An important benefit distributive impacts; and equity). The of cost estimates to account for of this final rule is that it will establish Unfunded Mandates Reform Act uncertainty with respect to both the a consistent standard of safety for requires that agencies prepare a written number of entities affected, and the marginal firms not currently following statement under section 202(a) of degree to which affected entities are voluntary industry standards and anticipated costs and benefits before already performing the activities guidelines and help to ensure proposing any rule that may result in an required by this final rule. equivalent protection from transmissible expenditure by State, local, and tribal diseases for all recipients of therapy governments, in the aggregate, or by the A. Objectives and Basis of the Proposed involving HCT/Ps, regardless of the private sector, of $100 million (adjusted Action health condition for which they are annually for inflation) in any one year. FDA is publishing this final rule as being treated. This final rule will help The Regulatory Flexibility Act requires the next step in establishing regulations minimize the risk to all HCT/P agencies to analyze whether a rule may for the rapidly evolving HCT/P industry. recipients of exposure to several life- have a significant economic impact on This final rule is needed to prevent threatening, in some cases incurable, a substantial number of small entities unwitting use of contaminated tissues diseases, including HIV, HBV, HCV, and, if it does, to analyze regulatory with the potential for transmitting CJD, HTLV, CMV, and others. These options that would minimize the infectious diseases, including HIV and risks will be minimized through impact. hepatitis. validated screening procedures, lab The agency believes that this final While acting to increase the safety of tests, recordkeeping and adequate rule is consistent with the regulatory the nation’s supply of HCT/Ps, FDA is product labeling to avoid unwitting use philosophy and principles identified in implementing regulations in a way that of unsafe HCT/Ps.

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B. The Type and Number of Entities CBER has a record of 178 voluntarily also has a 1996 list of approximately Affected registered facilities listing ‘‘stem cell’’ as 110 semen banks operating in the This final rule requires manufacturers a type of product or establishment. The United States. Although ASRM has of HCT/Ps to screen and test the donors National Marrow Donor Program published guidelines for donor of cells and tissue used in those (NMDP), which includes establishments screening and other aspects of oocyte products. The rule requires that donors that recover PBSCs, lists approximately donation, and for therapeutic donor be screened and tested for risk factors 92 donor centers and 113 collection insemination (TDI), ASRM does not for, and clinical evidence of, a relevant centers. Approximately 150 facilities exercise oversight or provide communicable disease agents and involved with PBSC production are accreditation of facilities that collect diseases. This final rule applies to a currently accredited by AABB and an donor reproductive tissue or use these estimated 107 are accredited by the tissue products in infertility treatment. range of activities conducted at facilities Foundation FACT. Industry sources such as conventional tissue banks, eye C. Nature of the Impact estimate that approximately 80 of these banks, semen banks, infertility facilities have or are seeking dual This final rule includes requirements treatment centers, and facilities AABB/FACT accreditation, suggesting for donor screening, donor testing, processing hematopoietic stem/ an unduplicated count of approximately recordkeeping, and quarantine of cells progenitor cells. 200 PBSC facilities assumed to be and tissue. Donor screening will involve Information obtained under the accredited by the AABB and/or FACT. the review of relevant medical records registration final rule forms the basis for However, the number and donor to include a medical history interview FDA’s estimates of the number of screening and testing practices of (particularly pertaining to affected eye banks and conventional nonaccredited facilities are unknown. communicable disease risk), a current tissue banks. The agency has not yet The International Bone Marrow report of a physical assessment for received all registration and listing Transplant Registry/Autologous Blood cadaveric donors, and a physical information from reproductive tissue and Marrow Transplant Registry examination for living donors. For and hematopoietic stem/progenitor cells (IBMTR/ABMTR) estimates that the living, repeat anonymous semen donors, establishments, because registration and total number of blood or bone marrow a complete donor-eligibility listing requirements for such facilities may be as high as 400 (e.g., 200 determination procedure will be establishments and products have not more than the number estimated to be required at least once every 6 months. yet gone into effect. The agency’s accredited by AABB and/or FACT), but This final rule requires that a donor estimates of the number of affected eye the number of IBMTR/ABMTR- specimen be tested for evidence of banks, hematopoietic stem/progenitor estimated facilities that actually process infection due to relevant communicable cell facilities, semen banks and ART peripheral blood (as opposed to bone disease agents and diseases, with testing facilities rely heavily on information marrow) is uncertain. For the purposes conducted within a specified time of obtained from various professional of this analysis, FDA has assumed that recovery of cells or tissue. In general, a organizations associated with the HCT/P 400 peripheral blood stem/progenitor donor may be determined eligible if free industry. Where good statistical data are cell facilities will be affected by this from risk factors for, and clinical not available, FDA’s estimates have final rule. evidence of, infection due to relevant incorporated the quantitative judgments Although there is no single national communicable disease agents and of individual experts identified through organization that keeps track of the diseases, and if the required testing is contacts with HCT/P industry number of facilities for umbilical cord negative or nonreactive. professional associations. blood banking, FDA estimates that there This final rule also requires As presented in table 1 of this are approximately 25 umbilical cord recordkeeping for donor-eligibility document, FDA has a record of 134 blood banks currently operating in the determinations. Manufacturers must registered facilities listing eye tissue United States. These facilities may also ship HCT/Ps accompanied by including 96 eye banks, 93 of which are seek accreditation through AABB or documentation of donor eligibility currently accredited by EBAA. FDA also FACT. Based on this information, the status, including a summary of records has a record of 166 registered tissue agency estimates that a total of 425 that includes the results of the required banks involved in the manufacture of establishments involved in testing and the name and address of the other conventional HCT/Ps, e.g., manufacturing hematopoetic stem/ establishment that made the eligibility pericardium, dura mater, heart valves, progenitor cells would be affected by determination. This final rule also skin and bone allografts, fascia, tendons this rule. requires that HCT/Ps be quarantined and ligaments (hereafter referred to as In addition, 67 establishments until a donor-eligibility determination is ‘‘conventional tissue banks’’). The produce licensed biological products or made, and that products be clearly American Association of Tissue Banks approved medical devices that are labeled as under quarantine during that (AATB) lists approximately 75 currently required to register under period. Manufacturers are responsible accredited tissue banks and projects an parts 207 and 807 (21 CFR parts 207 and for the appropriate labeling and additional 40 to 60 members not 807) but would also be subject to the documentation of HCT/Ps from a donor accredited. provisions of this final rule. who is found to be ineligible. Facilities that produce hematopoietic Finally, this final rule also applies to The economic impact of these stem/progenitor cell products from facilities involved with reproductive requirements is expected to be minor peripheral blood or umbilical cord tissue, primarily semen banks and ART because the leading industry blood will also be affected by this final facilities that collect and process donor associations have already established rule. FDA finds that available data with semen or donor oocytes. The American standards for screening, testing and which to estimate the number of Society of Reproductive Medicine recordkeeping that, in most cases, meet peripheral blood stem/progenitor cell (ASRM) has a membership of or exceed the criteria specified in this (PBSC) facilities and evaluate current approximately 400 fertility centers, 370 final rule, and because existing FDA practices are quite limited, and the of which have provided reports to the regulations already apply to certain actual number of PBSC facilities may 1999 Society for Assisted Reproductive HCT/Ps intended for transplantation range from 200 to 400. As of April 2002, Technology (SART) registry. The ASRM (see part 1270). Table 1 of this

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document lists the types of HCT/Ps that establishments affected by this final rule specific donor screening and testing will be affected by this final rule and the and the estimated percentage of requirements proposed by FDA can be associated establishments that establishments believed to be following compared with those currently required manufacture these products. Table 1 current industry standards for donor by the industry associations. also provides estimates of the number of screening and testing. The lists of

TABLE 1.—TYPE AND NUMBER OF ESTABLISHMENTS AFFECTED AND PERCENTAGE ALREADY IN COMPLIANCE WITH INDUSTRY STANDARDS FOR DONOR ELIGIBILITY SCREENING AND TESTING

FDA Regulatory Requirements Compared to Industry Estimated Percent Type of Entities Affected Standards of Entities in Com- Type of Human Tissue (and Estimated Total Num- pliance With Indus- ber) FDA Industry Standards try Standards

NonreproductiveTissue

Eye tissue 134 FDA registered eye tis- 21 CFR part 1270 and EBAA (s1 through s3)1 and 100% sue facilities, including 93 (s1,s2,s3)1 and (t1, t2, t3, (t1 through t3)2 EBAA accredited eye t5)2 banks (134 total)

Pericardium, dura-mater, 166 FDA registered tissue 21 CFR part 1270 and (s1 AATB (s1 through s3)1 and 100% heart valves, skin banks, including 75 AATB through s3)1 and (t1, t2, (t1 through t5)2 allograft, bone allograft, accredited tissue banks t3, t5)2 other viable (166 total)

Stem progenitor cells; pe- 178 FDA registered facili- (s1 through s3)1 and (t1 AABB/FACT (s1 through 100% ripheral blood ties, 92 NMDP donor cen- through t6)2 s3)1 and (t1 through t6)2 ters, and 113 NMDP col- lection centers (400 total)

Stem progenitor cells; um- Cord blood banks (25 total) (s1 through s3)1 and (t1 AABB/FACT (s1 through 100% bilical cord blood through t6)2 s3)1 and (t1 through t6)2

Licensed biological products 67 FDA registered estab- Currently regulated under 100% compliance and approved medical de- lishments (67 total) sections 351 and 361 of with 21 CFR vices the PHS Act, 21 CFR parts 207 and parts 207 and 807 807

Total 792 Facilities

ReproductiveTissue

Donor oocytes, embryos 370 ART facilities and asso- (s1 through s3)1 and (t1, t2, ASRM/CAP (s1)1 and Unknown ciate labsin the 1999 t3, t5)2 (t1,t2,t3,t5)2 SART report (400 total)

Donor semen 4 Semen banks in 1996 (s1 through s3)1 and (t1 AATB (s1 through s3)1 and Unknown AATB survey (110 total) through t8)2 (t1 through t8)2 and ASRM (s1)1 and (t1, t2, t3, t5, t7, t8)2

Total 510 Facilities 1 Screening for: s1: HIV, s2: hepatitis, s3: CJD 2 Laboratory Tests: t1: anti-HIV-1-2, t2: anti-HCV, t3: HBsAg, t4: anti-HTLV-I, t5: syphilis, t6: CMV, t7: Neisseria gonorrhea, t8: Chlamydia trachomatis

Based on communications with There is currently no single reliable require facility staff time to align current representatives of several industry source of information on fertility center quarantine, labeling, and recordkeeping associations and facility managers, FDA or semen bank adherence to AATB systems with the new requirements. As estimates that the number of facilities standards or ASRM guidelines. A small shown in table 2 of this document, all currently in compliance with industry percentage of semen banks are members of the industry associations already standards for donor screening and of the AATB and are known to follow specify requirements for these testing approaches 100 percent for that organization’s requirements for procedures. With the exception of several affected types of HCT/Ps. screening and testing, but little is facilities handling reproductive tissue, Facilities handling reproductive tissue known about the standards used at other the current industry standards adopted are the primary exception to this facilities. by most facilities are at least as stringent finding, and also represent the greatest In addition to the required donor as those included in this final rule. area of uncertainty for this analysis. screening and testing, this final rule will

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TABLE 2.—CORRESPONDENCE OF FDA REQUIREMENTS TO CURRENT INDUSTRY STANDARDS FOR SPECIMEN QUARANTINE, LABELING, AND RECORD RETENTION

FDA AATB EBAA AABB FACT ASRM

Quarantine X1 X1 X1 X1 X1

Labeling X1 X1 X1 X1 X1

Record Retention X1 X1 X1 X1 Recommended; not re- quired 1 X means corresponds.

Due to the disparity in the amount of 2. Impact on Reproductive Tissue (average) cost estimate of $13,500 (Ref. available information and the potential Establishments 22) per donor oocyte cycle, this impact of the rule on nonreproductive a. Impact of donor screening and translates into a 2.04 percent increase versus reproductive tissue testing. As indicated in table 1 of this ($275.40/$13,500) in the average cost of establishments, these two broad document, the number of reproductive therapy per cycle. categories of tissue establishments are tissue facilities currently following The cost of screening and testing treated separately in the cost impact industry standards is unknown. Thus, oocyte donors will depend on the analysis that follows. FDA cannot develop a precise estimate number of donor cycles attributable to each screened donor. If each donor 1. Impact on Nonreproductive Tissue of regulatory costs. To generate an upper contributes oocytes for only one cycle, Establishments bound cost estimate, however, FDA assumed that 100 percent of facilities and the rejection rate is low (assumed a. Impact of donor screening and involved with oocyte donation and 80 to be 0.57 percent, which is the testing. As summarized in table 1 of this percent of semen banks would need to estimated prevalence rate of HBsAg document, most nonreproductive tissue perform additional screening and positivity among parturient women) establishments are believed to be testing. Although semen banks not (Ref. 7), the number of donors to be already in compliance with FDA’s new currently following voluntary industry tested would be 9,118 (9,066/(1– donor screening and testing standards constitute a majority of the 0.0057)). If each donor contributes requirements, as a result of following firms in that industry, they are primarily oocytes for two donor cycles, the their own industry association small operations that are estimated to number of donors to be screened would standards and current FDA regulations. serve only 5 percent of all semen be 4,559. These alternative assumptions Therefore, the cost of compliance with donors. imply a total cost to U.S. facilities these provisions will be minimal for i. Oocyte donor screening and testing. involved in oocyte donation of from these establishments. The estimated impact of this final rule $1,255,549 to $2,511,097 per year, as b. Impact of recordkeeping and tissue on establishments involved in oocyte shown in table 3 of this document. quarantine. The burden of donation is based on 1999 data reported recordkeeping and tissue quarantine by SART, an organization of assisted TABLE 3.—ALTERNATIVE OOCYTE DO- requirements will reflect the staff time reproductive technology providers NATION SCENARIOS AND ASSOCI- needed to compare current affiliated with ASRM. In 1999, donor ATED DONOR SCREENING AND TEST- recordkeeping and facility procedures oocytes were used in approximately ING COSTS with those required under the new 10.4 percent of the 86,822 ART cycles standards and to make modifications reported, or 9,066 cycles (Ref. 4). FDA 2 ART Cy- 1 ART where needed in current facility SOPs believes that all infertility treatment Screening and cles per Cycle per related to these activities. Such changes centers already conduct medical exams Testing Cost Donor = Donor = are expected to be minor for most and history taking and perform some per Donor 4,559 Do- 9,118 Do- nors nors nonreproductive tissue establishments. laboratory testing before oocyte retrieval In the proposed rule, FDA estimated for any potential donor. Compliance $275.40 $1.26 mil- $2.5 million2 that it would take approximately 8 to 40 with this final rule, however, may entail lion1 hours to compare the new regulations further blood testing and adding some against a facility’s current SOPs and 1 $275.40 x 4,559 = $1,255,549 additional screening questions to the 2 $275.40 x 9,118 = $2,511,097 make any necessary modifications. interview. Since we received no comments from The cost of additional blood work FDA believes that much of the affected entities, we have retained this (including HIV 2, HTLV I and II, and additional screening and testing assumption. This process will be CMV IgG and IgM) is estimated at identified in table 3 of this document is performed by a staff person who acts as approximately $238.40 per donor (Ref. already being performed by ART clinics. a regulatory reviewer, a supervisor, or a 22). The additional time to interview Therefore, these estimates should be manager of quality assurance. Assuming and record information in donor viewed as maximum expected cost a labor cost of $40 per hour (Ref. 23), screening is estimated to cost about $37, burdens. Furthermore, certain methods this standards reconciliation effort will based on the assumption that of donor oocyte recovery, e.g., result in a one-time cost per facility approximately half of the required laparoscopy, are not directly connected ranging from $320 to $1,600. Applying screening is already being done, and with the transmission of sexually this range of cost per facility to the that the estimated cost of a full health transmitted and genitourinary diseases approximately 792 nonreproductive history interview is $75 ($37 = $75/2) and, therefore, testing for Neisseria tissue facilities yields an impact that (Ref. 6). Thus, the additional cost per gonorrhea and Chlamydia trachomatis ranges from $253,440 (= $320 x 792) to oocyte donation is estimated at $275.40 would not be required under this final $1,267,200 (= $1,600 x 792). ($238.40 + $37). Based on a reported rule. Use of such methods would be

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expected to lower the estimated testing advances in treatment for male factor Based on rates published on the Internet costs by approximately $40 per oocyte infertility. For example, the (Ref. 6), the agency estimates that a full donor. development of intracytoplasmic sperm medical exam costs $175, a less ii. Semen donor screening and testing. injection (ICSI) used in conjunction extensive followup exam will cost The agency has conducted an extensive with in vitro fertilization (IVF) has approximately $75 (a published fee for search for current information on the enabled some couples to forego TDI in a health history review), and the extent of infectious disease screening for favor of ICSI using the male partner’s abbreviated screening at the time of semen donors, but has found little sperm (Ref. 8). In 1985, an estimated each donation will cost approximately information available. The 70,000 women per year received TDI $15 (i.e., one-fifth of the time required Congressional Office of Technology (Ref. 9), compared to an estimated for a full history review). One repeat Assessment (OTA) conducted a survey 171,000 women who reported ever donor visit per year is assumed. Thus, of establishments involved in semen receiving artificial insemination with the total cost of this screening is donation in 1987, and found that all donor semen in the National Survey of estimated to be $265 per year per donor. commercial banks surveyed performed Family Growth (NSFG) conducted in The lab tests for prospective semen routine screening and testing for HIV, 1995. If the NSFG respondents referred donors include those listed in table 1 of but only 45 percent of private only to experience over the past 5 years, this document, with 6-month followup physicians included this screening. The this would translate to approximately blood tests. The cost of additional most recent available data includes a list 34,200 women receiving TDI per year. testing, based on screening test fees of approximately 110 commercial semen Assuming an average of three cycles of published on the Internet (Ref. 5), is banks developed by ASRM in 1996, and therapy per patient per year, these data $230.16 for initial complete blood a 1996 registration survey of the AATB yield an estimated demand for TDI testing, plus $123.40 for followup blood that includes data for 4 semen banks. donor units of approximately 102,600 testing after a 6-month quarantine Some semen banks that have applied, units per year. This figure is consistent period, plus $113.30 for bacterial but are not yet accredited members of with an industry expert estimate of testing. Thus, the total cost of the AATB, are nonetheless following AATB current U.S. TDI production of 100,000 additional lab work is estimated to be standards. It is also likely that some units per year. $467 per donor per year ($230.16 + other facilities have informally adopted The clinical literature indicates that $123.40 + $113.30 = $466.86). Because AATB standards. This analysis assumes most semen donor attrition occurs these estimates are based on charges to that all semen banks currently perform before the blood testing stage of the facility clients, they are likely to HIV screening and testing, as reported donor-eligibility determination. For represent an upper bound on actual by OTA in 1987, and that a smaller example, in one study of donor facility costs. Using these figures, the percentage of facilities additionally recruitment in which the clinic estimated total industry cost per year is follow all AATB screening and testing followed AATB and ASRM standards, of approximately $94,000 (128 x ($265 + standards. the total of 199 potential donors initially $467) = $93,696). Based on conversations with semen recruited, 174 were rejected; 172 of b. Impact of donor recordkeeping and banking industry experts, FDA estimates whom were rejected before blood tissue quarantine. The impact of that the 20 largest semen banks account testing, with only 2 (1 percent) rejected recordkeeping and tissue quarantine for approximately 95 percent of the based on the blood test results (Ref. 10). requirements for reproductive tissue commercial production of donor semen, For the purposes of this analysis, the establishments will reflect the staff time and are following AATB standards for agency assumes that the number of required for the following: (1) A one- donor screening and testing. The agency donors who will require infectious time review and modification of current analysis therefore assumes that the 20 disease testing is approximately equal to SOPs to bring them into alignment with largest facilities will experience the number of donors needed to supply the new standards, and (2) ongoing, minimal impact, while the remaining 90 the level of demand for TDI. Thus, expanded practices for each donor who facilities, which account for FDA’s estimate is based on the previous undergoes screening and testing to meet approximately 5 percent of total TDI unit demand combined with the the requirements of this final rule. industry production, will be more maximum number of births per donor In the proposed rule, FDA estimated significantly affected. These very small suggested in ASRM guidelines (Ref. 11), that the one-time review and alignment semen banks are described by an the average delivery rate per cycle of of current facility SOPs will require industry expert as typically functioning intrauterine insemination, an assumed approximately 8 to 40 hours at each within a physician office practice (e.g., 10 donated specimens per donor per facility. Since we received no comments that of an obstetrician or gynecologist). year, and 4 donation units per donor from affected entities, we have retained The semen banking in these facilities is specimen (Ref. 12). These factors yield this assumption. As with generally offered as an additional an estimated 2,565 donors required per nonreproductive tissue facilities, this service to patients receiving fertility year. Assuming that the number of process would be performed by a treatment, and is not the primary line of donors already screened and tested is regulatory affairs analyst, a supervisor, business within these establishments. proportionate to the volume of or a manager of quality assurance. The total estimated cost of the production accounted for by facilities Assuming a labor cost of $40 per hour proposed screening and testing compliant with AATB standards, FDA (Ref. 23), this standards reconciliation requirements for semen banking estimates that approximately 5 percent effort would result in a one-time cost facilities is based on the number of of all donors, or 128 donors per year per facility ranging from $320 to $1,600. semen donors who would require (128 = 0.05 x 2,565), may need to be Applying this range of cost per facility screening and testing, and their newly screened and tested to meet the to the 400 ART clinics and 110 semen respective unit costs. Due to the lack of requirements of this final rule. banks yields a potential one-time cost data on the actual number of semen The screening cost per semen donor is for all reproductive tissue facilities that donors, the agency estimated the assumed to include an initial medical ranges from $163,200 ($320 x (400 + number based on projected TDI history and physical, a 6-month 110)) to $816,000 ($1,600 x (400 + 110)). demand. The level of TDI demand has followup exam, and an abbreviated The estimated cost of the recurring likely decreased over time, with screening at the time of each donation. requirements for tissue quarantine,

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labeling, recordkeeping and record about typical donor practices for ART This translates into an average retention at reproductive tissue facilities facilities. If a higher rate of donation per annualized cost of $38 ($30,000/792) to are based on the estimated staff time donor is typically achieved by facilities $228 (180,000/792) per facility. needed to create and retain records of compared to that assumed in this The total annualized cost of medical history, screening information analysis, the cost burden may be much compliance for the ART industry ranges and lab testing for each prospective lower than these estimates would from approximately $1.71 to $3.5 donor from whom specimens are indicate. More generally, if the current million, reflecting uncertainty about the collected. These records must comply level of facility donor screening, testing number of oocyte donors, the number of with the requirements of this final rule and recordkeeping is more stringent ART cycles per donor per year and and are estimated to require among reproductive tissue facilities current screening, testing and approximately 4 hours per donor per than assumed in this analysis, the recordkeeping practices. These costs year of clerical staff time. Assuming a overall cost of compliance with this translate into an average annualized cost labor cost of $24 per hour (Ref. 24) for final rule will also be lower than these of approximately $4,270 ($1.708 clerical staff time implies a cost of $96 estimates suggest. million/400) to $8,693 ($3.5 million/ per donor per year. Table 4 of this Uncertainty about current practices 400) per facility. In general, assumed document summarizes the potential results in range estimates of the cost higher rates of donation per donor, or a range of recurring costs for all impact of this final rule. However, lower number of total donor cycles per reproductive tissue facilities. As shown because facilities in most HCT/P year, will result in lower industry costs. in table 4 of this document, the industry sectors already follow Similarly, lower rates of donation per estimated costs range from voluntary industry standards requiring donor, or a greater number of total approximately $450,000 to $888,000, donor screening and testing, the overall donor cycles per year, will result in depending on the assumed number of impact is expected to be minor. Tables higher industry compliance costs. oocyte donors. 5 and 6 of this document provide a summary of the expected cost impacts The total annualized cost impact on TABLE 4.—RANGE OF RECURRING across the different industry sectors the semen banking industry is based on COSTS FOR REPRODUCTIVE TISSUE included in the analysis. Table 5 of this an estimated TDI demand of document presents costs annualized at 7 approximately 103 thousand units per 128 semen donors and $449,9521 percent interest over 10 years, whereas year, and assumed current compliance 4,559 oocyte donors table 6 of this document presents of the top 20 commercial banks which (2 ART cycles per account for approximately 95 percent of donor) annualized costs for the same time period using a 3 percent interest rate. industry production. The total 128 semen donors and $887,6162 The total annualized cost for the 792 annualized costs range from 9,118 oocyte donors nonreproductive tissue facilities is approximately $110,000 to $131,000. (1 ART cycle per estimated to range from $30,000 to These industry totals yield an average donor) $180,000, reflecting agency uncertainty annualized cost range of $1,222 about the extent of effort necessary for ($110,000/(110–20)) to $1,456 1 $449,952 = (128 + 4,559) x $96 a one-time review and alignment of ($131,000/(110–20)) per facility 2 $887,616 = (128 + 9,118) x $96 existing SOPs with the donor screening currently noncompliant with this final The range of these estimates reflects and testing provisions of this final rule. rule. the agency’s current lack of information TABLE 5.—SUMMARY TABLE OF DONOR ELIGIBILITY COST ANALYSIS AT 7 PERCENT INTEREST OVER 10 YEARS1

Type of Facility Total One-time Cost Total Recurring Cost Total Annualized Cost

NonreproductiveTissue

(a) Donor screening and testing Minimal Minimal Minimal (b) Recordkeeping and quar- $253 to $1,267 Minimal $36 to $180 antine

Reproductive Tissue, ART Facilities

(a) Donor screening and testing Minimal $1,255 to $2,511 $1,255 to $2,511 (b) Recordkeeping and quar- $128 to $640 $438 to $875 $456 to $966 antine

ART subtotal $128 to $640 $1,693 to $3,386 $1,711 to $3,477

Reproductive Tissue, Semen banks

(a) Donor screening and testing Minimal $94 $94 (b) Recordkeeping and quar- $35 to $176 $12 $17 to $37 antine

Semen subtotal $35 to $176 $106 $111 to $131

Total Tissue Industry $416 to $2,083 $1,799 to $3,492 $1,858 to $3,788 1 All figures in thousands of dollars.

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TABLE 6.—SUMMARY TABLE OF DONOR ELIGIBILITY COST ANALYSIS AT 3 PERCENT INTEREST OVER 10 YEARS1

Type of Facility Total One-Time Cost Total Recurring Cost Total Annualized Cost

Nonreproductive Tissue

(a) Donor screening and testing Minimal Minimal Minimal (b) Recordkeeping and quar- $253 to $1,267 Minimal $30 to $149 antine

Reproductive Tissue, ART Facilities

(a) Donor screening and testing Minimal $1,255 to $2,511 $1,255 to $2,511 (b) Recordkeeping and quar- $128 to $640 $438 to $875 $453 to $950 antine

ART subtotal $128 to $640 $1,693 to $3,386 $1,708 to $3,461

Reproductive Tissue, Semen banks

(a) Donor screening and testing Minimal $94 $94 (b) Recordkeeping and quar- $35 to $176 $12 $16 to $33 antine

Semen subtotal $35 to $176 $106 $110 to $127

Total Tissue Industry $416 to $2,083 $1,799 to $3,492 $1,848 to $3,737 1 All figures in thousands of dollars.

D. Benefits of the Final Rule discussion of benefits resulting from carrying HBsAg) to inseminate several The risks of disease transmission vary this final rule will focus on some key women, one of whom later developed by type of HCT/P. Thus donor areas of risk and the potential benefit of HBV (Ref. 16). screening, testing, and other measures to the new requirements for reproductive HBV-infected mothers can transmit reduce the risks of transmission for tissue recipients. The discussion that the disease to their infants. Forty-two various types of tissue will follows will consider the risks of percent of infants born to women with correspondingly yield a different transmission of disease that will be HBsAg positivity (adjusted for HBeAg relative reduction in disease risk. For reduced through expanded screening status) are at risk of HBV infection, and example, expansion of blood donor and testing among reproductive tissue an additional 30 percent of infants born screening and improved laboratory donors, focusing on two life threatening to HBsAg positive mothers become testing has dramatically reduced the risk chronic diseases that can be transmitted infected between 1 and 5 years of age. of blood transfusion-transmitted through donor tissue: HBV and HCV. Prospective studies of infected infants disease. The risk of HIV infection has The expansion of screening among and young children indicate that 25 dropped from a reported 1 in 100 units reproductive tissue donors is expected percent will die from primary in some U.S. cities to approximately 1 to produce important reductions in the hepatocellular carcinoma (PHC) or in 1,930,000 units. The risk of risk of disease transmission, as cirrhosis as adults. The lifetime medical transmission of HBV has been reduced evidenced by the apparent reductions in cost per case of PHC and cirrhosis is from 1 in 2,100 to 1 in 137,000 units, HIV risk that have already been estimated to be $96,500 (Ref. 17). An and the transmission risk for HCV has achieved through screening. The risk of analysis of the cost-effectiveness of been lowered from 1 in 200 units in the HIV transmission through TDI appears prenatal screening and testing of early 1980s to the current level of 1 in to be very low since screening for HIV mothers, with vaccination for positive 1,000,000 units (Ref. 25). The levels of was recommended by CDC in 1985. A screens, estimates that such screening risk reduction associated with blood total of six documented and two and intervention would prevent 69 donation offer an illustration of the kind possible cases have been reported to the percent of the chronic HBV infections of improvements in safety that might be CDC as of December 1996 (Ref. 9). acquired perinatally or later in life (Ref. achieved through improved and The risks of transmitting HBV and 18). This rate of effectiveness may expanded screening and testing of HCV through reproductive tissue might provide an indication of the potential HCT/P donors. also be substantially reduced as a result benefit of HBV screening required by As described earlier in this document, of donor screening, based on the this final rule. most nonreproductive tissue significance of self-reported risk factors The risk of transmission is estimated establishments are assumed to be as predictors of the findings of blood to be lower for HCV, compared to HBV. already compliant with this final rule screening for HBV and HCV (Refs. 13 The CDC estimates the rate of sexual and, therefore, have already achieved and 14). Compared to HCV, HBV transmission between female to male much of the potential risk reduction. presents a greater risk of sexual partners, and the rate of transmission However, some reduction in transmission. In 1991, heterosexual from mother to child, to each be communicable disease transmission risk activity was reported to account for 41 approximately 5 percent. However, may still be realized under this final percent of all cases of HBV (Ref. 15). there is no vaccine intervention rule for firms that are not currently in HBV transmission has also been available for HCV, although interferon- compliance with the voluntary reported by way of TDI. In 1982, a alpha therapy has been found effective standards established by their respective physician used semen from an in eliminating the virus for at least some professional associations. The unscreened donor (later found to be patients, and drug combinations (e.g.,

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Interferon and Ribavirin) have been and 34,200 to 70,000 women receiving revenues of $11.5 million per year. found to be even more effective. TDI, and 8,800 newborns delivered as a Industry experts also estimate that 19 of Although most patients infected with result of that therapy. the 20 largest semen banks have average HCV are relatively healthy during most E. Small Entity Impacts and Analysis of annual revenues of approximately $2 of their lives, an estimated 30 percent of Alternatives million per year, and 1 of the 20 largest those infected will eventually die of facilities has annual revenues greater liver-related causes; an estimated 8,000 Based on its analysis, FDA found that than $8.5 million. Thus, the vast patients per year (Ref. 17). The average a substantial number of the majority of facilities in each HCT/P cost of care per year for persons with establishments required to comply with industry sector are small entities. liver disease from chronic HCV is this final rule may be small business Nevertheless, as noted in the preceding estimated to range from $24,600 for entities. The Small Business cost analysis, most of these facilities patients without interferon-alpha Administration defines a small business will not be significantly impacted by therapy to $26,500 per year for those in this industry sector (NAICS code this final rule because they are already receiving a 12-month course of therapy. 621991, Blood and Organ Banks) to be meeting the infectious disease screening The latter is estimated to provide an establishment with $8.5 million or and testing and recordkeeping patients with an additional 0.37 quality- less in annual receipts (Ref. 19). The requirements. adjusted life-years (QALYs) (Ref. 18). economic impact analysis presented in section IV.C of this document includes Table 7 of this document presents Screening reproductive tissue donors estimates of the number of entities to estimates of the average annualized cost is expected to significantly reduce the which this final rule will apply. Each per affected small facility expressed as excess morbidity and mortality sector of the tissue banking industry a percentage of average annual associated with HBV and HCV. As noted includes some facilities that would be revenues. In addition to facility previously in this document, there are classified as small business entities. revenues, table 7 presents the estimated an estimated 4,559 to 9,118 oocyte A 1995 study of conventional tissue annual revenue for physician-owned donors and 2,565 semen donors per banks (Ref. 20) reports average annual obstetrician/gynecologist (ob/gyn) year. If these populations experience revenues of $1.23 million per facility, practices, because some operate a small recently reported prevalence rates for which translates into $1.45 million per donor semen bank as an additional HCV (1.8 percent) and HBV (4.9 facility (in 2002 dollars) based on service to patients, but may not percent) (Refs. 13 and 14), then inflation data reported by the Bureau of currently comply with all of the screening for significant risk factors and Labor Statistics. Most nonreproductive requirements of this final rule. The disease markers will result in reduced tissue facilities are assumed to have a average annual practice revenue per HBV and HCV exposures for the patient comparable level of average revenues. self-employed physician in the ob/gyn population at risk. The population at Reproductive tissue industry experts specialty category was reported as risk each year is estimated to include estimate that 65 percent of ART $627,000 in 1998 (Ref. 21). This 3,022 to 9,066 women undergoing IVF facilities have average revenues of translates into $692,000 (in 2002 with donor eggs, and 2,285 newborns approximately $2.5 million per year and dollars) based on inflation data reported delivered as a result of this therapy1; the remaining 35 percent have average by the Bureau of Labor Statistics.

TABLE 7.—ESTIMATED ANNUALIZED COST PER FACILITY AS A PERCENTAGE OF ESTIMATED ANNUAL REVENUE

Number of Facilities That May Be Average Annualized Cost per Fa- Average Annual Revenue per Fa- Annualized Cost as Percentage Classified as Small Entities cility cility of Annual Revenue

Nonreproductive Tissue

792 (all potentially small entities) $38 to $228 $1.45 million 0.003 to 0.016%

Reproductive Tissue, ART Facilities

260 (65% of 400 facilities) $4,270 to $8,694 $2.5 million 0.17 to 0.35%

Reproductive Tissue, Semen banks

19 small commercial banks $1,222 to $1,456 $2.0 million 0.06 to 0.07%

90 small physician practice- $1,222 to $1,456 $692,000 0.18 to 0.21% based banks

As noted in table 7 of this document, current practices actually involve a believes that this approach represents the greatest expected cost will be much lower level of infectious disease an effective means of protecting patient incurred by facilities involved with screening and testing than assumed in safety and public health. The less reproductive tissue. Nevertheless, the this analysis, the impact of the new burdensome alternatives to this final estimated impact on most small requirements would be greater than rule involve fewer requirements for facilities does not appear to be expected. small entities (the vast majority of significant. The expected cost burden Although this final rule will impose facilities in the HCT/P industry), but fail per facility ranges up to 0.35 percent of some costs on small entities involved in to provide fundamental assurances of average annual revenues. However, if the manufacture of HCT/Ps, the agency product safety. For example, reliance on

1 The range of 3,022 to 9,066 patients is based on reported for 1999, varying the assumed number of based on an average success rate of 25.2 percent a reported 9,066 ART cycles using donor oocytes cycles per patient. The number of newborns is (live births per ART cycle).

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published FDA guidance for donor Most notably, the absence of regulation meet the same safety and quality eligibility determination, rather than allows reproductive tissue facilities to standards as large reproductive tissue establishing a regulatory requirement, omit the screening and testing of donors facilities and other HCT/P would provide the agency with no basis that is routinely performed for other manufacturers. The specific for ensuring compliance. Thus, agency types of HCT/Ps, thus exposing patients requirements for donor screening and guidance may have no greater influence undergoing infertility treatment to a testing, the required recordkeeping, and than current voluntary industry disproportionate risk of exposure to the required types of professional skills standards, which have similar several life-threatening infectious are described in the economic analysis provisions, but have failed to persuade disease agents. provided previously. This analysis all facilities to adopt comprehensive To help alleviate the impact on small includes an accounting of all major cost screening and testing practices. FDA’s entities while still protecting public factors, with the exception of the guidance, alone, therefore, would not be health, the agency is not requiring that reduced potential liability currently expected to provide adequate protection manufacturers follow screening and encountered by those reproductive from the public health risks associated testing procedures when an HCT/P is tissue facilities that fail to provide the with infected donor-derived HCT/Ps. used in the same person from whom it level of protection from infectious Another alternative would involve is obtained, or in a sexually intimate disease that is considered a standard of waiving some of the donor screening partner of a reproductive tissue donor. good practice in other sectors of the and testing requirements for small The agency believes the risk of disease HCT/P industry. The relevant Federal facilities. However, as noted previously, transmission from such activities is rules that are related to this final rule the vast majority of facilities in this minimal. Further, in the case of are discussed in section II of this industry are small. Moreover, this reproductive HCT/Ps, the 6-month document. This economic analysis alternative would increase the safety quarantine requirement applies only to provides a summary of the voluntary risks associated with HCT/Ps if small semen from anonymous donors and not industry standards that overlap this facilities that currently screen and test to oocytes and embryos. final Federal standard, but as discussed, donors on a voluntary basis choose to As part of the development process there is no current regulation of HCT/Ps discontinue this practice due to an FDA- for this final rule, FDA conducted an that will duplicate this final rule. granted waiver. For example, waiving a extensive outreach program in an effort Consequently, FDA finds that this final requirement for donor screening would to inform affected small entities and to rule will enhance both public health eliminate an extremely cost-effective request input regarding the potential and public confidence in the safety and first-tier level of safety protection economic impact. Representatives from utility of HCT/Ps, while imposing only because prospective donors deferred or CBER have given presentations on a minimum burden on the affected disqualified at this stage need not HCT/P donor eligibility related issues at industry sectors. undergo further testing. Similarly, the annual conferences of many of the waiving the requirements for blood professional associations representing V. Environmental Impact testing would expose patients, as well as affected entities including ASRM, The agency has determined under 21 tissue facility medical staff, to avoidable AATB, EBAA, and others. The agency CFR 25.30(h) and (j) that this action is risks of infectious disease that may be has also engaged in outreach activities of a type that is categorically excluded undocumented in a patient’s medical directed toward interested consumer from the preparation of an history, or be unknown to, or not groups such as RESOLVE and the environmental assessment because these mentioned by the living donor or American Infertility Association. At actions, as a class, will not result in the cadaveric donor’s family during their request, FDA also held individual production or distribution of any screening. meetings with groups such as ASRM, substance and therefore will not result We also considered waiving the EBAA and AATB to discuss specific in the production of any substance into requirement for semen quarantine and concerns regarding the impact of the the environment. anonymous donor retesting to detect donor eligibility rule. Some of these VI. Federalism Assessment infections during the window period, presentation materials and meeting when a donor’s infection may not yet be minutes are available on the CBER Web Executive Order 13132, dated August detectable by blood tests. However, this page at http://www.fda.gov/cber/tissue/ 4, 1999, establishes the procedure that alternative would expose recipients and min.htm. Additional materials Federal agencies must follow when the public to risks from infectious associated with the donor eligibility rule formulating and implementing policies disease agents that cannot be are available on the Internet at http:// that have federalism implications. The immediately detected after exposure www.fda.gov/cber/tissue/docs.htm. Executive order described nine through most currently available blood Finally, in the proposed rule, FDA fundamental federalism principles, tests (e.g., tests for HIV and HCV). requested industry comment regarding stressing the importance and Recordkeeping for donor screening and the assumptions upon which this sovereignty of State and local testing is also critical to protecting analysis of economic impacts was governments, and the contributions of product recipient and public safety. based. In particular, we requested individual States and communities to Adequate documentation and record detailed industry comment regarding the development of enlightened public retention ensure that HCT/Ps can be our estimates of the number and type of policy. Principles of federalism are tracked to their source in the event of entities affected, current donor inherent in the very structure of the infection or other adverse reactions that screening and testing practices, and Constitution and formalized in and result from donor tissue characteristics. expected compliance costs. To the protected by the Tenth Amendment. In summary, the agency believes that extent possible and appropriate, we Regulations have federalism abridged requirements for donor have incorporated these comments and implications whenever they have a screening and testing, based on our responses into the preamble and substantial direct effect on the States, on voluntary standards or facility size analysis of economic impacts of this the relationship between the National criteria, would provide inadequate final rule. Government and the States, or on the protection against the risk of infectious Under this final rule, small entities distribution of power and disease transmission through HCT/Ps. involved with reproductive tissue must responsibilities among the various

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levels of government. Whenever a in the rulemaking. We specifically noted donation and are thus more limited in regulation has this result, the agency that we would appreciate comment on their requirements than this final rule, must prepare a federalism assessment. the following topics: (1) The need for which requires testing and screening for The Executive order directs Federal uniform national standards for donor additional communicable disease agents agencies to: suitability determinations to prevent and diseases and does not apply only to 1. Encourage States to develop their communicable disease transmission semen (see e.g., Ind. Code 16–41–14–7; own policies to achieve program through human cellular and tissue- Md. Code Ann., Health-Gen. 18–334(e); objectives and to work with appropriate based products, (2) the scope of such 12 Va. Admin. Code 5–90–240, 5–90– officials in other States; proposed national requirements and 250). 2. Where possible, defer to the States their impact upon State laws, (3) FDA’s Directed donation of reproductive to establish standards; proposal not to preempt State laws on cells or tissue is another area of 3. In determining whether to establish legislative consent for cornea potential differences between State laws uniform national standards, consult transplants, and (4) any issues raised by and regulations and this final rule, with appropriate State and local this proposed rule possibly affecting which permits the use of fresh semen officials as to the need for national State laws and authorities. from directed reproductive donors standards and any alternatives that We received only one comment from without retesting of the donor 6 months would limit the scope of national a State official. This comment addressed after donation. The final rule is standards or otherwise preserve State abbreviated screening, which is consistent with the California Health prerogatives and authority; and discussed in comment 50 of this and Safety Code with respect to directed 4. Where national standards are document. The comment also asked that reproductive donors, but may be required by Federal statutes, consult we require deferral records for donors inconsistent with Indiana law, which with appropriate State and local determined to be unsuitable. Reviewing appears to require quarantine of all officials in developing those standards. deferral records before each donation semen donations pending retesting 6 This final rule establishes donor- would only be necessary in the case of months after donation (see Cal. Health eligibility and other related living donors who could donate more & Safety Code § 1644.5(c); Ind. Code 16– requirements for HCT/P establishments. than once, such as semen donors. As 41–14–7). We note that Indiana’s more In issuing this rule, we rely on the part of the screening process in stringent statute may coexist with this authority of section 361 of the PHS Act § 1271.75, establishments determining final rule. (42 U.S.C. 264), under which we may donor eligibility are required to review To the extent that additional make and enforce regulations necessary the donor’s relevant medical records, differences may exist between State to prevent the introduction, which would identify the donor as an statutes and regulations and this final transmission, or spread of unsuitable donor. Therefore, we believe rule with respect to reproductive cells communicable diseases between the that requiring deferral records would be and tissues and other areas where there States or from foreign countries into the burdensome. We received no comments has not previously been Federal States. (We also rely on our authority to from State officials on federalism issues. regulation, we recognize that there may issue CGMP regulations to amend the To the extent that these final be a federalism impact. However, to the existing CGMP regulations for drugs in regulations cover areas that are already extent there is such an impact, it is a 21 CFR parts 210 and 211, which subject to Federal regulation, rather than necessary part of our effort to institute include CGMP requirements, to regulation by the States, we believe the uniform screening and testing incorporate the testing and screening federalism implications of this final rule requirements, to prevent the provisions of part 1271 subpart C for are minimal or nonexistent, because introduction, transmission, or spread of HCT/Ps regulated as drugs, and/or national standards are already in place. communicable disease. biological products (see e.g., 21 U.S.C. Since 1993, there have been Federal In the proposed rule, we identified a 351(a)(2)(B)). regulations on human tissue intended particular area where we believed The donor-eligibility proposed rule for transplantation. These regulations, concerns about Federal preemption of was published after Executive Order contained in part 1270 (21 CFR part State laws could arise: Legislative 13132 was issued, but before it went 1270), govern donor screening, testing, consent, or the recovery of corneas in into effect. Nevertheless, we made a and other related issues. The regulations accordance with State laws that allow considerable effort after the publication now being made final replace the the medical examiner or coroner to of the proposed rule to ensure that regulations in part 1270. Although the procure corneal tissue without the States had the opportunity to review the new donor-eligibility regulations are consent of the donor’s next of kin (64 FR proposed rule and submit comments on more extensive in their requirements, 52696 at 52703). The proposed rule did it. We directed a mailing of the and apply to a greater range of HCT/Ps, not contain an exception from the donor proposed rule to State health officials to many of the establishments that will be medical history interview for corneas encourage their comments on the required to comply with this final rule procured under legislative consent. We proposed rule. We also sent copies of have been subject to the regulations in recognized that, when corneal tissue is the rule to each State attorney general. part 1270 or to drug or device procured without the consent of the To provide additional time to the States regulations. donor’s next of kin, a donor medical to comment on the proposed rule, we However, we acknowledge that this history interview with the donor’s next reopened the comment period. final rule will have an effect in those of kin does not necessarily occur. We In the Federal Register document areas where there has been no uniform noted, however, that the proposed reopening the comment period, we Federal regulation. For example, this definition of donor medical history noted that we had learned that several rule sets out testing and screening interview would permit the interview to States had enacted legislation and requirements for donors of reproductive be conducted with an individual issued regulations governing tissue cells and tissue, an area where there is knowledgeable about the donor’s donor suitability (65 FR 20774, April 18, a range of State regulation. Some of the medical history and relevant social 2000). Because those laws might conflict State statutes and regulations that have behavior and would not require an with provisions in the proposed rule, come to our attention focus on the risk interview with the next of kin. For that we invited State officials to participate of HIV transmission through semen reason, we considered that the proposed

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rule and State laws on legislative VII. The Paperwork Reduction Act of establishments must retain the records consent may coexist, and we stated that 1995 pertaining to HCT/Ps at least 10 years we did not intend at that time to This final rule contains information after the date of administration, preempt those laws. We requested that collection provisions that have been distribution, disposition, or expiration, affected parties submit specific, detailed reviewed by OMB under the Paperwork whichever is latest (§ 1271.55(d)(4)). When a product is shipped in comments on any potential conflicts Reduction Act of 1995 (the PRA) (44 quarantine, before completion of that might make it impossible to comply U.S.C. 3501–3520). (OMB control screening and testing, the HCT/P with both this regulation and State laws number 0910–0543 expires May 31, establishment must provide the donor on legislative consent. 2007.) A description of these provisions identification, a statement that the Many comments from industry is shown as follows with an estimate of donor-eligibility determination is not opposed our proposal to require a donor the annual reporting and recordkeeping completed and that the product is not to medical history interview for all HCT/P burden. Included in the estimate is the be used until eligibility determination is donors, including donors of corneas time for reviewing the instructions, recovered under legislative consent, and completed (§ 1271.60(c)). With the use searching existing data sources, of a product from an ineligible or some disputed our assertion that the gathering and maintaining the data regulation and State laws could coexist. incompletely tested donor the following needed, and completing and reviewing information must accompany the We address those comments in each collection of information. comments 45 and 46 of this document. HCT/P: The results of any completed Title: Eligibility Determination for donor screening and testing, and a list After considering the comments, we Donors of Human Cells, Tissues, and continue to consider the donor medical of any required screening and testing Cellular and Tissue-Based Products. not completed. When using an HCT/P history interview necessary for all Description: Under the authority of from an ineligible donor, documentation donors to prevent the introduction, section 361 of the PHS Act, FDA is by the HCT/P establishment is required transmission, or spread of requiring HCT/P establishments to communicable diseases, and decline to showing that the recipient’s physician screen and test the donors of cells and received notification of the screening make an exception for corneas donated tissue used in those products for risk under legislative consent. and testing results (§§ 1271.60(d)(3) and factors for and clinical evidence of 1271.65(b)(3)). Although we believe the final rule relevant communicable disease agents An HCT/P establishment also is provides sufficient flexibility to allow and diseases. FDA is requiring that required to establish and maintain for the continued recovery of corneas donor-eligibility determination procedures for all steps that are under legislative consent, we recognize regulations apply to all establishments performed in determining eligibility that there may be some difficulty in described in § 1271.1(b). The (§ 1271.47(a)), including the use of a communicating with the primary documented determination of whether a product from a donor testing positive for treating physician without obtaining donor is eligible or ineligible is made by CMV (§ 1271.85(b)(2)). The HCT/P permission from the deceased and/or a responsible person and is based on the establishment must record any the family of the deceased, and that, results of required donor screening, departure from the procedures therefore, this final rule may have a which includes a donor medical history (§ 1271.47(d)). negative effect on the ability of medical interview (§ 1271.3(n)), and testing These provisions are intended as examiners and coroners to recover (§ 1271.50(a)). HCT/P establishments are safeguards to prevent the transmission corneas under State legislative consent permitted to ship an HCT/P only if it is of communicable diseases that may laws. However, given the potential for accompanied by documentation of the occur with the use of cells and tissue corneas to transmit communicable donor-eligibility determination from infected donors. Through this disease, including TSE, we have (§ 1271.55(a)). This requirement applies action FDA will improve its ability to concluded that making an exception to an HCT/P from a donor determined protect public health by controlling the from the requirement for a donor to be eligible as well as to a product spread of communicable diseases. medical history interview in the case of from a donor who is determined to be Description of Respondents: HCT/P corneas obtained under legislative ineligible and made available for use establishments. consent is not justified. under certain provisions. The As required by section 3506(c)(2)(B) This final rule represents the exercise accompanying documentation must of the PRA, we provided an opportunity of a core Federal function: ‘‘* * * contain a summary of records used to for public comment on the information prevent[ing] the introduction, determine donor eligibility, and a collection requirements of the proposed transmission, or spread of statement whether, based on the results rule (64 FR at 52715). Under the PRA, communicable diseases from foreign of the screening and testing of the OMB reserved approval of the countries into the States or possessions, donor, the donor is determined to be information collection burden in the or from one State or possession into any eligible or ineligible. proposed rule stating that they will other State or possession’’ (section Records used in determining the make an assessment in light of public 361(a) of the PHS Act; 42 U.S.C. 264). eligibility of a donor, i.e., results and comments received on the proposed To prevent the transmission of interpretations of screening and testing, rule. One comment on the information communicable disease in the United the donor eligibility determination, the collection burden was submitted to the States, including the interstate name and address of the testing docket. transmission of disease, uniform laboratory or laboratories, and the name (Comment 99) One comment states national standards on donor testing and of the responsible person who made the that, although FDA invites comments on screening are necessary. No State determination and the date, must be whether the proposed collection of official commented otherwise. For these maintained (§ 1271.55(d)(1)). If any information is necessary for the proper reasons, and for the reasons discussed information on the donor is not in performance of FDA’s functions, previously in this document, this rule is English, the HCT/P establishment must including whether the information will consistent with the federalism retain the original record and the have practical utility, there are no data principles expressed in Executive Order statement of authenticity from the supporting any practical utility of the 13132. translator (§ 1271.55(d)(2)). HCT/P information collection, and that the

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estimated burden of the proposed user of the product that the donor of the information collection, but for collection of information is extremely product was adequately and demonstrating how the burden is low compared to the actual cost. appropriately screened and tested for calculated. Although the comment (Response) The reporting and evidence of specific disease agents. In states that the calculated burden is low, recordkeeping information collection addition, this information allows FDA the comment did not offer additional burdens are necessary to help ensure to monitor the compliance of HCT/P data in support of the comment. that the objective of the regulations (i.e., establishments with the regulations. to prevent the transmission of The data described in section V of the We estimate the burden of this communicable disease), is fulfilled. This proposed rule is not for the purpose of collection of information as follows: provides information to the consignee or supporting the practical utility of the

TABLE 8.—ESTIMATED ANNUAL REPORTING BURDEN1

Annual Fre- 21 CFR Section No. of Re- quency per Re- Total Annual Re- Hours per Response Total Hours spondents sponse sponses

1271.3(n) 1,302 60 78,136 1.0 78,136.0

1271.55(a) 1,235 787 972,417 0.5 486,208.5

1271.60(c) 1,069 208 222,417 0.5 111,208.5

Total 675,553.0 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 9.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

Annual Fre- 21 CFR Section No. of Record- quency per Total Annual Hours per Total Hours keepers Record-keeping Records Record

One-Time Burden (Creation of SOPs) 1271.47(a) and 1271.85(b)(2) 510 5 2,550 16 40,800

One-time Burden (Review of existing SOPs for compliance) 792 5 3,960 8 31,680

SOP Update 1,302 5 6,510 2 13,020

1271.47(d) 1,102 1 1,102 1 1,102

1271.55(d)(4) 195 1 195 120 23,400

1271.50(a) 510 9 4,640 5 23,200

1271.55(d)(1) 329 162.85 53,579 1 53,579

1271.55(d)(2) 1,302 1 1,302 1 1,302

1271.60(d)(3) and 1271.65(b)(3) 1,302 1 1,302 2 2,604

Total 190,687 1There are no capital costs or operating and maintenance costs associated with this collection of information.

In the proposed rule, we We also have adjusted our estimates current voluntary standards of a number underestimated the number of for the number of HCT/Ps annually of industry organizations, such as, respondents. Based on updated produced based on updated information AATB, EBAA, AABB, FACT, NMDP, information from FDA’s registration from industry provided to us at the time and the College of American data and trade organizations, we have we prepared the final rule. Pathologists, and the guidelines revised our estimate of establishments Our burden estimates for the annual provided by ASRM. In those cases to approximately 1,302 (i.e., frequency per response and average where a voluntary industry standard approximately 166 conventional tissue hours per response are based on appears to be equivalent to a regulation, establishments, 134 eye tissue institutional experience with we assumed that any reporting or establishments, 425 peripheral and cord comparable reporting and recordkeeping recordkeeping burden is a customary blood stem/progenitor cell provisions for biological products. and usual business practice of HCT/P establishments, 510 reproductive tissue These burden estimates have not establishments who are members of establishments, and 67 manufacturers of changed. Also, we are adding burden those organizations and no additional products regulated under the act and estimates for §§ 1271.3(n) and 1271.47. burden is calculated here. section 351 of the PHS Act). In estimating the burden, we Under § 1271.3(n), approximately compared the regulations with the 1,302 establishments (166 conventional

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tissue establishments, 134 eye tissue Once the SOPs are created, annual constitute collection of information establishments, 425 peripheral and cord SOP maintenance of existing SOPs is because information required to be on blood stem/progenitor cell estimated to involve 2 hours annually the labeling is originally supplied by establishments, 510 reproductive tissue per SOP for all HCT/P establishments. FDA to the establishments for the establishments, and 67 manufacturers of Annual total hours for maintaining the purpose of disclosure to the public to products regulated under the act and SOPs is estimated at 13,020. help ensure a safe supply of HCT/Ps and section 351 of the PHS Act) are required Under § 1271.47(d), an estimated protect public health. to have a documented medical history 1,102 HCT/P establishments would take The reporting of screening and testing interview about the donor’s medical approximately 1 hour to annually results to the physician in history and relevant social behavior as document one departure from an SOP. § 1271.60(d)(4) does not constitute part of the donor’s relevant medical Under § 1271.55(d)(4), we estimate additional reporting burden because it is records for each of the estimated 78,136 that 195 HCT/P establishments not calculated under the requirement for donors (approximately 20,000 currently following existing industry § 1271.55(a). conventional tissue donors, 47,796 eye standards will expend 120 hours (10 The information collection tissue donors, 5,700 peripheral and cord hours per month) annually to maintain requirements of the final rule have been blood stem/progenitor cell donors, and records for 10 years. submitted to OMB for review. Before the 4,640 reproductive cell and tissue Under § 1271.50(a), documentation of effective date of this final rule, we will donors). We estimate that the time to donor eligibility is required for the first publish a notice in the Federal Register conduct the interview with the donor, if time for approximately 510 reproductive announcing OMB’s decision to approve, living, or with an individual able to tissue establishments. Out of a total of modify, or disapprove the information provide the information sought in the 1,302 establishments of HCT/Ps, there collection provisions in this final rule. interview, is 1 hour. would be no added burden for An agency may not conduct or sponsor, approximately 792 other establishments Under § 1271.55(a), 972,417 HCT/Ps and a person is not required to respond who document donor eligibility as usual (approximately 750,000 conventional to, a collection of information unless it and customary business practice under displays a currently valid OMB control tissues, 94,186 eye tissues, 6,031 the trade organization standards. FDA number. hematopoetic stem/progenitor cells, and estimates that § 1271.50(a) would 122,200 reproductive cells and tissues) impose a new collection of information VIII. References are distributed per year. The agency requirement on 510 establishments of The following references have been estimates that, for each HCT/P, 1,235 reproductive HCT/Ps, each of which placed on display in the Division of establishments (1,302–67 would document the eligibility of an Dockets Management (see ADDRESSES) establishments with approved estimated 9 donors per year, or 4,640 and may be seen by interested persons applications) will expend donors, expending approximately 5 between 9 a.m. and 4 p.m., Monday approximately 0.5 hours to prepare the hours per document. through Friday. (FDA has verified the summary of records. Conventional and Approximately 329 HCT/P Web site addresses, but we are not eye tissue establishment are currently establishments would maintain responsible for subsequent changes to required to provide a summary of screening and testing records under the Web site after this document records under § 1270.33(d), which § 1271.55(d)(1) for an estimated 53,579 publishes in the Federal Register.) § 1271.55 replaces. donors, which would take 1. Dodd, R. Y., E. P. Notari, and S. L. Under § 1271.60(c), a record approximately one hour per donor. Stramer, ‘‘Current Prevalence and Incidence consisting of donor identification and a For documents originally not in of Infectious Disease Markers and Estimated statement that the donor-eligibility English, approximately 1,302 HCT/P Window-Period Risk in the American Red determination is not completed and that Cross Blood Donor Population,’’ Transfusion, establishments would maintain a record vol. 42(8), pp. 966–72, August 2002. the HCT/P is not to be used until the of translation with an authenticity 2. Stramer, S. L., ‘‘US NAT Yield: Where determination is completed, must statement by the translator and the Are We After Two Years?’’ Transfusion accompany each HCT/P shipped under original documents. We estimate that it Medicine, vol. 12, issue 4, pp. 243–253, 2002. quarantine. We estimate that would take one hour for each 3. Based on information presented on viral approximately 1,069 establishments establishment to maintain one such dynamics in early seroconversion by Dr. M. may ship an estimated 222,417 HCT/P document annually. P. Busch at the FDA BPAC meeting December under quarantine and that the Under §§ 1271.60(d)(3) and 2002. preparation of the record would take 4. CDC, 1999 ART Success Rates: National 1271.65(b)(3), when an HCT/P that is Summary and Fertility Clinic Reports (http:/ approximately 0.5 hours. ineligible or not fully screened or tested /www.cdc.gov/nccdphp/drh/art.htm). We assume that approximately 510 is used, approximately 1,302 5. Published fee for blood testing, reproductive HCT/P establishments establishments of HCT/Ps are required including Hepatitis B and Hepatitis C, HIV 1– would create 5 SOPs under to document the reason for using the 2, HTLV–1, and syphilis, reported for direct §§ 1271.47(a) and 1271.85(b)(2) for a product, and notice of the results of donor screening by The Sperm Bank of total of 2,550 records, and we estimate testing and screening to the physician. California (http:// that it would take 16 hours per new SOP www.thespermbankofca.org/services/ The agency estimates that such fees.htm). for a total of 40,800 hours as a 1-time documentation would occur 6. The Sperm Bank of California (http:// burden. We estimate that up to 5 SOPs approximately once annually per www.thespermbankofca.org/services/ would already exist for 792 HCT/P establishments and that each fees.htm). establishments as a result of complying establishment would expend 7. Margolis, H. S., P. J. Coleman, R. E. with current applicable regulations or approximately 2.0 hours to create such Brown, et al., ‘‘Prevention of Hepatitis B following industry organizational document. Virus Transmission by Immunization: An standards, and that it would take each Under section 1320.3(c)(2) of the PRA, Economic Analysis of Current Recommendations,’’ Journal of the American establishment approximately 8 hours the labeling requirements in proposed Medical Association, vol. 274, no. 15, pp. per SOP to complete the review for §§ 1271.60(d)(2), 1271.65(b)(2), 1201–1208, 1995. compliance with the requirements for a 1271.65(c)(1) and (c)(2), 1271.80(b)(1), 8. CDC, 1995 ART Success Rates: National total of 31,600 hours as a 1-time burden. (b)(2), and (b)(3) and 1271.90(b), do not Summary and Fertility Clinic Reports

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estimates that 11 percent of the ART therapy Employee Compensation, Technical practice procedures set forth in part performed included ICSI. Occupations (http://www.bls.gov/ncs/ect/sp/ 1271 subparts C and D of this chapter, 9. Wortley, P. M., T. A. Hammett, and P. ecechist.pdf), 1994–2001. in addition to the regulations in this L. Fleming, ‘‘Donor Insemination and Human 25. America’s Blood Centers, ‘‘Infectious part and in parts 211 through 226 of this Immunodeficiency Virus Transmission,’’ Risks of Blood Transfusion,’’ Blood Bulletin, chapter. Failure to comply with any Obstetrics & Gynecology, vol. 91, no. 4, pp. vol. 4, no. 2, December 2001. 515–518, 1998. 26. Van Voorhis, B. J., A. E. T. Sparks, B. applicable regulation set forth in this 10. Sidhu, R. S., R. K. Sharma, S. Kachoria, D. Allen, et al. ‘‘Cost-Effectiveness of part, in parts 211 through 226 of this et al., ‘‘Reasons for Rejecting Potential Infertility Treatments: A Cohort Study,’’ chapter, in part 1271 subpart C of this Donors From a Sperm Bank Program,’’ Fertility and Sterility, vol. 67, no. 5, May chapter, or in part 1271 subpart D of this Journal of Assisted Reproduction and 1997, pp. 830–836. chapter with respect to the manufacture, Genetics, vol. 14, no. 6, pp. 354–360, 1997. processing, packing or holding of a List of Subjects 11. The American Fertility Society, drug, renders an HCT/P adulterated ‘‘Guidelines for Therapeutic Donor 21 CFR Part 210 under section 501(a)(2)(B) of the act. Insemination: Sperm,’’ Fertility and Sterility, vol. 62, no. 5, pp. 101s–104s, November Drugs, Packaging and containers. Such HCT/P, as well as the person who 1994. is responsible for the failure to comply, 12. Government Accounting Office, 21 CFR Part 211 is subject to regulatory action. I ‘‘Human Tissue Banks: FDA Taking Steps to Drugs, Labeling, Laboratories, 3. Section 210.2 is revised to read as Improve Safety, but Some Concerns Remain,’’ Packaging and containers, Prescription follows: GAO/HEHS–98–25. drugs, Reporting and recordkeeping 13. Alter, M. J., D. Kruszon-Moran, O. V. § 210.2 Applicability of current good Nainan, et al., ‘‘The Prevalence of Hepatitis requirements, Warehouses. manufacturing practice regulations. C Virus Infection in the United States, 1988 21 CFR Part 820 (a) The regulations in this part and in Through 1994,’’ New England Journal of parts 211 through 226 of this chapter as Medicine, vol. 341(8), pp. 556–562, 1999. Medical devices, Reporting and they may pertain to a drug; in parts 600 14. McQuillan, G. M., P. J. Coleman, D. recordkeeping requirements. through 680 of this chapter as they may Kruszon-Moran, et al., ‘‘Prevalence of 21 CFR Part 1271 pertain to a biological product for Hepatitis B Virus Infection in the United human use; and in part 1271 of this States: The National Health and Nutrition Communicable diseases, HIV/AIDS, chapter as they are applicable to a Examination Surveys, 1976 Through 1994,’’ Human cells, tissues, and cellular and American Journal of Public Health, vol. human cell, tissue, or cellular or tissue- tissue-based products, Reporting and based product (HCT/P) that is a drug 89(1), pp. 14–8, 1999. recordkeeping requirements. 15. Kane, M., ‘‘Epidemiology of Hepatitis B (subject to review under an application I Infection in North America,’’ Vaccine, vol. Therefore, under the Federal Food, submitted under section 505 of the act 13, suppl. 1, pp. s16–s17, 1995. Drug, and Cosmetic Act and the Public or under a biological product license 16. Guinan, M. E., ‘‘Artificial Insemination Health Service Act, and under authority application under section 351 of the by Donor: Safety and Secrecy,’’ Journal of the delegated to the Commissioner of Food Public Health Service Act); shall be American Medical Association, vol. 173, no. and Drugs, chapter I of title 21 of the considered to supplement, not 11, pp. 890–891, March 1995. Code of Federal Regulations is amended supersede, each other, unless the 17. U.S. Centers for Disease Control and as follows: Prevention, 1997. regulations explicitly provide otherwise. In the event of a conflict between 18. Kim, W. R., J. J. Poterucha, J. E. PART 210—CURRENT GOOD applicable regulations in this part and Hermans, T. M. Therneau, E. R. Dickson, R. MANUFACTURING PRACTICE IN in other parts of this chapter, the W. Evans, and J. B. Gross, Jr., ‘‘Cost- MANUFACTURING, PROCESSING, effectiveness of 6 and 12 Months of regulation specifically applicable to the PACKING, OR HOLDING OF DRUGS; Interferon-a’’ Therapy for Chronic Hepatitis drug product in question shall GENERAL C,’’ Annals of Internal Medicine, vol. 127, no. supersede the more general. 10, November 1997. I 1. The authority citation for 21 CFR (b) If a person engages in only some 19. U.S. Small Business Administration, part 210 is revised to read as follows: operations subject to the regulations in Office of Size Standards, Table of Size this part, in parts 211 through 226 of Standards, Sector 62—Health Care and Social Authority: 21 U.S.C. 321, 351, 352, 355, Assistance, February 22, 2002. 360b, 371, 374; 42 U.S.C. 216, 262, 263a, 264. this chapter, in parts 600 through 680 of 20. Prottas, J., ‘‘A Study of the Tissue I 2. Section 210.1 is amended by adding this chapter, and in part 1271 of this Procurement and Distribution System of the paragraph (c) to read as follows: chapter, and not in others, that person United States,’’ Brandeis University, FDA/ need only comply with those HRSA contract no. 240–090–0048, October § 210.1 Status of current good regulations applicable to the operations 1995. manufacturing practice regulations. in which he or she is engaged. 21. American Medical Association, Center * * * * * for Health Policy Research, Physician (c) Owners and operators of PART 211—CURRENT GOOD Socioeconomic Statistics, 2000–2002 ed., establishments engaged in the recovery, MANUFACTURING PRACTICE FOR table 41, p. 83. FINISHED PHARMACEUTICALS 22. Based on information provided by Dr. donor screening, testing (including David Hoffman, NW Center for Infertility and donor testing), processing, storage, I 4. The authority citation for 21 CFR Reproductive Endocrinology, August 2001. labeling, packaging, or distribution of part 211 is revised to read as follows: 23. U.S. Department of Labor, Bureau of human cells, tissues, and cellular and Labor Statistics, Table 20, Private Industry, Authority: 21 U.S.C. 321, 351, 352, 355, tissue-based products (HCT/Ps), as 360b, 371, 374; 42 U.S.C. 216, 262, 263a, 264. Health Services by Occupational Group: defined in § 1271.3(d) of this chapter, I Employer Costs per Hour Worked for 5. Section 211.1 is amended by that are drugs (subject to review under revising paragraph (b) to read as follows: Employee Compensation, Professional an application submitted under section Specialty Occupations (http://www.bls.gov/ § 211.1 Scope. ncs/ect/sp/ecechist.pdf), 1994–2001. 505 of the act or under a biological 24. U.S. Department of Labor, Bureau of product license application under * * * * * Labor Statistics, Table 20, Private Industry, section 351 of the Public Health Service (b) The current good manufacturing Health Services by Occupational Group: Act), are subject to the donor-eligibility practice regulations in this chapter as Employer Costs per Hour Worked for and applicable current good tissue they pertain to drug products; in parts

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600 through 680 of this chapter, as they regulations in this part and in other by the recipient before donation. The pertain to drugs that are also biological parts of this chapter, the regulations term directed reproductive donor does products for human use; and in part specifically applicable to the device in not include a sexually intimate partner 1271 of this chapter, as they are question shall supersede any other under § 1271.90. applicable to drugs that are also human generally applicable requirements. (m) Donor means a person, living or cells, tissues, and cellular and tissue- * * * * * dead, who is the source of cells or tissue based products (HCT/Ps) and that are for an HCT/P. drugs (subject to review under an PART 1271—HUMAN CELLS, TISSUES, (n) Donor medical history interview application submitted under section 505 AND CELLULAR AND TISSUE-BASED means a documented dialog about the of the act or under a biological product PRODUCTS donor’s medical history and relevant license application under section 351 of social behavior, including activities, I the Public Health Service Act); 8. The authority citation for 21 CFR behaviors, and descriptions considered supplement and do not supersede the part 1271 is revised to read as follows: to increase the donor’s relevant regulations in this part unless the Authority: 42 U.S.C. 216, 243, 263a, 264, communicable disease risk: regulations explicitly provide otherwise. 271. (1) With the donor, if the donor is living and able to participate in the In the event of a conflict between § 1271.1 [Amended] applicable regulations in this part and interview, or I in other parts of this chapter, or in parts 9. Section 1271.1 What are the purpose (2) If not, with an individual or 600 through 680 of this chapter, or in and scope for this part? is amended by individuals able to provide the part 1271 of this chapter, the regulation removing the phrase ‘‘donor-suitability’’ information sought in the interview specifically applicable to the drug and adding in its place the phrase (e.g., the donor’s next-of-kin, the nearest product in question shall supersede the ‘‘donor-eligibility’’ wherever it appears. available relative, a member of the I more general. 10. Section 1271.3 is amended by donor’s household, an individual with adding paragraphs (h) through (x) to read * * * * * an affinity relationship, and/or the as follows: primary treating physician). PART 820—QUALITY SYSTEM § 1271.3 How does FDA define important (o) Physical assessment of a cadaveric REGULATION terms in this part? donor means a limited autopsy or recent antemortem or postmortem physical I * * * * * 6. The authority citation for 21 CFR examination of the donor to assess for (h) Biohazard legend appears on the part 820 is revised to read as follows: signs of a relevant communicable label as follows and is used to mark Authority: 21 U.S.C. 351, 352, 360, 360c, disease and for signs suggestive of any HCT/Ps that present a known or 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, risk factor for a relevant communicable suspected relevant communicable 381, 383; 42 U.S.C. 216, 262, 263a, 264. disease. I disease risk. 7. Section 820.1 is amended by adding (p) Plasma dilution means a decrease two sentences to the end of paragraph in the concentration of the donor’s (a)(1), and by revising paragraph (b) to plasma proteins and circulating antigens read as follows: or antibodies resulting from the § 820.1 Scope. transfusion of blood or blood (a) Applicability. (1) * * * components and/or infusion of fluids. Manufacturers of human cells, tissues, (q) Quarantine means the storage or and cellular and tissue-based products identification of an HCT/P, to prevent (HCT/Ps), as defined in § 1271.3(d) of improper release, in a physically this chapter, that are medical devices separate area clearly identified for such (subject to premarket review or use, or through use of other procedures, notification, or exempt from such as automated designation. (i) Blood component means a product (r) Relevant communicable disease notification, under an application containing a part of human blood agent or disease means: submitted under the device provisions separated by physical or mechanical (1)(i) For all human cells and tissues, of the act or under a biological product means. a communicable disease or disease license application under section 351 of (j) Colloid means: agent listed as follows: the Public Health Service Act) are (1) A protein or polysaccharide (A) Human immunodeficiency virus, subject to this part and are also subject solution, such as albumin, dextran, or types 1 and 2; to the donor-eligibility procedures set hetastarch, that can be used to increase (B) Hepatitis B virus; forth in part 1271 subpart C of this or maintain osmotic (oncotic) pressure (C) Hepatitis C virus; chapter and applicable current good in the intravascular compartment; or (D) Human transmissible spongiform tissue practice procedures in part 1271 (2) Blood components such as plasma encephalopathy, including Creutzfeldt- subpart D of this chapter. In the event and platelets. Jakob disease; and of a conflict between applicable (k) Crystalloid means an isotonic salt (E) Treponema pallidum. regulations in part 1271 and in other and/or glucose solution used for (ii) For viable, leukocyte-rich cells parts of this chapter, the regulation electrolyte replacement or to increase and tissues, a cell-associated disease specifically applicable to the device in intravascular volume, such as saline agent or disease listed as follows: question shall supersede the more solution, Ringer’s lactate solution, or 5 (A) Human T-lymphotropic virus, general. percent dextrose in water. type I; and * * * * * (l) Directed reproductive donor means (B) Human T-lymphotropic virus, (b) The quality system regulation in a donor of reproductive cells or tissue type II. this part supplements regulations in (including semen, oocytes, and embryos (iii) For reproductive cells or tissues, other parts of this chapter except where to which the donor contributed the a disease agent or disease of the explicitly stated otherwise. In the event spermatozoa or oocyte) to a specific genitourinary tract listed as follows: of a conflict between applicable recipient, and who knows and is known (A) Chlamydia trachomatis; and

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(B) Neisseria gonorrhea. (w) PHS Act means the Public Health any function described in this subpart, (2) A disease agent or disease not Service Act. you must comply with the requirements listed in paragraph (r)(1) of this section: (x) FDA means the Food and Drug contained in this subpart that are (i) For which there may be a risk of Administration. applicable to that function. transmission by an HCT/P, either to the I 11. Part 1271 is amended by adding recipient of the HCT/P or to those subpart C, consisting of §§ 1271.45 § 1271.47 What procedures must I people who may handle or otherwise through 1271.90, to read as follows: establish and maintain? come in contact with it, such as medical (a) General. You must establish and personnel, because the disease agent or Subpart C—Donor Eligibility maintain procedures for all steps that disease: you perform in testing, screening, (A) Is potentially transmissible by an Sec. determining donor eligibility, and HCT/P and 1271.45 What requirements does this complying with all other requirements (B) Either of the following applies: subpart contain? of this subpart. Establish and maintain (1) The disease agent or disease has 1271.47 What procedures must I means define, document (in writing or sufficient incidence and/or prevalence establish and maintain? electronically), and implement; then to affect the potential donor population, 1271.50 How do I determine whether follow, review, and as needed, revise on or a donor is eligible? an ongoing basis. You must design these (2) The disease agent or disease may 1271.55 What records must procedures to ensure compliance with have been released accidentally or accompany an HCT/P after the donor- the requirements of this subpart. intentionally in a manner that could eligibility determination is complete; (b) Review and approval. Before place potential donors at risk of and what records must I maintain? implementation, a responsible person infection; 1271.60 What quarantine and other must review and approve all (ii) That could be fatal or life- requirements apply before the donor- procedures. threatening, could result in permanent eligibility determination is complete? (c) Availability. Procedures must be impairment of a body function or 1271.65 How do I store an HCT/P readily available to the personnel in the permanent damage to body structure, or from a donor determined to be area where the operations to which they could necessitate medical or surgical ineligible, and what uses of the HCT/P relate are performed, or in a nearby area intervention to preclude permanent are not prohibited? if such availability is impractical. impairment of body function or 1271.75 How do I screen a donor? (d) Departures from procedures. You 1271.80 What are the general permanent damage to a body structure; must record and justify any departure and requirements for donor testing? 1271.85 What donor testing is from a procedure relevant to preventing (iii) For which appropriate screening risks of communicable disease measures have been developed and/or required for different types of cells and transmission at the time of its an appropriate screening test for donor tissues? occurrence. You must not make specimens has been licensed, approved, 1271.90 Are there exceptions from the available for distribution any HCT/P or cleared for such use by FDA and is requirement of determining donor from a donor whose eligibility is available. eligibility, and what labeling (s) Relevant medical records means a requirements apply? determined under such a departure collection of documents that includes a unless a responsible person has current donor medical history Subpart C—Donor Eligibility determined that the departure does not increase the risks of communicable interview; a current report of the § 1271.45 What requirements does this physical assessment of a cadaveric disease transmission through the use of subpart contain? the HCT/P. donor or the physical examination of a (a) General. This subpart sets out living donor; and, if available, the (e) Standard procedures. You may requirements for determining donor following: adopt current standard procedures, such eligibility, including donor screening (1) Laboratory test results (other than as those in a technical manual prepared results of testing for relevant and testing. The requirements contained by another organization, provided that communicable disease agents required in this subpart are a component of you have verified that the procedures under this subpart); current good tissue practice (CGTP) are consistent with and at least as (2) Medical records; requirements. stringent as the requirements of this part (3) Coroner and autopsy reports; and (b) Donor-eligibility determination and appropriate for your operations. (4) Records or other information required. A donor-eligibility received from any source pertaining to determination, based on donor § 1271.50 How do I determine whether a donor is eligible? risk factors for relevant communicable screening and testing for relevant disease (e.g., social behavior, clinical communicable disease agents and (a) Determination based on screening signs and symptoms of relevant diseases, is required for all donors of and testing. If you are the establishment communicable disease, and treatments cells or tissue used in HCT/Ps, except as responsible for making the donor- related to medical conditions suggestive provided under § 1271.90. In the case of eligibility determination, you must of risk for relevant communicable an embryo or of cells derived from an determine whether a donor is eligible disease). embryo, a donor-eligibility based upon the results of donor (t) Responsible person means a person determination is required for both the screening in accordance with § 1271.75 who is authorized to perform designated oocyte donor and the semen donor. and donor testing in accordance with functions for which he or she is trained (c) Prohibition on use. An HCT/P §§ 1271.80 and 1271.85. A responsible and qualified. must not be implanted, transplanted, person, as defined in § 1271.3(t), must (u) Urgent medical need means that infused, or transferred until the donor determine and document the eligibility no comparable HCT/P is available and has been determined to be eligible, of a cell or tissue donor. the recipient is likely to suffer death or except as provided under §§ 1271.60(d), (b) Eligible donor. A donor is eligible serious morbidity without the HCT/P. 1271.65(b), and 1271.90 of this subpart. under these provisions only if: (v) Act means the Federal Food, Drug, (d) Applicability of requirements. If (1) Donor screening in accordance and Cosmetic Act. you are an establishment that performs with § 1271.75 indicates that the donor:

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(i) Is free from risk factors for, and donor’s name or other personal you must keep it in quarantine during clinical evidence of, infection due to information that might identify the shipment. The HCT/P must be relevant communicable disease agents donor. accompanied by records: and diseases; and (d) Record retention requirements. (1) Identifying the donor (e.g., by a (ii) Is free from communicable disease (1) You must maintain documentation distinct identification code affixed to risks associated with of: the HCT/P container); xenotransplantation; and (i) Results and interpretation of all (2) Stating that the donor-eligibility (2) The results of donor testing for testing for relevant communicable determination has not been completed; relevant communicable disease agents disease agents in compliance with and in accordance with §§ 1271.80 and §§ 1271.80 and 1271.85, as well as the (3) Stating that the product must not 1271.85 are negative or nonreactive, name and address of the testing be implanted, transplanted, infused, or except as provided in § 1271.80(d)(1). laboratory or laboratories; transferred until completion of the (ii) Results and interpretation of all donor-eligibility determination, except § 1271.55 What records must accompany donor screening for communicable under the terms of paragraph (d) of this an HCT/P after the donor-eligibility diseases in compliance with § 1271.75; determination is complete; and what section. records must I retain? and (d) Use in cases of urgent medical (iii) The donor-eligibility need. (a) Accompanying records. Once a determination, including the name of (1) This subpart C does not prohibit donor-eligibility determination has been the responsible person who made the the implantation, transplantation, made, the following must accompany determination and the date of the infusion, or transfer of an HCT/P from the HCT/P at all times: determination. a donor for whom the donor-eligibility (1) A distinct identification code (2) All records must be accurate, determination is not complete if there is affixed to the HCT/P container, e.g., indelible, and legible. Information on a documented urgent medical need for alphanumeric, that relates the HCT/P to the identity and relevant medical the HCT/P, as defined in § 1271.3(u). the donor and to all records pertaining records of the donor, as defined in (2) If you make an HCT/P available for to the HCT/P and, except in the case of § 1271.3(s), must be in English or, if in use under the provisions of paragraph autologous or directed reproductive another language, must be retained and (d)(1) of this section, you must donations, does not include an translated to English and accompanied prominently label it ‘‘NOT individual’s name, social security by a statement of authenticity by the EVALUATED FOR INFECTIOUS number, or medical record number; translator that specifically identifies the SUBSTANCES,’’ and ‘‘WARNING: (2) A statement whether, based on the translated document. Advise patient of communicable disease results of screening and testing, the (3) You must retain required records risks.’’ The following information must donor has been determined to be and make them available for authorized accompany the HCT/P: eligible or ineligible; and inspection by or upon request from (i) The results of any donor screening (3) A summary of the records used to FDA. Records that can be readily required under § 1271.75 that has been make the donor-eligibility retrieved from another location by completed; determination. electronic means are considered (ii) The results of any testing required (b) Summary of records. The summary ‘‘retained.’’ under § 1271.80 or 1271.85 that has of records required by paragraph (a)(3) (4) You must retain the records been completed; and of this section must contain the pertaining to a particular HCT/P at least (iii) A list of any screening or testing following information: 10 years after the date of its required under § 1271.75, 1271.80 or (1) A statement that the administration, or if the date of 1271.85 that has not yet been communicable disease testing was administration is not known, then at completed. performed by a laboratory: least 10 years after the date of the (3) If you are the establishment that (i) Certified to perform such testing on HCT/P’s distribution, disposition, or manufactured an HCT/P used under the human specimens under the Clinical expiration, whichever is latest. provisions of paragraph (d)(1) of this Laboratory Improvement Amendments section, you must document that you of 1988 (42 U.S.C. 263a) and 42 CFR § 1271.60 What quarantine and other notified the physician using the HCT/P part 493; or requirements apply before the donor- eligibility determination is complete? that the testing and screening were not (ii) That has met equivalent complete. requirements as determined by the (a) Quarantine. You must keep an (4) In the case of an HCT/P used for Centers for Medicare and Medicaid HCT/P in quarantine, as defined in an urgent medical need under the Services in accordance with those § 1271.3(q), until completion of the provisions of paragraph (d)(1) of this provisions; donor-eligibility determination required section, you must complete the donor- (2) A listing and interpretation of the by § 1271.50. You must quarantine eligibility determination during or after results of all communicable disease tests semen from anonymous donors until the the use of the HCT/P, and you must performed; retesting required under § 1271.85(d) is inform the physician of the results of (3) The name and address of the complete. the determination. establishment that made the donor- (b) Identification of HCT/Ps in eligibility determination; and quarantine. You must clearly identify as § 1271.65 How do I store an HCT/P from a (4) In the case of an HCT/P from a quarantined an HCT/P that is in donor determined to be ineligible, and what donor who is ineligible based on quarantine pending completion of a uses of the HCT/P are not prohibited? screening and released under paragraph donor-eligibility determination. The (a) Storage. If you are the (b) of § 1271.65, a statement noting the quarantined HCT/P must be easily establishment that stores the HCT/P, reason(s) for the determination of distinguishable from HCT/Ps that are you must store or identify HCT/Ps from ineligibility. available for release and distribution. donors who have been determined to be (c) Deletion of personal information. (c) Shipping of HCT/Ps in quarantine. ineligible in a physically separate area The accompanying records required by If you ship an HCT/P before completion clearly identified for such use, or follow this section must not contain the of the donor-eligibility determination, other procedures, such as automated

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designation, that are adequate to prevent (b) Donors of viable, leukocyte-rich § 1271.80 What are the general improper release until destruction or cells or tissue. In addition to the requirements for donor testing? other disposition of the HCT/P in relevant communicable disease agents (a) Testing for relevant communicable accordance with paragraph (b) or (c) of and diseases for which screening is diseases is required. To adequately and this section. required under paragraph (a) of this appropriately reduce the risk of (b) Limited uses of HCT/P from section, and except as provided under transmission of relevant communicable ineligible donor. § 1271.90, you must screen the donor of diseases, and except as provided under (1) An HCT/P from a donor who has viable, leukocyte-rich cells or tissue by § 1271.90, if you are the establishment been determined to be ineligible, based reviewing the donor’s relevant medical that performs donor testing, you must on the results of required testing and/or records for risk factors for and clinical test a donor specimen for evidence of screening, is not prohibited by subpart evidence of relevant cell-associated infection due to communicable disease C of this part from use for implantation, communicable disease agents and agents in accordance with paragraph (c) transplantation, infusion, or transfer diseases, including Human T- of this section. You must test for those under the following circumstances: lymphotropic virus. communicable disease agents specified (i) The HCT/P is for allogeneic use in (c) Donors of reproductive cells or in § 1271.85. In the case of a donor 1 a first-degree or second-degree blood tissue. In addition to the relevant month of age or younger, you must test relative; a specimen from the birth mother (ii) The HCT/P consists of communicable disease agents and diseases for which screening is required instead of a specimen from the donor. reproductive cells or tissue from a (b) Timing of specimen collection. under paragraphs (a) and (b) of this directed reproductive donor, as defined You must collect the donor specimen at section, as applicable, and except as in § 1271.3(l); or the time of recovery of cells or tissue provided under § 1271.90, you must (iii) There is a documented urgent from the donor. However, if collection screen the donor of reproductive cells or medical need as defined in § 1271.3(u). at the time of recovery is not feasible, tissue by reviewing the donor’s relevant (2) You must prominently label an then you may collect the donor HCT/P made available for use under the medical records for risk factors for and specimen up to 7 days before or after provisions of paragraph (b)(1) of this clinical evidence of infection due to recovery or, for donors of peripheral section with the Biohazard legend relevant communicable diseases of the blood stem/progenitor cells only, up to shown in § 1271.3(h) with the statement genitourinary tract. Such screening must 30 days before recovery. In the case of ‘‘WARNING: Advise patient of include screening for the communicable a repeat semen donor from whom a communicable disease risks,’’ and, in disease agents listed in paragraphs (c)(1) specimen has already been collected the case of reactive test results, and (c)(2) of this section. However, if and tested, and for whom retesting is ‘‘WARNING: Reactive test results for the reproductive cells or tissues are required under § 1271.85(d), you are not (name of disease agent or disease).’’ The recovered by a method that ensures required to collect a donor specimen at HCT/P must be accompanied by the freedom from contamination of the cells the time of each donation. records required under § 1271.55. or tissue by infectious disease organisms (c) Tests. You must test using (3) If you are the establishment that that may be present in the genitourinary appropriate FDA-licensed, approved, or manufactured an HCT/P used under the tract, then screening for the cleared donor screening tests, in provisions of paragraph (b)(1) of this communicable disease agents listed in accordance with the manufacturer’s section, you must document that you paragraphs (c)(1) and (c)(2) of this instructions, to adequately and notified the physician using the HCT/P section is not required. Communicable appropriately reduce the risk of of the results of testing and screening. disease agents of the genitourinary tract transmission of relevant communicable (c) Nonclinical use. You may make for which you must screen include: disease agents or diseases; however, available for nonclinical purposes an (1) Chlamydia trachomatis; and until such time as appropriate FDA- HCT/P from a donor who has been (2) Neisseria gonorrhea. licensed, approved, or cleared donor determined to be ineligible, based on (d) Ineligible donors. You must screening tests for Chlamydia the results of required testing and/or determine ineligible a donor who is trachomatis and for Neisseria gonorrhea screening, provided that it is labeled: identified as having either of the are available, you must use FDA- (1) ‘‘For Nonclinical Use Only’’ and following: licensed, approved, or cleared tests (2) With the Biohazard legend shown labeled for the detection of those (1) A risk factor for or clinical in § 1271.3(h). organisms in an asymptomatic, low- evidence of any of the relevant prevalence population. You must use a § 1271.75 How do I screen a donor? communicable disease agents or test specifically labeled for cadaveric (a) All donors. Except as provided diseases for which screening is required specimens instead of a more generally under § 1271.90, if you are the under paragraphs (a)(1)(i), (b), or (c) of labeled test when applicable and when establishment that performs donor this section; or available. Required testing under this screening, you must screen a donor of (2) Any communicable disease risk cells or tissue by reviewing the donor’s section must be performed by a associated with xenotransplantation. laboratory that either is certified to relevant medical records for: (e) Abbreviated procedure for repeat (1) Risk factors for, and clinical perform such testing on human donors. If you have performed a evidence of, relevant communicable specimens under the Clinical Laboratory complete donor screening procedure on disease agents and diseases, including: Improvement Amendments of 1988 (42 (i) Human immunodeficiency virus; a living donor within the previous 6 U.S.C. 263a) and 42 CFR part 493, or has (ii) Hepatitis B virus; months, you may use an abbreviated met equivalent requirements as (iii) Hepatitis C virus; donor screening procedure on repeat determined by the Centers for Medicare (iv) Human transmissible spongiform donations. The abbreviated procedure and Medicaid Services. encephalopathy, including Creutzfeldt- must determine and document any (d) Ineligible donors. You must Jakob disease; changes in the donor’s medical history determine the following donors to be (v) Treponema pallidum; and since the previous donation that would ineligible: (2) Communicable disease risks make the donor ineligible, including (1) A donor whose specimen tests associated with xenotransplantation. relevant social behavior. reactive on a screening test for a

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communicable disease agent in (3) Hepatitis B virus; (e) Dura mater. For donors of dura accordance with § 1271.85, except for a (4) Hepatitis C virus; and mater, you must perform an adequate donor whose specimen tests reactive on (5) Treponema pallidum. assessment designed to detect evidence a non-treponemal screening test for (b) Donors of viable, leukocyte-rich of transmissible spongiform syphilis and negative on a specific cells or tissue. In addition to the encephalopathy. treponemal confirmatory test; relevant communicable disease agents (2)(i) A donor in whom plasma for which testing is required under § 1271.90 Are there exceptions from the dilution sufficient to affect the results of paragraph (a) of this section, and except requirement of determining donor eligibility, communicable disease testing is as provided under § 1271.90, and what labeling requirements apply? suspected, unless: (1) You must test a specimen from the donor of viable, leukocyte-rich cells or (a) Donor-eligibility determination not (A) You test a specimen taken from required. You are not required to make the donor before transfusion or infusion tissue to adequately and appropriately reduce the risk of transmission of a donor-eligibility determination under and up to 7 days before recovery of cells § 1271.50 or to perform donor screening or tissue; or relevant cell-associated communicable or testing under §§ 1271.75, 1271.80 and (B) You use an appropriate algorithm diseases, including: designed to evaluate volumes (i) Human T-lymphotropic virus, type 1271.85 for: administered in the 48 hours before I; and (1) Cells and tissues for autologous specimen collection, and the algorithm (ii) Human T-lymphotropic virus, use; or type II. shows that plasma dilution sufficient to (2) Reproductive cells or tissue affect the results of communicable (2) You must test a specimen from the donor of viable, leukocyte-rich cells or donated by a sexually intimate partner disease testing has not occurred. of the recipient for reproductive use; or (ii) Clinical situations in which you tissue for evidence of infection due to must suspect plasma dilution sufficient cytomegalovirus (CMV), to adequately (3) Cryopreserved cells or tissue for to affect the results of communicable and appropriately reduce the risk of reproductive use, originally exempt disease testing include but are not transmission. You must establish and under paragraph (a)(1) or (a)(2) at the limited to the following: maintain a standard operating time of donation, that are subsequently (A) Blood loss is known or suspected procedure governing the release of an intended for directed donation, in a donor over 12 years of age, and the HCT/P from a donor whose specimen provided that tests reactive for CMV. donor has received a transfusion or (i) Additional donations are infusion of any of the following, alone (c) Donors of reproductive cells or tissue. In addition to the communicable unavailable, for example, due to the or in combination: infertility or health of a donor of the (1) More than 2,000 milliliters (mL) of disease agents for which testing is required under paragraphs (a) and (b) of cryopreserved reproductive cells or blood (e.g., whole blood, red blood tissue; and cells) or colloids within 48 hours before this section, as applicable, and except as death or specimen collection, whichever provided under § 1271.90, you must test (ii) Appropriate measures are taken to occurred earlier, or a specimen from the donor of screen and test the donor(s) before (2) More than 2,000 mL of crystalloids reproductive cells or tissue to transfer to the recipient. adequately and appropriately reduce the within 1 hour before death or specimen (b) Required labeling. You must collection, whichever occurred earlier. risk of transmission of relevant communicable disease agents of the prominently label an HCT/P listed in (B) Regardless of the presence or paragraph (a) of this section: absence of blood loss, the donor is 12 genitourinary tract. Such testing must years of age or younger and has received include testing for the communicable (1) ‘‘FOR AUTOLOGOUS USE a transfusion or infusion of any amount disease agents listed in paragraphs (c)(1) ONLY,’’ if it is stored for autologous of any of the following, alone or in and (c)(2) of this section. However, if use; combination: the reproductive cells or tissues are (2) ‘‘NOT EVALUATED FOR (1) Blood (e.g., whole blood, red blood recovered by a method that ensures INFECTIOUS SUBSTANCES’’ and cells) or colloids within 48 hours before freedom from contamination of the cells ‘‘WARNING: Advise patient of death or specimen collection, whichever or tissue by infectious disease organisms communicable disease risks,’’ unless that may be present in the genitourinary occurred earlier, or you have performed all otherwise tract, then testing for the communicable (2) Crystalloids within 1 hour before applicable screening and testing under disease agents listed in paragraphs (c)(1) death or specimen collection, whichever §§ 1271.75, 1271.80, and 1271.85; and occurred earlier. and (c)(2) of this section is not required. Communicable disease agents of the (3) With the Biohazard legend shown § 1271.85 What donor testing is required genitourinary tract for which you must in § 1271.3(h), with the statement for different types of cells and tissues? test include: ‘‘WARNING: Advise patient of (a) All donors. To adequately and (1) Chlamydia trachomatis; and communicable disease risks,’’ and, in appropriately reduce the risk of (2) Neisseria gonorrhea. the case of reactive test results, transmission of relevant communicable (d) Retesting anonymous semen ‘‘WARNING: Reactive test results for diseases, and except as provided under donors. Except as provided under (name of disease agent or disease)’’ if § 1271.90, you must test a specimen § 1271.90 and except for directed the results of any screening or testing from the donor of cells or tissue, reproductive donors as defined in performed indicate: whether viable or nonviable, for § 1271.3(l), at least 6 months after the evidence of infection due to relevant date of donation of semen from (i) The presence of relevant communicable disease agents, anonymous donors, you must collect a communicable disease agents and/or including: new specimen from the donor and test (ii) Risk factors for or clinical (1) Human immunodeficiency virus, it for evidence of infection due to the evidence of relevant communicable type 1; communicable disease agents for which disease agents or diseases. (2) Human immunodeficiency virus, testing is required under paragraphs (a), type 2; (b), and (c) of this section.

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Dated: March 10, 2004. Lester M. Crawford, Acting Commissioner for Food and Drugs. Dated: March 10, 2004. Tommy G. Thompson, Secretary of Health and Human Services. [FR Doc. 04–11245 Filed 5–20–04; 8:45 am] BILLING CODE 4160–01–S

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DEPARTMENT OF HEALTH AND Rockville Pike, Rockville, MD 20852– substance of this document into a final HUMAN SERVICES 1448, 301–827–6210. guidance on donor eligibility. SUPPLEMENTARY INFORMATION: The draft guidance is being issued Food and Drug Administration I. Background consistent with FDA’s good guidance [Docket No. 2004D–0193] practices regulation (21 CFR 10.115). FDA is announcing the availability of a draft guidance entitled ‘‘Guidance for The draft guidance document, when Draft ‘‘Guidance for Industry: Eligibility finalized, will represent the agency’s Determination for Donors of Human Industry: Eligibility Determination for current thinking on this topic. It does Cells, Tissues, and Cellular and Donors of Human Cells, Tissues, and not create or confer any rights for or on Tissue-Based Products’’ Availability Cellular and Tissue-based Products (HCT/Ps)’’ dated May 2004. Because of any person and does not operate to bind AGENCY: Food and Drug Administration, their nature as derivatives of the human FDA or the public. An alternative HHS. body, HCT/Ps pose a risk of transmitting approach may be used if such approach ACTION: Notice. communicable diseases. For this reason, satisfies the requirements of the FDA is publishing a final rule applicable statutes and regulations. SUMMARY: The Food and Drug ‘‘Eligibility Determination for Donors of Administration (FDA) is announcing the Human Cells, Tissues, and Cellular and II. Paperwork Reduction Act of 1995 availability of a draft document entitled Tissue-Based Products (HCT/Ps)’’ This guidance contains information ‘‘Guidance for Industry: Eligibility elsewhere in this issue of the Federal collection provisions that are subject to Determination for Donors of Human Register. These donor-eligibility review by the Office of Management and Cells, Tissues, and Cellular and Tissue- requirements, which are contained in Budget (OMB) under the Paperwork Based Products (HCT/Ps)’’ dated May part 1271 (21 CFR part 1271), subpart C, Reduction Act of 1995 (44 USC 3501– 2004. The draft guidance provides to are part of the minimum requirements 3520). The collection(s) of information HCT/P establishments applicable both to HCT/Ps regulated recommendations for the appropriate solely under these regulations and addressed in the guidance document screening and testing of cell and tissue section 361 of the Public Health Service has been submitted to OMB for review donors for evidence of relevant Act and to those HCT/Ps also subject to in accordance with the PRA under the communicable diseases. These regulation as drugs, devices, and/or regulations governing donor-eligibility recommendations would assist HCT/P biological products. determination for donors of HCT/Ps establishments in complying with the In the draft guidance, FDA is (part 1271). requirements for the eligibility providing recommendations to HCT/P III. Comments determination for donors of HCT/Ps. establishments on how to comply with DATES: Submit written or electronic the requirements in 21 CFR part 1271, The draft guidance is being comments on the draft guidance by subpart C. The recommendations distributed for comment purposes only August 23, 2004, to ensure their address the following topics: and is not intended for implementation • adequate consideration in preparation of Elements of the donor eligibility at this time. Interested persons may the final guidance. General omments on determination, including procedures submit to the Division of Dockets agency guidance documents are and recordkeeping; • Management (see ADDRESSES) written or welcome at any time. Donor screening, including review of risk factors for, and clinical and electronic comments regarding the draft ADDRESSES: Submit written requests for physical evidence of, relevant guidance. Submit written or electronic single copies of the draft guidance to the communicable diseases; comments to ensure adequate Office of Communication, Training, and • Donor testing, including general consideration in preparation of the final Manufacturers Assistance (HFM–40), testing for all HCT/Ps and testing guidance. Submit a single copy of Center for Biologics Evaluation and specific for some types of HCT/Ps (e.g., electronic comments or two paper Research, Food and Drug reproductive cells and tissues); and copies of any mailed comments, except Administration, 1401 Rockville Pike, • Exceptions to donor screening and that individuals may submit one paper Rockville, MD 20852–1448. Send one testing. copy. Comments are to be identified self-addressed adhesive label to assist The draft guidance would apply to with the docket number found in the the office in processing your requests. cells and tissues recovered on or after brackets in the heading of this The draft guidance may also be obtained the effective date of the final rule document. A copy of the draft guidance by mail by calling the Center for published elsewhere in this issue of the and received comments are available for Biologics and Research Voice Federal Register. Part 1271 also public examination in the Division of Information System at 1–800–835–4709 contains other requirements applicable or 301–827–1800. See the Dockets Management between 9 a.m. to HCT/Ps (e.g., current good tissue and 4 p.m., Monday through Friday. SUPPLEMENTARY INFORMATION section for practice requirements), which are not electronic access to the draft guidance addressed in the draft guidance. IV. Electronic Access document. We previously have issued a separate Submit written comments on the draft draft guidance document entitled Persons with access to the Internet guidance to the Division of Dockets ‘‘Guidance for Industry: Preventive may obtain the draft guidance at either Management (HFA–305), Food and Drug Measures to Reduce the Possible Risk of http://www.fda.gov/cber/guidelines.htm Administration, 5630 Fishers Lane, rm. Transmission of Creutzfeldt-Jakob or http://www.fda.gov/ohrms/dockets/ 1061, Rockville, MD 20852. Submit Disease (CJD) and Variant Creutzfeldt- default.htm. electronic comments to http:// Jakob Disease (vCJD) by Human Cells, Dated: April 27, 2004. www.fda.gov/dockets/ecomments. Tissues, and Cellular and Tissue-Based Jeffrey Shuren, FOR FURTHER INFORMATION CONTACT: Products (HCT/Ps)’’ dated June 2002. Paula S. McKeever, Center for Biologics We intend to issue a single final Assistant Commissioner for Policy. Evaluation and Research (HFM–17), guidance document that incorporates [FR Doc. 04–11246 Filed 5–20–04; 8:45 am] Food and Drug Administration, 1401 our guidance on CJD and vCJD with the BILLING CODE 4160–01–S

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Part III

Department of Defense General Services Administration National Aeronautics and Space Administration 48 CFR Parts 14, 32, and 52 Federal Acquisition Regulation; Payment Withholding; Proposed Rule

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DEPARTMENT OF DEFENSE currently requires the contracting officer business, representing approximately 2 to withhold 5 percent of the amounts percent of all contracting. In addition, GENERAL SERVICES due, up to a maximum of $50,000, the rule eases the impact of the current ADMINISTRATION unless otherwise specified in the FAR by permitting the contracting contract Schedule. The Government officer to use judgment in deciding NATIONAL AERONAUTICS AND retains the withhold amount until the whether to withhold payments, thus the SPACE ADMINISTRATION contractor executes and delivers, at the number of contracts affected is a subset time of final payment, a release of the 2 percent figure. This change is 48 CFR Parts 14, 32, and 52 discharging the Government from all expected to have a small but beneficial [FAR Case 2004–003] liabilities, obligations, and claims impact on small businesses. An Initial arising under the contract. Regulatory Flexibility Analysis has, RIN 9000–AJ94 The rule proposes to add FAR therefore, not been performed. We invite 32.111(a)(7)(iii) to permit contracting comments from small businesses and Federal Acquisition Regulation; officers to use their judgment regarding other interested parties. The Councils Payment Withholding whether to withhold payments under will consider comments from small AGENCIES: Department of Defense (DoD), time-and-materials and labor-hour entities concerning the affected FAR General Services Administration (GSA), contracts so that the withhold would be parts in accordance with 5 U.S.C. 610. and National Aeronautics and Space applied only when necessary to protect Interested parties must submit such Administration (NASA). the Government’s interests. The comments separately and should cite 5 proposed rule makes it clear that, ACTION: Proposed rule with request for U.S.C. 601, et seq. (FAR case 2004–003), normally, there should be no need to comments. in correspondence. withhold payments when dealing with SUMMARY: The Civilian Agency contractors that typically comply with C. Paperwork Reduction Act Acquisition Council and the Defense contractual release requirements in a The Paperwork Reduction Act does Acquisition Regulations Council timely manner. This is in contrast to the not apply because the proposed changes (Councils) are proposing to amend the current requirement in time-and- to the FAR do not impose information Federal Acquisition Regulation (FAR) materials and labor-hour contracts that collection requirements that require the by removing the requirement that a contracting officers must withhold approval of the Office of Management contracting officer withhold 5 percent of payments unless other direction is and Budget under 44 U.S.C. 3501, et the payments due under a time-and provided in the contract. seq. materials or labor-hour contract, unless The rule also proposes to revise otherwise prescribed in the contract paragraph (a)(2) of the contract clause at List of Subjects in 48 CFR Parts 14, 32, Schedule. The proposed rule would FAR 52.232–7, to state that the and 52 permit, but not require, the contracting contracting officer may (rather than Government procurement. officer to withhold payment amounts if shall) withhold 5 percent of the amounts due. The rule also makes Dated: May, 19, 2004. the contracting officer determines the Ralph De Stefano, withholding to be necessary to protect several related editorial changes to Acting Director, Acquisition Policy Division. the Government’s interests. improve clarity and structure. The Councils are considering revising Therefore, DoD, GSA, and NASA DATES: Interested parties should submit its policy because the current comments in writing on or before July propose amending 48 CFR parts 14, 32, withholding provisions are and 52 as set forth below: 26, 2004 to be considered in the administratively burdensome and may, formulation of a final rule. 1. The authority citation for 48 CFR in some situations, result in the parts 14, 32, and 52 is revised to read ADDRESSES: Submit printed comments withholding of amounts that exceed as follows: to General Services Administration, reasonable amounts needed to protect FAR Secretariat (MVA), 1800 F Street, Authority: 40 U.S.C. 121(c); 10 U.S.C. the Government’s interests. In addition, chapter 137; and 42 U.S.C. 2473(c). NW., Room 4035, ATTN: Laurie Duarte, the contractor is already incentivized to Washington, DC 20405. Submit execute and deliver the release PART 14—SEALED BIDDING electronic comments via the Internet to discharging the Government from all the U.S. Government’s rulemaking liabilities, obligations, and claims under 14.408–3 [Amended] website at http://www.regulations.gov, the contract, since this release is a 2. Amend section 14.408–3 in or to GSA’s e-mailbox at farcase.2004– condition of final payment. paragraph (b) by removing ‘‘See [email protected]. This is not a significant regulatory 32.111(c)(1),’’ and adding ‘‘See Please submit comments only and cite action and, therefore, was not subject to 32.111(b)(1),’’ in its place. FAR case 2004–003 in all review under Section 6(b) of Executive correspondence related to this case. Order 12866, Regulatory Planning and PART 32—CONTRACT FINANCING FOR FURTHER INFORMATION CONTACT: The Review, dated September 30, 1993. This FAR Secretariat at (202) 501–4755 for rule is not a major rule under 5 U.S.C. 3. Amend section 32.111 by— information pertaining to status or 804. a. Removing ‘‘and’’ at the end of publication schedules. For clarification paragraph (a)(5); of content, contact Mr. Edward Loeb, B. Regulatory Flexibility Act b. Removing the period at the end of Policy Advisor, at (202) 501–0650. The Councils do not expect this paragraph (a)(6) and adding ‘‘; and’’ in Please cite FAR case 2004–003. proposed rule to have a significant its place; SUPPLEMENTARY INFORMATION: economic impact on a substantial c. Redesignating paragraph (b) as number of small entities within the paragraph (a)(7); A. Background meaning of the Regulatory Flexibility d. Redesignating paragraphs (c) and Federal Acquisition Regulation (FAR) Act, 5 U.S.C. 601, et seq., because the (d) as (b) and (c), respectively; and 52.232–7, Payments under Time-and rule applies only to time and material e. Revising newly designated Materials and Labor-Hour Contracts, and labor-hour contracts with small paragraph (a)(7) to read as follows:

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32.111 Contract clauses for non- amounts due until a reserve is set aside (2) Unless otherwise prescribed in the commercial purchases. in an amount the contracting officer Schedule, the Contracting Officer may (a) * * * considers to be necessary, but not to withhold 5 percent of the amounts due (7) The clause at 52.232–7, Payments exceed $50,000. Normally, there should under this paragraph (a), but the total under Time-and-Materials and Labor- be no need to withhold payment for a amount withheld shall not exceed Hour Contracts, in solicitations and contractor with a record of timely $50,000. The amounts withheld shall be contracts when a time-and-materials or submittal of the release discharging the retained until the Contractor executes labor-hour contract is contemplated. Government from all liabilities, and delivers the release required by (i) If the nature of the work to be obligations, and claims, as required by paragraph (f) of this clause. performed requires the contractor to paragraph (f) of the clause. * * * * * furnish material that is regularly sold to * * * * * the general public in the normal course 5. In the introductory text of section of business by the contractor and the PART 52—SOLICITATION PROVISIONS 52.232–8, remove ‘‘32.111(c)(1)’’ and price is under the limitations prescribed AND CONTRACT CLAUSES add ‘‘32.111(b)(1)’’ in its place. in 16.601(b)(3), the contracting officer 52.232–7 [Amended] 6. In the introductory text of section shall use the clause with its Alternate I. 52.232–9, remove ‘‘32.111(c)(2)’’ and (ii) If a labor-hour contract is 4. Amend section 52.232–7 by— add ‘‘32.111(b)(2)’’ in its place. contemplated, and if no specific a. Removing ‘‘32.111(b)’’ and adding reimbursement for materials furnished ‘‘32.111(a)(7)’’ in its place in the 7. In the introductory text of section is intended, the contracting officer may introductory text of section 52.232–7. 52.232–10, remove ‘‘32.111(d)(1)’’ and b. Revising the date of the clause to use the clause with its Alternate II. add ‘‘32.111(c)(1)’’ in its place. read ‘‘(XXX 2004)’’. (iii) If the contracting officer c. Revising paragraph (a)(2) to read as 8. In the introductory text of section determines that it is necessary to follows: 52.232–11, remove ‘‘32.111(d)(2)’’ and withhold payment to protect the add ‘‘32.111(c)(2)’’ in its place. Government’s interests, paragraph (a)(2) 52.232–7 Payments under Time-and- of the clause permits the contracting Materials and Labor-Hour Contracts. [FR Doc. 04–11736 Filed 5–24–04; 8:45 am] officer to withhold 5 percent of the (a) * * * BILLING CODE 6820–EP–S

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Part IV

The President Executive Order 13341—Further Amendment to Executive Order 11023, Providing for the Performance by the Secretary of Commerce of Certain Functions Relating to the National Oceanic and Atmospheric Administration

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Federal Register Presidential Documents Vol. 69, No. 101

Tuesday, May 25, 2004

Title 3— Executive Order 13341 of May 20, 2004

The President Further Amendment to Executive Order 11023, Providing for the Performance by the Secretary of Commerce of Certain Functions Relating to the National Oceanic and Atmospheric Administration

By the authority vested in me as President by the Constitution and the laws of the United States of America, including section 301 of title 3, United States Code, it is hereby ordered as follows: Section 1. As a result of the enactment of the National Oceanic and Atmos- pheric Administration Commissioned Officer Corps Act of 2002 (Public Law 107–372), the following conforming amendments are made to Executive Order 11023 of May 28, 1962, as amended: (a) In section 1(a), delete ‘‘section 6(b) of the Coast and Geodetic Survey Commissioned Officers Act of 1948 (62 Stat. 298; 33 U.S.C. 853e(b))’’ and insert in lieu thereof: ‘‘section 223(b) of the National Oceanic and Atmos- pheric Administration Commissioned Officer Corps Act of 2002 (Public Law 107–372; 33 U.S.C. 3023(b))’’. (b) In section 1(b), delete ‘‘section 12(a) of the Coast and Geodetic Survey Commissioned Officers Act of 1948, as amended (75 Stat. 506; 33 U.S.C. 853j–1(a))’’ and insert in lieu thereof: ‘‘section 229(a) of the National Oceanic and Atmospheric Administration Commissioned Officer Corps Act of 2002 (Public Law 107–372; 33 U.S.C. 3029(a))’’. (c) In section 1(c), delete ‘‘section 12(b) of the Coast and Geodetic Survey Commissioned Officers Act of 1948, as amended (75 Stat. 506; 33 U.S.C. 853j–1(b))’’ and insert in lieu thereof: ‘‘section 229(b) of the National Oceanic and Atmospheric Administration Commissioned Officer Corps Act of 2002 (Public Law 107–372; 33 U.S.C. 3029(b))’’. (d) In section 1(d), delete ‘‘section 12(c) of the Coast and Geodetic Survey Commissioned Officers Act of 1948, as amended (75 Stat. 506; 33 U.S.C. 853j–1(c))’’ and insert in lieu thereof: ‘‘section 229(c) of the National Oceanic and Atmospheric Administration Commissioned Officer Corps Act of 2002 (Public Law 107–372; 33 U.S.C. 3029(c))’’. (e) Section 1(e) shall be revised to read as follows: ‘‘The authority vested in the President by section 243(b) of the National Oceanic and Atmospheric Administration Commissioned Officer Corps Act of 2002 (Public Law 107– 372; 33 U.S.C. 3043(b)), to defer the retirement of an officer of the National Oceanic and Atmospheric Administration serving in a rank above that of captain who has attained 62 years of age, but such a deferment may not extend beyond the first day of the month in which the officer becomes 64 years of age.’’ (f) Section 1(f) shall be revised to read as follows: ‘‘The authority vested in the President by section 244 of the National Oceanic and Atmospheric Administration Commissioned Officer Corps Act of 2002 (Public Law 107– 372; 33 U.S.C. 3044), to retire from the active service any commissioned officer of the National Oceanic and Atmospheric Administration, upon his own application, who has completed 20 years of active service, of which at least 10 years was service as a commissioned officer.’’ (g) In section 1(g), delete ‘‘section 23(a) of the Coast and Geodetic Survey Commissioned Officers Act of 1948, as amended (75 Stat. 506; 33 U.S.C.

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853t(a))’’ and insert in lieu thereof: ‘‘section 221(a)(4) of the National Oceanic and Atmospheric Administration Commissioned Officer Corps Act of 2002 (Public Law 107–372; 33 U.S.C. 3021(a)(4))’’. (h) In section 1(h), delete ‘‘section 1(1) of the Act of December 3, 1942 (56 Stat. 1038; 33 U.S.C. 854a–1(1))’’ and insert in lieu thereof: ‘‘section 230(b)(1) of the National Oceanic and Atmospheric Administration Commis- sioned Officer Corps Act of 2002 (Public Law 107–372; 33 U.S.C. 3030(b)(1))’’. (i) In section 1(i), delete ‘‘section 1(2) of the Act of December 3, 1942 (56 Stat. 1038; 33 U.S.C. 854a–1(2))’’ and insert in lieu thereof: ‘‘section 230(b)(2) of the National Oceanic and Atmospheric Administration Commis- sioned Officer Corps Act of 2002 (Public Law 107–372; 33 U.S.C. 3030(b)(2))’’. (j) Section 1(j) shall be revised to read as follows: ‘‘The authority contained in section 230(b)(3) of the National Oceanic and Atmospheric Administration Commissioned Officer Corps Act of 2002 (Public Law 107–372; 33 U.S.C. 3030(b)(3)), to appoint temporarily in all grades to which original appoint- ments in the National Oceanic and Atmospheric Administration are author- ized to fill vacancies caused by transfer of officers to the military depart- ments.’’ (k) In section 1(k), delete ‘‘section 16 of the Act of May 22, 1917 (40 Stat. 87; 33 U.S.C. 855)’’ and insert in lieu thereof: ‘‘section 251 of the National Oceanic and Atmospheric Administration Commissioned Officer Corps Act of 2002 (Public Law 107–372; 33 U.S.C. 3061)’’, and delete the word ‘‘personnel’’ in the two places in which it appears and insert in lieu thereof: ‘‘officers’’. Sec. 2. Section 1(m) is added to Executive Order 11023 to read as follows: ‘‘(m) The authority vested in the President by Public Law 96–215, as amended (10 U.S.C. 716(a)), to transfer any commissioned officer with his consent from his uniformed service to, and appoint him in, the National Oceanic and Atmospheric Administration, provided consent for the transfer is given by the Secretary of Defense, the Secretary of Homeland Security, or the Secretary of Health and Human Services, as applicable, in accordance with joint regulations issued under that statute establishing the policies and proce- dures for such transfers and appointments.’’ W THE WHITE HOUSE, May 20, 2004.

[FR Doc. 04–11991 Filed 5–24–04; 10:09 am] Billing code 3195–01–P

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Reader Aids Federal Register Vol. 69, No. 101 Tuesday, May 25, 2004

CUSTOMER SERVICE AND INFORMATION CFR PARTS AFFECTED DURING MAY

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. 21, 2004 ...... 24907 Presidential Documents 2 CFR Executive orders and proclamations 741–6000 Subtitle A ...... 26276 5 CFR The United States Government Manual 741–6000 Subtitle B ...... 26276 532...... 26475 215...... 26281 Other Services 550...... 26475 595...... 27817 Electronic and on-line services (voice) 741–6020 3 CFR Privacy Act Compilation 741–6064 Proclamations: 7 CFR Public Laws Update Service (numbers, dates, etc.) 741–6043 7776...... 25283 1...... 28041 TTY for the deaf-and-hard-of-hearing 741–6086 7777...... 25285 7778...... 25287 6...... 27818 51...... 29171 ELECTRONIC RESEARCH 7779...... 25289 7780...... 25291 301 ...... 24909, 25303, 27821 World Wide Web 7781...... 26467 319...... 24916 Full text of the daily Federal Register, CFR and other publications 7782...... 26469 800...... 26476 is located at: http://www.gpoaccess.gov/nara/index.html 7783...... 26471 932...... 29171 1410...... 26755 Federal Register information and research tools, including Public 7784...... 26473 7785...... 29031 1415...... 29173 Inspection List, indexes, and links to GPO Access are located at: Proposed Rules: http://www.archives.gov/federallregister/ 7786...... 29033 7787...... 29035 301...... 29466 E-mail 7788...... 29037 319...... 29466 457...... 27864 FEDREGTOC-L (Federal Register Table of Contents LISTSERV) is Executive Orders: an open e-mail service that provides subscribers with a digital 10485 (See EO 762...... 24537 form of the Federal Register Table of Contents. The digital form 13337) ...... 25299 958...... 29244 of the Federal Register Table of Contents includes HTML and 10530 (See EO 989...... 29672 PDF links to the full text of each document. 13337) ...... 25299 1739...... 26777 1770...... 25848 To join or leave, go to http://listserv.access.gpo.gov and select 11023 (Amended By Online mailing list archives, FEDREGTOC-L, Join or leave the list EO 13341)...... 29843 9 CFR (orchange settings); then follow the instructions. 11423 (Amended By EO 13337)...... 25299 53...... 27823 PENS (Public Law Electronic Notification Service) is an e-mail 13047 (See Notice of 71...... 27823 service that notifies subscribers of recently enacted laws. May 17, 2004)...... 29041 92...... 25817 To subscribe, go to http://listserv.gsa.gov/archives/publaws-l.html 13096 (Revoked By 93...... 25820 and select Join or leave the list (or change settings); then follow EO 13336)...... 25299 94...... 25820 the instructions. 13175 (See EO 95...... 25820 FEDREGTOC-L and PENS are mailing lists only. We cannot 13336) ...... 25299 130...... 25305 respond to specific inquiries. 13212 (See EO 317...... 28042 13337) ...... 25299 381...... 28042 Reference questions. Send questions and comments about the 13224 (See EO Proposed Rules: Federal Register system to: [email protected] 13338) ...... 26751 78...... 25338 The Federal Register staff cannot interpret specific documents or 13303 (See Notice of 317...... 24539 regulations. May 20, 2004)...... 29409 381...... 24539 13310 (See Notice of 10 CFR FEDERAL REGISTER PAGES AND DATE, MAY May 17, 2004)...... 29041 13315 (See Notice of Ch. 1 ...... 29187 24063–24504...... 3 May 20, 2004)...... 29409 2...... 25997 24505–24904...... 4 13336...... 25299 70...... 28043 24905–25302...... 5 13337...... 25299 Proposed Rules: 25303–25478...... 6 13338...... 26751 30...... 28849 25479–25816...... 7 13339...... 28037 40...... 28849 25817–25996...... 10 13340...... 29043 50...... 28849 25997–26298...... 11 13341...... 29843 60...... 28849 26299–26472...... 12 Administrative Orders: 61...... 28849 70...... 28849 26473–26754...... 13 Notices: Notice of May 17, 72...... 28849 26755–27816...... 14 2004 ...... 29041 76...... 28849 27817–28040...... 17 Notice of May 20, 28041–28818...... 18 2004 ...... 29409 12 CFR 28819–29042...... 19 Presidential 208...... 25672 29043–29170...... 20 Determinations: 229...... 25826, 28819 29171–29410...... 21 No. 2004–29 of April 352...... 26490 29411–29650...... 24 21, 2004 ...... 24905 614...... 26763 29651–29844...... 25 No. 2004–30 of April 617...... 26763

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620...... 26763 611...... 29061 26 CFR 52 ...... 24986, 25835, 25839, 630...... 26763 26503, 27837, 28061, 29071, 17 CFR 1 ...... 24071, 24078, 25315, 701...... 27827 25489, 26038, 26040, 26304, 29074, 29234, 29253, 29254, 703...... 27827 211...... 29064 29066 29255, 29435, 29444, 29446, 709...... 27827 231...... 29064 29449, 29451 Proposed Rules: 241...... 29064 62...... 29658 715...... 27827 1 ...... 24107, 25534, 25535, Proposed Rules: 63...... 25321 723...... 27827 25856, 26782, 29113, 29246, 15...... 26333 82...... 29076 725...... 27827 29673 1805...... 26260 16...... 26333 85...... 26222 Proposed Rules: 17...... 26333 27 CFR 86...... 26222 18...... 26333 180 ...... 24984, 24992, 26305, 208...... 28851 9...... 25831 225...... 28851 19...... 26333 26770, 28832, 29454 21...... 26333 29 CFR 300...... 26506, 29076 13 CFR 210...... 26650 439...... 25324 228...... 26650 Proposed Rules: 121 ...... 25262, 29192, 29411 716...... 24517 229...... 26650 1926...... 27870 124...... 29192 Proposed Rules: 230...... 25182, 26650 4011...... 25797, 28992 125 ...... 25262, 29192, 29411 51 ...... 25184, 28874, 29118 232...... 26650 4022...... 26769 126...... 29411 52 ...... 25051, 25348, 25865, 239...... 25182, 26650 4044...... 26769 25866, 25869, 26533, 26786, 134...... 25262, 29192 240 ...... 25182, 25778, 26650 4071...... 25797, 28992 Proposed Rules: 29119, 29120, 29250, 29480, 242...... 26650 29481, 29674 121...... 27865 245...... 26650 30 CFR 126...... 26511 60...... 25052 249...... 25182, 26650 50...... 26499 62...... 29675 275...... 25778 14 CFR 203...... 25499 63...... 25052 279...... 25778 206...... 24959, 29432 72...... 28874 23...... 25998 250...... 29433 75...... 28874 25 ...... 24492, 24936, 26764 18 CFR 917...... 26500 81...... 25869 39 ...... 24063, 24938, 24940, 381...... 27833 Proposed Rules: 82...... 26059, 28992 24941, 24944, 24945, 24947, 20 CFR 948...... 26340 96...... 28874 24950, 24952, 24953, 24954, 180...... 26348 404...... 25949 25479, 25481, 25483, 25485, 31 CFR 191...... 29460 25488, 26000, 26001, 26003, 408...... 25949 Proposed Rules: 194...... 26351, 29460 26005, 26006, 26008, 26010, 21 CFR 50...... 25341 281...... 25053 26012, 26013, 26015, 26017, 103...... 28098 300...... 29120 26018, 26020, 26022, 26024, 1 ...... 24070, 28060, 29428 26025, 26027, 26299, 26434, 73...... 24511 32 CFR 42 CFR 110...... 29220 26494, 27829, 27831, 28044, 412...... 25674, 25752 172...... 24511, 29428 199...... 29226 28046, 28051, 29047, 29049, 1003...... 28842 175...... 24511 29054, 29055, 29209, 29210, 33 CFR Proposed Rules: 29212, 29216, 29217, 29218, 176...... 24511 177...... 24511 62...... 24979 403...... 28196 29651 412...... 28196 71 ...... 24063, 24064, 24065, 178...... 24511 66...... 24979 184...... 24511 67...... 24979 413...... 28196 24067, 24068, 25467, 26029, 418...... 28196 26030, 26031, 26033, 26034, 186...... 24511 72...... 24979 210...... 29786 100 ...... 24513, 28823, 29230 460...... 28196 26035, 29058, 29059, 29060, 480...... 28196 29651, 29653 211...... 29786 117 ...... 24080, 25316, 25317, 335...... 26301 26042, 27834 482...... 28196 95...... 24956 483...... 28196 97...... 24505, 28058 520...... 24958 165 ...... 24513, 24515, 25317, 522...... 25827 25319, 26043, 27836, 28825, 485...... 28196 139...... 24069 489...... 28196 Proposed Rules: 558 ...... 25315, 26498, 28820 28827, 29067, 29069, 29230, 39 ...... 24095, 24097, 24099, 600...... 26768 29232, 29433, 29653, 29656 44 CFR 24101, 24103, 24105, 25037, 807...... 25489 Proposed Rules: 820...... 29786 65...... 29662 25041, 25501, 25503, 25505, 110...... 26526 866...... 26036 206...... 24082 25507, 25511, 25514, 25517, 117 ...... 24548, 27870, 27872 872...... 26302 165 ...... 24112, 24549, 24552, Proposed Rules: 25519, 25521, 25523, 25525, 17...... 24114 1271...... 29786 26526, 26531, 26783, 28871, 26052, 26054, 26325, 26326, 21...... 24114 26329, 26331, 27865, 27866, Proposed Rules: 29114, 29246 27868, 28093, 28094, 28860, 3...... 25527 46 CFR 101...... 24541 36 CFR 28863, 28865, 28867, 29106, 310...... 29079 242...... 28847 29108, 29109, 29111, 29477, 22 CFR Proposed Rules: 29672 1200...... 26045 121...... 29222 221...... 29481 43...... 26054 Proposed Rules: 123...... 29222 71 ...... 26056, 26058, 28870 7...... 25043 47 CFR 121...... 27980 23 CFR 0 ...... 24996, 27843, 29459 37 CFR 655...... 25828 1...... 27843 15 CFR Proposed Rules: Proposed Rules: 15...... 29459 1...... 25861 736...... 26766 630...... 26513 25...... 28062 744...... 25312 54...... 25325 774 ...... 24507, 24508, 25314 24 CFR 39 CFR 61...... 25325 Proposed Rules: Proposed Rules: 111...... 25321, 26305 69...... 25325 754...... 25856 81...... 24228 Proposed Rules: 73 ...... 25844, 25845, 25846, 990...... 24547 501...... 25864 26312, 29241, 29242 16 CFR 1000...... 25340 97...... 24996 602...... 29061 40 CFR 101...... 25337, 28062 603...... 29061 25 CFR 9...... 24517 Proposed Rules: 604...... 29061 170...... 28821 51...... 28830 1...... 29676

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2...... 27874 52...... 25274 1853...... 29256 50 CFR 15...... 26790 217...... 26507 1872...... 29256 13...... 24084 43...... 29676 225...... 26508 17 ...... 24084, 29081, 29101, 63...... 29676 252...... 26508, 26509 49 CFR 29669 73 ...... 25873, 25874, 26061, 511...... 28063 100...... 28847 26353, 27874, 29252, 29253, 516...... 28063 15...... 28066 223...... 24997 29254, 29255 532...... 28063 192...... 27861 300...... 24997 74...... 27874 538...... 28063 232...... 29664 622...... 24532 546...... 28063 380...... 28846, 29384 648...... 26509 48 CFR 552...... 28063 391...... 28846 660 ...... 25013, 25026, 28086, Ch. 1 ...... 25280 1812...... 26775 1520...... 28066 29464 2...... 25274 1813...... 26776 Proposed Rules: 679 ...... 26313, 26320, 29670 5...... 25274 Proposed Rules: 171...... 25470 Proposed Rules: 6...... 25274 14...... 29838 172...... 25470 17 ...... 24876, 25055, 27886, 25...... 28104, 29632 13...... 25274 173...... 25470 29121, 29354, 29681 14...... 25274 31...... 29380 229...... 26539 175...... 25470 15...... 25274 32...... 29838 635 ...... 25357, 26540, 28106 19...... 25274 52...... 29838 178...... 25470, 26538 648...... 28875 33...... 25274 219...... 26533 571...... 27990 660...... 29482 36...... 25274 1852...... 29256 598...... 27990 679...... 25056

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REMINDERS due by 6-1-04; published 3- 04; published 5-5-04 published 3-31-04 [FR 04- The items in this list were 30-04 [FR 04-07003] [FR 04-10206] 06931] editorially compiled as an aid AGRICULTURE Pacific whiting; comments Flumioxazin; comments due to Federal Register users. DEPARTMENT due by 6-1-04; by 6-1-04; published 3-31- published 4-30-04 [FR 04 [FR 04-07198] Inclusion or exclusion from Forest Service this list has no legal 04-09844] Alaska National Interest Lands Rhamnolipid biosurfactant; significance. Marine mammals: Conservation Act; Title VIII comments due by 6-1-04; implementation (subsistence Commercial fishing published 3-31-04 [FR 04- priority): authorizations— 06933] RULES GOING INTO Zero Mortality Rate Goal; Zoxamide; comments due EFFECT MAY 25, 2004 Federal Subsistence Regional Advisory mortality and serious by 6-1-04; published 3-31- Councils; membership injury threshold level; 04 [FR 04-06932] COMMERCE DEPARTMENT qualifications; comments comments due by 6-1- Solid wastes: 04; published 4-29-04 National Oceanic and due by 6-1-04; published State underground storage [FR 04-09753] Atmospheric Administration 4-15-04 [FR 04-08569] tank program approvals— COURT SERVICES AND Fishery conservation and AGRICULTURE Missouri; comments due OFFENDER SUPERVISION management: DEPARTMENT by 6-4-04; published 5- AGENCY FOR THE Alaska; fisheries of 5-04 [FR 04-10214] Rural Utilities Service DISTRICT OF COLUMBIA Exclusive Economic FEDERAL Program regulations: Semi-annual agenda; Open for Zone— COMMUNICATIONS Seismic safety of federally comments until further Bering Sea and Aleutian COMMISSION assisted new building notice; published 12-22-03 Islands rock sole; construction; compliance [FR 03-25121] Common carrier services: published 5-25-04 requirements; comments Minimum customer account ENERGY DEPARTMENT ENVIRONMENTAL due by 6-1-04; published record exchange PROTECTION AGENCY 4-30-04 [FR 04-09611] Federal Energy Regulatory obligations on all local Commission Air programs; State authority COMMERCE DEPARTMENT and interexchange delegations: Electric rate and corporate carriers; implementation; Census Bureau regulation filings: Louisiana; published 3-26-04 comments due by 6-3-04; Special services and studies: Virginia Electric & Power published 4-19-04 [FR 04- HOMELAND SECURITY Age Search Program; fee Co. et al.; Open for 08481] DEPARTMENT structure; comments due comments until further FEDERAL TRADE by 6-1-04; published 4-30- Coast Guard notice; published 10-1-03 COMMISSION 04 [FR 04-09661] [FR 03-24818] Drawbridge operations: Hart-Scott-Rodino Antitrust Texas; published 5-6-04 COMMERCE DEPARTMENT ENVIRONMENTAL Improvements Act: PROTECTION AGENCY INTERIOR DEPARTMENT Industry and Security Premerger notification; Bureau Air quality implementation Fish and Wildlife Service reporting and waiting Export administration plans; approval and period requirements; Endangered Species Act: regulations: promulgation; various comments due by 6-4-04; States: Incidental take permit Libya; export and re-export published 4-8-04 [FR 04- revocation regulations; restrictions revision; West Virginia; comments 07537] withdrawn; published 5- comments due by 6-1-04; due by 6-4-04; published Telemarketing sales rule: 25-04 5-5-04 [FR 04-10095] published 4-29-04 [FR 04- National Do-Not-Call TRANSPORTATION 09717] Environmental statements; Registry; user fees; availability, etc.: DEPARTMENT COMMERCE DEPARTMENT comments due by 6-1-04; Federal Aviation Coastal nonpoint pollution published 4-30-04 [FR 04- National Oceanic and control program— Administration Atmospheric Administration 09848] Airworthiness directives: Minnesota and Texas; Fishery conservation and Open for comments HEALTH AND HUMAN Bombardier; published 4-22- management: until further notice; SERVICES DEPARTMENT 04 Alaska; fisheries of published 10-16-03 [FR Food and Drug TRANSPORTATION Exclusive Economic 03-26087] Administration DEPARTMENT Zone— Pesticides; tolerances in food, Medical devices: Federal Railroad Fish meal, fish oil, and animal feeds, and raw Orthopedic devices— Administration bone meal; comments agricultural commodities: Hip joint metal/polymer or Freight and other non- due by 6-4-04; 6-Benzyladenine; comments ceramic/polymer passenger trains and published 5-5-04 [FR due by 6-1-04; published semiconstrained equipment; brake system 04-10208] 4-2-04 [FR 04-07475] resurfacing cemented safety standards; end-of- Northeastern United States Bacillus thurigiensis prosthesis; premarket train devices; civil penalties fisheries— Cry2Ab2; comments due approval requirement schedule adjustment; Atlantic bluefish; by 6-1-04; published 3-31- effective date; published 5-25-04 comments due by 6-3- 04 [FR 04-07076] comments due by 6-3- 04; published 5-19-04 Bacillus thurigiensis CryIF 04; published 3-5-04 COMMENTS DUE NEXT [FR 04-11350] protein in cotton; [FR 04-04885] WEEK West Coast States and comments due by 6-1-04; Reports and guidance Western Pacific published 3-31-04 [FR 04- documents; availability, etc.: fisheries— 07077] Evaluating safety of AGRICULTURE Pacific Coast groundfish; Bacillus thuringiensis antimicrobial new animal DEPARTMENT comments due by 6-1- Cry3Bb1; comments due drugs with regard to their Agricultural Marketing 04; published 4-29-04 by 6-1-04; published 3-31- microbiological effects on Service [FR 04-09649] 04 [FR 04-06930] bacteria of human health Fluid milk promotion order; Pacific Coast groundfish; Bacillus thuringiensis VIP3A; concern; Open for regulatory review; comments comments due by 6-1- comments due by 6-1-04; comments until further

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notice; published 10-27-03 LABOR DEPARTMENT Empresa Brasileira de Regulatory Flexibility Act [FR 03-27113] Occupational Safety and Aeronautica S.A. Section 610 and plain (EMBRAER); comments language reviews; HOMELAND SECURITY Health Administration due by 6-1-04; published comments due by 6-1-04; DEPARTMENT Occupational safety and 4-29-04 [FR 04-09765] published 3-1-04 [FR 04- Health standards: Coast Guard Gulfstream; comments due 04401] Electrical installation; Anchorage regulations: by 6-2-04; published 5-3- TREASURY DEPARTMENT comments due by 6-4-04; Maryland; Open for 04 [FR 04-09901] published 4-5-04 [FR 04- Internal Revenue Service comments until further Gulfstream Aerospace; 07033] Income taxes: notice; published 1-14-04 comments due by 6-1-04; Corporate reorganizations; [FR 04-00749] Pipeline Safety Improvement published 4-29-04 [FR 04- Act; discrimination complaint asset and stock transfers; San Francisco Bay, CA; 09764] procedures; comments due transaction requirements; comments due by 6-1-04; Lancair Co.; comments due by 6-4-04; published 4-5-04 comments due by 6-1-04; published 4-1-04 [FR 04- by 6-1-04; published 3-26- [FR 04-07612] published 3-2-04 [FR 04- 07273] 04 [FR 04-06498] 04483] Drawbridge operations: NATIONAL AERONAUTICS New Piper Aircraft, Inc.; Modified accelerated cost AND SPACE comments due by 6-1-04; Mississippi; comments due recovery system property; ADMINISTRATION published 3-31-04 [FR 04- by 6-1-04; published 4-1- changes in use; 07128] 04 [FR 04-07272] Acquisition regulations: depreciation; comments Sikorsky Aircraft New York; comments due NASA FAR Supplement due by 6-1-04; published Subchapter F; reissuance; Corporation; comments 3-1-04 [FR 04-03993] by 6-3-04; published 5-4- due by 6-1-04; published comments due by 6-1-04; TREASURY DEPARTMENT 04 [FR 04-10114] 3-31-04 [FR 04-06777] published 3-31-04 [FR 04- Privacy Act; implementation; Ports and waterways safety: Airworthiness standards: 07239] comments due by 6-1-04; Boston Harbor, MA; safety Special conditions— NATIONAL ARCHIVES AND published 4-30-04 [FR 04- and security zones; Cessna Model 500, 550, RECORDS ADMINISTRATION 09813] comments due by 6-1-04; and S550 airplanes; published 3-31-04 [FR 04- Public availability and use: comments due by 6-4- 07109] Records and donated 04; published 5-5-04 LIST OF PUBLIC LAWS Hampton Roads, VA— historical materials use; [FR 04-10238] Security zone; comments research room Class C airspace; comments This is a continuing list of due by 6-3-04; procedures; comments due by 6-3-04; published 4- public bills from the current published 5-4-04 [FR due by 6-1-04; published 19-04 [FR 04-08809] session of Congress which 04-10115] 3-31-04 [FR 04-07169] Class E airspace; comments have become Federal laws. It due by 5-31-04; published may be used in conjunction HOUSING AND URBAN NUCLEAR REGULATORY 4-7-04 [FR 04-07879] with ‘‘PLUS’’ (Public Laws DEVELOPMENT COMMISSION Jet routes; comments due by Update Service) on 202–741– DEPARTMENT Environmental statements; 6043. This list is also availability, etc.: 6-1-04; published 4-15-04 HOME Investment [FR 04-08506] available online at http:// Partnerships Program: Fort Wayne State www.archives.gov/ TRANSPORTATION Developmental Center; federal—register/public—laws/ American Dream DEPARTMENT Downpayment Initiative; Open for comments until public—laws.html. comments due by 6-1-04; further notice; published National Highway Traffic 5-10-04 [FR 04-10516] Safety Administration The text of laws is not published 3-30-04 [FR 04- published in the Federal Motor vehicle safety 07122] SECURITIES AND Register but may be ordered standards: EXCHANGE COMMISSION in ‘‘slip law’’ (individual INTERIOR DEPARTMENT Defect and noncompliance— Self-regulatory organizations; pamphlet) form from the Fish and Wildlife Service proposed rule changes; Potential defects; Superintendent of Documents, Alaska National Interest Lands amendments; comments due information and U.S. Government Printing Conservation Act; Title VIII by 6-4-04; published 4-5-04 documents reporting; Office, Washington, DC 20402 implementation (subsistence [FR 04-07538] comments due by 6-1- (phone, 202–512–1808). The priority): 04; published 4-16-04 text will also be made Correction; comments due [FR 04-08716] Federal Subsistence by 6-4-04; published 4-30- available on the Internet from Occupant crash protection— Regional Advisory 04 [FR C4-07538] GPO Access at http:// Councils; membership Safety equipment removal; www.gpoaccess.gov/plaws/ qualifications; comments SMALL BUSINESS exemptions from make index.html. Some laws may due by 6-1-04; published ADMINISTRATION inoperative prohibition not yet be available. 4-15-04 [FR 04-08569] Disaster loan areas: for persons with S. 2315/P.L. 108–228 Endangered and threatened Maine; Open for comments disabilities; comments species permit applications: until further notice; due by 6-4-04; To amend the published 4-20-04 [FR Communications Satellite Act Critical habitat published 2-17-04 [FR 04- 04-08932] of 1962 to extend the designations— 03374] National Driver Register deadline for the INTELSAT Eggert’s sunflower; TRANSPORTATION Problem Driver Pointer initial public offering. (May 18, comments due by 6-4- DEPARTMENT System; receiving data and 2004; 118 Stat. 644) 04; published 4-5-04 Federal Aviation participation procedures; Last List May 10, 2004 [FR 04-07547] Administration comments due by 6-1-04; INTERIOR DEPARTMENT Airworthiness directives: published 3-31-04 [FR 04- National Park Service Airbus; comments due by 6- 07245] Public Laws Electronic Notification Service National Park System units in 2-04; published 5-3-04 TRANSPORTATION Alaska; amendments; [FR 04-09904] DEPARTMENT (PENS) comments due by 6-1-04; Bombardier; comments due Research and Special published 4-2-04 [FR 04- by 6-4-04; published 5-5- Programs Administration PENS is a free electronic mail 07131] 04 [FR 04-10253] Hazardous materials: notification service of newly

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enacted public laws. To Note: This service is strictly PENS cannot respond to subscribe, go to http:// for E-mail notification of new specific inquiries sent to this listserv.gsa.gov/archives/ laws. The text of laws is not address. publaws-l.html available through this service.

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