Vol. 76 Monday, No. 191 October 3, 2011

Pages 61033–61248

OFFICE OF THE FEDERAL REGISTER

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Contents Federal Register Vol. 76, No. 191

Monday, October 3, 2011

Administrative Conference of the United States Environmental Protection Agency NOTICES RULES Meetings: Approval and Promulgation of State Implementation Plans: Committees on Administration and Management, State of Colorado Regulation Number 3; Revisions to the Collaborative Governance, Judicial Review, and Air Pollutant Emission Notice Requirements and Regulation, 61072 Exemptions, 61054–61056 Revisions to the California State Implementation Plan: Agriculture Department Sacramento Metropolitan Air Quality Management See Animal and Plant Health Inspection Service District, Ventura County Air Pollution Control See Forest Service District, and Placer County Air Pollution Control NOTICES District, 61057–61059 Agency Information Collection Activities; Proposals, PROPOSED RULES Submissions, and Approvals, 61072–61073 Approvals and Promulgations of Implementation Plans: Increase in Fiscal Year 2011 Tariff-Rate Quota for Refined Arizona; Update to Stage II Gasoline Vapor Recovery Sugar, 61074 Program; Change in Definition of Gasoline To Exclude E85, 61062–61069 Revisions to the California State Implementation Plan: Animal and Plant Health Inspection Service Sacramento Metropolitan Air Quality Management PROPOSED RULES District, Ventura County Air Pollution Control Agricultural Bioterrorism Protection Act of 2002: District, and Placer County Air Pollution Control Biennial Review and Republication of the Select Agent District, 61069–61070 and Toxin List; Amendments to the Select Agent and NOTICES Toxin Regulations, 61228–61244 Determinations and Waivers of Preemption Decisions: Amendments to California’s Zero-Emission Vehicle Arctic Research Commission Standards, 61095–61098 NOTICES Exposure Factors Handbook; 2011 Edition, 61098 Meetings: Guidance for 1-Hour SO2 NAAQS SIP Submissions; Reports and Updates on Arctic Research Programs and Availability, 61098–61100 Projects, 61074–61075 Meetings: Local Government Advisory Committee, 61101 National and Governmental Advisory Committees to the Centers for Medicare & Medicaid Services U.S. Representative to the Commission for NOTICES Environmental Cooperation, 61100 Medicare Program; Comprehensive Primary Care Initiative, Science Advisory Board Biogenic Carbon Emissions 61103 Panel, 61100–61101

Commerce Department Executive Office of the President See Foreign-Trade Zones Board See Presidential Documents See International Trade Administration See National Oceanic and Atmospheric Administration Federal Aviation Administration RULES Defense Department Airworthiness Directives: See Navy Department Boeing Co. Model 737 Series Airplanes, 61033–61036 Gulfstream Aerospace LP Model Galaxy and Gulfstream Drug Enforcement Administration 200 Airplanes, 61036–61038 Standard Instrument Approach Procedures, and Takeoff NOTICES Minimums and Obstacle Departure Procedures, 61038– Decisions and Orders: 61041 Robert Raymond Reppy, D.O., 61154–61181 NOTICES Environmental Impact Statements; Availability, etc.: Employment and Training Administration Theodore Francis Green Airport; Warwick, RI, 61135 NOTICES Agency Information Collection Activities; Proposals, Federal Election Commission Submissions, and Approvals: NOTICES Migrant and Seasonal Farmworkers Monitoring Report Meetings; Sunshine Act, 61101–61102 and One-Stop Career Center Complaint/Referral Record, 61115–61117 Federal Emergency Management Agency PROPOSED RULES Energy Department Disaster Assistance; Hazard Mitigation Grant Program, See Federal Energy Regulatory Commission 61070–61071 See Western Area Power Administration Flood Elevation Determinations, 61070

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Federal Energy Regulatory Commission See National Institutes of Health NOTICES See Substance Abuse and Mental Health Services Combined Filings, 61093–61095 Administration PROPOSED RULES Federal Highway Administration Possession, Use, and Transfer of Select Agents and Toxins; NOTICES Biennial Review, 61206–61226 Environmental Impact Statements; Availability, etc.: El Paso County, TX, 61135–61136 Health Resources and Services Administration NOTICES Federal Motor Carrier Safety Administration Agency Information Collection Activities; Proposals, NOTICES Submissions, and Approvals, 61105–61106 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Homeland Security Department Commercial Driver Individual Differences Study, 61136– See Federal Emergency Management Agency 61137 Applications for Exemptions: Housing and Urban Development Department Western Pilot Service; Hours of Service of Drivers, NOTICES 61137–61138 Agency Information Collection Activities; Proposals, Environmental Assessments; Availability, etc.: Submissions, and Approvals: Pilot Program on NAFTA Long-Haul Trucking Provisions, Annual Progress Reports for Empowerment Zones, 61138–61139 61112–61113 Qualification of Drivers; Exemption Applications; Diabetes Self-Help Homeownership Opportunity Program, 61111– Mellitus, 61139–61143 61112 Qualification of Drivers; Exemption Applications; Vision, 61143–61145 Interior Department Federal Reserve System See Geological Survey See Land Management Bureau NOTICES Changes in Bank Control: Acquisitions of Shares of Savings and Loan Holding Internal Revenue Service Company, 61102 NOTICES Formations of, Acquisitions by, and Mergers of Bank Agency Information Collection Activities; Proposals, Holding Companies, 61102 Submissions, and Approvals, 61145–61147 Formations of, Acquisitions by, and Mergers of Savings and Meetings: Loan Holding Companies, 61102 Information Reporting Program Advisory Committee, 61147 Food and Drug Administration NOTICES International Trade Administration Draft Guidance for Industry and Staff; Availability: RULES De Novo Classification Process (Evaluation of Automatic Practice of Accepting Bonds During Provisional Measures Class III Designation), 61103–61105 Period in Antidumping and Countervailing Duty Investigations: Foreign-Trade Zones Board Modification of Regulations, 61042–61046 NOTICES NOTICES Applications for Reorganization Under Alternative Site Antidumping and Countervailing Duty Administrative Framework: Reviews; Initiations and Requests for Revocations in Foreign-Trade Zone 275, Lansing, MI, 61075 Part, 61076–61085 Applications for Reorganization/Expansion Under Antidumping Duty Administrative Reviews; Extensions of Alternative Site Framework: Preliminary Results: Foreign-Trade Zone 127, Columbia, SC, 61075–61076 Polyethylene Terephthalate Film, Sheet, and Strip From Applications for Subzones; Terminations of Reviews: the People’s Republic of China, 61085 Foreign-Trade Zone 57, Mecklenburg County, NC; FMS Antidumping or Countervailing Duty Orders, Findings, or Enterprises USA, Inc., Lincolnton, NC, 61076 Suspended Investigations: Opportunity To Request Administrative Reviews, 61085– Forest Service 61087 NOTICES Antidumping or Countervailing Duty Orders, Findings, or Meetings: Suspended Investigations; Sunset Reviews, 61087– Lake Tahoe Basin Federal Advisory Committee, 61074 61088 New Shipper Reviews; Initiations: Geological Survey Certain Frozen Fish Fillets From Socialist Republic of NOTICES Vietnam, 61088–61089 Meetings: Scientific Earthquake Studies Advisory Committee, 61113 Justice Department See Drug Enforcement Administration Health and Human Services Department NOTICES See Centers for Medicare & Medicaid Services Agency Information Collection Activities; Proposals, See Food and Drug Administration Submissions, and Approvals: See Health Resources and Services Administration COPS Application Package, 61114–61115

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Labor Department NOTICES See Employment and Training Administration Environmental Assessments; Availability, etc.: NOTICES Proposed Network Optimization, Nationwide, 61120 List of Goods From Countries Produced by Child or Forced Labor; 2011 Update, 61115 Presidential Documents ADMINISTRATIVE ORDERS Land Management Bureau Aviation Insurance Coverage for Commercial Air Carrier NOTICES Service in Domestic and International Operations Filing of Plats of Survey: (Memorandum of September 28, 2011), 61245–61247 Nevada, 61113–61114 Oregon/Washington, 61114 Securities and Exchange Commission NOTICES National Institutes of Health Agency Information Collection Activities; Proposals, NOTICES Submissions, and Approvals, 61120–61121 Environmental Impact Statements; Availability, etc., 61106– Self-Regulatory Organizations; Proposed Rule Changes, 61107 61121–61122 Self-Regulatory Organizations; Proposed Rule Changes: National Oceanic and Atmospheric Administration BATS Exchange, Inc., 61127–61129 RULES BATS Y-Exchange, Inc., 61125–61127 Fisheries of Northeastern United States: Financial Industry Regulatory Authority, Inc., 61124– Atlantic Herring Fishery; Sub-ACL (Annual Catch Limit) 61125 Harvested for Management Area 1B, 61059–61060 NASDAQ Stock Market LLC, 61122–61123, 61129 Atlantic Herring Fishery; Sub-ACL (Annual Catch Limit) Suspension of Trading Orders: Harvested for Management Area 3, 61061 BB Liquidation Inc., 61129 Northeast Multispecies Fishery; Correction to Cod Landing Limit for Handgear B Vessels in Common Small Business Administration Pool Fishery, 61060–61061 NOTICES NOTICES Damage Assessment, Remediation, and Restoration Agency Information Collection Activities; Proposals, Program: Submissions, and Approvals, 61129 Indirect Cost Rates for Fiscal Years 2009 and 2010, Disaster Declarations: 61089–61090 Maine; Amendment 1, 61130 Endangered and Threatened Species: Missouri, 61130 Counterpart Regulations, 61090 New Hampshire; Amendment 3, 61131 Meetings: New York; Amendment 3, 61130–61131 Hydrographic Services Review Panel, 61091 Pennsylvania; Amendment 1, 61130 South Atlantic Fishery Management Council, 61091 Rhode Island, 61131 Stock Assessment Reports; Availability: Dusky, Sandbar, and Blacknose Sharks in U.S. Atlantic State Department and Gulf of Mexico, 61092 NOTICES Determinations and Certifications: National Science Foundation Colombian Armed Forces, 61131–61132 NOTICES Privacy Act; Systems of Records, 61132–61133 Antarctic Conservation Act Permit Applications, 61117 Waivers of Restriction on Assistance: Meetings: Central Government of Angola, 61134 Advisory Committee for Computer and Information Central Government of Cameroon, 61134 Science and Engineering, 61118 Central Government of Central African Republic, 61134 Central Government of Chad, 61134 Navy Department Central Government of Coˆte d’Ivoire, 61135 NOTICES Central Government of Democratic Republic of Congo, Environmental Impact Statements; Availability, etc. 61134 TRIDENT Support Facilities Explosives Handling Wharf, Central Government of Ethiopia, 61134 Naval Base Kitsa, Bangor, WA, 61092–61093 Central Government of Gabon, 61135 Central Government of The Gambia, 61133 Nuclear Regulatory Commission Central Government of Guinea, 61133 NOTICES Central Government of Guinea–Bissau, 61133 Meetings: Central Government of Niger, 61133 Advisory Committee on Reactor Safeguards, 61118–61120 Central Government of the Kingdom of Swaziland, 61135 Advisory Committee on Reactor Safeguards Transitional Federal Government of Somalia, 61135 Subcommittee on Advanced Boiling Water Reactor, 61118 Substance Abuse and Mental Health Services Advisory Committee on Reactor Safeguards Administration Subcommittee on Planning and Procedures, 61119 NOTICES Postal Service Agency Information Collection Activities; Proposals, RULES Submissions, and Approvals, 61107–61110 Service Standards for Market-Dominant Special Services Laboratories and Testing Facilities Which Meet Minimum Products, 61052–61054 Standards for Urine Drug Testing, 61110–61111

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Transportation Department Separate Parts In This Issue See Federal Aviation Administration See Federal Highway Administration Part II See Federal Motor Carrier Safety Administration Justice Department, Drug Enforcement Administration, 61154–61181 Treasury Department See Internal Revenue Service RULES Part III Troubled Asset Relief Program; Conflicts of Interest, 61046– Energy Department, Western Area Power Administration, 61052 61184–61203

Veterans Affairs Department Part IV NOTICES Health and Human Services Department, 61206–61226 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Part V Application for U.S. Flag for Burial Purposes, 61148 Agriculture Department, Animal and Plant Health Approval of School Attendance, 61148–61149 Inspection Service, 61228–61244 Disability Benefits Questionnaires, 61149–61150 Fiduciary Statement in Support of Appointment, 61147– Part VI 61148 Presidential Documents, 61245–61247 Enhanced-Use Leases: Fort Howard, MD, 61150 Lyons, NJ, 61151 VA Connecticut Healthcare System, Newington Reader Aids Campus,CT, 61150 Consult the Reader Aids section at the end of this page for phone numbers, online resources, finding aids, reminders, Western Area Power Administration and notice of recently enacted public laws. NOTICES To subscribe to the Federal Register Table of Contents Rate Orders: LISTSERV electronic mailing list, go to http:// Loveland Area Projects—Western Area Colorado Missouri listserv.access.gpo.gov and select Online mailing list Balancing Authority, 61184–61203 archives, FEDREGTOC-L, Join or leave the list (or change 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 Administrative Orders: Memorandums: Memorandum of September 28, 2011 ...... 61247 7 CFR Proposed Rules: 331...... 61228 9 CFR Proposed Rules: 121...... 61228 14 CFR 39 (2 documents) ...... 61033, 61036 97 (2 documents) ...... 61038, 61040 19 CFR 351...... 61042 31 CFR 31...... 61046 39 CFR 122...... 61052 40 CFR 52 (2 documents) ...... 61054, 61057 Proposed Rules: 52 (2 documents) ...... 61062, 61069 42 CFR Proposed Rules: 73...... 61206 44 CFR Proposed Rules: 67...... 61070 206...... 61070 50 CFR 648 (3 documents) ...... 61059, 61060, 61061

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Rules and Regulations Federal Register Vol. 76, No. 191

Monday, October 3, 2011

This section of the FEDERAL REGISTER The Director of the Federal Register from the airplane since the airplane was contains regulatory documents having general approved the incorporation by reference manufactured. For airplanes on which applicability and legal effect, most of which of a certain publication listed in the AD an engine has been removed, the are keyed to and codified in the Code of as of November 7, 2011. original NPRM also requires an Federal Regulations, which is published under inspection of the aft engine mount to 50 titles pursuant to 44 U.S.C. 1510. ADDRESSES: For service information identified in this AD, contact Boeing determine if the center link assembly is The Code of Federal Regulations is sold by Commercial Airplanes, Attention: Data correctly installed, and follow-on the Superintendent of Documents. Prices of & Services Management, P.O. Box 3707, actions if necessary. The original NPRM new books are listed in the first FEDERAL MC 2H–65, Seattle, Washington 98124– also proposed to require those same REGISTER issue of each week. 2207; telephone 206–544–5000, actions on airplanes on which the extension 1; fax 206–766–5680; e-mail engine has not previously been [email protected]; Internet removed. The SNPRM proposed to DEPARTMENT OF TRANSPORTATION https://www.myboeingfleet.com. You further expand the applicability to include Model 737–900ER airplanes. Federal Aviation Administration may review copies of the referenced service information at the FAA, Comments 14 CFR Part 39 Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington. We gave the public the opportunity to [Docket No. FAA–2008–1118; Directorate For information on the availability of participate in developing this AD. The Identifier 2007–NM–318–AD; Amendment this material at the FAA, call 425–227– following presents the comments 39–16792; AD 2011–18–10] 1221. received on the proposal and the FAA’s response to each comment. RIN 2120–AA64 Examining the AD Docket Supportive Comments You may examine the AD docket on Airworthiness Directives; The Boeing Boeing and Continental Airlines Company Model 737–600, –700, –700C, the Internet at http:// www.regulations.gov; or in person at the concur with the SNPRM (76 FR 1552, –800, –900, and –900ER Series January 11, 2011). Airplanes Docket Management Facility between 9 a.m. and 5 p.m., Monday through Request for Information AGENCY: Federal Aviation Friday, except Federal holidays. The AD American Airlines stated that it has Administration (FAA), DOT. docket contains this AD, the regulatory accomplished the actions required by evaluation, any comments received, and ACTION: Final rule. AD 2003–03–01 (68 FR 4367, January other information. The address for the 29, 2003) and the SNPRM (76 FR 1552, SUMMARY: We are superseding an Docket Office (phone: 800–647–5527) is January 11, 2011), and although it will existing airworthiness directive (AD) for Document Management Facility, U.S. no longer be affected by the the products listed above. The existing Department of Transportation, Docket requirements in the SNPRM, asked the AD currently requires reviewing the Operations, M–30, West Building airplane maintenance records to following questions: Ground Floor, Room W12–140, 1200 • What action has the original determine whether an engine has been New Jersey Avenue, SE., Washington, equipment manufacturer, Boeing, taken removed from the airplane since the DC 20590. to prevent incorrect aft mount assembly airplane was manufactured. For FOR FURTHER INFORMATION CONTACT: installations? airplanes on which an engine has been Alan Pohl, Aerospace Engineer, • Can Boeing specifically identify the removed, the existing AD also requires Airframe Branch, ANM–120S, FAA, procedures and/or best practices an inspection of the aft engine mount to Seattle Aircraft Certification Office, incorporated into their production determine if the center link assembly is 1601 Lind Avenue, SW., Renton, process to prevent a recurrence of this correctly installed, and follow-on Washington 98057–3356; telephone type of event? actions if necessary. This new AD (425) 917–6450; fax (425) 917–6590. We acknowledge the commenter’s expands the applicability to include SUPPLEMENTARY INFORMATION: concerns and provide the following airplanes on which the engine has not responses: been previously removed, and Model Discussion • Boeing Alert Service Bulletin 737– 737–900ER airplanes. This AD was We issued a supplemental notice of 71A1462, Revision 2, dated May 29, prompted by reports indicating that proposed rulemaking (SNPRM) to 2003; and Revision 3, dated May 20, operators found that the center link amend 14 CFR part 39 to supersede 2004; specify marking of the hangar assembly for the aft engine mount was airworthiness directive (AD) 2003–03– fitting (pylon structure) and center link reversed on several airplanes that had 01, Amendment 39–13025 (68 FR 4367, (engine structure) assembly, which is not had an engine removed since January 29, 2003). That AD applies to the same as the marking incorporated delivery. We are issuing this AD to the specified products. The SNPRM previously in production. These marks prevent increased structural loads on published in the Federal Register on ‘‘L,’’ ‘‘AFT,’’ and ‘‘R,’’ applied to both the aft engine mount, which could January 11, 2011 (76 FR 1552). The the hangar fitting and center link result in failure of the aft engine mount original NPRM (73 FR 64568, October assembly will only be in close proximity and consequent separation of the engine 30, 2008) proposed to continue to if the center link is installed correctly. from the airplane. require reviewing the airplane • Boeing has advised us that it has DATES: This AD is effective November 7, maintenance records to determine revised the instructions in its 2011. whether an engine has been removed component maintenance manuals

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(assembly level) and aircraft indicate the part orientation when determined that air safety and the maintenance manuals (installation assembled, and the hanger assembly public interest require adopting the AD level) to put special emphasis on the was marked with ‘AFT’ at the center as proposed. center link installation. Boeing also line. Boeing has also developed a shop advised us that it implemented drawing aid for use at the facility where the parts Costs of Compliance changes affecting both production are fabricated and assembled which We estimate that this AD affects 854 assembly and field installation of this helps the assembler confirm the correct airplanes of U.S. registry. There are no part; these changes incorporated orientation of the parts. We have made new requirements in this AD; however, specific markings on both the center no change to the AD in this regard. we have expanded the applicability of link assembly and the hanger fitting to Conclusion which it is attached. Boeing noted that this AD. The current costs for this AD after 2003 the parts were marked with We reviewed the relevant data, are recalculated for the convenience of an ‘‘L’’ and ‘‘R’’ (left and right) to considered the comments received, and affected operators, as follows:

ESTIMATED COSTS

Cost per Action Work hours Parts airplane Fleet cost

Maintenance records review (required by AD 2003–03–01, Amendment 39– 13025 (68 FR 4367, January 29, 2003)) ...... 1 $0 $85 $72,590 Inspection for correct installation of center link assembly (new required ac- tion) ...... 1 0 85 72,590

Authority for This Rulemaking (4) Will not have a significant –800, –900, and –900ER series airplanes, certificated in any category. Title 49 of the United States Code economic impact, positive or negative, specifies the FAA’s authority to issue on a substantial number of small entities Subject rules on aviation safety. Subtitle I, under the criteria of the Regulatory (d) Air Transport Association (ATA) of section 106, describes the authority of Flexibility Act. America Code 71: Powerplant. the FAA Administrator. Subtitle VII: List of Subjects in 14 CFR Part 39 Unsafe Condition Aviation Programs, describes in more Air transportation, Aircraft, Aviation (e) This AD was prompted by reports detail the scope of the Agency’s safety, Incorporation by reference, indicating that operators found that the authority. Safety. center link assembly for the aft engine mount We are issuing this rulemaking under was reversed on several airplanes that had the authority described in Subtitle VII, Adoption of the Amendment not had an engine removed since delivery. We are issuing this AD to prevent increased Part A, Subpart III, Section 44701: Accordingly, under the authority ‘‘General requirements.’’ Under that structural loads on the aft engine mount, delegated to me by the Administrator, which could result in failure of the aft engine section, Congress charges the FAA with the FAA amends 14 CFR part 39 as promoting safe flight of civil aircraft in mount and consequent separation of the follows: engine from the airplane. air commerce by prescribing regulations for practices, methods, and procedures PART 39—AIRWORTHINESS Compliance the Administrator finds necessary for DIRECTIVES (f) You are responsible for having the safety in air commerce. This regulation actions required by this AD performed within is within the scope of that authority ■ 1. The authority citation for part 39 the compliance times specified, unless the because it addresses an unsafe condition continues to read as follows: actions have already been done. that is likely to exist or develop on Authority: 49 U.S.C. 106(g), 40113, 44701. Restatement of Requirements of AD 2003– products identified in this rulemaking 03–01 (68 FR 4367, January 29, 2003): action. § 39.13 [Amended] Review of Maintenance Records Regulatory Findings ■ 2. The FAA amends § 39.13 by (g) For Model 737–600, –700, –700C, –800, removing airworthiness directive (AD) and –900 series airplanes: Within 90 days This AD will not have federalism 2003–03–01, Amendment 39–13025 (68 after February 13, 2003 (the effective date of implications under Executive Order FR 4367, January 29, 2003), and by AD 2003–03–01 (68 FR 4367, January 29, 2003)), review the airplane maintenance 13132. This AD will not have a adding the following new AD: substantial direct effect on the States, on records to determine whether either engine the relationship between the national 2011–18–10 The Boeing Company: has been removed since the airplane’s date of manufacture. If neither engine has been government and the States, or on the Amendment 39–16792; Docket No. FAA–2008–1118; Directorate Identifier removed since the airplane’s date of distribution of power and 2007–NM–318–AD. manufacture, no further action is required by responsibilities among the various this paragraph. levels of government. Effective Date Inspection of Engines That Have Been For the reasons discussed above, I (a) This AD is effective November 7, 2011. Removed To Determine If Center Link certify that this AD: Affected ADs Assembly Is Installed Correctly (1) Is not a ‘‘significant regulatory action’’ under Executive Order 12866, (b) This AD supersedes AD 2003–03–01, (h) For Model 737–600, –700, –700C, –800, and –900 series airplanes on which any (2) Is not a ‘‘significant rule’’ under Amendment 39–13025 (68 FR 4367, January 29, 2003). installed engine has been removed from the DOT Regulatory Policies and Procedures airplane since the airplane’s date of (44 FR 11034, February 26, 1979), Applicability manufacture: Within 90 days after February (3) Will not affect intrastate aviation (c) This AD applies to all The Boeing 13, 2003, do a one-time general visual in Alaska, and Company Model 737–600, –700, –700C, inspection to determine if the center link

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assembly of the aft engine mount is installed Revision 3, dated May 20, 2004; except that New Requirements of This AD correctly, in accordance with the it is not necessary to submit a report of Accomplishment Instructions of Boeing Alert findings to the airplane manufacturer. As of Inspection of Engines That Have Not Been Service Bulletin 737–71A1462, Revision 1, the effective date of this AD, use only Boeing Removed To Determine If Center Link dated November 7, 2002; or Revision 3, dated Alert Service Bulletin 737–71A1462, Assembly Is Installed Correctly May 20, 2004. If the center link assembly is Revision 3, dated May 20, 2004. (k) For airplanes identified in Boeing Alert installed correctly, no further action is (1) Remove the center link assembly and Service Bulletin 737–71A1462, Revision 3, required by paragraph (h) or (i) of this AD for install it correctly. dated May 20, 2004, on which any installed that engine. As of the effective date of this (2) Perform a detailed inspection of the engine has not been removed from the AD, use only Boeing Alert Service Bulletin engine mounting lugs and engine turbine rear airplane since the airplane’s date of 737–71A1462, Revision 3, dated May 20, frame for cracking, yielding, buckling, or 2004. manufacture: Within 90 days after the wear damage. effective date of this AD, do a detailed (3) Perform a detailed inspection of the Note 1: For the purposes of this AD, a inspection to determine if the center link general visual inspection is: ‘‘A visual hardware for the aft engine mount; including assembly of the aft engine mount is installed examination of an interior or exterior area, the center link assembly, right link assembly, installation, or assembly to detect obvious aft mount hanger assembly, and link pins; for correctly, in accordance with the damage, failure, or irregularity. This level of cracking, yielding, buckling, or wear damage. Accomplishment Instructions of Boeing Alert inspection is made from within touching Service Bulletin 737–71A1462, Revision 3, distance unless otherwise specified. A mirror Note 2: For the purposes of this AD, a dated May 20, 2004. If the center link is may be necessary to ensure visual access to detailed inspection is: ‘‘An intensive installed correctly, no further action is all surfaces in the inspection area. This level examination of a specific item, installation, required by this paragraph for that engine. of inspection is made under normally or assembly to detect damage, failure, or available lighting conditions such as irregularity. Available lighting is normally Follow-On and Corrective Actions daylight, hanger lighting, flashlight, or supplemented with a direct source of good (l) For airplanes on which any center link lighting at an intensity deemed appropriate. droplight and may require removal or assembly is found installed incorrectly Inspection aids such as mirror, magnifying opening of access panels or doors. Stands, during the inspection required by paragraph lenses, etc., may be necessary. Surface ladders, or platforms may be required to gain (k) of this AD: Before further flight, do the proximity to the area being checked.’’ cleaning and elaborate procedures may be required.’’ follow-on and corrective actions required by Follow-On and Corrective Actions paragraph (i) of this AD. Repair (i) For airplanes on which any center link Credit for Actions Done Using Previous assembly is found installed incorrectly (j) If any cracking, yielding, buckling, or Service Information during any inspection required by paragraph wear damage is found during the inspections (h), (k), or (l) of this AD: Before further flight, required by paragraphs (i)(2) and (i)(3) of this (m) Inspections and corrective actions do the actions specified in paragraphs (i)(1), AD: Before further flight, replace the done before the effective date of this AD in (i)(2), and (i)(3) of this AD, in accordance discrepant part with a new or serviceable accordance with a Boeing service bulletin with the Accomplishment Instructions of part, or repair in accordance with a method listed in Table 1 of this AD are acceptable for Boeing Alert Service Bulletin 737–71A1462, approved in accordance with the procedures compliance with the corresponding Revision 1, dated November 7, 2002; or specified in paragraph (o) of this AD. requirements of this AD.

TABLE 1—PREVIOUS SERVICE BULLETINS

Boeing Alert Service Bulletin— Revision— Dated—

737–71A1462 ...... Original .... August 29, 2002. 737–71A1462 ...... 1 ...... November 7, 2002. 737–71A1462 ...... 2 ...... May 29, 2003.

Parts Installation Alternative Methods of Compliance (3) To request a different method of (n) As of the effective date of this AD, no (AMOCs) compliance or a different compliance time person may install an engine on any airplane (o) The certification office specified in for this AD, follow the procedures in 14 CFR identified in paragraph (c) of this AD unless paragraph (o)(1) or (o)(2) of this AD, as 39.19. Before using any approved AMOC on the actions required by paragraph (n)(1) or applicable, has the authority to approve any airplane to which the AMOC applies, (n)(2) of this AD are accomplished. AMOCs for paragraphs (i) and (j) of this AD, notify your appropriate principal inspector, (1) The inspection is accomplished in if requested using the procedures found in 14 or lacking a principal inspector, the manager accordance with the Accomplishment CFR 39.19. of the local flight standards district office/ Instructions of Boeing Alert Service Bulletin (1) For the structure identified in certificate holding district office. The AMOC 737–71A1462, Revision 3, dated May 20, paragraph (i)(2) of this AD: The Manager, approval letter must specifically reference 2004, and the center link assembly of the aft Engine Certification Office (ECO), FAA. Send this AD. engine mount is found to be installed information to ATTN: Antonio Cancelliere, (4) An AMOC that provides an acceptable correctly. Aerospace Engineer, ANE–141, FAA, ECO, level of safety may be used for any repair (2) The hanger fitting and center link 12 New England Executive Park, Burlington, required by paragraph (i)(3) of this AD if it assembly are marked and part marked in Massachusetts 01803–5299; telephone 781– is approved by Boeing Commercial Airplanes accordance with Part 2 of the 238–7751; fax 781–238–7199. Organization Designation Authorization Accomplishment Instructions of Boeing Alert (2) For the structure identified in (ODA) that has been authorized by the Service Bulletin 737–71A1462, Revision 3, paragraph (i)(3) of this AD: The Manager, Manager, Seattle ACO, to make those dated May 20, 2004. Seattle Aircraft Certification Office (ACO), findings. For a repair method to be approved, Note 3: For hanger fittings and center link FAA. Send information to ATTN: Alan Pohl, the repair must meet the certification basis of assemblies marked and part marked in Aerospace Engineer, Airframe Branch, ANM– the airplane, and the approval must production, as specified in Part 2 of the 120S, FAA, Seattle ACO, 1601 Lind Avenue, specifically refer to this AD. Accomplishment Instructions of Boeing Alert SW., Renton, Washington 98057–3356; Service Bulletin 737–71A1462, Revision 3, telephone (425) 917–6450; fax (425) 917– Material Incorporated by Reference dated May 20, 2004, the actions specified in 6590. Information may be e-mailed to: 9- (p) You must use Boeing Alert Service paragraph (n)(2) of this AD do not apply. [email protected]. Bulletin 737–71A1462, Revision 3, dated

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May 20, 2004, to do the actions required by Cracked nuts * * * were found on capability of the airplane. The required this AD, unless the AD specifies otherwise. aircraft’s production line during routine post actions include replacing nuts having (1) The Director of the Federal Register assembly inspection. Investigation revealed P/N MS21042L3, and in certain approved the incorporation by reference of that the cracks resulted from hydrogen locations, a one time radiographic Boeing Alert Service Bulletin 737–71A1462, embrittlement combined with high hardness. Revision 3, dated May 20, 2004, under 5 Non-conformity with certified mechanical inspection for cracked nuts and U.S.C. 552(a) and 1 CFR part 51. properties of this fastener can potentially replacing any cracked nuts. You may (2) For service information identified in lead to an unsafe condition. obtain further information by examining this AD, contact Boeing Commercial the MCAI in the AD docket. Airplanes, Attention: Data & Services The unsafe condition is cracked nuts in Management, P.O. Box 3707, MC 2H–65, multiple locations (including aileron Comments Seattle, Washington 98124–2207; telephone fittings, rudder tab assembly and We gave the public the opportunity to 206–544–5000, extension 1; fax 206–766– mounting structure for power drive participate in developing this AD. We 5680; e-mail [email protected]; units) could result in failure of affected Internet https://www.myboeingfleet.com. received no comments on the NPRM (76 locations and consequent reduced FR 38062, June 29, 2011) or on the (3) You may review copies of the controllability or reduced structural referenced service information at the FAA, determination of the cost to the public. Transport Airplane Directorate, 1601 Lind capability of the airplane. We are Avenue, SW., Renton, Washington. For issuing this AD to require actions to Conclusion correct the unsafe condition on these information on the availability of this We reviewed the available data and material at the FAA, call 425–227–1221. products. (4) You may also review copies of the determined that air safety and the service information that is incorporated by DATES: This AD becomes effective public interest require adopting the AD reference at the National Archives and November 7, 2011. as proposed. Records Administration (NARA). For The Director of the Federal Register information on the availability of this approved the incorporation by reference Differences Between This AD and the material at an NARA facility, call 202–741– of a certain publication listed in this AD MCAI or Service Information 6030, or go to http://www.archives.gov/ as of November 7, 2011. We have reviewed the MCAI and federal_register/code_of_federal_regulations/ ibr_locations.html. ADDRESSES: You may examine the AD related service information and, in docket on the Internet at http:// general, agree with their substance. But Issued in Renton, Washington on www.regulations.gov or in person at the we might have found it necessary to use September 8, 2011. U.S. Department of Transportation, different words from those in the MCAI Ali Bahrami, Docket Operations, M–30, West to ensure the AD is clear for U.S. Manager, Transport Airplane Directorate, Building Ground Floor, Room W12–140, operators and is enforceable. In making Aircraft Certification Service. 1200 New Jersey Avenue, SE., these changes, we do not intend to differ Peter A. White, Washington, DC. substantively from the information Manager, Engine and Propeller Directorate, FOR FURTHER INFORMATION CONTACT: provided in the MCAI and related Engine and Propeller Directorate, Aircraft service information. Certification Service. Mike Borfitz, Aerospace Engineer, International Branch, ANM–116, We might also have required different [FR Doc. 2011–24681 Filed 9–30–11; 8:45 am] Transport Airplane Directorate, FAA, actions in this AD from those in the BILLING CODE 4910–13–P 1601 Lind Avenue, SW., Renton, MCAI in order to follow our FAA Washington 98057–3356; telephone policies. Any such differences are highlighted in a NOTE within the AD. DEPARTMENT OF TRANSPORTATION (425) 227–2677; fax (425) 227–1149. SUPPLEMENTARY INFORMATION: Costs of Compliance Federal Aviation Administration Discussion We estimate that this AD will affect 2 14 CFR Part 39 We issued a notice of proposed products of U.S. registry. We also rulemaking (NPRM) to amend 14 CFR estimate that it will take about 227 [Docket No. FAA–2011–0646; Directorate part 39 to include an AD that would work-hours per product to comply with Identifier 2010–NM–224–AD; Amendment the basic requirements of this AD. The 39–16814; AD 2011–20–04] apply to the specified products. That NPRM was published in the Federal average labor rate is $85 per work-hour. RIN 2120–AA64 Register on June 29, 2011 (76 FR 38062). Required parts will cost about $0 per That NPRM proposed to correct an product. Where the service information Airworthiness Directives; Gulfstream unsafe condition for the specified lists required parts costs that are Aerospace LP Model Galaxy and products. The MCAI states: covered under warranty, we have Gulfstream 200 Airplanes assumed that there will be no charge for Cracked nuts (P/N [part number] MS– AGENCY: Federal Aviation 21042L3) were found on aircraft’s production these parts. As we do not control Administration (FAA), Department of line during routine post assembly inspection. warranty coverage for affected parties, Transportation (DOT). Investigation revealed that the cracks some parties may incur costs higher ACTION: Final rule. resulted from hydrogen embrittlement than estimated here. Based on these combined with high hardness. Non- figures, we estimate the cost of this AD SUMMARY: We are adopting a new conformity with certified mechanical to the U.S. operators to be $38,590, or airworthiness directive (AD) for the properties of this fastener can potentially $19,295 per product. products listed above. This AD results lead to an unsafe condition. Authority for This Rulemaking from mandatory continuing The unsafe condition of cracked nuts airworthiness information (MCAI) in multiple locations (including aileron Title 49 of the United States Code originated by an aviation authority of fittings, rudder tab assembly and specifies the FAA’s authority to issue another country to identify and correct mounting structure for power drive rules on aviation safety. Subtitle I, an unsafe condition on an aviation units) could result in failure of affected section 106, describes the authority of product. The MCAI describes the unsafe locations and consequent reduced the FAA Administrator. ‘‘Subtitle VII: condition as: controllability or reduced structural Aviation Programs,’’ describes in more

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detail the scope of the Agency’s the FAA amends 14 CFR part 39 as applicable areas identified in Steps 4, 5, 6, authority. follows: and 7 of the Accomplishment Instructions of We are issuing this rulemaking under Gulfstream Service Bulletin 200–51–366, the authority described in ‘‘Subtitle VII, PART 39—AIRWORTHINESS dated March 30, 2010, including Appendix A: Israel Aircraft Industries Document Part A, Subpart III, Section 44701: DIRECTIVES IS951400E, Radiographic Inspection of Self- General requirements.’’ Under that ■ 1. The authority citation for part 39 Locking Nut P/N MS21042L3, Revision A, section, Congress charges the FAA with continues to read as follows: dated January 25, 2010. promoting safe flight of civil aircraft in (2) For airplanes having serial numbers 224 air commerce by prescribing regulations Authority: 49 U.S.C. 106(g), 40113, 44701. through 231 inclusive: Do the actions in for practices, methods, and procedures § 39.13 [Amended] paragraphs (g)(2)(i) and (g)(2)(ii). the Administrator finds necessary for (i) Replace nuts having P/N MS21042L3 at ■ safety in air commerce. This regulation 2. The FAA amends § 39.13 by adding the location specified in Step 8.H. of the is within the scope of that authority the following new AD: Accomplishment Instructions of Gulfstream because it addresses an unsafe condition 2011–20–04 Gulfstream Aerospace LP: Service Bulletin 200–51–366, dated March that is likely to exist or develop on Amendment 39–16814. Docket No. 30, 2010, including Appendix A: Israel products identified in this rulemaking FAA–2011–0646; Directorate Identifier Aircraft Industries Document IS951400E, 2010–NM–224–AD. Radiographic Inspection of Self-Locking Nut action. P/N MS21042L3, Revision A, dated January Effective Date Regulatory Findings 25, 2010. (a) This airworthiness directive (AD) (ii) Do a radiographic inspection for We determined that this AD will not becomes effective November 7, 2011. cracking of nuts having P/N MS21042L3 at have federalism implications under Affected ADs the location specified in Step 8.J. of the Executive Order 13132. This AD will Accomplishment Instructions of Gulfstream not have a substantial direct effect on (b) None. Service Bulletin 200–51–366, dated March the States, on the relationship between Applicability 30, 2010, including Appendix A: Israel the national government and the States, (c) This AD applies to Gulfstream Aircraft Industries Document IS951400E, or on the distribution of power and Aerospace LP Model Galaxy and Gulfstream Radiographic Inspection of Self-Locking Nut responsibilities among the various 200 airplanes, certificated in any category, P/N MS21042L3, Revision A, dated January levels of government. serial numbers 219 through 231 inclusive. 25, 2010. Before further flight replace all cracked nuts. For the reasons discussed above, I Subject FAA AD Differences certify this AD: (d) Air Transport Association (ATA) of 1. Is not a ’’significant regulatory America Code 51: Standard Practices/ Note 1: This AD differs from the MCAI action’’ under Executive Order 12866; Structures. and/or service information as follows: No 2. Is not a ’’significant rule’’ under the Reason differences. DOT Regulatory Policies and Procedures (e) The mandatory continuing Other FAA AD Provisions (44 FR 11034, February 26, 1979); and airworthiness information (MCAI) states: 3. Will not have a significant (h) The following provisions also apply to economic impact, positive or negative, Cracked nuts * * * were found on this AD: aircraft’s production line during routine post on a substantial number of small entities (1) Alternative Methods of Compliance assembly inspection. Investigation revealed (AMOCs): The Manager, International under the criteria of the Regulatory that the cracks resulted from hydrogen Branch, ANM–116, Transport Airplane Flexibility Act. embrittlement combined with high hardness. Directorate, FAA, has the authority to We prepared a regulatory evaluation Non-conformity with certified mechanical approve AMOCs for this AD, if requested of the estimated costs to comply with properties of this fastener can potentially using the procedures found in 14 CFR 39.19. this AD and placed it in the AD docket. lead to an unsafe condition. In accordance with 14 CFR 39.19, send your The unsafe condition is cracked nuts in request to your principal inspector or local Examining the AD Docket multiple locations (including aileron fittings, Flight Standards District Office, as You may examine the AD docket on rudder tab assembly and mounting structure appropriate. If sending information directly the Internet at http:// for power drive units) could result in failure to the International Branch, send it to ATTN: www.regulations.gov; or in person at the of affected locations and consequent reduced Mike Borfitz, Aerospace Engineer, controllability or reduced structural International Branch, ANM–116, Transport Docket Operations office between 9 a.m. capability of the airplane. and 5 p.m., Monday through Friday, Airplane Directorate, FAA, 1601 Lind Compliance Avenue, SW., Renton, Washington 98057– except Federal holidays. The AD docket 3356; telephone (425) 227–2677; fax (425) contains the NPRM (76 FR 38062, June (f) You are responsible for having the 227–1149. Information may be e-mailed to: 9- 29, 2011), the regulatory evaluation, any actions required by this AD performed within [email protected]. comments received, and other the compliance times specified, unless the Before using any approved AMOC, notify information. The street address for the actions have already been done. your appropriate principal inspector, or Docket Operations office (telephone Actions lacking a principal inspector, the manager of (800) 647–5527) is in the ADDRESSES (g) Within 12 months after the effective the local flight standards district office/ section. Comments will be available in date of this AD, do the applicable actions certificate holding district office. The AMOC the AD docket shortly after receipt. specified in paragraphs (g)(1) and (g)(2) of approval letter must specifically reference this AD, in accordance with the this AD. List of Subjects in 14 CFR Part 39 Accomplishment Instructions in Gulfstream (2) Airworthy Product: For any requirement Air transportation, Aircraft, Aviation Service Bulletin 200–51–366, dated March in this AD to obtain corrective actions from a manufacturer or other source, use these safety, Incorporation by reference, 30, 2010, including Appendix A: Israel Aircraft Industries Document IS951400E, actions if they are FAA-approved. Corrective Safety. Radiographic Inspection of Self-Locking Nut actions are considered FAA-approved if they Adoption of the Amendment P/N MS21042L3, Revision A, dated January are approved by the State of Design Authority 25, 2010. (or their delegated agent). You are required Accordingly, under the authority (1) For all airplanes: Replace nuts having to assure the product is airworthy before it delegated to me by the Administrator, part number (P/N) MS21042L3 in the is returned to service.

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Related Information ACTION: Final rule. FOR FURTHER INFORMATION CONTACT: (i) Refer to MCAI Civil Aviation Authority Richard A. Dunham III, Flight Procedure of Israel (CAAI) Airworthiness Directive 57– SUMMARY: This establishes, amends, Standards Branch (AFS–420), Flight 10–06–18, dated July 27, 2010; and suspends, or revokes Standard Technologies and Programs Divisions, Gulfstream Service Bulletin 200–51–366, Instrument Approach Procedures Flight Standards Service, Federal dated March 30, 2010, including Appendix (SIAPs) and associated Takeoff Aviation Administration, Mike A: Israel Aircraft Industries Document Minimums and Obstacle Departure Monroney Aeronautical Center, 6500 IS951400E, Radiographic Inspection of Self- Procedures for operations at certain Locking Nut P/N MS21042L3, Revision A, South MacArthur Blvd., Oklahoma City, dated January 25, 2010; for related airports. These regulatory actions are OK 73169 (Mail Address: P.O. Box information. needed because of the adoption of new 25082, Oklahoma City, OK 73125) or revised criteria, or because of changes Telephone: (405) 954–4164. Material Incorporated by Reference occurring in the National Airspace SUPPLEMENTARY INFORMATION: This rule (j) You must use Gulfstream Service System, such as the commissioning of amends Title 14 of the Code of Federal Bulletin 200–51–366, dated March 30, 2010, new navigational facilities, adding new Regulations, Part 97 (14 CFR part 97), by including Appendix A: Israel Aircraft obstacles, or changing air traffic Industries Document IS951400E, establishing, amending, suspending, or requirements. These changes are Radiographic Inspection of Self-Locking Nut revoking SIAPS, Takeoff Minimums designed to provide safe and efficient P/N MS21042L3, Revision A, dated January and/or ODPS. The complete regulators use of the navigable airspace and to 25, 2010, to do the actions required by this description of each SIAP and its AD, unless the AD specifies otherwise. The promote safe flight operations under associated Takeoff Minimums or ODP document number specified on pages 1 instrument flight rules at the affected for an identified airport is listed on FAA through 14 of Appendix A of this document airports. is identified as ‘‘IS951400.’’ form documents which are incorporated (1) The Director of the Federal Register DATES: This rule is effective October 3, by reference in this amendment under 5 approved the incorporation by reference of 2011. The compliance date for each U.S.C. 552(a), 1 CFR part 51, and 14 this service information under 5 U.S.C. SIAP, associated Takeoff Minimums, CFR part 97.20. The applicable FAA 552(a) and 1 CFR part 51. and ODP is specified in the amendatory Forms are FAA Forms 8260–3, 8260–4, (2) For service information identified in provisions. 8260–5, 8260–15A, and 8260–15B when this AD, contact Gulfstream Aerospace The incorporation by reference of Corporation, P.O. Box 2206, Mail Station D– required by an entry on 8260–15A. 25, Savannah, Georgia 31402–2206; certain publications listed in the The large number of SIAPs, Takeoff telephone 800–810–4853; fax 912–965–3520; regulations is approved by the Director Minimums and ODPs, in addition to e-mail [email protected]; Internet http:// of the Federal Register as of October 3, their complex nature and the need for www.gulfstream.com/product_support/ 2011. a special format make publication in the _ technical pubs/pubs/index.htm. ADDRESSES: Availability of matters Federal Register expensive and (3) You may review copies of the service incorporated by reference in the impractical. Furthermore, airmen do not information at the FAA, Transport Airplane use the regulatory text of the SIAPs, Directorate, 1601 Lind Avenue, SW., Renton, amendment is as follows: Washington. For information on the For Examination— Takeoff Minimums or ODPs, but instead availability of this material at the FAA, call 1. FAA Rules Docket, FAA refer to their depiction on charts printed 425–227–1221. Headquarters Building, 800 by publishers of aeronautical materials. (4) You may also review copies of the Independence Avenue, SW., The advantages of incorporation by service information that is incorporated by Washington, DC 20591; reference are realized and publication of reference at the National Archives and 2. The FAA Regional Office of the the complete description of each SIAP, Records Administration (NARA). For region in which the affected airport is Takeoff Minimums and ODP listed on information on the availability of this located; FAA forms is unnecessary. This material at NARA, call 202–741–6030, or go to: http://www.archives.gov/federal_register/ 3. The National Flight Procedures amendment provides the affected CFR code_of_federal_regulations/ Office, 6500 South MacArthur Blvd., sections and specifies the types of SIAPs ibr_locations.html. Oklahoma City, OK 73169 or and the effective dates of the, associated 4. The National Archives and Records Issued in Renton, Washington on Takeoff Minimums and ODPs. This September 16, 2011. Administration (NARA). For amendment also identifies the airport Ali Bahrami, information on the availability of this and its location, the procedure, and the material at NARA, call 202–741–6030, amendment number. Manager, Transport Airplane Directorate, or go to Aircraft Certification Service. The Rule http://www.archives.gov/ [FR Doc. 2011–24683 Filed 9–30–11; 8:45 am] federal_register/ This amendment to 14 CFR part 97 is BILLING CODE 4910–13–P code_of_federal_regulations/ effective upon publication of each ibr_locations.html. separate SIAP, Takeoff Minimums and DEPARTMENT OF TRANSPORTATION Availability—All SIAPs and Takeoff ODP as contained in the transmittal. Minimums and ODPs are available Some SIAP and Takeoff Minimums and Federal Aviation Administration online free of charge. Visit http:// textual ODP amendments may have www.nfdc.faa.gov to register. been issued previously by the FAA in a 14 CFR Part 97 Additionally, individual SIAP and Flight Data Center (FDC) Notice to Takeoff Minimums and ODP copies may Airmen (NOTAM) as an emergency [Docket No. 30803; Amdt. No. 3444] be obtained from: action of immediate flight safety relating Standard Instrument Approach 1. FAA Public Inquiry Center (APA– directly to published aeronautical Procedures, and Takeoff Minimums 200), FAA Headquarters Building, 800 charts. The circumstances which and Obstacle Departure Procedures; Independence Avenue, SW., created the need for some SIAP and Miscellaneous Amendments Washington, DC 20591; or Takeoff Minimums and ODP 2. The FAA Regional Office of the amendments may require making them AGENCY: Federal Aviation region in which the affected airport is effective in less than 30 days. For the Administration (FAA), DOT. located. remaining SIAPS and Takeoff

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Minimums and ODPS, an effective date PART 97—STANDARD INSTRUMENT Ottawa, KS, Ottawa Muni, GPS RWY 17, at least 30 days after publication is APPROACH PROCEDURES Orig-A, CANCELLED provided. Ottawa, KS, Ottawa Muni, GPS RWY 35, ■ 1. The authority citation for part 97 Orig, CANCELLED Further, the SIAPs and Takeoff continues to read as follows: Ottawa, KS, Ottawa Muni, RNAV (GPS) RWY Minimums and ODPS contained in this 17, Orig amendment are based on the criteria Authority: 49 U.S.C. 106(g), 40103, 40106, Ottawa, KS, Ottawa Muni, RNAV (GPS) RWY 40113, 40114, 40120, 44502, 44514, 44701, contained in the U.S. Standard for 35, Orig 44719, 44721–44722. Ottawa, KS, Ottawa Muni, Takeoff Terminal Instrument Procedures ■ 2. Part 97 is amended to read as Minimums and Obstacle DP, Amdt 1 (TERPS). In developing these SIAPS and Topeka, KS, Forbes Field, NDB RWY 13, Takeoff Minimums and ODPs, the follows: Amdt 7 TERPS criteria were applied to the Effective 20 OCT 2011 Abbeville, LA, Abbeville Chris Crusta Memorial, LOC RWY 16, Orig conditions existing or anticipated at the West Memphis, AR, West Memphis Muni, Great Barrington, MA, Walter J. Koladza, affected airports. Because of the close ILS OR LOC RWY 17, Amdt 5 NDB–A, Amdt 6 Windsor Locks, CT, Bradley Intl, ILS OR LOC and immediate relationship between Gladwin, MI, Gladwin Zettel Memorial, RWY 6, ILS RWY 6 (SA CAT I), ILS RWY these SIAPs, Takeoff Minimums and Takeoff Minimums and Obstacle DP, Amdt 6 (CAT II), ILS RWY 6 (CAT III), Amdt 37 3 ODPs, and safety in air commerce, I find Windsor Locks, CT, Bradley Intl, ILS OR LOC Hastings, MI, Hastings, RNAV (GPS) RWY 12, that notice and public procedures before RWY 24, ILS RWY 24 (SA CAT I), ILS Orig adopting these SIAPS, Takeoff RWY 24 (SA CAT II), Amdt 12 Hastings, MI, Hastings, RNAV (GPS) RWY 30, Minimums and ODPs are impracticable Windsor Locks, CT, Bradley Intl, ILS OR LOC Orig RWY 33, Amdt 10 and contrary to the public interest and, Hannibal, MO, Hannibal Rgnl, NDB RWY 35, Windsor Locks, CT, Bradley Intl, RNAV where applicable, that good cause exists Amdt 4, CANCELLED (GPS) Y RWY 6, Amdt 2 Salem, MO, Salem Memorial, Takeoff for making some SIAPs effective in less Windsor Locks, CT, Bradley Intl, RNAV Minimums and Obstacle DP, Orig than 30 days. (GPS) Y RWY 15, Amdt 2 Wayne, NE, Wayne Muni/Stan Morris Field, Windsor Locks, CT, Bradley Intl, RNAV RNAV (GPS) RWY 18, Amdt 2 Conclusion (GPS) Y RWY 24, Amdt 3 Wayne, NE, Wayne Muni/Stan Morris Field, Windsor Locks, CT, Bradley Intl, RNAV The FAA has determined that this RNAV (GPS) RWY 23, Amdt 1 (GPS) Y RWY 33, Amdt 2 Wayne, NE, Wayne Muni/Stan Morris Field, regulation only involves an established Windsor Locks, CT, Bradley Intl, RNAV RNAV (GPS) RWY 36, Amdt 2 body of technical regulations for which (RNP) Z RWY 6, Orig Morristown, NJ, Morristown Muni, Takeoff frequent and routine amendments are Windsor Locks, CT, Bradley Intl, RNAV Minimums and Obstacle DP, Amdt 6 necessary to keep them operationally (RNP) Z RWY 24, Orig Windsor Locks, CT, Bradley Intl, VOR OR Pedricktown, NJ, Spitfire Aerodrome, Takeoff current. It, therefore—(1) is not a Minimums and Obstacle DP, Amdt 1 ‘‘significant regulatory action’’ under TACAN RWY 6, Orig-B, CANCELLED Windsor Locks, CT, Bradley Intl, VOR OR New York, NY, John F. Kennedy Intl, Takeoff Executive Order 12866; (2) is not a TACAN RWY 15, Amdt 2A, CANCELLED Minimums and Obstacle DP, Amdt 8 ‘‘significant rule ’’ under DOT Windsor Locks, CT, Bradley Intl, VOR OR New York, NY, La Guardia, Takeoff Regulatory Policies and Procedures (44 TACAN RWY 24, Orig-A, CANCELLED Minimums and Obstacle DP, Amdt 9 FR 11034; February 26,1979); and (3) Windsor Locks, CT, Bradley Intl, VOR OR Memphis, TN, Memphis Intl, Takeoff TACAN RWY 33, Orig-C, CANCELLED Minimums and Obstacle DP, Amdt 3 does not warrant preparation of a Dallas, TX, Dallas-Love Field, Takeoff regulatory evaluation as the anticipated Wilmington, DE, New Castle, ILS OR LOC RWY 1, Amdt 23 Minimums and Obstacle DP, Amdt 16 impact is so minimal. For the same Daytona Beach, FL, Daytona Beach Intl, ILS Laredo, TX, Laredo Intl, ILS OR LOC/DME reason, the FAA certifies that this OR LOC RWY 25R, Orig RWY 17R, Amdt 11 amendment will not have a significant Daytona Beach, FL, Daytona Beach Intl, LOC Laredo, TX, Laredo Intl, RNAV (GPS) RWY economic impact on a substantial BC RWY 25R, Amdt 16, CANCELLED 17R, Amdt 1 number of small entities under the Daytona Beach, FL, Daytona Beach Intl, Laredo, TX, Laredo Intl, Takeoff Minimums and Obstacle DP, Amdt 4 criteria of the Regulatory Flexibility Act. RNAV (GPS) RWY 25R, Amdt 3 Fitzgerald, GA, Fitzgerald Muni, Takeoff Palacios, TX, Palacios Muni, Takeoff List of Subjects in 14 CFR Part 97 Minimums and Obstacle DP, Amdt 1 Minimums and Obstacle DP, Orig Greenfield, IA, Greenfield Muni, NDB OR Sweetwater, TX, Avenger Field, NDB RWY Air traffic control, Airports, GPS RWY 32, Amdt 1, CANCELLED 17, Amdt 4 Lamoni, IA, Lamoni Muni, Takeoff Sweetwater, TX, Avenger Field, RNAV (GPS) Incorporation by reference, and RWY 4, Orig Navigation (air). Minimums and Obstacle DP, Orig Driggs, ID, Driggs-Reed Memorial, RNAV Sweetwater, TX, Avenger Field, RNAV (GPS) Issued in Washington, DC, on September (GPS) RWY 3, Amdt 1A, CANCELLED RWY 17, Orig 16, 2011. Driggs, ID, Driggs-Reed Memorial, RNAV Sweetwater, TX, Avenger Field, RNAV (GPS) (GPS) RWY 3, Orig RWY 22, Orig Ray Towles, Carmi, IL, Carmi Muni, GPS RWY 36, Orig- Sweetwater, TX, Avenger Field, RNAV (GPS) Deputy Director, Flight Standards Service. A, CANCELLED RWY 35, Orig Carmi, IL, Carmi Muni, RNAV (GPS) RWY Richlands, VA, Tazewell County, LOC/DME Adoption of the Amendment 36, Orig RWY 25, Amdt 1 Carmi, IL, Carmi Muni, Takeoff Minimums Richlands, VA, Tazewell County, RNAV Accordingly, pursuant to the and Obstacle DP, Amdt 2 (GPS) RWY 25, Amdt 1 authority delegated to me, Title 14, Belleville, KS, Belleville Muni, NDB RWY Milwaukee, WI, General Mitchell Intl, ILS OR Code of Federal Regulations, Part 97 (14 18, Amdt 5 LOC RWY 7R, Amdt 16 CFR part 97) is amended by Belleville, KS, Belleville Muni, NDB RWY Milwaukee, WI, General Mitchell Intl, LOC establishing, amending, suspending, or 36, Amdt 5 RWY 25L, Amdt 5 revoking Standard Instrument Approach Belleville, KS, Belleville Muni, RNAV (GPS) Milwaukee, WI, General Mitchell Intl, RNAV RWY 18, Orig (GPS) RWY 7R, Amdt 1 Procedures and/or Takeoff Minimums Belleville, KS, Belleville Muni, RNAV (GPS) Milwaukee, WI, General Mitchell Intl, RNAV and/or Obstacle Departure Procedures RWY 36, Orig (GPS) RWY 19R, Amdt 2 effective at 0902 UTC on the dates Belleville, KS, Belleville Muni, Takeoff Milwaukee, WI, General Mitchell Intl, RNAV specified, as follows: Minimums and Obstacle DP, Orig (GPS) RWY 25L, Amdt 1

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New Holstein, WI, New Holstein Muni, 1. FAA Rules Docket, FAA amendment provides the affected CFR RNAV (GPS) RWY 14, Orig Headquarters Building, 800 sections and specifies the types of SIAP New Holstein, WI, New Holstein Muni, Independence Avenue, SW., and the corresponding effective dates. RNAV (GPS) RWY 32, Orig Washington, DC 20591; This amendment also identifies the New Holstein, WI, New Holstein Muni, Takeoff Minimums and Obstacle DP, Orig 2. The FAA Regional Office of the airport and its location, the procedure New Holstein, WI, New Holstein Muni, VOR/ region in which the affected airport is and the amendment number. located; DME–A, Amdt 2 The Rule RESCINDED: On September 15, 2011 (76 3. The National Flight Procedures FR 56970), the FAA published an Office, 6500 South MacArthur Blvd., This amendment to 14 CFR part 97 is Amendment in Docket No. 30801, Amdt No. Oklahoma City, OK 73169 or effective upon publication of each 3442 to Part 97 of the Federal Aviation 4. The National Archives and Records separate SIAP as amended in the Regulations under section 97.25. The Administration (NARA). For transmittal. For safety and timeliness of following entry, effective September 22, information on the availability of this change considerations, this amendment 2011, is hereby rescinded in its entirety: material at NARA, call 202–741–6030, incorporates only specific changes Abbeville, LA, Abbeville Chris Crusta or go to: http://www.archives.gov/ contained for each SIAP as modified by Memorial, LOC RWY 16, Orig federal_register/ FDC/P–NOTAMs. [FR Doc. 2011–24724 Filed 9–30–11; 8:45 am] code_of_federal_regulations/ The SIAPs, as modified by FDC P– BILLING CODE 4910–13–P ibr_locations.html. NOTAM, and contained in this Availability—All SIAPs are available amendment are based on the criteria online free of charge. Visit http:// contained in the U.S. Standard for DEPARTMENT OF TRANSPORTATION nfdc.faa.gov to register. Additionally, Terminal Instrument Procedures individual SIAP and Takeoff Minimums (TERPS). In developing these changes to Federal Aviation Administration and ODP copies may be obtained from: SIAPs, the TERPS criteria were applied 1. FAA Public Inquiry Center (APA– only to specific conditions existing at 14 CFR Part 97 200), FAA Headquarters Building, 800 the affected airports. All SIAP [Docket No. 30804; Amdt. No. 3445] Independence Avenue, SW., amendments in this rule have been Washington, DC 20591; or previously issued by the FAA in a FDC Standard Instrument Approach 2. The FAA Regional Office of the NOTAM as an emergency action of Procedures, and Takeoff Minimums region in which the affected airport is immediate flight safety relating directly and Obstacle Departure Procedures; located. to published aeronautical charts. The Miscellaneous Amendments FOR FURTHER INFORMATION CONTACT: circumstances which created the need for all these SIAP amendments requires AGENCY: Federal Aviation Richard A. Dunham III, Flight Procedure making them effective in less than 30 Administration (FAA), DOT. Standards Branch (AFS–420) Flight Technologies and Programs Division, days. ACTION: Final rule. Because of the close and immediate Flight Standards Service, Federal relationship between these SIAPs and SUMMARY: This rule establishes, amends, Aviation Administration, Mike safety in air commerce, I find that notice suspends, or revokes Standard Monroney Aeronautical Center, 6500 and public procedure before adopting Instrument Approach Procedures South MacArthur Blvd., Oklahoma City, these SIAPs are impracticable and (SIAPs) and associated Takeoff OK 73169 (Mail Address: P.O. Box contrary to the public interest and, Minimums and Obstacle Departure 25082 Oklahoma City, OK 73125) where applicable, that good cause exists Procedures for operations at certain telephone: (405) 954–4164. airports. These regulatory actions are for making these SIAPs effective in less SUPPLEMENTARY INFORMATION: This rule than 30 days. needed because of the adoption of new amends Title 14, Code of Federal or revised criteria, or because of changes Regulations, part 97 (14 CFR part 97) by Conclusion occurring in the National Airspace amending the referenced SIAPs. The The FAA has determined that this System, such as the commissioning of complete regulatory description of each regulation only involves an established new navigational facilities, adding new SIAP is listed on the appropriate FAA body of technical regulations for which obstacles, or changing air traffic Form 8260, as modified by the National frequent and routine amendments are requirements. These changes are Flight Data Center (FDC)/Permanent necessary to keep them operationally designed to provide safe and efficient Notice to Airmen (P–NOTAM), and is current. It, therefore—(1) Is not a use of the navigable airspace and to incorporated by reference in the ‘‘significant regulatory action’’ under promote safe flight operations under amendment under 5 U.S.C. 552(a), 1 Executive Order 12866; (2) is not a instrument flight rules at the affected CFR part 51, and § 97.20 of Title 14 of ‘‘significant rule’’ under DOT regulatory airports. the Code of Federal Regulations. Policies and Procedures (44 FR 11034; DATES: This rule is effective October 3, The large number of SIAPs, their February 26, 1979); and (3) does not 2011. The compliance date for each complex nature, and the need for a warrant preparation of a regulatory SIAP, associated Takeoff Minimums, special format make their verbatim evaluation as the anticipated impact is and ODP is specified in the amendatory publication in the Federal Register so minimal. For the same reason, the provisions. expensive and impractical. Further, FAA certifies that this amendment will The incorporation by reference of airmen do not use the regulatory text of not have a significant economic impact certain publications listed in the the SIAPs, but refer to their graphic on a substantial number of small entities regulations is approved by the Director depiction on charts printed by under the criteria of the Regulatory of the Federal Register as of October 3, publishers of aeronautical materials. Flexibility Act. 2011. Thus, the advantages of incorporation List of Subjects in 14 CFR Part 97 ADDRESSES: Availability of matter by reference are realized and incorporated by reference in the publication of the complete description Air traffic control, Airports, amendment is as follows: of each SIAP contained in FAA form Incorporation by reference, and For Examination— documents is unnecessary. This Navigation (air).

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Issued in Washington, DC on September PART 97—STANDARD INSTRUMENT §§ 97.23, 97.25, 97.27, 97.29, 97.31, 97.33 16, 2011. APPROACH PROCEDURES and 97.35 [Amended] Ray Towles, By amending: § 97.23 VOR, VOR/ Deputy Director, Flight Standards Service. ■ 1. The authority citation for part 97 DME, VOR or TACAN, and VOR/DME Adoption of the Amendment continues to read as follows: or TACAN; § 97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; Accordingly, pursuant to the Authority: 49 U.S.C. 106(g), 40103, 40106, § 97.27 NDB, NDB/DME; § 97.29 ILS, authority delegated to me, Title 14, 40113, 40114, 40120, 44502, 44514, 44701, ILS/DME, MLS, MLS/DME, MLS/RNAV; Code of Federal Regulations, Part 97, 14 44719, 44721–44722. § 97.31 RADAR SIAPs; § 97.33 RNAV CFR part 97, is amended by amending ■ SIAPs; and § 97.35 COPTER SIAPs, Standard Instrument Approach 2. Part 97 is amended to read as Identified as follows: Procedures, effective at 0901 UTC on follows: the dates specified, as follows: * * * Effective Upon Publication

AIRAC date State City Airport FDC No. FDC Date Subject

20–Oct–11 .... NJ Readington ...... Solberg-Hunterdon ...... 1/0833 9/1/11 RNAV (GPS) RWY 4, Orig 20–Oct–11 .... NJ Readington ...... Solberg-Hunterdon ...... 1/0834 9/1/11 RNAV (GPS) RWY 22, Orig 20–Oct–11 .... NJ Readington ...... Solberg-Hunterdon ...... 1/0835 9/1/11 VOR RWY 4, Amdt 1 20–Oct–11 .... NJ Readington ...... Solberg-Hunterdon ...... 1/0836 9/1/11 VOR A, Amdt 9 20–Oct–11 .... TX Brownsville ...... Brownsville/South Padre Is- 1/1141 9/8/11 VOR/DME RNAV OR GPS RWY land Intl. 35, Amdt 3 20–Oct–11 .... TX Brownsville ...... Brownsville/South Padre Is- 1/1142 9/8/11 VOR OR TACAN OR GPS A, land Intl. Amdt 1A 20–Oct–11 .... TX Brownsville ...... Brownsville/South Padre Is- 1/1143 9/8/11 LOC BC RWY 31L, Amdt 11B land Intl. 20–Oct–11 .... AL Bay Minette ...... Bay Minette Muni ...... 1/1453 9/1/11 RNAV (GPS) RWY 26, Orig-B 20–Oct–11 .... IL Marion ...... Williamson County Rgnl ...... 1/2688 9/1/11 RNAV (GPS) RWY 2, Orig 20–Oct–11 .... IL Marion ...... Williamson County Rgnl ...... 1/2689 9/1/11 RNAV (GPS) RWY 20, Orig 20–Oct–11 .... IL Marion ...... Williamson County Rgnl ...... 1/2690 9/1/11 VOR RWY 2, Amdt 13 20–Oct–11 .... IL Marion ...... Williamson County Rgnl ...... 1/2691 9/1/11 NDB RWY 20, Amdt 10 20–Oct–11 .... IL Marion ...... Williamson County Rgnl ...... 1/2692 9/1/11 VOR RWY 20, Amdt 17 20–Oct–11 .... NY Albany ...... Albany Intl ...... 1/3420 9/1/11 ILS OR LOC RWY 1, Amdt 11 ; ILS RWY 1 (SA CAT II), Amdt 11 20–Oct–11 .... FL Tallahassee ...... Tallahassee Rgnl ...... 1/3426 9/1/11 RADAR–1, Amdt 5A 20–Oct–11 .... MA Nantucket ...... Nantucket Memorial ...... 1/4378 9/1/11 RNAV (GPS) RWY 24, Orig 20–Oct–11 .... MA Nantucket ...... Nantucket Memorial ...... 1/4379 9/1/11 ILS OR LOC RWY 6, Amdt 1 20–Oct–11 .... MA Nantucket ...... Nantucket Memorial ...... 1/4380 9/1/11 ILS OR LOC RWY 24, Amdt 15E 20–Oct–11 .... MA Nantucket ...... Nantucket Memorial ...... 1/4381 9/1/11 RNAV (GPS) RWY 6, Orig 20–Oct–11 .... MA Nantucket ...... Nantucket Memorial ...... 1/4382 9/1/11 VOR RWY 24, Amdt 14 20–Oct–11 .... WI Milwaukee ...... Milwaukee/Lawrence J. 1/4409 9/1/11 RNAV (GPS) RWY 4L, Orig Timmerman. 20–Oct–11 .... WI Milwaukee ...... Milwaukee/Lawrence J. 1/4410 9/1/11 RNAV (GPS) RWY 22R, Orig Timmerman. 20–Oct–11 .... IN Gary ...... Gary/Chicago Intl ...... 1/4565 9/8/11 NDB OR GPS RWY 30, Amdt 7B 20–Oct–11 .... NY New York ...... La Guardia ...... 1/5043 9/1/11 ILS OR LOC RWY 22, Amdt 20; ILS RWY 22 (SA CAT I), Amdt 20; ILS RWY 22 (SA CAT II), Amdt 20 20–Oct–11 .... IL Mount Vernon ...... Mount Vernon ...... 1/7201 9/8/11 RNAV (GPS) RWY 5, Orig 20–Oct–11 .... IL Mount Vernon ...... Mount Vernon ...... 1/7202 9/8/11 RNAV (GPS) RWY 23, Orig 20–Oct–11 .... IL Mount Vernon ...... Mount Vernon ...... 1/7233 9/8/11 VOR RWY 5, Amdt 16B 20–Oct–11 .... IL Mount Vernon ...... Mount Vernon ...... 1/7270 9/8/11 VOR RWY 23, Amdt 16 20–Oct–11 .... IA Pocahontas ...... Pocahontas Muni ...... 1/7324 9/8/11 RNAV (GPS) RWY 12, Orig 20–Oct–11 .... IA Pocahontas ...... Pocahontas Muni ...... 1/7325 9/8/11 NDB RWY 12, Amdt 5 20–Oct–11 .... TX Dallas ...... Dallas Executive ...... 1/8190 8/25/11 ILS OR LOC RWY 31, Amdt 8A

[FR Doc. 2011–24720 Filed 9–30–11; 8:45 am] BILLING CODE 4910–13–P

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DEPARTMENT OF COMMERCE the Federal eRulemaking Portal at owed should an investigation result in http://www.Regulations.gov under the imposition of an AD or CVD order International Trade Administration Docket Number ITA–2011–0005. After and, further, it will reduce some of the analyzing and carefully considering all burdens that U.S. Customs and Border 19 CFR Part 351 of the comments that the Department Protection (CBP) faces when trying to [Docket No. 110420253–1577–02] received in response to the Proposed collect AD and CVD duties. Certain Rule, the Department has adopted the parties commented on the explanation RIN 0625–AA88 modification and amended its the Department provided for this change regulations to establish that the in the Proposed Rule, and the Modification of Regulations Regarding provisional measures during an AD or Department has addressed those the Practice of Accepting Bonds CVD investigation will normally take comments in the section entitled During the Provisional Measures the form of a cash deposit. ‘‘Response to Comments on the Period in Antidumping and Proposed Rule’’. Countervailing Duty Investigations Explanation of Regulatory Provision Explanation of Final Modification to 19 Our regulations describe the AGENCY: Import Administration, CFR 351.205 International Trade Administration, preliminary determination in AD and Prior to this modification to the Department of Commerce. CVD investigations as the first point at regulations, the second sentence of 19 ACTION: Final rule. which the Department may provide a remedy if we preliminarily find that CFR 351.205(a) stated that ‘‘[t]he SUMMARY: The Department of Commerce dumping or countervailable remedy (sometimes referred to as (the Department) is amending its subsidization has occurred. The ‘provisional measures’) usually takes the regulations governing the effect of an regulations at 19 CFR 351.205(a) stated form of a bonding requirement to ensure affirmative preliminary determination that, ‘‘[t]he remedy (sometimes referred payment if antidumping or in antidumping or countervailing duty to as ‘provisional measures’) usually countervailing duties ultimately are proceedings to establish that the takes the form of a bonding requirement imposed.’’ The Department deleted most provisional measures will normally take to ensure payment if antidumping or of the sentence to no longer permit the form of a cash deposit. Requiring countervailing duties ultimately are under normal circumstances, U.S. that provisional measures will normally imposed.’’ Section 351.205(d) of the importers to post bonds during the take the form of a cash deposit will help Department’s regulations states that, provisional measures period. However, to strengthen the administration of the ‘‘[i]f the preliminary determination is the Department retained the phrase nation’s antidumping (AD) and affirmative, the Secretary will take the ‘‘(sometimes referred to as ‘provisional countervailing duty (CVD) laws by actions described in section 703(d) or measures’)’’ but moved it to the first making importers directly responsible section 733(d) (whichever is sentence of 19 CFR 351.205(a). We view for the payment of AD and CVD duties. applicable).’’ this phrase as a useful link between this The provisional measures period is part of our regulations and the DATES: This Final Rule is effective terminology under Article 7 of the WTO November 2, 2011. This rule will apply the period between the publication of the Department’s preliminary Agreement on Implementation of Article to all investigations initiated on the VI of the General Agreement on Tariffs basis of petitions filed on or after this affirmative determination and the earlier of (1) The expiration of the and Trade 1994 (‘‘ADA’’) and Article 17 effective date. of the Agreement on Subsidies and applicable time period set forth in FOR FURTHER INFORMATION CONTACT: Countervailing Measures (‘‘ASCM’’). sections 703(d) and 733(d) of the Tariff Thomas Futtner at (202) 482–3814, Further, to clarify that provisional Mark Ross at (202) 482–4794, or Joanna Act of 1930, as amended (the Act), or (2) measures will take the form of cash Theiss at (202) 482–5052. the publication of the International deposits, the Department added a Trade Commission (Commission)’s final SUPPLEMENTARY INFORMATION : 1 sentence to 19 CFR 351.205(d) that affirmative injury determination. states, ‘‘With respect to section Background During this time the Department is 703(d)(1)(B) and 733(d)(1)(B) of the Act, On April 26, 2011, the Department instructed by the Act to order ‘‘the the Secretary will normally order the published a proposed modification to its posting of a cash deposit, bond, or other posting of cash deposits to ensure regulations regarding the practice of security, as the administering authority payment if antidumping or accepting bonds during the provisional deems appropriate.’’ See Sections countervailing duties ultimately are measures period in AD and CVD 703(d)(1)(B) and 733(d)(1)(B) of the Act. imposed.’’ This change, in our view, investigations. See Modification of Requiring that provisional measures places the requirement for cash deposits Regulations Regarding the Practice of will normally take the form of a cash in the appropriate part of 19 CFR part Accepting Bonds During the Provisional deposit will help to strengthen the 351 (i.e., in the part that explains the Measures Period in Antidumping and administration of the nation’s AD and effects of an affirmative preliminary Countervailing Duty Investigations, 76 CVD laws by making importers directly determination). This amendment FR 23225 (April 26, 2011) (Proposed responsible for the payment of AD and reflects the Department’s change in Rule). The Proposed Rule explained the CVD duties. This change will help to practice to now normally require cash Department’s proposal to modify its ensure that the U.S. Government deposits rather than bonds during the regulations to establish that the collects the full amount of the duties provisional measures period. This provisional measures during an AD or modification is also in line with 19 CFR 1 Also, pursuant to sections 703(e)(2) and CVD investigation will normally take 733(e)(2) of the Act, if the Department makes an 351.205(d), which provides that ‘‘if the the form of a cash deposit. The affirmative determination of critical circumstances, preliminary determination is Department received numerous then provisional measures shall apply on or after affirmative, the Secretary will take the comments on the Proposed Rule and has the later of (A) The date which is 90 days before actions described in section 703(d) or the date on which the suspension of liquidation addressed these comments below. The was first ordered, or (B) the date on which notice section 733(d) of the Act (whichever is Proposed Rule, comments received, and of the determination to initiate the investigation is applicable)’’ because these sections of this Final Rule can be accessed using published in the Federal Register. the Act provide that the Department

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shall order the posting of cash deposits provisionally estimated margin of AD or CVD proceedings for which a or bonds, as the Department deems dumping.’’ (emphasis added). Article final determination has not yet been appropriate. 17.2 of the ASCM states that, issued. One commenter asserted that ‘‘[p]rovisional measures may take the implementation of this modification to Response to Comments on the Proposed form of provisional countervailing the Department’s regulations will Rule duties guaranteed by cash deposits or involve minimal administrative burden The Department received numerous bonds equal to the amount of the in light of the very limited number of comments on its Proposed Rule. As provisionally calculated amount of pending proceedings. indicated in the ‘‘Background’’ section, subsidization.’’ (emphasis added). U.S. Response: As indicated in the DATES these comments can be accessed using law and the WTO Agreements provide section above, this Final Rule will apply the Federal eRulemaking Portal at that the Department may require either to all investigations initiated on the http://www.Regulations.gov under the posting of cash deposits or bonds, basis of petitions filed on or after Docket Number ITA–2011–0005. The and do not prohibit the Department November 2, 2011. The Department Department has analyzed and carefully from normally requiring the posting of believes that this is a reasonable considered all of the comments cash deposits only during the approach to the effective date issue for received. Below is a summary of the provisional measures period. this particular rule change. Importantly, comments, grouped by issue category, implementing the Final Rule in this and followed by the Department’s Issue 2—Use of Bonding by Other manner will provide parties (e.g., response. Countries importers of merchandise that are Several commenters assert that the Issue 1—U.S. Law, the WTO subject to an AD or CVD investigation) practice of most, if not all, other WTO Agreements, and Cash Deposits During time to prepare for the new requirement members is to require cash deposits the Provisional Measures Period to normally post cash deposits upon the during the provisional measures period, publication of an affirmative Several commenters assert that and that the proposed modification will preliminary determination. section 703(d)(l)(B) and 733(d)(1)(B) of bring the United States in line with the the Act provide the Department practices of other WTO members. Other Issue 4—Financial Consequences of discretion to collect cash deposits as commenters assert that the laws of Cash Deposits provisional measures. Some of the same certain WTO members provide for an Several commenters assert that the parties also note that Article 7 of the option to post bonds or other security as change would have significant adverse ADA and Article 17 of the ASCM provisional measures. consequences for importers. They argue indicate that WTO members may Response: The Department has that it would be burdensome for the require importers to post cash deposits considered the information the importers, some of which are small as provisional measures. Another commenters provided on the practice of businesses, because their cash flow commenter asserts that Article 7 of the various countries of permitting or not would be negatively impacted. Certain ADA and Article 17 of the ASCM permitting importers the option of supporters of the change assert that any indicate no hierarchy between cash and posting bonds during the provisional burden placed on importers by the cash bond requirements for provisional measures period of AD and CVD deposit requirement is mitigated by the measures, and that allowing the investigations. As detailed in the above fact that provisional measures are in importer to choose the kind of guarantee section entitled ‘‘Issue 1—U.S. Law, the place for a short period of time. that is suitable for them reduces the WTO Agreements, and Cash Deposits Response: The Department chance of default. Another commented During the Provisional Measures acknowledges that, in the past, certain that the ADA and ASCM clearly provide Period,’’ requiring cash deposits is importers may have benefited from the for the acceptance of bonds as one of the permissible under the WTO Agreements option of posting bonds during the options for the purpose of covering and this also appears to be the practice provisional measures period and that provisional duties. of many WTO members. While certain upon implementation of this Final Rule Response: It is within the WTO members may provide for an that option will no longer be readily Department’s discretion to require that option to post bonds, sections available to them. Nonetheless, the Act provisional measures will normally take 703(d)(1)(B) and 733(d)(1)(B) of the Act clearly provides the Department with the form of a cash deposit. The Act does grant the Department the discretion to discretion to require either cash not specify a preference for cash select the form of security that it deems deposits or bonds should a company deposits or bonds, nor does it provide appropriate as a provisional measure. choose to import merchandise that has the importer with the option of selecting After considering all the comments been preliminarily determined to be which method the importer prefers. For received, and for the reasons outlined in dumped or subsidized and likely to be the provisional measures period in AD the Proposed Rule and this Final Rule, causing injury to an industry in the and CVD investigations, the Act we have decided to proceed with the United States. The Department provides for ‘‘the posting of a cash modifications to our regulations considers the security for provisional deposit, bond, or other security, as the specified in the Proposed Rule. measures to be an important matter for administering authority deems Accordingly, we are modifying our the collection of duties. The appropriate.’’ See sections 703(d)(1)(B) regulations to normally require cash requirement of a cash deposit will better and 733(d)(1)(B) of the Act. deposits rather than bonds during the ensure that importers bear full The modification to our regulations is provisional measures period of AD and responsibility for any future AD and also consistent with the ADA and the CVD duty investigations. CVD duties they may owe, as the ASCM. Article 7.2 of the ADA states Department and CBP have learned from that, ‘‘[p]rovisional measures may take Issue 3—Effective Date of Rule Change the agencies’ extensive experience in the form of a provisional duty or, Several commenters urged the the administration of the AD and CVD preferably, a security by cash deposit or Department to make the change effective laws. bond equal to the amount of the immediately. Two of these parties asked The provisional measures period antidumping duty provisionally that we apply the change not only in lasts, at most, six months. The estimated, being not greater than the future investigations, but to all pending Department considers this to be a

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relatively short period in the context of proceedings in that year, to find the of duties owed, should the investigation an AD or CVD proceeding. Further, percentage of ongoing proceedings in result in the imposition of an AD or importers will receive the cash deposit each year where provisional measures CVD order. back in full if the imports at issue are were applied. We found that the average Response: We disagree with the not dumped (sold in the United States of the results of this comparison for assertion that it is unfair to require cash at less than the normal value of the 2007, 2008 and 2009 was less than ten deposits based on a preliminary merchandise) or not found to benefit percent. This analysis was used for the determination in an AD or CVD from a countervailable subsidy (or the proposed regulatory change, and it investigation. Before imposing Commission issues a negative injury demonstrates that the change is not provisional measures, the Department finding). If the margin calculated for the significant because the change in the must make an affirmative preliminary final determination ends up lower than security requirement will impact less determination of dumping or the margin calculated at the preliminary than ten percent of ongoing AD/CVD countervailable subsidization and the determination, the statute requires that proceedings. Commission must also make a the difference be refunded to the For the Final Rule, our analysis preliminary determination as to whether importer. See Sections 707(a)(2) (CVD) included data from 2010, which we did dumping or subsidization are likely to and 737(a)(2) (AD) of the Act. However, not include in our initial analysis. The be causing material injury. While a if the margin calculated for the final 2010 data further supports our initial preliminary determination may occur determination is higher than the margin analysis: in 2010, there were 15 without an order being issued, in such calculated at the preliminary preliminary affirmative AD a circumstance any cash deposits are determination, the difference is determinations and six preliminary completely refunded to the importer(s). disregarded. See Sections 707(a)(1) affirmative CVD determinations, in We also disagree with the assertion that (CVD) and 737(a)(1) (AD) of the Act. In comparison to 260 ongoing AD the change would act as a trade barrier other words, in no circumstance will an proceedings and 46 ongoing CVD because AD and CVD measures, when importer be required to post cash proceedings. For 2010, approximately applied consistent with WTO rules, deposits which equal more than the seven percent of all AD and CVD remedy injury and harm caused by margin determined at the preliminary proceedings involved the application of market-distorting unfair trade practices. determination, and in fact will be provisional measures during the year. On August 26, 2010, in support of refunded its cash deposit to the extent Also, the simple average of the results President Obama’s National Export the deposit is higher than the duty that for each year from 2007 through 2010 is Initiative (NEI), the Department is determined to be due. less than ten percent. Thus, we find that announced a number of proposals to the market impact of altering the strengthen the agency’s administration Issue 5—Significance of Change to the provisional measures security of the nation’s AD and CVD laws. One Regulation requirement is not significant for of those proposals is the modification of One commenter stated that the purposes of making a regulatory change. the regulations regarding the acceptance Department’s reasoning as to why the Finally, we disagree with the assertion of bonds during the provisional change is not significant is ‘‘subjective that the Department is required to make measures period in AD and CVD and without factual basis, especially an analysis of the significance of the investigations. Specifically, the since the Department ignores the market change with regard to ‘‘small business Department indicated that it is impact of preliminary determinations industrial users/consumers.’’ The ‘‘[c]onsidering whether importers will on small business industrial users/ analytical requirements of 5 U.S.C. be required to post cash deposits rather consumers.’’ Certain supporters of the 605(b), requires that the Department than bonds for imports that fall within change argued that the percentage of consider the ‘‘economic impact on a the scope of an AD/CVD investigation U.S. imports subject to AD or CVD substantial number of small business starting with the issuance of the orders is extremely small. entities,’’ which requires the Department’s preliminary determination Response: In determining whether Department to analyze the economic (rather than following the imposition of this change to its regulations is impact on all small business entities, an AD/CVD order).’’ See ‘‘NEI Trade significant, the Department first and is not limited to industrial users/ Law Enforcement Package Fact Sheet’’ considered the fact that less than two consumers. at http://ia.ita.doc.gov/tlei/fachsheet- percent of all entries of merchandise tlei-20101108.pdf. As indicated in the Issue 6—Requiring Cash Deposits Based into the United States are subject to AD above section entitled ‘‘Explanation of on a Preliminary Determination or CVD duties. Next, the Department Final Modification to 19 CR 351.205,’’ examined the number of affirmative Several commenters argue that it is the posting of cash deposits rather than preliminary determinations which were unfair to require cash deposits based on bonds will make importers directly issued in both AD and CVD a preliminary determination, when a responsible for the payment of AD and investigations in 2007, 2008 and 2009. final order may not be issued. Some CVD duties. It will also help to ensure For instance, if an affirmative commenters assert that this change will that the U.S. Government collects the preliminary determination was serve as a trade barrier, and one party full amount of the duties owed should published in June 2007, importers were commented that the Department’s true an investigation result in the imposition required to post cash deposits or bonds intention is to benefit petitioners in of an AD or CVD order. Further, the generally beginning on the date of response to recent unfavorable WTO change will reduce some of the burdens publication for a four to six month and court decisions. Several supporters that CBP faces when trying to collect AD period. For each year, we also examined of the change assert that importers are and CVD duties. how many AD and CVD proceedings protected by the fact that provisional were ongoing, accounting for orders measures are not imposed without a Issue 7—Whether Bonds Will Be which had been revoked during a preliminary determination of dumping Accepted in Any Circumstance particular year. We then compared the (or countervailable subsidization) and One commenter argues that the number of affirmative preliminary injury. The parties also assert that the Proposed Rule would still allow determinations published in a given change will better ensure that the U.S. bonding as an option for provisional year to the number of ongoing government can collect the full amount measures, and suggests that the

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Department should set forth guidelines Transaction Bonds (STBs), which are rule, if promulgated, would not have a of circumstances in which bonding is required for the posting of bonds in AD significant economic impact on a permitted. Another argues that the and CVD investigations, must be substantial number of small business Department should consider other reviewed for sufficiency and adequacy. entities did not change. See Issue 5— options to address the issues it has Further, since bonds are legal Significance of Change to the experienced with the use of bonding documents, CBP must keep paper copies Regulation. As a result, a Final during the provisional measures period of STBs. CBP also has to manually enter Regulatory Flexibility analysis is not (such as those used in new shipper an electronic note in its Automated required and has not been prepared. reviews). Commercial System for STBs. Paperwork Reduction Act Response: The change to the Conversely, cash deposits are recorded regulation provides that ‘‘the Secretary electronically in ACS and are usually This rule does not contain a collection will normally order the posting of cash transmitted to CBP electronically and, of information for purposes of the deposits to ensure payment if thus, are recorded automatically. Paperwork Reduction Act of 1980, as antidumping or countervailing duties amended (44 U.S.C. 3501 et seq.). ultimately are imposed.’’ The Issue 9—The Use of Bonds in a Department considers that this change Retrospective Duty Assessment System List of Subjects in 19 CFR Part 351 appropriately addresses the concerns One commenter asserted that bonds Administrative practice and identified with the use of bonding are a more appropriate form of procedure, Antidumping, Business and during the provisional measures period provisional measures for the United industry, Cheese, Confidential business of AD and CVD investigations. The use States since it has a retrospective duty information, Countervailing duties, of the term ‘‘normally’’ provides the collection system, and requests that the Freedom of information, Investigations, Department flexibility to address those Department not modify the current Reporting and recordkeeping rare and unusual circumstances that the regulations and practice of accepting requirements. Department may find warrant the bonds during the provisional measures Dated: September 15, 2011. acceptance of bonds. The Department period. Ronald K. Lorentzen, intends to make such exceptional Response: The Department disagrees determinations on a case-by-case basis Deputy Assistant Secretary for Import with the assertion that bonds are a more Administration. (depending on the particular facts of appropriate form of provisional For the reasons stated, 19 CFR part each case) as warranted rather than measures, and notes that no information 351 is amended as follows: attempting to articulate a rule that or argument was provided to support predicts what unusual circumstances this assertion. The ADA and ASCM PART 351—ANTIDUMPING AND may arise in the future. With regard to permit the application of provisional COUNTERVAILING DUTIES the comment about new shipper measures in the form of cash or bond, reviews, unlike in investigations, regardless of whether the WTO member ■ 1. The authority citation for 19 CFR bonding in new shipper reviews is is operating a prospective or part 351 continues to read as follows: required by the Act. retrospective system. In either system, Authority: 5 U.S.C. 301; 19 U.S.C. 1202 Issue 8—Administrative Burdens of provisional measures serve the same note; 19 U.S.C. 1303 note; 19 U.S.C. 1671 et Permitting Bonding function—to provide adequate security seq.; and 19 U.S.C. 3538. for the payment of AD or CVD duties One commenter asserts that the pending the final determination of § 351.205 [Amended] Department cites a subjective and whether such duties are owed and in ■ unsubstantiated conclusion regarding 2. In § 351.205, revise paragraphs (a) the burden the bonding requirement what amount. and (d) to read as follows: imposes on CBP. Another commenter Classification (a) Introduction. A preliminary asserts that by requiring cash deposits, determination in an antidumping or the administrative burdens and Executive Order 12866 countervailing duty investigation expenses, such as ensuring adequate This rule has been determined to be constitutes the first point at which the bond coverage and handling claims for not significant for purposes of Executive Secretary may provide a remedy mitigation or relief from the bond Order 12866. (sometimes referred to as ‘‘provisional requirement, will be minimized. measures’’) if the Secretary Response: In the Proposed Rule the Regulatory Flexibility Act preliminarily finds that dumping or Department stated that, ‘‘[w]hile most of The Chief Counsel for Regulation has countervailable subsidization has the duties on entries secured by a bond certified to the Chief Counsel for occurred. Whether the Secretary’s during the provisional measures period Advocacy of the Small Business preliminary determination is affirmative are ultimately collected, these Administration under the provisions of or negative, the investigation continues. collections can be very slow and involve the Regulatory Flexibility Act, 5 U.S.C. This section contains rules regarding burdensome administrative problems 605(b), that this rule, if promulgated, deadlines for preliminary for (CBP).’’ This conclusion was based would not have a significant economic determinations, postponement of on the U.S. Government Accountability impact on a substantial number of small preliminary determinations, notices of Office’s (GAO) Report to Congress on business entities. The factual basis for preliminary determinations, and the Antidumping and Countervailing Duties the certification was published in the effects of affirmative preliminary (GAO–08–391) (March 2008), in which Proposed Rule. The Department determinations. the GAO stated that when an importer received a comment regarding the * * * * * fails to pay supplemental AD or CVD factual basis for this decision, which (d) Effect of affirmative preliminary duties, CBP frequently faces a lengthy appears in Issue 5—Significance of determination. If the preliminary process of trying to collect from bonding Change to the Regulation. Based upon determination is affirmative, the agents. Additionally, CBP reports the Department’s analysis, as discussed Secretary will take the actions described bonding is more burdensome than above, the factual basis used in the in section 703(d) or section 733(d) of the collecting cash deposits because Single Proposed Rule to determine that the Act (whichever is applicable). With

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respect to section 703(d)(1)(B) and Interim Rule and received requests from interests. The illustrations set forth in 733(d)(1)(B) of the Act, the Secretary several commentators requesting that the definitional provisions in section will normally order the posting of cash Treasury modify aspects of the Interim 31.201 are examples of situations that deposits to ensure payment if Rule. Treasury carefully considered all may give rise to a conflict of interest. antidumping or countervailing duties comments received and, in section II of They are not pronouncements that a ultimately are imposed. In making this rule, discusses the comments particular set of facts will necessarily information available to the received and sets out modifications in give rise to a conflict of interest, or that Commission under section 703(d)(3) or this final rule. such conflict of interest cannot be section 733(d)(3) of the Act, the The January 21, 2009, interim rule’s mitigated. Treasury also received a Secretary will make available to the provisions are available at 74 FR 3431. comment suggesting the rule include Commission and to employees of the The interim rule defines organizational specific mitigation plans for some of the Commission directly involved in the and personal conflicts of interest. conflicts examples. Treasury believes proceeding the information upon which Further, the interim rule sets forth: (1) that including specific mitigation plans the Secretary based the preliminary The requirements for retained entities to as part of the regulation would not be determination and which the search for, disclose, certify to, and useful because the facts and Commission may consider relevant to mitigate organizational or personal circumstances of each potential or its injury determination. conflicts of interest, (2) general actual conflict determine whether a * * * * * standards related to the handling of conflict of interest exists and dictate the conflicts of interest, favors, gifts, appropriate mitigation controls. [FR Doc. 2011–24666 Filed 9–30–11; 8:45 am] Treasury property, and items of Treasury notes that it routinely BILLING CODE 3510–DS–P monetary value, (3) limits on retained interfaces directly with retained entities entities’ activities concurrently with to formulate conflicts of interest providing services to Treasury, (4) limits mitigation plans that are dependent on DEPARTMENT OF THE TREASURY on retained entities’ communications the particular facts underlying the with Treasury employees, (5) potential conflict. 31 CFR Part 31 requirements with respect to the receipt Treasury also received comments RIN 1505–AC05 and handling of nonpublic information, questioning the relationship of the rule and (6) enforcement powers with to contractors versus financial agents. TARP Conflicts of Interest respect to the interim rule. To clarify, this final rule applies to both financial agency agreements and AGENCY: Departmental Offices, Treasury. II. Summary of Comments, Treasury’s procurement contracts. Of course, ACTION: Resulting Changes, and Final Rule Final rule. procurement contracts are also subject SUMMARY: On January 21, 2009, the Treasury is promulgating this rule to to the Federal Acquisition Regulation Department issued an interim rule that finalize the Interim Rule issued on (the ‘‘FAR’’) along with other regulatory provided guidance on conflicts of January 21, 2009. Interested members of requirements. Treasury also notes that interest pursuant to Section 108 of the the public submitted several comments the TARP Chief Compliance Officer Emergency Economic Stabilization Act to the Interim Rule. The comments have lacks the direct or delegated authority to of 2008 (‘‘EESA’’), which was enacted been carefully considered. Comments waive FAR rules related to are described below, as are the on October 3, 2008. This final rule takes organizational conflicts of interests. approaches that Treasury has taken in into account the public comments Thus, a waiver issued under 31 CFR addressing them. part 31 does not itself ensure received and adopts revisions to the Commentators asked Treasury to interim rule. compliance with the applicable FAR eliminate the reference to ‘‘management requirements. DATES: Effective date: November 2, officials’’ in 31 CFR 31.201 and 31 CFR Treasury notes that pursuant to 2011. 31.212. One commentator took issue section 31.200(b), vendors hired under FOR FURTHER INFORMATION CONTACT: For with what they felt was the an arrangement to perform purely further information regarding this final presumption, by defining management administrative services (e.g., parking rule contact the Troubled Asset Relief official, that such officials had services for Treasury) are not subject to Program Compliance Office, Office of knowledge related to the Treasury this rule because, in Treasury’s Financial Stability, Department of the arrangement by virtue of status, rather estimation, the providers of such Treasury, 1500 Pennsylvania Avenue, than by virtue of having a substantive services are not likely to exercise the Washington, DC, 20220, (202) 622–2000, role in the arrangement. Treasury discretion core to Treasury’s mission or [email protected]. agrees, and decided to limit various under the Troubled Asset Relief SUPPLEMENTARY INFORMATION: obligations previously required of Program (‘‘TARP’’) which would likely management officials to those key create conflicts of interest and, I. Background individuals who are personally and therefore, the burden of subjecting such Pursuant to Section 108 of EESA (Pub. substantially involved in providing vendors to the rule is unnecessary. L. 110–343; 122 Stat. 3765), which services under an arrangement with Treasury added a specific reference to authorizes the Secretary of the Treasury Treasury. Management officials the appearance of a conflict of interest to issue regulations or guidelines performing a substantive role under an to sections 31.200, 31.211 and 31.212 to necessary to address and manage or to arrangement will be subsumed in the clarify that facts or situations that give prohibit conflicts of interest that may definition of key individual, rendering rise to the appearance of a conflict of arise in connection with the the definition of management official interest are also considered potential administration and execution of the unnecessary. conflicts. This clarification is consistent EESA authorities, Treasury promulgated Treasury received a comment that with the overall approach of, and policy an interim final rule on conflicts of inquired whether Treasury considered underlying, the regulation. interest on January 21, 2009 (‘‘Interim the examples listed in the definitional One commentator advocated the Rule’’) (74 FR 3431). Treasury invited provisions in 31 CFR 31.201 to per se adoption of a rule that a retained entity the public to submit comments on the constitute organizational conflict of which is an SEC-registered investment

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adviser is per se deemed to have and can be tailored as necessary in the invites failure. It was requested that complied with the federal securities actual mitigation plan agreed upon by Treasury adopt a more flexible standard, laws mentioned in section 31.211(a) or the retained entity and Treasury. and one commentator even that, in the alternative, the rule should One comment maintained that the recommended eliminating the require that the compliance programs rule inappropriately places too much of notification requirement altogether and only be ‘‘reasonably designed’’ to detect the burden of discovering conflicts of relying only upon the periodic and prevent violations of federal interest, both organizational and certifications. Treasury believes such a securities laws and organizational personal, on the retained entity, and five day timeframe is appropriate and conflicts of interest. Treasury does not that the rule should be amended to does not need to be revised or agree with the first suggestion but agrees explicitly state the burden falls on both lengthened. Experience has shown five with the latter, and has revised section the retained entity and the Treasury. days is not too short of a period as the 31.211(a) accordingly. Treasury does not agree. Although retained entity need only provide Treasury also received comments that Treasury takes independent steps to Treasury notification of the conflict and the standards related to gifts in section identify conflicts of interest and the initial proposal for mitigating the 31.213(a)(1) should be limited to determine appropriate mitigants, the conflict. In addition, it is important for individuals deployed for Treasury and rule focuses on the obligation of the mitigation controls to be implemented include reasonable scope limitations. In retained entity, pursuant to section without delay. Eliminating the response, Treasury agreed to limit 31.211(a), to identify conflicts and notification requirement and relying application of section 31.213(a)(1) to formulate a conflicts of interest solely upon the periodic certification individuals performing work under the mitigation plan. may result in situations in which certain arrangement and added specific dollar One commentator stated the rule conflicts of interest have not been figures to the restriction on accepting or should specify the level of employee mitigated adequately and, thus, soliciting favors, gifts, or other items of within the retained entity that must Treasury’s ability to monitor such monetary value (above $20 per gift or learn of an organizational conflict of conflicts in a timely manner would be $50 for the year) to make it consistent interest before a reporting obligation is undercut. with the standards used by the Office of triggered. Treasury believes that such a One comment requested the Government Ethics. limitation would be opposed to its clarification that the notification Treasury clarifies that it intends to policy objectives that any employee of requirement applies only to conflicts of follow the same standard for ‘‘credible a retained entity who knows of a interest not yet identified, and not to evidence’’ in section 31.213 that is used conflict should be required to report it. new conflicts that can be addressed by in relation to FAR Clause 52.203–13(b) Treasury also received a comment in a previously-approved conflicts (3). favor of a materiality threshold in mitigation plan. The notification One commentator believed that the judging what constitutes an requirement applies to all new conflicts. definition of ‘‘retained entity’’ was organizational conflict of interest. The same comment questioned overly broad, in that it included Treasury was directed to look to whether the five day timeframe begins subcontractors and consultants hired to applicable case law concerning Rule at the time the new conflicts arises, or perform services under the arrangement, 10b–5 of the Securities Exchange Act of when the retained entity’s TARP and that the reference to subcontractors 1934. Treasury has not adopted a Compliance Officer is informed of the and consultants should be removed or, materiality threshold because Treasury new conflict. For avoidance of doubt, in the alternative, limited to those should be alerted to any possible the five day timeframe begins when any providing substantive services under the conflict of interest, and post-notification person at the retained entity becomes arrangement. Treasury disagrees and Treasury can decide whether a conflict aware of the new conflict (not just the notes that subcontractors and vendors is material. Additionally, the adoption TARP Compliance Officer). may possess conflicts of interest that of a materiality threshold could invite Treasury also received comments to could cause a reasonable person with abuse. the effect that the section 31.212(b) knowledge of the relevant facts to Treasury received a comment concept of identifying and monitoring question the retained entity’s objectivity expressing the view that, since the close personal relationships was or judgment. As stated previously, American Bar Association’s (ABA) improperly subjective because the pursuant to section 31.200(b), Rules of Professional Conduct already phrase ‘‘close personal relationship’’ is administrative contracts are excluded contain conflicts of interest provisions, open to broad interpretation. Treasury from the rule, thus avoiding application that Treasury should disregard agrees and revised the definition of a of the rule to entities unlikely to possess organizational conflicts of interest personal conflict of interest in section organizational conflicts of interest. concerns when the retained entity is a 31.201 and the requirements of section A commentator also recommended law firm that has complied with the 31.212(b) to include ‘‘an individual, or that ‘‘related entities’’ be defined more standards set forth in either these rules any dependent child (meaning son, narrowly, to eliminate parents, or applicable case law. Treasury does daughter, stepson or stepdaughter who subsidiaries, etc. which operate not adopt this change because this is either (a) Unmarried, under age 21, independently from the retained entity. regulation is specifically related to the and living in the individual’s house, or It was noted that some conflict requirements of EESA and the ABA (b) considered a ‘‘dependent’’ of the mitigation procedures, such as barriers Rules of Professional Conduct may not individual under the U.S. tax code),’’ In to eliminate the sharing of information, adequately address all conflicts of making this modification, Treasury may also inhibit the discovery of interest. adopted the standards used in conflicts of interest involving related Treasury received comments completing the Office of Government entities. Treasury understands the suggesting that the continuing Ethics (‘‘OGE’’) Form 450. commentator’s concern, but believes obligation to search for any potential Treasury received many comments revising the related entity definition is organizational and personal conflicts of expressing the view that requiring the unnecessary as the conflict mitigation interest and to report new conflicts of use of OGE Form 278 as a disclosure measures listed in section 31.211(c) are interest within five business days of standard in the personal conflicts provided for illustrative purposes only learning of them is unreasonable and inquiry process (section 31.212(b))

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presented an overly invasive, large number of key individuals), it may commentator’s concern, but believes the unwarranted burden, in that it took too request an extension. consequences of sensitive information long to fill out the form and that the Treasury also received a comment becoming public are such that form asked intrusive questions that the three-year document retention maintaining a broad determination of regarding personal activities. Treasury requirement in sections 31.211(h) and confidentiality is warranted and reviewed these comments in light of its 31.212(h) should be shortened. Treasury appropriately protective of confidential own experience, and also in light of believes the three-year document information. having received an official retention requirement is necessary in Treasury also received comments recommendation from the Government case any question should surface recommending that only management Accountability Office (GAO) suggesting regarding a past determination or officials and key personnel be subject to that Form 450 would be a more mitigation as to a particular personal a duty to report violations of appropriate model on which vendors conflict of interest. confidentiality obligations. As stated One commentator felt that section should base their inquiries into the earlier, Treasury believes that any 31.213(c) should be revised so that personal conflicts of their employees employee of the retained entity should Treasury would no longer refer all than Form 278. The GAO believed that be required to report a breach of violations of 18 U.S.C. 1001 to the the using Form 450 as a model could confidentiality. appropriately reduce the burden of Department of Justice and to SIGTARP, providing financial information as but would instead refer only those Treasury received one comment opposed to the Form 278. See violations relating to services under expressing the view that the penalties TROUBLED ASSET RELIEF PROGRAM: EESA and related certifications. contemplated by section 31.218(a) are March 2009 Status of Efforts to Address Treasury sees no reason to limit which overly broad and not reasonably Transparency and Accountability violations it refers to the Department of calculated to address the nature and Issues, GAO March 2009 p. 45, available Justice or to SIGTARP, as Treasury does severity of the perceived transgression. at http://www.gao.gov/new.items/ not wish for any false statements to go Treasury believes that the d09504.pdf. On these bases, Treasury unreported. appropriateness of the sanction will agrees that Form 450 is more Treasury received a comment that the depend heavily on the violation, such appropriate than Form 278 as a personal phrase ‘‘impermissible conflicts of that leaving the potential penalties conflicts inquiry model, and has interest’’ referred to in section 31.214 listed in the rule broad is appropriate. substituted Form 450 for Form 278 in should be limited so that it only relates Treasury received a comment the rule. to activities in connection with buying recommending that section 31.218(b) be Treasury received a comment or selling assets under the TARP eliminated due to perceived uncertainty asserting the rule did not provide program, and not to ‘‘customary’’ regarding Treasury’s expectations enough detail in regard to what would business activities such as managing regarding the times and extent of the constitute a personal conflict of interest, client accounts that hold securities or disclosure requirements found in the and what the related mitigation steps other financial instruments issued by rule. Treasury believes section 31.218(b) would be. Since the Interim Rule has TARP-funded entities. Treasury was encourages prompt disclosure of been released, Treasury has found that also urged to limit the prohibitions set violations of the rule, and thus rejects the definition of ‘‘personal conflicts of forth in section 31.214(a) and (b) to the recommendation. concurrent activities involving the interest’’ is sufficiently broad to The definition of ‘‘key individual’’ in encompass the wide range of personal specific assets for which the retained entity has entered into an arrangement section 31.201 has been changed to conflicts of interest that may arise, but clarify that the list of actions that may yet provides enough guidance for with Treasury, and further, to adopt a de minimis exception in order to permit a constitute personal and substantial retained entities to recognize which participation in a matter provides circumstances could constitute a retained entity to engage in certain examples and is not necessarily an personal conflict of interest, and that the incidental market activities involving exclusive list of such actions. This variables that would determine a TARP securities without such activities change is made to more closely track the sufficient mitigation plan are such that rising to the level of an ‘‘impermissible’’ language of 5 CFR 2635.402(b)(4), upon providing specific examples would be of conflict of interest. Treasury believes which the list is based. It should be limited value. that because such activities can be Some commentators expressed addressed in the retained entity’s stressed that while § 2635.402(b)(4), concern that the ten-business day conflicts mitigation plan agreed upon by which applies to Government timeframe for submitting the personal Treasury, and because section 31.214 employees, covers participation in a conflicts of interest certification is too specifically states its restrictions do not Government matter, personal and little time for a sound submission, apply if ‘‘Treasury agrees in writing to substantial participation in a decision or contending it is unlikely a retained specific mitigation measures,’’ including other matter under consideration by the entity would be able to gather, process, these exceptions in the rule is retained entity itself will satisfy the and certify the required information in unnecessary. criteria for a key individual under this that time. Treasury disagrees because it The same commentator argued that part 31. For example, an employee of has found in its experience in applying section 31.217(a)’s treatment of all the retained entity who provides advice the Interim Rule that ten business days information provided by Treasury to a to other employees of the retained entity is sufficient time to gather the retained entity under an arrangement as concerning performance of the information required to submit the non-public until Treasury determines arrangement qualifies as a key personal conflicts of interest otherwise is overbroad. It was individual if the other elements of the certification, particularly since the recommended that the confidentiality definition are satisfied. retained entity can begin at least part of requirement apply only to information For consistency, Treasury replaced the process before the arrangement is pertaining to a TARP beneficiary or its the previous definition of ‘‘troubled signed. If a retained entity feels ten assets, or that is otherwise marked by assets’’ (in section 31.201) with a business days may not be adequate (for Treasury as proprietary or confidential. reference to the definition given in example, if the retained entity has a Treasury understands the EESA, 12 U.S.C. 5209(9).

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III. Procedural Requirements 31.216 Communications with Treasury interpretation as such words have in 5 employees. CFR 2635.402(b)(4). Regulatory Planning and Review 31.217 Confidentiality of information. Organizational conflict of interest Executive Orders 13563 and 12866 31.218 Enforcement. means a situation in which the retained direct agencies to assess costs and Authority: 31 U.S.C. 321; Pub. L. 110–343; entity has an interest or relationship benefits of available regulatory 122 Stat. 3765. that could cause a reasonable person alternatives and, if regulation is § 31.1 General. with knowledge of the relevant facts to question the retained entity’s objectivity necessary, to select regulatory This part sets forth regulations to or judgment to perform under the approaches that maximize net benefits implement and administer the arrangement, or its ability to represent (including potential economic, Emergency Economic Stabilization Act the Treasury. Without limiting the scope environmental, public health and safety of 2008 (Pub. L. 110–343; 122 Stat. of this definition, organizational effects, distributive impacts, and 3765). equity). Executive Order 13563 conflicts of interest may include the emphasizes the importance of Subpart A—[Reserved] following situations: quantifying both costs and benefits, of (1) A prior or current arrangement reducing costs, of harmonizing rules, Subpart B—Conflicts of Interest between the Treasury and the retained and of promoting flexibility. This rule entity that may give the retained entity has been designated a ‘‘significant § 31.200 Purpose and scope. an unfair competitive advantage in regulatory action’’ although not (a) Purpose. This regulation sets forth obtaining a new arrangement with economically significant, under section standards to address and manage or to Treasury. 3(f) of Executive Order 12866. prohibit conflicts of interest that may (2) The retained entity is, or Accordingly, the rule has been reviewed arise in connection with the represents, a party in litigation against by the Office of Management and administration and execution of the the Treasury relating to activities under Budget. authorities under the Troubled Asset the EESA. Relief Program (TARP), established (3) The retained entity provides Regulatory Flexibility Act under sections 101 and 102 of the services for Treasury relating to the Because no notice of proposed Emergency Economic Stabilization Act acquisition, valuation, disposition, or rulemaking is required, this rule is not of 2008 (EESA). management of troubled assets at the subject to the provisions of the (b) Scope. This regulation addresses same time it provides those services for Regulatory Flexibility Act (5 U.S.C. actual and potential conflicts of interest, itself or others. chapter 6). or circumstances that give rise to the (4) The retained entity gains, or stands appearance of a conflict of interest, that to gain, an unfair competitive advantage Paperwork Reduction Act may arise from contracts and financial in private business arrangements or The information collections contained agency agreements between private investments by using information in the rule have been reviewed and sector entities and the Treasury for provided under an arrangement or approved by OMB under the Paperwork services under the TARP, other than obtained or developed pursuant to an Reduction Act (44 U.S.C. chapter 35) administrative services identified by the arrangement with Treasury. and assigned OMB control number TARP Chief Compliance Officer. (5) The retained entity is a potential candidate for relief under EESA, is 1505–0209. Under the Paperwork § 31.201 Definitions. Reduction Act, an agency may not currently participating in an EESA conduct or sponsor and a person is not As used in this part: program, or has a financial interest that Arrangement means a contract or required to respond to, a collection of could be affected by its performance of financial agency agreement between a information unless it displays a valid the arrangement. private sector entity and the Treasury (6) The retained entity maintains a OMB control number. for services under the TARP, other than business or financial relationship with List of Subjects in 31 CFR Part 31 administrative services identified by the institutions that have received funds TARP Chief Compliance Officer. from Treasury pursuant to the EESA. Conflicts of interest, Contracts, Dependent child means a son, Personal conflict of interest means a Troubled assets. daughter, stepson or stepdaughter who personal, business, or financial interest For the reasons set out in the is either (a) Unmarried, under age 21, of an individual, his or her spouse or preamble, Title 31 of the Code of and living in the individual’s house, or any dependent child that could Federal Regulations is amended as (b) considered a ‘‘dependent’’ of the adversely affect the individual’s ability follows: individual under the U.S. tax code. to perform under the arrangement, his ■ 1. Revise part 31 to read as follows: EESA means the Emergency or her objectivity or judgment in such Economic Stabilization Act of 2008, as performance, or his or her ability to PART 31—TROUBLED ASSET RELIEF amended. represent the interests of the Treasury. PROGRAM Key individual means an individual Related entity means the parent providing services to a private sector company and subsidiaries of a retained Sec. entity who participates personally and entity, any entity holding a controlling 31.1 General. substantially, through, for example, interest in the retained entity, and any Subpart A—[Reserved] decision, approval, disapproval, entity in which the retained entity holds Subpart B—Conflicts of Interest recommendation, or the rendering of a controlling interest. advice, in the negotiation or Retained entity means the individual 31.200 Purpose and scope. performance of, or monitoring for or entity seeking an arrangement with 31.201 Definitions. 31.211 Organizational conflicts of interest. compliance under, the arrangement the Treasury or having such an 31.212 Personal conflicts of interest. with the Treasury. For purposes of the arrangement with the Treasury, but does 31.213 General standards. definition of key individual, the words not include special government 31.214 Limitations on concurrent activities. ‘‘personally and substantially’’ shall employees. A ‘‘retained entity’’ includes 31.215 Grant of waivers. have the same meaning and the subcontractors and consultants it

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hires to perform services under the entity’s obligations under the Treasury under a plan approved by arrangement. arrangement with Treasury. Treasury or previously waived by Special government employee means (4) A description of all organizational Treasury. The retained entity shall an officer or employee serving the conflicts of interest and potential search regularly for conflicts and shall, Treasury, serving with or without conflicts of interest. within five (5) business days after compensation, for a period not to (5) A written detailed plan to mitigate learning of a potential organizational exceed 130 days during any 365-day all organizational conflicts of interest, conflict of interest, disclose the period on a full-time or intermittent along with supporting documents. potential conflict of interest in writing basis. (6) Any other information or to the TARP Chief Compliance Officer. Treasury means the United States documentation about the retained The disclosure shall describe the steps Department of the Treasury. entity, its proposed subcontractors, or it has taken or proposes to take to Treasury employee means an officer its related entities that Treasury may mitigate the potential conflict or request or employee of the Treasury, including request. a waiver from Treasury. a special government employee, or an (c) Plans to mitigate organizational (g) Periodic Certification. No later employee of any other government conflicts of interest. The steps necessary than one year after the arrangement’s agency who is properly acting on behalf to mitigate a conflict may depend on a effective date, and at least annually of the Treasury. variety of factors, including the type of thereafter, the retained entity shall Troubled assets, for purposes of this conflict, the scope of work under the certify in writing that it has no rule, shall have the same meaning as set arrangement, and the organizational organizational conflicts of interest, or forth in 12 U.S.C. 5202(9). structure of the retained entity. Some explain in detail the extent to which it conflicts may be so substantial and can certify, and describe the actions it § 31.211 Organizational conflicts of pervasive that they cannot be mitigated. has taken and plans to take to mitigate interest. Retained entities should consider the any conflicts. Treasury may require (a) Retained entity’s responsibility. A following measures when designing a more frequent certifications, depending retained entity working under an mitigation plan: on the arrangement. arrangement shall not permit an actual (1) Adopting, implementing, and (h) Retention of information. A or potential organizational conflict of enforcing appropriate information retained entity shall retain the interest (including a situation in which barriers to prevent unauthorized people information needed to comply with this the retained entity has an interest or from learning nonpublic information section and to support the certifications relationship that could cause a relating to the arrangement and isolate required by this section for three (3) reasonable person with knowledge of key individuals from learning how their years following termination or the relevant facts to question the performance under the arrangement expiration of the arrangement, and shall retained entity’s objectivity or judgment could affect the financial interests of the make that information available to to perform under the arrangement or its retained entity, its clients, and related Treasury upon request. Such retained ability to represent the Treasury), unless entities. information shall include, but is not the conflict has been disclosed to (2) Divesting assets that give rise to limited to, written documentation Treasury under this Section and conflicts of interest. regarding the factors the retained entity mitigated under a plan approved by (3) Terminating or refraining from considered in its mitigation plan as well Treasury, or Treasury has waived the business relationships that give rise to as written documentation addressing conflict. With respect to arrangements conflicts of interest. the results of the retained entities’ for the acquisition, valuation, (4) If consistent with the terms of the periodic review of the mitigation plan. management, or disposition of troubled arrangement and permitted by Treasury, assets, the retained entity shall maintain refraining from performing specific § 31.212 Personal conflicts of interest. a compliance program reasonably types of work under the arrangement. (a) Retained entity’s responsibility. A designed to detect and prevent (5) Any other steps appropriate under retained entity shall ensure that all key violations of federal securities laws and the circumstances. individuals have no personal conflicts organizational conflicts of interest. (d) Certification required. When the of interest (including a situation that (b) Information required about the retained entity provides the information would cause a reasonable person with retained entity. As early as possible required by paragraph (b) of this section, knowledge of the relevant facts to before entering an arrangement to the retained entity shall certify that the question the individual’s ability to perform services for Treasury under the information is complete and accurate in perform, his or her objectivity or EESA, a retained entity shall provide all material respects. judgment in such performance, or his or Treasury with sufficient information to (e) Determination required. Prior to her ability to represent the interests of evaluate any organizational conflicts of entering into any arrangement, the the Treasury), unless mitigation interest. The information shall include Treasury must conclude that no measures have neutralized the conflict, the following: organizational conflict of interest exists or Treasury has waived the conflict. (1) The retained entity’s relationship that has not been adequately mitigated, (b) Information required. Before key to any related entities. or if a conflict cannot be adequately individuals begin work under an (2) The categories of troubled assets mitigated, that Treasury has expressly arrangement, a retained entity shall owned or controlled by the retained waived it. Once Treasury has approved obtain information from each of them in entity and its related entities, if the a conflicts mitigation plan, the plan writing about their personal, business, arrangement relates to the acquisition, becomes an enforceable term under the and financial relationships, as well as valuation, disposition, or management arrangement. those of their spouses and dependent of troubled assets. (f) Subsequent notification. The children that would cause a reasonable (3) Information concerning all other retained entity has a continuing person with knowledge of the relevant business or financial interests of the obligation to search for, report, and facts to question the individual’s ability retained entity, its proposed mitigate any and all potential to perform, his or her objectivity or subcontractors, or its related entities, organizational conflicts of interest that judgment in such performance, or his or which could conflict with the retained have not already been disclosed to her ability to represent the interests of

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the Treasury. When the arrangement the arrangement, and shall make that involving fraud, conflict of interest, concerns the acquisition, valuation, information available to Treasury upon bribery, or gratuity violations found in management, or disposition of troubled request. Title 18 of the United States Code, or a assets, the information shall be no less violation of the civil False Claims Act extensive than that required of certain § 31.213 General standards. (31 U.S.C. 3729–3733). new federal employees under Office of (a) During the time period in which a Government Ethics Form 450. Treasury retained entity is seeking an § 31.214 Limitations on concurrent activities. may extend the time necessary to meet arrangement and during the term of any these requirements in urgent and arrangement: Treasury has determined that certain compelling circumstances. (1) The retained entity’s officers, market activities by a retained entity (c) Disqualification. The retained partners, or employees performing work during the arrangement are likely to entity shall disqualify key individuals under the arrangement shall not accept cause impermissible conflicts of with personal conflicts of interest from or solicit favors, gifts, or other items of interest. Accordingly, the following performing work pursuant to the monetary value above $20 from any restrictions shall apply unless waived arrangement unless mitigation measures individual or entity whom the retained pursuant to section 31.215, or Treasury have neutralized the conflict to the entity, officer, partner, or employee agrees in writing to specific mitigation satisfaction of the TARP Chief knows is seeking official action from the measures. Compliance Officer. The retained entity Treasury in connection with the (a) If the retained entity assists may seek a waiver from the TARP Chief arrangement or has interests which may Treasury in the acquisition, valuation, Compliance Officer to allow a key be substantially affected by the management, or disposition of specific individual with a personal conflict of performance or nonperformance of troubled assets, the retained entity and interest to work under the arrangement. duties to the Treasury under the key individuals shall not purchase or (d) Initial certification. No later than arrangement, provided that the total offer to purchase such assets from ten business days after the effective date value of gifts from the same person or Treasury, or assist anyone else in of the arrangement, the retained entity entity does not exceed $50 in any purchasing or offering to purchase such shall certify to the Treasury that all key calendar year. troubled assets from the Treasury, individuals performing services under (2) The retained entity and its officers during the term of its arrangement. the arrangement have no personal and partners, and its employees shall (b) If the retained entity advises conflicts of interest, or are subject to a not improperly use or allow the Treasury with respect to a program for mitigation plan or waiver approved by improper use of Treasury property for the purchase of troubled assets, the Treasury. In making this certification, the personal benefit of any individual or retained entity and key individuals shall the retained entity may rely on the entity other than the Treasury. not, during the term of the arrangement, information obtained pursuant to (3) The retained entity and its officers sell or offer to sell, or act on behalf of paragraph (b) of this section, unless the and partners, and its employees shall anyone with respect to a sale or offer to retained entity knows or should have not make any unauthorized promise or sell, any asset to Treasury under the known that the information provided is commitment on behalf of the Treasury. terms of that program. false or inaccurate. Treasury may extend (b) Any individual who acts for or on § 31.215 Grant of waivers. behalf of the Treasury pursuant to an the time necessary to meet these The TARP Chief Compliance Officer arrangement shall comply with 18 requirements where the retained entity may waive a requirement under this U.S.C. 201, which generally prohibits has a large number of key individuals, Part that is not otherwise imposed by the direct or indirect acceptance by a or in other appropriate circumstances. law when it is clear from the totality of public official of anything of value in (e) Periodic certification. No later than the circumstances that a waiver is in the return for being influenced in, or one year after the arrangement’s government’s interest. effective date, and at least annually because of, an official act. Violators are thereafter, the retained entity shall subject to criminal penalties. § 31.216 Communications with Treasury renew the certification required by (c) Any individual or entity that employees. paragraph (d) of this section. The provides information or makes a (a) Prohibitions. During the course of retained entity shall provide more certification to the Treasury that is any process for selecting a retained frequent certifications to Treasury when relating to services under EESA or entity (including any process using non- requested. required pursuant to 31 CFR Part 31 is competitive procedures), a retained (f) Retained entities’ responsibilities. subject to 18 U.S.C. 1001, which entity participating in the process and The retained entity shall adopt and generally prohibits the making of any its representatives shall not: implement procedures designed to false or fraudulent statement to a federal (1) Directly or indirectly make any search for, report, and mitigate personal officer. Upon receipt of information offer or promise of future employment conflicts of interest on a continuous indicating that any individual or entity or business opportunity to, or engage basis. has violated any provision of title 18 of directly or indirectly in any discussion (g) Subsequent notification. Within the U.S. Code or other provision of of future employment or business five business days after learning of a criminal law, Treasury shall refer such opportunity with, any Treasury personal conflict of interest, the retained information to the Department of Justice employee with personal or direct entity shall notify Treasury of the and the Special Inspector General for responsibility for that procurement. conflict and describe the steps it has the Troubled Asset Relief Program (2) Offer, give, or promise to offer or taken and will take in the future to (SIGTARP). give, directly or indirectly, any money, neutralize the conflict. (d) A retained entity shall disclose to gratuity, or other thing of value to any (h) Retention of information. A the SIGTARP, any credible evidence, in Treasury employee, except as permitted retained entity shall retain the connection with the designation, by the Standards of Conduct for information needed to comply with this services, or closeout of the arrangement, Employees of the Executive Branch, 5 section and to support the certifications that an employee, or contractor of the CFR part 2635. required by this section for three years retained entity has committed a (3) Solicit or obtain from any Treasury following termination or expiration of violation of Federal criminal law employee, directly or indirectly, any

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information that is not public and was arrangement has terminated. The (3) Debarment of the retained entity prepared for use by Treasury for the retained entity shall notify the TARP for Federal government contracting and/ purpose of evaluating an offer, Chief Compliance Officer in writing or disqualification of the retained entity quotation, or response to enter into an within five business days of detecting a from future financial agency arrangement. violation of the prohibitions in agreements. (b) Certification. Before a retained paragraph (b), above. The security (4) Imposition of any other remedy entity enters a new arrangement, the measures required by this paragraph available under the terms of the retained entity must certify to the shall include: arrangement or at law. following: (1) Security measures to prevent (5) In the event of violation of a (1) The retained entity is aware of the unauthorized access to facilities and criminal statue, referral to the prohibitions of paragraph (a) of this storage containers where nonpublic Department of Justice for prosecution of section and, to the best of its knowledge information is stored. the retained entity and/or its officers or after making reasonable inquiry, the (2) Security measures to detect and employees. In such cases, the retained entity has no information prevent unauthorized access to Department of Justice may make direct concerning a violation or possible computer equipment and data storage and derivative use of any statements violation of paragraph (a) of this section. devices that store or transmit nonpublic and information provided by any entity, (2) Each officer, employee, and information. its representatives and employees or any representative of the retained entity who (3) Periodic training to ensure that individual, to the extent permitted by participated personally and persons receiving nonpublic law. substantially in preparing and information know their obligation to (b) To the extent Treasury has submitting a bid, offer, proposal, or maintain its confidentiality and to use it discretion in selecting or imposing a request for modification of the only for purposes contemplated by the remedy, it will give significant arrangement has certified that he or she: arrangement. consideration to a retained entity’s (i) Is familiar with and will comply (4) Programs to ensure compliance prompt disclosure of any violation of with the requirements of paragraph (a) with federal securities laws, including these rules. of this section; and laws relating to insider trading, when Dated: September 19, 2011. (ii) Has no information of any the arrangement relates to the violations or possible violations of Timothy G. Massad, acquisition, valuation, management, or paragraph (a) of this section, and will Assistant Secretary for Financial Stability. disposition of troubled assets. report immediately to the retained [FR Doc. 2011–25443 Filed 9–30–11; 8:45 am] (5) A certification from each key entity any subsequently gained BILLING CODE 4810–25–P individual stating that he or she will information concerning a violation or comply with the requirements in section possible violation of paragraph (a) of 31.217(b). The retained entity shall this section. POSTAL SERVICE obtain this certification, in the form of § 31.217 Confidentiality of information. a nondisclosure agreement, before a key 39 CFR Part 122 (a) Nonpublic information defined. individual performs work under the Any information that Treasury provides arrangement, and then annually Service Standards for Market- to a retained entity under an thereafter. Dominant Special Services Products (d) Certification. No later than ten arrangement, or that the retained entity AGENCY: Postal Service. obtains or develops pursuant to the business days after the effective date of ACTION: Final rule. arrangement, shall be deemed the arrangement, the retained entity nonpublic until the Treasury determines shall certify to the Treasury that it has SUMMARY: This rule adds a service otherwise in writing, or the information received a certification form from each standard for Stamp Fulfillment Services becomes part of the body of public key individual stating that he or she will to the set of service standards for stand- information from a source other than the comply with the requirements in alone market-dominant special services retained entity. § 31.217(b). In making this certification, products set forth in our regulations. the retained entity may rely on the (b) Prohibitions. The retained entity DATES: Effective date: November 2, information obtained pursuant to shall not: 2011. (1) Disclose nonpublic information to paragraph (b) of this section, unless the anyone except as required to perform retained entity knows or should have FOR FURTHER INFORMATION CONTACT: the retained entity’s obligations known that the information provided is Khalid Hussain at 816–545–1250. pursuant to the arrangement, or false or inaccurate. SUPPLEMENTARY INFORMATION: Section pursuant to a lawful court order or valid 301 of the Postal Accountability and subpoena after giving prior notice to § 31.218 Enforcement. Enhancement Act of 2006, Public Law Treasury. (a) Compliance with these rules 109–435, 120 Stat. 3198 et seq., requires (2) Use or allow the use of any concerning conflicts of interest is of the the Postal Service to establish modern nonpublic information to further any utmost importance. In the event a service standards for its market- private interest other than as retained entity or any individual or dominant products within a year of the contemplated by the arrangement. entity providing information pursuant law’s December 20, 2006, enactment. (c) Retained entity’s responsibility. A to 31 U.S.C. part 31 violates any of these Section 301 also requires that these retained entity shall take appropriate rules, Treasury may impose or pursue service standards be revised ‘‘from time measures to ensure the confidentiality one or more of the following sanctions: to time.’’ With this final rule, the Postal of nonpublic information and to prevent (1) Rejection of work tainted by an Service adds a set of service standards its inappropriate use. The retained organizational conflict of interest or a for Stamp Fulfillment Services (SFS) to entity shall document these measures in personal conflict of interest and denial the previously-established set of modern sufficient detail to demonstrate of payment for that work. service standards. compliance, and shall maintain this (2) Termination of the arrangement for After extensive consultations with the documentation for three years after the default. Postal Regulatory Commission (PRC),

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the Postal Service established modern classification as a market-dominant philatelic), stamp products, and retail service standards for market-dominant product, the Postal Service now items. Once the order is processed, the products at 39 CFR Parts 121 and 122. considers it necessary to add a set of Postal Service transmits the items as See 72 FR 58946–70 (October 17, 2007) service standards for SFS to 39 CFR Part First-Class Mail, Priority Mail, Express (proposed rule); 72 FR 72216–31 122. Mail, Certified Mail, or Registered Mail, (December 19, 2007) (final rule).1 The SFS provides the fulfillment of stamp depending on the nature and priority of Postal Service also requested the PRC’s and product orders received by mail, the order. These mail channels are approval of proposed systems for the phone, fax, or Internet at the Postal subject to their own service standards, measurement of service standard Service’s SFS center in Kansas City, performance measurement, and achievement for its market-dominant Missouri. Orders can include stamps, reporting, where applicable, and so the products. See PRC Docket No. PI2008– stamped cards, envelopes, and Postal Service does not consider it 1, Notice of Request for Comments on stationery, and other philatelic items necessary or reasonable to add a Service Performance Measurement such as First Day Covers and stamp separate standard for the time that SFS Systems for Market Dominant Products collecting materials. The Postal Service is in transit as a mail shipment. Due to (December 4, 2007). charges a fee for order processing and the variety of customer orders received Since the establishment of the Postal handling. at SFS (mail use stamps, collectible Service’s service standards, the PRC Based on the nature of the fee, the stamps, retail product, etc.), the Postal added SFS to the market-dominant distinct aspect of SFS service consists of Service establishes a set of service products list. PRC Order No. 487 (July SFS’ intake, processing, and handling of standards for SFS based upon order 13, 2010). As a result of SFS’ orders for stamps (both mail use and profiles.

STAMP FULFILLMENT SERVICES—SERVICE STANDARDS FOR FULFILLMENT PROCESS

Customer order Service standard 1

Internet Orders: Non-Philatelic/Non-Custom ...... ≤ 2 Business Days. Business Level Orders ...... ≤ 5 Business Days. Philatelic/Custom and All Other Order Sources ...... ≤ 10 Business Days.

These service standards apply to the standard performance be measured by Authority: 39 U.S.C. 101, 401, 403, 404, period from receipt of the order with some objective external system, or by 1001, 3691. payment in Stamp Fulfillment Services’ internal methods approved by the PRC order intake system thru order under 39 U.S.C. 3691(b)(2). The Postal ■ 2. Section 122.2 is amended by adding completion for entry (pick up by mail Service will submit a plan for service paragraph (e) to read as follows: truck) into USPS mail stream. These performance measurement to the PRC § 122.2 Stand-Alone Special Services. standards exclude orders which may be for review. comprised of pre-orders, backorders, or * * * * * List of Subjects in 39 CFR Part 122 orders where merchandise is not (e) The service standards for Stamp fulfilled at SFS. Mail, Postal service. Fulfillment Services order fulfillment The service standards for SFS reflects For the reasons stated in the service is shipment of orders within the thorough consideration of the objectives preamble, the Postal Service amends 39 following timeframes, based from the listed in 39 U.S.C. 3691(b)(1) and the CFR Part 122 as follows: time of order receipt within SFS factors listed in 39 U.S.C. 3691(c), with systems, excluding designated postal an emphasis on customer satisfaction PART 122—[AMENDED] holidays. and customer needs. 39 U.S.C. 3691(b) requires that ■ 1. The authority citation for 39 CFR market-dominant product service Part 122 continues to read as follows:

STAMP FULFILLMENT SERVICES—SERVICE STANDARDS FOR FULFILLMENT PROCESS

Customer order Service standard 1

Internet Orders: Non-Philatelic/Non-Custom ...... ≤ 2 Business Days. Business Level Orders ...... ≤ 5 Business Days. Philatelic/Custom and All Other Order Sources ...... ≤ 10 Business Days.

1 By operation of 39 U.S.C. 410(a), the Postal makings. The Postal Service determined that public this notice, however, the Postal Service is Service is exempt from the notice and comment comment was appropriate for the initial service exercising its discretion to forego notice-and- requirements of the Administrative Procedure Act standards rulemaking in light of its unprecedented comment rulemaking in this instance. (5 U.S.C. 553 (b), (c)) regarding proposed rule role. Given the limited scope of the rules issued in

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Stanley F. Mires, Environmental Protection Agency, 2007 with the EPA-approved text of the Attorney, Legal Policy & Legislative Advice. Region 8, Mailcode 8P–AR, 1595 same APEN provision in the 1997 [FR Doc. 2011–25336 Filed 9–30–11; 8:45 am] Wynkoop, Denver, Colorado 80202– Colorado SIP. These changes are BILLING CODE 7710–12–P 1129, (303) 312–6602, detailed in the technical support [email protected]. document available in the docket for SUPPLEMENTARY INFORMATION: this action. In Table 1 of Section IV. ENVIRONMENTAL PROTECTION below, EPA provides the approvals, AGENCY Definitions disapprovals and no actions being taken For the purpose of this document, we for each provision number as of the 40 CFR Part 52 are giving meaning to certain words or August 1, 2007 submittal. The reasons for EPA’s final action are discussed in [EPA–R08–OAR–2007–0649; FRL–9290–2] initials as follows: (i) The words or initials Act or CAA our notice proposing action on these Approval and Promulgation of State mean or refer to the Clean Air Act, revisions and in the associated technical Implementation Plans; State of unless the context indicates otherwise. support document. (76 FR 4271 (Jan. 25, Colorado Regulation Number 3: (ii) The words EPA, we, us or our 2011)). Through this approach to the Revisions to the Air Pollutant Emission mean or refer to the United States cumulative revisions, EPA is taking final action on all APEN revisions— Notice Requirements and Exemptions Environmental Protection Agency. (iii) The initials SIP mean or refer to with certain exceptions noted below—as AGENCY: Environmental Protection State Implementation Plan. submitted by the State of Colorado on Agency (EPA). (iv) The words State or Colorado September 16, 1997, June 20, 2003, July ACTION: Final rule. mean the State of Colorado, unless the 11, 2005, August 8, 2006, and August 1, context indicates otherwise. 2007. SUMMARY: EPA is partially approving and partially disapproving State Table of Contents II. Response to Comments Implementation Plan (SIP) revisions I. Background EPA did not receive comments on our regarding the Air Pollutant Emission II. Response to Comments January 25, 2011 Federal Register Notice (APEN) regulations submitted by III. Section 110(l) of the CAA proposed action regarding the partial the State of Colorado on September 16, IV. Final Action approval and partial disapproval of 1997, June 20, 2003, July 11, 2005, V. Statutory and Executive Order Reviews Colorado’s SIP revisions to their August 8, 2006 and August 1, 2007. The I. Background Regulation Number 3, Part A, Sections APEN provisions in Sections II.A. II.A. through II.D. The State of Colorado submitted through II.D., Part A of Colorado’s formal revisions to their SIP between III. Section 110(l) of the CAA Regulation Number 3, specify the APEN 1997 and 2007 with Governor’s letters filing requirements for stationary Section 110(l) of the CAA states that dated as follows: September 16, 1997; sources and exemptions from such a SIP revision cannot be approved if the June 20, 2003; July 11, 2005; August 8, requirements. This action is being taken revision would interfere with any 2006; and August 1, 2007. These under section 110 of the Clean Air Act applicable requirement concerning submittals included revisions to the (CAA). attainment and reasonable further Colorado APEN provisions in progress toward attainment of the DATES: This final rule is effective Regulation Number 3, Part A, Sections National Ambient Air Quality Standards November 2, 2011. II.A. through II.D. The Colorado APEN (NAAQS) or any other applicable ADDRESSES: EPA has established a provisions in Regulation Number 3, Part requirements of the Act. Those portions docket for this action under Docket ID A, Sections II.A. through II.C., specify of the revisions to Colorado’s Regulation No. EPA–R08–OAR–2007–0649. All requirements for stationary sources Number 3, Part A, Sections II.A. through documents in the docket are listed in (major and minor) to file emission II.D. that we are approving satisfy the http://www.regulations.gov index. notices. These notices provide section 110(l), because those portions do Although listed in the index, some information such as the location where not relax existing SIP requirements. information is not publicly available, a source’s emissions will occur, the Instead, the revisions that EPA is e.g., CBI or other information whose nature of the source or of the activity approving increase stringency of disclosure is restricted by statute. generating the expected emissions, and existing provisions, clarify existing Certain other material, such as an estimate of the emissions’ quantity provisions, or remove obsolete copyrighted material, will be publicly and composition. The Colorado APEN provisions. Therefore, section 110(l) is available only in hard copy. Publicly provisions in Regulation Number 3, Part satisfied for the provisions that EPA is available docket materials are available A, Section II.D. exempt specific approving. However, EPA is either electronically in http:// categories of sources from APEN disapproving some exemptions in part www.regulations.gov or in hard copy at requirements. because those provisions relax existing the Air Program, Environmental EPA’s last final rulemaking action SIP requirements. (See 76 FR 4271.) Protection Agency (EPA), Region 8, addressing revisions to Colorado’s Because EPA is disapproving those 1595 Wynkoop Street, Denver, Colorado APEN provisions was published January provisions, section 110(l) is satisfied. 80202–1129. EPA requests that if at all 21, 1997 (62 FR 2910). The final rule possible, you contact the individual today addresses the APEN SIP revisions IV. Final Action listed in the FOR FURTHER INFORMATION discussed above. EPA’s final rule action EPA is partially approving and CONTACT section to view the hard copy on the revisions submitted by the State partially disapproving the Colorado SIP of the docket. You may view the hard does not trace the APEN provision revisions for APEN requirements and copy of the docket Monday through changes through each of the exemptions submitted by the State on Friday, 8 a.m. to 4 p.m., excluding submissions noted above. For reasons of September 16, 1997, June 20, 2003, July Federal holidays. efficiency and clarity, EPA compared 11, 2005, August 8, 2006, and August 1, FOR FURTHER INFORMATION CONTACT: the language of each APEN provision as 2007. As noted above, EPA’s evaluation Crystal Freeman, Air Program, U.S. submitted by the State on August 1, of the revisions submitted by the State

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does not track the APEN provision entirety of the language and their new vacuum pump exhausts; and (5) new changes through each of the location in Section I.B. The provision exemption II.D.1.ffff., applicable to Air submissions, but instead, for each references, before the renumbering, Curtain Destructors. provision, compared the textual changes were: II.B.5. and II.B.9. The references, EPA is taking no action on the between the EPA-approved Colorado after the renumbering, are, respectively, following provisions, also found in APEN provisions effective February 21, I.B.43 and I.B.16. Table 1 below, in Regulation Number 3, 1997, and the Colorado-adopted APEN EPA is disapproving revisions to the provisions included with the August 1, following provisions in Regulation Part A, Section II: (1) II.D.1.m; II.D.1.ee; 2007 submittal. Below is a Number 3, Part A, Section II, which can II.D.1.uu; II.D.1.ddd; and II.D.1.eeee., comprehensive summary of EPA’s final also be found in Table 1 below: (1) A because EPA already proposed approval action—approval, disapproval or no revision to II.D.1.q., regarding the APEN of the repeal of these exemptions in a action—for each of the Colorado APEN exemption for open burning activities; 1 separate action published on July 21, provisions in Regulation Number 3, Part (2) new exemption II.D.1.sss. and its 2010 (75 FR 42346); and (2) the revision A, Section II. The APEN provision subprovisions, which would exempt to APEN exemption II.D.1.uuu., because numbers are as codified in the August three tiers of stationary internal we proposed approval of the revision in 1, 2007 submission. combustion engines from APEN the same July 21, 2010 proposal. The In addition to Table 1 below, EPA is requirements; (3) new exemption remaining provisions listed in the ‘‘No approving revisions to the following II.D.1.ttt. and its subprovisions, which Action’’ section of the table were not provisions in Regulation Number 3, Part would exempt three tiers of emergency revised by the State in any of the A, Section II: (1) Deletion of provisions power generators from APEN submittals that are the subject of this II.B.8., II.B.10., and II.D.4.b.; and (2) requirements; (4) new exemption action. renumbering of APEN requirements, the II.D.1.xxx., which exempts deaerator/

TABLE 1—LIST OF COLORADO APEN PROVISIONS (REQUIREMENTS AND EXEMPTION IN SECTIONS II.A THROUGH II.D OF PART A, REGULATION NUMBER 3) BY EPA—FINAL RULE

EPA’s final rule APEN provision number in August 1, 2007 submission

Approval ...... II.A; II.B.1; II.B.1.b; II.B.2; II.B.3; II.B.3.a; II.B.4.a. through II.B.4.f; II.B.5; II.B.6 2; II.C., II.C.1, II.C.1.a; II.C.1.h; II.C.2; II.C.2.b; II.C.2.b.(i) through II.C.2.b.(iv); II.C.3; II.C.3.a through II.C.3.d; II.D; II.D.1; II.D.1.a; II.D.1.f through II.D.1.i; II.D.1.j; II.D.1.k; II.D.1.n; II.D.1.x; II.D.1.y; II.D.1.aa; II.D.1.bb; II.D.1.kk; II.D.1.nn; II.D.1.oo; II.D.1.aaa; II.D.1.bbb; II.D.1.ccc; II.D.1.fff; II.D.1.ggg; II.D.1.lll; II.D.1.nnn. through II.D.1.rrr; II.D.1.vvv; II.D.1.www; II.D.1.yyy through II.D.1.dddd; II.D.2 through II.D.6. Disapproval ...... II.D.1.q; II.D.1.sss; II.D.1.sss(i); II.D.1.sss(ii); II.D.1.sss(iii); II.D.1.ttt; II.D.1.ttt(i); II.D.1.ttt(ii); II.D.1.ttt(iii); II.D.1.xxx; II.D.1.ffff. No Action ...... II.B; II.B.1.a; II.B.3.b; II.B.4; II.C.1.b. through II.C.1.g; II.C.2.a; II.D.1.b. through II.D.1.e; II.D.1.i.(i). through II.D.1.i.(iii); II.D.1.l; II.D.1.m; II.D.1.o; II.D.1.p; II.D.1.r. through II.D.1.w; II.D.1.z; II.D.1.cc; II.D.1.dd; II.D.1.ee; II.D.1.ff. through II.D.1.jj; II.D.1.ll; II.D.1.mm; II.D.1.pp. through II.D.1.tt; II.D.1.uu; II.D.1.vv. through II.D.1.zz; II.D.1.ddd; II.D.1.eee; II.D.1.hhh. through II.D.1.kkk; II.D.1.mmm; II.D.1.uuu; II.D.1.eeee. 2 For provisions II.B.5. and II.B.6., we are approving the renumbering.

V. Statutory and Executive Order of the Paperwork Reduction Act (44 • Is not subject to requirements of Reviews U.S.C. 3501 et seq.); Section 12(d) of the National Under the Clean Air Act, the • Is certified as not having a Technology Transfer and Advancement Administrator is required to approve a significant economic impact on a Act of 1995 (15 U.S.C. 272 note) because SIP submission that complies with the substantial number of small entities application of those requirements would provisions of the Act and applicable under the Regulatory Flexibility Act be inconsistent with the Clean Air Act; Federal regulations. 42 U.S.C. 7410(k); (5 U.S.C. 601 et seq.); and 40 CFR 52.02(a). Thus, in reviewing SIP • Does not contain any unfunded • Does not provide EPA with the submissions, EPA’s role is to approve mandate or significantly or uniquely discretionary authority to address, as state choices, provided that they meet affect small governments, as described appropriate, disproportionate human the criteria of the Clean Air Act. in the Unfunded Mandates Reform Act health or environmental effects, using Accordingly, this action merely of 1995 (Pub. L. 104–4); practicable and legally permissible approves state law as meeting Federal • Does not have Federalism methods, under Executive Order 12898 requirements and does not impose implications as specified in Executive (59 FR 7629, February 16, 1994). additional requirements beyond those Order 13132 (64 FR 43255, August 10, imposed by state law. For that reason, In addition, this rule does not have 1999); Tribal implications as specified by this action: • • Is not a ‘‘significant regulatory Is not an economically significant Executive Order 13175 (65 FR 67249, action’’ subject to review by the Office regulatory action based on health or November 9, 2000), because the SIP is of Management and Budget under safety risks subject to Executive Order not approved to apply in Indian country Executive Order 12866 (58 FR 51735, 13045 (62 FR 19885, April 23, 1997); located in the state, and EPA notes that October 4, 1993); • Is not a significant regulatory action it will not impose substantial direct • Does not impose an information subject to Executive Order 13211 (66 FR costs on Tribal governments or preempt collection burden under the provisions 28355, May 22, 2001); Tribal law.

1 The revision changes the reference from Regulation Number 1 to Regulation Number 9, which is enforceable only by the State.

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The Congressional Review Act, 5 (F) Previously approved in paragraph ■ 3. Add paragraph (e) to § 52.329 as U.S.C. 801 et seq., as added by the Small (c)(72)(i)(D) under Regulation No. 3, Air follows: Business Regulatory Enforcement Contaminant Emissions Notices, 5 CCR Fairness Act of 1996, generally provides 1001–5. These sections are now deleted § 52.329 Rules and regulations. that before a rule may take effect, the without replacement: II.B.7., II.B.8., * * * * * agency promulgating the rule must II.B.9., II.B.10., and II.D.7, effective (e) The State of Colorado submitted submit a rule report, which includes a October 30, 2006. revisions on September 16, 1997, June 20, 2003, July 11, 2005, August 8, 2006 copy of the rule, to each House of the * * * * * Congress and to the Comptroller General and August 1, 2007 to Colorado’s 5 CCR (119) The State of Colorado submitted 1001–5 Regulation Number 3, Part A, of the United States. EPA will submit a revisions on September 16, 1997, June report containing this action and other Section II. One of the revisions deleted 20, 2003, July 11, 2005, August 8, 2006 two provisions from Section II and required information to the U.S. Senate, and August 1, 2007 to Colorado’s 5 CCR the U.S. House of Representatives, and moved them to Section I of Regulation 1001–5 Regulation Number 3, Part A, Number 3, Part A. The revised the Comptroller General of the United Section II. The August 1, 2007 submittal States prior to publication of the rule in regulatory provisions read as follows: included a renumbering of sections in (1) 5 CCR 1001–5, Regulation 3, the Federal Register. A major rule II.B and II.D. The incorporation by Stationary Source Permitting and Air cannot take effect until 60 days after it reference in (c)(119)(i)(A) reflects the Pollutant Emission Notice is published in the Federal Register. renumbered provisions as of the August Requirements, Part A, Concerning This action is not a ‘‘major rule’’ as 1, 2007 submittal. Additionally, the General Provisions Applicable to defined by 5 U.S.C. 804(2). State of Colorado deleted sections Reporting and Permitting, Section I, Under section 307(b)(1) of the Clean II.B.7., II.B.8., II.B.9., II.B.10., and II.D.7. Applicability, Section I.B.16, Criteria Air Act, petitions for judicial review of without replacement. The deletion of Pollutants,; effective June 30, 2004: this action must be filed in the United these provisions has been incorporated (i) Those pollutants for which the U.S. States Court of Appeals for the by reference at (c)(72)(i)(F) of this EPA has established national ambient appropriate circuit by December 2, section, the paragraph containing the air quality standards, including: carbon 2011. Filing a petition for original incorporation by reference of monoxide, nitrogen dioxide, sulfur reconsideration by the Administrator of the provisions. dioxide, PM10, total suspended this final rule does not affect the finality (i) Incorporation by reference. particulate matter, ozone, volatile of this action for the purposes of judicial (A) 5 CCR 1001–5, Regulation 3, organic compounds (as a precursor to review nor does it extend the time Stationary Source Permitting and Air ozone), and lead. For the purposes of within which a petition for judicial Pollutant Emission Notice Air Pollutant Emission Notice reporting, review may be filed, and shall not Requirements, Part A, Concerning criteria pollutants shall also include postpone the effectiveness of such rule General Provisions Applicable to nitrogen oxides, fluorides, sulfuric acid or action. This action may not be Reporting and Permitting, Section II, Air mist, hydrogen sulfide, total reduced challenged later in proceedings to Pollutant Emission Notice (APEN) sulfur, reduced sulfur compounds, enforce its requirements. (See section Requirements, Sections II.A, Air municipal waste combustor organics, 307(b)(2).) Pollutant Emission Notices for New, municipal waste combustor metals, and List of Subjects in 40 CFR Part 52 Modified, and Existing Sources; II. B, municipal waste combustor acid gases. General; II.B.1, Emission Estimate; (2) 5 CCR 1001–5, Regulation 3, Environmental protection, Air II.B.1.b, Other engineering calculations; Stationary Source Permitting and Air pollution control, Incorporation by II.B.2, Air Pollutant Emission Notice Pollutant Emission Notice reference, Intergovernmental relations, Term; II.B.3, APEN Applicability; Requirements, Part A, Concerning Nitrogen dioxide, Ozone, Particulate II.B.3.a, Criteria Pollutants; II.B.4.a; General Provisions Applicable to matter, Reporting and recordkeeping II.B.4.b; II.B.4.c; II.B.4.d; II.B.4.e; II.B.4.f; Reporting and Permitting, Section I, requirements, Volatile organic the undesignated text immediately Applicability, Section I.B.43, compounds. following II.B.4.f and preceding II.B.5; Uncontrolled Actual Emissions; Dated: March 24, 2011. II.B.5; II.B.6; II.C, Revised Air Pollutant effective June 30, 2004: Carol Rushin, Emission Notices; II.C.1; II.C.1.a; (i) The annual emission rate corresponding to the annual process rate Deputy Regional Administrator, Region 8. II.C.1.h; II.C.2; II.C.2.b; II.C.3; II.D, Exemptions from Air Pollutant Emission listed on the Air Pollutant Emission 40 CFR part 52 is amended as follows: Notice Requirements; II.D.1; the Notice form, without consideration of any emission control equipment or PART 52—[AMENDED] undesignated text immediately following II.D.1 and preceding II.D.1.a; procedures. The division may allow a source to forego calculating or ■ 1. The authority citation for part 52 II.D.1.a; II.D.1.f; II.D.1.g; II.D.1.h; II.D.1.i estimating its uncontrolled actual continues to read as follows: (excluding subprovisions); II.D.1.j; II.D.1.k; II.D.1.n; II.D.1.x; II.D.1.y; emissions of hazardous air pollutants Authority: 42 U.S.C. 7401 et seq. II.D.1.aa; II.D.1.bb; II.D.1.kk; II.D.1.nn; upon a showing by the source and a determination by the division that the Subpart G—Colorado II.D.1.oo; II.D.1.aaa; II.D.1.bbb; II.D.1.ccc; II.D.1.fff; II.D.1.ggg; II.D.1.lll; creation of such data is unreasonably costly, technically impractical or not ■ 2. Section 52.320 is amended by the undesignated text immediately reasonably related to information adding paragraphs (c)(72)(i)(F) and following II.D.1.lll and preceding necessary for making regulatory (c)(119) to read as follows: II.D.1.mmm; II.D.1.nnn., II.D.1.ooo; II.D.1.ppp; II.D.1.qqq; II.D.1.rrr; decisions with respect to that source. § 52.320 Identification of plan. II.D.1.vvv; II.D.1.www; II.D.1.yyy; The division’s final determination may * * * * * II.D.1.zzz; II.D.1.aaaa; II.D.1.bbbb; be appealed to the commission by the (c) * * * II.D.1.cccc; II.D.1.dddd; II.D.2; II.D.3; source. (72) * * * II.D.4; II.D.5; II.D.6; effective October 30, [FR Doc. 2011–25292 Filed 9–30–11; 8:45 am] (i) * * * 2006. BILLING CODE 6560–50–P

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ENVIRONMENTAL PROTECTION ADDRESSES: Submit comments, www.regulations.gov and in hard copy AGENCY identified by docket number EPA–R09– at EPA Region IX, 75 Hawthorne Street, OAR–2011–0580, by one of the San Francisco, California. While all 40 CFR Part 52 following methods: documents in the docket are listed at 1. Federal eRulemaking Portal: http:// http://www.regulations.gov, some [EPA–R09–OAR–2011–0580; FRL–9468–2] www.regulations.gov. Follow the on-line information may be publicly available instructions. only at the hard copy location (e.g., Revisions to the California State 2. E-mail: [email protected]. copyrighted material, large maps), and Implementation Plan, Sacramento 3. Mail or deliver: Andrew Steckel some may not be publicly available in Metropolitan Air Quality Management (Air-4), U.S. Environmental Protection either location (e.g., CBI). To inspect the District, Ventura County Air Pollution Agency Region IX, 75 Hawthorne Street, hard copy materials, please schedule an Control District, and Placer County Air San Francisco, CA 94105–3901. appointment during normal business Pollution Control District Instructions: All comments will be hours with the contact listed in the FOR included in the public docket without FURTHER INFORMATION CONTACT section. AGENCY: Environmental Protection change and may be made available Agency (EPA). online at http://www.regulations.gov, FOR FURTHER INFORMATION CONTACT: including any personal information David Grounds, EPA Region IX, (415) ACTION: Direct final rule. provided, unless the comment includes 972–3019, [email protected]. SUMMARY: EPA is taking direct final Confidential Business Information (CBI) SUPPLEMENTARY INFORMATION: action to approve revisions to the or other information whose disclosure is Throughout this document, ‘‘we,’’ ‘‘us,’’ Sacramento Metropolitan Air Quality restricted by statute. Information that and ‘‘our’’ refer to EPA. Management District (SMAQMD), you consider CBI or otherwise protected Table of Contents Ventura County Air Pollution Control should be clearly identified as such and District (VCAPCD), and Placer County should not be submitted through I. The State’s Submittal Air Pollution Control District (PCAPCD) http://www.regulations.gov or e-mail. A. What rules did the State submit? portion of the California State http://www.regulations.gov is an B. Are there other versions of these rules? Implementation Plan (SIP). These ‘‘anonymous access’’ system, and EPA C. What is the purpose of the submitted rules? revisions concern volatile organic will not know your identity or contact information unless you provide it in the II. EPA’s Evaluation and Action compound (VOC) emissions from body of your comment. If you send e- A. How is EPA evaluating the rules? organic chemical manufacturing, soil mail directly to EPA, your e-mail B. Do the rules meet the evaluation decontamination, and polyester resin address will be automatically captured criteria? operations. We are approving local rules C. EPA Recommendations To Further and included as part of the public that regulate these emission sources Improve the Rules comment. If EPA cannot read your under the Clean Air Act as amended in D. Public Comment and Final Action comment due to technical difficulties 1990 (CAA or the Act). III. Statutory and Executive Order Reviews and cannot contact you for clarification, DATES: This rule is effective on EPA may not be able to consider your I. The State’s Submittal December 2, 2011 without further comment. Electronic files should avoid A. What rules did the State submit? notice, unless EPA receives adverse the use of special characters, any form comments by November 2, 2011. If we of encryption, and be free of any defects Table 1 lists the rules we are receive such comments, we will publish or viruses. approving with the dates that they were a timely withdrawal in the Federal Docket: Generally, documents in the adopted by the local air agencies and Register to notify the public that this docket for this action are available submitted by the California Air direct final rule will not take effect. electronically at http:// Resources Board (CARB).

TABLE 1—SUBMITTED RULES

Local agency Rule No. Rule title Adopted Submitted

SMAQMD ...... 464 Organic Chemical Manufacturing Operations ...... 09/25/08 09/15/09 VCAPCD ...... 74.29 Soil Decontamination Operations ...... 04/08/08 01/10/10 PCAPCD ...... 243 Polyester Resin Operations ...... 04/10/03 12/07/10

On 01/21/10, EPA determined that the B. Are there other versions of these C. What is the purpose of the submitted submittal for SMAQMD Rule 464 met rules? rules? the completeness criteria in 40 CFR Part VOCs help produce ground-level 51 Appendix V, which must be met There are no previous versions of PCAPCD Rules 243 in the SIP. We ozone and smog, which harm human before formal EPA review. On 02/04/10, health and the environment. Section EPA determined that the submittal for approved an earlier version of SMAQMD Rule 464 into the SIP on 110(a) of the CAA requires States to VCAPCD Rule 74.29 met the submit regulations that control VOC 04/19/00 (65 FR 20912). We approved completeness criteria, and on 01/13/11, emissions. SMAQMD Rule 464 limits an earlier version of VCAPCD Rule EPA determined that the submittal for VOC emissions from organic chemical PCAPCD Rule 243 met the completeness 74.29 into the SIP on 07/16/02 (67 FR plants. VCAPCD Rule 74.29 establishes criteria. 46596). While we can act on only the procedures for the treatment of soil most recently submitted version, we contaminated with gasoline, diesel fuel have reviewed materials provided with or jet fuel. PCAPCD Rule 243 reduces previous submittals. the emissions of VOC from polyester resin operations. EPA’s technical

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support documents (TSDs) have more regarding enforceability, RACT, and SIP of the Paperwork Reduction Act (44 information about these rules. relaxations. The TSDs have more U.S.C. 3501 et seq.); information on our evaluation. • Is certified as not having a II. EPA’s Evaluation and Action significant economic impact on a C. EPA Recommendations To Further A. How is EPA evaluating these rules? substantial number of small entities Improve the Rules Generally, SIP rules must be under the Regulatory Flexibility Act The TSDs for VCAPCD and PCAPCD (5 U.S.C. 601 et seq.); enforceable (see section 110(a) of the • Act), must require Reasonably Available describe additional rule revisions that Does not contain any unfunded Control Technology (RACT) for each we recommend for the next time the mandate or significantly or uniquely category of sources covered by a Control local agency modifies the rule. affect small governments, as described in the Unfunded Mandates Reform Act Techniques Guidelines (CTG) document D. Public Comment and Final Action as well as each major source in of 1995 (Pub. L. 104–4); • Does not have Federalism nonattainment areas (see sections As authorized in section 110(k)(3) of 182(a)(2) and (b)(2)), and must not relax the Act, EPA is fully approving the implications as specified in Executive existing requirements (see sections submitted rules because we believe they Order 13132 (64 FR 43255, August 10, 110(l) and 193). SMAQMD regulates an fulfill all relevant requirements. We do 1999); • Is not an economically significant ozone nonattainment area (see 40 CFR not think anyone will object to this regulatory action based on health or part 81). SMAQMD has no major approval, so we are finalizing it without safety risks subject to Executive Order sources for this category but is covered proposing it in advance. However, in 13045 (62 FR 19885, April 23, 1997); by relevant CTGs. The stringency of the Proposed Rules section of this • Is not a significant regulatory action requirements in submitted Rule 464 is Federal Register, we are simultaneously subject to Executive Order 13211 (66 FR generally consistent with the relevant proposing approval of the same submitted rules. If we receive adverse 28355, May 22, 2001); guidance that help define RACT. • Is not subject to requirements of comments by November 2, 2011, we VCAPCD and PCAPCD also regulate Section 12(d) of the National will publish a timely withdrawal in the ozone nonattainment areas, but have no Technology Transfer and Advancement Federal Register to notify the public relevant major sources and no CTGs so Act of 1995 (15 U.S.C. 272 note) because that the direct final approval will not RACT is not required for these rules. application of those requirements would Guidance and policy documents that take effect and we will address the be inconsistent with the Clean Air Act; we use to evaluate enforceability and comments in a subsequent final action and based on the proposal. If we do not RACT requirements consistently • Does not provide EPA with the receive timely adverse comments, the include the following: discretionary authority to address 1. ‘‘Issues Relating to VOC Regulation direct final approval will be effective disproportionate human health or Cutpoints, Deficiencies, and without further notice on December 2, environmental effects with practical, Deviations,’’ EPA, May 25, 1988 (the 2011. This will incorporate these rules appropriate, and legally permissible Bluebook). into the Federally enforceable SIP. methods under Executive Order 12898 2. ‘‘Guidance Document for Correcting Please note that if EPA receives (59 FR 7629, February 16, 1994). Common VOC & Other Rule adverse comment on an amendment, In addition, these rules do not have Deficiencies,’’ EPA Region 9, August 21, paragraph, or section of this rule and if Tribal implications as specified by 2001 (the Little Bluebook). that provision may be severed from the Executive Order 13175 (65 FR 67249, 3. ‘‘Control of Volatile Organic remainder of the rule, EPA may adopt November 9, 2000), because the SIPs are Emissions from Batch Processes— as final those provisions of the rule that not approved to apply in Indian country Alternative Control Techniques are not the subject of an adverse located in the State, and EPA notes that Information Document’’ (EPA–453–93– comment. it will not impose substantial direct 017, 02/94). 4. ‘‘Control of Volatile Organic III. Statutory and Executive Order costs on Tribal governments or preempt Emissions from Manufacture of Reviews Tribal law. The Congressional Review Act, 5 Synthesized Pharmaceutical Products’’ Under the Clean Air Act, the U.S.C. 801 et seq., as added by the Small (EPA–450–2–78–029, 12/78). Administrator is required to approve a Business Regulatory Enforcement 5. ‘‘Control Techniques Guidelines for SIP submission that complies with the Industrial Cleaning Solvents’’ (EPA– Fairness Act of 1996, generally provides provisions of the Act and applicable that before a rule may take effect, the 453/R–06–001, 09/06). Federal regulations. 42 U.S.C. 7410(k); 6. ‘‘Control of VOC Emissions from agency promulgating the rule must 40 CFR 52.02(a). Thus, in reviewing SIP Manufacture of High-Density submit a rule report, which includes a submissions, EPA’s role is to approve Polyethylene, Polypropylene, and copy of the rule, to each House of the State choices, provided that they meet Polystyrene Resins’’ (EPA–450/3–83– Congress and to the Comptroller General the criteria of the Clean Air Act. 008, 11/83). of the United States. EPA will submit a 7. ‘‘Control of VOC Fugitive Accordingly, this action merely report containing this action and other Emissions from Synthetic Organic approves State law as meeting Federal required information to the U.S. Senate, Chemical Polymer and Resin requirements and does not impose the U.S. House of Representatives, and Manufacturing Equipment’’ (EPA–450/ additional requirements beyond those the Comptroller General of the United 3–83–006, 03/84). imposed by State law. For that reason, States prior to publication of the rule in 8. ‘‘Control Techniques Guidelines for this action: the Federal Register. A major rule • Fiberglass Boat Manufacturing Is not a ‘‘significant regulatory cannot take effect until 60 days after it Materials’’ (EPA–453/R–08–004, 09/08). action’’ subject to review by the Office is published in the Federal Register. of Management and Budget under This action is not a ‘‘major rule’’ as B. Do the rules meet the evaluation Executive Order 12866 (58 FR 51735, defined by 5 U.S.C. 804(2). criteria? October 4, 1993); Under section 307(b)(1) of the Clean We believe these rules are consistent • Does not impose an information Air Act, petitions for judicial review of with the relevant policy and guidance collection burden under the provisions this action must be filed in the United

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States Court of Appeals for the (389) * * * The regulations at § 648.201 require appropriate circuit by December 2, (i) * * * the Administrator, Northeast Region, 2011. Filing a petition for (B) Placer County Air Pollution NMFS (Regional Administrator), to reconsideration by the Administrator of Control. monitor the Atlantic herring fishery in these final rules does not affect the (1) Rule 243, ‘‘Polyester Resin each of the four management areas finality of these actions for the purposes Operations,’’ adopted on April 10, 2003. designated in the Fishery Management of judicial review nor does it extend the * * * * * Plan (FMP) for the Atlantic herring time within which a petition for judicial [FR Doc. 2011–25284 Filed 9–30–11; 8:45 am] fishery and, based upon dealer reports, review may be filed, and shall not BILLING CODE 6560–50–P state data, and other available postpone the effectiveness of such rules information, to determine when the or actions. Parties with objections to harvest of Atlantic herring is projected to reach 95 percent of the management these direct final rules are encouraged to DEPARTMENT OF COMMERCE file a comment in response to the area sub-ACL. When such a parallel notice of proposed rulemaking National Oceanic and Atmospheric determination is made, NMFS is for this action published in the Administration required to publish notification in the Proposed Rules section of today’s Federal Register and prohibit Atlantic Federal Register, rather than file an 50 CFR Part 648 herring vessel permit holders from immediate petition for judicial review of fishing for, catching, possessing, these direct final rules, so that EPA can [Docket No. 0907301205–0289–02] transferring, or landing more than 2,000 lb (907.2 kg) of herring per calendar day withdraw these direct final rules and RIN 0648–XA413 address the comment in the proposed in or from the specified management rulemaking. This action may not be Fisheries of the Northeastern United area for the remainder of the closure challenged later in proceedings to States; Atlantic Herring Fishery; Sub- period. Transiting of Area 1B with more enforce its requirements (see section ACL (Annual Catch Limit) Harvested than 2,000 lb (907.2 kg) of herring on 307(b)(2)). for Management Area 1B board is allowed under the conditions specified below. List of Subjects in 40 CFR Part 52 AGENCY: National Marine Fisheries The Regional Administrator has Environmental protection, Air Service (NMFS), National Oceanic and determined, based upon dealer reports pollution control, Incorporation by Atmospheric Administration (NOAA), and other available information that 95 reference, Intergovernmental relations, Commerce. percent of the total Atlantic herring sub- Reporting and recordkeeping ACTION: Temporary rule; closure. ACL allocated to Area 1B for FY 2011 requirements, Volatile organic is projected to be harvested. Therefore, compounds. SUMMARY: NMFS announces that, effective 0001 hr local time, October 1, effective 0001 hr, October 1, 2011, 2011, federally permitted vessels may Dated: August 16, 2011. federally permitted vessels may not fish not fish for, catch, possess, transfer, or Keith Tekata, for, catch, possess, transfer, or land land more than 2,000 lb (907.2 kg) of Acting Regional Administrator, Region IX. more than 2,000 lb (907.2 kg) of Atlantic Atlantic herring in or from Area 1B per Part 52, Chapter I, Title 40 of the Code herring (herring) in or from Management calendar day through December 31, of Federal Regulations is amended as Area 1B (Area 1B) per calendar day 2011. Vessels transiting Area 1B with follows: until January 1, 2012, when the 2012 more than 2,000 lb (907.2 kg) of herring sub-ACL for Area 1B becomes available, on board may land this amount, PART 52—[AMENDED] except when transiting as described in provided such herring was not caught in Area 1B and provided all fishing gear ■ 1. The authority citation for Part 52 this notice. This action is based on the aboard is stowed and not available for continues to read as follows: determination that 95 percent of the Atlantic herring sub-ACL allocated to immediate use as required by Authority: 42 U.S.C. 7401 et seq. Area 1B for 2011 is projected to be § 648.23(b). Effective October 1, 2011, federally permitted dealers are also Subpart F—California harvested by October 1, 2011. DATES: Effective 0001 hr local time, advised that they may not purchase ■ 2. Section 52.220 is amended by October 1, 2011, through December 31, Atlantic herring from federally adding paragraphs (c)(377)(i)(A)(5), 2011. permitted Atlantic herring vessels that harvest more than 2,000 lb (907.2 kg) of (c)(378)(i)(C)(2), and (c)(389)(i)(B) to FOR FURTHER INFORMATION CONTACT: Atlantic herring from Area 1B through read as follows: Lindsey Feldman, Fishery Management 2400 hr local time, December 31, 2011. § 52.220 Identification of plan. Specialist, (978) 675–2179. Classification * * * * * SUPPLEMENTARY INFORMATION: (c) * * * Regulations governing the Atlantic This action is required by 50 CFR part (377) * * * herring fishery are found at 50 CFR part 648 and is exempt from review under (i) * * * 648. The regulations require annual Executive Order 12866. (A) * * * specification of the overfishing limit, The Assistant Administrator for (5) Rule 464, ‘‘Organic Chemical acceptable biological catch, ACL, Fisheries, NOAA (AA), finds good cause Manufacturing Operations,’’ adopted on optimum yield, domestic harvest and pursuant to 5 U.S.C. 553(b)(B) to waive September 25, 2008. processing, U.S. at-sea processing, prior notice and the opportunity for * * * * * border transfer and sub-ACLs for each public comment because it would be (378) * * * management area. The 2011 Domestic contrary to the public interest. This (i) * * * Annual Harvest is 91,200 metric tons action closes the Atlantic herring fishery (C) * * * (mt); the 2011 sub-ACL allocated to for Management Area 1B until January (2) Rule74.29, ‘‘Soil Decontamination Area 1B is 4,362 mt and 0 mt of the sub- 1, 2012, under current regulations. The Operations,’’ adopted on April 8, 2008. ACL is set aside for research (75 FR regulations at § 648.201(a) require such * * * * * 48874, August 12, 2010). action to ensure that Atlantic herring

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vessels do not exceed the 2011 sub-ACL Specialist, (978) 675–2153, fax (978) remainder of FY 2011 (through April 30, allocated to Area 1B. The Atlantic 281–9135. 2012). herring fishery opened for the 2011 SUPPLEMENTARY INFORMATION: Catch will be closely monitored fishing year on January 1, 2011. Data Regulations governing possession and through dealer-reported landings, vessel indicating the Atlantic herring fleet will landing limits for Handgear B (HB) monitoring system (VMS) catch reports, have landed at least 95 percent of the vessels fishing under common pool and other available information. NMFS 2011 sub-ACL allocated to Area 1B have regulations at § 648.88(a)(1) state that may consider future inseason only recently become available. If the HB cod trip limit for the Gulf of adjustments to decrease the trip limit, or implementation of this closure is Maine (GOM) and Georges Bank (GB) to increase differential DAS measures, delayed to solicit prior public comment, shall be adjusted proportionally based on updated catch data and the sub-ACL for Area 1B for this fishing (rounded up to the nearest 25 lb (11.3 projections. Conversely, if the common year will be exceeded, thereby kg)) ‘‘if either the GOM or GB cod trip pool sub-annual catch limit (ACL) is undermining the conservation limit applicable to a vessel fishing projected to be under-harvested by the objectives of the FMP. The AA further under a Northeast (NE) multispecies end of FY 2011, NMFS will consider in- finds, pursuant to 5 U.S.C 553(d)(3), day-at-sea (DAS) permit, as specified in season adjustments, such as increasing good cause to waive the 30 day delayed § 648.86(b)(1) and (2), respectively, is the trip limit for the remainder of FY effectiveness period for the reasons adjusted by NMFS.’’ The initial GOM 2011. stated above. and GB cod trip limits for NE Classification Authority: 16 U.S.C. 1801 et seq. multispecies common pool vessels This action is authorized by 50 CFR Dated: September 28, 2011. fishing under a day-at-sea (DAS) are set part 648 and is exempt from review Steven Thur, at 800 lb (362.9 kg) per DAS and 2,000 under Executive Order 12866. Acting Director, Office of Sustainable lb (907.2 kg) per DAS respectively. The Assistant Administrator for Fisheries, National Marine Fisheries Service. However, for fishing year (FY) 2011, Fisheries, NOAA (AA) finds good cause [FR Doc. 2011–25423 Filed 9–29–11; 8:45 am] Framework Adjustment 45 (FW 45) pursuant to 5 U.S.C. 553(b)(3)(B) to reduced the initial GOM cod trip limit BILLING CODE 3510–22–P waive prior notice and the opportunity to 500 lb (226.8 kg) per DAS from 800 for public comment for this inseason lb (362.9 kg) per DAS (76 FR 23042; adjustment because notice and comment DEPARTMENT OF COMMERCE April 25, 2011). An inseason adjustment would be impracticable and contrary to on May 24, 2011, increased the GB cod the public interest. The regulations at National Oceanic and Atmospheric trip limit to 3,000 lb (1,360.8 kg) per § 648.86(o) grant the RA authority to Administration DAS from 2,000 lb (907.2 kg) per DAS adjust the NE multispecies trip limits (76 FR 30035; May 24, 2011). A second for common pool vessels in order to 50 CFR Part 648 inseason adjustment, on August 30, prevent the overharvest or underharvest [Docket No. 0910051338–0151–02] 2011, decreased the GOM cod trip limit of the pertinent common pool sub- to 350 lb (158.8 kg) per DAS and the GB ACLs. This action decreases the trip RIN 0648–XA732 cod trip limit to 300 lb (136.1 kg) per limits for GOM and GB cod to reduce DAS (76 FR 53832, August 30, 2011). their harvest in order to prevent the Fisheries of the Northeastern United Due to an oversight, the HB trip limits common pool sub-ACLs from being States; Northeast Multispecies for GOM and GB cod were not adjusted exceeded. The time necessary to provide Fishery; Correction to Cod Landing at the beginning of FY 2011 through the for prior notice and comment would Limit for Handgear B Vessels in the FW 45 final rule, at the time of the first prevent NMFS from implementing the Common Pool Fishery inseason adjustment, or the most recent necessary trip limit adjustments in a AGENCY: National Marine Fisheries inseason adjustment. timely manner. A resulting delay in the Service (NMFS), National Oceanic and In the GOM, the current 350 lb (158.8 reduction of trip limits would allow for Atmospheric Administration (NOAA), kg) per DAS landing limit represents a continued higher catch rates and Commerce. 56.3-percent reduction from the initial potentially allow the pertinent common ACTION: Temporary rule; inseason 800 lb (362.9 kg) per DAS limit. pool sub-ACLs to be exceeded. This is adjustment of landing limit. Therefore, the landing limit for HB contrary to NMFS’s obligation under the vessels for GOM cod is reduced to 50 lb Magnuson-Stevens Act to prevent SUMMARY: NMFS is decreasing the Gulf (22.7 kg) per trip (75 lb (34.0 kg) per trip overfishing. Further, if the sub-ACLs are of Maine and Georges Bank cod landing reduced by 56.3 percent = 32.8 lb (14.9 exceeded, this would trigger the limit to 50 lb (22.7 kg) and 25 lb (11.3 kg) per trip, rounded up to 50 lb (22.7 implementation of accountability kg) per trip for Northeast multispecies kg) per trip). On GB, the current 300 lb measures that would have negative open access Handgear B permitted (136.1 kg) per DAS landing limit economic impacts on the participants in vessels fishing in the common pool represents an 85-percent reduction from the common pool. Giving effect to this fishery for the remainder of the 2011 the initial 2,000 lb (907.2 kg) per DAS rule as soon as possible will prevent fishing year (through April 30, 2012). limit. Therefore, the landing limit for these unnecessary impacts. This action is authorized under the HB vessels for GB cod is reduced to 25 Further, the AA finds good cause authority of the Magnuson-Stevens lb (11.3 kg) per trip (75 lb (34.0 kg) per pursuant to 5 U.S.C. 553(d)(3) to waive Fishery Conservation and Management trip reduced by 85.0 percent = 11.3 lb the 30-day delay in effectiveness for this Act (Magnuson-Stevens Act), and is (5.1 kg) per trip, rounded up to 25 lb action. This action decreases the trip required by the regulations (11.3 kg) per trip). To correct the limits for GOM and GB cod to reduce implementing the Northeast oversights in the previous actions, their harvest in order to prevent the Multispecies Fishery Management Plan. NMFS is reducing the trip limit for common pool sub-ACLs from being DATES: Effective October 3, 2011, GOM cod to 50 lb (22.7 kg) per trip and exceeded. A delay in the reduction of through April 30, 2012. GB cod to 25 lb (11.3 kg) per trip for NE trip limits would allow for continued FOR FURTHER INFORMATION CONTACT: multispecies HB permitted vessels in higher catch rates and potentially allow Brett Alger, Fisheries Management the common pool fishery for the the pertinent common pool sub-ACLs to

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be exceeded. This is contrary to NMFS’s DATES: Effective 0001 hr local time, in or from Area 3 per calendar day obligation under the Magnuson-Stevens October 3, 2011, through December 31, through December 31, 2011. Vessels Act to prevent overfishing. Further, if 2011. may transit through Area 3 with more the sub-ACLs are exceeded, this would FOR FURTHER INFORMATION CONTACT: than 2,000 lb (907.2 kg) of herring on trigger the implementation of Lindsey Feldman, Fishery Management board, provided such herring was not accountability measures that will have Specialist, (978) 675–2179. caught in Area 3 and provided all negative economic impacts on the SUPPLEMENTARY INFORMATION: fishing gear aboard is stowed and not participants in the common pool. Giving Regulations governing the herring available for immediate use as required effect to this rule as soon as possible fishery are found at 50 CFR part 648. by § 648.23(b). Effective October 3, will prevent these unnecessary impacts The regulations require annual 2011, federally permitted dealers are Authority: 16 U.S.C. 1801 et seq. specification of the overfishing limit, also advised that they may not purchase acceptable biological catch, annual herring from federally permitted herring Dated: September 28, 2011. vessels that harvest more than 2,000 lb Steven Thur, catch limit (ACL), optimum yield, domestic harvest and processing, U.S. (907.2 kg) of herring from Area 3 Acting Director, Office of Sustainable through 2400 hr local time, December Fisheries, National Marine Fisheries Service. at-sea processing, border transfer, and sub-ACLs for each management area. 31, 2011. [FR Doc. 2011–25431 Filed 9–30–11; 8:45 am] The 2011 Domestic Annual Harvest is Classification BILLING CODE 3510–22–P 91,200 metric tons (mt); the 2011 sub- ACL allocated to Area 3 is 38,146 mt This action is required by 50 CFR part 648 and is exempt from review under DEPARTMENT OF COMMERCE and 0 mt of the sub-ACL is set aside for research (75 FR 48874, August 12, Executive Order 12866. National Oceanic and Atmospheric 2010). NMFS finds good cause pursuant to 5 Administration The regulations at § 648.201 require U.S.C. 553(b)(B) to waive prior notice the Administrator, Northeast Region, and the opportunity for public comment 50 CFR Part 648 NMFS (Regional Administrator), to because it would be contrary to the monitor the herring fishery in each of public interest. This action closes the [Docket No. 0907301205–0289–02] the four management areas designated herring fishery for Management Area 3 in the Fishery Management Plan for the until January 1, 2012, under current RIN 0648–XA649 herring fishery and, based upon dealer regulations. The regulations at Fisheries of the Northeastern United reports, state data, and other available § 648.201(a) require such action to States; Atlantic Herring Fishery; Sub- information, to determine when the ensure that herring vessels do not ACL (Annual Catch Limit) Harvested harvest of herring is projected to reach exceed the 2011 sub-ACL allocated to for Management Area 3 95 percent of the management area sub- Area 3. The herring fishery opened for ACL. When such a determination is the 2011 fishing year on January 1, AGENCY: National Marine Fisheries made, NMFS is required to publish 2011. Data indicating the herring fleet Service (NMFS), National Oceanic and notification in the Federal Register and will have landed at least 95 percent of Atmospheric Administration (NOAA), prohibit herring vessel permit holders the 2011 sub-ACL allocated to Area 3 Commerce. from fishing for, catching, possessing, have only recently become available. If ACTION: Temporary rule; closure. transferring, or landing more than 2,000 implementation of this closure is lb (907.2 kg) of herring per calendar day delayed to solicit prior public comment, SUMMARY: NMFS announces that, in or from the specified management the sub-ACL for Area 3 for this fishing effective 0001 hr, October 3, 2011, area for the remainder of the closure year can be exceeded, thereby federally permitted vessels may not fish period. Transiting of Area 3 with more undermining the conservation for, catch, possess, transfer, or land than 2,000 lb (907.2 kg) of herring on objectives of the FMP. NMFS further more than 2,000 lb (907.2 kg) of Atlantic board is allowed under the conditions finds, pursuant to 5 U.S.C 553(d)(3), herring (herring) in or from Management specified below. good cause to waive the 30 day delayed Area 3 (Area 3) per calendar day until The Regional Administrator has effectiveness period for the reasons January 1, 2012, when the 2012 sub- determined, based upon dealer reports stated above. ACL (annual catch limit) for Area 3 and other available information that 95 Authority: 16 U.S.C. 1801 et seq. becomes available, except when percent of the total herring sub-ACL transiting as described in this notice. allocated to Area 3 for 2011 is projected Dated: September 28, 2011. This action is based on the to be harvested. Therefore, effective Steven Thur, determination that 95 percent of the 0001 hr local time, October 3, 2011, Acting Director, Office of Sustainable herring sub-ACL allocated to Area 3 for federally permitted vessels may not fish Fisheries, National Marine Fisheries Service. 2011 is projected to be harvested by for, catch, possess, transfer, or land [FR Doc. 2011–25424 Filed 9–29–11; 8:45 am] October 3, 2011. more than 2,000 lb (907.2 kg) of herring BILLING CODE 3510–22–P

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Proposed Rules Federal Register Vol. 76, No. 191

Monday, October 3, 2011

This section of the FEDERAL REGISTER 1. Federal eRulemaking Portal: 3579, or by e-mail at contains notices to the public of the proposed http://www.regulations.gov.Follow the [email protected]. issuance of rules and regulations. The on-line instructions. purpose of these notices is to give interested SUPPLEMENTARY INFORMATION: persons an opportunity to participate in the 2. E-mail: [email protected]. Throughout this document, ‘‘we,’’ ‘‘us,’’ rule making prior to the adoption of the final 3. Mail or deliver: Andrew Steckel and ‘‘our’’ refer to EPA. (AIR–4), U.S. Environmental Protection rules. Table of Contents Agency Region IX, 75 Hawthorne Street, San Francisco, CA 94105–3901. I. The State’s Submittal ENVIRONMENTAL PROTECTION Instructions: All comments will be A. What did the state submit for EPA AGENCY action? included in the public docket without B. Are there other versions of these change and may be made available 40 CFR Part 52 provisions in the Arizona SIP? online at http://www.regulations.gov, C. What are the relevant statutory [EPA–R09–OAR–2010–0717; FRL–9473–7] including any personal information provisions? provided, unless the comment includes D. What is the purpose of the submitted Approval and Promulgation of Confidential Business Information (CBI) SIP revision? Implementation Plans; Arizona; Update or other information whose disclosure is II. EPA’s Evaluation and Action A. How is EPA evaluating the statutes and to Stage II Gasoline Vapor Recovery restricted by statute. Information that Program; Change in the Definition of rules? you consider CBI or otherwise protected B. Do the statutes and rules meet the ‘‘Gasoline’’ To Exclude ‘‘E85’’ should be clearly identified as such and evaluation criteria? AGENCY: Environmental Protection should not be submitted through http:// 1. Clean Air Act Requirements Agency (EPA). www.regulations.gov or e-mail. http:// 2. Arizona’s Stage II Vapor Recovery www.regulations.gov is an ‘‘anonymous Requirements ACTION: Proposed rule. access’’ system, and EPA will not know 3. Compliance With CAA Section 182(b)(3) Stage II Requirements SUMMARY: Under the Clean Air Act, EPA your identity or contact information 4. Compliance With CAA Section 110(l) is proposing to approve certain unless you provide it in the body of C. Correction of Previous Rulemaking revisions to the Arizona State your comment. If you send e-mail III. Proposed Action and Request for Public Implementation Plan submitted by the directly to EPA, your e-mail address Comment Arizona Department of Environmental will be automatically captured and IV. Statutory and Executive Order Reviews Quality. These revisions concern included as part of the public comment. I. The State’s Submittal amendments to the statutory and If EPA cannot read your comment due regulatory provisions adopted by the to technical difficulties and cannot A. What did the state submit for EPA State of Arizona to regulate volatile contact you for clarification, EPA may action? organic compound emissions from the not be able to consider your comment. On September 21, 2009, the Arizona transfer of gasoline from storage tanks to Electronic files should avoid the use of Department of Environmental Quality motor vehicle fuel tanks at gasoline special characters, any form of (ADEQ) submitted a revision to the dispensing sites, i.e., stage II vapor encryption, and be free of any defects or Arizona state implementation plan (SIP) recovery. The revisions would also viruses. updating the gasoline vapor recovery amend the definition of ‘‘gasoline’’ to Docket: The index to the docket for program that was originally submitted explicitly exclude E85 and thereby this action is available electronically at and approved by EPA in 1994 to meet amend the requirements for fuels http://www.regulations.gov and in hard certain applicable requirements of the available for use in the Phoenix copy at EPA Region IX, 75 Hawthorne Clean Air Act, as amended in 1990 metropolitan area as well as the Street, San Francisco, California. While (CAA or ‘‘Act’’).1 The specific revisions requirements for vapor recovery. In all documents in the docket are listed in include statutory provisions and proposing approval of the revisions, the index, some information may be administrative rules regulating the EPA is proposing to waive the statutory publicly available only at the hard copy emissions of volatile organic stage II vapor recovery requirements at location (e.g., copyrighted material), and compounds (VOC) due to the transfer of E85 dispensing pumps within the some may not be publicly available in gasoline from storage tanks (typically Phoenix area. Lastly, EPA is proposing either location (e.g., CBI). To inspect the underground) to motor vehicle fuel to correct an EPA rulemaking that hard copy materials, please schedule an tanks at gasoline stations in the Phoenix approved a previous version of the appointment during normal business metropolitan area. The statutory Arizona rules regulating these sources. hours with the contact listed in the FOR 1 DATES: FURTHER INFORMATION CONTACT section. Gasoline dispensing pump vapor control Comments must be received on devices, commonly referred to as ‘‘stage II’’ vapor or before December 2, 2011. Anyone FOR FURTHER INFORMATION CONTACT: For recovery, are systems that control VOC vapor wishing the opportunity for the oral further information on the revisions to releases during the refueling of motor vehicles. This presentation of data, views, or process takes the vapors normally emitted directly the Arizona State Implementation Plan into the atmosphere when pumping gas and arguments, must submit a request on or submitted by the Arizona Department of recycles them back into the fuel storage tank, before October 18, 2011. Environmental Quality, contact Mr. preventing them from polluting the air. For more ADDRESSES: Submit comments, Andrew Steckel, EPA Region IX, 75 information on Stage II vapor recovery systems, please see EPA’s proposed rule, ‘‘Air Quality: identified by docket number EPA–R09– Hawthorne Street (AIR–4), San Widespread Use for Onboard Refueling Vapor OAR–2010–0717, by one of the Francisco, CA 94105, phone number Recovery and Stage II Waiver,’’ 76 FR 41731, at following methods: (415) 947–4115, fax number (415) 947– 41734 (July 15, 2011).

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provisions and administrative rules are ‘‘gasoline’’ to exclude ‘‘E85,’’ a change materials submitted by ADEQ contained in enclosures 3 and 4 of that affects both the gasoline fuels demonstrate compliance with the ADEQ’s September 21, 2009 SIP program established for the Phoenix procedural requirements set forth in revision submittal package.2 metropolitan area and the stage II vapor section 110(l) of the Clean Air Act (CAA ADEQ’s submittal represents an recovery program because both or ‘‘Act’’). (The substantive update to the stage II requirements but programs now rely on that particular requirements of section 110(l) are is comprehensive in that the submitted definition. ADEQ’s September 21, 2009 discussed in section II.B.4 of this statutory and regulatory provisions also SIP revision submittal also contains document.) address general requirements related to adequate documentation of public stage I vapor recovery.3 While ADEQ’s Table 1 lists the statutory provisions, notice, opportunity for comment, and a submittal relates almost entirely to the and table 2 lists the administrative state’s vapor recovery program, it also public hearing on the proposed SIP rules, that were submitted by ADEQ on amends the State’s fuels program by revision (see enclosure 5 of the September 21, 2009 and that we are amending the definition of the term submittal). The public participation proposing to approve in today’s action.

TABLE 1—SUBMITTED STATUTORY PROVISIONS

Arizona revised statutes Title Submitted

Title 41, chapter 15, article 1, section 41– Definitions: subsection 6 (‘‘Certification’’), subsection 10 (‘‘Department’’), subsection 09/21/09 2051. 11 (‘‘Diesel fuel’’), subsection 12 (‘‘Director’’), and subsection 13 (‘‘E85’’). Title 41, chapter 15, article 6, section 41– Definitions: subsection 5 (‘‘Gasoline’’) ...... 09/21/09 2121. Title 41, chapter 15, article 7, section 41– Definitions: subsection 1 (‘‘Annual throughput’’), subsection 2 (‘‘Clean air act’’), sub- 09/21/09 2131. section 3 (‘‘Gasoline dispensing site’’), subsection 4 (‘‘Stage I vapor collection sys- tem’’), subsection 5 (‘‘Stage II vapor collection system’’), and subsection 6 (‘‘Vapor control system’’). Title 41, chapter 15, article 7, section 41– Stage I and stage II vapor recovery systems ...... 09/21/09 2132. Title 41, chapter 15, article 7, section 41– Compliance schedules ...... 09/21/09 2133.

TABLE 2—SUBMITTED RULES

Effective date Arizona administrative code Rule title (for state Submitted purposes)

Title 20, chapter 2, article 1, section R20–2–101 ...... Definitions ...... 06/05/04 09/21/09 Title 20, chapter 2, article 9, section R20–2–901 ...... Material Incorporated by Reference ...... 06/05/04 09/21/09 Title 20, chapter 2, article 9, section R20–2–902 ...... Exemptions ...... 06/05/04 09/21/09 Title 20, chapter 2, article 9, section R20–2–903 ...... Equipment and Installation ...... 06/05/04 09/21/09 Title 20, chapter 2, article 9, section R20–2–904 ...... Application Requirements and Process for Authority to 06/05/04 09/21/09 Construct Plan Approval. Title 20, chapter 2, article 9, section R20–2–905 ...... Initial Inspection and Testing ...... 06/05/04 09/21/09 Title 20, chapter 2, article 9, section R20–2–907 ...... Operation ...... 10/08/98 09/21/09 Title 20, chapter 2, article 9, section R20–2–908 ...... Training and Public Education ...... 10/08/98 09/21/09 Title 20, chapter 2, article 9, section R20–2–909 ...... Recordkeeping and Reporting ...... 10/08/98 09/21/09 Title 20, chapter 2, article 9, section R20–2–910 ...... Annual Inspection and Testing ...... 06/05/04 09/21/09 Title 20, chapter 2, article 9, section R20–2–911 ...... Compliance Inspections ...... 06/05/04 09/21/09 Title 20, chapter 2, article 9, section R20–2–912 ...... Enforcement ...... 06/05/04 09/21/09

On March 21, 2010, the submittal of B. Are there other versions of these following sections of title 4, chapter 31, these rules for ADEQ was deemed by provisions in the Arizona SIP? article 9 (‘‘Gasoline Vapor Control’’) of operation of law to meet the the Arizona Administrative Code (AAC): On November 1, 1994 (59 FR 54521), completeness criteria in 40 CFR part 51, • R4–31–901—Definitions; appendix V, which must be met before we approved Arizona’s stage II vapor • recovery rules that had been adopted by R4–31–902—Material incorporated formal EPA review. the Arizona Department of Weights and by reference; Measures (ADWM) on August 27, 1993 • R4–31–903—Exemptions; and submitted to us by ADEQ on May • R4–31–904—Equipment and 27, 1994. Specifically, we approved the installation;

2 By letter dated April 12, 2011, ADEQ Office of the Federal Register for incorporating such stage I vapor recovery regulation within the substituted the statutes and rules in enclosures 3 materials by reference into the Code of Federal Phoenix metropolitan area, Regulation III, Rule 353 and 4 as submitted on September 21, 2009 with Regulations. (‘‘Transfer of Gasoline into Stationary Storage official, published versions of the same statutes and 3 ‘‘Stage I’’ vapor recovery refers to the collection Dispensing Tanks’’). EPA approved MCAQD rule rules in keeping with the requirements. ADEQ did of VOC emissions expelled from underground 353 and incorporated it into the Arizona SIP. See so in response to an EPA request for the official, storage tanks at gasoline stations when being 61 FR 3578 (February 1, 1996). MCAQDM’s stage published versions of the statutes and rules to refilled by tank trucks. The Maricopa County Air I vapor recovery program and related rule are not comply with the requirements established by the Quality Department (MCAQD) implements its own affected by today’s proposed action.

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• R4–31–905—Plan review and date the facilities were built and the vehicle fleet would never be entirely approval; monthly volume of gasoline dispensed. equipped with ORVR. • R4–31–906—Operation; See CAA sections 182(b)(3)(A)–(B), and Recently, EPA proposed criteria for • R4–31–907—Training and public 324(a)–(c).5 determining whether ORVR is in education; However, the CAA provides ‘‘widespread use’’ for purposes of • R4–31–908—Recordkeeping and discretionary authority to the EPA controlling motor vehicle refueling reporting; Administrator to, by rule, revise or emissions throughout the motor vehicle • R4–31–909—Annual tests; and waive the section 182(b)(3) Stage II fleet. See 76 FR 41731 (July 15, 2011). • In EPA’s July 15, 2011 action, EPA also R4–31–910—Enforcement. requirement after the Administrator proposed, based on the proposed In our 1994 final rule, we made an determines that On-Board Refueling criteria, to establish June 30, 2013 as the error in how we codified the stage II Vapor Recovery (ORVR) is in date on which ‘‘widespread use’’ will vapor recovery rules into the Arizona widespread use throughout the motor occur nationally, and to establish June SIP, and are proposing to correct that vehicle fleet. See CAA section 202(a)(6). 30, 2013 as the date on which a error in today’s proposed action (see ORVR consists of an activated carbon nationwide waiver of Stage II gasoline section II.C of this document). canister installed in the vehicle into vapor recovery systems will be effective. The Arizona statutory provisions that which vapors being expelled from the While, if finalized as proposed, our July establish stage II vapor recovery vehicle fuel tanks are forced to flow. requirements were originally submitted 15, 2011 proposal would establish a There the vapors are captured by the nationwide date for determining when to EPA on November 13, 1992, and later activated carbon in the canister. When re-submitted on February 16, 1993, but, ORVR is in ‘‘widespread use’’ and for the engine is started, the vapors are waiving the Stage II requirement, it also in approving the amended Stage II vapor drawn off of the activated carbon and recovery rules submitted in 1994, EPA proposes to allow individual states to into the engine where they are burned submit SIP revisions that demonstrate inadvertently neglected to approve the as fuel. EPA promulgated ORVR statutory provisions that had been that ORVR widespread use has occurred standards on April 6, 1994, 59 FR (or will occur) on a date earlier than submitted the previous year. Thus, there 16262. are no previous versions of the ARS June 30, 2013 for areas in their states, provisions listed in table 1 with the EPA first began the phase-in of ORVR and to request that the EPA revise or exception of ARS 41–2121, paragraph by requiring that 40 percent of waive the section 182(b)(3) requirement (5), which defines the term ‘‘gasoline.’’ passenger cars manufactured in model as it applies to only those areas. See 76 We approved an earlier version of the year 1998 be equipped with ORVR. The FR at 41733. Consistent with EPA’s July definition for ‘‘gasoline’’ (then codified ORVR requirement for passenger cars 15, 2011 proposal to allow States to in paragraph (4) of ARS section 41– was increased to 100 percent by model submit such SIP revisions, EPA is today 2121) in connection with our approval year 2000. Phase-in continued for other proposing to approve an area-specific of the carbon monoxide redesignation vehicle types and ORVR has been a revision to the Arizona SIP and to request and maintenance plan for requirement on virtually all new approve a waiver for a specific portion Tucson area. See 65 FR 36353 (June 8, gasoline-powered motor vehicles of the motor vehicle fleet in the Phoenix 2000), as corrected at 65 FR 50651 (passenger cars, light trucks, and metropolitan area. complete 6 (August 21, 2000) and 69 FR 12802 heavy-duty gasoline powered D. What is the purpose of the submitted (March 18, 2004). vehicles under 10,000 lbs gross vehicle SIP revision? weight rating (GVWR)) sold since model C. What are the relevant statutory year 2006. See 40 CFR part 86. Under the Clean Air Act, as amended provisions? Currently, ORVR-equipped vehicles in 1990, the ‘‘Phoenix area,’’ defined by the Maricopa Association of Under CAA section 182(b)(3), Stage II comprise approximately 64 percent of the in-service vehicle fleet nationwide, Governments’ (MAGs’) urban planning vapor recovery systems are required to area boundary (but later revised to be used at larger gasoline dispensing and account for around 74 percent of the vehicle miles traveled (VMT) in the exclude the Gila River Indian facilities located in Serious, Severe, and Community at 70 FR 68339 (November Extreme nonattainment areas for ozone.4 nationwide fleet. The percentage of non- ORVR vehicles and the percentage of 10, 2005)), was classified as a Based on deadlines established in the ‘‘moderate’’ nonattainment area for the Act, within 24 months from the effective VMT driven by those vehicles declines each year as these older vehicles wear 1-hour ozone national ambient air date of the initial area designation and quality standard (NAAQS). See 56 FR classification, states must adopt a Stage out and are removed from service. Since certain vehicles are not required to have 56694, at 56717 (November 6, 1991). II program into their SIPs, and the Later, the Phoenix area was reclassified controls must be installed according to ORVR, including motorcycles and incomplete heavy-duty gasoline as ‘‘serious’’ for the 1-hour ozone specified deadlines following state rule standard (62 FR 60001, November 6, adoption. For existing facilities the powered trucks chassis, under current requirements the nationwide motor 1997). installation deadlines depend on the As noted above, section 182(b)(3) of the Act required States with ozone 4 See CAA section 182(b)(3), 42 U.S.C. 5 Section 182(b)(3)(B) has the following effective 7511a(b)(3). Originally, the section 182(b)(3) Stage date requirements for implementation of Stage II nonattainment areas such as the II requirement also applied in all Moderate ozone after the adoption date by a state of a Stage II rule: Phoenix area to adopt and submit a SIP nonattainment areas. However, under section 6 months after adoption of the state rule, for gas revision requiring gasoline dispensing 202(a)(6) of the CAA, 42 U.S.C. 7521(a)(6), the stations built after the enactment date (which for facilities to install and operate stage II requirements of section 182(b)(3) no longer apply in newly designated areas would be the designation Moderate ozone nonattainment areas after EPA date); 1 year after adoption date, for gas stations vapor recovery equipment. In response, promulgated ORVR standards on April 6, 1994, 59 pumping at least 100,000 gal/month based on in 1993, ADEQ submitted the statutory FR 16262, codified at 40 CFR parts 86 (including average monthly sales over 2-year period before provisions and rules establishing stage II 86.098–8), 88 and 600. Under implementation rules adoption date; 2 years after adoption, for all others. vapor recovery requirements in the issued in 2004 for the 1997 8-hour ozone standard, 6 For purposes of ORVR applicability, a EPA retained the Stage II-related requirements ‘‘complete’’ vehicle means a vehicle that leaves the Phoenix area, the only area in Arizona under section 182(b)(3) as they applied for the 1- primary manufacturer’s control with its primary subject to section 182(b)(3) of the Act. hour ozone standard. 40 CFR 51.900(f)(5). load carrying device or container attached. In May 1994, ADEQ submitted amended

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stage II vapor recovery rules, which EPA See 40 CFR 51.905(a). Thus, we have B. Do the statutes and rules meet the then approved later that year. See 59 FR evaluated the submitted statutory evaluation criteria? 54521 (November 1, 1994). provisions and rules to ensure Arizona’s More recently, the Arizona Legislature stage II program complies with section 1. Clean Air Act Requirements has amended the relevant statutes (1) to 182(b)(3) of the Act. In addition, we As discussed in section I.C. of this require ADWM to adopt rules to have evaluated the submitted statutory document, CAA section 182(b)(3) enhance compliance with the stage II provisions and rules for enforceability requires States with ozone vapor recovery requirements, (2) to (see CAA section 110(a)(2)), and for nonattainment areas classified as explicitly exclude ‘‘E85’’ from the non-interference with reasonable further ‘‘moderate’’ or worse to adopt definition of ‘‘gasoline,’’ and (3) to progress or attainment of the NAAQS regulations requiring owners or extend the geographic area to which (see CAA section 110(l)). operators of gasoline dispensing systems stage II vapor recovery requirements Guidance and policy documents that apply to ‘‘area A.’’ 7 Since our approval to install and operate stage II vapor we used to evaluate the submitted of the stage II vapor recovery rules in recovery equipment at their facilities. statutory provisions and rules for 1994, ADWM has renumbered and The Act specifies that these State rules enforceability and compliance with recodified its gasoline vapor recovery must apply to any facility that dispenses CAA section 182(b)(3) stage II vapor rules and amended them to enhance more than 10,000 gallons of gasoline per requirement requirements include the compliance with the requirements. The following: month, or, in the case of an independent purpose of ADEQ’s September 21, 2009 small business marketer (as defined in SIP revision is to incorporate the 1. ‘‘Issues Relating to VOC Regulation CAA section 324), any facility that statutory and regulatory changes Cutpoints, Deficiencies, and dispenses more than 50,000 gallons of described above into the Arizona SIP. Deviations,’’ EPA, May 25, 1988 (the gasoline per month. EPA’s ‘‘Technical Support Document Bluebook). Section 202(a)(6) of the Act required for EPA’s Notice of Proposed 2. ‘‘Guidance Document for Correcting EPA to promulgate standards requiring Rulemaking on Revisions to the Arizona Common VOC & Other Rule State Implementation Plan’’ (August Deficiencies,’’ EPA Region 9, August 21, that new light-duty vehicles be 2011) (TSD) has more information about 2001 (the Little Bluebook). equipped with onboard refueling vapor the statutory provisions and rules and recovery (ORVR) systems. ORVR 3. ‘‘Draft Model Rule, Gasoline our evaluation, and can be found in the regulations were promulgated by EPA Dispensing Facility—Stage II Vapor docket for this action. on April 6, 1994 (see 59 FR 16262, 40 Recovery,’’ EPA (August 17, 1992). CFR 86.001 and 40 CFR 86.098). Upon II. EPA’s Evaluation and Action 4. ‘‘Gasoline Vapor Recovery promulgation of the ORVR rules, under A. How is EPA evaluating the statutes Guidelines,’’ EPA Region IX (April 24, CAA section 202(a)(6) the stage II and rules? 2000). requirement of section 182(b)(3) no Since 1994, when EPA last approved 5. ‘‘Removal of Stage II Vapor longer applied to moderate areas, but Arizona’s stage II vapor recovery rules, Recovery in Situations Where only to serious and worse areas. Since EPA has designated a larger area Widespread Use of Onboard Vapor model year 2000, all passenger cars have referred to the ‘‘Phoenix-Mesa’’ area as Recovery is Demonstrated,’’ been required to have ORVR, and since nonattainment for the 1997 8-hour memorandum from Stephen D. Page, 2006, virtually all new gasoline ozone standard (69 23858, April 30, Director, EPA Office of Air Quality powered motor vehicles (passenger cars, 2004),8 approved the State’s 1-hour Planning and Standards, and Margo light trucks, and complete heavy-duty Tsirigotis Oge, Director, EPA Office of ozone redesignation request and gasoline powered vehicles) have been Transportation and Air Quality, to maintenance plan for the Phoenix area required to be equipped with ORVR. (70 FR 34362, June 14, 2005), and Regional Air Division Directors, dated revoked the 1-hour ozone standard December 12, 2006 (‘‘2006 Page/Oge The CAA anticipates that, over the (replaced by the 1997 8-hour ozone Memorandum’’).9 long-term, ORVR will reduce the benefit standard) effective June 15, 2005 (69 FR 6. ‘‘Removal of Stage II Vapor from, and the need for, stage II vapor 23951, April 30, 2004). Notwithstanding Recovery from Refueling of Corporate recovery systems at gasoline dispensing the redesignation of the Phoenix area Fleets,’’ memorandum from Stephen D. sites in ozone nonattainment areas. and the revocation of the 1-hour ozone Page, Director, EPA Office of Air Quality Section 202(a)(6) of the CAA allows standard, the Phoenix area remains Planning and Standards, and Margo EPA to revise or waive the application subject to the CAA section 182(b)(3) Tsirigotis Oge, Director, EPA Office of of stage II vapor recovery requirements stage II requirement by virtue of its Transportation and Air Quality, to for areas classified as serious, severe, or classification as ‘‘serious’’ for the 1-hour Regional Air Division Directors, dated extreme for ozone, as appropriate, after ozone standard on the effective date of November 28, 2007 (‘‘2007 Page/Oge such time as EPA determines that ORVR the area’s designation as Memorandum’’). systems are in widespread use ‘‘nonattainment’’ for the 8-hour ozone All of the above documents can be throughout the motor vehicle fleet. CAA standard (i.e., on June 15, 2004) under found in the docket for this rulemaking. section 202(a)(6) does not specify which the anti-backsliding provisions of EPA’s motor vehicle fleet must be the subject rules governing the transition from the 9 of a widespread use determination 1-hour to the 8-hour ozone standard. In EPA’s recent national rulemaking regarding waiver of Stage II requirements, we indicate that the before EPA may revise or waive the Agency continues to believe the 2006 Page/Oge section 182(b)(3) stage II requirement. 7 EPA most recently approved the definition of Memorandum is sound guidance in areas where ‘‘area A’’ as part of the Arizona SIP in 2004. See Stage II is currently being implemented, and is Nor does the CAA identify what level of 69 FR 10161 (March 4, 2004). unaffected by the proposed national widespread use ORVR use in the motor vehicle fleet 8 In 2009, EPA proposed to classify the Phoenix- determination. See 76 FR 41731, at 41737 (July 15, must be reached before it is Mesa nonattainment area as ‘‘marginal’’ for the 1997 2011). In today’s action, we rely primarily on the 8-hour ozone standard. See 74 FR 2936 (January 16, principles and rationale set forth in the 2006 Page/ ‘‘widespread.’’ To date, EPA has issued 2009). EPA has not taken final action on the January Oge Memorandum rather than those set forth in two memoranda addressing when ORVR 2009 proposed rule. EPA’s July 15, 2011 proposed rule.

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widespread use might be found for waiver of stage II vapor recovery ‘‘gasoline,’’ which is codified in particular fleets.10 requirements at gasoline dispensing paragraph (5) of ARS 41–2121, EPA expects the possibility of sites that exclusively fuel new specifically excludes ‘‘diesel fuel’’ and different rates of implementation of automobiles at assembly plants and ‘‘E85.’’ ORVR across different geographic rental cars at rental car facilities given ARS section 41–2132(G) directs regions and among different types of the high percentage (essentially 100%) ADWM to adopt by rule standards for motor vehicle fleets within any region. of ORVR-equipped vehicles associated the installation and operation of stage I Given this, EPA does not believe the with such facilities. and stage II vapor recovery systems. CAA section 202(a)(6) must be read ADWM’s rules for such systems are narrowly to allow a widespread use 2. Arizona’s Stage II Vapor Recovery codified at title 20, chapter 2, article 9 determination and waiver of the stage II Requirements (‘‘Gasoline Vapor Recovery’’), of the requirement for a given area or area’s Arizona’s stage II vapor recovery Arizona Administrative Code (AAC). fleet only if ORVR use has become requirements are set forth in state law These rules rely upon certain widespread through the entire United (codified in the Arizona Revised definitions in AAC, title 20, chapter 2, States, or only if ORVR use has reached Statutes) and administrative rules article 1 (‘‘Administration and a definite level in each area. Rather, adopted by ADWM (codified in the Procedures’’), section R20–2–101 EPA believes that section 202(a)(6) Arizona Administrative Code). Arizona (‘‘Definitions’’). ADEQ submitted these allows the Agency to apply the Revised Statutes (ARS) section 41–2132 rules and definition to EPA as part of widespread use criterion to either the (‘‘Stage I and stage II vapor recovery the stage II SIP revision dated entire motor vehicle fleet in a State or systems’’) requires gasoline dispensing September 21, 2009—see table 2 of this nonattainment area, or to special sites to be equipped with a stage II document. segments of the overall fleet for which vapor collection system. The We previously approved ADWM’s ORVR use is shown to be sufficiently requirement applies within ‘‘an ozone stage II vapor recovery rules (59 FR high, and to base widespread use nonattainment area designated as 54521, November 1, 1994), and in so determinations on differing levels of moderate, serious, severe or extreme by doing, found them to comply with CAA ORVR use, as appropriate. EPA also the United States environmental section 182(b)(3), to be consistent with believes that the Act allows the Agency protection agency under § 107(d) of the EPA guidance on stage II vapor recovery to use an area-specific rulemaking clean air act, area A or other regulations, and to be enforceable. Thus, approving a SIP revision to issue the geographical area * * *.’’ ARS section our action today is based on an section 202(a)(6) waiver for a relevant 41–2132(C). ‘‘Area A’’ is defined in ARS evaluation of the changes in ADWM’s fleet in a nonattainment area. section 49–541 and it includes all of the rules as submitted on September 21, One metric that EPA has metropolitan Phoenix former 1-hour 2009 relative to those that were recommended in determining whether ozone nonattainment area plus approved in 1994 and that are ORVR use is widespread within a given additional areas in Maricopa County to incorporated into the existing Arizona motor vehicle fleet considers when VOC the north, east, and west, as well as SIP. emissions resulting from the application small portions of Yavapai County and In addition to renumbering and of ORVR controls alone equal the VOC Pinal County. ADEQ did not submit recodification, ADWM’s vapor recovery emissions when both stage II vapor ARS section 49–541 to EPA as part of rules have been amended to delete, recovery systems and ORVR controls are the stage II vapor recovery SIP update modify, and add certain definitions; to used, after accounting for revision on September 21, 2009, but approve use of certain CARB test incompatibility excess emissions. The EPA has previously approved the procedures not previously approved; to incompatibility excess emissions factor current definition of ‘‘area A’’ from ARS include general requirements for stage I relates to losses in control efficiency section 49–541 into the SIP. See 69 FR vapor recovery systems; to add when certain types of stage II and ORVR 10161 (March 4, 2004). exemptions for motor raceways, motor are used together. EPA believes that one ARS 41–2132 also provides an vehicle proving grounds, and marine reasonable widespread use metric based exemption for gasoline dispensing sites and aircraft refueling facilities; to clarify on comparable VOC emissions will with a throughput of less than 10,000 and expand application requirements; likely have been reached when the gallons per month or less than 50,000 and to enhance compliance-related percentage of motor vehicles in service gallons per month in the case of an provisions. with ORVR, the vehicle miles traveled independent small business marketer as 3. Compliance With CAA Section (VMT) by ORVR-equipped vehicles, or defined in section 324 of the Clean Air 182(b)(3) Stage II Requirements the gasoline dispensed to ORVR- Act, and for gasoline dispensing sites equipped vehicles reaches 95 percent. that are located on a manufacturer’s As explained in this subsection, based See the 2006 Page/Oge Memorandum, proving ground. ARS 41–2133 sets forth on our review of Arizona’s stage II page 2. Application of the 95 percent certain compliance schedules related to requirements set forth in certain statutes criterion could lead, for example, to the stage II vapor recovery requirements and administrative rules, we conclude in ARS 41–2132. that the state meets the CAA section 10 ‘‘Removal of Stage II Vapor Recovery in The stage II vapor recovery 182(b)(3) stage II requirements. First, the Situations Where Widespread Use of Onboard requirements in ARS 41–2132 rely upon state is requiring stage II vapor recovery Vapor Recovery is Demonstrated,’’ memorandum from Stephen D. Page, Director, EPA Office of Air the definitions of certain terms, such as controls in an area that encompasses all Quality Planning and Standards, and Margo ‘‘gasoline,’’ ‘‘stage II vapor collection of the 1-hour ozone ‘‘serious’’ Tsirigotis Oge, Director, EPA Office of system,’’ and ‘‘E85,’’ among others, nonattainment area consistent with Transportation and Air Quality, to Regional Air which are codified in ARS sections 41– compliance schedules set forth in the Division Directors, dated December 12, 2006; and ‘‘Removal of Stage II Vapor Recovery from 2015, 41–2121, and 41–2131, and ADEQ Act. The state also provides low-volume Refueling of Corporate Fleets,’’ memorandum from included the relevant definitions, along throughput exemptions that are Stephen D. Page, Director, EPA Office of Air Quality with ARS sections 41–2132 and 41– consistent with those allowed for in Planning and Standards, and Margo Tsirigotis Oge, 2133, in the SIP revision submittal CAA section 182(b)(3). State law, Director, EPA Office of Transportation and Air Quality, to Regional Air Division Directors, dated dated September 21, 2009. See table 1 however, also provides an exemption November 28, 2007. of this document. The definition of for a ‘‘gasoline dispensing site that is

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located on a manufacturer’s proving nationwide were equipped with ORVR, activities occur: the first is the fueling ground.’’ See ARS 41–2132(C). This and we noted that the percentage of for service vehicles, and the second is exemption is not specifically allowed FFVs with ORVR will continue to climb the fueling for race cars during the under CAA section 182(b)(3); however, as older vehicles are taken out of service racing event. According to the ADWM indicates that the one facility to and new models join the fleet. We also information provided ADWM by the which the exemption had applied has noted that the percentage of FFVs facility, approximately 8,000 gallons of closed at its location within the equipped with ORVR varies across gasoline per year are dispensed at this nonattainment area, and the equipment different ozone nonattainment areas. In facility for service vehicles, which is far has been removed to a new location the Phoenix metropolitan area, ADWM below the 10,000-gallon per month low- outside of the nonattainment area.11 estimates, based on a vehicle database throughput threshold exemption in Furthermore, ADWM reports that, at the for 2008 provided by the Arizona CAA section 182(b)(3). Thus, as applied facility’s new location, the fuel Department of Transportation’s Motor to service vehicles, the exemption for throughput is less than the low- Vehicle Division, that approximately 87 gasoline dispensing sites at motor throughput (i.e., 10,000-gallon per percent of FFVs in the Phoenix raceways is acceptable. month) threshold exemption authorized metropolitan area are equipped with The facility’s fixed gasoline in section 182(b)(3). Assuming that the ORVR.12 Given how close the ORVR- dispensers, which are used to fuel fuel usage rate at the relocated facility equipped percentage for FFVs in the service vehicles, are not used for race is representative of the throughput at Phoenix metropolitan area (87 percent car fueling. Instead, for race events, the gasoline dispensing sites that would be in 2008 and climbing) is to the ORVR fuels are special blends that are trucked covered by the State’s exemption for widespread use threshold based on into the facility by the supplier and manufacturer’s proving ground in the comparable VOC emissions (95 percent), dispensed from a mobile truck into gas event that such an exempt facility discussed above, we conclude that cans to be used during the racing event. would locate once again within the ORVR is in widespread use in the FFV We believe it is reasonable to interpret nonattainment area, the exemption is vehicle fleet in the Phoenix CAA section 182(b)(3) as applying to acceptable under section 182(b)(3). metropolitan area for the purposes of ‘‘motor vehicles’’ as defined in CAA Because the state submitted the CAA section 202(a)(6) so long as the section 216(2) (‘‘As used in this part, definition of ‘‘gasoline’’ in ARS 41–2121 change in emissions due to use of E85 * * * (2) The term ‘‘motor vehicle’’ for our approval as part of the does not interfere with attainment and means any self-propelled vehicle September 21, 2009 SIP revision, we RFP of any of the NAAQS. As discussed designed for transporting persons or must consider whether the exclusion in in section II.B.4 of this document, we property on a street or highway’’), and ARS 41–2121 of ‘‘E85’’ from the conclude that allowing for greater use of as such, the motor raceway exemption definition of gasoline comports with ethanol (by amending the definition of as it applies to refueling of race cars, section 182(b)(3) vapor recovery ‘‘gasoline’’ to exclude E85) in the which are not designed for street or requirements. By excluding ‘‘E85’’ from Phoenix metropolitan area would not highway use, is acceptable under the definition of gasoline, Arizona’s interfere with attainment and RFP of section 182(b)(3). The same is also true stage II vapor recovery law (ARS 41– any of the NAAQS, and thus, under for the exemption for marine and 2132) would not apply to E85 CAA section 202(a)(6), we propose to aircraft refueling facilities, which refuel dispensing pumps within the ozone waive the stage II vapor recovery mobile sources that clearly are not nonattainment area. requirements for E85 dispensing pumps motor vehicles as defined in CAA E85 is a motor vehicle fuel that is a in the Phoenix metropolitan area. section 216(2). In sum, for the reasons blend of as little as 15 percent gasoline As noted above, in general, ADWM’s stated above, the new exemptions in and up to 85 percent ethanol. (In revisions clarify and improve the ADWM’s Stage II vapor recovery rules wintertime applications, the ratio may existing stage II vapor recovery rules for motor raceways, and for marine and be 30 percent gasoline and 70 percent that we previously approved. The only aircraft refueling facilities are ethanol.) E85 can only be used in significant changes potentially affecting acceptable. specially designed flexible fuel vehicles approvability with respect to CAA 4. Compliance With CAA Section 110(l) (FFVs), which have mostly been section 182(b)(3) are the new manufactured since 1998. Since these exemptions for motor raceways, and for Under CAA section 110(l), EPA must are newer vehicles, most of them are marine and aircraft refueling facilities. not approve a SIP revision if the equipped with ORVR, and every FFV ADWM has provided us information revision would interfere with any built today has ORVR. Thus, most concerning the dispensing of gasoline at applicable requirement concerning vehicles refueling at E85 dispensing the one motor raceway, the Phoenix reasonable further progress (RFP) and pumps are already having their International Raceway, to which the attainment of any of the NAAQS or any evaporative emissions captured, as in exemption applies.13 At the Phoenix other applicable requirement under the the cases of late model rental cars International Raceway, two types of fuel Act. With respect to this SIP revision, refueling at rental car facilities and we find that the only potentially newly manufactured cars being fueled 12 The information on the percentage of FFVs in significant adverse effect on emissions for the first time at automobile assembly the Phoenix metropolitan area that are ORVR- and, thus, potential for interference equipped is from a report titled ‘‘Widespread Use plants. At the time EPA released the stems from the exclusion of E85 from 2006 Page/Oge Memorandum, EPA Analysis for E85 Stage II Waiver Request,’’ sent to EPA by Duane M. Yantorno, Director, the definition of ‘‘gasoline’’ in ARS 41– estimated that 59 percent of FFVs in use Transportation Fuels and Air Quality Programs, 2121, which would allow for increased ADWM, via email on October 25, 2010. use of E85 (by FFVs) as a motor fuel in 11 The information concerning the application of 13 The information concerning the application of the exemption for gasoline dispensing sites located the exemption for motor raceways in the Phoenix the Phoenix metropolitan area, and the on a manufacturers’ proving ground is contained in metropolitan area is contained in a letter from relative difference in emissions from a letter from Duane M. Yantorno, Director, Duane M. Yantorno, Director, Transportation Fuels FFVs using E85 relative to the same Transportation Fuels and Air Quality Program, and Air Quality Program, Arizona Department of vehicles using the specially formulated Arizona Department of Weights and Measures, to Weights and Measures, to Andrew Steckel, Chief, Andrew Steckel, Chief, Rules Office, Air Division, Rules Office, Air Division, EPA Region IX, dated gasoline (referred to as ‘‘Arizona Cleaner EPA Region IX, dated August 1, 2011. August 1, 2011. Burning Gasoline,’’ or ‘‘Arizona CBG’’)

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otherwise required.14 (Arizona CBG is a which provides us with insight into the RFP and attainment for any of the boutique fuel established to reduce potential emissions effects. NAAQS. vehicle emissions in the Phoenix The E85 Vehicle Emissions Study C. Correction of Previous Rulemaking metropolitan area and to help meet CAA compiled the results from previous air quality planning requirements.) The published studies but also analyzed a On November 1, 1994, we took direct gasoline portion of E85 must continue to significantly larger database compiled final action to approve the meet the specifications for Arizona CBG by EPA for vehicle certification administrative rules adopted by the pursuant to AAC R20–2–718(B). purposes. Though the results vary by Arizona Department of Weights and We would normally look to EPA’s pollutant and between ‘‘tier 1’’ (i.e., Measures providing for the installation motor vehicle emissions model (the model year (MY) 1994–2003) and ‘‘tier and operation of stage II vapor recovery most recent of which is ‘‘MOVES2010’’) 2’’ (MY 2004–2008) vehicles, in general, systems. 59 FR 54521, November 1, to estimate changes in vehicle emissions the study suggests that FFVs emit fewer 1994. We incorporated the approved resulting from combustion of different rules into the Arizona SIP by adding a oxides of nitrogen (NOX), carbon fuel types, but MOVES2010 is only monoxide, and particulate matter (PM) new paragraph (69) to 40 CFR 52.120(c), designed to estimate the effects of relative to the same FFVs using which reads: ‘‘Maricopa County Bureau ethanol in gasoline up to 10% by gasoline. However, with respect to of Air Pollution Control stage II vapor volume, and thus is not capable of VOCs, FFVs may well emit greater VOCs recovery program, adopted on August estimating vehicle emissions using E85. than the same FFVs using gasoline 27, 1993.’’ The descriptive reference in (EPA is planning on evaluating recently [based on the measurement results for paragraph (69) was erroneous in that completed and ongoing studies using non-methane organic gases (NMOGs)].16 administrative rules governing the vapor E85 this year in order to add an E85 recovery program in the Phoenix Thus, with respect to nitrogen option to the next version of MOVES.) metropolitan area in Maricopa County, dioxide, carbon monoxide and However, we did review a recently and adopted on August 27, 1993, were particulate matter, because emissions published study in the Journal of the Air adopted by the Arizona Department of using E85 would be lower than those & Waste Management Association titled Weights and Measures, not the using CBG, the incremental substitution ‘‘Effect of E85 on Tailpipe Emissions Maricopa County Bureau of Air of CBG with E85 would not interfere from Light-Duty Vehicles 15’’ (herein, Pollution Control (since renamed the with RFP or attainment of the ambient the ‘‘E85 Vehicle Emissions Study’’), Maricopa County Air Quality standards for those pollutants. Department). Moreover, the descriptive 14 EPA’s guidance for States in developing their We also believe that the net effect on reference to the vapor recovery program Stage II SIPs in the early 1990s suggested that States ozone conditions in the Phoenix 8-hour alone does not inform the public and use the same definition of ‘‘gasoline’’ as the one ozone nonattainment area would be regulated community that our approval found in EPA’s Standard of Performance for Bulk beneficial despite the potential higher Gasoline Terminals at 40 CFR 60.501, which relates to specific rules, and thus is includes ‘‘any petroleum distillate or petroleum VOC emission rate by E85-fueled FFVs potentially confusing to the public and distillate/alcohol blend having a Reid vapor (relative to CBG-fueled FFVs) because of regulated community as to the contents pressure of 27.6 kilopascals or greater which is used the offsetting effect of NOX emissions of the SIP. as a fuel for internal combustion engines.’’ EPA reductions (from use of E85 relative to recommended using this definition to most broadly We are therefore, under section reach situations in which refueling of motor Arizona CBG) and because of the 110(k)(6) and 301(a) of the Clean Air vehicles results in evaporative VOC emissions that extension of Stage II vapor recovery Act,18 proposing to correct our previous contribute to ozone nonattainment concentrations, requirements to ‘‘Area A,’’ an area that codification of our approval of the stage and to avoid a narrow interpretation of what is is larger than the area formerly ‘‘gasoline’’ that would allow significant VOC II vapor recovery rules adopted by emissions from motor vehicle refueling activities in designated as nonattainment for the 1- ADWM on August 27, 1993, and nonattainment areas to go uncontrolled. hour ozone standard and that includes submitted by ADEQ on May 27, 1994, to In the existing SIP, Arizona includes a definition the fast-growing region west of the City identify the appropriate regulatory of ‘‘gasoline,’’ AAC R4–31–901(5), that is consistent of Phoenix.17 with the NSPS definition. The SIP revision for agency and to identify the specific rules which we are proposing approval in today’s action Therefore, we have determined that that were approved. would replace the existing SIP definition of this SIP revision, including the change ‘‘gasoline’’ from Arizona’s rules for gasoline vapor in the definition of ‘‘gasoline’’ to III. Proposed Action and Request for recovery (AAC title 20, chapter 2, article 9) with the exclude ‘‘E85,’’ would not interfere with Public Comment definition of ‘‘gasoline’’ from Arizona’s statutes governing motor fuel (ARS section 41–2121(5)). The As authorized in section 110(k)(3) of definition of ‘‘gasoline’’ in ARS section 41–2121(5) 16 Ethanol itself contains no lead (Pb) or sulfur, the Act, EPA is proposing to approve is as inclusive as the existing SIP definition in AAC but the ethanol portion of E85 does contain some the statutory provisions and updated R4–31–901(5), except for the explicit exclusion of Pb and sulfur due to the addition of a denaturant, administrative rules establishing certain E85. Given that E85 can only be used by FFVs, and which can comprise up to 5% of the ethanol based on our proposed ‘‘widespread use’’ portion of E85. The denaturant used by ethanol vapor recovery requirements in the determination with respect to the FFV fleet in the producers is typically gasoline (either RFG or Phoenix metropolitan area as a revision Phoenix area that would be fueled at E85 conventional gasoline, depending on where the to the Arizona SIP. Specifically, we are dispensing pumps, we find the exception for E85 ethanol plant is located), which has sulfur and Pb proposing to approve Arizona Revised from the definition of ‘‘gasoline’’ acceptable under specifications similar to those for CBG. Therefore, section 182(b)(3). Moreover, to allow for the a gallon of E85 would have less sulfur and Pb than Statutes (ARS) sections listed in table 1 distribution and sale of E85 in the Phoenix area, a a gallon of CBG (due to the dilution provided by change in the term of ‘‘gasoline’’ (to exclude E85) the ethanol), and thus the emissions of sulfur 18 Section 110(k)(6) of the CAA provides that, for stage II vapor recovery purposes alone would dioxide and Pb from use of E85 in FFVs would be whenever EPA determines that the Agency’s action not have sufficed. Because of the boutique fuel less than the corresponding emissions from use of approving, disapproving, or promulgating any plan requirements of Arizona CBG that have been CBG in those vehicles. Therefore, there would be or plan revision, area designation, redesignation, approved into the Arizona SIP, a change in the no interference with RFP or attainment of the Pb classification, or reclassification was in error, EPA definition of ‘‘gasoline’’ as a motor fuel (to exclude and sulfur dioxide NAAQS. may in the same manner as the approval, E85) was also necessary. 17 As submitted in 1993, ARS section 41–2132(C) disapproval, or promulgation revise such action as 15 Janet Yanowitz and Robert L. McCormick, established the stage II vapor recovery requirement appropriate without requiring any further ‘‘Effect of E85 on Tailpipe Emissions from Light- within the ozone nonattainment area, but the submission from the State. Section 301(a) of the Duty Vehicles,’’ Journal of the Air & Waste current version of this statute, which is included in CAA authorizes EPA to prescribe such regulations Management Association, Volume 59, February today’s proposed approval, extends the requirement as are necessary to carry out the Agency’s functions 2009, pages 172–182. to ‘‘Area A.’’ under the CAA.

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of this document and the Arizona • Does not impose an information ENVIRONMENTAL PROTECTION Administrative Code (AAC) sections collection burden under the provisions AGENCY listed in table 2 of this document.19 of the Paperwork Reduction Act (44 Second, as authorized under CAA U.S.C. 3501 et seq.); 40 CFR Part 52 section 202(a)(6), we are proposing to • Is certified as not having a [EPA–R09–OAR–2011–0580; FRL–9468–1] waive the stage II vapor recovery significant economic impact on a requirements at E85 dispensing pumps substantial number of small entities Revisions to the California State in the Phoenix area under CAA section Implementation Plan, Sacramento 202(a)(6) based on our conclusion that under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.); Metropolitan Air Quality Management ORVR is in widespread use among the District, Ventura County Air Pollution • FFVs that use such facilities. Does not contain any unfunded Control District, and Placer County Air In so doing, we propose to conclude mandate or significantly or uniquely Pollution Control District that the submitted statutory provisions affect small governments, as described and updated administrative rules meet in the Unfunded Mandates Reform Act AGENCY: Environmental Protection the related requirements for stage II of 1995 (Pub. L. 104–4); Agency (EPA). vapor recovery under CAA section • ACTION: Proposed rule. 182(b)(3) and would not interfere with Does not have Federalism attainment and RFP of any of the implications as specified in Executive SUMMARY: EPA is proposing to approve NAAQS or any other CAA applicable Order 13132 (64 FR 43255, August 10, revisions to the Sacramento requirement, consistent with the 1999); Metropolitan Air Quality Management requirements of CAA section 110(l). • Is not an economically significant District (SMAQMD), Ventura County Final EPA approval of the updated regulatory action based on health or Air Pollution Control District statutory provisions and rules and safety risks subject to Executive Order (VCAPCD), and Placer County Air incorporation of them into the Arizona 13045 (62 FR 19885, April 23, 1997); Pollution Control District (PCAPCD) SIP would make them federally portion of the California State • Is not a significant regulatory action enforceable. Implementation Plan (SIP). These subject to Executive Order 13211 (66 FR Lastly, under section 110(k)(6) and revisions concern volatile organic 301(a) of the CAA, we are proposing to 28355, May 22, 2001); compound (VOC) emissions from correct and clarify the incorporation of • Is not subject to requirements of organic chemical manufacturing, soil the previous version of these Section 12(d) of the National decontamination, and polyester resin administrative rules into the Arizona Technology Transfer and Advancement operations. We are proposing to approve SIP. Act of 1995 (15 U.S.C. 272 note) because local rules to regulate these emission We will accept comments from the application of those requirements would sources under the Clean Air Act as public on this proposed approval for the be inconsistent with the Clean Air Act; amended in 1990 (CAA or the Act). next 30 days. and DATES: Any comments on this proposal IV. Statutory and Executive Order • Does not provide EPA with the must arrive by November 2, 2011. Reviews discretionary authority to address ADDRESSES: Submit comments, Under the Clean Air Act, the disproportionate human health or identified by docket number EPA–R09– Administrator is required to approve a environmental effects with practical, OAR–2011–0580, by one of the SIP submission that complies with the appropriate, and legally permissible following methods: provisions of the Act and applicable methods under Executive Order 12898 1. Federal eRulemaking Portal: Federal regulations. 42 U.S.C. 7410(k); (59 FR 7629, February 16, 1994). www.regulations.gov. Follow the on-line 40 CFR 52.02(a). Thus, in reviewing SIP instructions. submissions, EPA’s role is to approve In addition, this proposed rule does 2. E-mail: [email protected]. State choices, provided that they meet not have tribal implications as specified 3. Mail or deliver: Andrew Steckel the criteria of the Clean Air Act. by Executive Order 13175 (65 FR 67249, (Air-4), U.S. Environmental Protection Accordingly, this action merely November 9, 2000), because the SIP is Agency Region IX, 75 Hawthorne Street, proposes to approve State law as not approved to apply in Indian country San Francisco, CA 94105–3901. meeting Federal requirements and does located in the State, and EPA notes that Instructions: All comments will be not impose additional requirements it will not impose substantial direct included in the public docket without beyond those imposed by State law. For costs on tribal governments or preempt change and may be made available that reason, this proposed action: tribal law. online at http://www.regulations.gov, • Is not a ‘‘significant regulatory including any personal information List of Subjects in 40 CFR Part 52 action’’ subject to review by the Office provided, unless the comment includes of Management and Budget under Environmental protection, Air Confidential Business Information (CBI) Executive Order 12866 (58 FR 51735, pollution control, Intergovernmental or other information whose disclosure is October 4, 1993) given the limited relations, Ozone, Reporting and restricted by statute. Information that nature of this SIP revision (as to you consider CBI or otherwise protected geographic scope and vehicle recordkeeping requirements, Volatile organic compounds. should be clearly identified as such and applicability); should not be submitted through http:// Dated: September 19, 2011. www.regulations.gov or e-mail. http:// 19 Our proposed approval of the statutory Keith Takata, www.regulations.gov is an ‘‘anonymous provisions and administrative rules would supersede the previously-approved versions of the Acting Regional Administrator, Region IX. access’’ system, and EPA will not know administrative rules in the Arizona SIP (i.e., AAC [FR Doc. 2011–25397 Filed 9–30–11; 8:45 am] your identity or contact information Article 9 (‘‘Gasoline Vapor Control’’), Rules R4–31– unless you provide it in the body of BILLING CODE 6560–50–P 901 through R4–31–910, adopted by the Arizona your comment. If you send e-mail Department of Weights and Measures on August 27, 1993, submitted on May 27, 1994, and approved on directly to EPA, your e-mail address November 1, 1994 (59 FR 54521). will be automatically captured and

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included as part of the public comment. DEPARTMENT OF HOMELAND warning systems from the list of eligible If EPA cannot read your comment due SECURITY project types; and modified language to technical difficulties and cannot relating to general, allowable open contact you for clarification, EPA may Federal Emergency Management space, recreational, and wetlands not be able to consider your comment. Agency management uses. FEMA is Electronic files should avoid the use of withdrawing the NPRM so that relevant special characters, any form of 44 CFR Part 67 issues involved in the NPRM may be encryption, and be free of any defects or [Docket ID FEMA–2010–0003; Internal further considered and because portions viruses. Agency Docket No. FEMA–B–1169] of it are redundant or outdated. Docket: Generally, documents in the DATES: The Notice of Proposed docket for this action are available Proposed Flood Elevation Rulemaking published on May 1, 1998 electronically at http:// Determinations (63 FR 24143), is withdrawn as of October 3, 2011. www.regulations.gov and in hard copy Correction at EPA Region IX, 75 Hawthorne Street, ADDRESSES: The Notice of Proposed San Francisco, California. While all In proposed rule document 2010– Rulemaking and this withdrawal notice documents in the docket are listed at 31549 appearing on pages 78664–78666 may be found under Docket ID: FEMA– http://www.regulations.gov, some in the issue of December 16, 2010, make 2011–0004 and are available online by information may be publicly available the following correction: going to http://www.regulations.gov, inserting FEMA–2011–0004 in the only at the hard copy location (e.g., § 67.4 [Corrected] copyrighted material, large maps), and ‘‘Keyword’’ box, and then clicking some may not be publicly available in On page 78665, in the fifth row from ‘‘Search.’’ The Docket is also available either location (e.g., CBI). To inspect the the bottom, immediately beneath the for inspection or copying at FEMA, 500 hard copy materials, please schedule an sentence ‘‘Maps are available for C Street, SW., Room 840, Washington, appointment during normal business inspection at the Meeker County DC 20472. Courthouse, 325 Sibley Avenue North, hours with the contact listed in the FOR FOR FURTHER INFORMATION CONTACT: Litchfield, MN 55355.’’, the heading FURTHER INFORMATION CONTACT section. Cecelia Rosenberg, Federal Insurance which was inadvertently omitted from and Mitigation, DHS/FEMA, 1800 South FOR FURTHER INFORMATION CONTACT: the table, is added to read ‘‘Carroll Bell Street, Arlington, VA 20598–3015. David Grounds, EPA Region IX, (415) County, Missouri, and Incorporated Phone: (202) 646–3321. Facsimile: (202) 972–3019, [email protected]. Areas’’. 646–2880. E-mail: SUPPLEMENTARY INFORMATION: This [FR Doc. C1–2010–31549 Filed 9–30–11; 8:45 am] [email protected]. proposal addresses the following local BILLING CODE 1505–01–P SUPPLEMENTARY INFORMATION: rules: SMAQMD Rule 464 (Organic Chemical Manufacturing Operations), I. Background DEPARTMENT OF HOMELAND VCAPCD Rule 74.29 (Soil Authorized by section 404 of the SECURITY Decontamination), and PCAPCD Rule Robert T. Stafford Disaster Relief and 243 (Polyester Resin Operations). In the Emergency Assistance Act (Stafford Rules and Regulations section of this Federal Emergency Management Agency Act), 42 U.S.C. 5170c, the Hazard Federal Register, we are approving Mitigation Grant Program (HMGP) these local rules in a direct final action 44 CFR Part 206 provides States, Tribes, and local without prior proposal because we governments financial assistance to believe these SIP revisions are not [Docket ID FEMA–2011–0004] implement measures that permanently controversial. If we receive adverse RIN 1660–AA02;Formerly 3067–AC69 reduce or eliminate future damages and comments, however, we will publish a losses from natural hazards. timely withdrawal of the direct final Disaster Assistance; Hazard Mitigation The HMGP regulations at 44 CFR part rule and address the comments in Grant Program 206, subpart N, address the eligibility of subsequent action based on this multi-hazard mitigation projects proposed rule. Please note that if we AGENCY: Federal Emergency through a list of general eligibility receive adverse comment on an Management Agency, DHS. criteria: a project must be cost-effective, amendment, paragraph, or section of ACTION: Proposed rule; withdrawal. be environmentally sound, must address this rule and if that provision may be a repetitive problem, and must severed from the remainder of the rule, SUMMARY: On May 1, 1998, the Federal contribute to a long-term solution. we may adopt as final those provisions Emergency Management Agency Further, HMGP funds cannot be used to of the rule that are not the subject of an (FEMA) published a Notice of Proposed fund projects that are available under adverse comment. Rulemaking (NPRM) to revise the other Federal authorities. The We do not plan to open a second categories of projects eligible for regulations also provide a list of eligible comment period, so anyone interested funding under the Hazard Mitigation types of projects. The project-type in commenting should do so at this Grant Program (HMGP). The NPRM listing is not all-inclusive. FEMA time. If we do not receive adverse proposed to define eligible mitigation published a Notice of Proposed comments, no further activity is activities under the HMGP to include Rulemaking (NPRM) (63 FR 24143, May planned. For further information, please minor flood control projects that do not 1, 1998) proposing the following see the direct final action. duplicate the efforts and authorities of revisions to the HMGP regulations. other Federal agencies. It proposed to Dated: August 16, 2011. include vegetation management Minor Flood Control Projects Jared Blumenfeld, programs for wildfire hazard mitigation Under the NPRM, minor flood control Regional Administrator, Region IX. and erosion hazard mitigation in the list projects that do not duplicate the flood [FR Doc. 2011–25283 Filed 9–30–11; 8:45 am] of eligible activities; it proposed to prevention activities of other Federal BILLING CODE 6560–50–P remove development or improvement of agencies would be eligible for HMGP

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funding. Major flood control projects, ‘‘pervious’’) with the more widely NPRM may be further considered and such as dikes, levees, dams, familiar term of permeable. because portions of it are redundant. channelization, channel widening, The definition of minor flood control II. Summary of Comments stream realignment, seawalls, groins, projects is being examined in greater and jetties, would be distinguished from FEMA received 12 comments on the detail relative to the HMGP eligibility minor flood control activities. Typically, NPRM from State and local criteria of the regulations at 44 CFR funding for major flood control projects governments. Several commenters had 206.434(c). Further, the distinction that would fall under the water resources reservations about the NPRM’s possible minor flood control projects not design and construction authorities of effects on the eligibility of certain flood duplicate the activities of other Federal the U.S. Army Corps of Engineers and control projects because these projects agencies is redundant because the the Natural Resources Conservation were viewed as good hazard mitigation existing program regulations, at 44 CFR Service of the U.S. Department of activities that should be funded by 206.434(f), clearly state that HMGP Agriculture. FEMA. Some commenters expressed funds cannot be used as a substitute or concern regarding the term ‘‘minor flood replacement to fund projects or Wildfire and Erosion control’’ and the criteria used to define programs that are available under other Under the NPRM, vegetation it. Two commenters were concerned Federal authorities. Therefore, to state management related to wildfire and that major flood control projects may the requirement again is redundant, and erosion hazard mitigation measures become ineligible due to concerns of to highlight it for minor flood control would be eligible for HMGP funding. duplicating other Federal assistance, projects over other project types may This would reflect FEMA’s multi-hazard and were concerned about the lead to some confusion regarding its HMGP objectives and priorities applicability of this rationale to the applicability to all project types. authorized by section 404 of the Stafford practice of partnering with other Federal FEMA considers the other provisions Act. agencies. One commenter urged FEMA of the NPRM to be outdated. Eligibility to recognize the importance of allowing Warning Systems considerations of vegetation HMGP funding to be used for mitigation management are addressed through The NPRM sought to minimize an activities related to facilities that would FEMA’s existing HMGP regulations emphasis on warning systems by be regarded as major structural flood identifying general eligibility removing them from the list of eligible control facilities. considerations, and there is no projects. This was due to benefit/cost One commenter expressed support for significant benefit derived from listing considerations. The benefits of some the wildfire and erosion vegetation them specifically. Removing warning hazard mitigation project types can be management provisions in the NPRM, systems from the list of eligible projects difficult to show using FEMA’s and was concerned that vegetation could create the impression that they conventional benefit/cost calculation management activities were not are not eligible for funding. methodology. Because of this in certain extended to other project types. Another The remaining proposed revision, to circumstances FEMA will allow commenter expressed concern that replace the word ‘‘previous’’ (a typo for applicants to demonstrate project cost- wildfire and erosion vegetation ‘‘pervious’’) with ‘‘permeable’’ is not effectiveness using means other than the provisions may conflict with other pre- sufficient reason for continuing the conventional benefit/cost methodology. existing regulatory requirements. NPRM as the original word and the The NPRM proposed to remove warning Two commenters expressed word proposed to replace it mean systems from the example list of eligible dissatisfaction with the NPRM’s essentially the same thing. project types because the project type removal of warning systems from the does not lend itself to use of the list of ‘‘traditionally’’ eligible HMGP IV. Conclusion conventional benefit/cost methodology. activities. FEMA is withdrawing the May 1, One commenter requested Allowable Open Space Uses 1998 NPRM for the reasons stated in consideration of allowable open space this notice. The NPRM proposed a revision to the activities beyond the scope of the list of allowable open space uses for NPRM. W. Craig Fugate, previously funded and acquired open Administrator, Federal Emergency space land by replacing the word III. Reason for Withdrawal Management Agency. ‘‘previous’’ (which was actually a typo FEMA is withdrawing the NPRM so [FR Doc. 2011–25102 Filed 9–30–11; 8:45 am] in the regulation that should have been that relevant issues involved in the BILLING CODE 9111–23–P

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Notices Federal Register Vol. 76, No. 191

Monday, October 3, 2011

This section of the FEDERAL REGISTER Committee on Administration and Designated Federal Officer: Reeve contains documents other than rules or Management Bull. proposed rules that are applicable to the public. Notices of hearings and investigations, The Committee on Administration Committee on Regulation committee meetings, agency decisions and and Management will meet to consider issues arising when agencies use The Committee on Regulation will rulings, delegations of authority, filing of meet to consider a project concerning petitions and applications and agency ‘‘incorporation by reference’’ in international regulatory cooperation. statements of organization and functions are regulations; i.e., when an agency examples of documents appearing in this regulation incorporates by reference This project will examine how the section. material available elsewhere. Among Conference might update its other things, the committee will discuss Recommendation 91–1, ‘‘Federal procedural and drafting issues that arise Agency Cooperation with Foreign ADMINISTRATIVE CONFERENCE OF when agencies use incorporation by Government Regulators,’’ in light of THE UNITED STATES reference, challenges agencies face in developments in United States updating such references, and ways to government structure, trade agreements, Committees on Administration and ensure the reasonable availability of and technology since the Management, Collaborative incorporated materials, which may be recommendation was adopted 20 years Governance, Judicial Review, and subject to copyright. ago. Regulation Date: Friday, October 28, 2011, from Date: Tuesday, October 25, 2011, from 9:30 a.m. to 12:30 p.m. 2 p.m. to 5 p.m. ACTION: Notice of public meetings. Designated Federal Officer: Scott Designated Federal Officer: Reeve Rafferty. Bull. SUMMARY: Notice is hereby given of Dated: September 28, 2011. public meetings of four committees of Committee on Collaborative Jonathan R. Siegel, the Assembly of the Administrative Governance Director of Research and Policy. Conference of the United States (ACUS). The Committee on Collaborative Each committee will meet to discuss Governance will consider [FR Doc. 2011–25393 Filed 9–30–11; 8:45 am] recommendations for consideration by recommending improvements to the BILLING CODE 6110–01–P the full Conference. Complete details Federal Advisory Committee Act regarding each committee’s meeting, (FACA) and the implementation of the related research reports, how to attend Act. Potential issues for discussion DEPARTMENT OF AGRICULTURE (including information about remote include the chartering requirements for access and obtaining special advisory committees; improving access Submission for OMB Review; accommodations for persons with to committee meetings and materials; Comment Request disabilities), and how to submit virtual committee meetings; and other September 27, 2011. comments to the committee can be improvements that might reduce the The Department of Agriculture has found in the ‘‘Research’’ section of the burdens imposed by FACA or improve submitted the following information ACUS Web site. Go to http:// the transparency of FACA committees. collection requirement(s) to OMB for www.acus.gov and click on Research -> The Committee on Collaborative review and clearance under the Committee Meetings. Additional project Governance may also discuss a project Paperwork Reduction Act of 1995, information may also be found by regarding the use of third-party Public Law 104–13. Comments clicking on Research -> Conference certification in government inspections. regarding (a) Whether the collection of Date: Tuesday, October 18, 2011, from Projects. information is necessary for the proper Comments may be submitted by e- 1:30 p.m. to 4:30 p.m. Designated Federal Officer: David performance of the functions of the mail to [email protected], with the Pritzker. agency, including whether the name of the relevant committee in the information will have practical utility; subject line, or by postal mail to ‘‘[Name Committee on Judicial Review (b) the accuracy of the agency’s estimate of Committee] Comments’’ at the The Committee on Judicial Review of burden including the validity of the address given below. To be guaranteed will discuss potential changes to 28 methodology and assumptions used; (c) consideration, comments must be U.S.C. 1500, which regulates the ways to enhance the quality, utility and received five calendar days before the jurisdiction of the Court of Federal clarity of the information to be meeting to which they are related. Claims (CFC). The statute currently collected; (d) ways to minimize the ADDRESSES: The meetings will be held at deprives the CFC of jurisdiction over a burden of the collection of information 1120 20th Street, NW., Suite 706 South, claim if the plaintiff has a claim based on those who are to respond, including Washington, DC 20036. on the same facts pending in another through the use of appropriate court. The committee will consider automated, electronic, mechanical, or FOR FURTHER INFORMATION CONTACT: The whether this statute should be repealed other technological collection Designated Federal Officer for the or revised. techniques or other forms of information individual committee (see listings The committee may also consider the technology should be addressed to: Desk below), ACUS, 1120 20th Street, NW., Congressional Review Act and agency Officer for Agriculture, Office of Suite 706 South, Washington, DC 20036; practices under the Act. Information and Regulatory Affairs, Telephone 202–480–2080. Date: Thursday, October 27, 2011, Office of Management and Budget SUPPLEMENTARY INFORMATION: from 1:30 p.m. to 4:30 p.m. (OMB),

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[email protected] of the regulations. Periodic inspections Description of Respondents: Business or fax (202) 395–5806 and to will be made to determine if licenses are or other for-profit; State, Local or Tribal Departmental Clearance Office, USDA, meeting the standards for operation of Government. OCIO, Mail Stop 7602, Washington, DC their approved facilities. Upon receipt Number of Respondents: 4. 20250–7602. Comments regarding these of the information from the Public information collections are best assured Health Officials, the information is used Frequency of Responses: Reporting: of having their full effect if received by Federal or State animal health On occasion . within 30 days of this notification. personnel to determine whether the Total Burden Hours: 62. Copies of the submission(s) may be waste collector is feeding garbage to obtained by calling (202) 720–8958. swine, whether it is being treated, and Animal and Plant Health Inspection An agency may not conduct or whether the feeder is licensed or needs Service sponsor a collection of information to be licensed. Title: Trichinae Certification Program. unless the collection of information Description of Respondents: Business displays a currently valid OMB control or other for profit; State, Local or Tribal OMB Control Number: 0579–0323. number and the agency informs Government. Summary of Collection: The Animal potential persons who are to respond to Number of Respondents: 2,105. Health Protection Act (AHPA) of 2002 is the collection of information that such Frequency of Responses: the primary Federal law governing the persons are not required to respond to Recordkeeping; Reporting: On occasion. protection of animal health. The law the collection of information unless it Total Burden Hours: 11,324. gives the Secretary of Agriculture broad displays a currently valid OMB control Animal and Plant Health Inspection authority to detect, control and number. Service eradicate pests or diseases of livestock Animal Plant and Health Inspection Title: CWD in Cervids; Payment of or poultry. The AHPA is contained in Service Indemnity. Title X, Subtitle E, Sections 10401–18 of Title: Swine Health Protection. OMB Control Number: 0579–0189. Public Law 107–171, May 13, 2002, the OMB Control Number: 0579–0065. Summary of Collection: The Animal Farm Security and Rural Investment Act Summary of Collection: The Animal Health Protection Act (AHPA) of 2002 is of 2002. Trichinelia spiralis is a Health Protection Act (AHPA) of 2002 is the primary Federal law governing the contagious nematode affecting animals the primary Federal law governing the protection of animal health. The law and people. The disease, trichinellosis protection of animal health. The law gives the Secretary of Agriculture broad is transmitted by consuming the meat of gives the Secretary of Agriculture broad authority to detect, control and an infected animal. The Animal Plant authority to detect, control, or eradicate eradicate pests or diseases of livestock and Health Inspection Service (APHIS) pests or diseases of livestock or poultry. or poultry, and to pay claims arising will collect information using certificate The AHPA is contained in Title X, from destruction of animals. Disease site audit, program audit form, request Subtitle E, Sections 10401–18 of P.O. prevention is the most effective method for information during a spot audit, 107–171, May 13, 2002, the Farm for maintaining a healthy animal animal disposal plan and Security and Rural Investment Act of population and enhancing the Animal 2002. Veterinary Services, a program and Plant Health Inspection Service recordkeeping, animal movement record with the Animal and Plant Health (APHIS) ability to compete in exporting and recordkeeping, rodent control Inspection Service (APHIS), is animals and animal products. Chronic logbook and recordkeeping, trichinae responsible for administering wasting disease (CWD) is a herd certification feed mill quality regulations intended to prevent the transmissible spongiform assurance affidavit and recordkeeping, dissemination of animal diseases within encephalopathy (TSE) of elk, deer and and records for slaughter testing and the United States. Garbage is one of the moose typified by chronic weight loss recordkeeping. primary media through which leading to death. Need and Use of the Information: numerous infections or communicable The presence of CWD disease in APHIS will collect information to certify diseases of swine are transmitted. cervids causes significant economic and swine are raised using practices that Because of the serious threat to the U.S. market losses to U.S. producers. APHIS will reduce or eliminate T. spiralis swine industry, Congress passed Public will collect information using VS Form exposure. If this information is not Law 96–468 ‘‘Swine Health Protection 1–23, Appraisal & Indemnity Claim collected, it will compromise APHIS’ Act’’ on October 17, 1980. This law form. ability to determine the trichinae requires USDA to ensure that all garbage Need and Use of the Information: infection status of pork produced in the is treated prior to its being fed to swine APHIS will collect the owner’s name United States. that are intended for interstate or foreign and address, the number of animals for commerce or that substantially affect which the owner is seeking payment, Description of Respondents: Business such commerce. The Act and the and the appraised value of each animal. or other for-profit; State, Local or Tribal regulations will allow only operators of The owner must also certify as to Government. garbage treatment facilities, which meet whether the animals are subject to a Number of Respondents: 1,250. certain specification to utilize garbage mortgage. If there is a mortgage the form for swine feeding. APHIS will use must be signed by the owner and each Frequency of Responses: various forms to collect information. person holding a mortgage. As a Recordkeeping; Reporting: On occasion. Need and Use of the Information: condition of receiving indemnity, herd Total Burden Hours: 7,494. APHIS collects information from owners must review and sign a written persons desiring to obtain a permit agreement with APHIS stating that the Ruth Brown, (license) to operate a facility to treat farm has been effectively cleaned and Departmental Information Collection garbage. Prior to issuance of a license, disinfected. Failure to collect this Clearance Officer. an inspection will be made of the information would cripple APHIS’ [FR Doc. 2011–25330 Filed 9–30–11; 8:45 am] facility by an authorized representative ability to effectively sustain its CWD BILLING CODE 3410–34–P to determine if it meets all requirements control program.

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DEPARTMENT OF AGRICULTURE Chapter 17, Additional U.S. Note All Lake Tahoe Basin Federal 5(a)(iv). Advisory Committee meetings are open Office of the Secretary USTR will allocate this increase to the public. Interested citizens are among supplying countries and customs encouraged to attend at the above USDA Increases the Fiscal Year 2011 areas. This action is being taken after a address. Issues may be brought to the Tariff-Rate Quota for Refined Sugar determination that additional supplies attention of the Committee during the AGENCY: Office of the Secretary, USDA. of refined sugar are necessary to reduce open public comment period at the risks associated with adverse weather meeting or by filing written statements ACTION: Notice. and other supply disruptions. Harvest of with the secretary for the Committee SUMMARY: The Secretary of Agriculture the FY 2012 sugar beet crop is before or after the meeting. Please refer today announced an increase in the significantly slower to date than during any written comments to the Lake fiscal year (FY) 2011 refined sugar tariff- several of the previous fiscal years. Tahoe Basin Management Unit at the rate quota (TRQ) of 136,078 metric tons USDA will closely monitor stocks, contact address stated above. raw value (MTRV). consumption, imports and all sugar Dated: September 27, 2011. market and program variables on an DATES: Effective: October 3, 2011. Jeff Marsolais, ongoing basis. Deputy Forest Supervisor. FOR FURTHER INFORMATION CONTACT: * Conversion factor: 1 metric ton = Angel F. Gonzalez, Import Policies and 1.10231125 short tons. [FR Doc. 2011–25361 Filed 9–30–11; 8:45 am] Export Reporting Division, Foreign BILLING CODE 3410–11–P Agricultural Service, AgStop 1021, U.S. Dated: September 27, 2011. Department of Agriculture, Washington, Darci L. Vetter, DC 20250–1021; or by telephone (202) Acting Under Secretary, Farm and Foreign UNITED STATES ARCTIC RESEARCH 720–2916; or by fax to (202) 720–0876; Agricultural Service. COMMISSION or by e-mail to [FR Doc. 2011–25329 Filed 9–30–11; 8:45 am] [email protected]. BILLING CODE 3410–10–P Reports and Updates on Arctic Research Programs and Projects; SUPPLEMENTARY INFORMATION: A quantity Meetings of 22,000 MTRV for sugars, syrups, and DEPARTMENT OF AGRICULTURE molasses (collectively referred to as Notice is hereby given that the US refined sugar) described in subheadings Forest Service Arctic Research Commission will hold 1701.12.10, 1701.91.10, 1701.99.10, its 96th meeting in Durham and 1702.90.10, and 2106.90.44 of the U.S. Lake Tahoe Basin Federal Advisory Hanover, NH, on October 5–7, 2011. The Harmonized Tariff Schedule (HTS) is Committee (LTFAC) business sessions on October 5 and 7 are the minimum level necessary to comply open to the public and will convene at AGENCY: Forest Service, USDA. with U.S. World Trade Organization 8:00 a.m. each day. On October 6, the Uruguay Round Agreements, of which ACTION: Notice of meeting. Commission will hold a meeting at the 1,656 MTRV is the minimum quantity to SUMMARY: The Lake Tahoe Federal US Army Cold Regions Research and be reserved for specialty sugar. On Advisory Committee will hold a Engineering Lab (CRREL), a secure US August 5, 2010, USDA established the meeting on October 21 or 24, 2011 at the Army facility with limited and pre- FY 2011 (October 1, 2010—September Lake Tahoe Basin Management Unit, 35 screened access for visitors. The 30, 2011) refined sugar TRQ at an College Drive, South Lake Tahoe, CA Commission will hold public question aggregate quantity of 99,111 MTRV, of 96150. This Committee, established by and comment sessions on both October which 20,344 MTRV, was refined sugar the Secretary of Agriculture on 5 and 7 between 5 and 5:30 p.m. where other than specialty sugar. On August December 15, 1998 (64 FR 2876), is the public is invited to address the 17, 2010, the Office of the U.S. Trade chartered to provide advice to the Commissioners about topics of interest Representative (USTR) allocated this Secretary on implementing the terms of related to research activities in the refined sugar as follows: 10,300 MTRV the Federal Interagency Partnership on Arctic. to Canada; 2,954 MTRV to Mexico; and the Lake Tahoe Region and other 96th Meeting Schedule: 7,090 MTRV to be administered on a matters raised by the Secretary. Wed., Oct. 5, 2011, University of New first-come, first-served basis. On August Hampshire, Durham, NH, Center for 2, 2011, the Secretary of Agriculture (the DATES: The meeting will be held Coastal & Ocean Mapping, Joint Secretary) increased the FY 2011 October 21 or 24, 2011, beginning at 9 Hydrographic Center, 24 Colovos Rd., specialty sugar TRQ by 9,072 MTRV, a.m. and ending at 3 p.m. A final date Admiral’s Conference Room, 2nd Floor, resulting in an FY 2011 specialty sugar can be confirmed at http:// Room 240, Public comment and TRQ to 87,839 MTRV, and an FY 2011 www.fs.fed.us/r5/ltbmu/local/ltfac. question period: Captain’s Library, 1st refined sugar TRQ to 108,183 MTRV. ADDRESSES: Lake Tahoe Basin Floor, Room 166. The Secretary today announced an Management Unit, 35 College Drive, Thurs., Oct. 6, 2011, CRREL, Hanover, increase in the FY 2011 refined sugar South Lake Tahoe, CA 96150. NH. TRQ of 136,078 MTRV, to a total of For Further Information or to Request Fri., Oct. 7, 2011 Dartmouth College, 244,261 MTRV. The authority to an Accommodation (One Week Prior to Rockefeller Center, 2 Webster Street, increase the refined sugar TRQ is found Meeting Date) Contact: Arla Hains, Lake 1930s Room, 1st Flr., Public Comment in the HTS, Chapter 17, Additional U.S. Tahoe Basin Management Unit, Forest and Question Period: Rockefeller Note 5(a)(ii). The Secretary also Service, 35 College Drive, South Lake Center, 2 Webster Street, 1930s Room, announced that sugar entering under the Tahoe, CA 96150, (530) 543–2773. 1st Floor. FY 2011 refined sugar TRQ would be SUPPLEMENTARY INFORMATION: Items to The Agenda items include: permitted to enter until November 30, be covered on the agenda: (1) Facilitated (1) Call to order and approval of the 2011. Authority for the Secretary to workshop to discuss a strategic agenda. permit entry of sugar in a subsequent workplan for Fiscal Year 2012, and (2) (2) Approval of the minutes from the quota period is found in the HTS, public comment. 95th meeting.

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(3) Commissioner and staff reports. The grantee’s proposed service area DEPARTMENT OF COMMERCE (4) Discussion and presentations under the ASF would be Clinton, Eaton, concerning Arctic research activities. Gratiot, Ingham, Isabella (portions), Foreign-Trade Zones Board The focus of the meeting will be Jackson, Livingston and Shiawassee [Docket 57–2011] reports and updates on Arctic research Counties, Michigan, as described in the programs and projects. application. If approved, the grantee Foreign-Trade Zone 127—Columbia, If you plan to attend this meeting, would be able to serve sites throughout SC; Application for Reorganization/ please notify us via the contact the service area based on companies’ Expansion Under Alternative Site information below. Any person needs for FTZ designation. The Framework planning to attend who requires special proposed service area is adjacent to the accessibility features and/or auxiliary An application has been submitted to user fee airport designated by U.S. the Foreign-Trade Zones (FTZ) Board aids, such as sign language interpreters, Customs and Border Protection at the must inform the Commission of those (the Board) by the Richland-Lexington Capital Regional International Airport, Airport District, grantee of FTZ 127, needs in advance of the meeting. Lansing. Contact person for further requesting authority to reorganize and information: John Farrell, Executive The applicant is requesting authority expand the zone under the alternative Director, US Arctic Research to reorganize its existing zone project to site framework (ASF) adopted by the Commission, 703–525–0111 or TDD include the existing site as a ‘‘magnet’’ Board (74 FR 1170, 1/12/09 (correction 703–306–0090. site. The ASF allows for the possible 74 FR 3987, 1/22/09); 75 FR 71069– exemption of one magnet site from the 71070, 11/22/10). The ASF is an option Yours truly, ‘‘sunset’’ time limits that generally for grantees for the establishment or John Farrell, apply to sites under the ASF, and the reorganization of general-purpose zones Executive Director. applicant proposes that Site 1 be so and can permit significantly greater [FR Doc. 2011–25176 Filed 9–29–11; 8:45 am] exempted. No usage-driven sites are flexibility in the designation of new BILLING CODE 7555–01–P being requested at this time. Because the ‘‘usage-driven’’ FTZ sites for operators/ ASF only pertains to establishing or users located within a grantee’s ‘‘service reorganizing a general-purpose zone, the area’’ in the context of the Board’s DEPARTMENT OF COMMERCE application would have no impact on standard 2,000-acre activation limit for FTZ 275’s authorized subzone. a general-purpose zone project. The Foreign-Trade Zones Board application was submitted pursuant to In accordance with the Board’s [Docket 58–2011] the Foreign-Trade Zones Act, as regulations, Elizabeth Whiteman of the amended (19 U.S.C. 81a–81u), and the FTZ Staff is designated examiner to Foreign-Trade Zone 275—Lansing, MI; regulations of the Board (15 CFR part Application for Reorganization Under evaluate and analyze the facts and 400). It was formally filed on September Alternative Site Framework information presented in the application 23, 2011. and case record and to report findings FTZ 127 was approved by the Board An application has been submitted to and recommendations to the Board. on July 2, 1986 (Board Order 333, 51 FR the Foreign-Trade Zones (FTZ) Board Public comment is invited from 25075, 7/10/86). The current zone (the Board) by the Capital Region interested parties. Submissions (original project includes the following sites: Site Airport Authority, grantee of FTZ 275, and 3 copies) shall be addressed to the 1 (109 acres)—Richland-Lexington requesting authority to reorganize the Board’s Executive Secretary at the Airport District, 125A Summer Lake zone under the alternative site address below. The closing period for Drive, West Columbia; and, Site 2 (44 framework (ASF) adopted by the Board their receipt is December 2, 2011. acres, expires 3/30/13)—Urban (74 FR 1170, 1/12/09 (correction 74 FR Rebuttal comments in response to Outfitters, Inc., Edgefield Industrial 3987, 1/22/09); 75 FR 71069–71070, material submitted during the foregoing Park, 30 Industrial Park Blvd., Trenton. 11/22/10). The ASF is an option for period may be submitted during the The grantee’s proposed service area grantees for the establishment or subsequent 15-day period to December under the ASF would be Aiken, reorganization of general-purpose zones 19, 2011. Allendale, Bamberg, Barnwell, Calhoun, and can permit significantly greater Clarendon, Edgefield, Fairfield, flexibility in the designation of new A copy of the application will be Kershaw, Lee, Lexington, McCormick, ‘‘usage-driven’’ FTZ sites for operators/ available for public inspection at the Newberry, Richland, Saluda, and users located within a grantee’s ‘‘service Office of the Executive Secretary, Sumter Counties, South Carolina, as area’’ in the context of the Board’s Foreign-Trade Zones Board, Room 2111, described in the application. If standard 2,000-acre activation limit for U.S. Department of Commerce, 1401 approved, the grantee would be able to a general-purpose zone project. The Constitution Avenue, NW., Washington, serve sites throughout the service area application was submitted pursuant to DC 20230–0002, and in the ‘‘Reading based on companies’ needs for FTZ the Foreign-Trade Zones Act, as Room’’ section of the Board’s Web site, designation. The proposed service area amended (19 U.S.C. 81a–81u), and the which is accessible via http:// is within and adjacent to the Columbia regulations of the Board (15 CFR part www.trade.gov/ftz. For further Customs and Border Protection port of 400). It was formally filed on September information, contact Elizabeth entry. 27, 2011. Whiteman at The applicant is requesting authority FTZ 275 was approved by the Board [email protected] or (202) to reorganize and expand its existing on August 12, 2009 (Board Order 1633, 482–0473. zone project to include Site 1 as a 74 FR 44822, 8/31/2011). Dated: September 27, 2011. ‘‘magnet’’ site and temporary Site 2 as The current zone project includes the a ‘‘usage-driven site’’. The ASF allows following site: Site 1 (846 acres)— Andrew McGilvray, for the possible exemption of one Capital Region International Airport, Executive Secretary. magnet site from the ‘‘sunset’’ time 4100 Capital City Boulevard, Lansing [FR Doc. 2011–25430 Filed 9–30–11; 8:45 am] limits that generally apply to sites under (Ingham County). BILLING CODE 3510–DS–P the ASF, and the applicant proposes

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that Site 1 be so exempted. Because the Dated: September 27, 2011. review (‘‘POR’’), it must notify the ASF only pertains to establishing or Andrew McGilvray, Department within 60 days of reorganizing a general-purpose zone, the Executive Secretary. publication of this notice in the Federal application would have no impact on [FR Doc. 2011–25428 Filed 9–30–11; 8:45 am] Register. All submissions must be filed FTZ 127’s authorized subzones. BILLING CODE P electronically at http:// In accordance with the Board’s iaaccess.trade.gov in accordance with regulations, Kathleen Boyce of the FTZ 19 CFR 351.303. See Antidumping and Staff is designated examiner to evaluate DEPARTMENT OF COMMERCE Countervailing Duty Proceedings: and analyze the facts and information Electronic Filing Procedures; presented in the application and case International Trade Administration Administrative Protective Order record and to report findings and Procedures, 76 FR 39263 (July 6, 2011). recommendations to the Board. Initiation of Antidumping and Such submissions are subject to Public comment is invited from Countervailing Duty Administrative verification in accordance with section interested parties. Submissions (original Reviews and Requests for Revocations 782(i) of the Tariff Act of 1930, as and 3 copies) shall be addressed to the in Part amended (‘‘Act’’). Further, in Board’s Executive Secretary at the AGENCY: Import Administration, accordance with 19 CFR address below. The closing period for International Trade Administration, 351.303(f)(3)(ii), a copy of each request their receipt is December 2, 2011. Department of Commerce. must be served on the petitioner and Rebuttal comments in response to each exporter or producer specified in SUMMARY: The Department of Commerce material submitted during the foregoing the request. period may be submitted during the (‘‘the Department’’) has received subsequent 15-day period to December requests to conduct administrative Respondent Selection 19, 2011. reviews of various antidumping and In the event the Department limits the A copy of the application will be countervailing duty orders and findings number of respondents for individual available for public inspection at the with August anniversary dates. In examination for administrative reviews, Office of the Executive Secretary, accordance with the Department’s the Department intends to select Foreign-Trade Zones Board, Room 2111, regulations, we are initiating those respondents based on U.S. Customs and U.S. Department of Commerce, 1401 administrative reviews. The Department Border Protection (‘‘CBP’’) data for U.S. Constitution Avenue, NW., Washington, also received requests to revoke three imports during the POR. We intend to DC 20230–0002, and in the ‘‘Reading antidumping duty orders in part. release the CBP data under Room’’ section of the Board’s website, DATES: Effective Date: October 3, 2011. Administrative Protective Order which is accessible via http:// FOR FURTHER INFORMATION CONTACT: (‘‘APO’’) to all parties having an APO www.trade.gov/ftz. For further Brenda Waters, Office of AD/CVD within seven days of publication of this information, contact Kathleen Boyce at Operations, Customs Unit, Import initiation notice and to make our Kathleen.Boyce @trade.gov or (202) Administration, International Trade decision regarding respondent selection 482–1346. Administration, U.S. Department of within 21 days of publication of this Dated: September 23, 2011. Commerce, 14th Street and Constitution Federal Register notice. The Andrew McGilvray, Avenue, NW., Washington, DC 20230, Department invites comments regarding the CBP data and respondent selection Executive Secretary. telephone: (202) 482–4735. SUPPLEMENTARY INFORMATION: within five days of placement of the [FR Doc. 2011–25316 Filed 9–30–11; 8:45 am] CBP data on the record of the applicable BILLING CODE;P Background review. The Department has received timely In the event the Department decides it is necessary to limit individual DEPARTMENT OF COMMERCE requests, in accordance with 19 CFR 351.213(b), for administrative reviews of examination of respondents and Foreign-Trade Zones Board various antidumping and countervailing conduct respondent selection under duty orders and findings with August section 777A(c)(2) of the Act: [Docket 7–2009] anniversary dates. The Department also In general, the Department has found that determinations concerning whether Foreign-Trade Zone 57—Mecklenburg received timely requests to revoke in part the antidumping duty orders on particular companies should be County, NC; Termination of Review of ‘‘collapsed’’ (i.e., treated as a single Application for Subzone; FMS Certain Corrosion-Resistant Carbon Steel Flat Products from the Republic of entity for purposes of calculating Enterprises USA, Inc. (Para-Aramid UD antidumping duty rates) require a Shield); Lincolnton, NC Korea for one exporter, on Light-Walled Rectangular Pipe and Tube from Mexico substantial amount of detailed Notice is hereby given of termination for one exporter, and on Certain Frozen information and analysis, which often of review of a subzone application Fish Fillets from the Socialist Republic require follow-up questions and submitted by the Charlotte Regional of Vietnam with respect to three analysis. Accordingly, the Department Partnership, grantee of FTZ 57, exporters. will not conduct collapsing analyses at requesting special-purpose subzone All deadlines for the submission of the respondent selection phase of this status with manufacturing authority for various types of information, review and will not collapse companies para-aramid UD shield at the certifications, or comments or actions by at the respondent selection phase unless manufacturing facility of FMS the Department discussed below refer to there has been a determination to Enterprises USA, Inc., located in the number of calendar days from the collapse certain companies in a Lincolnton, North Carolina. The applicable starting time. previous segment of this antidumping application was filed on February 12, proceeding (i.e., investigation, 2009 (74 FR 8904, 2/27/2009). Notice of No Sales administrative review, new shipper The termination is the result of If a producer or exporter named in review or changed circumstances changed circumstances, and the case this notice of initiation had no exports, review). For any company subject to this has been closed without prejudice. sales, or entries during the period of review, if the Department determined,

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or continued to treat, that company as is the Department’s policy to assign all of the proceeding 1 should timely file a collapsed with others, the Department exporters of merchandise subject to an Separate Rate Application to will assume that such companies administrative review in an NME demonstrate eligibility for a separate continue to operate in the same manner country this single rate unless an rate in this proceeding. In addition, and will collapse them for respondent exporter can demonstrate that it is companies that received a separate rate selection purposes. Otherwise, the sufficiently independent so as to be in a completed segment of the Department will not collapse companies entitled to a separate rate. proceeding that have subsequently for purposes of respondent selection. To establish whether a firm is made changes, including, but not Parties are requested to (a) Identify sufficiently independent from limited to, changes to corporate which companies subject to review government control of its export structure, acquisitions of new previously were collapsed, and (b) activities to be entitled to a separate companies or facilities, or changes to provide a citation to the proceeding in rate, the Department analyzes each their official company name,2 should which they were collapsed. Further, if entity exporting the subject timely file a Separate Rate Application companies are requested to complete merchandise under a test arising from to demonstrate eligibility for a separate the Quantity and Value Questionnaire the Final Determination of Sales at Less rate in this proceeding. The Separate for purposes of respondent selection, in Than Fair Value: Sparklers From the Rate Status Application will be general each company must report People’s Republic of China, 56 FR 20588 available on the Department’s Web site volume and value data separately for (May 6, 1991), as amplified by Final at http://www.trade.gov/ia on the date of itself. Parties should not include data Determination of Sales at Less Than publication of this Federal Register for any other party, even if they believe Fair Value: Silicon Carbide From the notice. In responding to the Separate they should be treated as a single entity People’s Republic of China, 59 FR 22585 Rate Status Application, refer to the with that other party. If a company was (May 2, 1994). In accordance with the instructions contained in the collapsed with another company or separate-rates criteria, the Department application. Separate Rate Status companies in the most recently assigns separate rates to companies in Applications are due to the Department completed segment of this proceeding NME cases only if respondents can no later than 60 calendar days of where the Department considered demonstrate the absence of both de jure publication of this Federal Register collapsing that entity, complete quantity and de facto government control over notice. The deadline and requirement and value data for that collapsed entity export activities. for submitting a Separate Rate Status must be submitted. All firms listed below that wish to Application applies equally to NME- Deadline for Withdrawal of Request for qualify for separate-rate status in the owned firms, wholly foreign-owned Administrative Review administrative reviews involving NME firms, and foreign sellers that purchase countries must complete, as Pursuant to 19 CFR 351.213(d)(1), a and export subject merchandise to the appropriate, either a separate-rate party that has requested a review may United States. application or certification, as described withdraw that request within 90 days of below. For these administrative reviews, For exporters and producers who the date of publication of the notice of in order to demonstrate separate-rate submit a separate-rate status application initiation of the requested review. The eligibility, the Department requires or certification and subsequently are regulation provides that the Department entities for whom a review was selected as mandatory respondents, may extend this time if it is reasonable these exporters and producers will no to do so. In order to provide parties requested, that were assigned a separate rate in the most recent segment of this longer be eligible for separate rate status additional certainty with respect to unless they respond to all parts of the when the Department will exercise its proceeding in which they participated, to certify that they continue to meet the questionnaire as mandatory discretion to extend this 90-day respondents. deadline, interested parties are advised criteria for obtaining a separate rate. The that, with regard to reviews requested Separate Rate Certification form will be Initiation of Reviews: on the basis of anniversary months on available on the Department’s Web site In accordance with 19 CFR or after August 2011, the Department at http://www.trade.gov/ia on the date of 351.221(c)(1)(i), we are initiating does not intend to extend the 90-day publication of this Federal Register administrative reviews of the following deadline unless the requestor notice. In responding to the antidumping and countervailing duty demonstrates that an extraordinary certification, please follow the orders and findings. We intend to issue circumstance has prevented it from ‘‘Instructions for Filing the the final results of these reviews not submitting a timely withdrawal request. Certification’’ in the Separate Rate later than August 31, 2012. Determinations by the Department to Certification. Separate Rate Certifications are due to the Department extend the 90-day deadline will be 1 Such entities include entities that have not made on a case-by-case basis. no later than 60 calendar days after participated in the proceeding, entities that were publication of this Federal Register preliminarily granted a separate rate in any Separate Rates notice. The deadline and requirement currently incomplete segment of the proceeding for submitting a Certification applies (e.g., an ongoing administrative review, new In proceedings involving non-market shipper review, etc.) and entities that lost their economy (‘‘NME’’) countries, the equally to NME-owned firms, wholly separate rate in the most recently complete segment Department begins with a rebuttable foreign-owned firms, and foreign sellers of the proceeding in which they participated. presumption that all companies within who purchase and export subject 2 Only changes to the official company name, merchandise to the United States. rather than trade names, need to be addressed via the country are subject to government a Separate Rate Application. Information regarding control and, thus, should be assigned a Entities that currently do not have a new trade names may be submitted via a Separate single antidumping duty deposit rate. It separate rate from a completed segment Rate Certification.

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Period to be reviewed

Antidumping Duty Proceedings Italy: Certain Pasta,3 A–475–818 ...... 7/1/10–6/30/11 Industria Alimentare Colavita, S.p.A. Japan: Tin Mill Products, A–588–854 ...... 8/1/10–7/31/11 JFE Steel Corporation Kawasaki Steel Corporation Nippon Steel Corporation NKK Corporation Toyo Kohan Co., Ltd. Mexico: Light-Walled Rectangular Pipe and Tube, A–201–836 ...... 8/1/10–7/31/11 Maquilacero S.A. de C.V. Regiomontana de Perfiles y Tubos S.A. de C.V. Republic of Korea: Corrosion-Resistant Carbon Steel Flat Products, A–580–816 ...... 8/1/10–7/31/11 Dongbu Steel Co., Ltd. Dongkuk Industries Co., Ltd. Haewon MSC Co., Ltd. Hyundai HYSCO LG Hausys, Ltd. LG Chem, Ltd. Pohang Iron and Steel Co., Ltd./Pohang Coated Steel Co., Ltd. Union Steel Manufacturing Co., Ltd. Romania: Certain Small Diameter Carbon and Alloy Seamless Standard, Line and Pressure Pipe, A–485–805 ...... 8/1/10–7/31/11 ArcelorMittal Tubular Products Roman S.A. Socialist Republic of Vietnam: Certain Frozen Fish Fillets,4 A–552–801 ...... 8/1/10–7/31/11 An Giang Agriculture and Foods Import-Export Joint Stock Company An Giang Fisheries Import and Export Joint Stock Company An Phu Seafood Corporation (also known as ASeafood) Anvifish Joint Stock Company Anvifish Co., Ltd. Asia Commerce Fisheries Joint Stock Company (also known as Anvifish JSC) Bien Dong Seafood Co., Ltd. Binh An Seafood Joint Stock Company Cadovimex II Seafood Import-Export and Processing Joint Stock Company (Cadovimex II) Cantho Import-Export Seafood Joint Stock Company (CASEAMEX) CUU Long Fish Joint Stock Company (aka CL-Fish) DOCIFISH Corporation East Sea Seafoods Limited Liability Company (formerly known as East Sea Seafoods Joint Venture Co., Ltd.) East Sea Seafoods Joint Venture Co., Ltd. East Sea Seafoods LLC GODACO Seafood Joint Stock Company Hiep Thanh Seafood Joint Stock Company Hung Vuong Seafood Joint Stock Company International Development & Investment Corporation (also known as IDI) Nam Viet Company Limited (aka NAVICO) Nam Viet Corporation NTSF Seafoods Joint Stock Company (also known as NTSF) QVD Food Company, Ltd. QVD Dong Thap Food Co., Ltd. Saigon-Mekong Fishery Co., Ltd. (SAMEFICO) Southern Fishery Industries Company, Ltd. (also known as South Vina) Thien Ma Seafood Co., Ltd. (also known as THIMACO) Thuan An Production Trading & Services Co., Ltd. (also known as TAFISHCO) Thuan Hung Co., Ltd. (also known as THUFICO) Vinh Hoan Corporation Vinh Hoan Company, Ltd. Vinh Quang Fisheries Corporation Thailand: Polyethylene Retail Carrier Bags, A–549–821 ...... 8/1/10–7/31/11 Apple Film Company, Ltd. First Pack Co. Ltd. Hi-Pack Company, Ltd. K International Packaging Co., Ltd. Landblue (Thailand) Co., Ltd. Multibax Public Co., Ltd. Praise Home Industry, Co. Ltd. Siam Flexible Industries Co., Ltd. Sombatchai Plastic Industry, Ltd. Thai Jirun Co., Ltd. Trinity Pac Co. Ltd. T.S.T. Plaspack Co., Ltd. U. Yong Industry Co., Ltd. The People’s Republic of China: Certain Steel Nails,5 A–570–909 ...... 8/1/10–7/31/11 ABF Freight System, Inc. Agritech Products Ltd.

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Period to be reviewed

Aihua Holding Group Co., Ltd. Aironware (Shanghai) Co., Ltd. Anping County Anning Wire Mesh Co. Anping Fuhua Wire Mesh Making Co. APM Global Logistics O/B Hasbro Toy Beijing Daruixing Global Trading Co., Ltd. Beijing Daruixing Nail Products Co., Ltd. Beijing Hong Sheng Metal Products Co., Ltd. Beijing Hongsheng Metal Products Co., Ltd. Beijing Jinheuang Co., Ltd. Beijing Kang Jie Kong Cargo Agent Beijing KJK Intl Cargo Agent Co., Ltd. Beijing Long Time Rich Tech Develop Beijing Tri-Metal Co., Ltd. Beijing Yonghongsheng Metal Products Co., Ltd. Besco Machinery Industry (Zhejiang) Co., Ltd. Brighten International, Inc. Cana (Tianjin) Hardware Ind., Co., Ltd. Century Shenzhen Xiamen Branch Certified Products International Inc. Changzhou MC I/E Co., Ltd. Changzhou Quyuan Machinery Co., Ltd. Changzhou Refine Flag & Crafts Co., Ltd. Chao Jinqiao Welding Material Co., Ltd. Chaohu Bridge Nail Industry Co., Ltd. Chaohu Jinqiao Welding Material Co. Chewink Corp. Chiieh Yung Metal Ind. Corp. China Container Line (Shanghai) Ltd. China Silk Trading & Logistics Co., Ltd. China Staple Enterprise (Tianjin) Co., Ltd. Chongqing Hybest Nailery Co., Ltd. Chongqing Hybest Tools Group Co., Ltd. Cintee Steel Products Co., Ltd. Cyber Express Corporation CYM (Nanjing) Ningquan Nail Manufacture Co., Ltd. (a.k.a. CYM (Nanjing) Nail Manufacture Co., Ltd.) Dagang Zhitong Metal Products Co., Ltd. Damco Shenzhen Daxing Niantan Industrial Delix International Co., Ltd. Dezhou Hualude Hardware Products Co., Ltd. Dingzhou Derunda Material and Trade Co., Ltd. Dingzhou Ruili Nail Production Co., Ltd. Dong’e Fuqiang Metal Products Co., Ltd. Dongguan Five Stone Machinery Products Trading Co., Ltd. ECO System Corporation Elite International Logistics Co. Elite Master International Ltd. England Rich Group (China) Ltd. Entech Manufacturing (Shenzhen) Ltd. Expeditors China Tianjin Branch Faithful Engineering Products Co., Ltd. Fedex International Freight Forward Agency Services (Shanghai) Co., Ltd. Feiyin Co., Ltd. Fension International Trade Co., Ltd. Foreign Economic Relations & Trade Fujiansmartness Imp. & Exp. Co., Ltd. Fuzhou Builddirect Ltd. Goal Well Stone Co., Ltd. Gold Union Group Ltd. Goldever International Logistics Co. Goldmax United Ltd. Grace News Inc. Guangdong Foreign Trade Import & Export Corporation Guangzhou Qiwei Imports and Exports Co., Ltd. Guoxin Group Wang Shun I/E Co., Ltd. GWP Industries (Tianjin) Co., Ltd. Haierce Industry Co., Ltd. Haixing Hongda Hardware Production Co., Ltd. Haixing Linhai Hardware Products Factory Haiyan Fefine Import and Export Co. Handuk Industrial Co., Ltd. Hangzhou Kelong Electrical Appliance & Tools Co. Ltd.

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Period to be reviewed

Hangzhou New Line Co., Ltd. Hangzhou Zhongding Imp. & Exp. Co., Ltd. Hebei Cangzhou New Century Foreign Trade Co., Ltd. Hebei Development Metals Co., Ltd. Hebei Jinsidun (JSD) Co., Ltd. Hebei Machinery Import and Export Co., Ltd. Hebei Minmetals Co., Ltd. Hebei My Foreign Trade Co., Ltd. Hebei Super Star Pneumatic Nails Co., Ltd. Henan Pengu Hardware Manufacturing Co., Ltd. Hengshui Mingyao Hardware & Mesh Products Co., Ltd. Heretops (Hong Kong) International Ltd. Hilti (China) Limited HK Villatao Sourcing Co., Ltd. Hong Kong Hailiang Metal Trading Ltd. Hong Kong Yu Xi Co., Ltd. Huadu Jin Chuan Manufactory Co., Ltd. Huanghua Honly Industry Corp. Huanghua Huarong Hardware Products Co., Ltd. Huanghua Jinhai Hardware Products Co., Ltd. Huanghua Jinhai Metal Products Co., Ltd. Huanghua Shenghua Hardware Manufactory Factory Huanghua Xinda Nail Production Co., Ltd. Huanghua Xionghua Hardware Products Co., Ltd. Huanghua Yufutai Hardware Products Co., Ltd. Hubei Boshilong Technology Co., Ltd. Huiyuan Int’l Commerce Exhibition Co., Ltd. Jiashan Superpower Tools Co., Ltd. Jiaxing Yaoliang Import & Export Co., Ltd. Jinding Metal Products Ltd. Jinhua Kaixin Imp & Exp Ltd. Jining Huarong Hardware Products Co., Ltd. Jisco Corporation Joto Enterprise Co., Ltd. Karuis Custom Metal Parts Mfg. Ltd. Kasy Logistics (Tianjin) Co., Ltd. K.E. Kingstone Koram Panagene Co., Ltd. Kuehne & Nagel Ltd. Kum Kang Trading Co., Ltd. Kyung Dong Corp. Le Group Industries Corp. Ltd. Leang Wey Int. Business Co., Ltd. Liang’s Industrial Corp. Lijiang Liantai Trading Co., Ltd. Linhai Chicheng Arts & Crafts Co., Ltd. Lins Corp. Linyi Flying Arrow Imp & Exp Co., Ltd. Maanshan Cintee Steel Products Co., Ltd. Maanshan Leader Metal Products Co., Ltd. Maanshan Longer Nail Product Co., Ltd. Manufacutersinchina (HK) Company Ltd. Marsh Trading Ltd. Master International Co., Ltd. Mingguang Abundant Hardware Products Co., Ltd. Montana (Taiwan) Int’l Co., Ltd. Nanjing Dayu Pneumatic Gun Nails Co., Ltd. Nanjing Yuechang Hardware Co., Ltd. Nantong Corporation for Internation Ningbo Bolun Electric Co., Ltd. Ningbo Dollar King Industrial Co., Ltd. Ningbo Endless Energy Electronic Co., Ltd. Ningbo Fension International Trade Center Ningbo Fortune Garden Tools and Equipment Inc. Ningbo Haixin Railroad Material Co. Ningbo Huamao Imp & Exp. Co., Ltd. Ningbo Hyderon Hardware Co., Ltd. Ningbo JF Tools Industrial Co., Ltd. Ningbo KCN Electric Co., Ltd. Ningbo Meizhi Tools Co., Ltd. Ningbo Ordam Import & Export Co., Ltd. OEC Logistics (Qingdao) Co. Ltd. Omega Products International

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Period to be reviewed

OOCL Logistics O B OF Winston Marketing Group Orisun Electronics HK Co., Ltd. Pacole International Ltd. Panagene Inc. Pavilion Investment Ltd. Perfect Seller Co., Ltd. Prominence Cargo Service, Inc. PT Enterprise Inc. Qianshan Huafeng Trading Co., Ltd. Qidong Liang Chyuan Metal Industry Co., Ltd. Qingdao Bestworld Industry Trading Qingdao D&L Group Ltd. Qingdao Denarius Manufacture Co. Limited Qingdao Golden Sunshine ELE–EAQ Co., Ltd. Qingdao International Fastening Systems Inc. Qingdao Jisco Co., Ltd. Qingdao Koram Steel Co., Ltd. Qingdao Lutai Industrial Products Manufacturing Co., Ltd. Qingdao Meijia Metal Products Co. Qingdao Rohuida International Trading Co., Ltd. Qingdao Sino-Sun International Trading Company Limited Qingdao Super United Metals & Wood Prods. Co. Ltd. Qingdao Tiger Hardware Co., Ltd. Qingfu Metal Craft Manufacturing Ltd. Qinghai Wutong (Group) Industry Co. Qingyuan County Hongyi Hardware Products Factory Qingyun Hongyi Hardware Factory Qinhuangdao Kaizheng Industry and Trade Co. Ltd. Q–Yield Outdoor Great Ltd. Region International Co., Ltd. Richard Hung Ent. Co. Ltd. River Display Ltd. Rizhao Changxing Nail-Making Co., Ltd. Rizhao Handuk Fasteners Co., Ltd. Rizhao Qingdong Electric Appliance Co., Ltd. Romp (Tianjin) Hardware Co., Ltd. Saikelong Electric Appliances (Suzhou) Co., Ltd. Se Jung (China) Shipping Co., Ltd. SDC International Australia Pty., Ltd. Senco Products, Inc. Senco-Xingya Metal Products (Taicang) Co., Ltd. Shandex Co., Ltd. Shandex Industrial Inc. Shandong Dinglong Import & Export Co., Ltd. Shandong Minmetals Co., Ltd. Shandong Oriental Cherry Hardware Group Co., Ltd. Shandong Oriental Cherry Hardware Import and Export Co., Ltd. Shanghai Chengkai Hardware Product Co., Ltd. Shanghai Colour Nail Co., Ltd. Shanghai Curvet Hardware Products Co., Ltd. Shanghai Ding Ying Printing & Dyeing CLO Shanghai GBR Group International Co. Shanghai Holiday Import & Export Co., Ltd. Shanghai Jade Shuttle Hardware Tools Co., Ltd. Shanghai Jian Jie International TRA Shanghai March Import & Export Company Ltd. Shanghai Mizhu Imp & Exp Corporation Shanghai Nanhui Jinjun Hardware Factory Shanghai Pioneer Speakers Co., Ltd. Shanghai Pudong Int’l Transporation Booking Dep’t Shanghai Seti Enterprise International Co., Ltd. Shanghai Shengxiang Hardware Co. Shanghai Suyu Railway Fastener Co. Shanghai Tengyu Hardware Tools Co., Ltd. Shanghai Tengyu Hardware Products Co., Ltd. Shanghai Tymex International Trade Co., Ltd. Shanghai Yueda Nails Industry Co., Ltd. Shanghai Yuet Commercial Consulting Co., Ltd. Shanxi Hairui Trade Co., Ltd. Shanxi Pioneer Hardware Industrial Co., Ltd. Shanxi Tianli Enterprise Co., Ltd. Shanxi Tianli Industries Co., Ltd. Shanxi Yuci Broad Wire Products Co., Ltd.

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Period to be reviewed

Shanxi Yuci Wire Material Factory Shaoguang International Trade Co. Shaoxing Chengye Metal Producting Co., Ltd. Shenyang Yulin International Shenzhen Changxinghongye Imp. Shenzhen Erisson Technology Co., Ltd. Shenzhen Meiyuda Trade Co., Ltd. Shenzhen Pacific-Net Logistics Inc. Shenzhen Shangqi Imports-Exports TR Shijiazhuang Anao Imp & Export Co. Ltd. Shijiazhuang Glory Way Trading Co. Shijiazhuang Fangyu Import & Export Corp. Shijiazhuang Fitex Trading Co., Ltd. Shijiazhuang Shuangjian Tools Co., Ltd. Shitong Int’l Holding Limited Shouguang Meiqing Nail Industry Co., Ltd. Sinochem Tianjin Imp & Exp Shenzhen Corp. Sirius Global Logistics Co., Ltd. S-mart (Tianjin) Technology Development Co., Ltd. Sunfield Enterprise Corporation Sunlife Enterprises (Yangjiang) Ltd. Suntec Industries Co., Ltd. Sunworld International Logistics Superior International Australia Pty Ltd. Suzhou Guoxin Group Wangshun I/E Co. Imp. Exp. Co., Ltd. Suzhou Xingya Nail Co., Ltd. Suzhou Yaotian Metal Products Co., Ltd. Stanley Black & Decker, Inc. The Stanley Works (Langfang) Fastening Systems Co., Ltd. Stanley Fastening Systems LP Shandex Industrial Inc. Telex Hong Kong Industry Co., Ltd. The Everest Corp. Thermwell Products Tian Jin Sundy Co., Ltd. (a/k/a Tianjin Sunny Co., Ltd.) Tianjin Baisheng Metal Product Co., Ltd. Tianjin Bosai Hardware Tools Co., Ltd. Tianjin Certified Products Inc. Tianjin Chengyi International Trading Co., Ltd. Tianjin Chentai International Trading Co., Ltd. Tianjin City Dagang Area Jinding Metal Products Factory Tianjin City Daman Port Area Jinding Metal Products Factory Tianjin City Jinchi Metal Products Co., Ltd. Tianjin Dagang Dongfu Metallic Products Co., Ltd. Tianjin Dagang Hewang Nail Factory Tianjin Dagang Hewang Nails Manufacture Plant Tianjin Dagang Huasheng Nailery Co., Ltd. Tianjin Dagang Jingang Nail Factory Tianjin Dagang Jingang Nails Manufacture Plant Tianjin Dagang Linda Metallic Products Co., Ltd. Tianjin Dagang Longhua Metal Products Plant Tianjin Dagang Shenda Metal Products Co., Ltd. Tianjin Dagang Yate Nail Co., Ltd. Tianjin Dery Import and Export Co., Ltd. Tianjin Everwin Metal Products Co, Ltd. Tianjin Foreign Trade (Group) Textile & Garment Co., Ltd. Tianjin Hewang Nail Making Factory Tianjin Huachang Metal Products Co., Ltd. Tianjin Huapeng Metal Company Tianjin Huasheng Nails Production Co., Ltd. Tianjin Jetcom Manufacturing Co, Ltd. Tianjin Jieli Hengyuan Metallic Products Co., Ltd. Tianjin Jietong Hardware Products Co., Ltd. Tianjin Jietong Metal Products Co., Ltd. Tianjin Jin Gang Metal Products Co., Ltd. Tianjin Jinchi Metal Products Co., Ltd. Tianjin Jinghai County Hongli Industry & Business Co., Ltd. Tianjin Jinjin Pharmaceutical Factory Co., Ltd. Tianjin Jishili Hardware Co., Ltd. Tianjin JLHY Metal Products Co., Ltd. Tianjin Jurum Metal Products Co., Ltd. Tianjin Jurun Metal Products Co., Ltd. Tianjin Kunxin Hardware Co., Ltd.

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Period to be reviewed

Tianjin Kunxin Metal Products Co., Ltd. Tianjin Lianda Group Co., Ltd. Tianjin Linda Metal Company Tianjin Longxing (Group) Huanyu Imp. & Exp. Co., Ltd. Tianjin Master Fastener Co., Ltd. (a/k/a Master Fastener Co., Ltd.) Tianjin Mei Jia Hua Trade Co., Ltd. Tianjin Metals and Minerals Tianjin Port Free Trade Zone Xiangtong Intl. Industry & Trade Corp. Tianjin Products & Energy Resources Dev. Co., Ltd. Tianjin Qichuan Metal Products Co., Ltd. Tianjin Ruiji Metal Products Co., Ltd. Tianjin Senbohengtong International Tianjin Senmiao Import and Export Co., Ltd. Tianjin Shenyuan Steel Producting Group Co., Ltd. Tianjin Shishun Metal Product Co., Ltd. Tianjin Shishun Metallic Products Co., Ltd. Tianjin Universal Machinery Imp & Exp Corporation Tianjin Xiantong Fucheng Gun Nail Manufacture Co., Ltd. Tianjin Xiantong Juxiang Metal MFG Co., Ltd. Tianjin Xiantong Material & Trade Co., Ltd. Tianjin Xinyuansheng Metal Products Co., Ltd. Tianjin Yihao Metallic Products Co., Ltd. Tianjin Yongchang Metal Product Co., Ltd. Tianjin Yongxu Metal Products Co., Ltd. Tianjin Yongye Furniture Tianjin Yongyi Standard Parts Production Co., Ltd. Tianjin Zhong Jian Wanli Stone Co., Ltd. Tianjin Zhonglian Metals Ware Co., Ltd. Tianjin Zhongsheng Garment Co., Ltd. Tianwoo Logistics Developing Co., Ltd. Topocean Consolidation Service (CHA) Ltd. Tradex Group, Inc. Traser Mexicana, S.A. De C.V. Treasure Way International Dev. Ltd. True Value Company (HK) Ltd. Unicatch Industrial Co., Ltd. Unigain Trading Co., Ltd. Union Enterprise (Kunshan) Co., Ltd. (a.k.a. Union Enterprise Co., Ltd.) Vinin Industries Limited Wintime Import & Export Corporation Limited of Zhongshan Wenzhou KLF Medical Plastics Co., Lt. Wenzhou Ouxin Foreign Trade Co., Ltd. Wenzhou Yuwei Foreign Trade Co., Ltd. Winsmart International Shipping Ltd. O/B Zhaoqing Harvest Nails Co., Ltd. Worldwide Logistics Co., Ltd. (Tianjin Branch) Wuhan Xinxin Native Produce & Animal By-Products Mfg. Co. Ltd. Wuhu Sheng Zhi Industrial Co., Ltd. Wuhu Shijie Hardware Co., Ltd. Wuhu Xin Lan De Industrial Co., Ltd. Wuqiao County Huifeng Hardware Products Factory Wuqiao County Xinchuang Hardware Products Factory Wuqiao Huifeng Hardware Production Co., Ltd. Wuxi Baolin Nail Enterprises Wuxi Baolin Nail-Making Machinery Co., Ltd. Wuxi Chengye Metal Products Co., Ltd. Wuxi Colour Nail Co., Ltd. Wuxi Qiangye Metalwork Production Co., Ltd. Wuxi Jinde Assets Management Co., Ltd. Wuxi Moresky Developing Co., Ltd. Xiamen New Kunlun Trade Co., Ltd. Xi’an Metals & Minerals Import and Export Co., Ltd. Xi’an Steel XL Metal Works Co., Ltd. XM International, Inc. Xuzhou CIP International Group Co., Ltd. Yeswin Corporation Yitian Nanjing Hardware Co., Ltd. Yiwu Dongshun Toys Manufacture Yiwu Excellent Import & Export Co., Ltd. Yiwu Jiehang Import & Export Co., Ltd. Yiwu Qiaoli Import & Export Co., Ltd. Yiwu Richway Imp & Exp Co., Ltd. Yiwu Zhongai Toys Co., Ltd.

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Period to be reviewed

Yongcheng Foreign Trade Corp. Yu Chi Hardware Co., Ltd. Yue Sang Plastic Factory Yuhuan Yazheng Importing Zhangjiagang Lianfeng Metals Products Co., Ltd. Zhangjiagang Longxiang Packing Materials Co., Ltd. Zhaoqing Harvest Nails Co., Ltd. Zhejiang Gem-Chun Hardware Accessory Co., Ltd. Zhejiang Hungyan Xingzhou Industria Zhejiang Jinhua Nail Factory Zhejiang Minmetals Sanhe Imp & Exp Co. Zhejiang Qifeng Hardware Make Co., Ltd. Zhejiang Taizhou Eagle Machinery Co. Zhejiang Yiwu Huishun Import/Export Co., Ltd. Zhongshan Junlong Nail Manufactures Co., Ltd. ZJG Lianfeng Metals Product Ltd. The People’s Republic of China: Floor-Standing Metal-Top Ironing Tables,6 A–570–888 ...... 8/1/10–7/31/11 Foshan Shunde Yongjian Housewares & Hardware Co., Ltd. The People’s Republic of China: Polyethylene Retail Carrier Bags,7 A–570–886 ...... 8/1/10–7/31/11 Dongguan Nozawa Plastics Products Co., Ltd. and United Power Packaging, Ltd. (collectively Nozawa) Countervailing Duty Proceedings Republic of Korea: Corrosion-Resistant Carbon Steel Flat Products, C–580–818 ...... 1/1/10–12/31/10 Dongbu Steel Co., Ltd. Hyandai HYSCO Pohang Iron & Steel Co., Ltd./Pohang Coated Steel Co., Ltd. (POSCO) Suspension Agreements None.

During any administrative review between the first and second or third suspended investigation (after sunset covering all or part of a period falling and fourth anniversary of the review), the Secretary, if requested by a publication of an antidumping duty domestic interested party within 30 3 The company listed was inadvertently omitted order under 19 CFR 351.211 or a days of the date of publication of the from the initiation notice that published on August determination under 19 CFR notice of initiation of the review, will 26, 2011 (76 FR 53404). 351.218(f)(4) to continue an order or determine, consistent with FAG Italia v. 4 If one of the above named companies does not United States, 291 F.3d 806 (Fed Cir. qualify for a separate rate, all other exporters of 6 If the above named company does not qualify frozen fish fillets from the Socialist Republic of for a separate rate, all other exporters of Floor- 2002), as appropriate, whether Vietnam who have not qualified for a separate rate Standing Metal-Top Ironing Tables from the PRC antidumping duties have been absorbed are deemed to be covered by this review as part of who have not qualified for a separate rate are by an exporter or producer subject to the the single Vietnam entity of which the named deemed to be covered by this review as part of the review if the subject merchandise is exporters are a part. single PRC entity of which the named exporters are 5 If one of the above named companies does not a part. sold in the United States through an qualify for a separate rate, all other exporters of 7 If the above named company does not qualify importer that is affiliated with such Certain Steel Nails from the People’s Republic of for a separate rate, all other exporters of exporter or producer. The request must China (‘‘PRC’’) who have not qualified for a separate Polyethylene Retail Carrier Bags from the PRC who include the name(s) of the exporter or rate are deemed to be covered by this review as part have not qualified for a separate rate are deemed to of the single PRC entity of which the named be covered by this review as part of the single PRC producer for which the inquiry is exporters are a part. entity of which the named exporters are a part. requested.

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For the first administrative review of DEPARTMENT OF COMMERCE However, if it is not practicable to any order, there will be no assessment complete the review within these time of antidumping or countervailing duties International Trade Administration periods, section 751(a)(3)(A) of the Act on entries of subject merchandise [A–570–924] allows the Department to extend the entered, or withdrawn from warehouse, time limit for the preliminary results to for consumption during the relevant Polyethylene Terephthalate Film, a maximum of 365 days after the last provisional-measures ‘‘gap’’ period, of Sheet, and Strip From the People’s day of the anniversary month. the order, if such a gap period is Republic of China: Extension of Extension of Time Limit for Preliminary applicable to the period of review. Preliminary Results of Antidumping Results of Review Duty Administrative Review Interested parties must submit The Department has determined that applications for disclosure under AGENCY: Import Administration, it is not practicable to complete the administrative protective orders in International Trade Administration, instant administrative review within the accordance with 19 CFR 351.305. On Department of Commerce. original time limits established by January 22, 2008, the Department SUMMARY: The Department of Commerce section 751(a)(3)(A) of the Act because published Antidumping and (‘‘the Department’’) is extending the we require additional time to evaluate Countervailing Duty Proceedings: time limits for the preliminary results of the respondents’ reporting methodology Documents Submission Procedures; the administrative review of for the consumption of direct raw APO Procedures, 73 FR 3634 (January polyethylene terephthalate film, sheet, material factors of production. 22, 2008). Those procedures apply to and strip (‘‘PET film’’) from the People’s Therefore, in accordance with section administrative reviews included in this Republic of China (‘‘PRC’’). This review 751(a)(3)(A) of the Act, the Department notice of initiation. Parties wishing to covers the period November 1, 2009, is extending the time period for participate in any of these through October 31, 2010. completing the preliminary results of administrative reviews should ensure DATES: Effective Date: October 3, 2011. the instant administrative review by an additional 30 days. The new deadline is that the meet the requirements of these FOR FURTHER INFORMATION CONTACT: October 31, 2011.1 The deadline for the procedures (e.g., the filing of separate Thomas Martin or Jonathan Hill, AD/ final results of this review continues to letters of appearance as discussed at 19 CVD Operations, Office 4, Import be 120 days after the publication of the CFR 351.103(d)). Administration, International Trade preliminary results. Administration, U.S. Department of Any party submitting factual We are issuing and publishing this Commerce, 14th Street and Constitution information in an antidumping duty or notice in accordance with sections Avenue, NW., Washington, DC 20230; countervailing duty proceeding must 751(a)(3)(A) and 777(i) of the Act. telephone: (202) 482–3936 or (202) 482– certify to the accuracy and completeness Dated: September 27, 2011. of that information. See section 782(b) 3518, respectively. Christian Marsh, of the Act. Parties are hereby reminded Background Deputy Assistant Secretary for Antidumping that revised certification requirements On December 28, 2010, the and Countervailing Duty Operations. are in effect for company/government Department published in the Federal [FR Doc. 2011–25417 Filed 9–30–11; 8:45 am] officials as well as their representatives Register a notice of initiation of the BILLING CODE 3510–DS–P in all segments of any antidumping duty second administrative review of the or countervailing duty proceedings antidumping duty order on PET film initiated on or after March 14, 2011. See from the PRC. See Initiation of DEPARTMENT OF COMMERCE Certification of Factual Information to Antidumping and Countervailing Duty Import Administration During Administrative Reviews and Requests International Trade Administration Antidumping and Countervailing Duty for Revocation in Part, 75 FR 81565 Proceedings: Interim Final Rule, 76 FR (December 28, 2010). On July 18, 2011, Antidumping or Countervailing Duty 7491 (February 10, 2011) (‘‘Interim Final the Department extended the time Order, Finding, or Suspended Investigation; Opportunity To Request Rule’’), amending 19 CFR 351.303(g)(1) period for completing the preliminary Administrative Review and (2). The formats for the revised results of the review by 60 days. See certifications are provided at the end of Polyethylene Terephthalate Film, Sheet, AGENCY: Import Administration, the Interim Final Rule. The Department and Strip From the People’s Republic of International Trade Administration, intends to reject factual submissions in China: Extension of Preliminary Results Department of Commerce. any proceeding segments initiated on or of Antidumping Duty Administrative FOR FURTHER INFORMATION CONTACT: after March 14, 2011 if the submitting Review, 76 FR 42113 (July 18, 2011). Brenda E. Waters, Office of AD/CVD party does not comply with the revised The preliminary results of this review Operations, Customs Unit, Import certification requirements. are currently due no later than October Administration, International Trade 3, 2011. These initiations and this notice are Administration, U.S. Department of in accordance with section 751(a) of the Statutory Time Limits 1 The initial 60 day extension in this Tariff Act of 1930, as amended In antidumping duty administrative administrative review fell on October 1, 2011 which (19 U.S.C. 1675(a)) and 19 CFR reviews, section 751(a)(3)(A) of the is a Saturday. Per the Department’s practice, the 351.221(c)(1)(i). Tariff Act of 1930, as amended (‘‘the Department set the deadline for completion of the preliminary results to be the next business day, Dated: September 26, 2011. Act’’), requires the Department to issue October 3, 2011. See Notice of Clarification: its preliminary results within 245 days Christian Marsh, Application of ‘‘Next Business Day’’ Rule for after the last day of the anniversary Administrative Determination Deadlines Pursuant Deputy Assistant Secretary for Antidumping month of an order for which a review to the Tariff Act of 1930, as Amended, 70 FR 24533 and Countervailing Duty Operations. is requested and to issue its final results (May 10, 2005). The Department will extend the [FR Doc. 2011–25432 Filed 9–30–11; 8:45 am] deadline for this second extension of the within 120 days after the date on which preliminary results of review based upon the BILLING CODE 3510–DS–P the preliminary results are published. original deadline date of October 1, 2011.

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Commerce, 14th Street and Constitution data and respondent selection within they should be treated as a single entity Avenue, NW., Washington, DC 20230, five days of placement of the CBP data with that other party. If a company was telephone: (202) 482–4735. on the record of the review. collapsed with another company or In the event the Department decides companies in the most recently Background it is necessary to limit individual completed segment of this proceeding Each year during the anniversary examination of respondents and where the Department considered month of the publication of an conduct respondent selection under collapsing that entity, complete quantity antidumping or countervailing duty section 777A(c)(2) of the Act: and value data for that collapsed entity order, finding, or suspended In general, the Department has found must be submitted. investigation, an interested party, as that determinations concerning whether defined in section 771(9) of the Tariff particular companies should be Deadline for Withdrawal of Request for Act of 1930, as amended (‘‘the Act’’), ‘‘collapsed’’ (i.e., treated as a single Administrative Review may request, in accordance with 19 CFR entity for purposes of calculating Pursuant to 19 CFR 351.213(d)(1), a 351.213 of the Department of Commerce antidumping duty rates) require a party that has requested a review may (‘‘the Department’’) regulations, that the substantial amount of detailed withdraw that request within 90 days of Department conduct an administrative information and analysis, which often the date of publication of the notice of review of that antidumping or require follow-up questions and initiation of the requested review. The countervailing duty order, finding, or analysis. Accordingly, the Department regulation provides that the Department suspended investigation. will not conduct collapsing analyses at may extend this time if it is reasonable All deadlines for the submission of the respondent selection phase of this to do so. In order to provide parties review and will not collapse companies comments or actions by the Department additional certainty with respect to at the respondent selection phase unless discussed below refer to the number of when the Department will exercise its there has been a determination to calendar days from the applicable discretion to extend this 90-day collapse certain companies in a starting date. deadline, interested parties are advised previous segment of this antidumping that, with regard to reviews requested Respondent Selection proceeding (i.e., investigation, on the basis of anniversary months on In the event the Department limits the administrative review, new shipper or after October 2011, the Department number of respondents for individual review or changed circumstances does not intend to extend the 90-day examination for administrative reviews review). For any company subject to this deadline unless the requestor initiated pursuant to requests made for review, if the Department determined, the orders identified below, the or continued to treat, that company as demonstrates that an extraordinary Department intends to select collapsed with others, the Department circumstance has prevented it from respondents based on U.S. Customs and will assume that such companies submitting a timely withdrawal request. Border Protection (‘‘CBP’’) data for U.S. continue to operate in the same manner Determinations by the Department to imports during the period of review. We and will collapse them for respondent extend the 90-day deadline will be intend to release the CBP data under selection purposes. Otherwise, the made on a case-by-case basis. Administrative Protective Order Department will not collapse companies The Department is providing this (‘‘APO’’) to all parties having an APO for purposes of respondent selection. notice on its website, as well as in its within five days of publication of the Parties are requested to (a) Identify ‘‘Opportunity to Request Administrative initiation notice and to make our which companies subject to review Review’’ notices, so that interested decision regarding respondent selection previously were collapsed, and (b) parties will be aware of the manner in within 21 days of publication of the provide a citation to the proceeding in which the Department intends to initiation Federal Register notice. which they were collapsed. Further, if exercise its discretion in the future. Therefore, we encourage all parties companies are requested to complete Opportunity to Request a Review: Not interested in commenting on respondent the Quantity and Value Questionnaire later than the last day of October 2011,1 selection to submit their APO for purposes of respondent selection, in interested parties may request applications on the date of publication general each company must report administrative review of the following of the initiation notice, or as soon volume and value data separately for orders, findings, or suspended thereafter as possible. The Department itself. Parties should not include data investigations, with anniversary dates in invites comments regarding the CBP for any other party, even if they believe October for the following periods:

Period of review

Antidumping Duty Proceedings Australia: Electrolytic Manganese Dioxide A–602–806 ...... 10/1/10–9/30/11 Brazil: Carbon and Certain Alloy Steel Wire Rod A–351–832 ...... 10/1/10–9/30/11 Indonesia: Carbon and Certain Alloy Steel Wire Rod A–560–815 ...... 10/1/10–9/30/11 Italy: Pressure Sensitive Plastic Tape A–475–059 ...... 10/1/10–9/30/11 Mexico: Carbon and Certain Alloy Steel Wire Rod A–201–830 ...... 10/1/10–9/30/11 Moldova: Carbon and Certain Alloy Steel Wire Rod A–841–805 ...... 10/1/10–9/30/11 Republic of Korea: Polyvinyl Alcohol A–580–850 ...... 10/1/10–9/30/11 The People’s Republic of China: Barium Carbonate A–570–880 ...... 10/1/10–9/30/11 Barium Chloride A–570–007 ...... 10/1/10–9/30/11 Electrolytic Manganese Dioxide A–570–919 ...... 10/1/10–9/30/11 Helical Spring Lock Washers A–570–822 ...... 10/1/10–9/30/11

1 Or the next business day, if the deadline falls on a weekend, federal holiday or any other day when the Department is closed.

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Period of review

Polyvinyl Alcohol A–570–879 ...... 10/1/10–9/30/11 Steel Wire Garment Hangers A–570–918 ...... 10/1/10–9/30/11 Trinidad and Tobago: Carbon and Certain Alloy Steel Wire Rod A–274–804 ...... 10/1/10–9/30/11 Ukraine: Carbon and Certain Alloy Steel Wire Rod A–823–812 ...... 10/1/10–9/30/11 Countervailing Duty Proceedings Brazil: Carbon and Certain Alloy Steel Wire Rod C–351–833 ...... 1/1/10–12/31/10 Iran: Roasted In-Shell Pistachios C–507–601 ...... 1/1/10–12/31/10 Suspension Agreements Russia: Uranium A–821–802 ...... 10/1/10–9/30/11

In accordance with 19 CFR has clarified its practice with respect to on entries of subject merchandise 351.213(b), an interested party as the collection of final antidumping entered, or withdrawn from warehouse, defined by section 771(9) of the Act may duties on imports of merchandise where for consumption during the relevant request in writing that the Secretary intermediate firms are involved. The provisional-measures ‘‘gap’’ period, of conduct an administrative review. For public should be aware of this the order, if such a gap period is both antidumping and countervailing clarification in determining whether to applicable to the period of review. duty reviews, the interested party must request an administrative review of This notice is not required by statute specify the individual producers or merchandise subject to antidumping but is published as a service to the exporters covered by an antidumping findings and orders. See also the Import international trading community. finding or an antidumping or Administration Web site at http:// Dated: September 26, 2011. countervailing duty order or suspension ia.ita.doc.gov. agreement for which it is requesting a All requests must be filed Christian Marsh, review. In addition, a domestic electronically in Import Deputy Assistant Secretary for Antidumping interested party or an interested party Administration’s Antidumping and and Countervailing Duty Operations. described in section 771(9)(B) of the Act Countervailing Duty Centralized [FR Doc. 2011–25422 Filed 9–30–11; 8:45 am] must state why it desires the Secretary Electronic Service System (‘‘IA BILLING CODE 3510–DS–P to review those particular producers or ACCESS’’) on the IA ACCESS Web site exporters.2 If the interested party at http://iaaccess.trade.gov. See intends for the Secretary to review sales Antidumping and Countervailing Duty DEPARTMENT OF COMMERCE Proceedings: Electronic Filing of merchandise by an exporter (or a International Trade Administration producer if that producer also exports Procedures; Administrative Protective Order Procedures, 76 FR 39263 (July 6, merchandise from other suppliers) Antidumping or Countervailing Duty 2011). Further, in accordance with which were produced in more than one Order, Finding, or Suspended 19 CFR 351.303(f)(l)(i), a copy of each country of origin and each country of Investigation; Advance Notification of request must be served on the petitioner origin is subject to a separate order, then Sunset Reviews the interested party must state and each exporter or producer specified specifically, on an order-by-order basis, in the request. AGENCY: Import Administration, The Department will publish in the which exporter(s) the request is International Trade Administration, Federal Register a notice of ‘‘Initiation intended to cover. Department of Commerce. of Administrative Review of Please note that, for any party the Antidumping or Countervailing Duty Background Department was unable to locate in Order, Finding, or Suspended prior segments, the Department will not Investigation’’ for requests received by Every five years, pursuant to section accept a request for an administrative the last day of October 2011. If the 751(c) of the Tariff Act of 1930, as review of that party absent new Department does not receive, by the last amended (‘‘the Act’’), the Department of information as to the party’s location. day of October 2011, a request for Commerce (‘‘the Department’’) and the Moreover, if the interested party who review of entries covered by an order, International Trade Commission files a request for review is unable to finding, or suspended investigation automatically initiate and conduct a locate the producer or exporter for listed in this notice and for the period review to determine whether revocation which it requested the review, the identified above, the Department will of a countervailing or antidumping duty interested party must provide an instruct the CBP to assess antidumping order or termination of an investigation explanation of the attempts it made to or countervailing duties on those entries suspended under section 704 or 734 of locate the producer or exporter at the at a rate equal to the cash deposit of (or the Act would be likely to lead to same time it files its request for review, bond for) estimated antidumping or continuation or recurrence of dumping in order for the Secretary to determine countervailing duties required on those or a countervailable subsidy (as the case if the interested party’s attempts were entries at the time of entry, or may be) and of material injury. reasonable, pursuant to 19 CFR withdrawal from warehouse, for Upcoming Sunset Reviews for 351.303(f)(3)(ii). consumption and to continue to collect November 2011 As explained in Antidumping and the cash deposit previously ordered. Countervailing Duty Proceedings: For the first administrative review of The following Sunset Reviews are Assessment of Antidumping Duties, 68 any order, there will be no assessment scheduled for initiation in November FR 23954 (May 6, 2003), the Department of antidumping or countervailing duties 2011 and will appear in that month’s

2 If the review request involves a non-market exporters of subject merchandise from the non- of the single entity of which the named firms are economy and the parties subject to the review market economy country who do not have a a part. request do not qualify for separate rates, all other separate rate will be covered by the review as part

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Notice of Initiation of Five-Year Sunset Reviews.

Antidumping duty proceedings Department contact

Silicon Metal from the People’s Republic of China (A–570–806) (3rd Review) ...... Julia Hancock, (202) 482–1394. Stainless Steel Butt-Weld Pipe Fittings from Italy (A–475–828) (2nd Review) ...... Dana Mermelstein, (202) 482–1391. Stainless Steel Butt-Weld Pipe Fittings from Malaysia (A–557–809) (2nd Review) ...... Dana Mermelstein, (202) 482–1391 Stainless Steel Butt-Weld Pipe Fittings from the Philippines (A–565–801) (2nd Review) ...... Dana Mermelstein, (202) 482–1391.

Countervailing Duty Proceedings DEPARTMENT OF COMMERCE need for clarification regarding certain information observed in data obtained No Sunset Review of countervailing International Trade Administration by the Department from U.S. Customs duty orders is scheduled from initiation [A–552–801] and Border Protection (‘‘CBP’’). The in November 2011. Department found no issue with the Suspended Investigations Certain Frozen Fish Fillets From the response given by An Phu. An Phu, Socialist Republic of Vietnam: GODACO, and DOCIFISH have certified No Sunset Review of suspended Initiation of New Shipper Reviews that they are both the producers and investigations is scheduled from exporters of the subject merchandise initiation in November 2011. AGENCY: Import Administration, upon which the requests for the new The Department’s procedures for the International Trade Administration, shipper review are based. Department of Commerce. conduct of Sunset Reviews are set forth Initiation of New Shipper Reviews in 19 CFR 351.218. Guidance on DATES: Effective Date: October 3, 2011. methodological or analytical issues SUMMARY: The Department of Commerce Pursuant to section 751(a)(2)(B)(i)(I) of relevant to the Department’s conduct of (‘‘Department’’) has determined that the the Tariff Act of 1930, as amended Sunset Reviews is set forth in the three requests for new shipper reviews (‘‘Act’’), and 19 CFR 351.214(b)(2), An Department’s Policy Bulletin 98.3— of the antidumping duty order on Phu, GODACO, and DOCIFISH certified Policies Regarding the Conduct of Five- certain frozen fish fillets from the that they did not export certain frozen year (‘‘Sunset’’) Reviews of Socialist Republic of Vietnam, received fish fillets to the United States during Antidumping and Countervailing Duty between August 3, 2011 and August 16, the period of investigation (‘‘POI’’). Orders; Policy Bulletin, 63 FR 18871 2011 meet the statutory and regulatory Pursuant to section 751(a)(2)(B)(i)(II) of (April 16, 1998) . The Notice of requirements for initiation. The period the Act and 19 CFR 351.214(b)(2)(iii)(A), Initiation of Five-Year (‘‘Sunset’’) of review (‘‘POR’’) of these new shipper An Phu, GODACO, and DOCIFISH Reviews provides further information reviews is August 1, 2010–July 31, 2011. certified that, since the initiation of the regarding what is required of all parties FOR FURTHER INFORMATION CONTACT: less-than-fair-value investigation, they to participate in Sunset Reviews. Jamie Blair-Walker, AD/CVD have never been affiliated with any Pursuant to 19 CFR 351.103(c), the Operations, Office 9, Import exporter or producer who exported Department will maintain and make Administration, International Trade certain frozen fish fillets to the United available a service list for these Administration, U.S. Department of States during the POI, including those proceedings. To facilitate the timely Commerce, 14th Street and Constitution not individually examined during the preparation of the service list(s), it is Avenue, NW., Washington, DC 20230; less-than-fair-value investigation. As requested that those seeking recognition telephone: (202) 482–2615. required by 19 CFR 351.214(b)(2)(iii)(B), An Phu, GODACO, and DOCIFISH have as interested parties to a proceeding SUPPLEMENTARY INFORMATION: contact the Department in writing also certified that their export activities within 10 days of the publication of the Background are not controlled by the central government of Vietnam. Notice of Initiation. The antidumping duty order on Please note that if the Department certain frozen fish fillets from the In addition to the certifications receives a Notice of Intent to Participate Socialist Republic of Vietnam was described above, An Phu, GODACO, from a member of the domestic industry published in the Federal Register on and DOCIFISH submitted within 15 days of the date of initiation, August 12, 2003. See Notice of documentation establishing the the review will continue. Thereafter, Antidumping Duty Order: Certain following: (1) The date on which the any interested party wishing to Frozen Fish Fillets From the Socialist company first shipped certain frozen participate in the Sunset Review must Republic of Vietnam, 68 FR 47909 fish fillets for export to the United provide substantive comments in (August 12, 2003). On August 3, 4, and States and the date on which the certain response to the notice of initiation no 16, 2011, respectively, we received a frozen fish fillets first entered, or later than 30 days after the date of timely request for a new shipper review withdrawn from warehouse, for initiation. from An Phu Seafood Corporation (‘‘An consumption; (2) the volume of the company’s first shipment; and (3) the This notice is not required by statute Phu’’), GODACO Seafood Joint Stock Company (‘‘GODACO’’), and DOCIFISH date of the company’s first sales to an but is published as a service to the unaffiliated customer in the United international trading community. Corporation (‘‘DOCIFISH’’). All three new shipper requests were filed in States. Dated: September 20, 2011. accordance with 19 CFR 351.214(c) and Pursuant to section 751(a)(2)(B) of the Christian Marsh, 351.214(d)(1). On August 25, 2011, An Act and 19 CFR 351.214(d)(1), we are Deputy Assistant Secretary for Antidumping Phu responded to the Department’s initiating these new shipper reviews for and Countervailing Duty Operations. August 19, 2011, supplemental shipments of certain frozen fish fillets [FR Doc. 2011–25420 Filed 9–30–11; 8:45 am] questionnaire. The questionnaire and from Vietnam produced and exported BILLING CODE 3510–DS–P corresponding response concerned the by An Phu, GODACO, and DOCIFISH.

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We intend to issue preliminary results ACTION: Notice of Indirect Cost Rates for the recovery of indirect cost rates of this review no later than 180 days the Damage Assessment, Remediation, subject to its requirements. from the date of initiation, and final and Restoration Program for Fiscal The DARRP’s Indirect Cost Effort results of these reviews no later than Years 2009 and 2010. 270 days from the date of initiation. See In December 1998, the DARRP hired section 751(a)(2)(B)(iv) of the Act. SUMMARY: The National Oceanic and the public accounting firm Rubino & We will instruct CBP to allow, at the Atmospheric Administration’s McGeehin, Chartered (R&M) to: evaluate option of the importer, the posting, until (NOAA’s) Damage Assessment, the DARRP cost accounting system and the completion of the review, of a bond Remediation, and Restoration Program allocation practices; recommend the or security in lieu of a cash deposit for (DARRP) is announcing new indirect appropriate indirect cost allocation each entry of the subject merchandise cost rates on the recovery of indirect methodology; and determine the indirect cost rates for the three from An Phu, GODACO, or DOCIFISH costs for its component organizations organizations that comprise the DARRP. in accordance with section involved in natural resource damage A Federal Register notice on R&M’s 751(a)(2)(B)(iii) of the Act and 19 CFR assessment and restoration activities for effort, their assessment of the DARRP’s 351.214(e). Because An Phu, GODACO, fiscal years (FY) 2009 and 2010. The cost accounting system and practice, and DOCIFISH certified that they have indirect cost rates for these fiscal years and their determination regarding the both produced and exported the subject and dates of implementation are most appropriate indirect cost merchandise, the sales of which are the provided in this notice. More methodology and rates for FYs 1993 bases for these new shipper review information on these rates and the through 1999 was published on requests, we will apply the bonding DARRP policy can be found at the December 7, 2000 (65 FR 76611). The privilege to these three companies only DARRP web site at www.darrp.noaa.gov. notice and report by R&M can also be for subject merchandise which the found on the DARRP Web site at respondents both produced and FOR FURTHER INFORMATION CONTACT: For http://www.darrp.noaa.gov. exported. further information, contact LaTonya R&M continued its assessment of This initiation notice serves as Burgess at 301–713–4248, ext. 211, by DARRP’s indirect cost rate system and notification to the three companies that fax at 301–713–4389, or e-mail at structure for FYs 2000 and 2001. A upon initiation of this new shipper [email protected]. second federal notice specifying the review, the Department will require An DARRP indirect rates for FYs 2000 and SUPPLEMENTARY INFORMATION: Phu, GODACO, and DOCIFISH to The 2001 was published on December 2, submit on an ongoing basis complete mission of the DARRP is to restore 2002 (67 FR 71537). transaction information concerning any natural resource injuries caused by In October 2002, DARRP hired the sales of subject merchandise to the releases of hazardous substances or oil accounting firm of Cotton and Company United States that were made under the Comprehensive LLP (Cotton) to review and certify subsequent to the period of review in Environmental Response, DARRP costs incurred on cases for order to assist in its analysis of the bona Compensation, and Liability Act purposes of cost recovery and to fides of the sales of the three companies. (CERCLA) (42 U.S.C. 9601 et seq.), the develop indirect rates for FY 2002 and Oil Pollution Act of 1990 (OPA) (33 Interested parties requiring access to subsequent years. As in the prior years, U.S.C. 2701 et seq.), and support proprietary information in these new Cotton concluded that the cost restoration of physical injuries to shipper reviews should submit accounting system and allocation National Marine Sanctuary resources applications for disclosure under practices of the DARRP component under the National Marine Sanctuaries administrative protective order in organizations are consistent with Act (NMSA) (16 U.S.C. 1431 et seq.). accordance with 19 CFR 351.305 and Federal accounting requirements. The DARRP consists of three component 351.306. This initiation and notice are Consistent with R&M’s previous organizations: the Office of Response in accordance with section 751(a)(2)(B) analyses, Cotton also determined that and Restoration (ORR) within the of the Act and 19 CFR 351.214 and the most appropriate indirect allocation National Ocean Service; the Restoration 351.221(c)(1)(i). method continues to be the Direct Labor Center within the National Marine Cost Base for all three DARRP Dated: September 26, 2011. Fisheries Service; and the Office of the component organizations. The Direct Gary Taverman, General Counsel for Natural Resources Labor Cost Base is computed by Acting Deputy Assistant Secretary for (GCNR). The DARRP conducts Natural allocating total indirect cost over the Antidumping and Countervailing Duty Resource Damage Assessments (NRDAs) sum of direct labor dollars, plus the Operations. as a basis for recovering damages from application of NOAA’s leave surcharge [FR Doc. 2011–25426 Filed 9–30–11; 8:45 am] responsible parties, and uses the funds and benefits rates to direct labor. Direct BILLING CODE 3510–DS–P recovered to restore injured natural labor costs for contractors from I.M. resources. Systems Group (IMSG) were included in Consistent with Federal accounting the direct labor base because Cotton DEPARTMENT OF COMMERCE requirements, the DARRP is required to determined that these costs have the National Oceanic and Atmospheric account for and report the full costs of same relationship to the indirect cost Administration its programs and activities. Further, the pool as NOAA direct labor costs. IMSG DARRP is authorized by law to recover provided on-site support to the DARRP Indirect Cost Rates for the Damage reasonable costs of damage assessment in the areas of injury assessment, Assessment, Remediation, and and restoration activities under natural resource economics, restoration Restoration Program for Fiscal Years CERCLA, OPA, and the NMSA. Within planning and implementation, and 2009 and 2010 the constraints of these legal provisions policy analysis. IMSG continues to and their regulatory applications, the provide on-site support to the DARRP. AGENCY: National Oceanic and DARRP has the discretion to develop Starting in FY 2010, contractors from Atmospheric Administration (NOAA), indirect cost rates for its component Genwest provide on-site support for cost Commerce. organizations and formulate policies on documentation. A third federal notice

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specifying the DARRP indirect rates for using the revised rates in this policy for Sayers, USFWS at 703–358–2171 or by FY 2002 was published on October 6, these fiscal years. Where a responsible fax at 703–358–1735. 2003 (68 FR 57672), a fourth notice for party has agreed to pay costs using SUPPLEMENTARY INFORMATION: the FY 2003 indirect cost rates appeared previous year’s indirect rates, but has Section on May 20, 2005 (70 FR 29280), and a not yet made the payment because the 7(a)(2) of the Endangered Species Act of fifth notice for the FY 2004 indirect cost settlement documents are not finalized, 1973, as amended (16 U.S.C. 1531 et rates was published on March 16, 2006 the costs will not be recalculated. seq.; hereafter ESA) requires federal (71 FR 13356). The notice for the FY The DARRP indirect cost rate policies agencies, in consultation with, and with 2005 indirect cost rates was published and procedures published in the Federal the assistance of, the Secretaries of on February 9, 2007 (72 FR 6221). The Register on December 7, 2000 (65 FR Commerce and Interior, to insure that notice for the FY 2006 rates was 76611), on December 2, 2002 (67 FR any action they authorize, fund, or carry published on June 3, 2008 (73 FR 71537), October 6, 2003 (68 FR 57672), out is not likely to jeopardize the 31679). Finally, the notice for the FY May 20, 2005 (70 FR 29280), March 16, continued existence of endangered or 2007 and FY 2008 rates was published 2006 (71 FR 13356), February 9, 2007 threatened species or destroy or on November 16, 2009 (74 FR 58948). (72 FR 6221), June 3, 2008 (73 FR adversely modify designated critical Cotton’s reports on these indirect rates 31679), and November 16, 2009 (74 FR habitat. The principles, practices, and can also be found on the DARRP Web 58948) remain in effect except as protocols for section 7 consultations are site at http://www.darrp.noaa.gov. updated by this notice. identified in the ESA, and regulations Cotton reaffirmed that the Direct Dated: September 15, 2011. promulgated in 1986 for implementing Labor Cost Base is the most appropriate David Westerholm, section 7 (50 CFR, part 402), further indirect allocation method for the Director, Office of Response and Restoration. expound the procedural and substantive development of the FY 2009 and FY [FR Doc. 2011–25373 Filed 9–30–11; 8:45 am] requirements for consultation. The 2010 indirect cost rates. BILLING CODE 3510–JE–P counterpart regulations provide an The DARRP’s Indirect Cost Rates and optional alternative to the standard Policies section 7 consultation process, and were DEPARTMENT OF COMMERCE The DARRP will apply the indirect developed specifically for agency cost rates for FY 2009 and FY 2010 as projects that authorize, fund, or carry National Oceanic and Atmospheric out actions that support the National recommended by Cotton for each of the Administration DARRP component organizations as Fire Plan. Upon entering into an ACA provided in the following table: RIN 0648–XA725 with the Services, action agencies may make ‘‘not likely to adversely affect’’ FY2007 FY2008 Endangered and Threatened Species; determinations for National Fire Plan DARRP Compo- Indirect Indirect Counterpart Regulations projects without consulting with the nent organization rate rate (percent) (percent) AGENCY: National Marine Fisheries Services. The March 4, 2004, ACAs Service (NMFS), National Oceanic and included specific requirements for Office of Response Atmospheric Administration (NOAA), reporting and conducting periodic and Restoration Commerce; Fish and Wildlife Service program monitoring of the use of the (ORR) ...... 197.44 125.88 (USFWS), Interior. counterpart regulations. Restoration Center ACTION: Notice of availability. (RC) ...... 142.07 90.42 NMFS and USFWS reviewed the General Counsel SUMMARY: The U.S. Forest Service and projects carried out during years two for Natural Re- Bureau of Land Management (together, through four by the action agencies. sources (GCNR) 83.93 49.49 action agencies) in coordination with Based on results of the review of these the USFWS and NMFS, have agreed to projects, the relatively limited use of the These rates are based on the Direct revoke the March 4, 2004, National Fire counterpart regulations since their Labor Cost Base allocation methodology. Plan Counterpart Regulation Alternative inception, the action agencies’ cursory The FY 2009 rates will be applied to Consultation Agreements (ACAs). assessment of the year five through all damage assessment and restoration seven projects, and the action agencies’ case costs incurred between October 1, DATES: This is effective on October 1, request to revoke the ACAs; NMFS and 2008 and September 30, 2009. The FY 2011. USFWS agree to terminate the ACAs 2010 rates will be applied to all damage ADDRESSES: The final decision of with the action agencies. assessment and restoration case costs revocation is available on the internet at incurred between October 1, 2009 and http://www.nmfs.noaa.gov/pr/laws/esa/ Dated: September 20, 2011. September 30, 2010. DARRP will use policies.htm#consultation and http:// Angela Somma, the FY 2010 indirect cost rates for future www.fws.gov/endangered/esa-library/ Chief, Endangered Species Division, Office fiscal years, beginning with FY 2011, index.html. Action Agency documents, of Protected Resources, National Marine until subsequent year-specific rates can as well as supporting documentation Fisheries Service. be developed. used in the preparation of this decision, [FR Doc. 2011–25425 Filed 9–30–11; 8:45 am] For cases that have settled and for will be available for public inspection, BILLING CODE 3510–22–P cost claims paid prior to the effective by appointment, during normal business date of the fiscal year in question, the hours at: NMFS Office of Protected DARRP will not re-open any resolved Resources, 1315 East-West Highway, matters for the purpose of applying the Room 13535, Silver Spring, MD 20910 revised rates in this policy for these or USFWS, 4401 N. Fairfax Drive, fiscal years. For cases not settled and Arlington, VA 22203. cost claims not paid prior to the FOR FURTHER INFORMATION CONTACT: effective date of the fiscal year in Angela Somma, NMFS, at 301–427– question, costs will be recalculated 8474 or by fax at 301–713–0376; or Rick

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DEPARTMENT OF COMMERCE LEOY Award will take place at the [email protected] or visit December 12–16, 2011 Council meeting the NOAA HSRP Web site at http:// National Oceanic and Atmospheric in Raleigh, NC. nauticalcharts.noaa.gov/ocs/hsrp/ Administration Special Accommodations hsrp.htm. RIN 0648–XA744 The LEAP conference call is SUPPLEMENTARY INFORMATION: The Fisheries of the South Atlantic; South physically accessible to people with meeting will be open to the public and Atlantic Fishery Management Council; disabilities. Requests for auxiliary aids public comment periods (on-site) will Public Meetings should be directed to the Council office be scheduled at various times (see ADDRESSES) 3 days prior to the throughout the meeting. These comment AGENCY: National Marine Fisheries conference call. periods will be included in the final Service (NMFS), National Oceanic and Note: The specific end time for each agenda published before verbal Atmospheric Administration (NOAA), conference call is subject to change. presentation will be limited to a total Commerce. time of five (5) minutes. Comments will ACTION: Notice of conference call Dated: September 28, 2011. be recorded. Written comments should meetings of the South Atlantic Fishery Tracey L. Thompson, be submitted to Management Council and the LEAP. Acting Director, Office of Sustainable [email protected] by Fisheries, National Marine Fisheries Service. SUMMARY: The Law Enforcement October 21, 2011. Written comments [FR Doc. 2011–25418 Filed 9–30–11; 8:45 am] Advisory Panel (LEAP) will meet via received after Oct 21, 2011, will be conference call on October 20, 2011 to BILLING CODE 3510–22–P distributed to the HSRP, but may not be select nominees for a Law Enforcement reviewed until the meeting. Office of the Year (LEOY) Award. The DEPARTMENT OF COMMERCE Approximately 30 seats will be available Council will meet via conference call on for the public, on a first-come, first- November 2, 2011 to review the LEAP’s National Oceanic and Atmospheric served basis. recommendations and select a deserving Administration Special Accommodations: HSRP law enforcement officer to receive the public meetings are physically SUPPLEMENTARY INFORMATION Hydrographic Services Review Panel award. See . accessible to people with disabilities. Meeting DATES: The LEAP conference call will Requests for sign language take place on October 20, 2011 from 10 AGENCY: National Ocean Service, interpretation or other auxiliary aids a.m. to 11 a.m. The Council conference National Oceanic and Atmospheric should be directed to Kathy Watson, call will take place on November 2, Administration (NOAA), Department of HSRP Program Coordinator, National 2011 from 10 a.m. to 11 a.m. See Commerce. Ocean Service (NOS), Office of Coast SUPPLEMENTARY INFORMATION. ACTION: Notice of open meeting. Survey, NOAA (N/CS), 1315 East West ADDRESSES: The meetings will take Highway, Silver Spring, Maryland place via conference call. For more SUMMARY: The Hydrographic Services 20910; Telephone: 301–713–2770 ext. information contact Kim Iverson (see Review Panel (HSRP) is a Federal 158, or E-mail: [email protected] FOR FURTHER INFORMATION CONTACT). Advisory Committee established to by October 17, 2011. FOR FURTHER INFORMATION CONTACT: Kim advise the Under Secretary of Iverson, Public Information Officer, Commerce for Oceans and Atmosphere Matters to be Considered: South Atlantic Fishery Management on matters related to the responsibilities Presentations from local and regional Council, 4055 Faber Place Drive, Suite and authorities set forth in section 303 key stakeholders to the HSRP Panel will 201, N. Charleston, SC, 29405; of the Hydrographic Services address issues such as: (1) Expanded telephone: (843) 571–4366 or toll free Improvement Act of 1998, its requirements for navigation data in (866) SAFMC–10; fax: (843) 769–4520; amendments, and such other Virginia; (2) the Port Access Route email: [email protected]. appropriate matters that the Under Study and shipping routes for the Port SUPPLEMENTARY INFORMATION: Members Secretary refers to the Panel for review of Virginia; (3) offshore wind energy of the Law Enforcement Advisory Panel and advice. development, and impacts to marine will meet via conference call from 10 Date and Time: The public meeting transportation; (4) planning for sea level a.m. until 11 a.m. on October 20, 2011. will be held on October 26–27, 2011. rise; and (5) the roles of the Federal The LEAP will review nominations for October 26th from 8:30 a.m. to 5:30 government, the ocean shipping a Law Enforcement of the Year (LEOY) p.m.; October 27th from 8:30 a.m. to industry, and other traditional maritime Award. The distinction is awarded by 4:30 p.m. users in coastal and marine spatial the Council to recognize an exceptional Location: Half Moone Cruise and planning. The HSRP will also engage in individual who has demonstrated a Celebration Center, One Waterside a strategic planning session to develop distinct pattern of service to enforcing Drive, Norfolk, Virginia 23510, tel: (757) and produce an outline of priority fisheries regulations in the South 664–1074. Refer to the HSRP Web site issues for the Panel to focus on over the Atlantic region. Nominees have been listed below for the most current next two to three years. provided to the LEAP for their review. meeting agenda. Times and agenda During the conference call, the LEAP topics are subject to change. Dated: September 23, 2011. will select and rank three nominees to FOR FURTHER INFORMATION CONTACT: John E. Lowell, Jr., recommend to the Council. Kathy Watson, HSRP Program Director, Office of Coast Survey, National Members of the Council will meet via Coordinator, National Ocean Service Ocean Service, National Oceanic and conference call from 10 a.m. to 11 a.m. (NOS), Office of Coast Survey, NOAA Atmospheric Administration. on November 2, 2011. The Council will (N/CS), 1315 East West Highway, Silver [FR Doc. 2011–25371 Filed 9–30–11; 8:45 am] review the three nominees provided by Spring, Maryland 20910; Telephone: BILLING CODE 3510–JE–P the LEAP and select a deserving officer 301–713–2770 ext. 158; Fax: 301–713– to receive the award. Presentation of the 4019; E-mail:

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DEPARTMENT OF COMMERCE workshops and webinars. The first Data assessments, NMFS will be making Workshop was held in Charleston, SC, stock status determinations in an National Oceanic and Atmospheric June 21–25, 2010 (May 4, 2010, 75 FR upcoming Federal Register notice for Administration 23676), and participants evaluated all four separate stocks: (1) Dusky Sharks, RIN 0648–XA662 available data and selected appropriate (2) sandbar sharks, (3) Gulf of Mexico sources for providing information on blacknose sharks, and (4) Atlantic Stock Assessment Reports for Dusky, life history characteristics, catch blacknose sharks. NMFS is also Sandbar, and Blacknose Sharks in the statistics, discard estimates, length and considering amending the 2006 U.S. Atlantic and Gulf of Mexico age composition, and fishery dependent Consolidated Highly Migratory Species and fishery independent measures of Fishery Management Plan, as necessary. AGENCY: National Marine Fisheries stock abundance. Authority: 16 U.S.C. 971 et seq., and 1801 Service (NMFS), National Oceanic and The Assessment Process was et seq. Atmospheric Administration (NOAA), conducted via a series of webinars Commerce. between September 2010 and January Dated: September 28, 2011. Steven Thur, ACTION: Notice of availability. 2011 (August 26, 2010, 75 FR 52510; October 12, 2010, 75 FR 62506; Acting Director, Office of Sustainable SUMMARY: NMFS announces the November 17, 2010, 75 FR 70216; Fisheries, National Marine Fisheries Service. availability of final stock assessment December 16, 2010, 75 FR 78679). [FR Doc. 2011–25429 Filed 9–30–11; 8:45 am] reports for dusky, sandbar, and During the assessment process, the BILLING CODE 3510–22–P blacknose sharks in the Atlantic and assessment models were developed and Gulf of Mexico. The reports summarize population parameters were estimated the consensus of an independent using the information provided from the DEPARTMENT OF DEFENSE Review Panel, describe methodologies Data Workshop. used to determine stock statuses, and The Review Workshop was the final Department of the Navy detail relevant working documents, workshop, in which a panel of Notice of Intent To Prepare a including copies of Data and independent experts met in Annapolis, Supplement to the Draft Environmental Assessment workshop reports. MD, April 18–22, 2011 (March 15, 2011, 76 FR 13985), and reviewed the data Impact Statement for the TRIDENT ADDRESSES: Electronic copies of the Support Facilities Explosives Handling stock assessments and all supporting and assessments developed during the Data Workshop and Assessment Wharf, Naval Base Kitsap at Bangor, documents may also be obtained on the Silverdale, Kitsap County, WA internet at: http://www.sefsc.noaa.gov/ Webinars. All workshops and webinars sedar/. A limited number of hard copies were open to the public. More AGENCY: Department of the Navy, DoD. are available. Requests for these hard information on the SEDAR process can ACTION: Notice. copies of the final stock assessment be found at http://www.sefsc.noaa.gov/ reports for dusky, sandbar, and sedar/. Additionally, the final stock SUMMARY: Pursuant to section 102 of the blacknose sharks should be sent to Peter assessment reports and all supporting National Environmental Policy Act of Cooper, Highly Migratory Species documents can be found at that Web site 1969, and the regulations implemented Management Division (F/SF1), National under the heading ‘‘SEDAR 21—HMS by the Council on Environmental Marine Fisheries Service (NMFS), 1315 Sandbar, Dusky, and Blacknose Sharks.’’ Quality (40 CFR parts 1500–1508), the East-West Highway, Silver Spring, MD Sandbar and dusky sharks were each Department of the Navy (DoN) announces its intent to prepare a 20910, or may be sent via facsimile (fax) assessed as one stock whereas, for the first time, blacknose sharks were Supplement to the Draft Environmental to (301) 713–1917 or phone (301) 427– assessed as two separate stocks: an Impact Statement (DEIS) for the 8503. Atlantic and Gulf of Mexico stock. The proposed second Explosives Handling FOR FURTHER INFORMATION CONTACT: For stock assessments provide information Wharf (EHW–2) at Naval Base Kitsap at information on the stock assessments, on the status of the stocks and project Bangor, Silverdale, WA. The contact Peter Cooper by phone at (301) their future abundance under a variety Supplement to the DEIS will focus on 427–8503 or by fax at (301) 713–1917. of catch levels in the U.S. Atlantic the methodology used to assess the SUPPLEMENTARY INFORMATION: The Ocean, Gulf of Mexico, and Caribbean potential for injurious impacts to the assessments for dusky, sandbar, and Sea. The 2010 assessments include marbled murrelet from impact pile blacknose sharks were conducted as updated catch estimates, new biological driving, the construction and operation part of the Southeast Data, Assessment, data, and a number of fishery- of new facilities and associated and Review (SEDAR) process to ensure independent and fishery-dependent infrastructure, and compensatory the best available data and techniques catch rate series for each species. mitigation options under consideration. were used. SEDAR is a cooperative The Review Panel for the Review Dates and Addresses: Written process initiated in 2002 to improve the Workshop of SEDAR 21 found that the comments must be submitted within 45 quality and reliability of fishery stock data and methods used were days of the Federal Register publication assessments in the South Atlantic, Gulf appropriate and the best available for date for the U.S. Environmental of Mexico, and U.S. Caribbean. The the dusky, sandbar, and Atlantic Protection Agency (EPA) Notice of SEDAR process emphasizes constituent blacknose shark assessments. However, Availability (NOA) of this Supplement and stakeholder participation in because the assessment model for the to the DEIS, and should be addressed to: assessment development, transparency Gulf of Mexico blacknose stock was Naval Facilities Engineering Command in the assessment process, and a unable to fit the apparent trends in some Northwest, 1101 Tautog Circle, rigorous and independent scientific of the abundance indices, and because Silverdale, WA 98315–1101, Attn: review of completed stock assessments. there was a fundamental lack of fit of Christine Stevenson, EHW–2 EIS Project SEDAR 21, which conducted the the model to some of the input data, the Manager. Written comments may also be stock assessments for dusky, sandbar, Review Panel did not accept the stock submitted online at http:// and blacknose sharks, was organized assessment for the Gulf of Mexico ehw.nbkeis.com during the comment around a series of face-to-face blacknose stock. Based on these period.

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FOR FURTHER INFORMATION CONTACT: the new underwater noise injury state, and local agencies, American Naval Facilities Engineering Command criterion of 202 dB SEL re: 1mPa2-sec Indian tribes, and interested persons are Northwest, 1101 Tautog Circle, cumulative of all impact hammer strikes encouraged to provide written Silverdale, WA 98315–1101, Attn: in a 24-hour period. comments. All written comments will Christine Stevenson, EHW–2 EIS Project The DEIS analyzed the impacts of become part of the public record and Manager, 360–396–0080; or http:// modifying or demolishing will be responded to in the Final EIS. ehw.nbkeis.com. approximately 20 existing facilities and/ Written comments must be postmarked or structures in proximity to the EHW– SUPPLEMENTARY INFORMATION: On May within 45 days of the Federal Register 15, 2009, the DoN provided notice in 2 to comply with Department of Defense publication date for the EPA’s NOA of the Federal Register (74 FR 22900) of its Explosives Safety Board and Naval this Supplement to the DEIS. Written intent to prepare an EIS for TRIDENT Ordnance Safety and Security Activity comments should be submitted to: requirements to protect buildings Support Facilities EHW–2, Naval Base Naval Facilities Engineering Command located in the vicinity of explosives Kitsap at Bangor, Silverdale, Kitsap Northwest, 1101 Tautog Circle, handling operations. Since release of the County, WA and to announce public Silverdale, WA 98315–1101, Attn: DEIS, the DoN has determined that four scoping meetings. The DoN held public Christine Stevenson, EHW–2 EIS Project new buildings and associated scoping meetings in Poulsbo, Port Manager. Written Comments may also infrastructure would be constructed to Ludlow, and Seattle, WA during June be submitted online at http:// replace the functions of five buildings to 2009. The DoN prepared and filed a ehw.nbkeis.com during the comment be demolished. This Supplement will DEIS with the EPA to evaluate the period. analyze the impacts from construction potential environmental effects of All public comments previously and operation of the four new buildings constructing and operating an EHW–2 at received during the March through May and associated infrastructure. Three 2011 DEIS public comment period are Naval Base Kitsap Bangor. A NOA was buildings would be constructed on a 2.6 published in the Federal Register by the still valid and will be considered and acre upland site located northwest of addressed in the Final EIS for this EPA on March 18, 2011 (76 FR 14968) Service Pier and 2.2 miles south of the for the DoN’s DEIS, announcing action. Previously submitted comments existing EHW. These buildings would need not be resubmitted. A NOA of the availability of the DEIS and house the functions of an commencing the 45 day public Supplement to the DEIS will be Administrative/Construction Field published by the EPA in the Federal comment period. The DoN extended the Office, an Inert Storage building, a public comment period to 60 days and Register. No decision will be made to Rigging Shop, and a Refit Support implement the proposed action until the published a notice of extension of the Facility and would include paved and comment period for the DEIS in the EIS process is completed and a Record fenced storage areas, associated roads, of Decision is signed by the DoN. Federal Register on May 3, 2011 (76 FR parking, and sidewalks. The fourth 24868). The EPA published a NOA building, a pure water facility, would be Dated: September 28, 2011. revision on May 13, 2011 (76 FR 28029) constructed along the Bangor waterfront J. M. Beal, announcing the comment period at the end of Delta Pier on a 0.5 acre site Lieutenant Commander, Office of the Judge extension. The DoN’s Notice of Public located approximately 1.0 miles south Advocate General, U.S. Navy, Federal Hearing for the DEIS was published in of the existing EHW. This facility would Register Liaison Officer. the Federal Register on March 21, 2011 house the function of the existing Pure [FR Doc. 2011–25421 Filed 9–30–11; 8:45 am] (76 FR 15302). Public hearings were Water Facility to be demolished and BILLING CODE 3810–FF–P held in Poulsbo, Chimacum, and would consist of a treatment building, Seattle, WA to receive oral and written an auxiliary water storage tank, liquid comments on the Draft EIS. nitrogen storage tank, sewage tank and DEPARTMENT OF ENERGY This Supplement to the DEIS will pump, loading aprons, parking areas, include analysis of new information that and new water lines between the facility Federal Energy Regulatory has become available since release of and Delta Pier. Commission the DEIS. The DEIS analysis of noise The DEIS presented compensatory impacts to the marbled murrelet, a mitigation the DoN is considering and Combined Notice of Filings #2 species listed as federally threatened identified the In Lieu Fee (ILF) Program Take notice that the Commission under the Endangered Species Act, was as the preferred compensatory received the following electric rate based on an underwater physical injury mitigation for the unavoidable impacts filings: m threshold of 180 dBpeak re: 1 Pa for any to aquatic resources from the proposed Docket Numbers: ER11–4595–000. single impact hammer strike. action as described in the Mitigation Applicants: Palmco Power OH, LLC. Concurrent with publication of the Action Plan in the DEIS. Since the Description: Palmco Power OH, LLC DEIS, the U.S. Fish and Wildlife Service public release of the DEIS, further submits tariff filing per 35.1: Palmco (USFWS) proposed an interim criterion development of the ILF Program has Power OH FERC Electric Tariff to be of 183 dB Sound Exposure Level (SEL) occurred. In addition to the preferred effective 9/22/2011. re: 1mPa2-sec. The USFWS and the DoN ILF compensatory mitigation strategy, Filed Date: 09/22/2011. collaborated to form the Marbled the DoN is also considering other Accession Number: 20110922–5030. Murrelet Science Panel to assist in compensatory mitigation alternatives. Comment Date: 5 p.m. Eastern Time development of a scientifically-based The DoN continues to review the on Thursday, October 13, 2011. injury criterion. The USFWS accepted feasibility, habitat values, and potential Docket Numbers: ER11–4596–000. the panel’s recommendation and benefits of all mitigation alternatives. Applicants: South Carolina Electric & notified the DoN on August 5, 2011 that This Supplement discusses Gas Company. the Endangered Species Act section 7 compensatory mitigation alternatives in Description: South Carolina Electric & consultation on EHW–2 would be based regard to Dabob Bay Conservation and Gas Company submits tariff filing per on this new criterion. This Supplement Washington State Parks Mitigation. 35.13(a)(2)(iii: Attachment C—Revision analyzes the impacts to the marbled The DoN is soliciting comments on for Clarification to be effective 9/22/ murrelet for all alternatives, based on the Supplement to the DEIS. Federal, 2011.

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Filed Date: 09/22/2011. Docket Numbers: ER11–4603–000. DEPARTMENT OF ENERGY Accession Number: 20110922–5032. Applicants: Monterey Consulting Federal Energy Regulatory Comment Date: 5 p.m. Eastern Time Associates, Inc. on Thursday, October 13, 2011. Commission Description: Monterey Consulting Docket Numbers: ER11–4597–000. Associates, Inc. submits tariff filing per Combined Notice of Filings #1 Applicants: KeyTex Energy, LLC. 35.1: Market Based Rates Re-file to be Description: KeyTex Energy, LLC effective 9/22/2011. Take notice that the Commission submits tariff filing per 35.1: KeyTex received the following electric rate Energy, LLC MBR Re-Filing to be Filed Date: 09/22/2011. filings: effective 9/22/2011. Accession Number: 20110922–5086. Docket Numbers: ER11–3616–001. Filed Date: 09/22/2011. Comment Date: 5 p.m. Eastern Time Applicants: California Independent Accession Number: 20110922–5034. on Thursday, October 13, 2011. System Operator Corporation. Comment Date: 5 p.m. Eastern Time Description: California Independent on Thursday, October 13, 2011. Docket Numbers: ER11–4604–000. System Operator Corporation submits Docket Numbers: ER11–4598–000. Applicants: Thicksten Grimm tariff filing per 35.17(b): 2011–09–21 Applicants: PJM Interconnection, Burgum, Inc. CAISO Deficiency Filing for RDRR Amendment to be effective 4/1/2012. LLC. Description: Thicksten Grimm Filed Date: 09/21/2011. Description: PJM Interconnection, Burgum, Inc. submits tariff filing per LLC submits tariff filing per Accession Number: 20110921–5105. 35.1: Market Based Rates Re-file to be Comment Date: 5 p.m. Eastern Time 35.13(a)(2)(iii: Queue No. W3–126; effective 9/22/2011. Original Service Agreement No. 3066 to on Wednesday, October 12, 2011. be effective 8/24/2011. Filed Date: 09/22/2011. Docket Numbers: ER11–3912–002. Filed Date: 09/22/2011. Accession Number: 20110922–5087. Applicants: Arizona Public Service Company. Accession Number: 20110922–5051. Comment Date: 5 p.m. Eastern Time Description: Arizona Public Service Comment Date: 5 p.m. Eastern Time on Thursday, October 13, 2011. on Thursday, October 13, 2011. Company submits tariff filing per 35: Docket Numbers: ER11–4599–000. Docket Numbers: ER11–4605–000. Compliance Filing, Service Agreement Applicants: PJM Interconnection, Applicants: Forest Investment Group, No. 311 to be effective 8/29/2011. LLC. LLC.. Filed Date: 09/21/2011. Description: PJM Interconnection, Accession Number: 20110921–5075. Description: Forest Investment Group, Comment Date: 5 p.m. Eastern Time LLC submits tariff filing per LLC submits tariff filing per 35.1: Forest 35.13(a)(2)(iii: Queue No. W3–032; on Wednesday, October 12, 2011. Investment Group Baseline Filing to be Docket Numbers: ER11–4103–001. Original Service Agreement No. 3062 to effective 9/22/2011. be effective 8/30/2011. Applicants: Arizona Public Service Filed Date: 09/22/2011. Filed Date: 09/22/2011. Company. Accession Number: 20110922–5053. Accession Number: 20110922–5089 Description: Arizona Public Service Company submits tariff filing per 35: Comment Date: 5 p.m. Eastern Time Comment Date: 5 p.m. Eastern Time on Thursday, October 13, 2011. Compliance Filing, Rate Schedule No. on Thursday, October 13, 2011. 253 to be effective 9/9/2011. Docket Numbers: ER11–4600–000. The filings are accessible in the Filed Date: 09/21/2011. Applicants: Moguai Energy LLC. Accession Number: 20110921–5074. Description: Moguai Energy LLC Commission’s eLibrary system by clicking on the links or querying the Comment Date: 5 p.m. Eastern Time submits tariff filing per 35.1: Baseline on Wednesday, October 12, 2011. 714 compliance to be effective 9/22/ docket number. Docket Numbers: ER11–4567–001. 2011. Any person desiring to intervene or Applicants: Pypha Energy LLC. Filed Date: 09/22/2011 protest in any of the above proceedings Description: Pypha Energy LLC Accession Number: 20110922–5055. must file in accordance with Rules 211 submits tariff filing per 35: Baseline Comment Date: 5 p.m. Eastern Time and 214 of the Commission’s MBR Tariff Filing to be effective 9/20/ on Thursday, October 13, 2011. Regulations (18 CFR 385.211 and 2011. Docket Numbers: ER11–4601–000. 385.214) on or before 5 p.m. Eastern Filed Date: 09/21/2011. Applicants: Avista Corporation. time on the specified comment date. Accession Number: 20110921–5099. Description: Avista Corporation Protests may be considered, but Comment Date: 5 p.m. Eastern Time submits tariff filing per 35.12: Avista intervention is necessary to become a on Wednesday, October 12, 2011. Corp Rate Schedule FERC No. 528 to be party to the proceeding. Docket Numbers: ER11–4582–000. effective 10/1/2011. eFiling is encouraged. More detailed Applicants: 511 Plaza Energy, LLC. Filed Date: 09/22/2011. information relating to filing Description: 511 Plaza Energy, LLC Accession Number: 20110922–5061. requirements, interventions, protests, submits tariff filing per 35.1: Baseline Comment Date: 5 p.m. Eastern Time service, and qualifying facilities filings Filing of Tariff to be effective 9/21/2011. on Thursday, October 13, 2011. can be found at: http://www.ferc.gov/ Filed Date: 09/21/2011. Docket Numbers: ER11–4602–000. docs-filing/efiling/filing-req.pdf. For Accession Number: 20110921–5039. Applicants: IDT Energy, Inc. other information, call (866) 208–3676 Comment Date: 5 p.m. Eastern Time Description: IDT Energy, Inc. submits (toll free). For TTY, call (202) 502–8659. on Wednesday, October 12, 2011. tariff filing per 35.1: Market-Based Rate Dated: September 22, 2011. Docket Numbers: ER11–4583–000. Tariff Baseline to be effective 9/22/2011. Applicants: PacifiCorp. Filed Date: 09/22/2011. Nathaniel J. Davis, Sr., Description: PacifiCorp submits tariff Accession Number: 20110922–5085. Deputy Secretary. filing per 35.13(a)(2)(iii: BPA AC Intertie Comment Date: 5 p.m. Eastern Time [FR Doc. 2011–25335 Filed 9–30–11; 8:45 am] Agreement 5th Revised to be effective on Thursday, October 13, 2011. BILLING CODE 6717–01–P 9/22/2011.

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Filed Date: 09/21/2011. Accession Number: 20110921–5100. Comment Date: 5 p.m. Eastern Time Accession Number: 20110921–5066. Comment Date: 5 p.m. Eastern Time on Wednesday, October 12, 2011. Comment Date: 5 p.m. Eastern Time on Wednesday, October 12, 2011. Docket Numbers: ES11–49–000. on Wednesday, October 12, 2011. Docket Numbers: ER11–4590–000. Applicants: Louisville Gas & Electric Docket Numbers: ER11–4584–000. Applicants: Westar Energy, Inc. Company. Applicants: Burgess Capital LLC. Description: Westar Energy, Inc. Description: Louisville Gas and Description: Burgess Capital LLC submits tariff filing per 35.13(a)(2)(iii: Electric Company’s Application under submits tariff filing per 35.1: Baseline Revisions to Schedule 3A, Balancing Section 204 of the Federal Power Act. 714 compliance to be effective 9/21/ Area Services Agreement to be effective Filed Date: 09/21/2011. 2011. 12/1/2011. Accession Number: 20110921–5132. Filed Date: 09/21/2011. Filed Date: 09/21/2011. Comment Date: 5 p.m. Eastern Time Accession Number: 20110921–5068. Accession Number: 20110921–5101. on Wednesday, October 12, 2011. Comment Date: 5 p.m. Eastern Time Comment Date: 5 p.m. Eastern Time The filings are accessible in the on Wednesday, October 12, 2011. on Wednesday, October 12, 2011. Commission’s eLibrary system by Docket Numbers: ER11–4585–000. Docket Numbers: ER11–4591–000. clicking on the links or querying the Applicants: New York Independent Applicants: Red Hills Wind Project, docket number. System Operator, Inc. LLC. Any person desiring to intervene or Description: New York Independent Description: Red Hills Wind Project, protest in any of the above proceedings System Operator, Inc. submits tariff LLC submits tariff filing per 35.1: Red must file in accordance with Rules 211 filing per 35: NYISO filing of tariff Hills Wind Project, LLC Baseline Tariff and 214 of the Commission’s revisions per NYISO PJM settlement to be effective 9/21/2011. Regulations (18 CFR 385.211 and agreement to be effective 9/16/2010. Filed Date: 09/21/2011. 385.214) on or before 5 p.m. Eastern Filed Date: 09/21/2011. Accession Number: 20110921–5102. time on the specified comment date. Accession Number: 20110921–5084. Comment Date: 5 p.m. Eastern Time Protests may be considered, but Comment Date: 5 p.m. Eastern Time on Wednesday, October 12, 2011. intervention is necessary to become a on Wednesday, October 12, 2011. Docket Numbers: ER11–4592–000. party to the proceeding. Docket Numbers: ER11–4586–000. Applicants: Tatanka Wind Power, eFiling is encouraged. More detailed Applicants: Florida Power & Light LLC. information relating to filing Company. Description: Tatanka Wind Power, requirements, interventions, protests, Description: Florida Power & Light LLC submits tariff filing per 35.1: service, and qualifying facilities filings Company submits tariff filing per Tatanka Wind Power, LLC Baseline can be found at: http://www.ferc.gov/ 35.13(a)(2)(iii: FPL and FMPA Third Tariff Filing to be effective 9/21/2011. docs-filing/efiling/filing-req.pdf. For Revised Service Agreement No. 80 to be Filed Date: 09/21/2011. other information, call (866) 208–3676 effective 10/1/2011. Accession Number: 20110921–5103. (toll free). For TTY, call (202) 502–8659. Filed Date: 09/21/2011. Comment Date: 5 p.m. Eastern Time Dated: September 22, 2011. Accession Number: 20110921–5096. on Wednesday, October 12, 2011. Nathaniel J. Davis, Sr., Comment Date: 5 p.m. Eastern Time Docket Numbers: ER11–4593–000. Deputy Secretary. on Wednesday, October 12, 2011. Applicants: Nevada Solar One, LLC. [FR Doc. 2011–25334 Filed 9–30–11; 8:45 am] Docket Numbers: ER11–4587–000. Description: Nevada Solar One, LLC BILLING CODE 6717–01–P Applicants: Glenwood Energy submits tariff filing per 35.1: Nevada Partners, Ltd. Solar One, LLC Baseline Tariff Filing to Description: Glenwood Energy be effective 9/21/2011. ENVIRONMENTAL PROTECTION Partners, Ltd. submits tariff filing per Filed Date: 09/21/2011. AGENCY 35.1: Glenwood FERC Rate Schedule Accession Number: 20110921–5104. No. 1 Baseline to be effective 9/21/2011. Comment Date: 5 p.m. Eastern Time [FRL–9474–5] Filed Date: 09/21/2011. on Wednesday, October 12, 2011. Accession Number: 20110921–5097. Docket Numbers: ER11–4594–000. California State Motor Vehicle Comment Date: 5 p.m. Eastern Time Applicants: Niagara Mohawk Power Pollution Control Standards; Within on Wednesday, October 12, 2011. Corporation. the Scope Determination and Waiver of Docket Numbers: ER11–4588–000. Description: Notice of Termination of Preemption Decision for Amendments Applicants: LoneStar Energy Partners Service Agreement No. 121 of Niagara to California’s Zero-Emission Vehicle LLC. Mohawk Power Corporation. (ZEV) Standards Description: LoneStar Energy Partners Filed Date: 09/21/2011. AGENCY: Environmental Protection LLC submits tariff filing per 35.1: Accession Number: 20110921–5133. Agency (EPA). Lonestar FERC Rate Schedule No. 1 Comment Date: 5 p.m. Eastern Time ACTION: Notice of Decision. Baseline to be effective 9/21/2011. on Wednesday, October 12, 2011. Filed Date: 09/21/2011. Take notice that the Commission SUMMARY: By this decision the Accession Number: 20110921–5098. received the following electric securities Environmental Protection Agency (EPA) Comment Date: 5 p.m. Eastern Time filings: has determined that provisions of the on Wednesday, October 12, 2011. Docket Numbers: ES11–48–000. California Air Resources Board’s Docket Numbers: ER11–4589–000. Applicants: Kentucky Utilities (CARB’s) 2008 amendments to the Applicants: EcoGrove Wind, LLC. Company. California Zero-Emission Vehicle (ZEV) Description: EcoGrove Wind, LLC Description: Kentucky Utilities regulations as they affect 2011 and prior submits tariff filing per 35.1: EcoGrove Company submits its Application under model years (MYs) are within the scope Wind LLC Baseline Tariff Filing to be Section 204 of the Federal Power Act. of previous waivers of preemption effective 9/21/2011. Filed Date: 09/21/2011. granted to California for its ZEV Filed Date: 09/21/2011. Accession Number: 20110921–5131. regulations. In the alternative, EPA is

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also granting a waiver of preemption for Innovative Strategies Division, U.S. EPA’s prior ZEV waivers.4 In addition, the 2008 ZEV amendments at they affect Environmental Protection Agency, Ariel CARB sought confirmation that its 2008 2011 and prior MYs. EPA is also Rios Building (6405J), 1200 ZEV amendments as they relate to 2012 granting California’s request for a waiver Pennsylvania Avenue, NW., and later MYs are within the scope of of preemption to enforce the 2008 ZEV Washington, DC 20460. Telephone: EPA’s prior ZEV waivers or, in the amendments as they affect 2012 and (202) 343–9256. E-Mail Address: alternative, meet the criteria for a full later MYs. [email protected] waiver of preemption.5 EPA issued a Federal Register notice that announced DATES: Under section 307(b)(1) of the SUPPLEMENTARY INFORMATION: Clean Air Act, judicial review of this a tentative hearing (a hearing only if one final action may be sought only in the I. Chronology was requested by a commenter; in this United States Court of Appeals for the California’s initial ZEV program was case no hearing was requested or held) District of Columbia Circuit. Petitions included as part of its first low-emission and opportunity for public comment for review must be filed December 2, and held the written comment period vehicle program known as LEV I. The 6 2011. Under section 307(b)(2) of the Act, ZEV component of this program had a open until May 17, 2010. EPA received judicial review of this final action may ZEV sales requirement that phased-in a comment written jointly by the Alliance of Automobile Manufacturers not be obtained in subsequent starting with the 1998 MY with a 10 and the Association of International enforcement proceedings. percent sales requirement by the 2003 Automobile Manufacturers ADDRESSES: The Agency’s Decision MY. EPA issued a waiver of preemption (Manufacturers’ Comments) and Document, containing an explanation of for these regulations on January 13, subsequent comment from CARB this decision, as well as all documents 1993.1 CARB subsequently amended its (CARB’s Supplemental Comments).7 relied upon in making that decision, ZEV regulations in March, 1996, by including those submitted to EPA by eliminating the ZEV sales requirement II. CARB’s Zero-Emission Vehicle CARB, are available at EPA’s Air and for the 1998–2002 MYs and retaining Amendments Radiation Docket (Air Docket). Materials the 10 percent sales requirement for the The 2008 ZEV amendments maintain relevant to this decision are contained 2003 and later MYs. EPA issued a the ZEV obligation or percentage ZEV in Docket No. EPA–HQ–OAR–2009– within-the-scope determination for requirements, but give manufacturers 2 0780. The docket is located in the EPA these amendments on January 25, 2001. increased flexibility to comply with the Headquarters Library, EPA West On December 21, 2006, EPA waived ZEV requirements by giving credit to Building, Room 3334, located at 1301 preemption for CARB’s 1999, 2001, and plug-in hybrid electric vehicles (PHEV), Constitution Avenue, NW., Washington, 2003 ZEV rulemaking amendments and establishing additional ZEV 3 DC 20460, and may be viewed between through the 2011 MY. EPA determined categories in recognition of new 8:30 a.m. and 4:30 p.m., Monday that certain provisions of the 1999–2003 developments in fuel cell vehicles (FCV) through Friday. The telephone is (202) amendments to the ZEV regulations as and battery electric vehicles (BEV). As 566–1742. A reasonable fee may be they affect 2006 and prior MYs were discussed below, a large-volume charged by EPA for copying docket within-the-scope of previous waivers of manufacturer is no longer expected to material. preemption granted to California for its produce fuel-cell vehicles to meet part Additionally, an electronic version of ZEV regulations pursuant to section of its gold vehicle credit requirements the public docket is available through 209(b) of the Clean Air Act (the Act). for 2012 and later MYs. The 2008 ZEV the Federal government’s electronic EPA also granted California’s request for amendments maintain the current public docket and comment system. a waiver of preemption to enforce options for large volume manufacturers You may access EPA dockets at http:// certain provisions of the ZEV to select either the Primary Compliance www.regulations.gov. After opening the regulations as they affected 2007 Path or the Alternative Compliance Path http://www.regulations.gov web site, through 2011 MY vehicles. EPA also through MY 2011. For MYs 2012 select ‘‘Environmental Protection stated that that although we believed it through 2017, the 2008 ZEV Agency’’ from the pull-down Agency appropriate to grant a full waiver of amendments establish a ‘‘New Path,’’ a list, then scroll to ‘‘Keyword or ID’’ and preemption for the 2007 MY, we also single compliance strategy or set of enter EPA–HQ–OAR–2009–0780 to believed it appropriate to consider the requirements that all large volume view documents in the record of this 2007 MY regulations (with one manufacturers are required to follow. California request. Although a part of exception noted) as within the scope of CARB’s requirements for the 2018 and the official docket, the public docket previous waivers of preemption, as they later MYs were not amended by the does not include Confidential Business applied to certain vehicles that were 2008 ZEV amendments apart from Information (CBI) or other information already subject to the pre-existing ZEV allowing additional flexibility in the whose disclosure is restricted by statute. regulations. In its December 21, 2006 EPA’s Office of Transportation and technologies that meet the ZEV decision EPA did not making any requirements.8 Air Quality (OTAQ) maintains a Web findings or determinations with regard

page that contains today’s decision to CARB’s ZEV regulations as they 4 along with the Decision Document; this EPA–HQ–OAR–2009–0780–0001. pertained to the 2012 and later MYs. 5 CARB’s 2008 ZEV Amendments were adopted page is accessible at http:// On September 17, 2009 CARB by Executive Order R–08–015 on December 17, www.epa.gov/otaq/climate/ca- submitted a request to EPA (Waiver 2008, and were approved by the California Office waiver.htm. OTAQ also maintains a Request) seeking confirmation that of Administrative Law on March 18, 2009. Web page that contains general 6 75 FR 11878 (March 12, 2010). amendments to its ZEV regulations 7 information on its review of California EPA–HQ–OAR–2009–0780–0003 and EPA–HQ– adopted in 2008 (2008 ZEV OAR–2009–0780–0004, respectively. waiver requests. Included on that page amendments) as they relate to the 2011 8 CARB’s 2008 ZEV amendments were adopted by are links to prior waiver decisions and and earlier MYs are within the scope of Executive Order R–08–015 on December 17, 2008 can be accessed at http://www.epa.gove/ and approved by the California Office of otaq/cafr.htm. Administrative Law on March 18, 2009. The 2008 1 58 FR 4166. ZEV amendments place the ZEV requirements in FOR FURTHER INFORMATION CONTACT: 2 66 FR 7751. two sections of title 13 of the California Code of David Dickinson, Compliance and 3 71 FR 78190 (December 28, 2006). Regulations—sections 1962 and 1962.1.

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III. Clean Air Act Waivers of Once California has received a waiver B. California’s Need for State Standards Preemption and Within the Scope for its standards and enforcement To Meet Compelling and Extraordinary Decisions procedures for a certain group or class Conditions Section 209(a) of the Act provides: of vehicles, it may adopt other CARB also demonstrated continuing conditions precedent to the initial retail No State or any political subdivision existence of compelling and thereof shall adopt or attempt to enforce any sale, titling or registration of these extraordinary conditions, justifying the standard relating to the control of emissions vehicles without the necessity of state’s need for its own motor vehicle from new motor vehicles or new motor receiving an additional waiver. pollution control program. Because EPA vehicle engines subject to this part. No State If California acts to amend a has not received adverse public shall require certification, inspection or any comment challenging the need for other approval relating to the control of previously waived standard or emissions from any new motor vehicle or accompanying enforcement procedure, CARB’s own motor vehicle pollution new motor vehicle engine as condition the amendment may be considered control program, I cannot deny the precedent to the initial retail sale, titling (if within the scope of a previously granted waiver based on a lack of compelling any), or registration of such motor vehicle, waiver provided that it does not and extraordinary conditions. motor vehicle engine, or equipment. undermine California’s determination C. Consistency With Section 202(a) of Section 209(b)(1) of the Act requires that its standards, in the aggregate, are the Clean Air Act the Administrator, after an opportunity as protective of public health and for public hearing, to waive application welfare as applicable Federal standards, CARB stated in its Waiver Request of the prohibitions of section 209(a) for does not affect its consistency with that the 2008 ZEV amendments provide any State that has adopted standards section 202(a) of the Act, and raises no manufacturers with additional (other than crankcase emission new issues affecting EPA’s previous compliance options and do not raise any standards) for the control of emissions waiver decisions.12 concerns with regard to the from new motor vehicles or new motor technological feasibility of its engines prior to March 30, 1966,9 if the IV. Analysis regulations when giving due consideration to lead time and costs. In State determines that standards will be, As explained in the Agency’s in the aggregate, at least as protective of addition, CARB notes that the 2008 ZEV Decision Document EPA examined amendments do not create an issue of public health and welfare as applicable CARB’s 2008 ZEV amendments, as they Federal standards. The Administrator test procedure inconsistency. affect 2011 and earlier MYs, under the The Manufacturers’ suggested that the must grant a waiver unless she finds within the scope criteria. EPA in the that: (A) The protectiveness 2008 ZEV amendments were not alternative also applied the full waiver determination of the State is arbitrary consistent with section 202(a). However, criteria to the 2011 and earlier MYs. and capricious; (B) the State does not as explained in EPA’s Decision Although CARB requested that EPA need the State standards to meet Document, EPA finds that the confirm that the 2008 ZEV amendments, compelling and extraordinary manufacturer groups opposing the as they affect 2012 and later MYs, are conditions; or (C) the State standards within the scope confirmation and the and accompanying enforcement within the scope of previous waivers of waiver of preemption have not met their procedures are not consistent with preemption, EPA instead applied the burden of proof that the 2008 ZEV section 202(a) of the Act. full waiver criteria to the regulations amendments are inconsistent with Previous waiver decisions have stated affecting those MYs. section 202(a) of the Act. I cannot find that CARB’s ZEV regulations, as noted, that State standards are inconsistent A. California’s Protectiveness would cause the California motor with section 202(a) if there is Determination inadequate lead time to permit the vehicle emission standards to be development of the necessary In its Waiver Request to EPA, CARB inconsistent with section 202(a). technology, given the cost of stated that the amendments to its ZEV D. New Issues compliance within that time, or if the requirements will not cause the Federal and State test procedures California standards, in the aggregate, to As explained in the Decision impose inconsistent certification be less protective of public health and Document, EPA finds that the 2008 ZEV requirements.10 welfare than the applicable Federal amendments raise no new issues for With regard to enforcement standards nor undermine CARB’s 2011 and earlier MYs. procedures accompanying standards, previous protectiveness determination. E. Decision the Administrator must grant the waiver Because EPA has not received adverse Therefore, I confirm that CARB’s 2008 unless she finds that these procedures public comment challenging CARB’s may cause the California standards, in ZEV amendments as they affect the 2011 protectiveness determination, I cannot and earlier MYs, as noted above, are the aggregate, to be less protective of find that CARB was arbitrary and public health and welfare than the within the scope of existing waivers of capricious in its protectiveness preemption. I also find that the 2008 applicable Federal standards determination and cannot deny the promulgated pursuant to section 202(a), ZEV amendments as they affect the 2011 within the scope determination nor the and earlier MYs meet the criteria for a or unless the Federal and California waiver based on this criterion. certification and test procedures are full waiver and thus I alternatively grant inconsistent.11 a waiver of preemption for the be identical to the Federal procedures. California regulations as they affect these MYs. I procedures would be inconsistent, however, if 9 California is the only State which meets section manufacturers would be unable to meet both the also grant a waiver of preemption of 209(b)(1) eligibility criteria for obtaining waivers. state and the Federal requirements with the same CARB’s 2008 ZEV amendments as they See e.g., S. Rep. No. 90–403, at 632 (1967). vehicle. See, e.g., 43 FR 36679–680 (Aug. 18, 1978). affect 2012 and later MYs. A full 10 See, e.g., 43 FR 32,182 (July 25, 1978). 12 Decision Documents accompanying within the explanation of EPA’s decision, 11 See Motor and Equip. Mfr. Assoc., Inc. v. EPA, scope of waiver determination in 66 FR 7751 including our review of comments 627 F.2d 1095, 1111–14 (DC Cir. 1979), cert. denied, (January 25, 2001) at p. 5, and 51 FR 12391 (April 446 U.S. 952 (1980); 43 FR 25,729 (Jun. 14, 1978). 10, 1986) at p. 2; see also, e.g., 46 FR 36742 (July received in opposition to CARB’s To be consistent, the California procedures need not 15, 1981). request, is contained in a Decision

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Document which may be obtained as in assessing exposure to environmental and/or U.S. EPA recommendations on explained above. chemicals. The handbook was first numeric estimates for behavioral and published in 1989 and was updated in physiological characteristics needed to V. Statutory and Executive Order 1997. This edition incorporates estimate exposure to environmental Reviews information made available from 1997 agents. Recommended values are My decision will affect not only up until July 2011. It also reflects the available for the general population and, persons in California but also the revisions made to the Child-Specific for most of the exposure factors, are also manufacturers outside the State who Exposure Factors Handbook, which was available by age, sex, as well as for other must comply with California’s last updated and published in 2008. populations that may have requirements in order to produce new Each chapter in the Exposure Factors characteristics different from the general motor vehicles for sale in California. For Handbook: 2011 Edition presents population. this reason, I hereby determine and find recommended values for the exposure Dated: September 23, 2011. that this is a final action of national factors covered in that particular Darrell A. Winner, applicability. chapter’s exposure route as well as a This action is not a rule as defined by discussion of the underlying data used Acting Director, National Center for Environmental Assessment. Executive Order 12866. Therefore, it is in developing the recommendations. exempt from review by the Office of The Exposure Factors Handbook: [FR Doc. 2011–25412 Filed 9–30–11; 8:45 am] Management and Budget as required for 2011 Edition (EPA/600/R–09/052F) is BILLING CODE 6560–50–P rules and regulations by Executive available via the Internet at http:// Order 12866. www.epa.gov/ncea. ENVIRONMENTAL PROTECTION In addition, this action is not a rule DATES: This report was posted AGENCY as defined in the Regulatory Flexibility publically on September 30, 2011. Act, 5 U.S.C. 601(2). Therefore, EPA has ADDRESSES: The report is available [EPA–HQ–OAR–2010–1059; FRL–9471–8] not prepared a supporting regulatory primarily via the Internet on the flexibility analysis addressing the National Center for Environmental Guidance for 1-Hour SO2 NAAQS SIP impact of this action on small business Assessment’s home page under the Submissions entities. Recent Additions and Publications AGENCY: Environmental Protection Further, the Congressional Review menus at http://www.epa.gov/ncea. Agency (EPA). Act, 5 U.S.C. 801, et seq., as added by Paper copies of the report are not ACTION: Notice of availability and public the Small Business Regulatory available. A limited number of CD– comment period. Enforcement Fairness Act of 1996, does ROMs will be available from the not apply because this action is not a Information Management Team, NCEA; SUMMARY: Notice is hereby given that rule for purposes of 5 U.S.C. 804(3). telephone: 703–347–8561; facsimile: the EPA has posted its draft non-binding Finally, the Administrator has 703–347–8691. If you are requesting a guidance titled, ‘‘Guidance for 1–Hour delegated the authority to make CD–ROM, please provide your name, SO2 NAAQS SIP Submissions’’ on its determinations regarding waivers under your mailing address, and the document Web site. The EPA invites public § 209(b) of the Act to the Assistant title. comments on this guidance document Administrator for Air and Radiation. FOR FURTHER INFORMATION CONTACT: For during the comment period specified Dated: September 26, 2011. additional information, contact the below, and plans to issue an updated Gina McCarthy, National Center for Environmental version of the guidance after reviewing Assistant Administrator for Air and Assessment; Jacqueline Moya; timely submitted comments. Radiation. telephone: 703–347–8539; or e-mail: DATES: Comments should be submitted [FR Doc. 2011–25399 Filed 9–30–11; 8:45 am] [email protected]. on or before November 2, 2011. Please BILLING CODE 6560–50–P SUPPLEMENTARY INFORMATION: refer to SUPPLEMENTARY INFORMATION for additional information on the comment I. Information About the Project/ period. Document ENVIRONMENTAL PROTECTION ADDRESSES: Submit your comments, AGENCY The Exposure Factors Handbook: identified by Docket ID No. EPA–HQ– 2011 Edition provides a summary of the OAR–2010–1059, by one of the [FRL–9474–2] available statistical data on various following methods: • Exposure Factors Handbook: 2011 factors used in assessing human http://www.regulations.gov. Follow Edition; Release of Final Report exposure. These factors include: the on-line instructions for submitting drinking water consumption; mouthing comments. AGENCY: Environmental Protection behavior; soil ingestion rates; inhalation • E-mail: [email protected]. Agency (EPA). rates; dermal factors, including skin area Attention Docket ID No. EPA–HQ– ACTION: Notice of Availability. and soil adherence factors; consumption OAR–2010–1059. of fruits and vegetables, fish, meats, • Fax: 202–566–9744. Attention SUMMARY: On September 30, 2011, the dairy products, and homegrown foods; Docket ID No. EPA–HQ–OAR–2010– EPA publically released the final report human milk intake; human activity 1059. entitled Exposure Factors Handbook: factors; consumer product use; and • Mail: Air Docket, Attention Docket 2011 Edition. The document was building characteristics. This handbook ID No. EPA–HQ–OAR–2010–1059, prepared by the National Center for is intended for use by exposure Environmental Protection Agency, Mail Environmental Assessment (NCEA) assessors, within the Agency as well as Code: 6102T, 1200 Pennsylvania Ave., within EPA’s Office of Research and those outside, as a reference tool and NW., Washington, DC 20460. Development. The Exposure Factors primary source of exposure factor • Hand Delivery: EPA Docket Center, Handbook: 2011 Edition provides information. It may be used by 1301 Constitution Avenue, NW., Room information on various physiological scientists, economists, and other 3334, Washington, DC. Such deliveries and behavioral factors commonly used interested parties as a source of data are only accepted during the Docket

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Center’s normal hours of operation, and 4:30 p.m., Monday through Friday, posted draft non-binding guidance special arrangements should be made excluding legal holidays. The telephone titled, ‘‘Guidance for 1–Hour SO2 for deliveries of boxed information. number for the Public Reading Room is NAAQS SIP Submissions.’’ This Instructions: Direct your comments to (202) 566–1744, and the telephone document is available online at http:// Docket ID No. EPA–HQ–OAR–2010– number for the Air Docket is (202) 566– www.epa.gov/airquality/sulfurdioxide/ 1059. The EPA’s policy is that all 1742. implement.html or within the associated comments received will be included in FOR FURTHER INFORMATION CONTACT: For docket, EPA–HQ–OAR–2010–1059. the public docket without change and questions concerning this action, please The draft guidance document is may be made available online at contact Larry D. Wallace, Ph.D., U.S. intended to assist state and tribal http://www.regulations.gov, including EPA, Office of Air Quality Planning and governments in preparing State any personal information provided, Standards, Air Quality Policy Division, Implementation Plan (SIP) submittals unless the comment includes C504–03, Research Triangle Park, NC under section 110(a)(1) of the Clean Air information claimed to be Confidential 27711, telephone (919) 541–0906, e-mail Act (CAA) to address implementation, Business Information (CBI) or other at [email protected]. maintenance, and enforcement of the 1- information whose disclosure is hour primary sulfur dioxide (SO2) restricted by statute. Do not submit SUPPLEMENTARY INFORMATION: National Ambient Quality Standards information that you consider to be CBI I. General Information (NAAQS). The CAA directs states to or otherwise protected through submit these SIPs to EPA by no later regulations.gov or e-mail. The ‘‘http:// A. What should I consider as I prepare than June 3, 2013, which is 3 years after my comments for EPA? www.regulations.gov’’ Web site is an promulgation of the primary SO2 ‘‘anonymous access’’ system, which 1. Submitting CBI. Do not submit this NAAQS. To be approved, the EPA means EPA will not know your identity information to EPA through http:// would expect the SIP submittals to or contact information unless you www.regulations.gov or e-mail. Clearly demonstrate through the use of refined provide it in the body of your comment. mark the part or all of the information air quality dispersion modeling that the If you send an e-mail comment directly that you claim to be CBI. For CBI affected areas will attain the standard as to EPA without going through http:// information in a disk or CD ROM that expeditiously as practicable. This draft www.regulations.gov, your e-mail you mail to EPA, mark the outside of the guidance provides the basic information address will be automatically captured disk or CD ROM as CBI and then that states, tribes and emission sources and included as part of the comment identify electronically within the disk or would need to address the section that is placed in the public docket and CD ROM the specific information that is 110(a)(1) SIP submittal for the 1-hour claimed as CBI. In addition to one made available on the Internet. If you SO2 NAAQS including modeling submit an electronic comment, EPA complete version of the comment that guidance. After receiving timely recommends that you include your includes information claimed as CBI, a submitted public comments on the draft name and other contact information in copy of the comment that does not guidance, the EPA plans to issue the body of your comment and with any contain the information claimed as CBI updated non-binding guidance. In disk or CD–ROM you submit. If EPA is must be submitted for inclusion in the addition, the EPA will continue to work unable to read your comment and public docket. Information so marked closely with states and tribes to address contact you for clarification due to will not be disclosed except in issues arising under the section technical difficulties, EPA may not be accordance with procedures set forth in 110(a)(1) SIP submittals. able to consider your comment. 40 CFR part 2. Send or deliver EPA invites public comment on all Electronic files should avoid the use of information identified as CBI only to the aspects of this draft guidance during the special characters, any form of following address: Roberto Morales, 30-day comment period. The draft encryption, and be free of any defects or U.S. EPA, Office of Air Quality Planning guidance is not a regulation or any other viruses. For additional information and Standards, Mail Code C404–02, kind of final action and does not about EPA’s public docket, visit the EPA Research Triangle Park, NC 27711, establish binding requirements on the Docket Center homepage at http:// telephone (919) 541–0880, e-mail at EPA or any state, local, or tribal agency www.epa.gov/epahome/dockets.htm. [email protected], Attention or any emissions source. While the EPA For additional instructions on Docket ID No. OAR–2010–1059. has established a docket and is submitting comments, go to Section II of 2. Tips for Preparing Your Comments. requesting public comment on the draft the SUPPLEMENTARY INFORMATION section When submitting comments, remember guidance, this procedure does not alter of this document. to: the nature or effect of the draft guidance Docket: All documents in the docket • Identify the docket number and and does not constitute a formal are listed in the http:// other identifying information (subject rulemaking process or require the EPA www.regulations.gov index. Although heading, Federal Register date and page to respond to public comments in the listed in the index, some information is number). updated guidance before the EPA or not publicly available, i.e., CBI or other • Follow directions. The agency may other agencies may use the guidance in information whose disclosure is ask you to respond to specific questions reaching decisions related to SIPs restricted by statute. Certain other or organize comments by referencing a submitted under section 110(a)(1). The material, such as copyrighted material, part or section number in the guidance. EPA retains the discretion to revise its is not placed on the Internet and will be • Explain why you agree or disagree guidance, issue additional guidance, publicly available only in hard copy with EPA’s guidance; and suggest propose regulations as appropriate, and form. Publicly available docket alternatives and substitute language that to utilize information submitted in materials are available either would help to clarify or better explain public comments to inform future electronically in http:// the points made and positions taken in decisions. Because this draft guidance www.regulations.gov or in hard copy at EPA’s guidance document. does not constitute a formal rulemaking the EPA Docket Center, EPA West, action, the EPA is not required to Room 3334, 1301 Constitution Avenue, II. Background respond to comments, but intends to NW., Washington, DC. The Public The purpose of this notice is to solicit take significant comments under Reading Room is open from 8:30 a.m. to public comments on EPA’s recently consideration in amending or updating

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the non-binding guidance. To the extent Tribal governments. The Committees are SUMMARY: The Environmental Protection that the EPA determines that comments responsible for providing advice to the Agency (EPA or Agency) Science received during the 30-day comment U.S. Representative on a wide range of Advisory Board (SAB) Staff Office period justify corrections or strategic, scientific, technological, announces a public face-to-face meeting clarifications to the guidance, the EPA regulatory, and economic issues related of the SAB Biogenic Carbon Emissions may revise and reissue the guidance and to implementation and further Panel to review EPA’s draft Accounting post the revised document at: http:// elaboration of the NAAEC. Framework for Biogenic CO2 Emissions www.epa.gov/airquality/sulfurdioxide/ The purpose of the meeting is to from Stationary Sources (September implement.html. provide advice on the CEC’s Draft 2011). Please refer to the ADDRESSES section Communication Strategy, and discuss DATES: The meeting will be held on above in this document for specific regional trans-boundary environmental October 25, 2011 from 8:30 a.m. to 5 instructions on submitting comments. issues. The meeting will also include a p.m., October 26, 2011 from 8:30 a.m. to public comment session. A copy of the 5 p.m. and on October 27, 2011 from III. Internet Web Site for Guidance agenda will be posted at http:// Information 8:30 a.m. to 12:30 p.m. (Eastern Time). www.epa.gov/ocem/nacgac-page.htm. ADDRESSES: The meeting will be held at The guidance titled, ‘‘Guidance for 1– DATES: The National and Governmental the Hyatt Regency at 400 New Jersey Hour SO2 NAAQS SIP Submissions’’ Advisory Committees will hold an open Avenue, NW., Washington, DC 20001. can be found at: http://www.epa.gov/ meeting on Thursday, October 20, 2011, FOR FURTHER INFORMATION CONTACT: Any airquality/sulfurdioxide/ from 8:30 a.m. to 5 p.m., and Friday, member of the public wishing further implement.html. October 21, from 8:30 a.m. until 2 p.m. information regarding this meeting may Dated: September 21, 2011. ADDRESSES: The meeting will be held at contact Dr. Holly Stallworth, Designated Mary Henigin, the DoubleTree Hotel, 1617 IH–35 Federal Officer (DFO), SAB Staff Office, Acting Director, Office of Air Quality Planning North, Austin, Texas 78702. Telephone: by telephone/voice mail at (202) 564– and Standards. 512–479–4000. The meeting is open to 2073 or via e-mail at stallworth.holly@ [FR Doc. 2011–25400 Filed 9–30–11; 8:45 am] the public, with limited seating on a epa.gov. General information BILLING CODE 6560–50–P first-come, first-served basis. concerning the EPA Science Advisory FOR FURTHER INFORMATION CONTACT: Board can be found at the EPA SAB Oscar Carrillo, Designated Federal Web site at http://www.epa.gov/sab. ENVIRONMENTAL PROTECTION Officer, [email protected], 202– SUPPLEMENTARY INFORMATION: AGENCY 564–0347, U.S. EPA, Office of Federal Background: The SAB was Advisory Committee Management and established pursuant to the [FRL–9474–3] Outreach (1601–M), 1200 Pennsylvania Environmental Research, Development, National and Governmental Advisory Avenue NW, Washington, DC 20460. and Demonstration Authorization Act Committees to the U.S. Representative SUPPLEMENTARY INFORMATION: Requests (ERDAA) codified at 42 U.S.C. 4365, to to the Commission for Environmental to make oral comments, or provide provide independent scientific and Cooperation written comments to the Committees, technical peer review, advice, should be sent to Oscar Carrillo, consultation, and recommendations to AGENCY: Environmental Protection Designated Federal Officer, at the the EPA Administrator on the technical Agency (EPA). contact information above. basis for EPA actions. As a Federal ACTION: Notice of meeting. Meeting Access: For information on Advisory Committee, the SAB conducts access or services for individuals with business in accordance with the Federal SUMMARY: Under the Federal Advisory disabilities, please contact Oscar Advisory Committee Act (FACA) (5 Committee Act, Public Law 92–463, Carrillo at 202–564–0347 or U.S.C. App. 2) and related regulations. EPA gives notice of a meeting of the [email protected]. To request Pursuant to FACA and EPA policy, National Advisory Committee (NAC) accommodation of a disability, please notice is hereby given that the SAB and Governmental Advisory Committee contact Oscar Carrillo, preferably at Biogenic Carbon Emissions Panel will (GAC) to the U.S. Representative to the least 10 days prior to the meeting, to hold a public meeting to review EPA’s North American Commission for give EPA as much time as possible to draft Accounting Framework for Environmental Cooperation (CEC). The process your request. Biogenic CO2 Emissions from Stationary National and Governmental Advisory Dated: September 22, 2011. Sources (September 2011). The SAB Committees advise the EPA Oscar Carrillo, will comply with the provisions of Administrator in her capacity as the FACA and all appropriate SAB Staff Designated Federal Officer. U.S. Representative to the CEC Council. Office procedural policies. The Committees are authorized under [FR Doc. 2011–25398 Filed 9–30–11; 8:45 am] EPA’s Office of Atmospheric Articles 17 and 18 of the North BILLING CODE 6560–50–P Programs (OAP) in EPA’s Office of Air American Agreement on Environmental and Radiation has requested SAB Cooperation (NAAEC), North American review of the draft report and Free Trade Agreement Implementation ENVIRONMENTAL PROTECTION accounting framework. The SAB Staff Act,Public Law 103–182, and as AGENCY Office requested public nominations of directed by Executive Order 12915, [FRL–9474–6] experts to serve on a review panel to entitled ‘‘Federal Implementation of the advise the Agency on April 27, 2011 (76 North American Agreement on Notification of a Public Meeting of the FR 23587–23588). The SAB Staff Office Environmental Cooperation.’’ The NAC Science Advisory Board Biogenic sought nominations of nationally and is composed of 13 members Carbon Emissions Panel internationally recognized scientists and representing academia, environmental AGENCY: Environmental Protection experts with demonstrated expertise in non-governmental organizations, and Agency (EPA). forestry, agriculture, measurement and private industry. The GAC consists of 12 carbon accounting methodologies, land ACTION: Notice. members representing state, local, and use economics, climate change,

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engineering and monitoring and Written Statements: Written October 24, 2011. Individuals or accounting approaches for agriculture, statements should be received in the organizations wishing to address the land use, land-use change and forestry. SAB Staff Office by October 18, 2011 so Committee will be allowed a maximum On June 23, 2011, the SAB Staff Office that the information may be made of five minutes to present their point of posted a notice on the SAB website available to the SAB Panel for their view. Also, written comments should be inviting public comments on candidates consideration. Written statements submitted electronically to for the panel by July 15, 2011. should be supplied to the DFO in [email protected]. Please contact Information about formation of the electronic format via e-mail (acceptable the Designated Federal Officer (DFO) at panel can be found at http://yosemite. file formats: Adobe Acrobat PDF, the number listed below to schedule a epa.gov/sab/sabproduct.nsf/fedrgstr_ WordPerfect, MS Word, MS PowerPoint, time on the agenda. Time will be activites/Accounting%20for%20 or Rich Text files in IBM–PC/Windows allotted on a first come first serve basis, biogenic%20CO2?OpenDocument. The 98/2000/XP format). It is the SAB Staff and the total period for comments may purpose of the October 25–27, 2011, Office general policy to post written be extended if the number of requests meeting is for the Panel to review and comments on the Web page for the for appearances requires it. provide advice on EPA’s draft advisory meeting or teleconference. Dates and Addresses: The Local Accounting Framework for Biogenic CO2 Submitters are requested to provide an Government Advisory Committee Emissions from Stationary Sources unsigned version of each document meeting will be held by teleconference (September 2011). because the SAB Staff Office does not on Monday, October 24, 2011, at 2:30 Availability of the review materials: publish documents with signatures on p.m.–4 p.m. (ET). The Committee’s EPA’s review document and charge to its Web sites. Members of the public meeting summary will be available after the Panel Agenda and other meeting should be aware that their personal the meeting online at http:// materials will be made available at the contact information, if included in any www.epa.gov/ocir/scas and can be URL above. For questions concerning written comments, may be posted to the obtained by written request to the DFO. EPA’s draft Accounting Framework for SAB Web site. Copyrighted material will FOR FURTHER INFORMATION CONTACT: Biogenic CO2 Emissions from Stationary not be posted without explicit Frances Eargle, the Designated Federal Sources (September 2011), please permission of the copyright holder. Officer for the Local Government contact Dr. Jennifer Jenkins, Climate Accessibility: For information on Advisory Committee (LGAC) at (202) Change Division, at access or services for individuals with 564–3115 or e-mail at [email protected] or 202–343– disabilities, please contact Dr. Holly [email protected]. 9361 or Sara Ohrel at Stallworth at the phone number or e- Information on Services for Those [email protected] or 202–343–9712. mail address noted above, preferably at With Disabilities: For information on Procedures for Providing Public Input: least ten days prior to the meeting, to access or services for individuals with Public comment for consideration by give EPA as much time as possible to disabilities, please contact Frances EPA’s federal advisory committees and process your request. Eargle at (202) 564–3115 or panels has a different purpose from [email protected]. To request Dated: September 27, 2011. public comment provided to EPA accommodation of a disability, please program offices. Therefore, the process Vanessa T. Vu, request it 10 days prior to the meeting, for submitting comments to a federal Director, EPA Science Advisory Board Staff to give EPA as much time as possible to advisory committee is different from the Office. process your request. process used to submit comments to an [FR Doc. 2011–25406 Filed 9–30–11; 8:45 am] Dated: September 27, 2011. EPA program office. Federal advisory BILLING CODE 6560–50–P committees and panels, including Frances Eargle, scientific advisory committees, provide Designated Federal Officer, Local Government independent advice to EPA. Members of ENVIRONMENTAL PROTECTION Advisory Committee. the public can submit relevant AGENCY [FR Doc. 2011–25407 Filed 9–30–11; 8:45 am] BILLING CODE 6560–50–P comments for a federal advisory [FRL–9474–7] committee to consider pertaining to EPA’s charge to the panel. Input from Reschedule—Meeting of the Local the public to the SAB will have the most Government Advisory Committee FEDERAL ELECTION COMMISSION impact if it consists of comments that provide specific scientific or technical AGENCY: Environmental Protection Sunshine Act Notice information or analysis for the SAB Agency. AGENCY: Federal Election Commission, panel to consider or if it relates to the ACTION: Notice. DATE & TIME: clarity or accuracy of the technical Thursday, October 6, 2011 information. SUMMARY: The Local Government at 10 a.m. Members of the public wishing to Advisory Committee will meet via PLACE: 999 E Street, NW., Washington, provide comment should contact the teleconference on Monday, October 24, DC (Ninth Floor) Designated Federal Officer for the 2011, 2:30–4 p.m. (ET). The Committee STATUS: This meeting will be open to the relevant advisory committee directly. will discuss the recommendations of the public. Oral Statements: In general, individuals Gulf Coast Restoration Workgroup on ITEMS TO BE DISCUSSED: or groups requesting an oral ways EPA can engage local government Correction and Approval of the Minutes presentation at this public meeting will officials in the Gulf Coast Ecosystem for the Meetings of September 1 and be limited to five minutes per speaker. restoration efforts and other issues of 22, 2011. Interested parties should contact Dr. environmental concern to locally Agency Procedure Following the Holly Stallworth, DFO, in writing elected officials. This is an open Submission of Probable Cause Briefs (preferably via e-mail), at the contact meeting and all interested persons are by the Office of General Counsel. information noted above, by October 18, invited to participate. The Committee Draft Advance Notice of Proposed 2011 to be placed on the list of public will hear comments from the public Rulemaking for Internet speakers for the meeting. between 2:45 p.m.–3 p.m. on Monday, Communication Disclaimers.

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Draft Advisory Opinion 2011–18: FEDERAL RESERVE SYSTEM pursuant to the Home Owners’ Loan Act Western Representation PAC (12 U.S.C. 1461 et seq.) (HOLA), Management and Administrative Formations of, Acquisitions by, and Regulation LL (12 CFR part 238), and Matters. Mergers of Bank Holding Companies Regulation MM (12 CFR part 239), and Individuals who plan to attend and The companies listed in this notice all other applicable statutes and require special assistance, such as sign have applied to the Board for approval, regulations to become a savings and language interpretation or other pursuant to the Bank Holding Company loan holding company and/or to acquire reasonable accommodations, should Act of 1956 (12 U.S.C. 1841 et seq.) the assets or the ownership of, control contact Shawn Woodhead Werth, (BHC Act), Regulation Y (12 CFR part of, or the power to vote shares of a Secretary and Clerk, at (202) 694–1040, 225), and all other applicable statutes savings association and nonbanking at least 72 hours prior to the hearing and regulations to become a bank companies owned by the savings and date. holding company and/or to acquire the loan holding company, including the assets or the ownership of, control of, or companies listed below. PERSON TO CONTACT FOR INFORMATION: the power to vote shares of a bank or The applications listed below, as well Judith Ingram, Press Officer, Telephone: bank holding company and all of the as other related filings required by the (202) 694–1220. banks and nonbanking companies Board, are available for immediate Shawn Woodhead Werth, owned by the bank holding company, inspection at the Federal Reserve Bank Secretary and Clerk of the Commission. including the companies listed below. indicated. The application also will be [FR Doc. 2011–25592 Filed 9–29–11; 4:15 pm] The applications listed below, as well available for inspection at the offices of as other related filings required by the BILLING CODE 6715–01–P the Board of Governors. Interested Board, are available for immediate persons may express their views in inspection at the Federal Reserve Bank writing on the standards enumerated in indicated. The application also will be the HOLA (12 U.S.C. 1467a(e)). If the FEDERAL RESERVE SYSTEM available for inspection at the offices of proposal also involves the acquisition of the Board of Governors. Interested a nonbanking company, the review also Change in Bank Control Notices; persons may express their views in includes whether the acquisition of the Acquisitions of Shares of a Savings writing on the standards enumerated in nonbanking company complies with the and Loan Holding Company the BHC Act (12 U.S.C. 1842(c)). If the standards in section 10(c)(4)(B) of the proposal also involves the acquisition of HOLA (12 U.S.C. 1467a(c)(4)(B)). Unless The notificants listed below have a nonbanking company, the review also otherwise noted, nonbanking activities applied under the Change in Bank includes whether the acquisition of the will be conducted throughout the Control Act (12 U.S.C. 1817(j)) and the nonbanking company complies with the United States. Board’s Regulation LL (12 CFR part 238) standards in section 4 of the BHC Act Unless otherwise noted, comments to acquire shares of a savings and loan (12 U.S.C. 1843). Unless otherwise regarding each of these applications holding company. The factors that are noted, nonbanking activities will be must be received at the Reserve Bank considered in acting on the notices are conducted throughout the United States. indicated or the offices of the Board of set forth in paragraph 7 of the Act (12 Unless otherwise noted, comments Governors not later than October 18, U.S.C. 1817(j)(7)). regarding each of these applications 2011. The notices are available for must be received at the Reserve Bank immediate inspection at the Federal indicated or the offices of the Board of A. Federal Reserve Bank of San Reserve Bank indicated. The notices Governors not later than October 28, Francisco (Kenneth Binning, Vice also will be available for inspection at 2011. President, Applications and A. Federal Reserve Bank of Atlanta the offices of the Board of Governors. Enforcement) 101 Market Street, San (Chapelle Davis, Assistant Vice Interested persons may express their Francisco, California 94105–1579: President) 1000 Peachtree Street, NE., views in writing to the Reserve Bank 1. Opus Bank, Redondo Beach, Atlanta, Georgia 30309: indicated for that notice or to the offices California, to become a savings and loan 1. Platinum Bank Holding Company, of the Board of Governors. Comments holding company by acquiring shares of to become a bank holding company by must be received not later than October RMG Capital Corporation, and thereby acquiring 100 percent of the voting 18, 2011. indirectly acquire Fullerton Community shares of Platinum Bank, both in Bank, both in Fullerton, California. In A. Federal Reserve Bank of Cleveland Brandon, Florida. (Nadine Wallman, Vice President) 1455 connection with this application, Board of Governors of the Federal Reserve Fullerton Community Bank will merge East Sixth Street, Cleveland, Ohio System. 44101–2566: into Opus Bank. Dated: September 28, 2011. 1. Timothy O’Dell Investor Group, In connection with this application, Robert deV. Frierson, Applicant also has applied to acquire New Albany, Ohio; to acquire no more Deputy Secretary of the Board. than 24.99 percent of the voting shares RMG Development Corporation, [FR Doc. 2011–25405 Filed 9–30–11; 8:45 am] of Central Federal Corporation, and Fullerton, California, and thereby thereby indirectly acquire voting share BILLING CODE 6210–01–P engage in real estate development joint of CF Bank, both in Fairlawn, Ohio. venture activities, pursuant to section 238.53(b)(4) and (5) of Regulation LL. Board of Governors of the Federal Reserve FEDERAL RESERVE SYSTEM System. Board of Governors of the Federal Reserve Dated: September 28, 2011. Formations of, Acquisitions by, and System, September 28, 2011. Robert deV. Frierson, Mergers of Savings and Loan Holding Robert deV. Frierson, Deputy Secretary of the Board. Companies Deputy Secretary of the Board. [FR Doc. 2011–25403 Filed 9–30–11; 8:45 am] The companies listed in this notice [FR Doc. 2011–25404 Filed 9–30–11; 8:45 am] BILLING CODE 6210–01–P have applied to the Board for approval, BILLING CODE 6210–01–P

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DEPARTMENT OF HEALTH AND of comprehensive, accountable primary beneficiary-per-month care management HUMAN SERVICES care supported by multiple payers. We payment to primary care on behalf of are seeking to collaborate with other Medicaid fee-forservice beneficiaries; Centers for Medicare & Medicaid payers in select markets and with shared savings will not be a part of the Services approximately 75 primary care practices payment methodology for Medicaid fee- [CMS–5508–N] in each market over the course of this for–service. 4-year initiative. This solicitation is directed to public and private health III. Collection of Information Medicare Program; Comprehensive Requirements Primary Care Initiative care payers who will respond individually to the Innovation Center. Section 1115A(d)(3)of the Act AGENCY: Centers for Medicare & Once payers and markets have been specifies that the requirements of the Medicaid Services (CMS), HHS. selected, primary care practices will be Paperwork Reduction Act of 1995 do ACTION: Notice. recruited and selected in those markets. not apply with respect to the testing and evaluation of payment and service II. Provisions of the Notice SUMMARY: This notice announces a delivery models or the expansion of solicitation for health care payer Consistent with its authority under these models under section 1115A of organizations to participate in the section 1115A of the Social Security Act the Act. Comprehensive Primary Care initiative (the Act) as added by section 3021 of the (CPC), a multipayer model designed to Affordable Care Act, to test innovative Authority: Section 1115A of the Social Security Act. improve primary care. payment and service delivery models DATES: Letter of Intent Submission that reduce spending under Medicare, Dated: September 27, 2011. Deadlines: Interested organizations must Medicaid or CHIP, while preserving or Donald M. Berwick, submit a nonbinding letter of intent enhancing the quality of care, the Administrator, Centers for Medicare & (LOI), which includes an Excel Innovation Center aims to achieve the Medicaid Services. document identifying preliminary following goals through the [FR Doc. 2011–25356 Filed 9–28–11; 11:15 am] markets of interest by November 15, implementation of the Comprehensive BILLING CODE 4120–01–P 2011 using the LOI template provided Primary Care (CPC) initiative: on the Innovation Center Web site at • To collaborate with other payers on http://www.innovation.cms.gov/. aligned strategies to support the DEPARTMENT OF HEALTH AND Application Submission Deadline: delivery of comprehensive primary care HUMAN SERVICES Applications must be received through services provided by practices an online portal, on or before 5 p.m., participating in the initiative (as Food and Drug Administration Eastern Standard Time (E.S.T) on described in Section D of the [Docket No. FDA–2011–D–0689] January 17, 2012. We reserve the right solicitation). • to request additional information from To test whether a set of Draft Guidance for Industry and Food applicants in order to assess their comprehensive primary care functions, and Drug Administration Staff; De applications. coupled with payment reform, use of Novo Classification Process data to guide improvement, and (Evaluation of Automatic Class III ADDRESSES: Letters of Intent should be meaningful use of health information Designation); Availability submitted electronically in PDF format technology can achieve the three-part via encrypted e-mail to the following e- aim of better care, improved health and AGENCY: Food and Drug Administration, mail address by the applicable date reduced costs that could ultimately be HHS. specified in the DATES section of this adopted by Medicare and Medicaid ACTION: Notice. notice: [email protected]. Letters of programs. Intent will only be accepted via e-mail. We will pay a per-beneficiary-per- SUMMARY: The Food and Drug Applications will only be accepted via month care management payment to Administration (FDA) is announcing the the online application portal. each participating primary care availability of the draft guidance FOR FURTHER INFORMATION CONTACT: practices for comprehensive primary entitled ‘‘De Novo Classification Process [email protected] for questions care services that the practice provides (Evaluation of Automatic Class III regarding the aspects of the to its Medicare fee-for-service Designation).’’ The purpose of this Comprehensive Primary Care initiative beneficiaries We will offer an document is to provide guidance to FDA or the application process. opportunity for participating practices staff and industry on the process for the SUPPLEMENTARY INFORMATION: to share in savings in years 2 through 4 submission and review of petitions of the program if the market in which submitted under the Federal Food, I. Background the practice participates experiences Drug, and Cosmetic Act (FD&C Act), The Centers for Medicare & Medicaid reductions in its reductions in its total also known as the de novo classification Services (CMS) are committed to the health system costs (a described in process. FDA is issuing this draft three-part aim of better health, better Section F of the solicitation). Each payer guidance to provide updated health care, and lower per-capita costs applying for this initiative will propose recommendations for efficient for Medicare, Medicaid and Children’s a strategy that is aligned with the interaction with FDA, including what Health Insurance Program (CHIP) Innovation Center’s approach to information to submit, when seeking a beneficiaries. One potential mechanism supporting comprehensive primary care. path to market for a novel device via the for achieving this goal is to support Learning systems will support de novo process. This draft guidance is practice redesign in primary care participating practices throughout the not final nor is it in effect at this time. through payment reform. initiative. Payer selection criteria are DATES: Although you can comment on The Center for Medicare & Medicaid described in section II of the any guidance at any time (see 21 CFR Innovation (Innovation Center) is Solicitation. 10.115(g)(5)), to ensure that the agency seeking to strengthen free-standing To the extent that States apply, the considers your comment on this draft primary care capacity by testing a model Innovation Center will also pay a per- guidance before it begins work on the

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final version of the guidance, submit de novo process). Congress included electronic copy of the document or send either electronic or written comments this section to limit unnecessary a fax request to 301–847–8149 to receive on the draft guidance by December 2, expenditure of FDA and industry a hard copy. Please use the document 2011. Submit either electronic or resources that could occur if lower risk number 1769 to identify the guidance written comments concerning proposed devices were subject to premarket you are requesting. approval under section 515 of the FD&C collection of information by December IV. Paperwork Reduction Act of 1995 2, 2011. Act (21 U.S.C. 360e). Under the PRA (44 U.S.C. 3501– ADDRESSES: Submit written requests for FDA issued a guidance document to single copies of the draft guidance explain the procedures involved with 3502), Federal Agencies must obtain document entitled ‘‘De Novo the de novo program, which has been in approval from the Office of Management Classification Process (Evaluation of place since 1998. Over the past 13 years, and Budget (OMB) for each collection of information they conduct or sponsor. Automatic Class III Designation)’’ to the even though a number of new medical ‘‘Collection of information’’ is defined Division of Small Manufacturers, devices have been evaluated by FDA in 44 U.S.C. 3502(3) and 5 CFR International, and Consumer Assistance, under the de novo process, FDA 1320.3(c) and includes Agency requests Center for Devices and Radiological believes that the program has been or requirements that members of the Health, Food and Drug Administration, under-utilized, and has evaluated what public submit reports, keep records, or 10903 New Hampshire Ave., Bldg. 66, improvements could be made to provide information to a third party. rm. 4613, Silver Spring, MD 20993– enhance the utility and productivity of Section 3506(c)(2)(A) of the PRA (44 0002 or to the Office of Communication, the program. FDA evaluated its U.S.C. 3506(c)(2)(A)) requires Federal Outreach and Development (HFM–40), extensive experience gained with agencies to provide a 60-day notice in Center for Biologics Evaluation and respect to the evidence necessary to conduct comprehensive reviews of de the Federal Register concerning each Research (CBER), Food and Drug novo applications. Accordingly, FDA is proposed collection of information Administration, 1401 Rockville, MD issuing this draft guidance to provide before submitting the collection to OMB 20852–1448. Send one self-addressed updated recommendations designed to for approval. To comply with this adhesive label to assist that office in foster efficient interaction with FDA, requirement, FDA is publishing notice processing your request, or fax your including what information to submit, of the proposed collection of request to 301–847–8149. See the when seeking a path to market via the information set forth in this document. SUPPLEMENTARY INFORMATION section for de novo process. This guidance With respect to the following information on electronic access to the describes a mechanism to provide collection of information, FDA invites guidance. greater clarity about the suitability of a comments on these topics: (1) Whether Submit electronic comments on the device for de novo review, and timely the proposed collection of information draft guidance to http:// input on the type of data necessary to is necessary for the proper performance www.regulations.gov. Submit written support de novo classification of an of FDA’s functions, including whether comments to the Division of Dockets eligible device. the information will have practical Management (HFA–305), Food and Drug utility; (2) the accuracy of FDA’s Administration, 5630 Fishers Lane, rm. II. Significance of Guidance estimate of the burden of the proposed 1061, Rockville, MD 20852. Identify This draft guidance is being issued collection of information, including the comments with the docket number consistent with FDA’s good guidance validity of the methodology and found in brackets in the heading of this practices regulation (21 CFR 10.115). assumptions used; (3) ways to enhance document. The draft guidance, when finalized, will the quality, utility, and clarity of the FOR FURTHER INFORMATION CONTACT: represent the Agency’s current thinking information to be collected; and (4) Melissa Burns, Center for Devices and on the de novo classification process. It ways to minimize the burden of the Radiological Health, Food and Drug does not create or confer any rights for collection of information on Administration, 10903 New Hampshire or on any person and does not operate respondents, including through the use Ave., Bldg. 66, rm. 1646, Silver Spring, to bind FDA or the public. An of automated collection techniques, MD 20993–0002, 301–796–5616; or alternative approach may be used if when appropriate, and other forms of Stephen Ripley, Center for Biologics such approach satisfies the information technology. Evaluation and Research (HFM–17), requirements of the applicable statute Food and Drug Administration, 1401 and regulations. Draft Guidance for Industry and Food Rockville Pike, suite 200N, Rockville, and Drug Administration Staff: De Novo MD 20852, 301–827–6210. III. Electronic Access Classification Process (Evaluation of Persons interested in obtaining a copy Automatic Class III Designation) I. Background of the draft guidance may do so by using This draft guidance describes how A medical device that is of a new type the Internet. A search capability for all FDA’s Center for Devices and that FDA has not yet classified based on CDRH guidance documents is available Radiological Health (CDRH) and Center risk, and therefore cannot be found to be at http://www.fda.gov/MedicalDevices/ for Biologics Evaluation and Research substantially equivalent to a legally DeviceRegulationandGuidance/ (CBER) intend to implement this marketed predicate device, may remain GuidanceDocuments/default.htm. provision of the law. When final, this in class III even if the risks it presents Guidance documents are also available document will supersede ‘‘New Section are relatively low. This is the scenario at http://www.regulations.gov or from 513(f)(2)—Evaluation of Automatic targeted by Congress when it enacted CBER at http://www.fda.gov/Biologics Class III Designation, Guidance for section 513(f)(2) of the FD&C Act (21 BloodVaccines/GuidanceCompliance Industry and CDRH Staff’’ dated U.S.C. 360c(f)(2)) as part of the Food RegulatoryInformation/default.htm. To February 19, 1998. and Drug Administration Modernization receive ‘‘De Novo Classification Process The proposed collections of Act of 1997 (FDAMA). The process (Evaluation of Automatic Class III information are necessary to satisfy the created by this provision is referred to Designation),’’ from CDRH you may previously mentioned statutory in FDAMA as the Evaluation of either send an e-mail request to requirements for implementing this Automatic Class III Designation (e.g., the [email protected] to receive an voluntary submission program.

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FDA estimates the burden of this collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Number of Average Number of responses per Total annual burden per Submission of information for de novo petition program respondents respondent responses respondent Total hours per year (in hours)

CDRH ...... 25 1 25 100 2,500 CBER ...... 1 1 1 100 100

Total ...... 2,600 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Respondents are medical device expected that the number of petitions FDA administrative and technical staff manufacturers seeking to market will increase over its current rate and who are familiar with the requirements medical device products that have been reach a steady rate of approximately 26 for submission of a de novo petition classified into class III under section submissions per year (and related materials), have consulted 513(f)(2) of the FD&C Act. Based on FDA estimates from past experience and advised manufacturers on these FDA’s experience with the de novo with the de novo petition program that requirements, and have reviewed the petition program, FDA expects the the complete process involved with the documentation submitted. program to continue to be utilized as a program takes approximately 100 hours. Therefore, the total reporting burden viable program in the future. It is This average is based upon estimates by hours is estimated to be 2,600 hours.

TABLE 2

Total burden Number of respondents hours Hourly wage Total cost annualized rate annualized

26 ...... 100 $150 $390,000

The average to industry per hour for Dated: September 27, 2011. Proposed Project: ADAP Data Report— this type of work is $150, resulting in Nancy K. Stade, [New] a cost of $15,000 per respondent. The Deputy Director for Policy, Center for Devices HRSA’s AIDS Drug Assistance estimated submission cost of $15,000 and Radiological Health. Program (ADAP) is funded through the multiplied by 26 submissions per year [FR Doc. 2011–25367 Filed 9–30–11; 8:45 am] Ryan White HIV/AIDS Program, Part B, equals $390,000, which is the BILLING CODE 4160–01–P of Title XXVI of the Public Health aggregated industry reporting cost Service Act, which provides grants to annualized. states and territories. Each of the 50 This draft guidance also refers to DEPARTMENT OF HEALTH AND states, the District of Columbia, Puerto currently approved information HUMAN SERVICES Rico, and several territories receive collections found in FDA regulations. ADAP grants. The ADAP provides Health Resources and Services The collections of information in 21 medications for the treatment of HIV/ Administration CFR part 807, subpart E, are approved AIDS. Program funds may also be used to purchase health insurance for eligible under OMB control number 0910–0120. Agency Information Collection clients or for services that enhance V. Comments Activities: Submission for OMB access, adherence, and monitoring of Review: Comment Request drug treatments. Interested persons may submit to the The Ryan White HIV/AIDS Program Division of Dockets Management (see Periodically, the Health Resources specifies HRSA’s responsibilities in the ADDRESSES), either electronic or written and Services Administration (HRSA) administration of grant funds, the comments regarding this document. It is publishes abstracts of information allocation of funds, the evaluation of only necessary to send one set of collection requests under review by the programs for the population served, and comments. It is no longer necessary to Office of Management and Budget, in the improvement of quality of care. send two copies of mailed comments. compliance with the Paperwork Accurate records of the grantees Identify comments with the docket Reduction Act of 1995 (44 U.S.C. receiving Ryan White HIV/AIDS number found in brackets in the Chapter 35). To request a copy of the Program funding, the services provided, heading of this document. Received clearance requests submitted to OMB for and the clients served, continue to be comments may be seen in the Division review, call the HRSA Reports critical issues for the implementation of of Dockets Management between 9 a.m. Clearance Office at (301) 443–1129. The the legislation and are necessary for and 4 p.m., Monday through Friday. following request has been submitted to HRSA to fulfill its responsibilities. The ADAP Data Report (ADR) OMB for review under the Paperwork provides data on the characteristics of Reduction Act of 1995: ADAP grantees and the clients being served with program funds. The ADR is

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intended to support clinical quality monitor grantee performance, to first year, including the estimated time management, performance measure the Government Performance to adjust existing or develop new data measurement, service delivery, and and Results Act (GPRA) and the collection systems to collect the client monitoring at the system and Performance Assessment Rating Tool elements that HRSA is requesting. This client levels. The reporting system (PART) goals, and to meet reporting is a one-time burden for grantees and consists of an online data form—the responsibilities to the Department, will not be a factor after the first year. Grantee Report—and a data file Congress, and OMB. The second table represents the containing the client-level data In addition to meeting the goal of estimated burden for subsequent years. accountability to Congress, clients, elements. Data will be submitted every The Grantee Report burden remains six months. The Grantee Report advocacy groups, and the general unchanged across the three years of the includes information about program public, information collected through information collection, as the administration, funding, and the ADR is critical to HRSA and expenditures, in addition to the grantees for assessing the status of submission is consistent with current medication formulary. The client-level existing HIV-related service delivery reporting requirements. The Client data include demographic, clinical, systems, investigating trends in service Report burden is expected to decrease enrollment, and service data for each utilization, and identifying the areas of slightly in subsequent years as grantees patient who is determined eligible and greatest need. become more proficient with reporting enrolled in the ADAP. Discussions were held with nine client-level data, based on feedback and The legislation specifies grantee volunteer grantee agencies representing technical assistance resources that accountability and links budget to a variety of ADAP models, as a basis for HRSA will provide. performance. The ADR will be used to the burden estimates for the ADR that The annual estimate of burden for the ensure compliance with the follows. These burden estimates are first year of the information collection is requirements of the legislation, to presented in two tables. The first table as follows: evaluate the progress of programs, to represents the estimated burden for the

Responses Instrument Number of per Total Hours per Total burden respondents respondent responses response hours

Grantee Report ...... 57 2 114 12.50 1,425.00 Client Report ...... 57 2 114 34.19 3,897.66 Data Collection System ...... 57 1 57 826.00 47,082.00

Total: ...... 52,404.66

The annual estimate of burden for subsequent years is as follows:

Responses Instrument Number of per Total Hours per Total burden respondents respondent responses response hours

Grantee Report ...... 57 2 114 12.50 1,425.00 Client Report ...... 57 2 114 24.00 2,736.00

Total: ...... 4,161.00

Written comments and DEPARTMENT OF HEALTH AND Research Facilities, NIH, B13/2S11, recommendations concerning the HUMAN SERVICES 9000 Rockville Pike, Bethesda, proposed information collection should Maryland 20892, telephone 301–496– be sent within 30 days of this notice to National Institutes of Health 7775; fax 301–480–8056; or e-mail the desk officer for HRSA, either by e- [email protected]. Notice of Intent To Prepare an mail to OIRA— Environmental Impact Statement Supplementary Information: The NIH [email protected] or by fax to Animal Center is located on 513 acres 202–395–6974. Please direct all Summary: In accordance with the 4 miles southwest of the City of correspondence to the ‘‘attention of the National Environmental Policy Act, the Poolesville, a small agricultural desk officer for HRSA.’’ National Institutes of Health (NIH), an community located in western agency of the Department of Health and Maryland. The campus is a component Dated: September 26, 2011. Human Services (HHS), is issuing this of the National Institutes of Health Wendy Ponton, notice to advise the public that an (NIH), one of the world’s largest Director, Office of Management. environmental impact statement will be biomedical research facilities and the [FR Doc. 2011–25339 Filed 9–30–11; 8:45 am] prepared for the NIH Animal Center at Federal government’s focal point for BILLING CODE 4165–15–P Poolesville Master Plan, Poolesville, medical and behavioral research. The Montgomery County, Maryland. NIH Animal Center at Poolesville is a For Further Information Contact: major extension of animal holding and Valerie Nottingham, Chief, production facilities at Bethesda and Environmental Quality Branch, Division consists of a number of buildings used of Environmental Protection, Office of to house, quarantine, and study the

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behavior and immunological conduct of The NIH will be sponsoring a public Mental Health Services (CMHS) funds a a variety of animal models. The NIH Scoping Meeting to provide individuals National Suicide Prevention Lifeline Animal Center at Poolesville conducts an opportunity to share their ideas on Network (‘‘Lifeline’’), consisting of a and supports research protocols for the master planning effort, including toll-free telephone number that routes various Institutes and Centers, which recommended alternatives and calls from anywhere in the United includes the studies of animal behavior, environmental issues the EIS should States to a network of local crisis conduct of immunologic procedures and consider. The meeting is planned for centers. In turn, the local centers link sampling, and surgical investigation. 6:30 p.m. to 9 p.m. on October 25, 2011 callers to local emergency, mental Total building space on the campus at the Town Hall Building at 19721 health, and social service resources. amounts to approximately 364,507 gsf. Beall Street, Poolesville, Maryland The overarching purpose of the Approximately 199 people work at the 20837. All interested parties are proposed Evaluation of the Lifeline NIH Animal Center site. encouraged to attend. The NIH has Policies for Helping Callers at Imminent A Master Plan is an integrated series established a 30-day public comment Risk is to implement data collection to of documents that present in graphic, period for the scoping process. Scoping evaluate hotline counselors’ narrative, and tabular form the current comments must be postmarked no later management of imminent risk callers composition of NIH campuses and the than November 18, 2011 to ensure they and third party callers concerned about plan for their orderly and are considered. All comments and persons at imminent risk, and counselor comprehensive development over a 20- questions on the EIS should be directed adherence to Lifeline Policies and year period. The plan provides guidance to Valerie Nottingham at the address Guidelines for Helping Callers at in coordinating the physical listed above, telephone 301–496–7775; Imminent Risk of Suicide. Specifically, development of NIH campuses, fax 301–480–8056; or e-mail the Evaluation of the Lifeline Policies including building locations, utility [email protected]. for Helping Callers at Imminent Risk will collect data, using an imminent risk capacities, road alignments, parking Dated: September 23, 2011. facilities, and the treatment of open form, to inform the network’s Daniel G. Wheeland, knowledge of the extent to which spaces. General design guidelines are Director, Office of Research Facilities also used to provide detailed guidance counselors are aware of and being Development and Operations, National guided by the Lifeline’s imminent risk for the placement and design of physical Institutes of Health. improvements. guidelines; counselors’ definitions of [FR Doc. 2011–25385 Filed 9–30–11; 8:45 am] imminent risk; the rates of active rescue The proposed action is to develop a BILLING CODE 4140–01–P of imminent risk callers; types of rescue; long-range physical master plan for the barriers to intervention; and the NIH Animal Center. The plan will cover circumstances in which active rescue is a 20-year planning period and address DEPARTMENT OF HEALTH AND initiated, including the caller’s the future development of the NIH HUMAN SERVICES agreement to receive the intervention. Animal Center site, including placement Clearance is being requested for one Substance Abuse and Mental Health of future construction; vehicular and activity to assess the knowledge, Services Administration pedestrian circulation on- and off- actions, and practices of counselors to campus; parking within the property Agency Information Collection aid callers who are determined to be at boundaries; open space in and around imminent risk for suicide and who may the campus; required setbacks; historic Activities: Submission for OMB Review; Comment Request require active rescue. This evaluation properties; natural and scenic resources; will allow researchers to examine and noise; and lighting. The plan will Periodically, the Substance Abuse and understand the actions taken by examine potential growth in the NIH Mental Health Services Administration counselors to aid imminent risk callers, Animal Center personnel, and (SAMHSA) will publish a summary of the need for active rescue, and, consequent construction of space over information collection requests under ultimately, to improve the delivery of the planning period. Future OMB review, in compliance with the crisis hotline services to imminent risk construction on the site could include Paperwork Reduction Act (44 U.S.C. callers. A total of eight centers will such facilities as: new animal holding, Chapter 35). To request a copy of these participate in this evaluation. Thus, research laboratories, and support documents, call the SAMHSA Reports SAMHSA is requesting OMB review and facilities. Clearance Officer on (240) 276–1243. approval of the National Suicide In accordance with 40 CFR 1500–1508 Prevention Lifeline—Imminent Risk Project: Networking Suicide Prevention and DHHS environmental procedures, Form. This activity is distinct from the Hotlines—Evaluation of the Lifeline NIH will prepare an Environmental Crisis Center Survey data collection, Impact Statement (EIS) for the proposed Policies for Helping Callers at which targets the entire network of master plan. The EIS will evaluate the Imminent Risk (NEW) crisis centers and focuses on a different impacts of the master plan should This proposed project is a new data domain of questions (specifically, the development occur as proposed. Among collection that builds on previously makeup, strengths, and needs of crisis the items the EIS will examine are the approved data collection activities centers.) The information gathered from implications of the master plan on [Evaluation of Networking Suicide the Crisis Center Survey cannot provide community infrastructure, including, Prevention Hotlines Follow–Up a profile of imminent risk callers or but not limited to, utilities, storm water Assessment (OMB No. 0930–0274) and details about interventions with management, traffic and transportation, Call Monitoring of National Suicide imminent risk or third party callers. and other public services. Prevention Lifeline Form (OMB No. Crisis counselors at eight participating To ensure that the public is afforded 0930–0275)]. This new data collection is centers will record information the greatest opportunity to participate in an effort to advance the understanding discussed with imminent risk callers on the planning and environmental review of crisis hotline utilization and its the Imminent Risk Form, which does process, the NIH is inviting oral and impact. The Substance Abuse and not require direct data collection from written comments on the master plan Mental Health Services callers. As with previously approved and related environmental issues. Administration’s (SAMHSA), Center for evaluations, callers will maintain

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anonymity. Counselors will be asked to following sections: (1) Call type, (2) and (14) steps taken when emergency complete the form for 100% of gender, (3) age, (4) suicidal desire, (5) contact was NOT made with person at imminent risk callers to the eight suicidal intent, (6) suicidal capability, risk. The form will take approximately centers participating in the evaluation. (7) buffers to suicide, (8) interventions 15 minutes to complete and may be This form requests information in 14 agreed to by caller or implemented by completed by the counselor during or content areas, each with multiple sub- counselor without consent, (9) whether after the call. It is expected that a total items and response options. Response imminent risk was reduced enough such of 1,440 forms will be completed by 360 options include open-ended, yes/no, that active rescue was not needed, (10) counselors over the two-year data Likert-type ratings, and multiple choice/ interventions for third party callers collection period. check all that apply. The form also calling about a person at imminent risk, requests demographic information on (11) if supervisory consultation The estimated response burden to the caller, the identification of the occurred, (12) barriers to getting needed collect this information is annualized center and counselor submitting the help to the person at imminent risk, (13) over the requested two-year clearance form, and the date of the call. steps taken to confirm emergency period and is presented below: Specifically, the form is divided into the contact was made with person at risk,

TOTAL AND ANNUALIZED AVERAGES: RESPONDENTS, RESPONSES AND HOURS

Number of Responses/ Total Hours per Total hour Instrument respondents respondent responses response burden

National Suicide Prevention Lifeline—Imminent Risk Form 360 2 720 .25 180

Written comments and Paperwork Reduction Act (44 U.S.C. clearance under OMB No. 0930–0208 recommendations concerning the Chapter 35). To request a copy of these and Cohort 6 grants previously received proposed information collection should documents, call the SAMHSA Reports clearance under OMB No. 0930–0298. be sent by November 2, 2011 to the Clearance Officer on (240) 276–1243. Since neither the HIV Cohort 4 nor the SAMHSA Desk Officer at the Office of Cohort 5 Programs were cross-site Project: Cross-Site Evaluation of the Information and Regulatory Affairs, studies, they did not require OMB Minority Substance Abuse/HIV Office of Management and Budget clearance. The current HIV Minority Prevention Program—(OMB No. 0930– (OMB). To ensure timely receipt of SA/HIV Prevention Program funded: 0298)—Revision comments, and to avoid potential delays • Cohorts 7 and 8 Prevention of in OMB’s receipt and processing of mail The Substance Abuse and Mental Substance Abuse (SA) and HIV for At- sent through the U.S. Postal Service, Health Services Administration Risk Racial/Ethnic Minority commenters are encouraged to submit (SAMHSA), Center for Substance Abuse Subpopulations Cooperative their comments to OMB via e-mail to: Prevention (CSAP) is requesting from Agreements—60 grants for 5 years, [email protected]. the Office of Management and Budget • Cohort 9 Ready-To-Respond Although commenters are encouraged to (OMB) approval for the revision of data Initiative—35 grants for 5 years and, send their comments via e-mail, collection activities for the cross-site • Cohort 10 Capacity Building commenters may also fax their study of the Minority HIV/AIDS Initiative—27 grants for 5 years. comments to: 202–395–7285. Initiative (MAI), which includes both Grantees are community based Commenters may also mail them to: youth and adult questionnaires. This organizations that are required to Office of Management and Budget, revision includes the addition of 4 address the SAMHSA Strategic Office of Information and Regulatory cohorts, changes to the data collection Prevention Framework (SPF) and Affairs, New Executive Office Building, procedures based on intervention participate in this cross-site evaluation. Room 10102, Washington, DC 20503. duration, and the addition of two The grantees are expected to provide questions on binge drinking behavior. leadership and coordination on the Rose Shannon, The current approval is under OMB No. planning and implementation of the Director, Division of Executive 0930–0298, which expires on 4/30/12. SPF that targets minority populations, Correspondence. This cross-site evaluation supports the minority reentry population, as well [FR Doc. 2011–25375 Filed 9–30–11; 8:45 am] two of SAMHSA’s 8 Strategic Initiatives: as other high risk groups residing in BILLING CODE 4162–20–P Prevention of Substance Abuse and communities of color with high Mental Illness and Data, Outcomes, and prevalence of SA and HIV/AIDS. The Quality. It builds on six previous grant primary objectives of the cross-site DEPARTMENT OF HEALTH AND programs funded by SAMHSA’s CSAP study are to: (1) Determine the success HUMAN SERVICES to provide substance abuse and HIV of the MAI in preventing, delaying, and/ prevention services for minority or reducing the use of alcohol, tobacco, Substance Abuse and Mental Health populations. The first two were and other drugs (ATOD) among the Services Administration planning grant programs and the last target populations. The results of this Agency Information Collection four were service grant programs. The cross-site study will assist SAMHSA/ Activities: Submission for OMB goals for the Cohort 3–6 grants were to CSAP in promoting and disseminating Review; Comment Request add, increase, or enhance integrated optimally effective prevention substance abuse (SA) and HIV programs; (2) Measure the effectiveness Periodically, the Substance Abuse and prevention services by providing of evidence-based programs and Mental Health Services Administration supportive services and strengthening infrastructure development activities (SAMHSA) will publish a summary of linkages between service providers for such as: outreach and training, information collection requests under at-risk minority populations. The HIV mobilization of key stakeholders, OMB review, in compliance with the Cohort 1–3 previously received substance abuse and HIV/AIDS

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counseling and education, referrals to this information will be collected 2. Males only: During the past 30 appropriate medical treatment and/or through self-report questionnaires days, on how many days did you have other intervention strategies (i.e., administered to program participants. 5 or more drinks on the same occasion? cultural enrichment activities, All grantees will use two instruments, Sample size, respondent burden, and educational and vocational resources, one for youth aged between 12 and 17 intrusiveness have been minimized to and computer-based curricula); and (3) and one for adults aged 18 and older. be consistent with the cross-site Assess the process of adopting and Participants in interventions lasting 30 objectives. Procedures are employed to implementing the Strategic Prevention days or longer will complete safeguard the privacy and Framework (SPF) with the target questionnaires three times, taking an confidentiality of participants. Every populations. average of 50 minutes for baseline, exit, effort has been made to coordinate The grantees are expected to provide and follow-up questionnaires. cross-site data collection with local data an effective prevention process, Participants in interventions lasting 2– collection efforts in an attempt to direction, and a common set of goals, 29 days will complete questionnaires minimize respondent burden. expectations, and accountabilities to be two times taking an average of 30 adapted and integrated at the minutes to complete. Single-session The cross-site evaluation results will community level. While the grantees intervention participants will complete have significant implications for the have substantial flexibility in choosing one questionnaire at exit only. The substance abuse and HIV/AIDS their individual evidence-based GPRA and NOMs measures on the prevention fields, the allocation of grant programs, they are all required to base instruments have already been approved funds, and other evaluation activities them on the five steps of the SPF to by OMB (OMB No. 0930–0230), and the conducted by multiple Federal, State, build service capacity specific to SA remaining HIV-related questions have and local government agencies. They and HIV prevention services. been approved under OMB No. 0930– will be used to develop Federal policy Conducting this cross-site evaluation 0298.The youth questionnaire contains in support of SAMHSA/CSAP program will assist SAMHSA/CSAP in 125 questions, of which 28 relate to initiatives, inform the public of lessons promoting and disseminating optimally HIV/AIDS and the adult questionnaire learned and findings, improve existing effective prevention programs. contains 118 items, 47 of which relate programs, and promote replication and Grantees must also conduct ongoing to HIV/AIDS. Two additional questions dissemination of effective prevention monitoring and evaluation of their have been added to address SAMHSA’s strategies. projects to assess program effectiveness need to collect information on binge Total Estimates of Annualized Hour including Federal reporting of the drinking behavior. Burden Government Performance and Results These questions are: Act (GPRA) of 1993, SAMHSA/CSAP 1. Females only: During the past 30 The following table shows the National Outcome Measures (NOMs), days, on how many days did you have estimated annualized burden for data and HIV Counseling and Testing. All of 4 or more drinks on the same occasion? collection.

TABLE 1A—ESTIMATES OF ANNUALIZED HOUR BURDEN BY INTERVENTION LENGTH

Responses Intervention length Number of per Total Hours per Total hour respondents respondent responses response burden

30-Days or More Intervention: Base line...... 7,937 1 7,937 0.83 6,588 Exit ...... 4,887 1 4,887 0.83 4,056 Follow-up ...... 2,942 1 2,942 0.83 2442 Subtotal ...... 7,937 ...... 15,766 ...... 13,086 2 to 29 Day Intervention: Base line ...... 1,416 1 1,416 0.5 708 Exit ...... 872 1 872 0.5 436 Subtotal ...... 1,416 ...... 2,288 ...... 1,144 Single Day Intervention: Exit ...... 2,458 1 2,458 0.25 614 Annualized Total...... 11,811 ...... 20,512 ...... 14,844

TABLE 1B—ESTIMATES OF ANNUALIZED HOUR BURDEN BY SURVEY TYPE

Questionnaire Number of respondents Total responses Total hour burden

Annualized Total Adult ...... 9,682 16,899 12,234 Annualized Total Youth ...... 2,128 3,612 2,610

Annualized Total ...... 11,811 20,512 14,844

Written comments and Office of Management and Budget their comments to OMB via e-mail to: recommendations concerning the (OMB). To ensure timely receipt of [email protected]. proposed information collection should comments, and to avoid potential delays Although commenters are encouraged to be sent by November 2, 2011 to the in OMB’s receipt and processing of mail send their comments via e-mail, SAMHSA Desk Officer at the Office of sent through the U.S. Postal Service, commenters may also fax their Information and Regulatory Affairs, commenters are encouraged to submit comments to: 202–395–7285.

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Commenters may also mail them to: 2–1042, One Choke Cherry Road, Alere Toxicology Services, 450 Office of Management and Budget, Rockville, Maryland 20857; 240–276– Southlake Blvd., Richmond, VA Office of Information and Regulatory 2600 (voice), 240–276–2610 (fax). 23236, 804–378–9130. (Formerly: Affairs, New Executive Office Building, SUPPLEMENTARY INFORMATION: The Kroll Laboratory Specialists, Inc., Room 10102, Washington, DC 20503. Mandatory Guidelines were initially Scientific Testing Laboratories, Inc.; Kroll Scientific Testing Laboratories, Rose Shannon, developed in accordance with Executive Order 12564 and section 503 of Public Inc.) Director, Division of Executive Baptist Medical Center-Toxicology Correspondence. Law 100–71. The ‘‘Mandatory Laboratory, 11401 I–30, Little Rock, [FR Doc. 2011–25374 Filed 9–30–11; 8:45 am] Guidelines for Federal Workplace Drug Testing Programs,’’ as amended in the AR 72209–7056, 501–202–2783. BILLING CODE 4162–20–P revisions listed above, requires {or set} (Formerly: Forensic Toxicology strict standards that Laboratories and Laboratory Baptist Medical Center.) Clinical Reference Lab, 8433 Quivira DEPARTMENT OF HEALTH AND Instrumented Initial Testing Facilities Road, Lenexa, KS 66215–2802, 800– HUMAN SERVICES (IITF) must meet in order to conduct drug and specimen validity tests on 445–6917. Substance Abuse and Mental Health urine specimens for Federal agencies. Doctors Laboratory, Inc., 2906 Julia Services Administration To become certified, an applicant Drive, Valdosta, GA 31602, 229–671– Laboratory/IITF must undergo three 2281. Current List of Laboratories and rounds of performance testing plus an DrugScan, Inc., P.O. Box 2969, 1119 Instrumented Initial Testing Facilities on-site inspection. To maintain that Mearns Road, Warminster, PA 18974, Which Meet Minimum Standards To certification, a Laboratory/IITF must 215–674–9310. Engage in Urine Drug Testing for participate in a quarterly performance ElSohly Laboratories, Inc., 5 Industrial Federal Agencies testing program plus undergo periodic, Park Drive, Oxford, MS 38655, 662– 236–2609. AGENCY: Substance Abuse and Mental on-site inspections. Laboratories and Instrumented Initial Gamma-Dynacare Medical Health Services Administration, HHS. Testing Facilities (IITF) in the applicant Laboratories,* A Division of the ACTION: Notice. stage of certification are not to be Gamma-Dynacare Laboratory Partnership, 245 Pall Mall Street, SUMMARY: considered as meeting the minimum The Department of Health and London, ONT, Canada N6A 1P4, 519– Human Services (HHS) notifies Federal requirements described in the HHS Mandatory Guidelines. A Laboratory/ 679–1630. agencies of the Laboratories and Laboratory Corporation of America IITF must have its letter of certification Instrumented Initial Testing Facilities Holdings, 7207 N. Gessner Road, from HHS/SAMHSA (formerly: HHS/ (IITF) currently certified to meet the Houston, TX 77040, 713–856–8288/ NIDA) which attests that it has met standards of the Mandatory Guidelines 800–800–2387. for Federal Workplace Drug Testing minimum standards. In accordance with the Mandatory Laboratory Corporation of America Programs (Mandatory Guidelines). The Holdings, 69 First Ave., Raritan, NJ Mandatory Guidelines were first Guidelines dated November 25, 2008 (73 FR 71858), the following 08869, 908–526–2400/800–437–4986. published in the Federal Register on (Formerly: Roche Biomedical April 11, 1988 (53 FR 11970), and Laboratories and Instrumented Initial Testing Facilities (IITF) meet the Laboratories, Inc.) subsequently revised in the Federal Laboratory Corporation of America minimum standards to conduct drug Register on June 9, 1994 (59 FR 29908); Holdings, 1904 Alexander Drive, and specimen validity tests on urine September 30, 1997 (62 FR 51118); Research Triangle Park, NC 27709, specimens: April 13, 2004 (69 FR 19644); November 919–572–6900/800–833–3984. 25, 2008 (73 FR 71858); December 10, Instrumented Initial Testing Facilities (Formerly: LabCorp Occupational 2008 (73 FR 75122); and on April 30, (IITF) Testing Service Inc., CompuChem 2010 (75 FR 22809). None. Laboratories, Inc.; CompuChem A notice listing all currently certified Laboratories, Inc., A Subsidiary of Laboratories and Instrumented Initial Laboratories Roche Biomedical Laboratory; Roche Testing Facilities (IITF) is published in ACL Laboratories, 8901 W. Lincoln CompuChem Laboratories, Inc., A the Federal Register during the first Ave., West Allis, WI 53227, 414–328– Member of the Roche Group.) week of each month. If any Laboratory/ 7840/800–877–7016. (Formerly: Laboratory Corporation of America IITF’s certification is suspended or Bayshore Clinical Laboratory). Holdings, 1120 Main Street, revoked, the Laboratory/IITF will be ACM Medical Laboratory, Inc., 160 Southaven, MS 38671, 866–827–8042/ omitted from subsequent lists until such Elmgrove Park, Rochester, NY 14624, 800–233–6339. (Formerly: LabCorp time as it is restored to full certification 585–429–2264. Occupational Testing Services, Inc.; under the Mandatory Guidelines. Advanced Toxicology Network, 3560 MedExpress/National Laboratory If any Laboratory/IITF has withdrawn Air Center Cove, Suite 101, Memphis, Center.) from the HHS National Laboratory TN 38118, 901–794–5770/888–290– LabOne, Inc. d/b/a Quest Diagnostics, Certification Program (NLCP) during the 1150. 10101 Renner Blvd., Lenexa, KS past month, it will be listed at the end Aegis Analytical Laboratories, 345 Hill 66219, 913–888–3927/800–873–8845. and will be omitted from the monthly Ave., Nashville, TN 37210, 615–255– (Formerly: Quest Diagnostics listing thereafter. 2400. (Formerly: Aegis Sciences Incorporated; LabOne, Inc.; Center for This notice is also available on the Corporation, Aegis Analytical Laboratory Services, a Division of Internet at http:// Laboratories, Inc.) LabOne, Inc.) www.workplace.samhsa.gov and http:// Alere Toxicology Services, 1111 Newton Maxxam Analytics,* 6740 Campobello www.drugfreeworkplace.gov. St., Gretna, LA 70053, 504–361–8989/ Road, Mississauga, ON, Canada L5N FOR FURTHER INFORMATION CONTACT: Mrs. 800–433 –3823. (Formerly: Kroll 2L8, 905–817–5700. (Formerly: Giselle Hersh, Division of Workplace Laboratory Specialists, Inc., Maxxam Analytics Inc., NOVAMANN Programs, SAMHSA/CSAP, Room Laboratory Specialists, Inc.) (Ontario), Inc.)

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MedTox Laboratories, Inc., 402 W. Toxicology Testing Service, Inc., 5426 DATES: Comment Due Date: December 2, County Road D, St. Paul, MN 55112, N.W. 79th Ave., Miami, FL 33166, 2011. 651–636–7466/800–832–3244. 305–593–2260. ADDRESSES: Interested persons are MetroLab-Legacy Laboratory Services, U.S. Army Forensic Toxicology Drug invited to submit comments regarding 1225 NE 2nd Ave., Portland, OR Testing Laboratory, 2490 Wilson St., this proposal. Comments should refer to 97232, 503–413–5295/800–950–5295. Fort George G. Meade, MD 20755– the proposal by name and/or OMB Minneapolis Veterans Affairs Medical 5235, 301–677–7085. Control Number and should be sent to: Center, Forensic Toxicology * The Standards Council of Canada (SCC) Rudene Thomas, Reports Liaison Laboratory, 1 Veterans Drive, voted to end its Laboratory Accreditation Officer, U.S. Department of Housing and Minneapolis, MN 55417, 612–725– Program for Substance Abuse (LAPSA) Urban Development, 451 Seventh Street, 2088. effective May 12, 1998. Laboratories certified SW., Room 7233, Washington, DC National Toxicology Laboratories, Inc., through that program were accredited to 20410–4500. 1100 California Ave., Bakersfield, CA conduct forensic urine drug testing as required by U.S. Department of FOR FURTHER INFORMATION CONTACT: 93304, 661–322–4250/800–350–3515. Ginger Macomber, SHOP Program One Source Toxicology Laboratory, Inc., Transportation (DOT) regulations. As of that Manager, Office of Affordable Housing 1213 Genoa-Red Bluff, Pasadena, TX date, the certification of those accredited Canadian laboratories will continue under Programs, U.S. Department of Housing 77504, 888–747–3774. (Formerly: DOT authority. The responsibility for and Urban Development, 451 Seventh University of Texas Medical Branch, conducting quarterly performance testing Street, SW., Room 7162, Washington, Clinical Chemistry Division; UTMB plus periodic on-site inspections of those DC 20410–4500; telephone 202–402– Pathology-Toxicology Laboratory.) LAPSA-accredited laboratories was 4605 (this is not a toll-free number) or Pacific Toxicology Laboratories, 9348 transferred to the U.S. HHS, with the HHS’ by e-mail at [email protected]. DeSoto Ave., Chatsworth, CA 91311, NLCP contractor continuing to have an active 800–328–6942. (Formerly: Centinela role in the performance testing and SUPPLEMENTARY INFORMATION: The Hospital Airport Toxicology laboratory inspection processes. Other Department is submitting the proposed Laboratory.) Canadian laboratories wishing to be information collection to OMB for Pathology Associates Medical considered for the NLCP may apply directly review, as required by the Paperwork to the NLCP contractor just as U.S. Laboratories, 110 West Cliff Dr., Reduction Act of 1995 (44 U.S.C. laboratories do. chapter 35, as amended). Spokane, WA 99204, 509–755–8991/ Upon finding a Canadian laboratory to be 800–541–7891 x7. This Notice is soliciting comments qualified, HHS will recommend that DOT from members of the public and affected Phamatech, Inc., 10151 Barnes Canyon certify the laboratory (Federal Register, July Road, San Diego, CA 92121, 858–643– 16, 1996) as meeting the minimum standards agencies concerning the proposed 5555. of the Mandatory Guidelines published in the collection of information to: (1) Evaluate Quest Diagnostics Incorporated, 1777 Federal Register on April 30, 2010 (75 FR whether the proposed collection of Montreal Circle, Tucker, GA 30084, 22809). After receiving DOT certification, the information is necessary for the proper 800–729–6432. (Formerly: SmithKline laboratory will be included in the monthly performance of the functions of the Beecham Clinical Laboratories; list of HHS-certified laboratories and agency, including whether the participate in the NLCP certification information will have practical utility; SmithKline Bio-Science Laboratories.) maintenance program. Quest Diagnostics Incorporated, 400 (2) Evaluate the accuracy of the agency’s Egypt Road, Norristown, PA 19403, Dated: September 21, 2011. estimate of the burden of the proposed 610–631–4600/877–642–2216. Elaine Parry, collection of information; (3) Enhance (Formerly: SmithKline Beecham Director, Office of Management, Technology, the quality, utility, and clarity of the Clinical Laboratories; SmithKline Bio- and Operations, SAMHSA. information to be collected; and (4) Science Laboratories.) [FR Doc. 2011–25225 Filed 9–30–11; 8:45 am] Minimize the burden of the collection of Quest Diagnostics Incorporated, 8401 BILLING CODE 4160–20–P information on those who are to Fallbrook Ave., West Hills, CA 91304, respond; including through the use of 800–877–2520. (Formerly: SmithKline appropriate automated collection Beecham Clinical Laboratories.) DEPARTMENT OF HOUSING AND techniques or other forms of information S.E.D. Medical Laboratories, 5601 Office URBAN DEVELOPMENT technology, e.g., permitting electronic Blvd., Albuquerque, NM 87109, 505– submission of responses. 727–6300/800–999–5227. [Docket No. FR–5481–N–13] The Self-Help Homeownership South Bend Medical Foundation, Inc., Opportunity Program (SHOP) is Notice of Proposed Information 530 N. Lafayette Blvd., South Bend, authorized by the Housing Opportunity Collection: Comment Request Self- IN 46601, 574–234–4176 x1276. Program Extension Act of 1996, Section Help Homeownership Opportunity Southwest Laboratories, 4625 E. Cotton 11. The purpose of SHOP is to provide Program (SHOP) Center Boulevard, Suite 177, Phoenix, grant funds to facilitate and encourage AZ 85040, 602–438–8507/800–279– AGENCY: Office of the Assistant innovative homeownership 0027. Secretary for Community Planning and opportunities on a national, St. Anthony Hospital Toxicology Development, HUD. geographically diverse basis through the Laboratory, 1000 N. Lee St., ACTION: Notice of proposed information provision of self-help homeownership Oklahoma City, OK 73101, 405–272– collection. housing programs. SHOP funds are 7052. appropriated by Congress, generally STERLING Reference Laboratories, 2617 SUMMARY: The proposed information annually. HUD publishes a SHOP East L Street, Tacoma, Washington collection requirement described below Notice of Funding Availability (NOFA) 98421, 800–442–0438. will be submitted to the Office of that announces the amount of SHOP Toxicology & Drug Monitoring Management and Budget (OMB) for grant funds and the application criteria, Laboratory, University of Missouri review, as required by the Paperwork including the rating and ranking system Hospital & Clinics, 301 Business Loop Reduction Act. The Department is HUD will use to select grantees. 70 West, Suite 208, Columbia, MO soliciting public comments on the SHOP grant funds may be used for 65203, 573–882–1273. subject proposal. land acquisition, the installation or

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improvement of infrastructure, and for This Notice also lists the following HUD–2990, HUD–2993, HUD–2995, reasonable and necessary planning, information: HUD–9601, HUD–96011. administration and management costs. Title of Proposal: Self-Help Members of Affected Public: National The average SHOP expenditure for the Homeownership Opportunity Program and regional non-profit self-help combined costs of land and (SHOP). housing organizations (including infrastructure must not exceed $15,000 OMB Control Number: 2506–0157. consortia) that apply for funds in per dwelling unit. SHOP homeowners Expiration Date: July 31, 2011. response to the SHOP NOFA. must contribute a significant amount of Description of the Need for the Estimation of the total number of sweat equity towards the purchase of Information and Proposed Use: This is hours needed to prepare the information their units. Donated volunteer labor is a proposed information collection for collection including number of also required. Assisted units must be submission requirements under the respondents, hours per response, decent, safe, and sanitary non-luxury SHOP Notice of Funding Availability frequency of response, and total hours (NOFA). HUD requires information in of response for all respondents. dwellings that comply with local order to ensure the eligibility of SHOP The estimates of the average hours building and safety codes and applicants and SHOP proposals, to rate needed to prepare the information standards. These units must be sold to and rank SHOP applications, and to collection are based on information eligible low-income homebuyers at select applicants for grant awards. provided by previous applicants. Actual prices below the prevailing market Information is collected on an annual hours will vary depending on the price. The homebuyer’s sweat equity basis from each applicant that responds proposed scope of the applicant’s contribution must not be mortgaged or to the SHOP NOFA. The SHOP NOFA program, the applicant’s geographic otherwise restricted upon future sale of requires applicants to submit specific service area and the number of affiliate the SHOP unit. SHOP grantees may forms and narrative responses. organizations. The information burden award SHOP funds to affiliates to carry Agency Form Numbers: HUD–424, is generally greater for national out the grantee’s SHOP program. HUD–424B, HUD–424CB, HUD–2880, organizations with numerous affiliates.

Number of Hours per Total annual Paperwork requirement respondents Frequency response hours

HUD–424 ...... 10 1 1 10 HUD–424B ...... 10 1 .5 5 HUD–424CB ...... 10 1 10 10 HUD–424 CBW ...... 10 1 30 300 SF–LLL ...... 10 1 .5 5 HUD–2880 ...... 10 1 .5 5 HUD–2990 ...... 10 1 1 .5 15 HUD–2993 ...... 10 1 .5 5 HUD–2995 ...... 10 1 .5 5 HUD–96010 ...... 10 1 20 200 HUD–96011 ...... 10 1 .5 5 Applicant Eligibility ...... 10 1 10 100 SHOP Program Design and Scope of Work ...... 10 1 30 300 Rating Factor 1 ...... 10 1 25 250 Rating Factor 2 ...... 10 1 25 250 Rating Factor 3 ...... 10 1 55 550 Rating Factor 4 ...... 10 1 30 300 Rating Factor 5 ...... 10 1 25 250

Total Annual Hour Burden ...... 265 .5 2,655

Frequency of Submission: Annually in DEPARTMENT OF HOUSING AND soliciting public comments on the response to the issuance of a SHOP URBAN DEVELOPMENT subject proposal. NOFA. DATES: Comments Due Date: December Status of the proposed information [Docket No. FR 5481–N–16] 2, 2011. collection: Extension of a currently approved collection. Notice of Proposed Information ADDRESSES: Interested persons are Collection: Comment Request; Annual invited to submit comments regarding Authority: Section 3506 of the Paperwork Progress Reports for Empowerment this proposal. Comments should refer to Reduction Act of 1995, 44 U.S.C. chapter 35, Zones the proposal by name and/or OMB as amended. Control Number and should be sent to: Dated: September 27, 2011. AGENCY: Office of Community Planning Colette Pollard, Departmental Reports Clifford Taffet, and Development, HUD. Management Officer, QDAM, General Deputy Assistant Secretary for ACTION: Notice. Department of Housing and Urban Community Planning and Development. Development, 451 Seventh Street, SW., [FR Doc. 2011–25410 Filed 9–30–11; 8:45 am] SUMMARY: The proposed information Room 4160, Washington, DC 20410; telephone: 202–708–0306, (this is not a BILLING CODE 4210–67–P collection requirement described below will be submitted to the Office of toll-free number) or e-mail Ms. Pollard Management and Budget (OMB) for at [email protected] for a copy review, as required by the Paperwork of the proposed form and other available Reduction Act. The Department is information.

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FOR FURTHER INFORMATION CONTACT: agency, including whether the an information collection for reporting Judith Mize, Office of Community information will have practical utility; requirements of 30 Urban Renewal, Office of Community Planning (2) Evaluate the accuracy of the agency’s Empowerment Zones (EZs). HUD will and Development, Department of estimate of the burden of the proposed regularly evaluate the progress of Housing and Urban Development, 451 collection of information; (3) Enhance implementation of the strategic plan in Seventh Street, SW., Washington, DC the quality, utility, and clarity of the each designated Empowerment Zone 20410; telephone (202) 402–4167 (this is information to be collected; and (4) (Rounds I, II and III) as required by not a toll-free number). Minimize the burden of the collection of HUD’s regulations (24 CFR 597.400 and SUPPLEMENTARY INFORMATION: The information on those who are to 24 CFR 598.415). The information Department will submit the proposed respond; including through the use of submitted will enable HUD to assess information collection to OMB for appropriate automated collection performance of designees and the review, as required by the Paperwork techniques or other forms of information effectiveness of the Empowerment Zone Reduction Act of 1995 (44 U.S.C. technology, e.g., permitting electronic Initiative. Chapter 35, as amended). submission of responses. Agency form numbers, if applicable: This Notice is soliciting comments This Notice also lists the following Members of affected public: State or from members of the public and affected information: local governments. agencies concerning the proposed Title of proposal: Annual Progress Estimation of the total number of collection of information to: (1) Evaluate Reports for Empowerment Zones. hours needed to prepare the information whether the proposed collection of OMB Control Number: 2506–0148. collection including number of information is necessary for the proper Description of the need for the respondents, frequency of response, and performance of the functions of the information and proposed use: This is hours of response:

Number of Frequency Annual Hours per Burden Paperwork requirement respondents of response responses response hours

Annual Reports: Round I EZs ...... 7 2 7 10 70 Round II EZs ...... 15 15 15 10 150 Round III EZs ...... 8 2 8 10 80 Response to a letter of warning ...... 0 2 ...... 4 8

Total ...... 30 ...... 30 ...... 308

Frequency of submission: Periodically academia, industry, and State DEPARTMENT OF THE INTERIOR and annually. government. The Committee shall Status of the proposed information advise the Director of the U.S. Bureau of Land Management collection: Extension of a currently Geological Survey (USGS) on matters [LLNV952000 L14200000.BJ0000 241A; 11– approved collection. relating to the USGS’s participation in 08807; MO#4500025674; TAS: 14X1109] Authority: section 3506 of the Paperwork the National Earthquake Hazards Reduction Act of 1995, 44 U.S.C. Chapter 35, Reduction Program. Filing of Plats of Survey; Nevada as amended. The Committee will receive updates AGENCY: Bureau of Land Management, Dated: September 22, 2011. and provide guidance on Earthquake Interior. Clifford Taffet, Hazards Program activities and the ACTION: Notice. General Deputy Assistant Secretary for status of teams supported by the Community Planning and Development. Program. SUMMARY: The purpose of this notice is to inform the public and interested state [FR Doc. 2011–25411 Filed 9–30–11; 8:45 am] Meetings of the Scientific Earthquake BILLING CODE 4210–67–P and local government officials of the Studies Advisory Committee are open to filing of plats of survey in Nevada. the public. DATES: Effective Dates: Filing is effective DEPARTMENT OF THE INTERIOR DATES: November 2–3, 2011, at 10:00 a.m. on the dates indicated commencing at 8:30 a.m. on the first day below. U.S. Geological Survey and adjourning at Noon on November 3, FOR FURTHER INFORMATION CONTACT: 2011. Scientific Earthquake Studies Advisory David D. Morlan, Chief, Branch of Committee Contact: Dr. William Leith, U.S. Geographic Sciences, Bureau of Land Geological Survey, MS 905, 12201 Management (BLM), Nevada State AGENCY: U.S. Geological Survey, Sunrise Valley Drive, Reston, Virginia Office, 1340 Financial Blvd., Reno, NV Interior. 20192, (703) 648–6786, [email protected]. 89502, phone: 775–861–6541. Persons ACTION: Notice of meeting. who use a telecommunications device Dated: September 21, 2011. for the deaf (TDD) may call the Federal SUMMARY: Pursuant to Public Law 106– David Applegate, Information Relay Service (FIRS) at 1– 503, the Scientific Earthquake Studies Associate Director for Natural Hazards. 800–877–8339 to contact the above Advisory Committee (SESAC) will hold [FR Doc. 2011–25401 Filed 9–30–11; 8:45 am] individual during normal business its next meeting at the Incorporated BILLING CODE P hours. The FIRS is available 24 hours a Research Institutions for Seismology, day, 7 days a week, to leave a message 1200 New York Avenue, Suite 800, or question with the above individual. Washington, DC 20005. The Committee You will receive a reply during normal is comprised of members from business hours.

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SUPPLEMENTARY INFORMATION: 1. The plat DEPARTMENT OF THE INTERIOR information from public review, we of survey of the following described cannot guarantee that we will be able to land will be officially filed at the BLM Bureau of Land Management do so. Nevada State Office in Reno on the first [LLOR957000–L63100000–HD0000: HAG11– Fred O’Ferrall, business day after 30 days from the 0349] Chief, Branch of Land, Mineral, and Energy publication of this notice: Resources. Filing of Plats of Survey: Oregon/ This plat represents the survey of a Washington [FR Doc. 2011–25363 Filed 9–30–11; 8:45 am] portion of the sub-divisional lines of BILLING CODE 4310–33–P Township 12 North, Range 30 East, AGENCY: Bureau of Land Management, Mount Diablo Meridian, Nevada, under Interior. Group No. 898, and was accepted on ACTION: Notice. DEPARTMENT OF JUSTICE September 1, 2011. This survey was executed to meet certain administrative SUMMARY: The plats of survey of the [OMB Number 1103–0098] needs of the Bureau of Indian Affairs following described lands are scheduled and the BLM. to be officially filed in the Bureau of Agency Information Collection Land Management Oregon/Washington Activities: Revision of a Previously 2. The plat of survey of the following State Office, Portland, Oregon, 30 days Approved Collection, With Change; described lands will be officially filed at from the date of this publication. Comments Requested COPS the BLM Nevada State Office in Reno on Application Package the first business day after 30 days from Willamette Meridian the publication of this notice: ACTION: 60-Day Notice of Information Oregon Collection Under Review. This plat represents the survey of a T. 25 S., R. 8 W., accepted September 6, 2011 portion of the sub-divisional lines of T. 30 S., R. 8 W., accepted September 6, 2011 The Department of Justice (DOJ) Township 13 North, Range 31 East, T. 30 S., R. 7 W., accepted September 6, 2011 Office of Community Oriented Policing Mount Diablo Meridian, Nevada, under T. 17 S., R. 1 W., accepted September 7, 2011 Services (COPS), will be submitting the Group No. 899, and was accepted on T. 15 S., R. 2 W., accepted September 7, 2011 following information collection request September 1, 2011. This survey was T. 13 S., R. 42 E., accepted September 7, 2011 T. 33 S., R. 3 W., accepted September 7, 2011 to the Office of Management and Budget executed to meet certain administrative T. 27 S., R. 3 W., accepted September 7, 2011 (OMB) for review and approval in needs of the Bureau of Indian Affairs T. 18 S., R. 1 W., accepted September 7, 2011 accordance with the Paperwork and the BLM. Reduction Act of 1995. The revision of ADDRESSES: A copy of the plats may be Subject to valid existing rights, the a previously approved information obtained from the Land Office at the provisions of existing withdrawals and collection is published to obtain Bureau of Land Management, Oregon/ classifications, the requirement of comments from the public and affected Washington State Office, 333 S.W. 1st agencies. applicable laws, and other segregations Avenue, Portland, Oregon 97204, upon of record, these lands are open to The purpose of this notice is to allow required payment. A person or party for 60 days for public comment until application, petition, and disposal, who wishes to protest against a survey December 2, 2011. This process is including application under the mineral must file a notice that they wish to conducted in accordance with 5 CFR leasing laws. All such valid applications protest (at the above address) with the 1320.10. received on or before the official filing Oregon/Washington State Director, If you have comments, especially on of the plats of survey described above, Bureau of Land Management, Portland, the estimated public burden or shall be considered as simultaneously Oregon. associated response time, suggestions, filed at that time. Applications received FOR FURTHER INFORMATION CONTACT: Kyle or need a copy of the proposed thereafter shall be considered in order of Hensley, (503) 808–6124, Branch of information collection instrument with filing. Geographic Sciences, Bureau of Land instructions or additional information, The above-listed surveys are now the Management, 333 S.W. 1st Avenue, please contact Ashley Hoornstra, basic record for describing the lands for Portland, Oregon 97204. Persons who Department of Justice Office of all authorized purposes. These surveys use a telecommunications device for the Community Oriented Policing Services, have been placed in the open files at the deaf (TDD) may call the Federal 145 N Street, NE., Washington, DC BLM Nevada State Office and are Information Relay Service (FIRS) at 1– 20530. available to the public as a matter of 800–877–8339 to contact the above Written comments and suggestions information. Copies of the surveys and individual during normal business from the public and affected agencies related field notes may be furnished to hours. The FIRS is available 24 hours a concerning the proposed collection of day, 7 days a week, to leave a message information are encouraged. Your the public upon payment of the or question with the above individual. comments should address one or more appropriate fees. You will receive a reply during normal of the following four points: Dated: September 16, 2011. business hours. —Evaluate whether the proposed David D. Morlan, SUPPLEMENTARY INFORMATION: Before collection of information is necessary Chief Cadastral Surveyor, Nevada. including your address, phone number, for the proper performance of the [FR Doc. 2011–25362 Filed 9–30–11; 8:45 am] e-mail address, or other personal functions of the agency, including BILLING CODE 4310–HC–P identifying information in your whether the information will have comment, you should be aware that practical utility; your entire comment—including your —Evaluate the accuracy of the agency’s personal identifying information—may estimate of the burden of the be made publicly available at any time. proposed collection of information, While you can ask us in your comment including the validity of the to withhold your personal identifying methodology and assumptions used;

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—Enhance the quality, utility, and DEPARTMENT OF LABOR carries out the mandates of section clarity of the information to be 105(b)(1) of the TVPRA, Public Law collected; and Office of the Secretary 109–164. For complete information on —Minimize the burden of the collection OCFT’s TVPRA activities, please visit Bureau of International Labor Affairs of information on those who are to the Web site listed above. respond, including through the use of Previous Federal Register notices Notice of Publication of 2011 Update to issued on this subject include: Notice of appropriate automated, electronic, The Department of Labor’s List of mechanical, or other technological Proposed Procedural Guidelines for the Goods From Countries Produced by Development and Maintenance of the collection techniques or other forms Child Labor or Forced Labor of information technology, e.g., List of Goods From Countries Pursuant permitting electronic submission of AGENCY: Bureau of International Labor to the Trafficking Victims Protection responses. Affairs, Department of Labor. Reauthorization Act of 2005 (72 Fed. Reg. 55808, Oct. 1, 2007); Notice of ACTION: Announcement of public Overview of This Information availability of updated list of goods. Procedural Guidelines for the Collection Development and Maintenance of the SUMMARY: This notice announces the List of Goods From Countries Produced (1) Type of Information Collection: publication of an updated list of by Child Labor or Forced Labor; Request Revision of a previously approved goods—along with countries of origin— for Information (72 FR 73374, Dec. 27, collection, with change; comments that the Bureau of International Labor 2007); Notice of Public Hearing To requested. Affairs (ILAB) has reason to believe are Collect Information To Assist in the (2) Title of the Form/Collection: COPS produced by child labor or forced labor Development of the List of Goods From Application Package. in violation of international standards. Countries Produced by Child Labor or (3) Agency form number, if any, and ILAB is required to develop and make Forced Labor (73 FR 21985, Apr. 23, the applicable component of the available to the public the List pursuant 2008); and Notice of Publication of The Department sponsoring the collection: to the Trafficking Victims Protection Department of Labor’s List of Goods None. U.S. Department of Justice Office Reauthorization Act (TVPRA) of 2005. From Countries Produced by Child of Community Oriented Policing FOR FURTHER INFORMATION CONTACT: Labor or Forced Labor (74 FR 46620, Services. Director, Office of Child Labor, Forced Sept. 10, 2009). (4) Affected public who will be asked Labor, and Human Trafficking, Bureau Signed at Washington, DC, this 20th day of or required to respond, as well as a brief of International Labor Affairs, U.S. September, 2011. abstract: Law enforcement agencies and Department of Labor at (202) 693–4843 Carol Pier, other public and private entities that (this is not a toll-free number). Associate Deputy Undersecretary for apply for COPS Office grants or SUPPLEMENTARY INFORMATION: The International Affairs. cooperative agreements will be asked Bureau of International Labor Affairs [FR Doc. 2011–24625 Filed 9–30–11; 8:45 am] complete the COPS Application announces the publication of a second BILLING CODE 4510–28–P Package. The COPS Application Package update to the List of Goods Produced by includes all of the necessary forms and Child Labor or Forced Labor (List), instructions that an applicant needs to pursuant to the TVPRA of 2005. The DEPARTMENT OF LABOR review and complete to apply for COPS TVPRA mandated that ILAB develop Employment and Training grant funding. The package is used as a and publish a list of goods from Administration standard template for all COPS countries that ILAB ‘‘has reason to believe are produced with child labor or programs. Migrant and Seasonal Farmworkers forced labor in violation of international (5) An estimate of the total number of (MSFWs) Monitoring Report and One- standards.’’ ILAB published the initial respondents and the amount of time Stop Career Center Complaint/Referral List on September 10, 2009, and estimated for an average respondent to Record: Comments published its first update on December respond/reply: It is estimated that 4,200 15, 2010. This update adds 2 new goods AGENCY: respondents annually will complete the Employment and Training and 1 new country to the List and adds form within 9.4 hours. Administration, Labor. additional products from countries ACTION: Notice. (6) An estimate of the total public already on the list. With this update, the burden (in hours) associated with the List has a total of 130 goods from 71 SUMMARY: The Department of Labor, as collection: There are an estimated 39 countries. part of its continuing effort to reduce total annual burden hours associated The primary purposes of the List are paperwork and respondent burden, with this collection. to raise public awareness about the conducts a pre-clearance consultation If additional information is required incidence of child labor and forced program to provide the general public contact: Jerri Murray, Department labor in the production of goods in the and Federal agencies with an Clearance Officer, United States countries listed and to promote efforts opportunity to comment on proposed Department of Justice, Justice to eliminate such practices. A full and/or continuing collections of Management Division, Policy and report, including the updated List and a information in accordance with the Planning Staff, Two Constitution discussion of the List’s context, scope, Paperwork Reduction Act of 1995 Square, 145 N Street, NE., Room 2E– methodology, and limitations, as well as (PRA95) [44 U.S.C. 3506(c)(2)(A)]. This 508, Washington, DC 20530. Frequently Asked Questions and a program helps to ensure that requested bibliography of sources, are available on data can be provided in the desired Jerri Murray, the DOL Web site at: http:// format, reporting burden (time and Department Clearance Officer, PRA, U.S. www.dol.gov/ilab/programs/ocft/ financial resources) is minimized, Department of Justice. tvpra.htm. collection instruments are clearly [FR Doc. 2011–25337 Filed 9–30–11; 8:45 am] ILAB’s Office of Child Labor, Forced understood, and the impact of collection BILLING CODE 4410–AT–P Labor, and Human Trafficking (OCFT) requirements on respondents can be

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properly assessed. Currently, the compliance with 20 CFR 653.109, the OMB Number: 1205–0039. Employment and Training Department of Labor established record Affected Public: State. Administration (ETA) is soliciting keeping requirements to allow for the Type of Response: Mandatory. comments concerning the proposed efficient and effective monitoring of Number of Respondents: (See Below). extension of the expiration date without State Workforce Agencies’ (SWA) Annual Responses: (See Below). revision for ETA Form 5148, Services to regulatory compliance. The ETA Form Breakdown of Burden Hours: (See Migrant and Seasonal Farm Workers 5148, Services to Migrant and Seasonal Below). Report, and an extension with revision Farmworkers Report, is used to collect for ETA Form 8429, One-Stop Career data which are primarily used to Complaint Form 8429 Center Complaint/Referral Record, to monitor and measure the extent and 1. Recordkeeping March 1, 2015. The changes effectiveness of SWA service delivery to incorporated to ETA Form 8429 include MSFWs. The ETA Form 8429, One-Stop Number of record keepers: 50 states. the following: (1) In Part I, of item 8, Career Center Complaint/Referral Annual number of records: 3,000 (60 increased the space provided for Record, is used to collect and document reports per state, 50 states × ports). description of complaint, (2) in Part II, complaints filed by MSFWs and non- Annual hours per record keeper: .13 of items 2 and 3, added the word ‘‘Job MSFWs pursuant to the regulatory (8 minutes per report). Service,’’ and (3) Part II, item 9 at the framework established at 20 CFR Total record-keeper hours: 400 (3,000 bottom added ‘‘Complaint resolved? 658.400. reports × 8 min. per report). b Yes b No—If ‘‘No,’’ explain.’’ II. Desired Focus of Comments The current Office of Management 2. Processing Currently, ETA is soliciting comments and Budget (OMB) Information Annual average number of forms: concerning the proposed extension of Collection Request (ICR) authorization 3,000. the Services to Migrant and Seasonal number 1205–0039 expires on February Minutes per form: 120 (2 hrs.). 29, 2012. A copy of the proposed ICR Farm Workers Report, ETA Form 5148, and the One-Stop Career Center Total processing hours: 6,000 (3,000 can be obtained by contacting the office reports at 2 hours each). listed below in the addressee section of Complaint/Referral Record, ETA Form Estimated Total Burden Hours for this notice or by accessing: http:// 8429 to March 1, 2015, which: • ETA 8429: 6,400 ¥ (400 + 6,000). www.doleta.gov/OMBCN/ Evaluate whether the proposed OMBControlNumber.cfm. collection of information is necessary Comments: Not all complaints that are for the proper performance of the logged utilize the Employment Service DATES: Submit comments on or before functions of the agency, including Complaint/Referral Record, ETA Form December 2, 2011. whether the information will have 8429. The SWA’s are only required to ADDRESSES: Send comments to: practical utility; utilize this form for MSFW complaints Kimberly Vitelli, U.S. Department of • Evaluate the accuracy of the and ES related complaints from non- Labor, Employment and Training agency’s estimate of the burden of the MSFWs. Based upon contacts with Administration, Office of Workforce proposed collection of information, those states with the highest level of Investment, 200 Constitution Avenue, including the validity of the reported complaint activity, we believe NW., Room C–4510, Washington, DC methodology and assumptions used; that approximately 3,000 complaints 20210, telephone number: 202–693– • Enhance the quality, utility, and were captured on the ETA Forms 8429 3045, fax: 202–693–3015, and e-mail clarity of the information to be in the previous program year. address: [email protected]. collected; and • 5148 Report FOR FURTHER INFORMATION CONTACT: Juan Minimize the burden of the Regalado, U.S. Department of Labor, collection of information on those who 1. Recordkeeping Employment and Training are to respond by including the use of Number of record-keepers: 50 states. Administration, Office of Workforce appropriate automated, electronic, mechanical, or other technological Annual number of records: 200 Investment, Division of National × Programs, Tools and Technical collection techniques or other forms of (record keepers = 50 reports = 4 = Assistance, Migrant and Seasonal information technology, e.g., permitting 200). Farmworkers Monitor Advocate, Room electronic submissions of responses. Estimated hours per record-keeper: S–4209, 200 Constitution Avenue, NW., A copy of the proposed Information 1.16 (70 minutes per report). Washington, DC 20210, telephone Collection Request (ICR) can be Total Record-keeping hours: 233.3. obtained by contacting the office listed number 202–693–2661, fax: 202–693– 2. Compilation and Reporting 3945, and e-mail address: above in the addressee section of this notice. [email protected]. Number of Respondents: 50. Annual number of reports: 4. SUPPLEMENTARY INFORMATION: III. Current Actions Total number of reports: 200. Type of Review: Extension with I. Background revision of a currently approved Estimated minutes per report: 90 (1.5 Wagner-Peyser regulations at 20 CFR collection. hrs.). 651, 653, and 658 set forth requirements Agency: Employment and Training Total Record-keeping hours: 300 (200 × to ensure that Migrant and Seasonal Administration. reports 90 minutes = 18,000/60). Farmworkers (MSFWs) receive services Title: Migrant and Seasonal Estimated Total Burden Hours for that are qualitatively equivalent and Farmworker (MSFW) Monitoring Report ETA 5148: 533 (233 + 300). quantitatively proportionate to the and One-Stop Career Center Complaint/ Estimated Total Burden Cost: services provided to non-MSFWs. In Referral Record. $172,211:

Total annual Annual Total bur- hours One FTE FTE salary den cost

SMA—5148 ...... 533 1,920 0.28 $65,000 $18,044

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Total annual Annual Total bur- hours One FTE FTE salary den cost

Local OSC—8429 ...... 6,000 1,920 3.13 45,000 140,625 SMA—8429 ...... 400 1,920 0.21 65,000 13,542

Total Burden Cost for 8429 & 5148 ...... 172,211

A local One-Stop Center Record (SMA) is $65,000 for Record Keeping, on ETA 8429 and ETA 5148 Keeper average annual salary is $45,000 Processing, Compilation and Reporting respectively. and for the State Monitor Advocate

Working Monthly Months in Hours per Hours per day days hours year year

8 ...... 20 160 12 1,920

Comments: The calculations are based SUMMARY: The National Science of Oceanography, Eller Oceanography & on a normal work week for most jobs are Foundation (NSF) is required to publish Meteorology Bldg., Rm. 608, 3146 8 hours a day for 5 days. a notice of permit applications received TAMU, College Station, TX 77843– There are 52 weeks in a year but most to conduct activities regulated under the 3146. workers get a two week vacation. So, 8 Antarctic Conservation Act of 1978. Activity for Which Permit Is Requested × 5 × 50 = 2000 hours worked in a year. NSF has published regulations under Many companies also give 10 the Antarctic Conservation Act at Title Enter Antarctic Specially Protected holidays, which brings it down to: 8 × 45 part 670 of the Code of Federal Areas. The applicant plans to enter the 5 × 48 = 1920. Regulations. This is the required notice Antarctic Specially Protect Areas of Hut Also the calculations are based on the of permit applications received. Point, Ross Island (ASPA 158), Arrival average median salary of one local one- DATES: Interested parties are invited to Heights, Ross Island (ASPA 122), stop center record keeper’s of $45,000 submit written data, comments, or Backdoor Bay, Cape Royds (ASPA 157), per year and the average median salary views with respect to this permit and New College Valley, Cape Bird of a State Monitor Advocate of $65,000 application by November 2, 2011. This (ASPA 116). These sites are specifically per year, and the estimated hours application may be inspected by targeted because of the nature of their expended in record keeping and interested parties at the Permit Office, geology, climatic influences and processing on ETA Form 8429 and ETA address below. topography. Backdoor Bay (ASPA 157) Form 5148 respectively, providing the and New College Valley (ASPA 116) are ADDRESSES: Comments should be grand total of burden cost reflected two sampling sites used as reference addressed to Permit Office, Room 755, above. controls for the study of the temporal Office of Polar Programs, National Comments submitted in response to and spatial scales of various types of Science Foundation, 4201 Wilson this notice will be summarized and/or disturbances in and around McMurdo Boulevard, Arlington, Virginia 22230. included in the request for Office of Station. The sampling locations at Management and Budget approval of the FOR FURTHER INFORMATION CONTACT: Backdoor Bay and New College Valley information collection request; they will Polly A. Penhale at the above address or will be situated to avoid disturbance to also become a matter of public record. (703) 292–7420. biota in the area. The other sites, Arrival Dated: Washington, DC, this 21st day of SUPPLEMENTARY INFORMATION: The Heights (ASPA 122) and Hut Point September, 2011. National Science Foundation, as (ASPA 158 have been sampled in Jane Oates, directed by the Antarctic Conservation previous field seasons and are slated to Assistant Secretary, Employment and Act of 1978 (Pub. L. 95–541), as be sampled as part of the ongoing Training Administration. amended by the Antarctic Science, environmental monitoring program. Tourism and Conservation Act of 1996, [FR Doc. 2011–25388 Filed 9–30–11; 8:45 am] Location has developed regulations for the BILLING CODE 4510–FN–P establishment of a permit system for Hut Point, Ross Island (ASPA 158), various activities in Antarctica and Arrival Heights, Ross Island (ASPA designation of certain animals and 122), Backdoor Bay, Cape Royds (ASPA NATIONAL SCIENCE FOUNDATION certain geographic areas as requiring 157), and New College Valley, Cape Bird (ASPA 116). Notice of Permit Applications Received special protection. The regulations Under the Antarctic Conservation Act establish such a permit system to Dates of 1978 (Pub. L. 95–541) designate Antarctic Specially Protected Areas. November 11, 2011 to December 31, AGENCY: National Science Foundation. The applications received are as 2011. ACTION: Notice of Permit Applications follows: Nadene G. Kennedy, Received under the Antarctic Permit Application: 2012–010 Permit Officer, Office of Polar Programs. Conservation Act of 1978, Public Law [FR Doc. 2011–25320 Filed 9–30–11; 8:45 am] 95–541. 1. Applicant: Mahlon C. Kennicutt, II, Professor of Oceanography, Department BILLING CODE 7555–01–P

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NATIONAL SCIENCE FOUNDATION for the South Texas Project (STP) Units Dated: September 27, 2011. 3 and 4. The Subcommittee will hear Yoira Diaz-Sanabria, Advisory Committee for Computer and presentations by and hold discussions Technical Assistant, Technical Support Information Science and Engineering; with the NRC staff, South Texas Project Branch, Advisory Committee on Reactor Notice of Meeting Nuclear Operating Company (STPNOC), Safeguards. In accordance with the Federal and other interested persons. The [FR Doc. 2011–25384 Filed 9–30–11; 8:45 am] Advisory Committee Act (Pub. L. 92– Subcommittee will gather information, BILLING CODE 7590–01–P 463, as amended), the National Science analyze relevant issues and facts, and formulate proposed positions and Foundation announces the following NUCLEAR REGULATORY actions, as appropriate, for deliberation meeting: COMMISSION Name: Advisory Committee for Computer by the Full Committee. and Information Science and Engineering Members of the public desiring to Advisory Committee on Reactor (1115). provide oral statements and/or written Safeguards; Revised Meeting Notice Date and Time: November 1, 2011 from 12 comments should notify the Designated p.m.–5:30 p.m. November 2, 2011 from 8 The Agenda for the 587th ACRS Federal Official (DFO), Maitri Banerjee a.m.–12 p.m. meeting, scheduled to be held on Place: National Science Foundation, 4201 (Telephone 301–415–6973 or E-mail: October 6–8, 2011, has been revised as Wilson Blvd., Room 1235, Arlington, VA. [email protected]) five days prior noted below. Notice of this meeting was Type of Meeting: Open. to the meeting, if possible, so that previously published in the Federal Contact Person: Carmen Whitson, appropriate arrangements can be made. Register on September 26, 2011 (76 FR Directorate for Computer and Information Thirty five hard copies of each 59449–59450). Science and Engineering, National Science presentation or handout should be Foundation, 4201 Wilson Blvd., Suite 1105, The discussion on the Development of Arlington, VA 22230. Telephone: (703) 292– provided to the DFO thirty minutes Draft Fire Human Reliability Analysis 8900. before the meeting. In addition, one (HRA) Guidelines—NUREG–1921 Minutes: May be obtained from the contact electronic copy of each presentation scheduled to be held on Friday, October person listed above. should be e-mailed to the DFO one day 7, 2011 between 10:15 a.m. and 11:45 Purpose of Meeting: To advise NSF on the before meeting. If an electronic copy a.m. is being postponed to a future impact of its policies, programs and activities cannot be provided within this meeting. The Preparation of ACRS on the CISE community. To provide advice Reports will now start at 10:15 a.m. on to the Assistant Director for CISE on issues timeframe, presenters should provide related to long-range planning, and to form the DFO with a CD containing each Friday, October 7, 2011. ad hoc subcommittees to carry out needed presentation at least thirty minutes A revised agenda is posted on the studies and tasks. before the meeting. Electronic NRC Web site at http://www.nrc.gov/ reading-rm/adams.html or http:// Dated: September 28, 2011. recordings will be permitted only during those portions of the meeting www.nrc.gov/reading-rm/doc- Susanne Bolton, collections/ACRS/. Committee Management Officer. that are open to the public. Detailed procedures for the conduct of and Further information regarding this [FR Doc. 2011–25355 Filed 9–30–11; 8:45 am] participation in ACRS meetings were meeting can be obtained by contacting BILLING CODE 7555–01–P published in the Federal Register on Ms. Ilka Berrios of the ACRS staff (Telephone: 301–415–3179, E-mail: October 21, 2010, (75 FR 65038–65039). [email protected]). Detailed meeting agendas and meeting NUCLEAR REGULATORY Dated: September 27, 2011. COMMISSION transcripts are available on the NRC Andrew L. Bates, Web site at http://www.nrc.gov/reading- Advisory Committee on Reactor rm/doc-collections/acrs. Information Advisory Committee Management Officer. Safeguards (ACRS) regarding topics to be discussed, [FR Doc. 2011–25387 Filed 9–30–11; 8:45 am] changes to the agenda, whether the BILLING CODE 7590–01–P Meeting of the ACRS Subcommittee on meeting has been canceled or Advanced Boiling Water Reactor; Notice of Meeting rescheduled, and the time allotted to NUCLEAR REGULATORY present oral statements can be obtained COMMISSION The ACRS Subcommittee on from the Web site cited above or by Advanced Boiling Water Reactor contacting the identified DFO. Advisory Committee on Reactor (ABWR) will hold a meeting on October Moreover, in view of the possibility that Safeguards (ACRS) Meeting of the 4, 2011, Room T–2B1, 11545 Rockville the schedule for ACRS meetings may be ACRS Subcommittee on Plant Pike, Rockville, MD. adjusted by the Chairman as necessary Operations and Fire Protection; Notice The entire meeting will be open to to facilitate the conduct of the meeting, of Meeting public attendance, with the exception of persons planning to attend should check The ACRS Subcommittee on Plant a portion that may be closed to protect with these references if such Operations and Fire Protection will hold information that is proprietary pursuant rescheduling would result in a major to 5 U.S.C. 552b(c)(4). a meeting on October 5, 2011, Room T– inconvenience. The agenda for the subject meeting 2B3, 11545 Rockville Pike, Rockville, shall be as follows: If attending this meeting, please enter MD. Tuesday, October 4, 2011—8:30 a.m. through the One White Flint North The entire meeting will be open to until 2 p.m. building, 11555 Rockville Pike, public attendance, with the exception of The Subcommittee will review Rockville, MD. After registering with a portion that may be closed to protect proposed resolution of ACRS Action security, please contact Mr. Theron information that is proprietary pursuant Items related to long term cooling and Brown (240–888–9835) to be escorted to to 5 U.S.C. 552b(c)(4). other issues associated with the the meeting room. The agenda for the subject meeting Combined License Application (COLA) shall be as follows:

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Wednesday, October 5, 2011—8:30 Dated: 09/27/2011. Information regarding topics to be a.m. thru 5 p.m. Yoira Diaz-Sanabria, discussed, changes to the agenda, The Subcommittee will review the Technical Assistant, Reactor Safety Branch, whether the meeting has been canceled supplemental Safety Evaluation Reports Advisory Committee on Reactor Safeguards. or rescheduled, and the time allotted to (SERs) associated with the staff’s review [FR Doc. 2011–25392 Filed 9–30–11; 8:45 am] present oral statements can be obtained of the Watts Bar Unit 2 Operating BILLING CODE 7590–01–P from the website cited above or by License application. The Subcommittee contacting the identified DFO. will hear presentations by and hold Moreover, in view of the possibility that discussions the NRC staff and other NUCLEAR REGULATORY the schedule for ACRS meetings may be interested persons regarding this matter. COMMISSION adjusted by the Chairman as necessary The Subcommittee will gather to facilitate the conduct of the meeting, information, analyze relevant issues and Advisory Committee on Reactor persons planning to attend should check facts, and formulate proposed positions Safeguards (ACRS) Meeting of the with these references if such and actions, as appropriate, for ACRS Subcommittee on Planning and rescheduling would result in a major deliberation by the Full Committee. Procedures; Notice of Meeting inconvenience. If attending this meeting, please enter Members of the public desiring to The ACRS Subcommittee on Planning through the One White Flint North provide oral statements and/or written and Procedures will hold a meeting on building, 11555 Rockville Pike, comments should notify the Designated October 5, 2011, Room T–2B3, 11545 Rockville, MD. After registering with Federal Official (DFO), Girija Shukla Rockville Pike, Rockville, Maryland. (Telephone 301–415–6855 or e-mail: The entire meeting will be open to security, please contact Mr. Theron [email protected] five days prior to public attendance, with the exception of Brown (240–888–9835) to be escorted to the meeting, if possible, so that a portion that may be closed pursuant the meeting room. appropriate arrangements can be made. to 5 U.S.C. 552b (c)(2) and (6) to discuss Dated: 09/27/2011. Thirty-five hard copies of each organizational and personnel matters Yoira Diaz-Sanabria, presentation or handout should be that relate solely to the internal Technical Assistant, Reactor Safety Branch, provided to the DFO thirty minutes personnel rules and practices of the Advisory Committee on Reactor Safeguards. before the meeting. In addition, one ACRS, and information the release of [FR Doc. 2011–25390 Filed 9–30–11; 8:45 am] electronic copy of each presentation which would constitute a clearly BILLING CODE 7590–01–P should be emailed to the DFO one day unwarranted invasion of personal before the meeting. If an electronic copy privacy. cannot be provided within this The agenda for the subject meeting NUCLEAR REGULATORY timeframe, presenters should provide shall be as follows: COMMISSION the DFO with a CD containing each Wednesday, October 5, 2011—12 p.m. presentation at least thirty minutes until 1 p.m. Advisory Committee on Reactor before the meeting. Electronic The Subcommittee will discuss Safeguards (ACRS) Meeting of the recordings will be permitted only proposed ACRS activities and related ACRS Subcommittee on Radiation during those portions of the meeting matters. The Subcommittee will gather Protection and Nuclear Materials; that are open to the public. Detailed information, analyze relevant issues and Notice of Meeting procedures for the conduct of and facts, and formulate proposed positions The ACRS Subcommittee on participation in ACRS meetings were and actions, as appropriate, for Radiation Protection and Nuclear published in the Federal Register on deliberation by the Full Committee. Materials will hold a meeting on October 21, 2010, (75 FR 65038–65039). Members of the public desiring to October 4, 2011, Room T–2B1, 11545 Detailed meeting agendas and meeting provide oral statements and/or written Rockville Pike, Rockville, Maryland. transcripts are available on the NRC comments should notify the Designated The entire meeting will be open to Web site at http://www.nrc.gov/reading- Federal Official (DFO), Mrs. Ilka Berrios public attendance. rm/doc-collections/acrs. Information (Telephone 301–415–3179 or E-mail: The agenda for the subject meeting regarding topics to be discussed, [email protected]) five days prior to shall be as follows: changes to the agenda, whether the the meeting, if possible, so that Tuesday, October 4, 2011—2 p.m. meeting has been canceled or appropriate arrangements can be made. until 4:30 p.m. rescheduled, and the time allotted to Thirty-five hard copies of each The Subcommittee will review the present oral statements can be obtained presentation or handout should be revised Branch Technical Position on from the website cited above or by provided to the DFO thirty minutes Concentration Averaging and contacting the identified DFO. before the meeting. In addition, one Encapsulation regarding the Moreover, in view of the possibility that electronic copy of each presentation circumstances under which large scale the schedule for ACRS meetings may be should be emailed to the DFO one day blending of low-level radioactive waste, adjusted by the Chairman as necessary before the meeting. If an electronic copy as described in SECY–10–0043, is to facilitate the conduct of the meeting, cannot be provided within this acceptable. The Subcommittee will hear persons planning to attend should check timeframe, presenters should provide presentations by and hold discussions with these references if such the DFO with a CD containing each with the NRC staff and other interested rescheduling would result in a major presentation at least thirty minutes persons regarding this matter. The inconvenience. before the meeting. Electronic Subcommittee will gather information, If attending this meeting, please enter recordings will be permitted only analyze relevant issues and facts, and through the One White Flint North during those portions of the meeting formulate proposed positions and building, 11555 Rockville Pike, that are open to the public. Detailed actions, as appropriate, for deliberation Rockville, MD. After registering with procedures for the conduct of and by the Full Committee. security, please contact Mr. Theron participation in ACRS meetings were Members of the public desiring to Brown (240–888–9835) to be escorted to published in the Federal Register on provide oral statements and/or written the meeting room. October 21, 2010, (75 FR 65038–65039). comments should notify the Designated

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Federal Official (DFO), Derek Widmayer ACTION: Notice of intent to prepare a The proposal under consideration (Telephone 301–415–7366 or E-mail: Programmatic Environmental includes studying nearly 250 processing [email protected]) five days Assessment; Notice of Public Scoping facilities for possible consolidation or prior to the meeting, if possible, so that Period. closure, reducing mail processing appropriate arrangements can be made. equipment by as much as 50 percent, Thirty-five hard copies of each SUMMARY: To comply with the dramatically decreasing the nationwide presentation or handout should be requirements of the National transportation network, adjusting the provided to the DFO thirty minutes Environmental Policy Act (NEPA), the workforce size by as many as 35,000 before the meeting. In addition, one Postal Service intends to prepare a positions, and revising service standards electronic copy of each presentation Programmatic Environmental for mail services, including First-Class should be emailed to the DFO one day Assessment (PEA) to assess the Network Mail from 1–3 days to 2–3 days. before the meeting. If an electronic copy Optimization initiative (the ‘‘Proposed Alternatives that will be evaluated by cannot be provided within this Action’’), which would create a more the Postal Service in the PEA include timeframe, presenters should provide streamlined processing and distribution the above-described Proposed Action the DFO with a CD containing each network using fewer facilities to handle and a ‘‘No Action’’ alternative. Under presentation at least thirty minutes reduced mail volume. The proposal also the ‘‘No Action’’ alternative, the Postal before the meeting. Electronic includes revisions to mailing standards. Service would maintain its current recordings will be permitted only This PEA will evaluate the processing and distribution network and during those portions of the meeting environmental impacts of the proposed service standards. The Postal Service that are open to the public. Detailed action versus taking no action. Public may consider other reasonable procedures for the conduct of and input is sought on the scope of alternatives identified during the public participation in ACRS meetings were environmental issues to be addressed in scoping process. published in the Federal Register on the PEA. Additional information about the October 21, 2010, (75 FR 65038–65039). DATES: Written scoping comments must Network Optimization initiative, Detailed meeting agendas and meeting be submitted by October 30, 2011. It is including a list of the facilities being transcripts are available on the NRC estimated that the Programmatic studied for closure and consolidation, is Web site at http://www.nrc.gov/reading- Environmental Assessment will be located at the following URL: http:// rm/doc-collections/acrs. Information completed by January 20, 2012. about.usps.com/news/electronic-press- regarding topics to be discussed, ADDRESSES: Interested parties may kits/our-future-network/welcome.htm. changes to the agenda, whether the submit written scoping comments or Hard copies of this information are meeting has been canceled or direct questions or requests for available upon request. rescheduled, and the time allotted to additional information to: Thomas G. Stanley F. Mires, present oral statements can be obtained Day, Chief Sustainability Officer, United Attorney, Legal Policy & Legislative Advice. from the website cited above or by States Postal Service, 475 L’Enfant [FR Doc. 2011–25331 Filed 9–30–11; 8:45 am] contacting the identified DFO. Plaza, SW., Room 2737, Washington DC, BILLING CODE 7710–12–P Moreover, in view of the possibility that 20260; (202) 268–7488. the schedule for ACRS meetings may be SUPPLEMENTARY INFORMATION: adjusted by the Chairman as necessary Purpose. This notice concerns the SECURITIES AND EXCHANGE to facilitate the conduct of the meeting, Network Optimization initiative and the COMMISSION persons planning to attend should check intent of the Postal Service, pursuant to with these references if such the requirements of the National Submission for OMB Review; rescheduling would result in a major Environmental Policy Act (NEPA) of Comment Request inconvenience. 1969, its implementing procedures at 39 If attending this meeting, please enter CFR 775, and the President’s Council on Upon Written Request, Copies Available through the One White Flint North Environmental Quality Regulations (40 From: Securities and Exchange building, 11555 Rockville Pike, CFR Parts 1500–1508), to prepare a Commission, Office of Investor Rockville, MD. After registering with Programmatic Environmental Education and Advocacy, security, please contact Mr. Theron Assessment to evaluate the Washington, DC 20549–0213. Brown (240–888–9835) to be escorted to environmental impacts of the proposed Extension: the meeting room. action versus taking ‘‘no action.’’ Rule 10A–1; SEC File No. 270–425; OMB Dated: September 21, 2011. Proposed Action. The Postal Service Control No. 3235–0468. Yoira Diaz-Sanabria, is exploring options to accelerate Notice is hereby given that, pursuant Technical Assistant, Technical Support ongoing network optimization efforts. to the Paperwork Reduction Act of 1995 Branch, Advisory Committee on Reactor The recently announced Network (44 U.S.C. 3501 et seq.), the Securities Safeguards. Optimization initiative (herein referred and Exchange Commission [FR Doc. 2011–25386 Filed 9–30–11; 8:45 am] to as the ‘‘Proposed Action’’) seeks to (‘‘Commission’’) has submitted to the BILLING CODE 7590–01–P create a more streamlined processing Office of Management and Budget and distribution network, using fewer (‘‘OMB’’) a request for extension of the facilities to handle the reduced mail previously approved collection of volume. This initiative also includes information discussed below. POSTAL SERVICE proposals to revise mailing standards to Rule 10A–1 (17 CFR 240.10A–1) Notice of Intent To Prepare a better reflect the capacity of a new, implements the reporting requirements Programmatic Environmental smaller network and may result in in Section 10A of the Exchange Act (15 Assessment for Proposed Network numerous mail processing facility U.S.C. 78j–1), which was enacted by Optimization, Nationwide; Notice of closures and network consolidations. Congress on December 22, 1995 as part Public Scoping Period The Proposed Action will be addressed of the Private Securities Litigation programmatically under the National Reform Act of 1995, Public Law 104–67, AGENCY: Postal Service. Environmental Policy Act (NEPA). 109 Stat 737. Under section 10A and

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Rule 10A–1 reporting occurs only if a must be submitted to OMB within 30 Commission received 18 comments on registrant’s board of directors receives a days of this notice. the proposed Plan.5 6 report from its auditor that (1) There is Dated: September 26, 2011. Rule 608 under Section 11A of the Act 7 provides that within 120 days of an illegal act material to the registrant’s Elizabeth M. Murphy, financial statements, (2) senior the date of publication of notice of filing Secretary. management and the board have not of a national market system plan or an taken timely and appropriate remedial [FR Doc. 2011–25368 Filed 9–30–11; 8:45 am] amendment to an effective national action, and (3) the failure to take such BILLING CODE 8011–01–P market system plan, or within such action is reasonably expected to warrant longer period as the Commission may the auditor’s modification of the audit designate up to 180 days of such date if SECURITIES AND EXCHANGE report or resignation from the audit it finds such longer period to be COMMISSION engagement. The board of directors appropriate and publishes its reasons must notify the Commission within one [Release No. 34–65410; File No. 4–631] business day of receiving such a report. 5 See Letter from Steve Wunsch, Wunsch Auction If the board fails to provide that notice, Joint Industry Plan; Notice of Associates, LLC, to Elizabeth M. Murphy, Secretary, Designation of a Longer Period for Commission, dated June 2, 2011; Letter from Peter then the auditor, within the next J. Driscoll, Investment Professional, Chicago, IL, to business day, must provide the Commission Action on the National Elizabeth M. Murphy, Secretary, Commission, dated Commission with a copy of the report Market System Plan To Address June 17, 2011; Letter from Stuart J. Kaswell, Extraordinary Market Volatility by Executive Vice President & Managing Director, that it gave to the board. General Counsel, Managed Funds Association, to Likely respondents are those BATS Exchange, Inc., BATS Y– Elizabeth M. Murphy, Secretary, Commission, dated registrants filing audited financial Exchange, Inc., Chicago Board June 21, 2011; Letter from George U. Sauter, statements under the Securities Options Exchange, Incorporated, Managing Director and Chief Investment Officer, Chicago Stock Exchange, Inc., EDGA The Vanguard Group, Inc., to Elizabeth M. Murphy, Exchange Act of 1934 (15 U.S.C. 78a, et Secretary, Commission, dated June 22, 2011; Letter seq.) and the Investment Company Act Exchange, Inc., EDGX Exchange, Inc., from Karrie McMillan, General Counsel, Investment of 1940 (15 U.S.C. 80a–1, et seq.). Financial Industry Regulatory Company Institute, to Elizabeth M. Murphy, It is estimated that Rule 10A–1 results Authority, Inc., NASDAQ OMX BX, Inc., Secretary, Commission, dated June 22, 2011; Letter NASDAQ OMX PHLX LLC, The Nasdaq from Manisha Kimmel, Executive Director, in an aggregate additional reporting Financial Information Forum, to Elizabeth M. burden of 10 hours per year. The Stock Market LLC, National Stock Murphy, Secretary, Commission, dated June 22, estimated average burden hours are Exchange, Inc., New York Stock 2011; Letter from Craig S. Donohue, Chief Executive solely for purposes of the Paperwork Exchange LLC, NYSE Amex LLC, and Officer, CME Group Inc., to Elizabeth M. Murphy, NYSE Arca, Inc. Secretary, Commission, dated June 22, 2011; Letter Reduction Act and are not derived from from Joseph N. Cangemi, Chairman, and Jim Toes, a comprehensive or even a September 27, 2011. President and Chief Executive Officer, Security representative survey or study of the Traders Association, to Elizabeth M. Murphy, On April 5, 2011, NYSE Euronext, on Secretary, Commission, dated June 22, 2011; Letter costs of SEC rules or forms. behalf of New York Stock Exchange LLC from Leonard J. Amoruso, General Counsel, Knight There are no recordkeeping retention (‘‘NYSE’’), NYSE Amex LLC (‘‘NYSE Capital Group, Inc., to Elizabeth M. Murphy, periods in Rule 10A–1. Because of the Amex’’), and NYSE Arca, Inc. (‘‘NYSE Secretary, Commission, dated June 22, 2011; Letter one business day reporting periods, from Ann L. Vlcek, Managing Director and Arca’’), and the following parties to the Associate General Counsel, Securities Industry and recordkeeping retention periods should proposed National Market System Plan: Financial Markets Association, to Elizabeth M. not be significant. BATS Exchange, Inc., BATS Y– Murphy, Secretary, Commission, dated June 22, Filing the notice or report under Rule Exchange, Inc., Chicago Board Options 2011; Letter from Jamie Selway, Managing Director, 10A–1 is mandatory once the conditions and Patrick Chi, Chief Compliance Officer, ITG Inc., Exchange, Incorporated, Chicago Stock to Elizabeth M. Murphy, Secretary, Commission, noted above have been satisfied. Exchange, Inc., EDGA Exchange, Inc., dated June 23, 2011; Letter from Jose Marques, Because these notices and reports EDGX Exchange, Inc., Financial Managing Director and Global Head of Electronic discuss potential illegal acts, they are Industry Regulatory Authority, Inc., Equity Trading, Deutsche Bank Securities Inc., to considered to be investigative records Elizabeth M. Murphy, Secretary, Commission, dated NASDAQ OMX BX, Inc., NASDAQ June 23, 2011; Letter from Kimberly Unger, Esq., and are kept confidential. OMX PHLX LLC, the Nasdaq Stock Executive Director, The Security Traders An agency may not conduct or Market LLC, and National Stock Association of New York, Inc., to Elizabeth M. sponsor, and a person is not required to Exchange, Inc. (collectively with NYSE, Murphy, Secretary, Commission, dated June 23, respond to, a collection of information 2011; Letter from James J. Angel, PhD, CFA, NYSE Amex, and NYSE Arca, the Associate Professor of Finance, Georgetown unless it displays a currently valid ‘‘Participants’’), filed with the Securities University, McDonough School of Business, to control number. and Exchange Commission Commission, dated June 24, 2011; Letter from John The public may view the information (‘‘Commission’’), pursuant to Section A. McCarthy, General Counsel, GETCO, to Elizabeth discussed in this notice at http:// M. Murphy, Secretary, Commission, dated June 24, 11A of the Securities Exchange Act of 2011; Letter from Andrew C. Small, Executive www.reginfo.gov. Comments should be 1934 (‘‘Act’’),1 and Rule 608 of Director and General Counsel, Scottrade, Inc., to directed to: (i) Desk Officer for the Regulation NMS (‘‘Rule 608’’) Elizabeth M. Murphy, Secretary, Commission, dated Securities and Exchange Commission, thereunder,2 a proposed Plan to Address July 5, 2011; Letter from Peter Skopp, President, Office of Information and Regulatory Molinete Trading Inc., to Elizabeth M. Murphy, Extraordinary Market Volatility Secretary, Commission, dated July 19, 2011; and Affairs, Office of Management and (‘‘Plan’’).3 The proposed Plan was Letter from Sal Arnuk, Joe Saluzzi, and Paul Zajac, Budget, Room 10102, New Executive published for comment in the Federal Themis Trading, LLC, to Elizabeth M. Murphy, Office Building, Washington, DC 20503, Register on June 1, 2011.4 The Secretary, Commission. Copies of all comments or by sending an e-mail to: received on the proposed Plan are available on the _ Commission’s Web site, located at http:// Shagufta [email protected]; and (ii) 1 15 U.S.C. 78k–1. www.sec.gov/comments/4–631/4–631.shtml. Thomas Bayer, Director/Chief 2 17 CFR 242.608. Comments are also available for Web site viewing Information Officer, Securities and 3 See Letter from Janet M. McGinness, Senior Vice and printing in the Commission’s Public Reference Exchange Commission, c/o Remi Pavlik- President, Legal and Corporate Secretary, NYSE Room, 100 F Street, NE., Washington, DC 20549, on Euronext, to Elizabeth M. Murphy, Secretary, official business days between the hours of 10 a.m. Simon, 6432 General Green Way, Commission, dated April 5, 2011. and 3 p.m ET. Alexandria, VA 22312 or send an e-mail 4 See Securities Exchange Act Release No. 64547 6 17 CFR 242.608. to: [email protected]. Comments (May 25, 2011), 76 FR 31647. 7 15 U.S.C. 78k–1.

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for so finding or as to which the SECURITIES AND EXCHANGE determine the range of prices at which sponsors consent, the Commission shall COMMISSION orders may be executed. When an order is initially received, the range would be approve such plan or amendment, with [Release No. 34–65405; File No. SR– such changes or subject to such NASDAQ–2011–105] calculated by adding (for buy orders) or conditions as the Commission may subtracting (for sell orders) a value to deem necessary or appropriate, if it Self-Regulatory Organizations; The the National Best Offer (‘‘NBO’’) (for buy finds that such plan or amendment is NASDAQ Stock Market LLC; Order orders) or the National Best Bid (‘‘NBB’’) necessary or appropriate in the public Approving Proposed Rule Change To (for sell orders) to determine the range interest, for the protection of investors Establish an Acceptable Trade Range of prices that would be valid for execution. A buy (sell) order would be and the maintenance of fair and orderly for Quotes and Orders Entered on The allowed to execute up (down) to and markets, to remove impediments to, and NASDAQ Options Market including the maximum (minimum) perfect the mechanisms of, a national September 27, 2011. price within the ATR (‘‘Threshold market system, or otherwise in I. Introduction Price’’). If an order could not be furtherance of the purposes of the Act. executed completely within the ATR, The 120th day for this notice of filing On August 2, 2011, The NASDAQ the unexecuted portion of the original of a national market system plan is Stock Market LLC (‘‘NASDAQ’’ or order would be posted at the Threshold September 29, 2011. ‘‘Exchange’’) filed with the Securities Price for a brief period, not to exceed The Commission is hereby extending and Exchange Commission one second (‘‘Posting Period’’), to allow the 120-day time period for Commission (‘‘Commission’’), pursuant to Section the market to refresh and determine action on the proposed rule change. The 19(b)(1) of the Securities Exchange Act whether or not more liquidity becomes of 1934 (‘‘Act’’),1 and Rule 19b-4 Commission finds that it is appropriate available on NOM (or any other thereunder,2 a proposed rule change to to designate a longer period within exchange if the order is designated as establish an Acceptable Trade Range which to take action on the proposed routable) within the posted price of the (‘‘ATR’’) for quotes and orders entered rule change. In particular, the extension order before moving on to a new on The NASDAQ Options Market Threshold Price. The Threshold Price, at of time will ensure that the Commission (‘‘NOM’’). The proposed rule change which the order is posted, would then has sufficient time to consider and take was published for comment in the become the new reference price,6 and a action on the Participants’ proposal, in Federal Register on August 18, 2011.3 new ATR would be calculated. light of, among other things, the The Commission received no comment Once the Posting Period has expired, comments received on the proposal. letters regarding the proposal. This if the order has not been fully executed, Accordingly, pursuant to Section 11A order approves the proposed rule it would be allowed to execute up to of the Act 8 and Rule 608 thereunder,9 change. and including the Threshold Price of the new ATR. During the Posting Period, the Commission designates November II. Description of the Proposal 28, 2011 as the date by which the NOM would display the ATR Threshold The Exchange proposes to establish Commission shall approve the proposed Price on one side of the market and the an ATR for quotes and orders entered on Plan (File Number 4–631), with such best available price on the opposite side NOM, which is intended to create a changes or subject to such conditions as of the market using a ‘‘non-firm’’ level of protection on NOM that indicator. The order setting the ATR the Commission may deem necessary or prevents the market from moving appropriate, if it finds that such plan or retains price/time priority in the NOM beyond set thresholds. These thresholds book.7 The Exchange notes that, if NOM amendment is necessary or appropriate would consist of a reference price plus were to display trading interest in the public interest, for the protection or minus set dollar amounts based on available on the opposite side of the of investors and the maintenance of fair the nature and premium of the option. market, that trading interest would be and orderly markets, to remove This mechanism is intended to prevent automatically accessible to later-entered impediments to, and perfect the the NOM trading system from orders during the period when the order mechanisms of, a national market experiencing dramatic price swings, triggering the ATR is paused.8 system, or otherwise in furtherance of which can exist if, for example, a market Following the Posting Period, the the purposes of the Act. order or aggressively-priced limit order Exchange would return to a normal For the Commission, by the Division of is entered that is larger than the total trading state and disseminate its best Trading and Markets, pursuant to delegated volume of contracts quoted at the top- bid and offer. authority.10 of-book across all U.S. options The ATR will be neutral with respect exchanges.4 The Exchange believes that, Elizabeth M. Murphy, to away markets in that NOM will route without the ATR, options could execute orders to other destinations to access Secretary. at prices that have little or no relation liquidity priced within the ATR, [FR Doc. 2011–25353 Filed 9–30–11; 8:45 am] to the theoretical price of the option, provided the order is designated as BILLING CODE 8011–01–P resulting in potential harm to investors.5 routable.9 If an order remains A. ATR Operation unexecuted, the process would repeat until it is executed, cancelled, or posted Prior to executing orders received by at its limit price. If an order is routed NOM, an ATR would be calculated to 6 If a new NBB is received that is greater than a 1 15 U.S.C. 78s(b)(1). buy order posted at the Threshold Price, or a new 2 17 CFR 240.19b–4. NBO is received that is lower than a sell order 3 See Securities Exchange Act Release No. 65125 posted at the Threshold Price, the new NBB (for buy (August 12, 2011), 76 FR 51453 (August 18, 2011) orders) or NBO (for sell orders) would become the (‘‘Notice’’). new reference price. 8 Id. 4 Id. 7 See Notice, supra note 3, 76 FR at 51454. 9 17 CFR 242.608. 5 The Exchange provides an example of such 8 Id. 10 17 CFR 200.30–3(a)(42). executions in the Notice. Id. 9 Id.

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to the full size of an away exchange and the underlying security.18 Initially, the protecting investors and the public additional size remains available on Exchange expects to set ATRs for three interest. NOM, the remaining contracts would be categories of options: Standard Penny The Exchange believes that posted on NOM at a price that assumes Pilot, Special Penny Pilot (e.g., IWM, 19 disseminating a non-firm quotation the away market has executed the QQQQ, SPY), and Non-Penny Pilot. message during the Posting Period routed order. The Exchange believes III. Discussion would be consistent with its obligations this practice of routing and then posting under the Quote Rule.25 Specifically, would be consistent with the national After careful review of the proposal, the Exchange believes that volatility market system plan governing trading the Commission finds that the proposed strong enough to trigger the ATR on and routing of options orders and the rule change is consistent with the NOM policies and procedures that NOM qualifies as an unusual market requirements of the Act and the rules 26 implement that plan.10 and regulations thereunder applicable to condition. The Exchange expects such a national securities exchange.20 In situations to be rare, and the Exchange B. Setting ATR Values particular, the Commission finds that will set the parameters of the ATR at levels that would ensure that it is The Exchange represents that the the proposal is consistent with Section 21 triggered infrequently.27 The options class premium would be the 6(b)(5) of the Act, which requires, Commission believes that the dominant factor in determining the among other things, that the rules of an ATR.11 The Exchange further represents exchange be designed to promote just Exchange’s dissemination of a non-firm that options with lower premiums tend and equitable principles of trade, to quotation on the opposite side of the to be more liquid and have tighter bid/ foster cooperation and coordination market from the Threshold Price of the ask spreads, while options with higher with persons engaged in regulating paused order during the Posting Period premiums have wider spreads and less transactions in securities, to remove is consistent with the Quote Rule’s liquidity.12 Accordingly, the Exchange impediments to and perfect the provisions regarding non-firm proposes to use a table consisting of mechanism of a free and open market quotations.28 and a national market system, and, in several steps based on the premium of IV. Conclusion the option to determine how far the general, to protect investors and the market for a given option would be public interest. The Commission also It Is Therefore Ordered, pursuant to allowed to move. The table(s) would be finds that the proposed rule change is Section 19(b)(2) of the Act,29 that the listed on the NASDAQTrader.com consistent with the provisions of proposed rule change (SR–NASDAQ– Section 6(b)(8) of the Act,22 which website, and any periodic updates to the 2011–105) be, and hereby is, approved. table(s) would be announced via an requires that the rules of an exchange Options Trader Alert (‘‘OTA’’).13 The not impose any burden on competition For the Commission, by the Division of not necessary or appropriate in Trading and Markets, pursuant to delegated Exchange does not anticipate updating 30 the table(s) frequently or intraday.14 The furtherance of the purposes of the Act. authority. Exchange will provide sufficient The ATR is intended to reduce the Elizabeth M. Murphy, advanced notice of changes to the ATR negative impacts of sudden, Secretary. table(s) to its membership via OTAs.15 unanticipated volatility in individual [FR Doc. 2011–25351 Filed 9–30–11; 8:45 am] Other market conditions, such as NOM options, assist in preserving an BILLING CODE 8011–01–P extreme volatility or historically low orderly market in a transparent and liquidity, would also be considered uniform manner, enhance the price- when determining the ATR. The discovery process, increase overall market confidence, and promote fair Exchange believes these different 25 Id. market conditions could present the and orderly markets and the protection of investors.23 The Commission notes 26 Id. need to adjust the ATRs from time to 27 Id. The ATR will cause the market to pause for time to ensure a well-functioning that the ATR will be neutral with respect to away markets in that NOM no more than one second, which the Exchange market.16 Without adjustments, the notes is a briefer pause than occurs in other markets Exchange believes the market could will route orders to other destinations to that experience and attempt to dampen volatility. become too constrained or, conversely, access liquidity priced within the ATR, For example, the Posting Period would be briefer prone to wide price swings.17 provided the order is designated as than the pause triggered by the Liquidity routable.24 The Commission believes Replenishment Point (‘‘LRP’’) employed by the New The Exchange represents that the ATR that the ATR functionality should result York Stock Exchange LLC (‘‘NYSE’’). See NYSE would be generally the same across all in greater continuity in prices as it is Rules 1000(a)(iv) and 60(d). options traded on NOM, but it proposes designed to prevent immediate or rapid 28 See 17 CFR 242.602(a)(3)(i)–(ii). Specifically, to maintain flexibility to set them executions at far away prices; thereby Rule 602(a)(3) provides that, if, at any time a separately based on characteristics of national securities exchange is open for trading, the exchange determines, pursuant to rules approved 18 The Exchange provides examples of options by the Commission, that the level of trading 10 See Notice, supra note 3, 76 FR at 51455, n.9 that could require this flexibility because of the activities or the existence of unusual market and accompanying text. The Exchange provides underlying securities. Id. The Exchange notes that conditions is such that the exchange is incapable of examples of this process in the Notice. Id. at 51455– the Acceptable Range Test in place at NASDAQ collecting, processing, and making available to 56. OMX PHLX LLC (‘‘Phlx’’) currently provides for 11 Id. at 51456. this flexibility. See Phlx Rule 1082(a)(ii)(B)(3)(f). vendors the data for a subject security required to 12 Id. 19 See Notice, supra note 3, 76 FR at 51456. be made available in a manner that accurately reflects the current state of the market on such 13 The value added to or subtracted from the 20 In approving this proposed rule change, the reference price would be set by the Exchange and Commission has considered the proposed rule’s exchange, such exchange shall immediately notify posted on the Exchange Web site: http:// impact on efficiency, competition, and capital all specified persons of that determination and, www.nasdasqtrader.com. formation. See 15 U.S.C. 78c(f). upon such notification, the exchange is generally 14 See Notice, supra note 3, 76 FR at 51455. 21 15 U.S.C. 78f(b)(5). relieved of its obligations relating to collecting and 15 Id. 22 15 U.S.C. 78f(b)(8). disseminating quotations. 16 Id. 23 See Notice, supra note 3, 76 FR at 51456. 29 15 U.S.C. 78s(b)(2). 17 Id. 24 See id. at 51454. 30 17 CFR 200.30–3(a)(12).

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SECURITIES AND EXCHANGE comments it received on the proposed paragraph (a)(1). However, FINRA is not COMMISSION rule change. The text of these statements proposing any changes to this process. may be examined at the places specified In addition, FINRA is proposing to [Release No. 34–65408; File No. SR–FINRA– adopt a stated policy with respect to the 2011–049] in Item IV below. FINRA has prepared summaries, set forth in sections A, B, timing of recognition of aggregation Self-Regulatory Organizations; and C below, of the most significant requests. Because bills for the FINRA/ Financial Industry Regulatory aspects of such statements. NASDAQ TRF are prepared on a Authority, Inc.; Notice of Filing and monthly basis, recognizing an affiliation A. Self-Regulatory Organization’s in the middle of a month would require Immediate Effectiveness of Proposed Statement of the Purpose of, and Rule Change Relating to Aggregation a complex proration of members’ bills. Statutory Basis for, the Proposed Rule Accordingly, it has been the FINRA/ of Activity of Affiliated Members for Change Purposes of FINRA/Nasdaq TRF Fees NASDAQ TRF’s practice to recognize an and Credits 1. Purpose affiliation request either at the beginning of the month in which the September 27, 2011. Rule 7630A allows affiliated members affiliation occurs or at the beginning of Pursuant to Section 19(b)(1) of the to aggregate their activity under certain the following month. FINRA is Securities Exchange Act of 1934 provisions of the fee and credit schedule proposing to adopt new paragraph (a)(2) (‘‘Act’’) 1 and Rule 19b–4 thereunder,2 applicable to the FINRA/NASDAQ TRF of Rule 7630A, which provides that if notice is hereby given that on that make fees and credits dependent two or more members become affiliated September 13, 2011, Financial Industry upon the volume of their activity. For on or prior to the sixteenth day of a Regulatory Authority, Inc. (‘‘FINRA’’) example, Rule 7620A caps fees for month and submit a request for filed with the Securities and Exchange members with a daily average number of aggregation on or prior to the twenty- Commission (‘‘SEC’’ or ‘‘Commission’’) media/executing party trades during the second day of the month, approval of the proposed rule change as described month in excess of 2500. Affiliated the request shall be deemed effective as in Items I, II, and III below, which Items members that might not qualify for the of the first day of that month. Thus, for have been prepared by FINRA. FINRA cap by themselves may be able to example, if one member acquires has designated the proposed rule change qualify by aggregating their activity. another, the acquisition is completed by June 16, and the members file a request as ‘‘constituting a stated policy, Under Rule 7630A, a member may for aggregation by June 22, approval of practice, or interpretation with respect request that the FINRA/NASDAQ TRF the request would allow the members to to the meaning, administration, or aggregate its activity with the activity of aggregate all activity during June. This enforcement of an existing rule’’ under its affiliates.5 The rule defines an 3 would be the case regardless of the time Section 19(b)(3)(A)(i) of the Act and ‘‘affiliate’’ of the member as any wholly 4 required to review and approve the Rule 19b–4(f)(1) thereunder, which owned subsidiary, parent or sister (as request. However, if members become renders the proposal effective upon those terms are defined under the rule) affiliated after the sixteenth day of the receipt of this filing by the Commission. of the member that is also a member. month, or do not submit a request for The Commission is publishing this Thus, the rule requires that one aggregation until after the twenty- notice to solicit comments on the affiliated member own 100% of the second day of the month, the request proposed rule change from interested voting interests in the other, or that they would not be recognized until the persons. both be under the common control of a following month. I. Self-Regulatory Organization’s parent that owns 100% of each. A FINRA has filed the proposed rule Statement of the Terms of Substance of member requesting aggregation of change for immediate effectiveness. The the Proposed Rule Change affiliate activity under Rule 7630A is effective date and the implementation required to certify the affiliate status of FINRA is proposing to amend Rule date will be the date of filing. entities whose activity it seeks to 7630A (Aggregation of Activity of aggregate and immediately to provide 2. Statutory Basis Affiliated Members) relating to the notice of any event that causes an entity pricing schedule for the FINRA/ FINRA believes that the proposed rule to cease to be an affiliate. A review of NASDAQ Trade Reporting Facility (the change is consistent with the provisions information regarding the entities is 7 ‘‘FINRA/NASDAQ TRF’’) under the of Section 15(b)(6) of the Act, which conducted, and the member may be Rule 7600A Series. requires, among other things, that requested to provide additional The text of the proposed rule change FINRA rules be designed to prevent information to verify the affiliate status is available on FINRA’s Web site at fraudulent and manipulative acts and of an entity. A request will be approved http:/www.finra.org, at the principal practices, to promote just and equitable unless it is determined that the office of FINRA, and at the principles of trade, and, in general, to member’s certification is not accurate.6 Commission’s Public Reference Room. protect investors and the public interest. FINRA is proposing to clarify Rule FINRA believes that the proposed rule II. Self-Regulatory Organization’s 7630A by describing the process for change, by adopting a clear policy with Statement of the Purpose of, and review and approval in proposed respect to the meaning, administration Statutory Basis for, the Proposed Rule and enforcement of Rule 7630A, will Change 5 The rule is administered by The NASDAQ OMX promote members’ understanding of the Group, Inc. (‘‘NASDAQ’’), in its capacity as the parameters of the rule and enhance the In its filing with the Commission, ‘‘Business Member’’ and operator of the FINRA/ FINRA included statements concerning NASDAQ TRF on behalf of FINRA. FINRA’s efficiency of its administration. the purpose of and basis for the oversight of this function performed by the FINRA further believes that the proposed rule change and discussed any Business Member is conducted through an annual proposed rule change is consistent with assessment and review of TRF operations by an Section 15A(b)(5) of the Act,8 which outside independent audit firm. 1 requires, among other things, that 15 U.S.C. 78s(b)(1). 6 In the event of an inaccurate certification, 2 17 CFR 240.19b–4. FINRA would investigate whether the member had 3 15 U.S.C. 78s(b)(3)(A)(i). violated FINRA rules and would take appropriate 7 15 U.S.C. 78o–3(b)(6). 4 17 CFR 240.19b–4(f)(1). disciplinary action. 8 15 U.S.C. 78o–3(b)(5).

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FINRA rules provide for the equitable arguments concerning the foregoing, For the Commission, by the Division of allocation of reasonable dues, fees and including whether the proposed rule Trading and Markets, pursuant to delegated 11 other charges among members and change is consistent with the Act. authority. issuers and other persons using any Comments may be submitted by any of Elizabeth M. Murphy, facility or system that FINRA operates the following methods: Secretary. or controls. All similarly situated [FR Doc. 2011–25352 Filed 9–30–11; 8:45 am] members are subject to the same fee Electronic Comments BILLING CODE 8011–01–P structure, and access to the FINRA/ • Use the Commission’s Internet NASDAQ TRF is offered on fair and comment form (http://www.sec.gov/ non-discriminatory terms. The proposed SECURITIES AND EXCHANGE rules/sro.shtml); or rule change is reasonable because it COMMISSION • establishes a standard for recognition of Send an e-mail to rule- [Release No. 34–65406; File No. SR–BYX– aggregation requests that is easy to [email protected]. Please include File 2011–023] administer and that reflects the need to Number SR–FINRA–2011–049 on the review and approve aggregation requests subject line. Self-Regulatory Organizations; BATS while avoiding the complexities Y-Exchange, Inc.; Notice of Filing and associated with proration of the bills of Paper Comments Immediate Effectiveness of Proposed Rule Change Related to Fees for Use members that affiliate during the course • Send paper comments in triplicate of BATS Y-Exchange, Inc. of a month. The proposed rule change to Elizabeth M. Murphy, Secretary, is equitable because all members Securities and Exchange Commission, September 27, 2011. seeking to aggregate their activity are 100 F Street, NE., Washington, DC Pursuant to Section 19(b)(1) of the subject to the same parameters, in 20549–1090. Securities Exchange Act of 1934 (the accordance with a commonsense ‘‘Act’’),1 and Rule 19b–4 thereunder,2 All submissions should refer to File standard that recognizes an affiliation as notice is hereby given that on of the month’s beginning closest in time Number SR–FINRA–2011–049. This file September 14, 2011, BATS Y-Exchange, to when the affiliation occurs, provided number should be included on the Inc. (the ‘‘Exchange’’ or ‘‘BYX’’) filed the members submit a timely request. subject line if e-mail is used. To help the with the Securities and Exchange B. Self-Regulatory Organization’s Commission process and review your Commission (‘‘Commission’’) the Statement on Burden on Competition comments more efficiently, please use proposed rule change as described in only one method. The Commission will Items I and II below, which Items have FINRA does not believe that the post all comments on the Commission’s been prepared by the Exchange. The proposed rule change will result in any Internet Web site (http://www.sec.gov/ Exchange has designated the proposed burden on competition that is not rules/sro.shtml). Copies of the rule change as one establishing or necessary or appropriate in furtherance submission, all subsequent changing a member due, fee, or other of the purposes of the Act. amendments, all written statements charge imposed by the Exchange under C. Self-Regulatory Organization’s with respect to the proposed rule Section 19(b)(3)(A)(ii) of the Act 3 and Statement on Comments on the change that are filed with the Rule 19b–4(f)(2) thereunder,4 which Proposed Rule Change Received From Commission, and all written renders the proposed rule change Members, Participants, or Others communications relating to the effective upon filing with the Written comments were neither proposed rule change between the Commission. The Commission is solicited nor received. Commission and any person, other than publishing this notice to solicit those that may be withheld from the comments on the proposed rule change III. Date of Effectiveness of the from interested persons. Proposed Rule Change and Timing for public in accordance with the Commission Action provisions of 5 U.S.C. 552, will be I. Self-Regulatory Organization’s available for Web site viewing and Statement of the Terms of Substance of The foregoing rule change has become printing in the Commission’s Public the Proposed Rule Change effective pursuant to Section 19(b)(3)(A) Reference Room, 100 F Street, NE., The Exchange proposes to amend the of the Act 9 and paragraph (f)(1) of Rule Washington, DC 20549, on official fee schedule applicable to Members5 of 19b–4 thereunder.10 At any time within business days between the hours of 10 the Exchange pursuant to BYX Rules 60 days of the filing of the proposed rule a.m. and 3 p.m. Copies of such filing 15.1(a) and (c). While changes to the fee change, the Commission summarily may also will be available for inspection and schedule pursuant to this proposal will temporarily suspend such rule change if be effective upon filing, the changes will it appears to the Commission that such copying at the principal office of become operative on September 16, action is necessary or appropriate in the FINRA. All comments received will be 2011. public interest, for the protection of posted without change; the Commission does not edit personal identifying The text of the proposed rule change investors, or otherwise in furtherance of is available at the Exchange’s Web site the purposes of the Act. If the information from submissions. You should submit only information that at http://www.batstrading.com, at the Commission takes such action, the principal office of the Exchange, and at Commission shall institute proceedings you wish to make publicly available. All submissions should refer to File the Commission’s Public Reference to determine whether the proposed rule Room. should be approved or disapproved. Number SR–FINRA–2011–049 and should be submitted on or before IV. Solicitation of Comments 11 17 CFR 200.30–3(a)(12). October 24, 2011. 1 15 U.S.C. 78s(b)(1). Interested persons are invited to 2 17 CFR 240.19b–4. submit written data, views, and 3 15 U.S.C. 78s(b)(3)(A)(ii). 4 17 CFR 240.19b–4(f)(2). 9 15 U.S.C. 78s(b)(3)(A). 5 A Member is any registered broker or dealer that 10 17 CFR 240.19b–4(f)(1). has been admitted to membership in the Exchange.

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II. Self-Regulatory Organization’s aggressive than the price at which such price sliding that receive price Statement of the Purpose of, and order is ranked. Specifically, in the improvement is appropriate because the Statutory Basis for, the Proposed Rule event an order submitted to the price improvement received will offset Change Exchange on the side opposite such a the change in the fee structure for such In its filing with the Commission, the price slid order is a market order or a orders. Exchange included statements limit order priced more aggressively than the locking price, the Exchange B. Self-Regulatory Organization’s concerning the purpose of and basis for Statement on Burden on Competition the proposed rule change and discussed will execute the resting order subject to any comments it received on the price sliding at, in the case of a resting The Exchange does not believe that proposed rule change. The text of these bid, one-half minimum price variation the proposed rule change imposes any statements may be examined at the less than the locking price, and, in the burden on competition. case of a resting offer, at one-half places specified in Item IV below. The C. Self-Regulatory Organization’s minimum price variation more than the Exchange has prepared summaries, set Statement on Comments on the locking price. Based on the forth in Sections A, B, and C below, of Proposed Rule Change Received From functionality, orders executed as the most significant parts of such Members, Participants, or Others statements. described above will receive price improvement over the price at which No written comments were solicited A. Self-Regulatory Organization’s such orders are ranked. Because price or received. Statement of the Purpose of, and slid orders subject to the order handling III. Date of Effectiveness of the Statutory Basis for, the Proposed Rule process described above will receive Proposed Rule Change and Timing for Change price improvement, the Exchange Commission Action 1. Purpose proposes to execute the orders subject to a fee of $0.0030 per share, which is the Pursuant to Section 19(b)(3)(A)(ii) of The Exchange proposes to modify its same fee imposed for executions of non- the Act9 and Rule 19b–4(f)(2) fee schedule applicable to use of the displayed orders that receive price thereunder,10 the Exchange has Exchange effective September 16, 2011, improvement when executed. The designated this proposal as establishing in order to adopt a fee for any order Exchange believes that price or changing a due, fee, or other charge subject to price sliding that adds improvement received for executions of applicable to the Exchange’s Members liquidity to the Exchange and receives orders subject to price sliding will offset and non-members, which renders the price improvement over its ranked price the additional fee charged by the proposed rule change effective upon when executed. Pursuant to Exchange Exchange for such orders. filing. price sliding, an order that would lock At any time within 60 days of the 2. Statutory Basis or cross a protected quotation is ranked filing of the proposed rule change, the on the Exchange’s order book at the The Exchange believes that the Commission summarily may locked price and then displayed at one proposed rule change is consistent with temporarily suspend such rule change if minimum price level less aggressive the requirements of the Act and the it appears to the Commission that such than the locking price. For bids, this rules and regulations thereunder that action is necessary or appropriate in the means that a price slid order is are applicable to a national securities public interest, for the protection of displayed at one minimum price exchange, and, in particular, with the investors, or otherwise in furtherance of variation less than the current national requirements of Section 6 of the Act.7 the purposes of the Act. If the best offer (‘‘NBO’’), and for offers, this Specifically, the Exchange believes that Commission takes such action, the means that a price slid order is the proposed rule change is consistent Commission shall institute proceedings displayed at one minimum price with Section 6(b)(4) of the Act,8 in that to determine whether the proposed rule variation more than the current national it provides for the equitable allocation should be approved or disapproved. best bid (‘‘NBB’’). of reasonable dues, fees and other The Exchange received approval in charges among members and other IV. Solicitation of Comments June of a rule change to allow a non- persons using any facility or system Interested persons are invited to displayed order or an order subject to which the Exchange operates or submit written data, views, and the price sliding process that is not controls. The Exchange notes that it arguments concerning the foregoing, executable at its most aggressive price to operates in a highly competitive market including whether the proposed rule be executed at one-half minimum price in which market participants can change is consistent with the Act. variation less aggressive than the price readily direct order flow to competing Comments may be submitted by any of 6 at which it is ranked. The Exchange venues if they deem fee levels at a the following methods: immediately implemented the change particular venue to be excessive. The for non-displayed orders, but delayed Exchange believes that the proposed fee Electronic Comments the implementation related to orders applicable to any execution of a price • Use the Commission’s Internet subject to price sliding in order to slid order that receives price comment form (http://www.sec.gov/ complete development of the necessary improvement over its ranked price is rules/sro.shtml); or system functionality. On September 16, competitive, fair and reasonable, and • Send an e-mail to rule- 2011, the Exchange plans to implement non-discriminatory in that the fee will [email protected]. Please include File the systems change to allow an order apply uniformly to all Members and Number SR–BYX–2011–023 on the subject to price sliding to execute at because the proposed fee is the same fee subject line. one-half minimum price variation less imposed for non-displayed orders that are handled similarly. Finally, the Paper Comments 6 See Securities Exchange Act Release No. 64753 Exchange believes that the additional • Send paper comments in triplicate (June 27, 2011), 76 FR 38714 (July 1, 2011) (SR– fee for executions of orders subject to BYX–2011–009) (Order Approving a Proposed Rule to Elizabeth M. Murphy, Secretary, Change to Amend BATS Rule 11.9, entitled ‘‘Orders and Modifiers’’ and BATS Rule 11.13, entitled 7 15 U.S.C. 78f. 9 15 U.S.C. 78s(b)(3)(A)(ii). ‘‘Order Execution’’). 8 15 U.S.C. 78f(b)(4). 10 17 CFR 240.19b–4(f)(2).

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Securities and Exchange Commission, notice is hereby given that on in order to: (1) Discontinue payment of 100 F Street, NE., Washington, DC September 19, 2011, BATS Exchange, a liquidity rebate for any order subject 20549–1090. Inc. (the ‘‘Exchange’’ or ‘‘BATS’’) filed to price sliding that adds liquidity to the All submissions should refer to File with the Securities and Exchange Exchange and receives price Number SR–BYX–2011–023. This file Commission (‘‘Commission’’) the improvement over its ranked price number should be included on the proposed rule change as described in when executed; and (2) modify the subject line if e-mail is used. To help the Items I and II below, which Items have ‘‘Options Pricing’’ section of its fee Commission process and review your been prepared by the Exchange. The schedule to impose a fee for newly comments more efficiently, please use Exchange has designated the proposed available logical ports with bulk-quoting only one method. The Commission will rule change as one establishing or capabilities, as further described below. changing a member due, fee, or other post all comments on the Commission’s Orders Subject to Price Sliding Internet Web site (http://www.sec.gov/ charge imposed by the Exchange under rules/sro.shtml). Copies of the Section 19(b)(3)(A)(ii) of the Act 3 and The Exchange proposes to submission, all subsequent Rule 19b–4(f)(2) thereunder,4 which discontinue payment of a liquidity amendments, all written statements renders the proposed rule change rebate for any order subject to price with respect to the proposed rule effective upon filing with the sliding that adds liquidity to the change that are filed with the Commission. The Commission is Exchange and receives price Commission, and all written publishing this notice to solicit improvement over its ranked price communications relating to the comments on the proposed rule change when executed. Pursuant to Exchange proposed rule change between the from interested persons. price sliding, an order that would lock or cross a protected quotation is ranked Commission and any person, other than I. Self-Regulatory Organization’s those that may be withheld from the on the Exchange’s order book at the Statement of the Terms of Substance of locked price and then displayed at one public in accordance with the the Proposed Rule Change provisions of 5 U.S.C. 552, will be minimum price level less aggressive available for Web site viewing and The Exchange proposes amend the fee than the locking price. For bids, this printing in the Commission’s Public schedule applicable to Members 5 and means that a price slid order is Reference Room on official business non-members of the Exchange pursuant displayed at one minimum price days between the hours of 10 a.m. and to BATS Rules 15.1(a) and (c). While variation less than the current national 3 p.m. Copies of such filing also will be changes to the fee schedule pursuant to best offer (‘‘NBO’’), and for offers, this available for inspection and copying at this proposal will be effective upon means that a price slid order is the principal office of the Exchange. All filing, the changes will become displayed at one minimum price comments received will be posted operative on September 23, 2011. variation more than the current national without change; the Commission does The text of the proposed rule change best bid (‘‘NBB’’). not edit personal identifying is available at the Exchange’s Web site The Exchange received approval in information from submissions. You at http://www.batstrading.com, at the June of a rule change to allow a non- should submit only information that principal office of the Exchange, and at displayed order or an order subject to you wish to make available publicly. All the Commission’s Public Reference the price sliding process that is not submissions should refer to File Room. executable at its most aggressive price to be executed at one-half minimum price Number SR–BYX–2011–023 and should II. Self-Regulatory Organization’s be submitted on or before October 24, variation less aggressive than the price Statement of the Purpose of, and 6 2011. at which it is ranked. The Exchange Statutory Basis for, the Proposed Rule immediately implemented the change For the Commission, by the Division of Change for non-displayed orders, but delayed Trading and Markets, pursuant to delegated the implementation related to orders authority.11 In its filing with the Commission, the Exchange included statements subject to price sliding in order to Elizabeth M. Murphy, concerning the purpose of and basis for complete development of the necessary Secretary. the proposed rule change and discussed system functionality. On September 23, [FR Doc. 2011–25378 Filed 9–30–11; 8:45 am] any comments it received on the 2011, the Exchange plans to implement BILLING CODE 8011–01–P proposed rule change. The text of these the systems change to allow an order statements may be examined at the subject to price sliding to execute at places specified in Item IV below. The one-half minimum price variation less SECURITIES AND EXCHANGE Exchange has prepared summaries, set aggressive than the price at which such COMMISSION forth in Sections A, B, and C below, of order is ranked. Specifically, in the [Release No. 34–65407; File No. SR–BATS– the most significant parts of such event an order submitted to the 2011–037] statements. Exchange on the side opposite such a price slid order is a market order or a Self-Regulatory Organizations; BATS A. Self-Regulatory Organization’s limit order priced more aggressively Exchange, Inc.; Notice of Filing and Statement of the Purpose of, and than the locking price, the Exchange Immediate Effectiveness of Proposed Statutory Basis for, the Proposed Rule will execute the resting order subject to Rule Change Related to Fees for Use Change price sliding at, in the case of a resting of BATS Exchange, Inc. 1. Purpose bid, one-half minimum price variation September 27, 2011. The Exchange proposes to modify its less than the locking price, and, in the Pursuant to Section 19(b)(1) of the fee schedule applicable to use of the case of a resting offer, at one-half Securities Exchange Act of 1934 (the Exchange effective September 23, 2011, ‘‘Act’’),1 and Rule 19b–4 thereunder,2 6 See Securities Exchange Act Release No. 64754 (June 27, 2011), 76 FR 38712 (July 1, 2011) (SR– 3 15 U.S.C. 78s(b)(3)(A)(ii). BATS–2011–01 [sic]) (Order Approving a Proposed 11 17 CFR 200.30–3(a)(12). 4 17 CFR 240.19b–4(f)(2). Rule Change to Amend BATS Rule 11.9, entitled 1 15 U.S.C. 78s(b)(1). 5 A Member is any registered broker or dealer that ‘‘Orders and Modifiers’’ and BATS Rule 11.13, 2 17 CFR 240.19b–4. has been admitted to membership in the Exchange. entitled ‘‘Order Execution’’).

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minimum price variation more than the any logical port with bulk-quoting the change in the fee structure for such locking price. Based on the capabilities. The bulk-quoting interface orders. functionality, orders executed as allows Users to provide both a bid and With respect to the proposed charge described above will receive price an offer in one message as well as for ports with bulk-quoting improvement over the price at which bundle several quote updates into one functionality, the Exchange notes that such orders are ranked. Because price bulk message. This is a useful feature for the use of such ports is optional, and slid orders subject to the order handling Users that provide quotations in many that market participants can continue to process described above will receive different options. As proposed, the access BATS Options through other price improvement, the Exchange change applies to any User that obtains logical ports free of charge. At the same proposes to eliminate the payment of a a port enabled with bulk-quoting time, the Exchange believes that its fees liquidity rebate for such executions, functionality to access the Exchange. for bulk-quoting logical ports are which is the same fee structure applied In order to differentiate logical port reasonable, given the benefits and added to executions of non-displayed orders fees from physical connection charges efficiencies Users of BATS Options will that receive price improvement when and because the fee described above is realize through such ports. In addition, executed. The Exchange believes that applicable only to BATS Options, the the Exchange believes that its fees are price improvement received for Exchange also proposes to modify a sub- equitably allocated among its executions of orders subject to price heading included in the ‘‘Equities constituents as they are uniform in sliding will offset the change in the fee Pricing’’ section of the Exchange’s fee application to all Users of BATS structure for such orders. schedule from ‘‘Port Fees’’ to ‘‘Equities Options. The Exchange believes that Options Logical Port Fees Logical Port Fees.’’ Although the fees for each port with bulk-quoting Exchange is implementing this fee The Exchange currently charges a fee capabilities will enable it to cover the effective September 23, 2011, the of $400.00 per month per logical port development and infrastructure costs Exchange will not charge any User of used by Members or non-members to associated with offering and continuing access and receive information from the BATS Options a fee for bulk-quoting to offer bulk-quoting capabilities to Exchange’s cash equities platform. A ports until October 1, 2011. BATS Options Users. logical port is also commonly referred to 2. Statutory Basis B. Self-Regulatory Organization’s as a TCP/IP port, and represents a port Statement on Burden on Competition established by the Exchange within the The Exchange believes that the Exchange’s system for trading and proposed rule change is consistent with The Exchange does not believe that billing purposes. Each logical port the requirements of the Act and the the proposed rule change imposes any established is specific to a Member or rules and regulations thereunder that burden on competition. non-member and grants that Member or are applicable to a national securities C. Self-Regulatory Organization’s non-member the ability to operate a exchange, and, in particular, with the 10 Statement on Comments on the specific application, such as FIX order requirements of Section 6 of the Act. Proposed Rule Change Received From entry or PITCH data receipt. Specifically, the Exchange believes that In contrast to its cash equities the proposed rule change is consistent Members, Participants, or Others with Section 6(b)(4) of the Act,11 in that platform, the Exchange currently No written comments were solicited it provides for the equitable allocation provides logical ports free of charge to or received. Members and non-members that have of reasonable dues, fees and other access to or receive data from the charges among members and other III. Date of Effectiveness of the Exchange’s equity options platform persons using any facility or system Proposed Rule Change and Timing for (‘‘BATS Options’’). On August 9, 2011, which the Exchange operates or Commission Action the Exchange filed an immediately controls. The Exchange notes that it operates in a highly competitive market Pursuant to Section 19(b)(3)(A)(ii) of effective rule filing for BATS Options to 12 in which market participants can the Act and Rule 19b–4(f)(2) introduce a bulk-quoting interface for 13 registered BATS Options market makers readily direct order flow to competing thereunder, the Exchange has to allow such market makers to provide venues if they deem fee levels at a designated this proposal as establishing liquidity to the market in a broader set particular venue to be excessive. With or changing a due, fee, or other charge of series in a more efficient manner.7 On respect to the fee change related to price applicable to the Exchange’s Members September 2, 2011, the Exchange filed slid orders, the Exchange believes that and non-members, which renders the an immediately effective rule filing for the lack of a fee or rebate for any proposed rule change effective upon BATS Options to expand the availability execution of a price slid order that filing. of the bulk-quoting interface to all receives price improvement over its At any time within 60 days of the Users 8 of BATS Options.9 Due to the ranked price is competitive, fair and filing of the proposed rule change, the development and infrastructure costs reasonable, and non-discriminatory in Commission summarily may associated with bulk-quoting that this fee structure will apply temporarily suspend such rule change if functionality, the Exchange proposes to uniformly to all Members and because it appears to the Commission that such charge Users $1,000.00 per month for the proposed fee structure is the same action is necessary or appropriate in the fee structure imposed for non-displayed public interest, for the protection of 7 See Securities Exchange Act Release No. 65133 orders that are handled similarly. investors, or otherwise in furtherance of (August 15, 2011), 76 FR 52032 (August 19, 2011) Finally, the Exchange believes that the the purposes of the Act. If the (SR–BATS–2011–029). 8 As defined in BATS Rule 16.1(a)(62), a ‘‘User’’ lack of a rebate for executions of orders Commission takes such action, the on BATS Options is either a member of BATS subject to price sliding that receive price Commission shall institute proceedings Options or a sponsored participant who is improvement is appropriate because the to determine whether the proposed rule authorized to obtain access to the Exchange’s price improvement received will offset should be approved or disapproved. system pursuant to BATS Rule 11.3. 9 See Securities Exchange Act Release No. 65307 (September 9, 2011), 76 FR 57092 (September 15, 10 15 U.S.C. 78f. 12 15 U.S.C. 78s(b)(3)(A)(ii). 2011) (SR–BATS–2011–034). 11 15 U.S.C. 78f(b)(4). 13 17 CFR 240.19b–4(f)(2).

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IV. Solicitation of Comments For the Commission, by the Division of By the Commission. Trading and Markets, pursuant to delegated Elizabeth M. Murphy, 14 Interested persons are invited to authority. Secretary. submit written data, views, and Elizabeth M. Murphy, [FR Doc. 2011–25506 Filed 9–29–11; 4:15 pm] arguments concerning the foregoing, Secretary. BILLING CODE 8011–01–P including whether the proposed rule [FR Doc. 2011–25379 Filed 9–30–11; 8:45 am] change is consistent with the Act. BILLING CODE 8011–01–P Comments may be submitted by any of the following methods: SMALL BUSINESS ADMINISTRATION SECURITIES AND EXCHANGE Electronic Comments COMMISSION Reporting and Recordkeeping • Use the Commission’s Internet Requirements Under OMB Review comment form (http://www.sec.gov/ [Release No. 34–65317; File No. SR– AGENCY: Small Business Administration. rules/sro.shtml); or NASDAQ–2011–127] • ACTION: Notice of Reporting Send an e-mail to rule- Self-Regulatory Organizations; The Requirements Submitted for OMB [email protected]. Please include File NASDAQ Stock Market LLC; Notice of Review. Number SR–BATS–2011–037 on the Filing and Immediate Effectiveness of subject line. Proposed Rule Change To Modify Fees SUMMARY: Under the provisions of the for Members Using the NASDAQ Paper Comments Paperwork Reduction Act (44 U.S.C. Options Market Chapter 35), agencies are required to • submit proposed reporting and Send paper comments in triplicate September 12, 2011. to Elizabeth M. Murphy, Secretary, recordkeeping requirements to OMB for Securities and Exchange Commission, Correction review and approval, and to publish a 100 F Street, NE., Washington, DC In notice document 2010–23721 notice in the Federal Register notifying 20549–1090. beginning on page 57778 the issue of the public that the agency has made Friday, September 16, 2011 make the such a submission. All submissions should refer to File following correction: DATES: Submit comments on or before Number SR–BATS–2011–037. This file On page 57781, in the first column, in November 2, 2011. If you intend to number should be included on the the 8th line from the bottom of the page, comment but cannot prepare comments subject line if e-mail is used. To help the ‘‘October 6, 2011’’ should read ‘‘October promptly, please advise the OMB Commission process and review your 7, 2011’’. Reviewer and the Agency Clearance comments more efficiently, please use [FR Doc. C1–2011–23721 Filed 9–30–11; 8:45 am] Officer before the deadline. only one method. The Commission will BILLING CODE 1505–01–D Copies: Request for clearance (OMB post all comments on the Commission’s 83–1), supporting statement, and other Internet Web site (http://www.sec.gov/ documents submitted to OMB for rules/sro.shtml). Copies of the SECURITIES AND EXCHANGE review may be obtained from the submission, all subsequent COMMISSION Agency Clearance Officer. amendments, all written statements ADDRESSES: with respect to the proposed rule Address all comments [File No. 500–1] concerning this notice to: Agency change that are filed with the Clearance Officer, Jacqueline White, Commission, and all written BB Liquidation Inc., Order of Small Business Administration, 409 3rd communications relating to the Suspension of Trading Street, SW., 5th Floor, Washington, DC proposed rule change between the 20416; and OMB Reviewer, Office of Commission and any person, other than September 29, 2011. It appears to the Securities and Information and Regulatory Affairs, those that may be withheld from the Office of Management and Budget, New public in accordance with the Exchange Commission that there is a lack of current and accurate information Executive Office Building, Washington, provisions of 5 U.S.C. 552, will be concerning the securities of BB DC 20503. available for Web site viewing and Liquidation Inc. because of assertions in FOR FURTHER INFORMATION CONTACT: printing in the Commission’s Public third-party press releases to investors Jacqueline White, Agency Clearance Reference Room on official business concerning, among other things, the Officer, (202) 205–7044. days between the hours of 10 a.m. and company’s current financial condition SUPPLEMENTARY INFORMATION: 3 p.m. Copies of such filing also will be and business prospects. available for inspection and copying at The Commission is of the opinion that Title: ‘‘Gulf Opportunity Pilot Loan the principal office of the Exchange. All the public interest and the protection of Program (GO) Loan Pilot’’. comments received will be posted investors require a suspension of trading Frequency: On Occasion. without change; the Commission does in the securities of the company listed SBA Form Number: 2276 A, B, C 2281 not edit personal identifying above. 2282. information from submissions. You Therefore, it is ordered, pursuant to Description of Respondents: Loan should submit only information that Section 12(k) of the Securities Exchange Borrowers. you wish to make available publicly. All Act of 1934, that trading in the Responses: 580. submissions should refer to File securities of the company listed above is Annual Burden: 362. Number SR–BATS–2011–037 and suspended for the period from 9:30 a.m. should be submitted on or before EDT, September 29, 2011, through 11:59 Jacqueline White, October 24, 2011. p.m. EDT, on October 12, 2011. Chief, Administrative Information Branch. [FR Doc. 2011–25409 Filed 9–30–11; 8:45 am] 14 17 CFR 200.30–3(a)(12). BILLING CODE 8025–01–P

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SMALL BUSINESS ADMINISTRATION (Catalog of Federal Domestic Assistance ACTION: Amendment 1. Numbers 59002 and 59008) SUMMARY: This is an amendment of the [Disaster Declaration #12856 and #12857] James E. Rivera, Presidential declaration of a major Associate Administrator for Disaster Missouri Disaster #MO–00054 disaster for the Commonwealth of Assistance. Pennsylvania (FEMA–4030–DR), dated [FR Doc. 2011–25348 Filed 9–30–11; 8:45 am] AGENCY: U.S. Small Business 09/12/2011. BILLING CODE 8025–01–P Administration. Incident: Tropical Storm Lee. Incident Period: 09/03/2011 and ACTION: Notice. continuing. SMALL BUSINESS ADMINISTRATION Effective Date: 09/23/2011. SUMMARY : This is a Notice of the [Disaster Declaration #12826 and #12827] Physical Loan Application Deadline Presidential declaration of a major Date: 11/14/2011. disaster for Public Assistance Only for Maine Disaster Number ME–00029 EIDL Loan Application Deadline Date: the State of Missouri (FEMA–4012–DR), 06/12/2012. AGENCY: U.S. Small Business dated 09/09/2011. ADDRESSES: Submit completed loan Administration. Incident: Flooding. applications to: U.S. Small Business ACTION: Amendment 1. Incident Period: 06/01/2011 through Administration, Processing and 08/01/2011. SUMMARY: This is an amendment of the Disbursement Center, 14925 Kingsport Effective Date: 09/09/2011. Presidential declaration of a major Road, Fort Worth, TX 76155. FOR FURTHER INFORMATION CONTACT: A. Physical Loan Application Deadline disaster for Public Assistance Only for Escobar, Office of Disaster Assistance, Date: 11/08/2011. the State of Maine (FEMA–4032–DR), dated 09/13/2011. U.S. Small Business Administration, Economic Injury (EIDL) Loan Incident: Tropical Storm Irene. 409 3rd Street, SW., Suite 6050, Application Deadline Date: 06/06/2012. Incident Period: 08/27/2011 through Washington, DC 20416. ADDRESSES: Submit completed loan 08/29/2011. SUPPLEMENTARY INFORMATION: The notice applications to: U.S. Small Business Effective Date: 09/23/2011. of the Presidential disaster declaration Administration, Processing and Physical Loan Application Deadline for the Commonwealth of Pennsylvania, Disbursement Center, 14925 Kingsport Date: 11/14/2011. dated 09/12/2011 is hereby amended to Road, Fort Worth, TX 76155. Economic Injury (EIDL) Loan include the following areas as adversely Application Deadline Date: 06/13/2012. FOR FURTHER INFORMATION CONTACT: A. affected by the disaster: ADDRESSES: Submit completed loan Primary Counties: (Physical Damage Escobar, Office of Disaster Assistance, applications to: U.S. Small Business U.S. Small Business Administration, and Economic Injury Loans): Berks, Administration, Processing and Bucks, Chester, Delaware, 409 3rd Street, SW., Suite 6050, Disbursement Center, 14925 Kingsport Washington, DC 20416. Montgomery, Northampton, Road, Fort Worth, TX 76155. Philadelphia. SUPPLEMENTARY INFORMATION: Notice is FOR FURTHER INFORMATION CONTACT: A. Contiguous Counties: (Economic Injury hereby given that as a result of the Escobar, Office of Disaster Assistance, Loans Only): President’s major disaster declaration on U.S. Small Business Administration, Delaware: New Castle. 09/09/2011, Private Non-Profit 409 3rd Street, SW., Suite 6050, New Jersey: Burlington, Camden, organizations that provide essential Washington, DC 20416. Gloucester, Hunterdon, Mercer, services of governmental nature may file SUPPLEMENTARY INFORMATION: The notice Warren. disaster loan applications at the address of the President’s major disaster listed above or other locally announced All other information in the original declaration for Private Non-Profit declaration remains unchanged. locations. organizations in the State of Maine, The following areas have been dated 09/13/2011, is hereby amended to (Catalog of Federal Domestic Assistance determined to be adversely affected by include the following areas as adversely Numbers 59002 and 59008) the disaster: affected by the disaster. James E. Rivera, Primary Counties: Andrew, Atchison, Primary Counties: Lincoln. Associate Administrator for Disaster Buchanan, Carroll, Cooper, Holt, All other information in the original Assistance. Howard, Lafayette, Platte, Ray, Saline. declaration remains unchanged. [FR Doc. 2011–25346 Filed 9–30–11; 8:45 am] The Interest Rates are: (Catalog of Federal Domestic Assistance BILLING CODE 8025–01–P Numbers 59002 and 59008) Percent James E. Rivera, SMALL BUSINESS ADMINISTRATION Associate Administrator for Disaster For Physical Damage: [Disaster Declaration #12824 and #12825] Non-Profit Organizations with Assistance. Credit Available Elsewhere ... 3.250 [FR Doc. 2011–25347 Filed 9–30–11; 8:45 am] New York Disaster Number NY–00110 Non-Profit Organizations with- BILLING CODE 8025–01–P out Credit Available Else- AGENCY: U.S. Small Business where ...... 3.000 Administration. For Economic Injury: SMALL BUSINESS ADMINISTRATION ACTION: Amendment 3. Non-Profit Organizations with- [Disaster Declaration #12822 and #12823] out Credit Available Else- SUMMARY: This is an amendment of the where ...... 3.000 Pennsylvania Disaster Number PA– Presidential declaration of a major 00044 disaster for the State of New York The number assigned to this disaster (FEMA–4031–DR), dated 09/13/2011. for physical damage is 128566 and for AGENCY: U.S. Small Business Incident: Remnants of Tropical Storm economic injury is 128576. Administration. Lee.

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Incident Period: 09/07/2011 through SUPPLEMENTARY INFORMATION: The notice Percent 09/11/2011. of the President’s major disaster Effective Date: 09/23/2011. declaration for Private Non-Profit For Physical Damage: Physical Loan Application Deadline organizations in the State of New Homeowners with Credit Avail- Date: 11/14/2011. Hampshire, dated 09/03/2011, is hereby able Elsewhere ...... 5.000 Homeowners without Credit EIDL Loan Application Deadline Date: amended to include the following areas 06/13/2012. Available Elsewhere ...... 2.500 as adversely affected by the disaster. Businesses with Credit Avail- ADDRESSES: Submit completed loan Primary Counties: Belknap. able Elsewhere ...... 6.000 applications to: U.S. Small Business All other information in the original Businesses without Credit Administration, Processing and declaration remains unchanged. Available Elsewhere ...... 4.000 Disbursement Center, 14925 Kingsport Non-Profit Organizations with Road, Fort Worth, TX 76155. (Catalog of Federal Domestic Assistance Credit Available Elsewhere ... 3.250 Numbers 59002 and 59008) FOR FURTHER INFORMATION CONTACT: A. Non-Profit Organizations with- Escobar, Office of Disaster Assistance, out Credit Available Else- James E. Rivera, where ...... 3.000 U.S. Small Business Administration, Associate Administrator for Disaster For Economic Injury: 409 3rd Street, SW., Suite 6050, Assistance. Businesses & Small Agricultural Washington, DC 20416. [FR Doc. 2011–25357 Filed 9–30–11; 8:45 am] Cooperatives without Credit SUPPLEMENTARY INFORMATION: The notice BILLING CODE 8025–01–P Available Elsewhere ...... 4.000 of the President’s major disaster Non-Profit Organizations with- declaration for the State of New York, out Credit Available Else- dated 09/13/2011 is hereby amended to SMALL BUSINESS ADMINISTRATION where ...... 3.000 establish the incident period for this [Disaster Declaration #12850 and #12851] The number assigned to this disaster disaster as beginning 09/07/2011 and for physical damage is 12850 8 and for continuing through 09/11/2011. Rhode Island Disaster #RI–00008 All other information in the original economic injury is 12851 0. The States which received an EIDL declaration remains unchanged. AGENCY: U.S. Small Business Declaration # are Rhode Island, Administration. (Catalog of Federal Domestic Assistance Connecticut, Massachusetts. Numbers 59002 and 59008) ACTION: Notice. (Catalog of Federal Domestic Assistance James E. Rivera, SUMMARY: This is a notice of an Numbers 59002 and 59008) Associate Administrator for Disaster Administrative declaration of a disaster Dated: September 26, 2011. Assistance. for the State of Rhode Island dated 09/ Karen G. Mills, [FR Doc. 2011–25345 Filed 9–30–11; 8:45 am] 26/2011. Administrator. BILLING CODE 8025–01–P Incident: Hurricane Irene. [FR Doc. 2011–25358 Filed 9–30–11; 8:45 am] Incident Period: 08/27/2011 through BILLING CODE 8025–01–P 08/29/2011. SMALL BUSINESS ADMINISTRATION Effective Date: 09/26/2011. Physical Loan Application Deadline [Disaster Declaration #12809 and #12810] DEPARTMENT OF STATE Date: 11/25/2011. New Hampshire Disaster Number NH– Economic Injury (EIDL) Loan [Public Notice 7617] 00020 Application Deadline Date: 06/26/2012. Determination and Certification ADDRESSES: Submit completed loan AGENCY: U.S. Small Business Related to Colombian Armed Forces applications to: U.S. Small Business Administration. Under Section 7046(b) of the Administration, Processing and ACTION: Amendment 3. Department of State, Foreign Disbursement Center, 14925 Kingsport Operations, and Related Programs SUMMARY: This is an amendment of the Road, Fort Worth, TX 76155. Appropriations Act, 2010 Presidential declaration of a major FOR FURTHER INFORMATION CONTACT: A. disaster for Public Assistance Only for Escobar, Office of Disaster Assistance, Pursuant to the authority vested in the the State of New Hampshire (FEMA– U.S. Small Business Administration, Secretary of State, including under 4026–DR), dated 09/03/2011. 409 3rd Street, SW., Suite 6050, section 7046(b) of the Department of Incident: Tropical Storm Irene. Washington, DC 20416. State, Foreign Operations, and Related Incident Period: 08/26/2011 through Programs Appropriations Act, 2010 09/06/2011. SUPPLEMENTARY INFORMATION: Notice is hereby given that as a result of the (Div. F, Pub. L. 111–117) (‘‘FY 2010 DATES: Effective Date: 09/23/2011. Administrator’s disaster declaration, SFOAA’’), as carried forward in the Physical Loan Application Deadline Full-Year Continuing Appropriations Date: 11/02/2011. applications for disaster loans may be filed at the address listed above or other Act, 2011 (Div. B, Pub. L. 112–10) I Economic Injury (EIDL) Loan hereby determine, certify, and report Application Deadline Date: 06/05/2012. locally announced locations. The following areas have been that the Government of Colombia is ADDRESSES: Submit completed loan determined to be adversely affected by meeting the conditions contained in applications to: U.S. Small Business the disaster: section 7046(b)(1)(B) and section Administration, Processing and 7046(b)(2) of the Department of State, Disbursement Center, 14925 Kingsport Primary Counties: Providence. Foreign Operations, and Related Road, Fort Worth, TX 76155. Contiguous Counties: Programs Appropriations Act, 2009 Rhode Island: Bristol, Kent. FOR FURTHER INFORMATION CONTACT: A. (Div. H, Pub. L. 111–8) (‘‘FY 2009 Escobar, Office of Disaster Assistance, Connecticut: Windham. SFOAA’’). U.S. Small Business Administration, Massachusetts: Bristol, Norfolk, Pursuant to section 7046(b) of the FY 409 3rd Street, SW., Suite 6050, Worcester. 2010 SFOAA, the Department of State Washington, DC 20416. The Interest Rates are: has periodically consulted with

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Colombian and internationally The Department’s report was filed routine uses apply to Country Clearance recognized human rights organizations with the Office of Management and Records, State-77. regarding the Colombian Armed Forces’ Budget. The new system description, POLICIES AND PRACTICES FOR STORING, progress in meeting the above- ‘‘Country Clearance Records, State-77’’ RETRIEVING, ACCESSING, RETAINING AND mentioned conditions, as provided in will read as set forth below. DISPOSING OF RECORDS IN THE SYSTEM: section 7046(c) of the FY 2009 SFOAA. Dated: September 8, 2011. STORAGE: This Determination and Certification Keith D. Miller, shall be published in the Federal Electronic and paper records. Director, Office of Operations, Bureau of Register, and copies shall be transmitted Administration, U.S. Department of State. RETRIEVABILITY: to the appropriate committees of Congress. STATE–77 Records are retrieved by the individual’s name or itinerary number. Dated: September 7, 2011. SYSTEM NAME: SAFEGUARDS: William J. Burns, Country Clearance Records. Deputy Secretary of State. All users are given cyber security [FR Doc. 2011–25448 Filed 9–30–11; 8:45 am] SECURITY CLASSIFICATION: awareness training which covers the BILLING CODE 4710–29–P Unclassified. procedures for handling Sensitive but Unclassified information, including SYSTEM LOCATION: personally identifiable information (PII). DEPARTMENT OF STATE Office of Management Policy, Annual refresher training is mandatory. Rightsizing and Innovation (M/PRI), In addition, all Foreign Service and [Public Notice: 7632] Department of State, 2201 C Street NW., Civil Service employees and those Privacy Act; System of Records: State- Washington, DC 20520–3822; all U.S. Locally Engaged Staff who handle PII 77, Country Clearance Records posts and missions abroad; and are required to take the Foreign Service corresponding automated data Institute distance learning course SUMMARY: Notice is hereby given that processing facilities. instructing employees on privacy and the Department of State proposes to security requirements, including the create a system of records, Country CATEGORIES OF INDIVIDUALS COVERED BY THE Rules of Behavior for handling PII and Clearance Records, State-77, pursuant to SYSTEM: the potential consequences if it is the provisions of the Privacy Act of Employees and contractors of the handled improperly. Before being 1974, as amended (5 U.S.C. 552a) and Department of State and other Executive granted access to Country Clearance Office of Management and Budget Branch agencies of the U.S. Records, a user must first be granted Circular No. A–130, Appendix I. Government. access to the Department of State computer system. DATES: This system of records will CATEGORIES OF RECORDS IN THE SYSTEM: become effective on November 14, 2011, Remote access to the Department of Individual name, email address, State network from non-Department unless we receive comments that will phone number, passport country and result in a contrary determination. owned systems is authorized only number, agency, employment type, through a Department approved access ADDRESSES: Any persons interested in country of birth, emergency contact program. Remote access to the network commenting on this new system of information, purpose of visit, lodging is configured with the Office of records may do so by submitting information, carrier information, level of Management and Budget Memorandum comments in writing to the Director; security clearance and travel itineraries. M–07–16 security requirements, which Office of Information Programs and include but are not limited to two-factor Services, A/GIS/IPS; Department of AUTHORITY FOR MAINTENANCE OF THE SYSTEM: authentication and time out function. State, SA–2; 515 22nd Street, NW.; 22 U.S.C. 3927, Chief of Mission. All Department of State employees Washington, DC 20522–8001. PURPOSE: and contractors with authorized access FOR FURTHER INFORMATION CONTACT: To request permission from the chief have undergone a thorough background Director; Office of Information Programs security investigation. Access to the and Services, A/GIS/IPS; Department of of mission for the planned presence in his or her country, post, or mission of Department of State, its annexes, posts, State, SA–2; 515 22nd Street, NW.; and missions abroad is controlled by Washington, DC 20522–8001. an employee or contractor of the Department of State or other Executive security guards and admission is limited SUPPLEMENTARY INFORMATION: Branch agency. to those individuals possessing a valid The Department of State proposes the identification card or individuals under new system of records named ‘‘Country ROUTINE USES OF RECORDS MAINTAINED IN THE proper escort. All paper records Clearance Records.’’ During a review of SYSTEM, INCLUDING CATEGORIES OF USERS AND containing personal information are Department of State operations, this PURPOSES OF SUCH USES: maintained in secured file cabinets in system was identified as being in The Department shares Country restricted areas, access to which is operation and subject to the provisions Clearance records with designated limited to authorized personnel only. of the Privacy Act. This notice is being administrators of other Executive Access to computerized files is published to address the requirements Branch agencies utilizing the eCountry password-protected and under the of the Privacy Act of 1974, as amended. Clearance system for employees or direct supervision of the system The proposed system will maintain contractors on official travel to U.S. manager. The system manager has the information required to request posts and missions abroad. capability of printing audit trails of permission from the chief of mission for The Department of State periodically access from the computer media, the planned presence in his or her publishes in the Federal Register its thereby permitting regular and ad hoc country, post, or mission of an standard routine uses which apply to all monitoring of computer usage. employee or contractor of the of its Privacy Act systems of records. When it is determined that a user no Department of State or other Executive These notices appear in the form of a longer needs access, the user account is Branch agency. Prefatory Statement. These standard disabled.

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RETENTION AND DISPOSAL: DEPARTMENT OF STATE DEPARTMENT OF STATE Records are disposed of in accordance with published Department of State [Public Notice 7631] [Public Notice: 7629] Records Disposition Schedules as approved by the National Archives and Waiver of Restriction on Assistance to Waiver of Restriction on Assistance to Records Administration (NARA). More the Central Government of Niger the Central Government of Guinea specific information may be obtained by writing to the Director, Office of Pursuant to Section 7086(c)(2) of the Pursuant to Section 7086(c)(2) of the Information Programs and Services, Department of State, Foreign Department of State, Foreign Department of State, SA–2, 515 22nd Operations, and Related Programs Operations, and Related Programs Street, NW., Washington, DC 20522– Appropriations Act, 2010 (Div. F, Pub. Appropriations Act, 2010 (Div. F, Pub. 8001. L. 111–117), as carried forward by the L. 111–117), as carried forward by the Full-Year Continuing Appropriations Full-Year Continuing Appropriations SYSTEM MANAGER AND ADDRESS: Act, 2011 (Div. B, Pub. L. 112–10) (‘‘the Act, 2011 (Div. B, Pub. L. 112–10) (‘‘the Director, Office of Management Act’’), and Department of State Act’’), and Department of State Policy, Rightsizing and Innovation (M/ Delegation of Authority Number 245–1, Delegation of Authority Number 245–1, PRI), 2201 C Street, NW., Washington, I hereby determine that it is important I hereby determine that it is important DC 20520–3822. to the national interest of the United to the national interest of the United States to waive the requirements of States to waive the requirements of NOTIFICATION PROCEDURES: Section 7086(c)(1) of the Act with Section 7086(c)(1) of the Act with respect to Niger and I hereby waive such Individuals who have reason to respect to Guinea and I hereby waive restriction. believe that the Office of Management such restriction. Policy, Rightsizing and Innovation (M/ This determination shall be reported This determination shall be reported PRI) may have information pertaining to to the Congress, and published in the to the Congress, and published in the them may write to the Director, Office Federal Register. Federal Register. of Information Programs and Services, Dated: July 22, 2011. Department of State, SA–2, 515 22nd Dated: July 22, 2011. Thomas Nides, Street, NW., Washington, DC 20522– Thomas Nides, 8001. The individual must specify that Deputy Secretary of State for Management Deputy Secretary of State for Management he/she wishes Country Clearance and Resources. and Resources. [FR Doc. 2011–25435 Filed 9–30–11; 8:45 am] Records to be checked. At a minimum, [FR Doc. 2011–25447 Filed 9–30–11; 8:45 am] BILLING CODE 4710–26–P the individual should include his or her BILLING CODE 4710–26–P name, current mailing address, zip code, and signature; and a brief description of the circumstances that caused the DEPARTMENT OF STATE DEPARTMENT OF STATE individual to believe that the system of records contains records pertaining to [Public Notice: 7626] [Public Notice: 7625] him or her, including dates and locations of travel episodes for which Waiver of Restriction on Assistance to Waiver of Restriction on Assistance to the individual believes he or she may the Central Government of Guinea- the Central Government of The Gambia have caused the creation of country Bissau clearance records. Pursuant to Section 7086(c)(2) of the Pursuant to Section 7086(c)(2) of the Department of State, Foreign RECORD ACCESS PROCEDURES: Department of State, Foreign Operations, and Related Programs Individuals who wish to gain access Operations, and Related Programs Appropriations Act, 2010 (Division F, Appropriations Act, 2010 (Div. F, Pub. to or amend records pertaining to them Pub. L. 111–117), as carried forward by L. 111–117), as carried forward by the should write to the Director, Office of the Full-Year Continuing Full-Year Continuing Appropriations Information Programs and Services Appropriations Act, 2011 (Div. B, Pub. Act, 2011 (Div. B, Pub. L. 112–10) (‘‘the (address above). L. 112–10) (‘‘the Act’’), and Department Act’’), and Department of State of State Delegation of Authority Number CONTESTING RECORD PROCEDURES: Delegation of Authority Number 245–1, I hereby determine that it is important 245–1, I hereby determine that it is (See above). to the national interest of the United important to the national interest of the United States to waive the requirements RECORD SOURCE CATEGORIES: States to waive the requirements of Section 7086(c)(1) of the Act with of Section 7086(c)(1) of the Act with These records contain information respect to Guinea-Bissau and I hereby respect to The Gambia and I hereby obtained directly from the individual waive such restriction. waive such restriction. who is the subject of these records, from This determination shall be reported This determination shall be reported the Executive Branch agency employing to the Congress, and published in the to the Congress, and published in the the individual, and M/PRI and post or Federal Register. Federal Register. mission staff abroad. Dated: July 22, 2011. Dated: July 28, 2011. SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS Thomas Nides, Thomas Nides, OF THE ACT: Deputy Secretary of State for Management Deputy Secretary of State for Management None. and Resources. and Resources. [FR Doc. 2011–25433 Filed 9–30–11; 8:45 am] [FR Doc. 2011–25444 Filed 9–30–11; 8:45 am] [FR Doc. 2011–25451 Filed 9–30–11; 8:45 am] BILLING CODE 4710–24–P BILLING CODE 4710–26–P BILLING CODE 4710–26–P

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DEPARTMENT OF STATE DEPARTMENT OF STATE DEPARTMENT OF STATE

[Public Notice: 7623] [Public Notice: 7618] [Public Notice: 7920]

Waiver of Restriction on Assistance to Waiver of Restriction on Assistance to Waiver of Restriction on Assistance to the Central Government of Ethiopia the Central Government of the Central the Central Government of Angola African Republic Pursuant to Section 7086(c)(2) of the Pursuant to Section 7086(c)(2) of the Department of State, Foreign Pursuant to Section 7086(c)(2) of the Department of State, Foreign Operations, and Related Programs Department of State, Foreign Operations, and Related Programs Appropriations Act, 2010 (Div. F, Pub. Operations, and Related Programs Appropriations Act, 2010 (Div. F, Pub. L. 111–117) as carried forward by the Appropriations Act, 2010 (Div. F, Pub. L. 111–117), as carried forward by the Full-Year Continuing Appropriations L. 111–117) as carried forward by the Full-Year Continuing Appropriations Act, 2011 (Div. B, Pub. L. 112–10) (‘‘the Full-Year Continuing Appropriations Act, 2011 (Div. B, Pub. L. 112–10) (‘‘the Act’’), and Department of State Act, 2011 (Div. B, Pub. L. 112–10) (‘‘the Act’’), and Department of State Delegation of Authority Number 245–1, Act’’), and Department of State Delegation of Authority Number 245–1, I hereby determine that it is important Delegation of Authority Number 245–1, I hereby determine that it is important to the national interest of the United to the national interest of the United I hereby determine that it is important States to waive the requirements of States to waive the requirements of to the national interest of the United Section 7086(c)(1) of the Act with Section 7086(c)(1) of the Act with States to waive the requirements of Section 7086(c)(1) of the Act with respect to Angola and I hereby waive respect to Ethiopia and I hereby waive such restriction. such restriction. respect to the Central African Republic and I hereby waive such restriction. This determination shall be reported This determination shall be reported This determination shall be reported to the Congress, and published in the to the Congress, and published in the Federal Register. Federal Register. to the Congress, and published in the Federal Register. Dated: July 20, 2011. Dated: July 11, 2011. Dated: August 1, 2011. Thomas Nides, Thomas Nides, Thomas Nides, Deputy Secretary of State for Management Deputy Secretary of State for Management and Resources. and Resources. Deputy Secretary of State for Management and Resources. [FR Doc. 2011–25436 Filed 9–30–11; 8:45 am] [FR Doc. 2011–25453 Filed 9–30–11; 8:45 am] BILLING CODE 4710–26–P [FR Doc. 2011–25446 Filed 9–30–11; 8:45 am] BILLING CODE 4710–26–P BILLING CODE 4710–26–P DEPARTMENT OF STATE DEPARTMENT OF STATE DEPARTMENT OF STATE [Public Notice 7622] [Public Notice 7921] [Public Notice: 7919] Waiver of Restriction on Assistance to Waiver of Restriction on Assistance to the Central Government of the the Central Government of Chad Waiver of Restriction on Assistance to Democratic Republic of the Congo the Central Government of Cameroon Pursuant to Section 7086(c)(2) of the Pursuant to Section 7086(c)(2) of the Department of State, Foreign Pursuant to Section 7086(c)(2) of the Department of State, Foreign Operations, and Related Programs Department of State, Foreign Operations, and Related Programs Appropriations Act, 2010 (Div. F, Pub. Operations, and Related Programs Appropriations Act, 2010 (Div. F, Pub. Appropriations Act, 2010 (Div. F, Pub. L.111–117) as carried forward by the L. 111–117), as carried forward by the L. 111–117) as carried forward by the Full-Year Continuing Appropriations Full-Year Continuing Appropriations Full-Year Continuing Appropriations Act, 2011 (Div. B, Pub. L. 112–10) (‘‘the Act, 2011 (Div. B, Pub. L. 112–10), (‘‘the Act, 2011 (Div. B, Pub. L. 112–10) (‘‘the Act’’), and Department of State Act’’), and Department of State Act’’), and Department of State Delegation of Authority Number 245–1, Delegation of Authority Number 245–1, Delegation of Authority Number 245–1, I hereby determine that it is important I hereby determine that it is important I hereby determine that it is important to the national interest of the United to the national interest of the United to the national interest of the United States to waive the requirements of States to waive the requirements of States to waive the requirements of Section 7086(c)(1) of the Act with Section 7086(c)(1) of the Act with Section 7086(c)(1) of the Act with respect to the Democratic Republic of respect to Chad and I hereby waive such respect to Cameroon and I hereby waive the Congo and I hereby waive such restriction. such restriction. restriction. This determination shall be reported This determination shall be reported This determination shall be reported to the Congress, and published in the to the Congress, and published in the to the Congress, and published in the Federal Register. Federal Register. Federal Register. Dated: July 29, 2011. Dated: August 1, 2011. Dated: July 11, 2011. Thomas Nides, Thomas Nides, Thomas Nides, Deputy Secretary of State for Management Deputy Secretary of State for Management Deputy Secretary of State for Management and Resources . and Resources. and Resources. [FR Doc. 2011–25455 Filed 9–30–11; 8:45 am] [FR Doc. 2011–25442 Filed 9–30–11; 8:45 am] [FR Doc. 2011–25454 Filed 9–30–11; 8:45 am] BILLING CODE 4710–26–P BILLING CODE 4710–26–P BILLING CODE 4710–26–P

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DEPARTMENT OF STATE DEPARTMENT OF STATE DEPARTMENT OF TRANSPORTATION [Public Notice: 7627] Federal Aviation Administration [Public Notice: 7624] Waiver of Restriction on Assistance to Environmental Impact Statement: Waiver of Restriction on Assistance to the Transitional Federal Government of Theodore Francis Green Airport, the Central Government of Gabon Somalia Warwick, RI Pursuant to Section 7086(c)(2) of the Pursuant to Section 7086(c)(2) of the AGENCY: Federal Aviation Department of State, Foreign Department of State, Foreign Administration (FAA), DOT. Operations, and Related Programs Operations, and Related Programs ACTION: Notice of Availability. Appropriations Act, 2010 (Division F, Appropriations Act, 2010 (Div. F, Pub. Pub. L. 111–117), as carried forward by L. 111–117) as carried forward by the SUMMARY: The FAA is issuing this notice the Full-Year Continuing Full-Year Continuing Appropriations to advise the public that a Record of Appropriations Act, 2011 (Div. B, Pub. Act, 2011 (Div. B, Pub. L. 112–10) (‘‘the Decision (ROD), resulting from an L. 112–10) (‘‘the Act’’), and Department Act’’), and Department of State Environmental Impact Statement (EIS) of State Delegation of Authority Number Delegation of Authority Number 245–1, has been prepared for Theodore Francis 245–1, I hereby determine that it is I hereby determine that it is important Green Airport, in Warwick, Rhode important to the national interest of the to the national interest of the United Island. United States to waive the requirements States to waive the requirements of FOR FURTHER INFORMATION CONTACT: of Section 7086(c)(1) of the Act with Section 7086(c)(1) of the Act with Richard Doucette, Environmental respect to Gabon and I hereby waive respect to Somalia and I hereby waive Program Manager, Federal Aviation such restriction. such restriction. Administration New England, 12 New This determination shall be reported This determination shall be reported England Executive Park, Burlington, to the Congress, and published in the MA. Telephone (781) 238–7613. to the Congress, and published in the Federal Register. Federal Register. SUPPLEMENTARY INFORMATION: The FAA Dated: July 28, 2011. is making available a ROD regarding Dated: July 28, 2011. Thomas Nides, installation of runway safety areas, other Thomas Nides, Deputy Secretary of State for Management safety improvements, a runway Deputy Secretary of State for Management and Resources. extension, and other efficiency and Resources. [FR Doc. 2011–25445 Filed 9–30–11; 8:45 am] improvements at Theodore Francis [FR Doc. 2011–25452 Filed 9–30–11; 8:45 am] BILLING CODE 4710–26–P Green Airport, in Warwick, Rhode BILLING CODE 4710–26–P Island. The ROD documents the final Agency decisions regarding the DEPARTMENT OF STATE proposed projects as described and DEPARTMENT OF STATE analyzed in the EIS. The ROD is [Public Notice 7630] available for review during normal [Public Notice: 7628] Waiver of Restriction on Assistance to business hours at the following the Central Government of Coˆ te locations: FAA New England Region, Waiver of Restriction on Assistance to d’Ivoire Airports Division, 16 New England the Central Government of the Executive Park, Burlington, Kingdom of Swaziland Pursuant to Section 7086(c)(2) of the Massachusetts (781) 238–7613, Department of State, Foreign Theodore Francis Green Airport, 2000 Pursuant to Section 7086(c)(2) of the Operations, and Related Programs Post Rd, Warwick, Rhode Island, and at Department of State, Foreign Appropriations Act, 2010 (Div. F, Pub. public libraries in Warwick and Operations, and Related Programs L. 111–117) (SFOAA), Section Cranston, Rhode Island. Appropriations Act, 2010 (Div. F, Pub. 7086(c)(2) of the SFOAA as carried Issued on: September 23, 2011. forward by the Full-Year Continuing L.111–117), as carried forward by the Bryon H. Rakoff, Full-Year Continuing Appropriations Appropriations Act 2011(Div. B, Pub. L. 112–10), and Department of State Acting Manager, Airports Division. Act, 2011 (Div. B, Pub. L. 112–10) (‘‘the [FR Doc. 2011–25414 Filed 9–30–11; 8:45 am] Act’’), and Department of State Delegation of Authority Number 245–1, BILLING CODE 4910–13–P Delegation of Authority Number 245–1, I hereby determine that it is important I hereby determine that it is important to the national interest of the United States to waive the requirements of to the national interest of the United DEPARTMENT OF TRANSPORTATION States to waive the requirements of Section 7086(c)(1) of the SFOAA and Section 7086(c)(1) of the Act with Section 7086(c)(1) of the 2011 Full-Year Federal Highway Administration respect to the Kingdom of Swaziland Continuing Appropriations Act with and I hereby waive such restriction. respect to Coˆte d’Ivoire and I hereby Environmental Impact Statement: El waive such restrictions. Paso County, TX This determination shall be reported This determination shall be reported to the Congress, and published in the to the Congress, and published in the AGENCY: Federal Highway Federal Register. Federal Register. Administration (FHWA), DOT. ACTION: Dated: June 24, 2011. Dated: July 20, 2011. Rescind Notice of Intent (NOI) to prepare an EIS. Thomas Nides, Thomas Nides, Deputy Secretary of State for Management Deputy Secretary of State for Management SUMMARY: FHWA is issuing this notice and Resources. and Resources. to advise the public that the NOI to [FR Doc. 2011–25449 Filed 9–30–11; 8:45 am] [FR Doc. 2011–25438 Filed 9–30–11; 8:45 am] prepare an environmental impact BILLING CODE 4710–26–P BILLING CODE 4710–26–P statement (EIS) for proposed

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improvements to Loop 375 Border environmental process. Comments or p.m. e.t., Monday through Friday, Highway West, in El Paso County, questions concerning the rescission of except Federal holidays. Texas, is being rescinded. this proposed action and the EIS should Instructions: All submissions must FOR FURTHER INFORMATION CONTACT: be directed to the FHWA at the address include the Agency name and docket Gregory S. Punske, P.E., District provided above. number. For detailed instructions on submitting comments and additional Engineer, Federal Highway Gregory S. Punske, Administration, Texas Division, 300 information on the exemption process, District Engineer, Austin, Texas. East 8th Street, Room 826, Austin, Texas see the Public Participation heading 78701, Telephone (512) 536–5960. [FR Doc. 2011–25364 Filed 9–30–11; 8:45 am] below. Note that all comments received BILLING CODE 4910–22–P SUPPLEMENTARY INFORMATION: In will be posted without change to September 2007, the Texas Department http://www.regulations.gov, including any personal information provided. of Transportation (TxDOT) and FHWA DEPARTMENT OF TRANSPORTATION announced their intent to prepare an Please see the Privacy Act heading EIS pursuant to 40 CFR 1508.22 and 43 Federal Motor Carrier Safety below. Docket: For access to the docket to TAC Sec. 2.5(e)(2) for the proposed Administration Loop 375 Ce´sar Cha´vez Highway read background documents or (Border Highway West Extension) in El [Docket No. FMCSA–2011–0225] comments received, go to http:// Paso, Texas, to include the Texas, New www.regulations.gov, and follow the Mexico, and Ciudad Jua´rez, Chihuahua Agency Information Collection online instructions for accessing the Me´xico border region. The proposed Activities; New Information Collection dockets, or go to the street address listed Border Highway West Extension project Request: Commercial Driver Individual above. limits extended approximately 13.8 Differences Study Privacy Act: Anyone is able to search miles to provide a continuous route the electronic form of all comments AGENCY: Federal Motor Carrier Safety received into any of our dockets by the from Interstate 10 (I–10) east of State Administration (FMCSA), DOT. Highway (SH) 20 (Mesa Street) to name of the individual submitting the ACTION: Sunland Park Drive and continued on Notice and request for comment (or signing the comment, if Loop 375 to end at United States comments. submitted on behalf of an association, Highway (US) 54. The proposed project business, labor union, etc.). You may SUMMARY: In accordance with the review DOT’s complete Privacy Act was part of an alternate route to provide Paperwork Reduction Act of 1995, congestion relief for I–10, an east-west Statement for the Federal Docket FMCSA announces its plan to submit Management System published in the facility north of the project. The Loop the Information Collection Request (ICR) 375 Border Highway West Extension Federal Register on January 17, 2008 described below to the Office of (73 FR 3316), or you may visit http:// Project was originally included in the Management and Budget (OMB) for its Gateway 2030 Metropolitan edocket.access.gpo.gov/2008/pdfE8- review and approval and invites public 794.pdf. Transportation Plan (MTP); and is comment. The FMCSA requests currently included in the current Public Participation: The Federal approval of a new ICR that is associated eRulemaking Portal is available 24 Mission 2035 MTP, a transportation with a study that will be conducted by program adopted by the El Paso hours each day, 365 days each year. You a research contractor to investigate the can obtain electronic submission and Metropolitan Planning Organization differences among the characteristics of (MPO) in August of 2010 and approved retrieval help and guidelines under the individual commercial drivers. This ‘‘help’’ section of the Federal for air conformity on January 28, 2011. information collection will aid FMCSA The EIS was in the preliminary stages eRulemaking Portal Web site. If you in developing future safety initiatives by want us to notify you that we received of development. Two scoping meetings examining a wide array of driver and were held for cooperating and your comments, please include a self- situational factors to determine if they addressed, stamped envelope or participating agencies on October 23, are associated with increased or 2007 and October 30, 2007 at the El postcard, or print the acknowledgement decreased crash and incident page that appears after submitting Paso International Airport Board Room, involvement. 6701 Convair Road, El Paso, Texas. In comments online. Comments received addition, two public scoping meetings DATES: Comments must be submitted on after the comment closing date will be were held on these same dates at Hilos or before December 2, 2011. included in the docket and will be de Plata Senior Center and the Westside ADDRESSES: You may submit comments considered to the extent practicable. Regional Command Center, El Paso, identified by Federal Docket FOR FURTHER INFORMATION CONTACT: Texas. Management System (FDMS) Docket Theresa Hallquist, Federal Motor Carrier FHWA and TxDOT have decided to Number FMCSA–2011–0225 using any Safety Administration, Office of rescind the Notice of Intent because the of the following methods: Analysis, Research and Technology, Texas Department of Transportation • Federal eRulemaking Portal: http:// Federal Motor Carrier Safety will be using State funding for the www.regulations.gov. Follow the online Administration, 1200 New Jersey delivery of the project. A project instructions for submitting comments. Avenue, SE., Washington, DC 20590– containing no Federal funds or Federal • Fax: 1–202–493–2251. 0001. Telephone (202) 366–1064 or e- actions is not required to complete • Mail: Docket Management Facility; mail [email protected]., Office NEPA project approvals. Further, the U.S. Department of Transportation, 1200 hours are from 8 a.m. to 4 p.m., ET, project will be broken into several New Jersey Avenue, SE., West Building, Monday through Friday, except Federal phases or projects, all to be funded with Ground Floor, Room W12–140, 20590– holidays. State funds and all to have logical 0001. SUPPLEMENTARY INFORMATION: The termini and independent utility. • Hand Delivery or Courier: West purpose of this study is to identify, Consequently, the previously proposed Building, Ground Floor, Room W12– verify, quantify, and prioritize project will undergo several 140, 1200 New Jersey Avenue, SE., commercial driver risk factors. environmental evaluations under a State Washington, DC, between 9 a.m. and 5 Primarily, these are personal factors

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such as demographic characteristics, hours + 20 Managers completing Fleet ADDRESSES: You may submit comments medical conditions, personality traits, Manager Survey × 10 minutes + Carrier identified by Federal Docket and performance capabilities. Risk managers delivering monthly crash Management System Number [FMCSA– factors may also include work reports to VTTI (20 carriers × 36 2011–0084] by any of the following environmental conditions, such as months) × 30 minutes / 60 minutes = methods: carrier operations type. The study will 2,143/3 years = 714 hours]. 8,822 hours • Federal eRulemaking Portal: http:// identify risk factors by linking the for CMV driver participants + 714 hours www.regulations.gov. Follow the online characteristics of individual drivers for Carriers Operations = 9,536 hours. instructions for submitting comments. with their driving records, especially • Fax: 1–202–493–2251. Public Comments Invited: You are • the presence or absence of DOT asked to comment on any aspect of this Mail: Docket Management Facility, reportable crashes. revised information collection request, U.S. Department of Transportation, 1200 Title: Commercial Driver Individual including: (1) The necessity and New Jersey Avenue, SE., West Building, Differences Study. usefulness of the information collection Ground Floor, Room W12–140, OMB Control Number: 2126–XXXX. for FMCSA to meet its goal in reducing Washington, DC 20590–0001. • Hand Delivery or Courier: West Type of Request: New ICR. truck crashes; (2) the accuracy of the Building, Ground Floor, Room W12– Respondents: Commercial motor estimated burdens; (3) ways to enhance 140, 1200 New Jersey Avenue, SE., vehicle drivers and fleet managers. the quality, usefulness, and clarity of Estimated Number of Respondents: between 9 a.m. and 5 p.m. E.T., Monday the collected information; and (4) ways 21,020. through Friday, except Federal holidays. Estimated Time per Response: The to minimize the collection burden Instructions: All submissions must estimated average time per responses without reducing the quality of the include the Agency name and docket are as follow: 1 hour, 5 minutes for collected information. The agency will number. For detailed instructions on paper and 1 hour for electronic Form summarize and/or include your submitting comments and additional MCSA–5863, ‘‘Commercial Motor comments in the request for OMB’s information on the exemption process, Vehicle Driver Survey,’’ submissions; 35 clearance of this information collection. see the Public Participation heading minutes for paper and 30 minutes for Issued on: September 23, 2011. below. Note that all comments received electronically Form MCSA–5864, Kelly Leone, will be posted without change to ‘‘Follow-Up Survey of Recent Life Associate Administrator for Research and http://www.regulations.gov, including Experiences,’’ submissions; 75 minutes Information Technology. any personal information provided. for paper and 70 minutes for electronic [FR Doc. 2011–25325 Filed 9–30–11; 8:45 am] Please see the Privacy Act heading Driver Survey and Job Descriptive Index BILLING CODE 4910–EX–P below. from the Follow-up Survey submissions; Docket: For access to the docket to and 10 minutes for the Form MCSA– read background documents or 5865, ‘‘Fleet Managers Survey,’’ DEPARTMENT OF TRANSPORTATION comments received, go to http:// submissions. www.regulations.gov, and follow the Expiration Date: N/A. This is a new Federal Motor Carrier Safety online instructions for accessing the information collection request. Administration dockets, or go to the street address listed Frequency of Response: This above. information collection will be a single, [Docket No. FMCSA–2011–0084] Privacy Act: Anyone is able to search nonrecurring event for 16,000 CMV the electronic form of all comments driver participants and 20 fleet Hours of Service of Drivers: Western received into any of our dockets by the managers. For at least 5,000 CMV driver Pilot Service Application for name of the individual submitting the participants, the information collection Exemption comment (or signing the comment, if will occur twice. submitted on behalf of an association, Estimated Total Annual Burden: AGENCY: Federal Motor Carrier Safety business, labor union, etc.). You may 9,536 hours. 8,822 hours for CMV driver Administration (FMCSA), DOT. review DOT’s complete Privacy Act participants: [16,800 CMV drivers ACTION: Notice of application for Statement in the Federal Register completing paper Driver Survey × 65 exemption; request for comments. published on April 11, 2000 (65 FR minutes + 4,200 CMV drivers 19476) or you may visit http:// completing electronic Driver Survey × 1 SUMMARY: FMCSA has received an DocketInfo.dot.gov. hour + 4,000 drivers completing paper application from Western Pilot Service Public participation: The Federal Follow-Up Survey × 35 minutes per (‘‘Western’’) requesting an exemption eRulemaking Portal is available 24 driver / 60 minutes + 1,000 drivers from certain hours-of-service (HOS) hours each day, 365 days each year. You completing electronic Follow-Up provisions of the Federal Motor Carrier can get electronic submission and Survey × 30 minutes per driver / 60 Safety Regulations (FMCSRs). The retrieval help and guidelines under the minutes + 800 CMV drivers completing exemption request is for Western’s ‘‘help’’ section of the Federal paper Driver Survey and Job Descriptive drivers who transport aviation fuel for eRulemaking Portal Web site. If you Index × 75 minutes per driver / 60 aircraft used in wild-land firefighting want us to notify you that we received minutes + 200 CMV drivers completing operations. Western specifically your comments, please include a self- paper Driver Survey and Job Descriptive requests an exemption for up to 15 addressed, stamped envelope or Inde× × 70 minutes per driver / 60 drivers from § 395.3(b)(2), the HOS postcard, or print the acknowledgement minutes = 26,466 hours/3 years = 8,822 prohibition against driving a page that appears after submitting hours] + 714 hours for Carrier commercial motor vehicle (CMV) after comments online. Comments received Operations: [20 participating carriers × 2 the 70th hour of cumulative on-duty after the comment closing date will be hours to learn about and agree to time in any 8-day period. FMCSA included in the docket, and we will participation + 40 carrier managers requests public comment on the consider late comments to the extent completing IRB training × 2 hours + 20 Western application for exemption. practicable. Managers recruiting and handling data DATES: Comments must be received on FOR FURTHER INFORMATION CONTACT: Mr. collection of 20,000 respondents × 83 or before November 2, 2011. Thomas Yager, Chief, FMCSA Driver

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and Carrier Operations Division; Office a gooseneck trailer transporting various that these drivers operate in a relaxing, of Bus and Truck Standards and mixing tanks, motors, and aviation fuel. stress-free environment. Operations; Telephone: 202–366–4325. Western states that its contracts require A copy of the Western Pilot Service E-mail: [email protected]. it to staff its units for a minimum of 9 exemption application is available for SUPPLEMENTARY INFORMATION: hours and up to a maximum of 14 hours review in the docket for this notice. a day. Western’s equipment must be set Request for Comments Background up at a designated government base and Section 4007 of the Transportation be ready to mix, load, fuel, and service In accordance with 49 U.S.C. 31136(e) Equity Act for the 21st Century (Pub. L. its aircraft at all times during daylight and 31315(b)(4), FMCSA requests public 105–178, 112 Stat. 107, 401, June 9, hours and must be capable of going to comment on the Western application for 1998) amended 49 U.S.C. 31136(e) and an alternative base when requested. The an exemption from the ‘‘70-hour/8-day 31315 to provide authority to grant ground support vehicles carry aviation rule’’ in 49 CFR part 395. The Agency exemptions from the FMCSRs. Under its fuel for their respective aircraft; the will consider all comments received by regulations, FMCSA must publish a primary role of the driver is to service close of business on November 2, 2011. notice of each exemption request in the and re-fuel the aircraft. While the Comments will be available for Federal Register (49 CFR 381.315(a)). operation of the ground support vehicle examination in the docket at the The Agency must provide the public an is a secondary role, each driver is location listed under the ADDRESSES opportunity to inspect the information subject to the FMCSRs including 49 CFR section of this notice. The Agency will relevant to the application, including part 395. consider to the extent practicable any safety analyses that have been Western states that on a typical day its comments received in the public docket conducted. The Agency must also drivers report to work at 9 a.m. and after the closing date of the comment provide an opportunity for public perform a pre-trip inspection. The period. comment on the request. drivers prepare their daily logs, Issued on: September 16, 2011. The Agency reviews safety analyses manifest, load logs, and mileage logs Larry W. Minor, and public comments submitted, and and attend a fire weather outlook Associate Administrator for Policy. determines whether granting the briefing. The drivers may relax and [FR Doc. 2011–25323 Filed 9–30–11; 8:45 am] exemption would likely achieve a level sleep if they feel the need after the of safety equivalent to, or greater than, briefing and completion of any portion BILLING CODE 4910–EX–P the level that would be achieved by the of daily duty requirements. If there is no current regulation (49 CFR 381.305). late afternoon fire activity, the drivers DEPARTMENT OF TRANSPORTATION The decision of the Agency must be are usually released at 6 p.m. (9-hour published in the Federal Register (49 day). Federal Motor Carrier Safety CFR 381.315(b)) with the reasons for Western contends that with no fire Administration denying or granting the application and, activity, drivers may perform no more if granted, the name of the person or than 4 hours of actual physical and [Docket No. FMCSA–2011–0097] mental work in a given day. While class of persons receiving the Pilot Program on NAFTA Long-Haul Western’s drivers wait for an aircraft to exemption, and the regulatory provision Trucking Provisions from which the exemption is granted. be dispatched or land, they are The notice must also specify the ‘‘available’’ and in ‘‘readiness to work,’’ AGENCY: Federal Motor Carrier Safety effective period, and explain the terms and are therefore considered to be ‘‘on- Administration (FMCSA), DOT. and conditions, of the exemption. The duty, not driving’’ and subject to the 70- ACTION: Notice of availability. exemption may be renewed (49 CFR hour/8-day rule. 381.300(b)). The problem arises because Western’s SUMMARY: FMCSA announces the drivers sometimes run out of available availability of a Final Environmental Request for Exemption hours in 5 days at 14 hours on duty per Assessment (FEA) that evaluates the The HOS regulations in 49 CFR day, based on the 70-hour/8-day rule. potential environmental impacts 395.3(b)(2) prohibit a property-carrying Currently, Western has relief drivers resulting from the implementation of its commercial motor vehicle (CMV) driver who travel to give regular drivers 2 days United States-Mexico cross-border long- from driving a CMV after having been off every 7 days to ensure that they stay haul trucking pilot program. FMCSA on duty for 70 cumulative hours in any in compliance with the HOS received five comments to its draft period of 8 consecutive days, if the regulations. environmental assessment (DEA) and employing motor carrier operates CMVs Instead of complying with the 70- responds to those comments in the FEA. every day of the week. hour/8-day rule, Western would like FMCSA concludes that the potential Western is a tactical aerial firefighting drivers to have 2 consecutive days off in environmental impacts from the pilot company that operates in support of a 14-day period so that they are on the program are not significant and do not wild-land firefighting operations under same schedule as the pilots operating warrant additional environmental contract with various government the aircraft, who are required by Federal analysis in the form of an agencies such as the U. S. Forest Aviation Administration rules to have 2 Environmental Impact Statement. Service, Bureau of Land Management, consecutive days off daily in a 2-week FMCSA issues a Finding of No and the Bureau of Indian Affairs. period. Western states that if its Significant Impact (FONSI) based on the Western is based in Phoenix, Arizona. exemption request is granted, the conclusions in the FEA, which is also The requested exemption would apply drivers would still be held to the 14- available in the docket. to no more than 15 ground support hour driving windows and 11-hour Instructions: To view the FEA or the truck drivers employed by Western. The driving limit every day the drivers are FONSI, go to the online docket company operates a total of 12 ground on duty. Western reasons that because (Regulations.gov) at http:// support CMVs. its regular drivers have access to rest www.regulations.gov/ and enter in the Each Western firefighting aircraft is facilities, and permission to rest and docket number (FMCSA–2011–0097) teamed with a ground unit, which relax during the day, they are not and search for the ‘‘Final Environmental includes a driver and a CMV that pulls becoming fatigued. Western contends Assessment’’ or ‘‘FONSI.’’

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Docket: For access to the docket to Environment Quality regulations 0001. Office hours are from 8:30 a.m. to read background documents or (40 CFR parts 1500–1508), FMCSA’s 5 p.m., Monday through Friday, except comments received, go to http:// Order 5610.1, issued March 1, 2004 (69 Federal holidays. www.regulations.gov at any time or to FR 9680), and other applicable guidance SUPPLEMENTARY INFORMATION: DOT Headquarters, West Building and requirements, FMCSA prepared a Ground Floor, Room W12–140, 1200 DEA for the U.S.-Mexican cross-border Electronic Access New Jersey Avenue, SE., Washington, long-haul trucking program. FMCSA You may see all the comments online DC, between 9 a.m. and 5 p.m., e.t., analyzed the potential impacts to the through the Federal Document Monday through Friday, except Federal environment that may result from Management System (FDMS) at: http:// holidays. implementing the pilot project. In the www.regulations.gov. Privacy Act: Anyone is able to search DEA, FMCSA evaluated environmental Docket: For access to the docket to the electronic form for all comments issues such as emissions from vehicles, read background documents or received into any of our dockets by the air quality impacts, and other pertinent comments, go to http:// name of the individual submitting the matters, and requested public www.regulations.gov and/or Room comment. You may review the U.S. comments. FMCSA received five W12–140 on the ground level of the Department of Transportation’s (DOT) comments to the DEA and responded to West Building, 1200 New Jersey complete Privacy Act Statement in the those comments in the FEA. Avenue, SE., Washington, DC, between Federal Register published on January Additionally, after reviewing those 9 a.m. and 5 p.m., Monday through 17, 2008 (73 FR 3316), or you may visit comments, FMCSA has concluded that Friday, except Federal holidays. http://edocket.access.gpo.gov/2008/pdf/ the potential environmental impacts Privacy Act: Anyone may search the E8-785.pdf. from the pilot program are not electronic form of all comments received into any of DOT’s dockets by FOR FURTHER INFORMATION CONTACT: significant and do not warrant Michael M. Johnsen, Environmental additional environmental analysis in the the name of the individual submitting Protection Specialist, Analysis Division, form of an Environmental Impact the comment (or of the person signing Federal Motor Carrier Safety Statement. Accordingly, FMCSA is the comment, if submitted on behalf of Administration, U.S. Department of issuing a FONSI based on the an association, business, labor union, or Transportation, 1200 New Jersey conclusions in the FEA, which is also other entity). You may review DOT’s Avenue, SE., Washington, DC 20590, available in the docket. Privacy Act Statement for the Federal (202) 366–4111. Docket Management System (FDMS) Issued on: September 27, 2011. published in the Federal Register on SUPPLEMENTARY INFORMATION: Kenneth M. Leonard, January 17, 2008 (73 FR 3316), or you Background on the Pilot Project on the Special Projects Officer, Office of Research may visit http://edocket.access.gpo.gov/ and Information Technology, FMCSA. U.S.-Mexico Cross-Border Long-Haul 2008/pdf/E8-785.pdf. Trucking Program [FR Doc. 2011–25389 Filed 9–30–11; 8:45 am] BILLING CODE 4910–EX–P Background The pilot program is part of FMCSA’s On August 4, 2011, FMCSA published implementation of the North American a notice of receipt of Federal diabetes Free Trade Agreement (NAFTA) cross- DEPARTMENT OF TRANSPORTATION exemption applications from thirty- border long-haul trucking provisions. three individuals and requested This pilot program would allow Mexico- Federal Motor Carrier Safety comments from the public (76 FR domiciled motor carriers to operate Administration 47291). The public comment period throughout the United States for up to [FMCSA Docket No. FMCSA–2011–0192] closed on September 6, 2011 and no 3 years. U.S.-domiciled motor carriers comments were received. would be granted reciprocal rights to Qualification of Drivers; Exemption FMCSA has evaluated the eligibility operate in Mexico for the same period. Applications; Diabetes Mellitus of the thirty-three applicants and Participating Mexican carriers and determined that granting the AGENCY: drivers would be required to comply Federal Motor Carrier Safety exemptions to these individuals would with all applicable U.S. laws and Administration (FMCSA), DOT. achieve a level of safety equivalent to or regulations, including those concerned ACTION: Notice of final disposition. greater than the level that would be with motor carrier safety, customs, SUMMARY: FMCSA announces its achieved by complying with the current immigration, vehicle registration and regulation 49 CFR 391.41(b)(3). taxation, and fuel taxation. The safety of decision to exempt thirty-three the participating carriers would be individuals from its rule prohibiting Diabetes Mellitus and Driving tracked closely by FMCSA with input persons with insulin-treated diabetes Experience of the Applicants from the Motor Carrier Safety Advisory mellitus (ITDM) from operating The Agency established the current Committee, a Federal advisory commercial motor vehicles (CMVs) in standard for diabetes in 1970 because committee. For further information interstate commerce. The exemptions several risk studies indicated that regarding this pilot program, including will enable these individuals to operate drivers with diabetes had a higher rate additional background and comments, CMVs in interstate commerce. of crash involvement than the general please see the Federal Register notice of DATES: The exemptions are effective population. The diabetes rule provides the Pilot Program on NAFTA Long Haul October 3, 2011. The exemptions expire that ‘‘A person is physically qualified to Trucking Provisions in docket FMCSA– on October 3, 2013. drive a commercial motor vehicle if that 2011–0097. FOR FURTHER INFORMATION CONTACT: person has no established medical Elaine M. Papp, Chief, Medical history or clinical diagnosis of diabetes Final Environmental Assessment Programs, (202) 366–4001, mellitus currently requiring insulin for In accordance with the National [email protected], FMCSA, Room control’’ (49 CFR 391.41(b)(3)). Environmental Policy Act of 1969 W64–224, Department of FMCSA established its diabetes (NEPA) (section 102(2)(c)), as Transportation, 1200 New Jersey exemption program, based on the implemented by the Council on Avenue, SE., Washington, DC 20590– Agency’s July 2000 study entitled ‘‘A

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Report to Congress on the Feasibility of 391.41(b)(3) is likely to achieve a level was maintained before it was granted; or a Program to Qualify Individuals with of safety equal to that existing without (3) continuation of the exemption would Insulin-Treated Diabetes Mellitus to the exemption. not be consistent with the goals and Operate in Interstate Commerce as objectives of 49 U.S.C. 31136(e) and Conditions and Requirements Directed by the Transportation Act for 31315. If the exemption is still effective the 21st Century.’’ The report concluded The terms and conditions of the at the end of the 2-year period, the that a safe and practicable protocol to exemption will be provided to the person may apply to FMCSA for a allow some drivers with ITDM to applicants in the exemption document renewal under procedures in effect at operate CMVs is feasible. and they include the following: (1) That that time. each individual submit a quarterly The September 3, 2003 (68 FR 52441) Issued on: September 26, 2011. Federal Register notice in conjunction monitoring checklist completed by the Larry W. Minor, with the November 8, 2005 (70 FR treating endocrinologist as well as an 67777) Federal Register notice provides annual checklist with a comprehensive Associate Administrator for Policy. the current protocol for allowing such medical evaluation; (2) that each [FR Doc. 2011–25328 Filed 9–30–11; 8:45 am] drivers to operate CMVs in interstate individual report within 2 business days BILLING CODE 4910–EX–P commerce. of occurrence, all episodes of severe These thirty-three applicants have hypoglycemia, significant had ITDM over a range of 1 to 38 years. complications, or inability to manage DEPARTMENT OF TRANSPORTATION These applicants report no severe diabetes; also, any involvement in an Federal Motor Carrier Safety hypoglycemic reactions resulting in loss accident or any other adverse event in Administration of consciousness or seizure, requiring a CMV or personal vehicle, whether or the assistance of another person, or not it is related to an episode of [Docket No. FMCSA–2011–0194] resulting in impaired cognitive function hypoglycemia; (3) that each individual that occurred without warning provide a copy of the ophthalmologist’s Qualification of Drivers; Exemption symptoms, in the past 12 months and no or optometrist’s report to the medical Applications; Diabetes Mellitus examiner at the time of the annual recurrent (2 or more) severe AGENCY: medical examination; and (4) that each Federal Motor Carrier Safety hypoglycemic episodes in the past 5 Administration (FMCSA), DOT. years. In each case, an endocrinologist individual provide a copy of the annual ACTION: Notice of applications for verified that the driver has medical certification to the employer for retention in the driver’s qualification exemption from the diabetes mellitus demonstrated a willingness to properly standard; request for comments. monitor and manage his/her diabetes file, or keep a copy in his/her driver’s qualification file if he/she is self- mellitus, received education related to SUMMARY: FMCSA announces receipt of diabetes management, and is on a stable employed. The driver must also have a applications from 16 individuals for copy of the certification when driving, insulin regimen. These drivers report no exemption from the prohibition against for presentation to a duly authorized other disqualifying conditions, persons with insulin-treated diabetes Federal, State, or local enforcement including diabetes-related mellitus (ITDM) operating commercial official. complications. Each meets the vision motor vehicles (CMVs) in interstate standard at 49 CFR 391.41(b)(10). Conclusion commerce. If granted, the exemptions The qualifications and medical Based upon its evaluation of the would enable these individuals with condition of each applicant were stated thirty-three exemption applications, ITDM to operate CMVs in interstate and discussed in detail in the August 4, FMCSA exempts, Michael J. Alexander, commerce. 2011, Federal Register notice and they Larry E. Baumgartner, Stanley R. Boots, DATES: Comments must be received on will not be repeated in this notice. Carl D. Braddock, Dean A. Chamberlin, or before November 2, 2011. Discussion of Comment Michael E. Conner, Edna R. Contreras, ADDRESSES: You may submit comments FMCSA did not receive any Craig E. Cusick, Ronald D. Fatka, Robert bearing the Federal Docket Management comments in this proceeding. M. Fleming, David W. Hammons, Frank System (FDMS) Docket No. FMCSA– B. Hernandez, Jeffrey D. Horsey, Dale A. 2011–0194 using any of the following Basis for Exemption Determination Iverson, John H. Krastel, Joshua L. methods: Under 49 U.S.C. 31136(e) and 31315, Kroetch, Larry D. Lilley, Edward J. • Federal eRulemaking Portal: Go to FMCSA may grant an exemption from Linhart, Larry D. Matson, Michael L. http://www.regulations.gov. Follow the the diabetes standard in 49 CFR O’Clair, David W. Payne, Matthew B. on-line instructions for submitting 391.41(b)(3) if the exemption is likely to Rhodes, Jim B. Robertson, II, Donald M. comments. achieve an equivalent or greater level of Rush, Jr., Barry A. Sircy, Andre M. St. • Mail: Docket Management Facility; safety than would be achieved without Pierre, John S. Starchevich, Michael B. U.S. Department of Transportation, 1200 the exemption. The exemption allows Tortora, Gregory J. Vigil, Charlotte C. New Jersey Avenue, SE., West Building the applicants to operate CMVs in Watson, Wayne W. Wenzel, Shaun M. Ground Floor, Room W12–140, interstate commerce. Wheeler and James J. Wolf, Jr. from the Washington, DC 20590–0001. To evaluate the effect of these ITDM standard in 49 CFR 391.41(b)(3), • Hand Delivery: West Building exemptions on safety, FMCSA subject to the conditions listed under Ground Floor, Room W12–140, 1200 considered medical reports about the ‘‘Conditions and Requirements’’ above. New Jersey Avenue, SE., Washington, applicants’ ITDM and vision, and In accordance with 49 U.S.C. 31136(e) DC, between 9 a.m. and 5 p.m., Monday reviewed the treating endocrinologists’ and 31315 each exemption will be valid through Friday, except Federal holidays. medical opinion related to the ability of for two years unless revoked earlier by • Fax: 1–202–493–2251. the driver to safely operate a CMV while FMCSA. The exemption will be revoked Instructions: Each submission must using insulin. if: (1) The person fails to comply with include the Agency name and the Consequently, FMCSA finds that in the terms and conditions of the docket numbers for this notice. Note each case exempting these applicants exemption; (2) the exemption has that all comments received will be from the diabetes standard in 49 CFR resulted in a lower level of safety than posted without change to http://

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www.regulations.gov, including any Qualifications of Applicants requirements of the vision standard at personal information provided. Please 49 CFR 391.41(b)(10). His optometrist Mark D. Andersen see the Privacy Act heading below for examined him in 2011 and certified that further information. Mr. Andersen, age 40, has had ITDM he does not have diabetic retinopathy. Docket: For access to the docket to since 2010. His endocrinologist He holds a Class B CDL from Vermont. read background documents or examined him in 2011 and certified that Eric D. Blocker, Sr. comments, go to http:// he has had no severe hypoglycemic www.regulations.gov at any time or reactions resulting in loss of Mr. Blocker, 56, has had ITDM since Room W12–140 on the ground level of consciousness, requiring the assistance before September 2009. His the West Building, 1200 New Jersey of another person, or resulting in endocrinologist examined him in 2011 Avenue, SE., Washington, DC, between impaired cognitive function that and certified that he has had no severe 9 a.m. and 5 p.m., Monday through occurred without warning in the past hypoglycemic reactions resulting in loss Friday, except Federal holidays. The 12 months and no recurrent (2 or more) of consciousness, requiring the Federal Docket Management System severe hypoglycemic episodes in the assistance of another person, or (FDMS) is available 24 hours each day, last 5 years. His endocrinologist certifies resulting in impaired cognitive function 365 days each year. If you want that Mr. Andersen understands diabetes that occurred without warning in the acknowledgment that we received your management and monitoring, has stable past 12 months and no recurrent (2 or comments, please include a self- control of his diabetes using insulin, more) severe hypoglycemic episodes in addressed, stamped envelope or and is able to drive a CMV safely. Mr. the last 5 years. His endocrinologist postcard or print the acknowledgement Andersen meets the requirements of the certifies that Mr. Blocker understands page that appears after submitting vision standard at 49 CFR 391.41(b)(10). diabetes management and monitoring, comments on-line. His optometrist examined him in 2011 has stable control of his diabetes using Privacy Act: Anyone may search the and certified that he does not have insulin, and is able to drive a CMV electronic form of all comments diabetic retinopathy. He holds a Class A safely. Mr. Blocker meets the received into any of our dockets by the Commercial Driver’s License (CDL) from requirements of the vision standard at name of the individual submitting the Iowa. 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2011 comment (or of the person signing the David A. Basher comment, if submitted on behalf of an and certified that he has stable Mr. Basher, 55, has had ITDM since nonproliferative diabetic retinopathy. association, business, labor union, etc.). 2006. His endocrinologist examined him You may review DOT’s Privacy Act He holds a Class A CDL from North in 2011 and certified that he has had no Carolina. Statement for the FDMS published in severe hypoglycemic reactions resulting the Federal Register on January 17, in loss of consciousness, requiring the Barry W. Campbell 2008 (73 FR 3316), or you may visit assistance of another person, or Mr. Campbell, 45, has had ITDM since http://edocket.access.gpo.gov/2008/pdf/ resulting in impaired cognitive function 2009. His endocrinologist examined him E8-785.pdf. that occurred without warning in the in 2011 and certified that he has had no FOR FURTHER INFORMATION CONTACT: past 12 months and no recurrent (2 or severe hypoglycemic reactions resulting Elaine M. Papp, Chief, Medical more) severe hypoglycemic episodes in in loss of consciousness, requiring the Programs, (202) 366–4001, the last 5 years. His endocrinologist assistance of another person, or [email protected], FMCSA, certifies that Mr. Basher understands resulting in impaired cognitive function Department of Transportation, 1200 diabetes management and monitoring, that occurred without warning in the New Jersey Avenue, SE., Room W64– has stable control of his diabetes using past 12 months and no recurrent (2 or 224, Washington, DC 20590–0001. insulin, and is able to drive a CMV more) severe hypoglycemic episodes in Office hours are from 8:30 a.m. to safely. Mr. Basher meets the the last 5 years. His endocrinologist 5 p.m., Monday through Friday, except requirements of the vision standard at certifies that Mr. Campbell understands Federal holidays. 49 CFR 391.41(b)(10). His diabetes management and monitoring, SUPPLEMENTARY INFORMATION: ophthalmologist examined him in 2011 has stable control of his diabetes using Background and certified that he does not have insulin, and is able to drive a CMV diabetic retinopathy. He holds a Class A safely. Mr. Campbell meets the Under 49 U.S.C. 31136(e) and 31315, CDL from Massachusetts. requirements of the vision standard at FMCSA may grant an exemption from 49 CFR 391.41(b)(10). His optometrist Brian H. Berthiaume the Federal Motor Carrier Safety examined him in 2011 and certified that Regulations for a 2-year period if it finds Mr. Berthiaume, 44, has had ITDM he does not have diabetic retinopathy. ‘‘such exemption would likely achieve a since 1994. His endocrinologist He holds a Class D operator’s license level of safety that is equivalent to or examined him in 2011 and certified that from Wisconsin. greater than the level that would be he has had no severe hypoglycemic achieved absent such exemption.’’ The reactions resulting in loss of Kevin M. Donohue statute also allows the Agency to renew consciousness, requiring the assistance Mr. Donohue, 27, has had ITDM since exemptions at the end of the 2-year of another person, or resulting in 2005. His endocrinologist examined him period. The 16 individuals listed in this impaired cognitive function that in 2011 and certified that he has had no notice have recently requested such an occurred without warning in the past 12 severe hypoglycemic reactions resulting exemption from the diabetes prohibition months and no recurrent (2 or more) in loss of consciousness, requiring the in 49 CFR 391.41(b)(3), which applies to severe hypoglycemic episodes in the assistance of another person, or drivers of CMVs in interstate commerce. last 5 years. His endocrinologist certifies resulting in impaired cognitive function Accordingly, the Agency will evaluate that Mr. Berthiaume understands that occurred without warning in the the qualifications of each applicant to diabetes management and monitoring, past 12 months and no recurrent (2 or determine whether granting the has stable control of his diabetes using more) severe hypoglycemic episodes in exemption will achieve the required insulin, and is able to drive a CMV the last 5 years. His endocrinologist level of safety mandated by the statutes. safely. Mr. Berthiaume meets the certifies that Mr. Donohue understands

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diabetes management and monitoring, more) severe hypoglycemic episodes in resulting in impaired cognitive function has stable control of his diabetes using the last 5 years. His endocrinologist that occurred without warning in the insulin, and is able to drive a CMV certifies that Mr. Johnson understands past 12 months and no recurrent (2 or safely. Mr. Donohue meets the diabetes management and monitoring, more) severe hypoglycemic episodes in requirements of the vision standard at has stable control of his diabetes using the last 5 years. His endocrinologist 49 CFR 391.41(b)(10). His insulin, and is able to drive a CMV certifies that Mr. Pritchett understands ophthalmologist examined him in 2011 safely. Mr. Johnson meets the diabetes management and monitoring, and certified that he does not have requirements of the vision standard at has stable control of his diabetes using diabetic retinopathy. He holds a Class D 49 CFR 391.41(b)(10). His optometrist insulin, and is able to drive a CMV operator’s license from New Jersey. examined him in 2011 and certified that safely. Mr. Pritchett meets the he does not have diabetic retinopathy. requirements of the vision standard at Milton T. Gardiner He holds a Class A CDL from 49 CFR 391.41(b)(10). His Mr. Gardiner, 43, has had ITDM since Wisconsin. ophthalmologist examined him in 2011 2010. His endocrinologist examined him and certified that he has stable Kenny B. Keels, Jr. in 2011 and certified that he has had no nonproliferative diabetic retinopathy. severe hypoglycemic reactions resulting Mr. Keels, 27, has had ITDM since He holds a Class A CDL from Michigan. in loss of consciousness, requiring the 1997. His endocrinologist examined him assistance of another person, or in 2011 and certified that he has had no Steven R. Sibert resulting in impaired cognitive function severe hypoglycemic reactions resulting Mr. Sibert, 42, has had ITDM since that occurred without warning in the in loss of consciousness, requiring the 2011. His endocrinologist examined him past 12 months and no recurrent (2 or assistance of another person, or in 2011 and certified that he has had no more) severe hypoglycemic episodes in resulting in impaired cognitive function severe hypoglycemic reactions resulting the last 5 years. His endocrinologist that occurred without warning in the in loss of consciousness, requiring the certifies that Mr. Gardiner understands past 12 months and no recurrent (2 or assistance of another person, or diabetes management and monitoring, more) severe hypoglycemic episodes in resulting in impaired cognitive function has stable control of his diabetes using the last 5 years. His endocrinologist that occurred without warning in the insulin, and is able to drive a CMV certifies that Mr. Keels understands past 12 months and no recurrent (2 or safely. Mr. Gardiner meets the diabetes management and monitoring, more) severe hypoglycemic episodes in requirements of the vision standard at has stable control of his diabetes using the last 5 years. His endocrinologist 49 CFR 391.41(b)(10). His optometrist insulin, and is able to drive a CMV certifies that Mr. Sibert understands examined him in 2011 and certified that safely. Mr. Keels meets the requirements diabetes management and monitoring, he does not have diabetic retinopathy. of the vision standard at 49 CFR has stable control of his diabetes using He holds a Class 10 operator’s license 391.41(b)(10). His ophthalmologist insulin, and is able to drive a CMV from Rhode Island. examined him in 2011 and certified that safely. Mr. Sibert meets the he does not have diabetic retinopathy. requirements of the vision standard at Raymond A. Jack He holds a Class D operator’s license 49 CFR 391.41(b)(10). His optometrist Mr. Jack, 52, has had ITDM since from South Carolina. examined him in 2011 and certified that 2010. His endocrinologist examined him he does not have diabetic retinopathy. Gene A. Michaels in 2011 and certified that he has had no He holds a Class A CDL from severe hypoglycemic reactions resulting Mr. Michaels, 67, has had ITDM since Minnesota. in loss of consciousness, requiring the 1985. His endocrinologist examined him assistance of another person, or in 2011 and certified that he has had no Cassie J. Silbernagel resulting in impaired cognitive function severe hypoglycemic reactions resulting Mr. Silbernagel, 33, has had ITDM that occurred without warning in the in loss of consciousness, requiring the since 2011. His endocrinologist past 12 months and no recurrent (2 or assistance of another person, or examined him in 2011 and certified that more) severe hypoglycemic episodes in resulting in impaired cognitive function he has had no severe hypoglycemic the last 3 years. His endocrinologist that occurred without warning in the reactions resulting in loss of certifies that Mr. Jack understands past 12 months and no recurrent (2 or consciousness, requiring the assistance diabetes management and monitoring, more) severe hypoglycemic episodes in of another person, or resulting in has stable control of his diabetes using the last 5 years. His endocrinologist impaired cognitive function that insulin, and is able to drive a CMV certifies that Mr. Michaels understands occurred without warning in the past safely. Mr. Jack meets the requirements diabetes management and monitoring, 12 months and no recurrent (2 or more) of the vision standard at 49 CFR has stable control of his diabetes using severe hypoglycemic episodes in the 391.41(b)(10). His ophthalmologist insulin, and is able to drive a CMV last 5 years. His endocrinologist certifies examined him in 2011 and certified that safely. Mr. Michaels meets the that Mr. Silbernagel understands he has stable proliferative diabetic requirements of the vision standard at diabetes management and monitoring, retinopathy. He holds a Class A CDL 49 CFR 391.41(b)(10). His has stable control of his diabetes using from Washington. ophthalmologist examined him in 2011 insulin, and is able to drive a CMV and certified that he has stable safely. Mr. Silbernagel meets the Quency T. Johnson nonproliferative diabetic retinopathy. requirements of the vision standard at Mr. Johnson, 47, has had ITDM since He holds a Class A CDL from Michigan. 49 CFR 391.41(b)(10). His optometrist 2004. His endocrinologist examined him examined him in 2011 and certified that Jason M. Pritchett in 2011 and certified that he has had no he does not have diabetic retinopathy. severe hypoglycemic reactions resulting Mr. Pritchett, 39, has had ITDM since He holds a Class A CDL from South in loss of consciousness, requiring the 1990. His endocrinologist examined him Dakota. assistance of another person, or in 2011 and certified that he has had no resulting in impaired cognitive function severe hypoglycemic reactions resulting Lewis B. Taylor that occurred without warning in the in loss of consciousness, requiring the Mr. Taylor, 39, has had ITDM since past 12 months and no recurrent (2 or assistance of another person, or 2011. His endocrinologist examined him

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in 2011 and certified that he has had no 4018 of the Transportation Equity Act has concluded that granting these severe hypoglycemic reactions resulting for the 21st Century (49 U.S.C. 31305). exemptions will provide a level of safety in loss of consciousness, requiring the Section 4129 requires: (1) Elimination that is equivalent to or greater than the assistance of another person, or of the requirement for 3 years of level of safety maintained without the resulting in impaired cognitive function experience operating CMVs while being exemptions for these CMV drivers. that occurred without warning in the treated with insulin; and (2) DATES: The exemptions are effective past 12 months and no recurrent (2 or establishment of a specified minimum October 3, 2011. The exemptions expire more) severe hypoglycemic episodes in period of insulin use to demonstrate on October 3, 2013. the last 5 years. His endocrinologist stable control of diabetes before being FOR FURTHER INFORMATION CONTACT: certifies that Mr. Taylor understands allowed to operate a CMV. Elaine M. Papp, Chief, Medical diabetes management and monitoring, In response to section 4129, FMCSA Programs, (202) 366–4001, has stable control of his diabetes using made immediate revisions to the [email protected], FMCSA, insulin, and is able to drive a CMV diabetes exemption program established Department of Transportation, 1200 safely. Mr. Taylor meets the by the September 3, 2003 notice. New Jersey Avenue, SE., Room W64– requirements of the vision standard at FMCSA discontinued use of the 3-year 224, Washington, DC 20590–0001. 49 CFR 391.41(b)(10). His optometrist driving experience and fulfilled the Office hours are from 8:30 a.m. to 5 p.m. examined him in 2011 and certified that requirements of section 4129 while Monday through Friday, except Federal he does not have diabetic retinopathy. continuing to ensure that operation of holidays. He holds a Class A CDL from Illinois. CMVs by drivers with ITDM will SUPPLEMENTARY INFORMATION: achieve the requisite level of safety James A. Terilli required of all exemptions granted Electronic Access Mr. Terilli, 61, has had ITDM since under 49 USC. 31136(e). You may see all the comments online 2008. His endocrinologist examined him Section 4129(d) also directed FMCSA through the Federal Document in 2011 and certified that he has had no to ensure that drivers of CMVs with Management System (FDMS) at http:// severe hypoglycemic reactions resulting ITDM are not held to a higher standard www.regulations.gov. in loss of consciousness, requiring the than other drivers, with the exception of Docket: For access to the docket to assistance of another person, or limited operating, monitoring and read background documents or resulting in impaired cognitive function medical requirements that are deemed comments, go to http:// that occurred without warning in the medically necessary. www.regulations.gov at any time or past 12 months and no recurrent (2 or The FMCSA concluded that all of the Room W12–140 on the ground level of more) severe hypoglycemic episodes in operating, monitoring and medical the West Building, 1200 New Jersey the last 5 years. His endocrinologist requirements set out in the September 3, Avenue, SE., Washington, DC, between certifies that Mr. Terilli understands 2003 notice, except as modified, were in 9 a.m. and 5 p.m., Monday through diabetes management and monitoring, compliance with section 4129(d). Friday, except Federal holidays. The has stable control of his diabetes using Therefore, all of the requirements set FDMS is available 24 hours each day, insulin, and is able to drive a CMV out in the September 3, 2003 notice, 365 days each year. If you want safely. Mr. Terilli meets the except as modified by the notice in the acknowledgment that we received your requirements of the vision standard at Federal Register on November 8, 2005 comments, please include a self- 49 CFR 391.41(b)(10). His optometrist (70 FR 67777), remain in effect. addressed, stamped envelope or postcard or print the acknowledgement examined him in 2011 and certified that Issued on: September 26, 2011. he does not have diabetic retinopathy. page that appears after submitting Larry W. Minor, He holds a Class D operator’s license comments on-line. from New York. Associate Administrator for Policy. Privacy Act: Anyone may search the [FR Doc. 2011–25327 Filed 9–30–11; 8:45 am] electronic form of all comments Request for Comments BILLING CODE 4910–EX–P received into any of our dockets by the In accordance with 49 U.S.C. 31136(e) name of the individual submitting the and 31315, FMCSA requests public comment (or of the person signing the comment from all interested persons on DEPARTMENT OF TRANSPORTATION comment, if submitted on behalf of an the exemption petitions described in association, business, labor union, etc.). Federal Motor Carrier Safety You may review DOT’s Privacy Act this notice. We will consider all Administration comments received before the close of Statement for the FDMS published in business on the closing date indicated [Docket No. FMCSA–2011–0142] the Federal Register on January 17, in the date section of the notice. 2008 (73 FR 3316), or you may visit FMCSA notes that section 4129 of the Qualification of Drivers; Exemption http://edocket.access.gpo.gov/2008/pdf/ Safe, Accountable, Flexible and Applications; Vision E8-785.pdf. Efficient Transportation Equity Act: A AGENCY: Federal Motor Carrier Safety Background Legacy for Users requires the Secretary Administration (FMCSA), DOT. On August 10, 2011, FMCSA to revise its diabetes exemption program ACTION: published a notice of receipt of established on September 3, 2003 (68 FR Notice of final disposition. 1 exemption applications from certain 52441). The revision must provide for SUMMARY: FMCSA announces its individuals, and requested comments individual assessment of drivers with decision to exempt 17 individuals from from the public (76 FR 49528). That diabetes mellitus, and be consistent the vision requirement in the Federal notice listed 17 applicants’ case with the criteria described in section Motor Carrier Safety Regulations histories. The 17 individuals applied for (FMCSRs). The exemptions will enable exemptions from the vision requirement 1 Section 4129(a) refers to the 2003 notice as a these individuals to operate commercial in 49 CFR 391.41(b)(10), for drivers who ‘‘final rule.’’ However, the 2003 notice did not issue a ‘‘final rule’’ but did establish the procedures and motor vehicles (CMVs) in interstate operate CMVs in interstate commerce. standards for issuing exemptions for drivers with commerce without meeting the Under 49 U.S.C. 31136(e) and 31315, ITDM. prescribed vision standard. The Agency FMCSA may grant an exemption for a 2-

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year period if it finds ‘‘such exemption requirements, the applicants monocular drivers in the program is would likely achieve a level of safety demonstrated their ability to operate a better than that of all CMV drivers that is equivalent to or greater than the commercial vehicle, with their limited collectively (See 61 FR 13338, 13345, level that would be achieved absent vision, to the satisfaction of the State. March 26, 1996). The fact that such exemption.’’ The statute also While possessing a valid CDL or non- experienced monocular drivers allows the Agency to renew exemptions CDL, these 17 drivers have been demonstrated safe driving records in the at the end of the 2-year period. authorized to drive a CMV in intrastate waiver program supports a conclusion Accordingly, FMCSA has evaluated the commerce, even though their vision that other monocular drivers, meeting 17 applications on their merits and disqualified them from driving in the same qualifying conditions as those made a determination to grant interstate commerce. They have driven required by the waiver program, are also exemptions to each of them. CMVs with their limited vision for likely to have adapted to their vision careers ranging from 3 to 42 years. In the deficiency and will continue to operate Vision and Driving Experience of the past 3 years, one of the drivers was safely. Applicants involved in a crash and four were The first major research correlating The vision requirement in the convicted of moving violations in a past and future performance was done FMCSRs provides: CMV. in England by Greenwood and Yule in A person is physically qualified to The qualifications, experience, and 1920. Subsequent studies, building on drive a commercial motor vehicle if that medical condition of each applicant that model, concluded that crash rates person has distant visual acuity of at were stated and discussed in detail in for the same individual exposed to least 20/40 (Snellen) in each eye the August 10, 2011 notice (76 FR certain risks for two different time without corrective lenses or visual 49528). periods vary only slightly (See Bates acuity separately corrected to 20/40 and Neyman, University of California Basis for Exemption Determination (Snellen) or better with corrective Publications in Statistics, April 1952). lenses, distant binocular acuity of a least Under 49 U.S.C. 31136(e) and 31315, Other studies demonstrated theories of 20/40 (Snellen) in both eyes with or FMCSA may grant an exemption from predicting crash proneness from crash without corrective lenses, field of vision the vision standard in 49 CFR history coupled with other factors. of at least 70° in the horizontal meridian 391.41(b)(10) if the exemption is likely These factors—such as age, sex, in each eye, and the ability to recognize to achieve an equivalent or greater level geographic location, mileage driven and the colors of traffic signals and devices of safety than would be achieved conviction history—are used every day showing standard red, green, and amber without the exemption. Without the by insurance companies and motor (49 CFR 391.41(b)(10)). exemption, applicants will continue to vehicle bureaus to predict the FMCSA recognizes that some drivers be restricted to intrastate driving. With probability of an individual do not meet the vision standard, but the exemption, applicants can drive in experiencing future crashes (See Weber, have adapted their driving to interstate commerce. Thus, our analysis Donald C., ‘‘Accident Rate Potential: An accommodate their vision limitation focuses on whether an equal or greater Application of Multiple Regression and demonstrated their ability to drive level of safety is likely to be achieved by Analysis of a Poisson Process,’’ Journal safely. The 17 exemption applicants permitting each of these drivers to drive of American Statistical Association, listed in this notice are in this category. in interstate commerce as opposed to June 1971). A 1964 California Driver They are unable to meet the vision restricting him or her to driving in Record Study prepared by the California standard in one eye for various reasons, intrastate commerce. Department of Motor Vehicles including amblyopia, glaucoma, To evaluate the effect of these concluded that the best overall crash macular scar, hyperopia, complete loss exemptions on safety, FMCSA predictor for both concurrent and of vision, ruptured globe, prosthesis and considered not only the medical reports nonconcurrent events is the number of macular hole. In most cases, their eye about the applicants’ vision, but also single convictions. This study used 3 conditions were not recently developed. their driving records and experience consecutive years of data, comparing the 13 of the applicants were either born with the vision deficiency. experiences of drivers in the first 2 years with their vision impairments or have To qualify for an exemption from the with their experiences in the final year. had them since childhood. The 4 vision standard, FMCSA requires a Applying principles from these individuals who sustained their vision person to present verifiable evidence studies to the past 3-year record of the conditions as adults have had them for that he/she has driven a commercial 17 applicants, one of the applicants was periods ranging from 3 to 17 years. vehicle safely with the vision deficiency involved in a crash and four of the Although each applicant has one eye for the past 3 years. Recent driving applicants were convicted of moving which does not meet the vision standard performance is especially important in violations in a CMV. All the applicants in 49 CFR 391.41(b)(10), each has at evaluating future safety, according to achieved a record of safety while least 20/40 corrected vision in the other several research studies designed to driving with their vision impairment, eye, and in a doctor’s opinion, has correlate past and future driving demonstrating the likelihood that they sufficient vision to perform all the tasks performance. Results of these studies have adapted their driving skills to necessary to operate a CMV. Doctors’ support the principle that the best accommodate their condition. As the opinions are supported by the predictor of future performance by a applicants’ ample driving histories with applicants’ possession of valid driver is his/her past record of crashes their vision deficiencies are good commercial driver’s licenses (CDLs) or and traffic violations. Copies of the predictors of future performance, non-CDLs to operate CMVs. Before studies may be found at Docket Number FMCSA concludes their ability to drive issuing CDLs, States subject drivers to FMCSA–1998–3637. safely can be projected into the future. knowledge and skills tests designed to We believe we can properly apply the We believe that the applicants’ evaluate their qualifications to operate a principle to monocular drivers, because intrastate driving experience and history CMV. data from the Federal Highway provide an adequate basis for predicting All of these applicants satisfied the Administration’s (FHWA) former waiver their ability to drive safely in interstate testing standards for their State of study program clearly demonstrate the commerce. Intrastate driving, like residence. By meeting State licensing driving performance of experienced interstate operations, involves

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substantial driving on highways on the Discussion of Comments opportunity to comment on proposed interstate system and on other roads FMCSA received one comment in this and/or continuing information built to interstate standards. Moreover, proceeding. The comment was collections, as required by the driving in congested urban areas considered and discussed below. Paperwork Reduction Act of 1995, exposes the driver to more pedestrian The Pennsylvania Department of Public Law 104–13 (44 U.S.C. and vehicular traffic than exists on Transportation is in favor of granting a 3506(c)(2)(A)). Currently, the IRS is interstate highways. Faster reaction to Federal vision exemption to Jason W. soliciting comments concerning Form traffic and traffic signals is generally Rupp, they indicated that they have 8899, Notice of Income Donated required because distances between reviewed the driving history of the Intellectual Property. them are more compact. These applicant and have no objections to DATES: Written comments should be conditions tax visual capacity and FMCSA granting him a vision received on or before December 2, 2011 driver response just as intensely as exemption. to be assured of consideration. interstate driving conditions. The ADDRESSES: Direct all written comments veteran drivers in this proceeding have Conclusion to Yvette B. Lawrence, Internal Revenue operated CMVs safely under those Based upon its evaluation of the 17 Service, room 6129, 1111 Constitution conditions for at least 3 years, most for exemption applications, FMCSA Avenue, NW., Washington, DC 20224. much longer. Their experience and exempts, Stephan P. Adamczyk, Shaun FOR FURTHER INFORMATION CONTACT: driving records lead us to believe that E. Burnett, Kevin W. Cannon, Daniel W. Requests for additional information or each applicant is capable of operating in Eynon, Anton Filic, Mark E. Gessner, copies of the form and instructions interstate commerce as safely as he/she Stephen A. Grieser, Michael L. Harrison, should be directed to Joel Goldberger at has been performing in intrastate Dennis H. Heller, Reginald J. Horner, Internal Revenue Service, room 6129, commerce. Consequently, FMCSA finds Eric L. Kinner, Everett H. Logan, Robert 1111 Constitution Avenue, NW., that exempting these applicants from E. Morgan, Jr., Jerry R. Orndorff, Gerald Washington, DC 20224, or at (202) 927– the vision standard in 49 CFR A. Pilarski, Jason W. Rupp and John F. 9368, or through the Internet at 391.41(b)(10) is likely to achieve a level Zalar from the vision requirement in 49 [email protected]. of safety equal to that existing without CFR 391.41(b)(10), subject to the SUPPLEMENTARY INFORMATION: the exemption. For this reason, the requirements cited above (49 CFR Title: Notice of Income Donated Agency is granting the exemptions for 391.64(b)). Intellectual Property. the 2-year period allowed by 49 U.S.C. In accordance with 49 U.S.C. 31136(e) OMB Number: 1545–1962. 31136(e) and 31315 to the 17 applicants and 31315, each exemption will be valid Form Number: Form 8899. listed in the notice of August 10, 2011 for 2 years unless revoked earlier by Abstract: Form 8899 is filed by (76 FR 49528). FMCSA. The exemption will be revoked charitable org. receiving donations of We recognize that the vision of an if: (1) The person fails to comply with intellectual property if the donor applicant may change and affect his/her the terms and conditions of the provides timely notice. The initial ability to operate a CMV as safely as in exemption; (2) the exemption has deduction is limited to the donor’s the past. As a condition of the resulted in a lower level of safety than basis; additional deductions are allowed exemption, therefore, FMCSA will was maintained before it was granted; or to the extent of income from the impose requirements on the 17 (3) continuation of the exemption would property, reducing excessive individuals consistent with the not be consistent with the goals and deductions. grandfathering provisions applied to objectives of 49 U.S.C. 31136 and 31315. Current Actions: There is no change drivers who participated in the If the exemption is still effective at the in the paperwork burden previously Agency’s vision waiver program. end of the 2-year period, the person may approved by OMB. This form is being apply to FMCSA for a renewal under submitted for renewal purposes only. Those requirements are found at 49 procedures in effect at that time. Type of Review: Extension of a CFR 391.64(b) and include the Issued on: September 26, 2011. currently approved collection. following: (1) That each individual be Affected Public: Business or other for- physically examined every year (a) By Larry W. Minor, Associate Administrator of Policy. profit, and not-for-profit institutions. an ophthalmologist or optometrist who Estimated Number of Respondents: [FR Doc. 2011–25326 Filed 9–30–11; 8:45 am] attests that the vision in the better eye 1,000. continues to meet the standard in 49 BILLING CODE 4910–EX–P Estimated Time per Respondent: 3 CFR 391.41(b)(10), and (b) by a medical hrs. examiner who attests that the individual Estimated Total Annual Burden is otherwise physically qualified under DEPARTMENT OF THE TREASURY Hours: 5,430. 49 CFR 391.41; (2) that each individual The following paragraph applies to all provide a copy of the ophthalmologist’s Internal Revenue Service of the collections of information covered or optometrist’s report to the medical Proposed Collection; Comment by this notice: examiner at the time of the annual Request for Form 8899 An agency may not conduct or medical examination; and (3) that each sponsor, and a person is not required to individual provide a copy of the annual AGENCY: Internal Revenue Service (IRS), respond to, a collection of information medical certification to the employer for Treasury. unless the collection of information retention in the driver’s qualification ACTION: Notice and request for displays a valid OMB control number. file, or keep a copy in his/her driver’s comments. Books or records relating to a collection qualification file if he/she is self- of information must be retained as long employed. The driver must also have a SUMMARY: The Department of the as their contents may become material copy of the certification when driving, Treasury, as part of its continuing effort in the administration of any internal for presentation to a duly authorized to reduce paperwork and respondent revenue law. Generally, tax returns and Federal, State, or local enforcement burden, invites the general public and tax return information are confidential, official. other Federal agencies to take this as required by 26 U.S.C. 6103.

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Request for Comments: Comments 9368, Internal Revenue Service, room other forms of information technology; submitted in response to this notice will 6129, 1111 Constitution Avenue, NW., and (e) estimates of capital or start-up be summarized and/or included in the Washington, DC 20224 or through the costs and costs of operation, request for OMB approval. All internet ([email protected]). maintenance, and purchase of services comments will become a matter of SUPPLEMENTARY INFORMATION: to provide information. public record. Title: Cooperative Housing Approved: September 17, 2011. Comments are invited on: (a) Whether Corporations. Yvette B. Lawrence, the collection of information is OMB Number: 1545–1041. IRS Reports Clearance Officer. necessary for the proper performance of Regulation Project Number: T.D. 8316. [FR Doc. 2011–25343 Filed 9–30–11; 8:45 am] the functions of the agency, including Abstract: Section 1.216–1(d)(2) of this BILLING CODE 4830–01–P whether the information shall have regulation allows cooperative housing practical utility; (b) the accuracy of the corporations to make an election agency’s estimate of the burden of the whereby the amounts of mortgage DEPARTMENT OF THE TREASURY collection of information; (c) ways to interest and/or real estate taxes enhance the quality, utility, and clarity allocated to tenant-stockholders of the Internal Revenue Service of the information to be collected; (d) corporation will be based on a [Third-Party Disclosure in IRS Regulations] ways to minimize the burden of the reasonable estimate of the actual costs collection of information on attributable to each tenant-stockholder Proposed Collection; Comment respondents, including through the use based on the number of shares held in Request for Regulation Project of automated collection techniques or the corporation. other forms of information technology; Current Actions: There is no change to AGENCY: Internal Revenue Service (IRS), and (e) estimates of capital or start-up this existing regulation. Treasury. costs and costs of operation, Type of Review: Extension of a ACTION: Notice and request for maintenance, and purchase of services currently approved collection. comments. to provide information. Affected Public: Individuals or SUMMARY: The Department of the households, and business or other for- Approved: September 21, 2011. Treasury, as part of its continuing effort profit organizations. Yvette B. Lawrence, to reduce paperwork and respondent Estimated Number of Respondents: IRS Reports Clearance Officer. burden, invites the general public and 2,500. [FR Doc. 2011–25340 Filed 9–30–11; 8:45 am] other Federal agencies to take this Estimated Time per Respondent: 15 BILLING CODE 4830–01–P opportunity to comment on proposed minutes. and/or continuing information Estimated Total Annual Burden collections, as required by the Hours: 625. DEPARTMENT OF THE TREASURY Paperwork Reduction Act of 1995, The following paragraph applies to all Public Law 104–13 (44 U.S.C. of the collections of information covered Internal Revenue Service 3506(c)(2)(A)). The IRS is soliciting by this notice. comments concerning third-party Proposed Collection; Comment An agency may not conduct or disclosure requirements in IRS Request for Regulation Project sponsor, and a person is not required to regulations. respond to, a collection of information AGENCY: Internal Revenue Service (IRS), unless the collection of information DATES: Written comments should be Treasury. displays a valid OMB control number. received on or before December 2, 2011 ACTION: Notice and request for Books or records relating to a collection to be assured of consideration. comments. of information must be retained as long ADDRESSES: Direct all written comments as their contents may become material to Yvette B. Lawrence, Internal Revenue SUMMARY: The Department of the Service, room 6129, 1111 Constitution Treasury, as part of its continuing effort in the administration of any internal Avenue, NW., Washington, DC 20224. to reduce paperwork and respondent revenue law. Generally, tax returns and burden, invites the general public and tax return information are confidential, FOR FURTHER INFORMATION CONTACT: other Federal agencies to take this as required by 26 U.S.C. 6103. Requests for additional information or opportunity to comment on proposed Request for Comments: Comments copies of the regulations should be and/or continuing information submitted in response to this notice will directed to Joel Goldberger, at (202) collections, as required by the be summarized and/or included in the 927–9368, or at Internal Revenue Paperwork Reduction Act of 1995, request for OMB approval. All Service, room 6129, 1111 Constitution Public Law 104–13 (44 U.S.C. comments will become a matter of Avenue, NW., Washington, DC 20224, 3506(c)(2)(A)). The IRS is soliciting public record. or through the Internet, at comments concerning cooperative Comments are invited on: (a) Whether [email protected]. the collection of information is housing corporations. SUPPLEMENTARY INFORMATION: necessary for the proper performance of DATES: Written comments should be Title: Third-Party Disclosure the functions of the agency, including requirements in IRS Regulations. received on or before December 2, 2011 whether the information shall have to be assured of consideration. OMB Number: 1545–1466. practical utility; (b) the accuracy of the Abstract: These existing regulations ADDRESSES: Direct all written comments agency’s estimate of the burden of the contain third-party disclosure to Yvette B. Lawrence, Internal Revenue collection of information; (c) ways to requirements that are subject to the Service, room 6129, 1111 Constitution enhance the quality, utility, and clarity Paperwork Reduction Act of 1995. Avenue, NW., Washington, DC 20224. of the information to be collected; (d) Current Actions: There are no changes FOR FURTHER INFORMATION CONTACT: ways to minimize the burden of the being made to these regulations at this Requests for additional information or collection of information on time. copies of this regulation should be respondents, including through the use Type of Review: Extension of directed to Joel Goldberger, (202) 927– of automated collection techniques or currently approved collection.

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Affected Public: Individuals or will hold a public meeting on Dated: September 23, 2011. households, business or other for-profit Wednesday, October 26, 2011. Candice Cromling, organizations, and not-for-profit Director, National Public Liaison. FOR FURTHER INFORMATION CONTACT: Ms. institutions. Caryl Grant, National Public Liaison, [FR Doc. 2011–25342 Filed 9–30–11; 8:45 am] Estimated Number of Responses: BILLING CODE 4830–01–P 307,064,630. CL:NPL:SRM, Rm. 7559, 1111 Estimated Time per Respondent: Constitution Avenue, NW., Washington, Varies. DC 20224. Phone: 202–927–3641 (not a toll-free number). E-mail address: DEPARTMENT OF VETERANS Estimated Total Annual Burden AFFAIRS Hours: 68,885,183. *[email protected]. The following paragraph applies to all [OMB Control No. 2900–0670] SUPPLEMENTARY INFORMATION: of the collections of information covered Notice is by this notice: hereby given pursuant to section Proposed Information Collection An agency may not conduct or 10(a)(2) of the Federal Advisory (Fiduciary Statement in Support of sponsor, and a person is not required to Committee Act, 5 U.S.C. App. (1988), Appointment) Activity: Comment respond to, a collection of information that a public meeting of the IRPAC will Request be held on Wednesday, October 26, unless the collection of information AGENCY: Veterans Benefits 2011 from 9 a.m. to 12 p.m. at the displays a valid OMB control number. Administration, Department of Veterans United States Access Board, 1331 F Books or records relating to a collection Affairs. Street, NW., Washington, DC 20004. of information must be retained as long ACTION: Notice. as their contents may become material Report recommendations on issues that in the administration of any internal may be discussed include: Foreign SUMMARY: The Veterans Benefits revenue law. Generally, tax returns and Account Tax Compliance Act, § 6050W Administration (VBA), Department of tax return information are confidential, information reporting of payments made Veterans Affairs (VA), is announcing an as required by 26 U.S.C. 6103. in settlement of payment card and third opportunity for public comment on the Request for Comments: Comments party network transactions and Form proposed collection of certain submitted in response to this notice will 1099–K, information regarding non- information by the agency. Under the be summarized and/or included in the resident alien taxation and tax Paperwork Reduction Act (PRA) of request for OMB approval. All reporting, withholding tax issues, 1995, Federal agencies are required to comments will become a matter of identity theft, tax credit bonds, publish notice in the Federal Register public record. Comments are invited on: Affordable Care Act—employer and concerning each proposed collection of (a) Whether the collection of insurer reporting, tip income reporting information, including each proposed information is necessary for the proper compliance and enforcement efforts, extension of currently approved performance of the functions of the employer identification numbers for collection, and allow 60 days for public agency, including whether the retirement plans, Form 1099–R comment in response to the notice. This information shall have practical utility; reporting and withholding guidance for notice solicits comments for information (b) the accuracy of the agency’s estimate certain installment payments, Form needed to determine a claimant’s of the burden of the collection of 1099 instructions, taxpayer qualification as a fiduciary. information; (c) ways to enhance the identification number masking on payee DATES: Written comments and quality, utility, and clarity of the 1099s, Form 1099–B modifications, recommendations on the proposed information to be collected; (d) ways to business master file address change collection of information should be minimize the burden of the collection of procedures, program problems received on or before December 2, 2011. information on respondents, including encountered by foreign artists when ADDRESSES: Submit written comments through the use of automated collection applying for U.S. social security on the collection of information through techniques or other forms of information numbers, withholding and reporting on http://www.Regulations.gov or to Nancy technology; and (e) estimates of capital payments for freight, shipping, and J. Kessinger, Veterans Benefits or start-up costs and costs of operation, other transportation expenses, changes Administration (20M33), Department of maintenance, and purchase of services to Publication 3908, gaming tax law and Veterans Affairs, 810 Vermont Avenue, to provide information. Bank Secrecy Act issues for Indian tribal NW., Washington, DC 20420 or e-mail to Approved: September 21, 2011. governments, Form 5500EZ, erroneous [email protected]. Please refer to Yvette B. Lawrence, claims for itemized deductions for ‘‘OMB Control No. 2900–0670’’ in any correspondence. During the comment IRS Reports Clearance Officer. unreimbursed business expenses, and fringe benefit information. Last minute period, comments may be viewed online [FR Doc. 2011–25341 Filed 9–30–11; 8:45 am] through the Federal Docket Management BILLING CODE 4830–01–P agenda changes may preclude advance notice. Due to limited seating and System (FDMS) at http:// security requirements, please call or e- www.Regulations.gov. DEPARTMENT OF THE TREASURY mail Caryl Grant to confirm your FOR FURTHER INFORMATION CONTACT: attendance. Ms. Grant can be reached at Nancy J. Kessinger at (202) 461–9769 or Internal Revenue Service 202–927–3641 or fax (202) 275–5947. *[email protected]. Should you SUPPLEMENTARY INFORMATION: Under the Advisory Committee to the Internal wish the IRPAC to consider a written PRA of 1995 (Pub. L. 104–13; 44 U.S.C. Revenue Service; Meeting statement, please call 202–927–3641, or 3501–3521), Federal agencies must AGENCY: Internal Revenue Service (IRS), write to: Internal Revenue Service, obtain approval from the Office of Treasury. Office of National Public Liaison, Management and Budget (OMB) for each ACTION: Notice of meeting. CL:NPL:SRM, Room 7559, 1111 collection of information they conduct Constitution Avenue, NW., Washington, or sponsor. This request for comment is SUMMARY: The Information Reporting DC 20224 or e-mail: being made pursuant to Section Program Advisory Committee (IRPAC) *[email protected]. 3506(c)(2)(A) of the PRA.

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With respect to the following 1995, Federal agencies are required to a deceased veteran eligibility for collection of information, VBA invites publish notice in the Federal Register issuance of a burial flag. comments on: (1) Whether the proposed concerning each proposed collection of Affected Public: Individuals or collection of information is necessary information, including each proposed households. for the proper performance of VBA’s extension of currently approved Estimated Annual Burden: 162,500 functions, including whether the collection, and allow 60 days for public hours. information will have practical utility; comment in response to the notice. This Estimated Average Burden per (2) the accuracy of VBA’s estimate of the notice solicits comments on the Respondent: 15 minutes. burden of the proposed collection of information needed to determine Frequency of Response: One time. information; (3) ways to enhance the eligibility for issuance of a burial flag for Estimated Number of Respondents: quality, utility, and clarity of the a deceased veteran. 650,000. information to be collected; and (4) DATES: Written comments and Dated: September 28, 2011. ways to minimize the burden of the recommendations on the proposed By direction of the Secretary. collection of information on collection of information should be Denise McLamb, respondents, including through the use received on or before December 2, 2011. of automated collection techniques or Program Analyst, Enterprise Records Service. ADDRESSES: Submit written comments the use of other forms of information [FR Doc. 2011–25383 Filed 9–30–11; 8:45 am] on the collection of information through technology. BILLING CODE 8320–01–P http://www.Regulations.gov or to Nancy Title: Fiduciary Statement in Support J. Kessinger, Veterans Benefits of Appointment, VA Form 21–0792. Administration (20M33), Department of OMB Control Number: 2900–0670. DEPARTMENT OF VETERANS Type of Review: Extension of a Veterans Affairs, 810 Vermont Avenue, AFFAIRS currently approved collection. NW., Washington, DC 20420 or e-mail to Abstract: Individual’s seeking [email protected]. Please refer to [OMB Control No. 2900–0049] ‘‘OMB Control No. 2900–0013’’ in any appointment as a fiduciary of VA Proposed Information Collection beneficiaries complete VA Form 21– correspondence. During the comment period, comments may be viewed online (Approval of School Attendance) 0792. VA uses the data collected to Activity: Comment Request determine the individual’s qualification through the Federal Docket Management System (FDMS) at http:// as a fiduciary and to inquire about his AGENCY: Veterans Benefits or her credit and criminal background. www.Regulations.gov. Administration, Department of Veterans Affected Public: Individuals or FOR FURTHER INFORMATION CONTACT: Affairs. households. Nancy J. Kessinger at (202) 461–9769 or ACTION: Notice. Estimated Annual Burden: 1,875 FAX (202) 275–5947. hours. SUPPLEMENTARY INFORMATION: Under the SUMMARY: The Veterans Benefits Estimated Average Burden per PRA of 1995 (Pub. L. 104–13; 44 U.S.C. Administration (VBA), Department of Respondent: 15 minutes. 3501–3521), Federal agencies must Veterans Affairs (VA), is announcing an Frequency of Response: One time. obtain approval from the Office of opportunity for public comment on the Estimated Number of Respondents: Management and Budget (OMB) for each proposed collection of certain 7,500. collection of information they conduct information by the agency. Under the Dated: September 28, 2011. or sponsor. This request for comment is Paperwork Reduction Act (PRA) of By direction of the Secretary. being made pursuant to Section 1995, Federal agencies are required to 3506(c)(2)(A) of the PRA. publish notice in the Federal Register Denise McLamb, concerning each proposed collection of Program Analyst, Enterprise Records Service. With respect to the following collection of information, VBA invites information, including each proposed [FR Doc. 2011–25381 Filed 9–30–11; 8:45 am] comments on: (1) Whether the proposed extension of a currently approved BILLING CODE 8320–01–P collection of information is necessary collection, and allow 60 days for public for the proper performance of VBA’s comment in response to the notice. This functions, including whether the notice solicits comments for information DEPARTMENT OF VETERANS necessary to determine entitlement to AFFAIRS information will have practical utility; (2) the accuracy of VBA’s estimate of the compensation and pension benefits for [OMB Control No. 2900–0013] burden of the proposed collection of a child between the ages of 18 and 23 information; (3) ways to enhance the attending school. Proposed Information Collection quality, utility, and clarity of the DATES: Written comments and (Application for United States Flag for information to be collected; and (4) recommendations on the proposed Burial Purposes) Activity: Comment ways to minimize the burden of the collection of information should be Request collection of information on received on or before December 2, 2011. AGENCY: Veterans Benefits respondents, including through the use ADDRESSES: Submit written comments Administration, Department of Veterans of automated collection techniques or on the collection of information through Affairs. the use of other forms of information http://www.Regulations.gov or to Nancy ACTION: Notice. technology. J. Kessinger, Veterans Benefits Title: Application for United States Administration (20M33), Department of SUMMARY: The Veterans Benefits Flag for Burial Purposes, VA Form 21– Veterans Affairs, 810 Vermont Avenue, Administration (VBA), Department of 2008. NW., Washington, DC 20420 or e-mail to Veterans Affairs (VA), is announcing an OMB Control Number: 2900–0013. [email protected]. Please refer to opportunity for public comment on the Type of Review: Extension of a ‘‘OMB Control No. 2900–0049’’ in any proposed collection of certain currently approved collection. correspondence. During the comment information by the agency. Under the Abstract: VA Form 21–2008 is used to period, comments may be viewed online Paperwork Reduction Act (PRA) of determine a family member or friend of through the Federal Docket Management

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System (FDMS) at http:// a. VA Forms 21–674 and 674c— Fibromyalgia Disability Benefits www.Regulations.gov. 138,000 hours. Questionnaire, VA Form 21– FOR FURTHER INFORMATION CONTACT: b. VA Form 21–674b—39,500 hours. 0960C7. Nancy J. Kessinger at (202) 461–9769 or Dated: September 28, 2011. Seizure Disorders (Epilepsy) Disability Benefits Questionnaire, VA Form fax (202) 275–5947. By direction of the Secretary. 21–0960C11. SUPPLEMENTARY INFORMATION: Under the Denise McLamb, Dental and Oral Conditions, including PRA of 1995 (Pub. L. 104–13; 44 U.S.C. Program Analyst, Enterprise Records Service. Mouth, Lips, and Tongue (Other 3501–3521), Federal agencies must [FR Doc. 2011–25380 Filed 9–30–11; 8:45 am] than Temporomandibular Joint obtain approval from the Office of BILLING CODE 8320–01–P Conditions) Disability Benefits Management and Budget (OMB) for each Questionnaire, VA Form 21– collection of information they conduct 0960D1. or sponsor. This request for comment is DEPARTMENT OF VETERANS Endocrine Diseases (other than Thyroid, being made pursuant to Section AFFAIRS Parathyroid or Diabetes Mellitus). 3506(c)(2)(A) of the PRA. [OMB Control No. 2900–New (DBQs—Group Disability Benefits Questionnaire, With respect to the following 4)] VA Form 21–0960–E–2. collection of information, VBA invites Thyroid & Parathyroid Conditions comments on: (1) Whether the proposed Agency Information Collection Disability Benefits Questionnaire, collection of information is necessary (Disability Benefits Questionnaires— VA Form 21–0960–E–3. for the proper performance of VBA’s Group 4) Activity Under OMB Review Hernias (Including Abdominal, functions, including whether the Inguinal, and Femoral Hernias) AGENCY: information will have practical utility; Veterans Benefits Disability Benefits Questionnaire, (2) the accuracy of VBA’s estimate of the Administration, Department of Veterans VA Form 21–0960–H–1. burden of the proposed collection of Affairs. HIV-Related Illnesses Disability Benefits information; (3) ways to enhance the ACTION: Notice. Questionnaire, VA Form 21–0960– quality, utility, and clarity of the I–2. SUMMARY: In compliance with the information to be collected; and (4) Infectious Diseases (Other Than HIV- Paperwork Reduction Act (PRA) of 1995 ways to minimize the burden of the Related Illness, Chronic Fatigue (44 U.S.C. 3501–3521), this notice collection of information on Syndrome, or Tuberculosis) announces that the Veterans Benefits respondents, including through the use Disability Benefits Questionnaire, Administration (VBA), Department of of automated collection techniques or VA Form 21–0960–I–3. the use of other forms of information Veterans Affairs, will submit the Systemic Lupus Erythematosus (SLE) technology. collection of information abstracted and Other Autoimmune Diseases Titles: below to the Office of Management and Disability Benefits Questionnaire, a. Request for Approval of School Budget (OMB) for review and comment. VA Form 21–0960–I–4. Attendance, VA Form 21–674 and 21– The PRA submission describes the Nutritional Deficiencies Disability 674c. nature of the information collection and Benefits Questionnaire, VA Form b. School Attendance Report, VA its expected cost and burden; it includes 21–0960–I–5. Form 21–674b. the actual data collection instrument. Urinary Tract (including Bladder & OMB Control Number: 2900–0049. DATES: Comments must be submitted on Urethra) Conditions (excluding Type of Review: Extension of a or before November 2, 2011. Male Reproductive System) currently approved collection. ADDRESSES: Submit written comments Disability Benefits Questionnaire, Abstract: Recipients of disability on the collection of information through VA Form 21–0960–J–4. compensation, dependency and http://www.Regulations.gov or to VA’s Respiratory Conditions (other than indemnity compensation, disability OMB Desk Officer, OMB Human Tuberculosis and Sleep Apnea) pension, and death pension are entitled Resources and Housing Branch, New Disability Benefits Questionnaire, to benefits for eligible children between Executive Office Building, Room 10235, VA Form 21–0960–L–1. the ages of 18 and 23 who are attending Washington, DC 20503 (202) 395–7316. Loss of Sense of Smell and/or Taste school. VA Forms 21–674, 21–674c and Please refer to ‘‘OMB Control No. 2900– Disability Benefits Questionnaire, 21–674b are used to confirm school New (DBQs–Group 4)’’ in any VA Form 21–0960–N–3. attendance of children for whom VA correspondence. Sinusitis/Rhinitis and Other Conditions compensation or pension benefits are of the Nose, Throat, Larynx, and FOR FURTHER INFORMATION CONTACT: being paid and to report any changes in Pharynx Disability Benefits Denise McLamb, Enterprise Records entitlement factors, including marriages, Questionnaire, VA Form 21–0960– Service (005R1B), Department of a change in course of instruction and N–4. Veterans Affairs, 810 Vermont Avenue, termination of school attendance. Chronic Fatigue Syndrome Disability NW., Washington, DC 20420, (202) 461– Affected Public: Individuals or Benefits Questionnaire, VA Form 7485, fax (202) 461–0966 or e-mail households. 21–0960–Q–1. Estimated Annual Burden: [email protected]. Please refer to OMB Control Number: 2900–New a. VA Forms 21–674 and 674c— ‘‘OMB Control No. 2900–New (DBQs– (DBQs—Group 4). 34,500 hours. Group 4).’’ Type of Review: New collection. b. VA Form 21–674b—3,292 hours. SUPPLEMENTARY INFORMATION: Abstract: Data collected on VA Form Estimated Average Burden Per Titles: 21–0960 series will be used to obtain Respondent: Cranial Nerve Conditions Disability information from claimants’ treating a. VA Forms 21–674 and 674c—15 Benefits Questionnaire, VA Form physician that is necessary to adjudicate minutes. 21–0960C3. a claim for disability benefits. b. VA Form 21–674b—5 minutes. Narcolepsy Disability Benefits An agency may not conduct or Frequency of Response: On occasion. Questionnaire, VA Form 21– sponsor, and a person is not required to Estimated Number of Respondents: 0960C6. respond to a collection of information

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unless it displays a currently valid OMB DEPARTMENT OF VETERANS DEPARTMENT OF VETERANS control number. The Federal Register AFFAIRS AFFAIRS Notice with a 60-day comment period soliciting comments on this collection Enhanced-Use Lease (EUL) of Enhanced-Use Lease (EUL) of of information was published on July Department of Veterans Affairs (VA) Department of Veterans Affairs (VA) 27, 2011, at pages 45008–45008. Real Property at the VA Connecticut Real Property for the Development of Affected Public: Individuals or Healthcare System, Newington a Senior Living Retirement and households. Campus Affordable Housing Community in Fort Estimated Annual Burden: Howard, MD a. VAF 21–0960–C–3—5,000. AGENCY: Department of Veterans Affairs. b. VAF 21–0960–C–6—1,250. AGENCY: Department of Veterans Affairs. c. VAF 21–0960–C–7—1,250. ACTION: Notice of Intent to Enter into an VAF 21–0960–C–11—1,250. Enhanced-Use Lease. ACTION: Notice of Intent to Enter into an VAF 21–0960–D–1—1,250. Enhanced-Use Lease. VAF 21–0960–E–2—2,500. SUMMARY: The Secretary of VA intends d. VAF 21–0960–E–3—2,500. to enter into an EUL on an 11.2-acre SUMMARY: The Secretary of VA intends VAF 21–0960–H–1—3,750. parcel of land and improvements to to enter into an EUL for 94 acres of land e. VAF 21–0960–I–2—1,250. include renovating an existing building and thirty-seven (37) buildings at the f. VAF 21–0960–I–3—2,500. at the VA Connecticut Healthcare Fort Howard VA Campus in Fort VAF 21–0960–I–4—2,500. g. VAF 21–0960–I–5—1,250. System, Newington campus. The Howard, Maryland. The selected lessee VAF 21–0960–J–4—3,750. selected lessee will finance, design, will finance, design, renovate, construct, VAF 21–0960–L–1—10,000. develop, renovate, manage, maintain manage, maintain and operate the EUL VAF 21–0960–N–3—1,250. and operate the EUL development. As development. As consideration for the VAF 21–0960–N–4—10,000. consideration for the lease, the lessee lease, the lessee will be required to VAF 21–0960–Q–1—2,500. will be required to renovate, operate, provide a new community-based Estimated Average Burden per and maintain a permanent supportive outpatient clinic, profit sharing, and Respondent: housing facility; provide preference and discounted rent to Veterans residing in a. VAF 21–0960–C–3—30 minutes. priority placement for homeless the senior living retirement and b. VAF 21–0960–C–6—15 minutes. Veterans and Veterans at risk of affordable housing community. Fifty c. VAF 21–0960–C–7—15 minutes. homelessness; and provide a supportive units will be set aside to provide VAF 21–0960–C–11—15 minutes. services program that guides resident transitional housing and supportive VAF 21–0960–D–1—15 minutes. VAF 21–0960–E–2—15 minutes. Veterans toward attaining long-term services for homeless and at-risk d. VAF 21–0960–E–3—15 minutes. self-sufficiency. Veterans. VAF 21–0960–H–1—15 minutes. FOR FURTHER INFORMATION CONTACT: FOR FURTHER INFORMATION CONTACT: e. VAF 21–0960–I–2—15 minutes. Edward Bradley, Office of Asset f. VAF 21–0960–I–3—15 minutes. Edward L. Bradley, III, Office of Asset VAF 21–0960–I–4—30 minutes. Enterprise Management (044C), Enterprise Management (044), g. VAF 21–0960–I–5—15 minutes. Department of Veterans Affairs, 810 Department of Veterans Affairs, 810 VAF 21–0960–J–4—15 minutes. Vermont Avenue, NW., Washington, DC Vermont Avenue, NW., Washington, DC VAF 21–0960–L–1—30 minutes. 20420, (202) 461–7778 (this is not a toll- 20420. Telephone: (202) 461–7778 (this VAF 21–0960–N–3—15 minutes. free number). is not a toll-free number). VAF 21–0960–N–4—30 minutes. VAF 21–0960–Q–1—15 minutes. SUPPLEMENTARY INFORMATION: Title 38 SUPPLEMENTARY INFORMATION: Title 38 Frequency of Response: On occasion. U.S.C. 8161 et seq. states that the U.S.C. 8161 et seq. states that the Estimated Number of Respondents: Secretary may enter into an enhanced- Secretary may enter into an enhanced- a. VAF 21–0960–C–3—10,000. use lease if he determines that use lease if he determines that b. VAF 21–0960–C–6—5,000. implementation of a business plan implementation of a business plan c. VAF 21–0960–C–7—5,000. proposed by the Under Secretary for proposed by the Under Secretary for VAF 21–0960–C–11—5,000. Health for applying the consideration Health for applying the consideration VAF 21–0960–D–1—5,000. under such a lease for the provision of under such a lease for the provision of VAF 21–0960–E–2—10,000. medical care and services would result medical care and services would result d. VAF 21–0960–E–3—10,000. in a demonstrable improvement of in a demonstrable improvement of VAF 21–0960–H–1—15,000. services to eligible Veterans in the services to eligible Veterans in the e. VAF 21–0960–I–2—5,000. geographic service-delivery area within f. VAF 21–0960–I–3—10,000. geographic service-delivery area within VAF 21–0960–I–4—5,000. which the property is located. This which the property is located. This g. VAF 21–0960–I–5—5,000. project meets this requirement. project meets this requirement. VAF 21–0960–J–4—15,000. Approved: September 26, 2011. Approved: September 26, 2011. VAF 21–0960–L–1—20,000. Eric K. Shinseki, VAF 21–0960–N–3—5,000. Eric K. Shinseki, VAF 21–0960–N–4—20,000. Secretary of Veterans Affairs. Secretary of Veterans Affairs. VAF 21–0960–Q–1—10,000. [FR Doc. 2011–25365 Filed 9–30–11; 8:45 am] [FR Doc. 2011–25366 Filed 9–30–11; 8:45 am] Dated: September 28, 2011. BILLING CODE 8320–01–P BILLING CODE P By direction of the Secretary. Denise McLamb, Program Analyst, Enterprise Records Service. [FR Doc. 2011–25382 Filed 9–30–11; 8:45 am] BILLING CODE 8320–01–P

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DEPARTMENT OF VETERANS and operate the EUL development. As SUPPLEMENTARY INFORMATION: Title 38 AFFAIRS consideration for the lease, the lessee U.S.C. 8161 et seq. states that the will be required to construct, operate, Secretary may enter into an enhanced- Enhanced-Use Lease (EUL) of and maintain a permanent housing use lease if he determines that Department of Veterans Affairs (VA) facility; provide preference and priority implementation of a business plan Real Property for the Development of placement for homeless Veterans and proposed by the Under Secretary for a Permanent Supportive Housing Veterans at risk of homelessness and Health for applying the consideration Facility in Lyons, NJ their families; and provide a supportive under such a lease for the provision of medical care and services would result AGENCY: Department of Veterans Affairs. services program that guides resident Veterans toward attaining long-term in a demonstrable improvement of ACTION: Notice of Intent to Enter into an self-sufficiency. services to eligible Veterans in the Enhanced-Use Lease. geographic service-delivery area within FOR FURTHER INFORMATION CONTACT: which the property is located. This SUMMARY: The Secretary of VA intends Edward Bradley, Office of Asset project meets this requirement. to enter into an EUL on a 16-acre parcel Enterprise Management (044), of land at the VA New Jersey Health Approved: September 26, 2011. Department of Veterans Affairs, 810 Eric K. Shinseki, Care System—Lyons Campus Medical Vermont Avenue, NW., Washington, DC Secretary of Veterans Affairs. Center in Lyons, New Jersey. The 20420, (202) 461–7778 (this is not a toll- [FR Doc. 2011–25322 Filed 9–30–11; 8:45 am] selected lessee will finance, design, free number). develop, construct, manage, maintain BILLING CODE P

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Part II

Department of Justice

Drug Enforcement Administration Robert Raymond Reppy, D.O.; Decision and Order; Notice

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DEPARTMENT OF JUSTICE financial interest in United Prescription physical examination of the patient.’’ Id. Services. Id. at 60–61, 151. The MBC also held that a ‘‘medical Drug Enforcement Administration As for Respondent’s assertion that he indication’’ is determined only after the [Docket No. 09–50] was unable to find ‘‘anybody’’ definitely taking of a history, the conducting of a saying that it was illegal to prescribe physical examination, and an Robert Raymond Reppy, D.O.; controlled substances over the internet assessment of ‘‘the patient’s condition.’’ Decision and Order to persons he never examined, this may Id. The MBC further explained that ‘‘[a] be consistent with his claim that he did physician cannot determine whether On March 31, 2011, Administrative ‘‘little research.’’ However, it clearly was there is a medical indication for Law Judge (ALJ) Timothy D. Wing not the case, as even by 2002, multiple prescription of a dangerous drug issued the attached recommended States had enacted statutes, without performing a physical decision. Neither party filed exceptions promulgated rules, or published policy examination.’’ Id. to the decision. statements to the effect that prescribing In April 2001, Ohio enacted a statute Having reviewed the entire record drugs in this manner was illegal. which defines ‘‘telemedicine’’ as ‘‘the including the parties’ briefs, I have Moreover, as explained below, it was practice of medicine in this state decided to adopt the ALJ’s clearly unreasonable for Respondent to through the use of any communication, recommended ruling, findings of fact, rely on Carr’s purported advice. including oral, written, or electronic conclusions of law, and recommended In 2000, California enacted a communication, by a physician outside order. Accordingly, I will order that provision which prohibits the th[e] state’’ and also requires that a Respondent’s DEA Certificate of prescribing or dispensing of a dangerous physician obtain a ‘‘telemedicine Registration be revoked and that any drug ‘‘on the Internet for delivery to any certificate’’ to lawfully prescribe within pending applications be denied. person in this state, without an the State, id. § 4731.296 (effective 4–10– As the ALJ found, between 2002 and appropriate prior examination and 01), and a ‘‘special activity certificate.’’ 2006, Respondent wrote thousands of medical indication therefore.’’ Cal. Bus. Id. § 4731.294 (effective 4–10–01). controlled- substance prescriptions & Prof. Code § 2242.1. Moreover, as Moreover, in 2002, Ohio adopted a (approximately 5000 each year) to early as November 2001, the Medical regulation which, except for in patients who sought such drugs as Board of California (MBC) issued a circumstances not at issue here, hydrocodone and alprazolam through citation order to an out-of-state prohibits the dispensing of controlled the internet, most of whom (at least 90 physician for prescribing over the substances ‘‘to a person who the percent) he never physically examined, Internet to California residents. See physician has never personally let alone met. ALJ at 12, 20–21.1 Citation Order, Carlos Gustav Levy examined and diagnosed.’’ Ohio Admin. Respondent wrote the prescriptions (Nov. 30, 2001). The MBC cited both the Code § 4731–11–09(A). based on medical records which were physician’s failure to conduct ‘‘a good In 2002, Tennessee law prohibited (as sent to him not by the patients’ doctors, faith prior examination,’’ as well as his it still does) the practice of medicine but by the patients themselves, and a lack of ‘‘a valid California Physician and within the State without a license telephone consultation with the Surgeon’s License to practice medicine issued by the State. Tenn. Code Ann. patients. Id. at 20–21. As the ALJ found, in California.’’ Id. at 1. The Board § 63–6–201(a) (2002); see also id. § 63– ‘‘Respondent rarely contacted a patient’s further ordered Doctor Levy ‘‘to cease 6–204 (2002) (defining ‘‘a person [who primary care physician whose records and desist from Internet prescribing to is] regarded as practicing medicine’’ as he was reviewing’’ and had no way of individuals in California without first one ‘‘who treats, or professes to verifying whether the person he performing a good faith prior diagnose, treat, operate[] on or prescribed to was the actual person examination, without having medical prescribes for any physical ailment or whose record he was reviewing. Id. at indication to prescribe such medication any physical injury to or deformity of 21. and without having a California another’’). Like Ohio, Tennessee also Respondent maintains that in 2002, Physician and Surgeon’s License,’’ and provides for ‘‘restricted licenses and when he agreed to write the fined him $25,000. Id. at 1–2. See also special licenses based upon licensure to prescriptions, the legality of prescribing Citation Order, Martin P. Feldman (Aug. another state for the limited purpose of controlled substances via the internet 15, 2003); see also Citation Order, Harry authorizing the practice of was ‘‘a gray area’’ and that the standards Hoff (June 17, 2003); Citation Order, telemedicine.’’ Id. § 63–6–209(b) (1996). were not the same ‘‘as are agreed upon Carlos Gustavo Levy (Jan. 28, 2003). See also Tennessee Board of Medical now.’’ Tr. 64. Respondent further claims In addition, in January 2003 (and Examiners, Position Statement: that he did his ‘‘due diligence,’’ which prior to much of Respondent’s Prerequisites to Prescribing or included doing ‘‘a little research on [his] prescribing activity which continued Dispensing Drugs-In Person, own,’’ with the result being that he until October 2006), the MBC revoked a Electronically or Over the Internet (Sept. ‘‘couldn’t find anybody saying * * * for physician’s medical license when he 2000) (‘‘[I]t shall be a prima facie definite that you cannot do this’’ and engaged in practices similar to those of violation of [State law] for a physician that he was even shown a letter from Respondent. See In re Steven Opsahl, to prescribe or dispense any drug to any ‘‘DEA giving permission to do it.’’ Id. at M.D., Decision and Order, at 3 (Med. Bd. individual, whether in person or by 60. Respondent was shown this letter by Cal. 2003) (available by query at http:// electronic means or over the Internet or an attorney, Mr. Robert Carr, who publicdocs.mbc.ca.gov/pdl/mbc.aspx). over telephone lines, unless the happened to be the founder and In Opsahl, the MBC held that physician has first done and President of United Prescription ‘‘[b]efore prescribing a dangerous drug, appropriately documents, for the person Services, a Tampa, Florida-based a physical examination must be to whom a prescription is to be issued pharmacy which was to fill most of the performed’’ and that a physician or drugs dispensed, all of the following: prescriptions Respondent issued; ‘‘cannot do a good faith prior (a) Performed an appropriate history Respondent knew that Carr had a examination based on a history, a and physical examination * * * ’’).2 review of medical records, responses to 1 All citations to the ALJ’s decision are to the slip a questionnaire, and a telephone 2 This statement likewise recognizes three opinion as originally issued. consultation with the patient, without a situations in which a drug may be prescribed

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Prior to Respondent’s prescribing conditions and/or contra-indications to the physician has not examined the activity, Tennessee had also the treatment recommended.’’ Ga. patient and established a diagnostic promulgated a regulation which Comp. R. & Regs. 360–3–.02 (2002). basis for such therapy.’’ Louisiana State provided clear notice that, before While the regulation provided an Board of Medical Examiners, Statement issuing a prescription for a controlled exception in the case of a licensee who of Position on Internet/Telephonic substance ‘‘by electronic means or over is on call or covering for another doctor, Prescribing, at 2 (available at http:// the Internet or over telephone lines,’’ a the exception did not apply to www.lsbme.la.gov/Statements physician must ‘‘[p]erform[] an Respondent’s internet prescribing. See %20of%20position.html). The Board appropriate history and medical also S.C. Code Reg. 81–28(A) (effective further explained that: examination,’’ ‘‘[m]a[k]e a diagnosis May 25, 2001) (requiring prescribing A physician establishes a physician- based upon the examinations and all physician to ‘‘[p]ersonally perform an patient relationship by: diagnostic and laboratory tests appropriate history and physical • Verifying that the person requesting consistent with good medical care,’’ examination’’). the medication is in fact who they claim ‘‘[f]ormulate[] a therapeutic plan,’’ and In addition, prior to Respondent’s to be; • ‘‘[i]nsure[] availability of the physician commencement of internet prescribing, Conducting an appropriate numerous state boards had issued examination of the patient; or coverage for the patient for • appropriate follow-up care.’’ Tenn. policy statements which made clear that Establishing a diagnosis through the Comp. R. & Regs. 0880–2–14.(7)(a) this activity was unprofessional conduct use of accepted medical practices, i.e., a (2002). and illegal. For example, in November patient history, mental status, In April 2000, the Alabama State 1999, the North Carolina Medical Board examination, physical examination and Board of Medical Examiners issued a position statement entitled appropriate diagnostic and laboratory ‘‘Contact With Patients Before testing; promulgated its ‘‘Contact with Patients • before Prescribing’’ rule. The rule states Prescribing’’ (available at http://www. Discussing with the patient the _ the Board’s position: ncmedboard.org/position statements/ diagnosis, risks and benefits of various detail/contact_with_patients_before_ treatment options; and that prescribing drugs to an individual the prescribing/). Therein, the Board stated • Insuring the availability for prescriber has not personally examined is ‘‘that prescribing drugs to an individual appropriate follow-up care. usually inappropriate. Before prescribing a Id. at 2. The Louisiana Board further drug, the physician should make an informed the prescriber has not personally medical judgment based on the examined is inappropriate’’ except in stated that ‘‘[a]s a matter of law, to be circumstances of the situation and on his or the case of admission orders for newly valid, effective and lawful, each her training and experience. Ordinarily, this hospitalized patients, taking call for prescription or order for medication will require that the physician perform an another physician, and on short-term must be issued or given by an appropriate history and physical basis prior to a patient’s first authorized practitioner (i.e., a Louisiana examination, make a diagnosis, and appointment. The Board further licensed physician) with respect to an formulate a therapeutic plan, a part of which explained that ‘‘[o]rdinarily, this will individually identified patient, based on might be a prescription. require that the physician perform an the practitioner’s examination and Ala. Admin Code r.540–X–9.11(1). appropriate history and physical diagnosis of the patient.’’ Id. at 3. While the Alabama rule also recognizes examination, make a diagnosis, and Finally, the Board explained that: that in certain situations a prescribing formulate a therapeutic plan, part of because the [State’s] Medical Practice Act physician is not required to have which might be a prescription.’’ restricts the practice of medicine to persons performed a physical exam of the In December 1999, the Texas State possessing a license issued by [it,] [a]n patient (such as admission orders for a Board of Medical Examiners issued its individual who issues a prescription or newly admitted patient, where the Internet Prescribing Policy. This Policy orders medication for an individual who is prescriber is taking call for another stated that ‘‘[i]t is unprofessional a resident of or located in Louisiana, who physician, and where the prescriber conduct for a physician to initially does not possess a Louisiana medical license continues medication ‘‘on a short-term prescribe any dangerous drugs or or other authorization to practice medicine in controlled substances without first this state, is necessarily engaged in the basis for a new patient prior to the unauthorized practice of medicine in patient’s first appointment’’), none of establishing a proper physician-patient contravention of the Medical Practice Act. these exceptions applied to relationship.’’ Texas State Board of Respondent’s internet prescribing. Id. Medical Examiners, Internet Prescribing Id. r.540–X–9.11(2). Policy (available at http://www.tmb. Moreover, in November 2000, the In February 2002, the Georgia state.tx.us/rules/guidelines/ipp.php). Oklahoma State Board of Medical Composite State Board of Medical The Policy further explained that ‘‘at a Licensure and Supervision adopted its Examiners amended its regulation minimum,’’ this requires, inter alia, Policy on Internet Prescribing. The defining ‘‘Unprofessional Conduct’’ to ‘‘verifying that the person requesting the Oklahoma Board adopted most of the include ‘‘[p]roviding treatment and/or medication is in fact who they claim to same standards as the Louisiana consultation recommendations via be,’’ and ‘‘establishing a diagnosis statement, including that ‘‘at a electronic or other means unless the through the use of accepted medical minimum,’’ a physician must verify the licensee has performed a history and practices such as a patient history, identity of a patient requesting physical examination of the patient mental status exam, physical medication and ‘‘establish[] a diagnosis adequate to establish differential examination and appropriate diagnostic through the use of accepted medical diagnoses and identify underlying and laboratory testing.’’ Id. practices such as a patient history, In May 2000, the Louisiana State mental status exam, physical without the physician having performed a physical Board of Medical Examiners issued a examinations and appropriate examination of the patient: (1) In admission orders Statement of Position on Internet/ diagnostic and laboratory testing by the for new admitted hospital patients, (2) when Telephonic Prescribing, which stated prescribing physician.’’ Oklahoma State covering for another physician, and (3) on a short- term basis for a new patients prior to the patient’s ‘‘the Board’s view, [that] it is unlawful Board of Medical Licensure and first appointment. None of these applied to for a physician to prescribe medication, Supervision, Policy on Internet Respondent’s internet practice. treatment or a plan of care generally if Prescribing (available at http://www.

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okmedicalboard.org/download/308/ Board further advised that the physician and the patient,’’ and that precribing+on+the+Internet.htm). The ‘‘[p]rescribing over the internet while this was ‘‘[b]lack and white.’’ Oklahoma Board also stated that deviating from these requirements is The fact that a physician-relationship ‘‘[c]omplete management of a patient by therefore unlawful.’’ 4 ‘‘is clearly established when a physician Internet, e-mail, or other forms of At the instant hearing, Respondent agrees to undertake diagnosis and electronic communications is did not testify as to any state laws or treatment,’’ RX 9, at 7, however, does inappropriate.’’ Id.; see also Washington Board positions (with the exception of not mean that a physician has Medical Quality Assurance Florida) he found which authorized established an adequate physician- Commission, Position on Internet prescribing to patients he would not patient relationship sufficient to support Prescribing (Winter 2001) (available at meet, based on a review of records and the diagnosis of a patient and the http://www.doh.wa.gov/hsqa/mqac/ a telephone consultation. Instead, he issuance of a prescription. Indeed, the policies.htm) (‘‘The standard of medical maintained that ‘‘as part of [his] due Guidelines further state that practice in the state of Washington diligence’’ in deciding whether to ‘‘[t]reatment and consultation requires a physician, when prescribing engage in Internet prescribing, he recommendations made in an online medication to [inter alia,] verify that the reviewed the Model Guidelines for the setting, including issuing a prescription person requesting the medication is in Appropriate Use of the Internet in via electronic means, will be held to the fact who he or she claims to be,’’ and Medical Practice (RX 9), a policy same standards of appropriate practice ‘‘establish a diagnosis through the use of document issued by the Federation of as those in traditional (face-to-face) accepted medical practices such as a State Medical Boards of the United settings.’’ Id. at 8. At the hearing, patient interview, physical examination, States (FSMB). Tr. 76–77. Respondent Respondent offered no explanation as to and appropriate ancillary testing.’’). testified that this document gave him what he thought this statement meant. To similar effect, in May 2000, the the impression that Attorney Carr’s Just one page later, the Guidelines Mississippi State Board of Medical advice that Internet prescribing was further state that ‘‘[p]hysicians who treat Licensure issued a policy statement on legal was accurate ‘‘because it or prescribe through Internet Web sites Internet Prescribing. The Mississippi specifically says the physician/patient are practicing medicine and must policy stated that the ‘‘[e]ssential relationships exists whether or not there possess appropriate licensure in all components of proper prescribing and has been a personal encounter between jurisdictions where patients reside.’’ Id. legitimate medical practice require that at 9. Respondent admitted that during the physician obtains a thorough physician must ‘‘conduct[] an appropriate physical’’ the period of his internet prescribing, he medical history and conducts an examination. It further stated that ‘‘[i]ssuance of a was licensed only in the State of appropriate physical examination before prescription, by any means, including the Internet Florida. Respondent thus engaged in the or other electronic process, that does not meet these unauthorized practice of medicine in prescribing any medication for the first requirements is therefore unlawful.’’ time.’’ Mississippi State Board of 4 Other States adopted similar statutes, rules and/ numerous States. As the California Medical Licensure, Internet Prescribing or policy statements on Internet prescribing within Court of Appeals has explained, the (available at http://www.msbml.state. the next several years and well before Respondent ‘‘proscription of the unlicensed practice ceased his internet prescribing. See Colorado Board of medicine is neither an obscure nor an ms.us/regulations/ of Medical Examiners, Policy 40–9: Guidelines 2004%20policy%20book.pdf). While Regarding Prescribing for Unknown Patients (Nov. unusual state prohibition of which the Mississippi Board recognized 16, 2003) (available at http://www.dora.state.co.us/ ignorance can reasonably be claimed, exceptions for admission orders for medical/policies/40-09.pdf) ; Ind. Admin Code 5–41 and certainly not by persons * * * who (Oct. 2003) (‘‘Except in institutional settings, on-call are licensed health care providers. Nor newly hospitalized patients, cross- situations, cross-coverage situations, and situations coverage situations, and for short-term involving advanced practice nurses with can such persons reasonably claim prescribing prior to a new patient’s first prescriptive authority * * * a physician shall not ignorance of the fact that authorization appointment, as noted previously, none prescribe, dispense, or otherwise provide, or cause of a prescription pharmaceutical to be provided, any controlled substance to a person constitutes the practice of medicine.’’ of these situations applied to who the physician has never personally physically Respondent’s internet prescribing. examined and diagnosed.’’); New York State Board Hageseth v. Superior Court, 59 Cal. In December 2001, the Massachusetts for Professional Medical Conduct, Statements on Rptr.3d 385, 403 (Ct. App. 2007). State Board of Registration in Medicine Telemedicine (Dec. 24, 2003) (available at http:// Respondent’s assertion that he relied www.health.ny.gov/professionals/doctors/conduct/ on the FSMB Guidelines and yet amended its Prescribing Practices Policy telemedicine.htm.) (‘‘All the current standards of and Guidelines to address the subject of care regarding the practice of medicine apply. The ‘‘couldn’t find anybody saying * * * for Internet Prescriptions. The Board stated fact that an electronic medium is utilized for definite that you cannot do this,’’ Tr. 60, that ‘‘a prescription to be legally valid contact between parties or as a substitute for face- is especially remarkable given that the to-face consultation does not change the standards Guidelines included a list of References. must be issued within the context of a of care.’’). While these provisions were adopted physician-patient relationship under after Respondent commenced his Internet RX 9, at 11. Among the authorities cited circumstances in which the physician prescribing, Respondent had a continuing therein are the position/policy has conformed to certain minimum obligation to keep track of the law as it changed. statements of the Boards of Louisiana, norms and standards for the care of In addition, as early as June 2001, DEA had New York, North Carolina, Oklahoma, revoked the registration of a physician whose state South Carolina, Texas and Washington patients, such as taking an adequate controlled substance registration and medical medical history and conducting an licenses had been suspended for prescribing over State, each of which—as discussed appropriate physical examination.’’ the Internet. See Rick Joe Nelson, 66 FR 30752 above—provided ample notice that each Massachusetts State Board of (2001). This same physician was ultimately of these Board’s considered internet indicted for conspiracy to distribute controlled Registration in Medicine, Prescribing prescribing to violate the accepted substances outside of the usual course of 5 Practices Policy and Guidelines, Internet professional practice, 21 U.S.C. 846, and convicted. standards of professional practice. In Prescriptions (available at http://www. See United States v. Nelson, 383 F.3d 1227 (10th mass.gov/Eeohhs2/docs/borim/policies_ Cir. 2004). Of note, his conviction was affirmed (in 5 In April 2001, DEA published a Guidance _ _ 3 a published decision) on September 20, 2004, more Document entitled Dispensing and Purchasing guidelines/policy 03 06.pdf). The than two years before Respondent left the clinic. Controlled Substances over the Internet, 66 FR See also Mark Wade, 69 FR 7018, 7021 (Feb. 12, 21181 (2001). The Guidance explained that ‘‘[o]nly 3 The Board subsequently amended its policy on 2004) (revoking registration of Internet prescriber practitioners acting in the usual course of their December 17, 2003; the amended policy did not and noting physician had pled guilty to violation professional practice may prescribe controlled change the requirement that the prescribing of 21 U.S.C. 846). substances. These practitioners must be registered

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short, Respondent’s assertion that he prescriptions must be issued for a practicing medicine and must possess did ‘‘a little research’’ is an accurate legitimate medical purpose,’’ and that appropriate licensure in all jurisdictions statement only to the extent that ‘‘this is usually defined and interpreted where patients reside.’’ RX 9, at 8–9. emphasis is placed on the word ‘‘little.’’ by the prescriber’s respective state Thus, because it is clear that Respondent also asserts that a professional licensing board.’’ 6 Id. Respondent did not reasonably rely on February 27, 2002 letter from the Chief Thus, contrary to Respondent’s claim, Carr’s advice, this is not a mitigating of the DEA’s Office of Diversion the DEA letter did nothing more than factor. Control’s Liaison and Policy Section to address the lawfulness of the Carr, ‘‘g[ave] permission to do it.’’ Tr. pharmacy’s dispensing of prescriptions Finally, Respondent asserts that his 60; see also RX 4. According to and did so based on Carr’s cooperation in the proceeding involving Respondent, Carr showed him the letter representation that the underlying United Prescription Services, Inc., 72 FR which ‘‘seemed very convincing’’ and prescriptions would be lawfully issued. 50397 (2007), should be considered as a that the letter ‘‘basically said they [DEA] The letter thus provides no comfort to factor in mitigation. Resp. Br. 25. The were okay with it.’’ Tr. 90–91. Respondent. Government did not dispute that While the letter stated ‘‘[i]t appears As for his reliance on Carr’s purported Respondent provided testimony and an that the submitted policies and legal advice, Respondent stated that he affidavit in that matter that was of some procedures meet the federal ‘‘assumed the lawyer would give me his benefit to the Government. Tr. 78. requirements regarding controlled honest opinion and expertise and I That being said, I conclude that substances prescriptions,’’ it further wouldn’t have to go around consulting Respondent’s cooperation is noted that the pharmacy had three or four of them to get the same substantially outweighed by the represented that under its policies, it thing.’’ Tr. 60–61. Yet Respondent extensive and egregious misconduct he ‘‘plans to verify the authenticity and acknowledged that he knew Carr had a committed. As the ALJ found, with the legal authority to prescribe of each financial interest in the pharmacy. Id. at exception of a period of several months prescriber.’’ RX 4, at 1. More 61. Given Carr’s financial interest, and during which he was on a leave of specifically, the letter noted that even assuming (without deciding) that absence, see GX 10, at 85; for more than ‘‘[m]anagement personnel will verify Carr and Respondent entered into an four years, Respondent wrote thousands several elements including, but not attorney-client relationship, Respondent of controlled substances prescriptions limited to * * * [p]rofessional had ample reason to question whether outside of the usual course of licensure, DEA registration, [l]egitimate Carr was capable of providing professional practice and which lacked patient/prescriber relationship, disinterested legal advice. Id. at 60–61. a legitimate medical purpose. ALJ at 54, [p]rescriptions are issued in the usual Moreover, Carr’s advice was 60; see also 21 CFR 1306.04(a). course of professional practice, and fundamentally at odds with various [p]rescriptions are issued for a statements contained in the Model While this is reason alone to reject’s legitimate medical purpose.’’ Id. Guidelines, a document which Respondent cooperation as a mitigating (emphasis added). Continuing, the letter Respondent purportedly read, including factor, in addition, the ALJ also found noted ‘‘valid controlled substance the statements that: (1) ‘‘[t]reatment and that Respondent flagrantly failed to consultation recommendations made in supervise a Physician Assistant, who with DEA and licensed to prescribe controlled an online setting, including issuing a wrote thousands of controlled substance substances by the State(s) in which they operate.’’ prescription via electronic means, will prescriptions under his registration. ALJ Id. at 21181 (emphasis added). be held to the same standards of at 65. As the ALJ found, the PA wrote In addition, the Guidance Document specifically 14,000 prescriptions, many of which stated that ‘‘Federal law requires that ‘[a] appropriate practice as those in prescription for a controlled substance to be traditional (face-to-face) settings’’; and were for controlled substances, during effective must be issued for a legitimate medical (2) ‘‘[p]hysicians who treat or prescribe the period in which Respondent was on purpose by an individual practitioner acting in the through Internet Web sites are leave of absence. Id. Upon his return in usual course of his professional practice.’ ’’ Id. at March 2004, Respondent discovered 21182 (quoting 21 CFR 1306.04(a)). The Guidance explained that ‘‘[e]very state separately imposes the 6 As explained above, this was not an entirely that the PA had written some controlled same requirement under its laws’’ and that ‘‘[u]nder accurate statement of the law with regards a substance prescriptions in his name, Tr. Federal and state law, for a doctor to be acting in physician’s prescribing to patients who reside in a 38, 139; a violation of both state and the usual course of professional practice, there must different State. As the Model Guidelines explained, federal law. See Fla. Sta. Ann. be a bona fide doctor/patient relationship.’’ Id. most (if not all) States deem prescribing to a Continuing, the Guidance explained that ‘‘[f]or resident to be practicing medicine within the State, § 459.022(4)(e) (prohibiting PAs from purposes of state law, many state authorities, with and thus, a physician doing so is subject to both the prescribing controlled substances); 21 the endorsement of medical societies, consider the licensing and medical practice standards of the U.S.C. 843(a)(2) (prohibiting dispensing existence of the following four elements as an patient’s State and the physician’s State. See RX 9, of a controlled substance by use of a indication that a legitimate doctor/patient at 9; see also discussion above. relationship has been established: However, Respondent produced no evidence registration number ‘‘issued to another A patient has a medical complaint; showing that Carr, in requesting DEA’s review of its person’’); id. § 822(a)(2) (requiring A medical history has been taken; policies, disclosed to the Agency that the doctors ‘‘[e]very person who dispenses’’ to whose prescriptions it filled would be practicing A physical examination has been performed; and obtain a registration). medicine across state lines. See RX 3. Moreover, Some logical connection exists between the even if Respondent relied on the Florida The evidence showed that medical complaint, the medical history, the Telemedicine Regulation, and even conceding that Respondent was upset that the PA was physical examination, and the drug prescribed. the regulation did not clearly state on its face that Id. at 21182–83. the prescriber (as opposed to another doctor) must writing prescriptions under his The Guidance further stated that ‘‘[c]ompleting a perform a physical exam, see Fla. Admin. Code registration without complying with his questionnaire that is then reviewed by a doctor r.64B15–14.008(2), having claimed to have instructions and could not be hired by the internet pharmacy could not be reviewed the Model Guidelines (and having controlled. Tr. 139. Respondent considered the basis for a doctor/patient previously been licensed in other States), relationship.’’ Id. at 21183. Respondent cannot credibly claim ignorance of the complained to the clinic’s owner ‘‘about While the DEA Guidance Document does not fact that the regulation of the practice of medicine [the PA’s] prescribing patterns using have the force and effect of law, it nonetheless is a state function and that each State has its own [his] DEA registration,’’ RX 12, at 4; and provided an additional source of information as to Board and set of rules with which he was required asked him to fire the PA several times; the potential illegality of Respondent’s Internet to comply. See, e.g., Hageseth, 59 Cal.Rptr.3d, at prescribing. 403. however, the clinic’s owner refused to

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do so.7 Tr. 37–38; see GX 10, at 106. sincerely wish I had never been duped 1. Respondent has a DEA COR Nonetheless, Respondent continued to into being any part of their operation at scheduled to expire by its own terms on work for the clinic and did so for more all’’). April 30, 2009; than another year. Notwithstanding In sum, as the ALJ found, Respondent 2. Respondent issued prescriptions to Respondent’s professed concern that the ‘‘fail[ed] to sustain his burden to Internet customers from early 2004 until PA ‘‘was being pretty arrogant [and] credibly accept responsibility for his October 2006; doing a lot of things on his own,’’ Tr. misconduct and demonstrate that he 3. Respondent allowed a physician’s 121, and his awareness of the PA’s will not engage in future misconduct.’’ assistant (PA) to use Respondent’s COR prescribing irregularities, RX 12, at 4; ALJ at 71. Accordingly, I will adopt the to issue purported prescriptions to Respondent offered no evidence that he ALJ’s recommended sanction. Internet customers, in violation of 21 had reported the PA to either law Order U.S.C. 846 and Fla. Stat. Ann. § 458.347 enforcement or regulatory authorities. (2008); Pursuant to the authority vested in me This provides an additional reason to 4. The above-referenced prescriptions reject Respondent’s cooperation as a by 21 U.S.C. 823(f) & 824(a)(4), as well as by 28 CFR 0.100(b), I order that DEA were issued without a legitimate ground for mitigating the sanction. medical purpose and outside the usual In conclusion, the record here Certificate of Registration BR5287342, course of professional practice, in establishes that over the course of more issued to Robert Raymond Reppy, D.O., violation of 21 CFR 1306.04(a) and 21 than four years, Respondent was be, and it hereby is, revoked. I further U.S.C. 841(a)(1); responsible for the issuance of order that any application for renewal or thousands of illegal controlled- modification of such registration be, and 5. Respondent issued purported substance prescriptions. Respondent’s it hereby is, denied. This Order is prescriptions of controlled substances to misconduct was egregious, and the effective November 2, 2011. customers throughout the United States even though Respondent is licensed to Agency’s interest in deterring similar Dated: September 19, 2011. misconduct on the part of others practice medicine only in Florida; Michele M. Leonhart, 6. The above-referenced prescriptions provides ample justification to support Administrator. the ALJ’s recommended order. See violated state laws prohibiting the Joseph Gaudio, 74 FR 10083, 10094 D. Linden Barber, Esq., for the unauthorized practice of medicine, (2009); Southwood Pharmaceuticals, Government. including unlicensed, out-of-state A.S. Weekley, Jr., M.D., Esq., for Inc., 72 FR 36487, 36504 (2007) (citing physicians issuing controlled substance Respondent. Butz v. Glover Livestock Commission prescriptions to state residents. See e.g., Co., Inc., 411 U.S. 182, 187–88 (1973)). Recommended Ruling, Findings of Fact, Miss. Code Ann. § 73–25–34; Cal. Bus. Moreover, as the ALJ explained, while Conclusions of Law and Decision of the & Prof. Code § 2052; Ala. Code § 34–24– at the hearing, Respondent occasionally Administrative Law Judge 51; and acknowledged some wrongdoing, most 7. Respondent violated Florida law I. Introduction of his testimony was then spent on and regulations prohibiting licensed blaming others or offering absurd or Timothy D. Wing, Administrative Law physicians from issuing controlled disingenuous justifications for his Judge. This proceeding is an substance prescriptions in excessive or egregious misconduct. See ALJ at 65 adjudication pursuant to the inappropriate quantities, from issuing (discussing verification of internet Administrative Procedure Act (APA), 5 prescriptions via the Internet without customers’ identities—‘‘I’m relying on U.S.C. 551 et seq., to determine whether documented patient evaluation and the state that issued their driver’s the drug enforcement administration without discussing treatment options license attesting their identity. If the (DEA) should revoke a physician’s with patients. Fla. Stat. Ann. state did not adequately check their certificate of registration (COR) as a § 458.331(q); Fla. Admin. Code Ann. r. identity before issuing them a driver’s practitioner and deny any pending 64B8–9.014. license, then * * * I had no way of applications for renewal or modification On May 26, 2009, Respondent, determining that. * * * I used the same of that registration. Without this through counsel, requested a hearing on method of checking their identity’ as I registration the practitioner Robert the allegations in the OSC.8 Following would if they were present in front of Raymond Reppy, D.O. (Respondent or prehearing procedures,9 a hearing was me.’’). See also id. at 66–67 (finding that Dr. Reppy), of Tampa, Florida, will be held on November 16, 2010, in ‘‘rather than admit that * * * his unable to lawfully prescribe, dispense Bradenton, Florida, with both the telemedicine practices were in clear or otherwise handle controlled Government and Respondent violation of contemporaneous standards substances in the course of his practice. represented by counsel. Both parties * * * Respondent * * * attempted to On April 28, 2009, the DEA Deputy called witnesses to testify and cast doubt on the clarity of the rules.’’); Assistant Administrator, Office of introduced documentary evidence. After id. at 68 (comparing Respondent’s Diversion Control, issued an Order to the hearing, both parties filed proposed testimony that he was ‘‘sorry’’ for the Show Cause (OSC) to Respondent, findings of fact, conclusions of law and prescriptions but then stating that ‘‘if I giving Respondent notice of an argument. All of the evidence and post- thought I was doing anything wrong, I opportunity to show cause why the DEA hearing submissions have been wouldn’t have done it’’); id. (stating that should not revoke Respondent’s DEA considered, and to the extent the he was remorseful, but adding ‘‘I COR BR5287342 pursuant to 21 U.S.C. parties’ proposed findings of fact have 824(a)(4), and deny any pending 7 In an affidavit given in the United Prescription applications for renewal or modification 8 Respondent submitted an application to renew Services proceeding, Respondent stated that the pursuant to 21 U.S.C. 823(f), on the clinic owner removed the PA from the clinic. RX his COR on April 6, 2009. (ALJ Ex. 3 at 1.) 12, at 4. However, in both the united and instant grounds that Respondent’s continued 9 This case was originally assigned to proceedings, Respondent testified that the clinic registration would be inconsistent with Administrative Law Judge Mary Ellen Bittner. (See, owner ‘‘would never fire [the PA], no matter how the public interest as that term is used e.g., OPHS May 27, 2009.) On January 15, 2010, many times I requested it.’’ GX 10, at 106; Tr. 37. Administrative Law Judge Gail A. Randall was Respondent also testified the PA ‘‘was kept away in 21 U.S.C. 824(a)(4) and 823(f). assigned to the case. (Mem. Jan. 15, 2010.) Judge from me,’’ TR.101, and that the PA would In substance, the OSC alleges as Randall reassigned the case to me on July 19, 2010. frequently work from home. follows: (Mem. Jul. 19, 2010.)

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been adopted, they are substantively Administrator, apparently arguing that I subsequent litigation. See, e.g., incorporated into those set forth below. should give weight to those conclusions Restatement (Second) of Judgments § 24; here. (See Gov’t Br. 5–6 (discussing Black’s Law Dictionary (9th Ed.) (res II. Preliminary Evidentiary Issues Factors Two and Four of 21 U.S.C. judicata).14 Agency precedent has Prior to discussing the evidence and 823(f)).) acknowledged the Supreme Court’s reaching the substantive issues in this At issue, therefore, is whether legal recognition of the applicability of the case, a threshold evidentiary issue is the conclusions from a prior proceeding res judicata doctrine in DEA weight to be given, if any, to (1) the relating to the conduct of a non-party administrative proceedings. Christopher Deputy Administrator’s conclusions of witness should be given weight or Henry Lister, P.A., 75 FR 28,068, 28,069 law regarding Dr. Reppy’s compliance controlling effect in a subsequent (DEA 2010) (citing Univ. of Tenn. v. with state law contained in United proceeding against the witness. I note at Elliot, 478 U.S. 788, 797–98 (1986) Prescription Services, Inc., 72 FR 50,397 the outset that Dr. Reppy was not named (‘‘When an administrative agency is (DEA 2007), a separate proceeding in as a party in United Prescription acting in a judicial capacity and resolves which Dr. Reppy was a witness but not Services, had not yet had any adverse disputed issues of fact properly before it a party; (2) a transcript of Dr. Reppy’s action taken against him by the DEA which the parties have had an adequate sworn testimony in that case, admitted with respect to his COR (see Gov’t Ex. opportunity to litigate, the courts have without objection as Government 10 at 61), and was apparently not hesitated to apply res judicata Exhibit 10 in the present proceeding; unrepresented by counsel at the time. * * *’’)). and (3) affidavits of Respondent’s The APA provides that ‘‘[t]he It is conceded that the Deputy current employees and patients offered transcript of testimony and exhibits, Administrator’s conclusions in United as Respondent’s Exhibit 19, and an together with all papers and requests Prescription Services concerning Dr. affidavit of Respondent offered as filed in the proceeding, constitutes the Reppy’s compliance with state law, Respondent’s Exhibit 13. exclusive record for decision’’ in this including the extent of his supervision administrative proceeding. 5 U.S.C. of his PA, went to the merits of that A. The 2007 Final Order in United 556(e). The APA further defines ‘‘party’’ decision, and that the decision Prescription Services, Inc. to include a person or agency named or constituted the Agency’s final order. On August 23, 2007, the Federal admitted as a party, or properly seeking However, Dr. Reppy was not a party to Register published a final order in and entitled as of right to be admitted that proceeding. See 5 U.S.C. 551(3), United Prescription Services, Inc., 72 FR as a party * * *.’’ 5 U.S.C. 551(3), amended by Public Law 111–350, Jan. 4, 50,397 (DEA 2007). Therein, the then- amended by Public Law 111–350, Jan. 4, 2011, 124 Stat. 3677 (no relevant Deputy Administrator made legal 2011, 124 Stat. 3677 (no relevant changes) (the term ‘‘‘party’ includes a conclusions touching upon the conduct changes) (‘‘party[] in an agency person or agency named or admitted as of Dr. Reppy, who testified in that case proceeding’’). In the instant case, the a party, or properly seeking and entitled but was not named as a party. The final Agency decision in United as of right to be admitted as a party’’). Deputy Administrator found that ‘‘Dr. Prescription Services cannot serve as Indeed, as the United States Court of Reppy violated the laws of California, substantial evidence because it is not Appeals for the Fifth Circuit found Tennessee, Indiana, and Louisiana’’ part of the ‘‘exclusive record for before that Circuit split into the Fifth because ‘‘[e]ven if Dr. Reppy’s * * * decision’’ to which Dr. Reppy was a and Eleventh Circuits, ‘‘the offensive conduct established a valid doctor- party.11 I therefore find that the APA use of collateral estoppel calls for the patient relationship under Florida law precludes me from considering the courts to use special care in examining (a dubious proposition at that), [he] individualized legal conclusions on the the circumstances to ascertain that the 12 violated the laws of other States which ultimate issues regarding Dr. Reppy defendant has in fact had a full and fair clearly require that the prescriber contained in United Prescription opportunity to litigate and that personally perform the physical exam Services as a potential basis for preclusion will not lead to unjust 13 except in limited situations not imposing a sanction in this case. See results.’’ 15 Johnson v. United States, 576 applicable here.’’ United Prescription id. § 556(e). F.2d 606, 614 (5th Cir. 1978). After Servs., 72 FR at 50,408 (internal I further find that the doctrine of res carefully examining the circumstances, I citations omitted). The Deputy judicata, or collateral estoppel, provides conclude that when the Agency issued Administrator also concluded that Dr. no basis for adopting without analysis the final order in United Prescription Reppy’s PA, Mr. Protheroe, ‘‘used Dr. the Deputy Administrator’s findings in Services, Dr. Reppy had not been United Prescription Services that Dr. Reppy’s DEA registration while Reppy afforded a full and fair opportunity to Reppy violated state law. Under the was on leave of absence and not litigate whether he violated the laws of doctrine of res judicata, (1) a final supervising him * * *. These California, Tennessee, Indiana, judgment (2) on the merits (3) between prescriptions violated the State of Louisiana and Florida. Res judicata is the parties is binding on the parties in Florida’s regulations’’ regarding Dr. therefore inapplicable. See East Main Reppy’s delegation of authority to a Street Pharmacy, 75 FR 66,149, 66,154 PA.10 Id. at 50,409. 11 Although the Government offered the United Prescription Services decision as an exhibit in its In the ‘‘proposed conclusions of law’’ January 19, 2010 supplemental prehearing 14 Accord, e.g., Ritch v. State, 14 So.3d 1104, 1107 section of the Government’s post- statement (Gov’t Supp. PHS at 5), it withdrew the n.5 (Fla. App. 1 Dist. 2009) (‘‘Collateral estoppel hearing brief in the present case, the exhibit at hearing (see Tr. 6–7). bars relitigation of an issue only when (1) an Government cites a number of such 12 As used herein, ‘‘ultimate issues,’’ also called identical issue was presented in the prior ‘‘mixed questions of law and fact’’ and ‘‘deep proceeding; (2) the issue was a critical and conclusions by the Deputy issues,’’ are distinguishable from precedential necessary part of the prior determination; (3) there holdings of general applicability. was a full and fair opportunity to litigate that issue; 10 Specifically, United Prescription Services cites 13 I do not suggest that United Prescription (4) the parties in the two proceedings are identical; Fla. Admin. Code Ann. r. 64B8–30.008(2). See 72 Services is without binding effect as Agency and (5) the issue was actually litigated.’’). FR at 50,409. As discussed below, that rule is precedent with respect to its holdings of general 15 In Bonner v. City of Prichard, 661 F.2d 1206, inapplicable to Dr. Reppy because he is an applicability. See, e.g., supra Section VI(C)(c) 1209 (11th Cir. 1981) (en banc), the United States osteopathic physician; the applicable rule (which is (citing United Prescription Services for the Court of Appeals for the Eleventh Circuit adopted textually identical) is r. 64B15–6.0038. Infra text proposition that state law controls the question of as binding precedent all decisions of the former following note 63. whether a doctor-patient relationship exists). Fifth Circuit handed down prior to October 1, 1981.

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n.24 (DEA 2010) (‘‘While I previously that recounted witness’s former and Janice Viscio and his patients found [in a prior decision that a patient] testimony before state medical board). ‘‘[C.K.]’’ 20 and ‘‘[D.C.],’’ who did not had died of multiple drug intoxication Here, the transcript of Respondent’s testify in person. (Tr. 166.) In addition, and had both oxycodone and previous testimony in United Respondent testified at hearing that, alprazolam in her system, Respondent Prescription Services is reliable pursuant to his prior testimony in was not a party to that proceeding. The insomuch as it contains Respondent’s United Prescription Services, he Government was thus required to prove sworn testimony at a formal provided an affidavit beneficial to the this fact anew * * *.’’ (internal administrative hearing (see Tr.127 Government, which he signed. (Tr. 78.) citations omitted)). (referring to what Respondent said Respondent further testified that For the foregoing reasons, I find that ‘‘under oath’’)) and Respondent testified Respondent’s Exhibit 12 is an unsigned the Deputy Administrator’s finding in a at the present proceeding that his former copy of that affidavit. (Tr. 78.) By prior case to which Dr. Reppy was not testimony was accurate, true and 18 stipulation of the parties, I admitted a party that ‘‘Dr. Reppy violated the correct. (Tr. 80.) Moreover, Respondent’s affidavit. (Tr. 7–9; see Respondent gave the prior testimony in laws of California, Tennessee, Indiana, Resp’t Ex. 12.) Louisiana’’ and Florida, 72 FR at 2007, closer in time to the events at An issue is what weight, if any, to 50,408–09 (internal citations omitted), issue in the present case, presenting an does not constitute substantial evidence increased chance that his memory give these affidavits. in the above-captioned proceeding, and accurately reflected the events.19 The Because the patient and employee I give that finding no weight in this transcript of Respondent’s prior affidavits address Respondent’s Recommended Decision.16 testimony is probative and material to professional conduct since the conduct the extent it addresses matters at issue alleged in the OSC, they are relevant to B. Respondent’s Prior Testimony in the present proceeding, to include the issue of whether Respondent is In its January 19, 2010 supplemental without limitation the state(s) in which currently in compliance with state and prehearing statement (Gov’t Supp. PHS Respondent held a medical license from federal standards for the prescribing and at 5), the Government noticed its 2004 to 2006 (Gov’t Ex. 10 at 69); the practice of controlled substances. intention to offer into evidence a relationship between witnesses and Moreover, the contents of Respondent’s transcript of Dr. Reppy’s testimony in between the clinic and pharmacy at affidavit also bear on matters directly which Respondent allegedly worked United Prescription Services, Inc., 72 FR relevant to this case, to include his and had prescriptions filled, 50,397 (DEA 2007). Dr. Reppy was not employment and the extent of his respectively (Gov’t Ex. 10 at 10, 42, 55, a named party in that proceeding, had supervision of his PA, John Protheroe, 65, 74–77, 82, 89); the evolving not yet had any adverse action taken among other topics. Finally, the against him by the DEA with respect to ownership and name of the clinic at which Respondent allegedly worked Government stipulates and does not his COR (see Gov’t Ex. 10 at 61) and at object to the admission of any of the the time was apparently unrepresented (Gov’t Ex. 10 at 6, 9, 46); the extent of Respondent’s supervision of a PA (Gov’t affidavits. I therefore find it proper to by counsel. In the present case, on give weight to relevant portions of consent of the parties,17 I admitted the Ex. 10 at 84–85, 95–97, 101, 106); the practices of Respondent with respect to affidavits of Respondent and transcript of Dr. Reppy’s former Respondent’s employees and patients. testimony. (Tr. 126–27.) A preliminary patient evaluation and treatment (Gov’t Ex. 10 at 12, 25–26, 30, 73–74, 77, 78– See 5 U.S.C. 556(d); 21 CFR 1316.59(a) issue in this Recommended Decision is (2010). what weight, if any, to give to that 80, 93–94); and other topics. Finally, testimony. although the transcript of Respondent’s III. Substantive Issue prior testimony covers many of the The APA provides that final topics he addressed in his testimony at Whether a preponderance of the determinations in Agency hearing, I find that it is not unduly evidence establishes that, pursuant to 21 administrative proceedings must be repetitious and that any repetition is based upon ‘‘reliable, probative and U.S.C. 824(a)(4), Respondent’s DEA offset by its probative value. substantial evidence.’’ 5 U.S.C. 556(d). COR BR5287342 should be revoked and For the foregoing reasons, I find it any pending applications for renewal or In addition, I may consider ‘‘evidence proper to give weight to relevant that is competent, relevant, material and modification denied, because portions of the transcript of Respondent’s continued registration not unduly repetitious.’’ 21 CFR Respondent’s prior testimony in 1316.59(a) (2010). Where prior would be inconsistent with the public University Prescription Services. (See interest as that term is used in 21 U.S.C. testimony from a previous proceeding is Gov’t Ex. 10.) reliable, probative, material and not 823(f). unduly repetitious, Agency precedent C. Affidavits of Respondent’s IV. Evidence and Incorporated Findings supports the admission of such Employees, Respondent’s Patients and of Fact testimony. See United Prescription Respondent Servs., Inc., 72 FR 50,397, 50,403 (DEA The parties stipulated at hearing to I find, by a preponderance of the 2007) (crediting documentary evidence the admission of affidavits of evidence, the following facts: containing substance of witness’s prior Respondent’s employees Adele Durina A. The Clinic and the Pharmacy testimony ‘‘[i]n another proceeding’’); see also Nestor A. Garcia, M.D., 61 FR 18 I draw a distinction between reliability, on the Significant testimony at hearing 30,099, 30,100 (DEA 1996) (giving one hand, and accuracy, on the other. Although I related to Respondent’s connection with weight to witness’s testimony at hearing find that Respondent’s prior testimony in United Prescription Services is reliable, only a balancing of two entities: University Physicians the transcript against other evidence in this case Resources (UPR), a medical clinic, and 16 Compare supra note 13. can shed light on whether it is accurate. United Prescription Services (UPS), a 17 Counsel for Respondent asked Respondent a 19 As noted throughout this Recommended pharmacy. (See, e.g., Tr. 23.) series of questions regarding whether his former Decision, I also find that statements contained in testimony included various topics and was the transcript of Respondent’s prior testimony are accurate; Respondent answered in the affirmative. generally consistent with Respondent’s testimony at 20 To protect the privacy of Respondent’s (Tr. 78–80.) hearing. patients, only initials are used.

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B. The Witnesses and Affiants 21 (see Tr. 67–68) (Ms. Messick), was licenses to ship pain relievers to Respondent Robert Raymond Reppy, employed by UPS from 2001 to 2005. anywhere in the country by working 27 D.O., is licensed as an osteopathic (Tr. 129, 132.) She testified that she was with a number of physicians. (Tr. 143; physician in the State of Florida in a position to observe Respondent’s see also Resp’t Ex. 5 ¶ 4.) pursuant to license number OS7246. work. (Tr. 129.) Ms. Messick is not a Before joining UPR, Respondent (Tr. 20; Gov’t Ex. 15 at 1.) His licensure medical practitioner and lacks legal or worked at Home Harbor Urgent Care status is Obligation/Active.22 (ALJ Ex. 3 medical training. (Tr. 135.) In a prior Center. (Tr. 61.) After leaving UPR, at 1.) Although Respondent was proceeding, Respondent testified that a Respondent worked at a clinic called previously licensed to practice medicine ‘‘Ms. Messich’’ presently owns UPR. Gulf Shore from 2007–2009; between in Georgia, California and Hawaii, since (Gov’t Ex. 10 at 10; see also id. at 76– 2009 and the present, he has worked at 2000 he has only been licensed in 77.) Cosmopolitan Clinic in Brooksville, Respondent’s affiant Janice Vischio presumably in Florida. (Tr. 56, 68, 107; Florida. (Tr. 20–21; Gov’t Ex. 10 at 69.) 25 Respondent is registered with the DEA (Ms. Vischio) has been a LPN for Resp’t Ex. 17.) Gulf Shore was a pain as a practitioner in Schedules II through twenty years, of which she has spent management practice run by an V pursuant to DEA COR BR5287342. fifteen years in Florida. Her license is in anesthesiologist. (Tr. 57.) Cosmopolitan (ALJ Ex. 3 at 1.) Respondent’s COR was good standing with the Florida is a combination family practice and scheduled to expire by its terms on Department of Health. As of July 15, pain management clinic. (Tr. 57.) April 30, 2009. On April 6, 2009, DEA 2010, she had worked with Respondent In his testimony in a prior proceeding, received Respondent’s application for for at least eighteen months. (See Resp’t Respondent testified that UPR changed renewal.23 (ALJ Ex. 3 at 1.) Ex. 19 at 2.) Ms. Vischio handles its name to MediHealth, which evolved Respondent’s witness Robert Arthur administrative work for Respondent and into a general family practice. (Gov’t Ex. Carr, Esq. (Mr. Carr) is an attorney who does not see patients. (Id. at ¶ 3.) 10 at 6, 9; see generally Tr. 107–08.) has worked in the area of medical Respondent’s affiant Adele Durina This testimony is consistent with malpractice for twenty years. (Tr. 143.) (Ms. Durina) has over twenty years of Respondent’s testimony in the present He is not a physician and has no medical office experience and presently case that from 2007 to 2009 Respondent medical training. (Tr. 156–57; see also works as Respondent’s Office Manager worked part-time at MediHealth, a Tr. 61.) Mr. Carr testified that he knew and Medical Assistant. (Resp’t Ex. 19 at clinic owned by Ms. Messick. (Tr. 67– Respondent when he worked at UPS. 6 ¶ 2.) As of as late as July 15, 2010, Ms. 68.) (Tr. 142.) Mr. Carr stated that he had no Durina had worked with Respondent ownership interest in UPR, but at one since he began working at Cosmopolitan (a) The Connection between UPR and point he did have a financial interest in Clinic. (Id. at ¶ 3; see also Tr. 167.) UPS As of July 15, 2010, [C.K.] has been a UPS.24 (Tr. 151–52; see Resp’t Ex. 5.) Respondent testified that UPS is a patient of Respondent since Respondent Every prescription filled by UPS pharmacy. (Tr. 23.) UPR, by contrast, is began practicing in the local area and represented revenue for Mr. Carr. (Tr. a medical clinic. (Tr. 23.) The two [D.C.] had been a patient of Respondent 152.) organizations had close connections. for approximately thirteen to fourteen Respondent’s witness Melissa For instance, Respondent learned in Messick, also known as Missy Messick months for the treatment of degenerative spondylosis. (Resp’t Ex. 19 at 12 ¶ 2; id. 2006 that UPS owned UPR and that a Sam Bollinger 28 (Mr. Bollinger) was the 21 In its prehearing statement and supplements at 9 ¶¶ 1–2.) 29 thereto, the Government identified Diversion owner of both UPR and UPS. (Tr. 22– Investigator Peter W. Flagg, Special Agent Daniel A. C. Respondent, the Clinic and the 23.) Respondent stated, however, that Forde, Diversion Investigator Deborah Y. Butcher, Pharmacy Mr. Bollinger ‘‘had always represented and Respondent as witnesses. At hearing, however, Although he did not remember the to me that no financial link was the Government rested upon the testimony of 30 Respondent alone, along with the exhibits it precise dates, Respondent testified that there.’’ (Tr. 23.) In addition, Mr. Carr introduced into evidence. Moreover, Respondent’s he was employed at UPR, a medical testified that he formed UPS in 2001 (Tr. counsel did not conduct a separate direct 143; see Tr. 61; see also Resp’t Ex. 5) examination of Respondent during Respondent’s clinic, for four years beginning in 2002 case-in-chief. Instead, I permitted counsel to until approximately 2006. (Tr. 21–23, and that UPS worked in the mail-order expand the scope of cross examination. 51.) Respondent’s salary at UPR was the pharmacy realm and acquired licenses 22 Respondent’s Curriculum Vitae (CV) facially same as his salary at his previous to ship pain relievers to anywhere in the contradicts this stipulation, stating that employer; he was paid by the hour or Respondent’s Florida medical license expired on 27 March 31, 2008. The CV, however, appears to be the day rather than by the number of The contradiction is perhaps explained by outdated, notwithstanding Respondent’s prescriptions he wrote.26 (Tr. 61, 79.) Respondent’s testimony in a prior proceeding that representation in his post-hearing brief that it is another physician worked at UPR before When Respondent was first Respondent began working there. (See Gov’t Ex. 10 ‘‘accurate’’ (Resp’t Br. at 2) and his argument that approached about working at UPR, he I accept evidence that is uncontroverted (Resp’t Br. at 65.) Moreover, the record contains no evidence at 26–27). For instance, the CV indicates that understood that customers would that UPR was the sole clinic with which UPS Respondent is presently employed at UPR (Resp’t interact with UPR via the Internet. (Tr. worked. Ex. 10 at 4), despite the otherwise uncontroverted 59–60.) Respondent testified that he was 28 The transcript of hearing in the above- testimony at hearing that Respondent stopped captioned case spells the name ‘‘Bollinger,’’ (e.g., working at UPR in 2006. (Tr. 21–23, 51.) In light the only physician who worked at UPR. Tr. 23) and that is the convention adopted here. But of this and other evidence concerning the status of (Tr. 23.) This statement is somewhat see Gov’t Ex. 10 at 9 (‘‘Ballinger’’); Resp’t Ex. 12 Respondent’s state medical license, I find that the inconsistent with testimony by Mr. Carr (same); Resp’t Ex. 5 (same). weight of the evidence contradicts any inference that the company worked in the mail- 29 Mr. Bollinger is not a medical professional. (Tr. that Respondent lacks state authority to handle order pharmacy realm and acquired 24.) controlled substances in Florida. 30 In his testimony in a prior proceeding, 23 Pursuant to 5 U.S.C. 558(c), Respondent’s COR however, Respondent testified that Mr. Bollinger continues in effect until DEA takes final action on 25 Although the record in this case is silent, required Respondent to send his patients’ the renewal application. (See, e.g., ALJ Ex. 3.) various provisions of federal law define the term prescriptions to UPS, that the vast majority of his 24 In his testimony at a prior proceeding, ‘‘LPN’’ as ‘‘licensed practical nurse.’’ See, e.g., 32 prescriptions from 2005 and 2006 were filled at Respondent testified that a Mr. Jerome Carr and a CFR 199.2; 42 CFR 482.51(a)(2). UPS, that most of the clerks and staff at UPR had Mr. Rob Carr were listed as president of UPS in 26 Respondent also testified that he did not have at one time worked at UPS and that Mr. Bollinger 2003. (Gov’t Ex. 10 at 76, 89.) The inconsistency any ownership affiliation with UPS. (Gov’t Ex. 10 ‘‘pretty much ran the show.’’ (Gov’t Ex. 10 at 42, was never explained. at 46.) 55, 74–76, 82.)

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country by ‘‘working with a number of the ‘‘Community Pharmacy’’ UPS and are issued in the usual course of physicians.’’ 31 (Tr. 143.) solicits Ms. Good’s ‘‘views on whether professional practice, and In addition, Respondent testified that any requirements or changes are [p]rescriptions are issued for a the UPS pharmacy filled the vast warranted in our policy.’’ (Resp’t Ex. 3; legitimate medical purpose.’’ (Resp’t Ex. majority of the prescriptions Tr. 90.) Although the letter recites that 4 at 1.) Respondent wrote while at UPR. (Tr. a copy of UPS’s policies is attached Although Respondent now concedes 61.) Respondent testified that although (Resp’t Ex. 3), no policy pages are that Mr. Carr’s assurances that he thought he was working for the clinic attached to the record copy (see Resp’t Respondent was complying with the UPR, he inadvertently was working for Ex. 3) and Respondent testified that he law were inaccurate (Tr. 110–11), he UPS. (Tr. 94.) He then contradicted never saw the policy pages.32 (Tr. 96.) devoted significant testimony to himself, stating that he wasn’t working Mr. Carr confirmed that he contacted defending his reliance on Mr. Carr’s for UPS. (Tr. 94.) Mr. Carr stated that the DEA on January 28, 2002, to inquire advice. (See Tr. 64, 67, 98, 100–01.) Respondent was not employed by UPS. whether the policies of UPS were in Mr. Carr also testified as to the legal (Tr. 151–52.) He denied supervising conformity with the law. (Tr. 144–45.) status of Internet prescribing practices Respondent, and further denied having Slightly less than one month later, Mr. as well as his own role in establishing any say over Respondent’s medical Carr received a response. (Tr. 146.) A UPS. Mr. Carr stated that he researched practice. (Tr. 152.) Ms. Messick testified February 27, 2002 letter by Ms. Good, the law regarding telemedicine and that she was employed simultaneously addressed to ‘‘Mr. Robert Carr/ related prescribing practices, surveying by UPS and UPR from 2001 to 2005. (Tr. President/United Prescription Services, the laws of all fifty states addressing the 129, 132, 133.) She described it as a Incorporated’’ opined that ‘‘the regulation of pharmacies, general ‘‘back and forth,’’ and she observed submitted policies and procedures meet medicine and pain medication. (Tr. what went on at UPS and UPR. (Tr. the federal requirements regarding 144.) He said he searched for anything 133.) She confirmed that she observed controlled substance prescriptions.’’ 33 in the telemedicine realm, compiling a Respondent’s work at UPR, and stated (Resp’t Ex. 4 at 1; see Tr. 91.) Mr. Carr file ‘‘well over a foot high of documents that Respondent didn’t work at UPS. testified that the DEA advised him that that I reviewed extensively from various (Tr. 133.) She had seen Respondent in ‘‘there was no further things [sic] we states, various regulatory authorities.’’ the pharmacy at UPS only once. (Tr. had to be concerned with our (Tr. 150.) He stated that in 2001 the 134.) She testified that she was in a physicians that were practicing statutes and regulations were very position to observe Respondent’s work, telemedicine.’’ (Tr. 146.) Respondent minimal on telemedicine. Mr. Carr and that Respondent followed and Mr. Carr agreed that Mr. Carr testified that the only reference was a guidelines set by Mr. Carr. (Tr. 129.) advised Respondent that by following statute from an unidentified jurisdiction addressing neural radiology in Mr. Carr’s guidance, Respondent would (b) Respondent’s and Mr. Carr’s telemedicine. (Tr. 144.) be in compliance with state and federal Telemedicine Research Mr. Carr stated that ‘‘California is one law. (Compare Tr. 91, with Tr. 147.) of the states that we were prescribing to, Respondent stated that when he began Respondent testified that Mr. Carr prescribing controlled substances to or shipping drugs to.’’ (Tr. 158.) He showed him Ms. Good’s February 27, could not, however, identify the individuals who contacted him at UPR 2002 letter (Tr. 91) and that Respondent primarily via the Internet, telemedicine effective date of the California law believed the letter gave Respondent requiring that a physician hold a was a new practice; ‘‘the legal permission to prescribe to patients in community was struggling in a gray area California medical license before multiple jurisdictions who contacted prescribing to people in California over to determine what those [legal him via an Internet web site but did not standards] would be * * *.’’ (Tr. 64.) the Internet. (Tr. 150, 157.) He moreover necessarily meet with him face to face. could not confirm whether he Consequently, Respondent viewed his (See Tr. 59–60, 110.) Respondent work at UPR as an experiment involving specifically researched California’s law, conceded, however, that Mr. Carr’s stating only that ‘‘yes, there would have new ways to use the Internet. (Tr. 31.) letter asks about the dispensing He had some concerns about the been a review of all California licenses practices of the pharmacy, not the * * * in 2002 * * * .’’ (Tr. 158.) legitimacy of the practice, ‘‘[s]o I did my prescribing practices of physicians. (Tr. due diligence.’’ (Tr. 60). He ‘‘did a little Mr. Carr also testified regarding the 97.) Respondent further conceded that Model Guidelines for the Appropriate research on my own,’’ consulted with he lacked specific knowledge of what the attorney Mr. Carr and relied on ‘‘a Use of the Internet in Medical Practice policies Ms. Good approved for the (Model Guidelines).34 He did not recall letter shown me from the DEA giving pharmacy. (Tr. 96.) And in any event, permission to do it.’’ (Tr. 60; see also Tr. seeing that document in particular the record reflects that Ms. Good’s during the course of his research of 89–92.) general expression of approval of the The letter to which Respondent telemedicine. He stated, however, that if pharmacy came with a number of it was published in 2002, he would have referred was preceded by a letter dated caveats: ‘‘Management personnel will January 28, 2002, and signed by ‘‘Robert reviewed it extensively. (Tr. 149–50.) He verify several elements including * * * also stated that he was generally Carr/President/United Prescription professional licensure[,] DEA Services, Inc.’’ (Resp’t Ex. 3.) Addressed familiar with the document. (Tr. 155.) registration[, l]egitimate patient/ Page nine of the Model Guidelines to Patricia M. Good, Chief, Liaison and prescriber relationship[, p]rescriptions Policy Section, Office of Diversion contains the following provision: ‘‘Physicians who treat or prescribe Control, DEA, Mr. Carr’s letter describes 32 Mr. Carr’s description of the policies that he through Internet Web sites are sent to DEA for review (see Tr. 145–46, 158–59) 31 In light of Respondent’s testimony that he was accordingly have little bearing, if any, on the practicing medicine and must possess the only physician employed by UPR between 2002 question of what Respondent believed at the time appropriate licensure in all jurisdictions and 2006 (Tr. 21–23, 51), Mr. Carr’s statement that he read the letter. where patients reside.’’ (Resp’t Ex. 9 at UPS worked with ‘‘a number of physicians’’ (Tr. 33 Mr. Carr testified that he no longer has a copy 9; See Tr. 156.) Mr. Carr testified that he 143) may be explained by Respondent’s testimony of the policy documents he submitted to the DEA that a Dr. Long and a Dr. Ibanez previously worked with his June 28, 2002 letter, explaining that he left did not previously see that sentence. at UPR (See, e.g., Gov’t Ex. 10 at 80–81). See note them with UPS when he sold the company. (Tr. 27, supra. 158.) 34 See Resp’t Ex. 9.

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(Tr. 156.) ‘‘I would not have advised practices as operating in the state of Protheroe had written the prescriptions [Respondent] of that’’ because ‘‘there Florida. (Tr. 160–61.) in question. (Tr. 41.) Respondent wasn’t to my knowledge any specific testified that the number of D. Respondent’s Physician’s Assistant requirement in Florida as to determine prescriptions that Mr. Protheroe wrote (PA) the nexus of where physician/patient without Respondent’s authorization was relationship was in fact occurring and Significant testimony at hearing at least 14,000. (Tr. 80; see generally Tr. where the medical practice was concerned actions allegedly taken by 132; Gov’t Ex. 10 at 84–85.) Respondent occurring.’’ (Tr. 156.) John Protheroe (Mr. Protheroe), a PA, did, however, acknowledge occasions in Mr. Carr further testified that he relied and the extent, if any, of Respondent’s which Respondent approved on statements, such as the one supervision of Mr. Protheroe. prescriptions written by Mr. Protheroe. appearing in the Model Guidelines, that Mr. Protheroe began working for UPR (Tr. 38.) Respondent estimated the ‘‘the [physician-patient] relationship is a few months after Respondent started quantity as ‘‘only a few a day.’’ (Tr. 42.) clearly established when the physician working there in 2002. (Tr. 37, 38, 120.) The vast majority of Mr. Protheroe’s agrees to undertake diagnosis and Respondent did not hire him, but he prescriptions, however, Respondent was treatment of the patient * * * whether worked under Respondent’s license. (Tr. unaware of. (Tr. 38.) or not there has been a personal 37, 131.) Respondent testified that ‘‘[Mr. Respondent testified that Mr. encounter between the physician * * * Protheroe] was hired because * * * I Protheroe wrote the majority of the and patient.’’ (Tr. 163; Resp’t Ex. 9 at 7.) was not making Mr. Bollinger happy objectionable prescriptions while He did not recall, however, seeing that with the amount of restrictions that I Respondent was away from the office statement in particular during the was placing on the patients and thus from November 2004 to March 2005 course of his research of telemedicine. slowing everything down * * * he after his wife was diagnosed with a He could confirm only that hired Mr. Protheroe to go behind my serious health issue. (Tr. 121–22, 132; ‘‘[s]omething like this was something I’d back and speed things up. He never Gov’t Ex. 10 at 85, 96, 101.) Mr. probably even send down to the doctors discussed with me ‘do you need one?’ ’’ Protheroe’s misconduct continued the to give them * * * assurances.’’ (Tr. (Tr. 120.) entire time Mr. Protheroe worked there, 163.) Mr. Protheroe was not often present until Mr. Protheroe left in 2005, shortly Ms. Messick’s testimony in this regard while Respondent was in the office, and after Respondent returned from medical was consistent, if equally vague: Ms. frequently worked from home. (Tr. 37, leave. (Tr. 138.) It was only after Messick explained that Mr. Carr had 38, 41; Gov’t Ex. 10 at 85 (‘‘He was returning that Respondent complained provided statutes and regulations on purportedly * * * supposed to work about Mr. Protheroe to Ms. Messick, practicing telemedicine and the under my license, submit himself to my who recalled Respondent’s complaint physician-patient relationship to review * * * And yet he was allowed that Mr. Protheroe wrote prescriptions physicians at UPR.35 (Tr. 134–35.) Ms. to review patients’ charts from his own without accurately reading the Messick testified that the guidance Mr. home, away from the office where no diagnoses or medical records. (Tr. 131, Carr provided to Respondent was legal, one could see him.’’).) Mr. Protheroe 138–39.) not medical, and dealt with Respondent approached Mr. Bollinger was a PA only to Respondent, and not telemedicine and how to maintain a several times and requested that Mr. to any other doctor. (Tr. 120.) physician-patient relationship. (Tr. 135.) Protheroe be fired. (Tr. 37; see also Tr. Respondent testified to having an Ms. Messick elaborated that this 131; Gov’t Ex. 10 at 106.) Respondent antagonistic relationship with Mr. question was a controversial subject of said he did not need Mr. Protheroe, and Protheroe (Tr. 37) and developing a much discussion in the office.36 (Tr. that Mr. Protheroe ‘‘was put there by number of concerns before November 136.) someone else and I had no power to 2003. (Tr. 121.) Respondent accused Mr. Mr. Carr testified that he relied on a remove him because I did not pay his Protheroe of exploiting Respondent’s Federal Register Notice entitled salary. I could not tell him to leave.’’ license ‘‘behind my back without my ‘‘Dispensing and Purchasing Controlled (Tr. 37; see Tr. 122.) In July 2005, Mr. permission’’ (Tr. 37, 42), and failing to Substances Over the Internet.’’ (Tr. 153; Bollinger removed Mr. Protheroe from adhere to the criteria by which see generally Resp’t Ex. 8.) That UPR. (Resp’t Ex. 12 at 4.) document provides that ‘‘practitioners Respondent rejected patients (Tr. 122). Respondent testified that he was must be registered with DEA and Mr. Protheroe’s compensation was precluded from a full right to supervise licensed to prescribe controlled connected to the number of Mr. Protheroe, which he now regrets so substances by the state(s) in which they prescriptions Mr. Protheroe wrote, most much that ‘‘it’s so soured me on the operate.’’ (Tr. 154; see Resp’t Ex. 8 at 3.) of which were for controlled substances. experience that I’ve never hired any Yet, while UPS filled prescriptions (Tr. 79; Gov’t Ex. 10 at 96–97; Resp’t Ex. physician’s assistants since and I don’t written by Respondent and shipped 12 at 2.) Ms. Messick testified that Mr. think I ever will.’’ (Tr. 108–09.) But them all over the United States, Protheroe was compensated at a rate of Respondent’s testimony that he lacked Respondent was not licensed to practice fifteen dollars per prescription. (Tr. the full authority to supervise Mr. medicine in any state other than 132.) According to Respondent, Mr. Protheroe, including the right to fire Florida. (Tr. 154.) Many of Respondent’s Protheroe ‘‘wrote so many prescriptions him if necessary, is substantially patients did not come to Florida, but without my authorization using a stamp undercut both by the relationship (Mr. interacted with Respondent of my signature’’ that Respondent was Protheroe was the physician’s assistant electronically. (See Tr. 25, 154.) Mr. uncertain whether Respondent had and Respondent was the physician), as Carr explained that he interpreted completed the conduct charged in an well as by Respondent’s affidavit, Respondent’s Internet prescribing administrative complaint by the Florida affirming that Respondent was medical 37 Department of Health, or whether Mr. director of UPR and its sole corporate 35 He did not provide them to Ms. Messick, officer beginning in 2004. (See Resp’t however. (Tr. 135.) 37 As detailed below, the Florida Department of 36 For instance, Ms. Messick cited the question of Health accused Respondent of prescribing Ex. 12 at 2.) whether ‘‘the patient actually had to be seen by the controlled substances to a patient without: physician or the physician’s office [or] another conducting a face-to-face meeting, performing an medical history, documenting a treatment plan or physician.’’ (Tr. 137.) adequate physical exam, taking an adequate making referrals, inter alia. (Gov’t Ex. 14 at 4.)

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Negligibly mitigating this necessary.’’ (See Tr. 25.) Approximately Respondent rarely contacted a patient’s contradiction is a statement by ninety percent of the consultations primary care physician whose records Respondent that he did not realize he occurred exclusively by telephone, he was reviewing. (Tr. 32, 34–35, 80; was UPR’s sole corporate officer until without an in-person meeting. (See Tr. Gov’t Ex. 10 at 30, 78.) 2006, even though as early as 2004, he 26; see also Gov’t Ex. 10 at 77 (ten Although he sometimes would do so, understood he was medical director: percent or ‘‘[m]aybe less than five Respondent did not always find it In 2004, Mr. Bollinger asked me to sign percent’’).) In approximately 2005, appropriate to tell customers that online some corporate documents for [UPR]. I Respondent began encouraging more communication cannot take the place of understood that these documents would list patients to come to the clinic in Florida. face-to-face communication. (Tr. 102– me as the medical director of [UPR]. I learned (See, e.g., Gov’t Ex. 10 at 93–94.) 03.) in late 2006, that Mr. Bollinger made me the Before phone consultations took sole corporate officer and removed himself as place, patient records ‘‘were compiled (b) Extent of Respondent’s Verification a corporate officer of [UPR] by having me by the customer and sent to me.’’ 39 (Tr. of Patient Identities at UPR sign these documents. When Mr. Bollinger 34.) Other doctors did not send patient did this, Mr. Bollinger listed my address as Respondent had no face-to-face 2304 East Fletcher Avenue, Tampa, Florida. records to Respondent; patients sent interactions with as many as ninety 40 That is not the address of [UPR], nor is it the them. (Tr. 34, 79–80.) Respondent percent of his patients. (Tr. 26, 55.) address at which I worked. The address Mr. testified that ‘‘Patients did not make When ascertaining a patient’s identity Bollinger listed for me on the corporate them up on their own.’’ (Tr. 34.) before issuing a controlled substance filings is the address for [UPS]. Respondent’s staff at UPR would prescription, therefore, Respondent (Resp’t Ex. 12 at 2.) initially ‘‘screen’’ patients and compile relied on representations made by the After carefully evaluating charts containing patients’ contact radiologist who read the patient’s CAT Respondent’s testimony, other record information, diagnoses and medical scan or MRI, or the office notes of the evidence and Respondent’s demeanor documentation verifying their physician who first saw the patient. (Tr. while testifying, I find that conditions. (Tr. 24–25, 37.) The staff 54.) Respondent’s testimony regarding the would provide a chart ‘‘whenever I As for how he verified the identity of 41 scope of his authority over Mr. requested it.’’ (Tr. 70.) patients with whom he never physically Protheroe is not fully credible. For During the four years that Respondent interacted, Respondent testified that ‘‘I instance, to the extent that Respondent worked at UPR (Tr. 35–36, 51), other used the same method of checking their testified that he lacked the authority to doctors referred approximately 300 identity as I would if they were present supervise or fire Mr. Protheroe after patients to Respondent. (Tr. 35–36.) As in front of me.’’ (Tr. 54.) Yet Respondent for the rest of Respondent’s thousands 2004, this testimony stands in stark conceded that he never looked at the of patients (e.g., Tr. 43), the physicians contrast with Respondent’s own face of the vast majority of people to whose records Respondent relied on to evidence that Respondent understood whom he issued prescriptions. (Tr. 55.) justify prescribing controlled substances Respondent was medical director of He conceded that it was possible, were not affiliated with Respondent and UPR in 2004. Additionally, the evidence therefore, that a family member could did not provide any medical services, includes Respondent’s concession that take the medical records and testing or evaluation at Respondent’s he had an obligation to properly identification of a deceased person, and request. (Tr. 36.) supervise Mr. Protheroe (Tr. 101; see Respondent would have no way of Resp’t Ex. 9 at 5 (‘‘physicians should Respondent testified that to have a valid doctor-patient relationship, a knowing whether the person on the * * * [p]roperly supervise physician phone was actually the person whose extenders’’)), and his assertion that he servicing medical professional must have conducted a physical examination medical records and identification did, in fact supervise Mr. Protheroe Respondent was reviewing. (Tr. 55–56.) ‘‘when he was in the office * * *.’’ of the patient. (Gov’t Ex. 10 at 79–80 (‘‘Someone must have done [a physical Respondent explained that ‘‘I was (Gov’t Ex. 10 at 105.) For the foregoing rather good at detecting fraud’’ by reasons, I find that Respondent examination]).’’) For follow-up consultations, Respondent did not comparing font and language in possessed both the obligation and the different parts of patient medical authority to supervise Mr. Protheroe.38 require ‘‘a new physical exam with every consult. When it became, in my records. (Tr. 56.) Respondent added: ‘‘If E. Respondent’s Prescriptions to Internet opinion, too dated, then I would the state did not adequately check their Customers, 2004 Through October 2006 demand another physical exam.’’ (Gov’t identity before issuing them a driver’s license * * * I had no way of (a) Respondent’s Service to Internet Ex. 10 at 79.) But Respondent performed determining that.’’ (Tr. 54.) Customers at UPR, Generally physical examinations on only two percent of his patients in his first year Respondent testified as to how he (c) Extent of Respondent’s Patient of employment with UPR, a percentage handled prescription requests from Evaluation and Documentation Practices customers when he worked at UPR. which rose to no more than seven at UPR percent of patients in later years. (Tr. Respondent conducted a telephonic or When he worked at UPR, Respondent 25–26.) Moreover, in a given week, in-person consultation with every conducted physical examinations on person to whom he prescribed 39 See also Gov’t Ex. 10 at 73 (‘‘Usually it was the some of the individuals who contacted controlled substances. (Tr. 29.) patient’s job to gather the records and forward them him through Internet Web sites. (Tr. 25.) Respondent would interview most to me.’’). The percentage was very small. (Tr. 25.) patients over the phone and then 40 There is also evidence that an entity called ‘‘It went from about two percent in the determine whether to issue a FedexMeds.com was an occasional referral source beginning to six or seven percent prescription or order any ‘‘tests on of patients, which occasionally transmitted medical records to Respondent. (Gov’t Ex. 10 at 73–74; see towards the end.’’ (Tr. 26.) Respondent further verifications that were generally Resp’t Ex. 12 at 3.) did not conduct physical examinations 41 This testimony is consistent with Ms. Messick’s on more than ninety percent of his 38 A later section of this Recommended Decision testimony that she or her staff provided medical patients. (Tr. 26.) Nor did other addresses whether Respondent had any legal records to Respondent before he conducted obligation or authority in this regard, and if so, telephone interviews with Internet patients or physicians perform examinations of whether Respondent discharged it. prescribed medication to them. (Tr. 130.) those patients at Respondent’s

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direction.42 (Tr. 36.) Respondent The record also reflects allegations by 116.) Asked whether any patient elaborated that other physicians had the Florida Department of Health that suffered an overdose death, Respondent already performed examinations or tests Respondent failed to adequately discuss answered that ‘‘I know none of them did before the patient came into contact and document treatment options with while I was prescribing. If it happened with Respondent, explaining ‘‘That’s the patients (see, e.g., Gov’t Ex. 14 at 3–4), since that time, then it happened whole point.’’ (Tr. 36.) Respondent had although these allegations were resolved because someone else was prescribing no affiliation with the physicians whose by settlement agreement (Gov’t Exs. 15 it. I can’t be responsible for what some records he relied on. (Tr. 36.) He & 16). other doctor did.’’ (Tr. 117.) ‘‘I’m sure admitted to prescribing hydrocodone to At hearing, Respondent confessed that there would have been a lawsuit if there thousands of individuals without a face- his evaluation of patients and was one and I never received any.’’ (Tr. to-face examination. (Tr. 43; see Tr. 53.) documentation at UPR ‘‘is not 123.) He conceded, however, that he has Each day Respondent consulted with considered adequate,’’ and that ‘‘I have not stayed in touch with all of his UPR approximately thirty customers. (Tr. 26, a different standard now because I’ve Patients since leaving UPR. (Tr. 117.) 51.) He worked five days per week. (Tr. been educated about it.’’ (Tr. 45–46.) 35; 51–52.) On average, he issued ‘‘[T]he happy medium [in fighting (e) Location of Respondent’s Customers controlled substances prescriptions to controlled substance abuse] is to insist Respondent testified that most of the 150 patients per week. (Tr. 52.) on proper documentation—and try to individuals to whom Respondent Respondent worked at least forty weeks wean people off it when you can.’’ (Tr. prescribed controlled substances per year, usually more. (Tr. 52.) Thus, 66.) Reflecting on his current practice at became Respondent’s customers on approximately 5000 occasions per Cosmopolitan, Respondent stated that through Internet Web sites. (Tr. 25.) year or more, Respondent issued he has been lowering patient dosages Respondent testified that he issued controlled substance prescriptions to and ‘‘getting rid of the people who had prescriptions for controlled substances new or repeat customers. (Tr. 53.) abuse potential.’’ (Tr. 66.) ‘‘I think I’ve to people located all across the United Many patients came to him pre- done a good job where I am of * * * States. (Tr. 27, 39.) Although he did not diagnosed, and Respondent stated that cleaning up the practice.’’ (Tr. 66.) remember precisely how many different they had to prove what the diagnosis states, he said the list was ‘‘long.’’ (Tr. was. (Tr. 29.) Although Respondent (d) Respondent’s Internet Consulting 39; see Resp’t Ex. 12 at 3 (‘‘hundreds of testified that he contacted a patient’s and Prescribing Policies at UPR patients who lived outside of Florida’’).) primary physician whose medical Respondent testified to his belief that For instance, in response to questioning records he was reviewing ‘‘on occasion’’ his patients’ primary care physicians by counsel for the Government, (Tr. 80) and ‘‘whenever it was had undertaken personal encounters Respondent conceded issuing necessary’’ (Tr. 32), he also testified that with patients, and therefore patients prescriptions for controlled substances he only consulted one or two physicians ‘‘were not placing their whole care in to people in Tennessee, California, out of the 150 patients he serviced in a my hands.’’ (Tr. 110.) He further Illinois and North Carolina. (Tr. 38.) given week, (Tr. 34, 35; see generally testified that in 2002, the Federation of Respondent said that Kentucky and Gov’t Ex. 10 at 30, 78 (‘‘I generally did State Medical Boards stated that a face- Mississippi were ‘‘off limits,’’ but did not have to do that on a regular basis. to-face encounter was not necessary as not actually deny prescribing to That was less than once a day. It was long as the patient expected that the individuals in those states. (Tr. 28.) when I had specific questions.’’)). doctor would take over the treatment Respondent admitted that he was not Respondent testified that it is not a plan and review medical licensed to practice medicine in all fifty common practice to speak with the documentation. (Tr. 43–44.) states while he worked at UPR. (Tr. 28.) medical professional who prepares The Federation of State Medical He presently understands that he has an medical records such as MRIs and Boards, however, is ‘‘a collection of obligation to prescribe or dispense radiology reports. (Tr. 32.) licensing bodies from all the states.’’ (Tr. controlled substances in accordance Respondent stated that it would be 44.) Respondent testified that he did not with all applicable state laws, and that inappropriate and ‘‘not smart medicine’’ initially know whether it is itself a prescribing across state lines sometimes (Gov’t Ex. 10 at 26) to complete a first- licensing authority. (Tr. 45.) But he then includes the application of laws other time diagnosis over the phone, but not conceded that ‘‘I realize now that it was than the laws of the State of Florida. (Tr. necessarily a subsequent diagnosis.43 a mistake after people with more legal 63.) He concedes that, in hindsight, the (Tr. 29–30, 104.) Later, however, he expertise than I have told me’’ that prescriptions he issued at UPR to stated that ‘‘I have enough expertise to statements by the Federation of State Internet customers ‘‘did not meet the know whether someone has a Medical Boards do not carry ‘‘legal highest standard * * * and I’m sorry.’’ respiratory problem at the moment by weight.’’ 44 (Tr. 45; see also Tr. 164.) (Tr. 63–64.) In his post-hearing brief, how they’re talking to me over the Respondent disputed the suggestion Respondent states that he ‘‘now realizes phone.’’ (Tr. 115.) that he failed to adequately perform that the prescriptions he issued at [UPR] Respondent conceded that it would be patient evaluations at UPR, testifying to Internet patients were not issued in inappropriate to prescribe controlled that his interaction with patients was the usual course of professional practice substances to an individual who had not adequate according to his understanding * * * .’’ (Resp’t Br. at 17.) When asked been diagnosed with having a legitimate of what was required by the Federation whether he now knows that his Internet medical need for the drugs. (Tr. 30.) of State Medical Boards. (Tr. 43.) He prescribing at UPR was not consistent further stated that none of his patients with the law as it was at that time, 42 As Respondent explained, ‘‘the physical for whom he prescribed over the Respondent answered ‘‘Absolutely.’’ examination has to be done by someone else in the Internet came to any harm: ‘‘there were (Tr. 91–92.) Contradicting himself case of telemedicine. [Patients] have to have seen no mortalities, no morbidity.’’ 45 (Tr. a local doctor that actually saw them and performed somewhat, Respondent also stated that the physical examination, and gotten those notes to me, so that I know what was seen and have the 44 In any event, Respondent conceded that he any injuries or complaints by patients as a result of information available.’’ (Gov’t Ex. 10 at 25–26.) personally has not received a license from the Respondent’s prescribing practices. (Tr. 130.) She 43 See also Gov’t Ex. 10 at 12 (‘‘it’s certainly not Federation of State Medical Boards. (Tr. 45.) conceded, however, that she had not stayed in considered appropriate to make new diagnoses in 45 This testimony is consistent with testimony of touch with the thousands of Internet patients with a telemedicine format’’). Ms. Messick, who stated that she was not aware of whom Respondent consulted. (Tr. 137.)

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at the time he engaged in the prescribing Patients requested these drugs before to-face meeting with Respondent. (Gov’t practices that are the subject of the OSC, Respondent consulted with them. (Tr. Ex. 14 at 2, 3.) It further alleged that he wasn’t doing anything wrong (Tr. 64– 29.) Respondent explained that patients Respondent failed to perform an 65), explaining that ‘‘if I thought I was ‘‘were just reiterating what their own adequate evaluation of [D.P.], including doing anything wrong, I wouldn’t have physician had put them on.’’ (Tr. 70.) an adequate medical history and an done it.’’ (Tr. 65.) Respondent testified that on many adequate physical examination to justify Significant testimony addressed the occasions, he reduced the amount of prescribing controlled substances; that extent of Respondent’s reliance on and medications for some patients and Respondent failed to document understanding of the Model Guidelines. suggested alternate treatment methods. discussing the risks and benefits with Respondent admitted that before (Tr. 79–80.) [D.P.]; that Respondent failed to prepare accepting employment with UPR, he In Respondent’s professional medical and document an adequate treatment does not recall whether he read the opinion, the abuse of controlled plan or keep adequate medical records provision from ‘‘Section Five[:] substances is a significant problem. (Tr. of his treatment of [D.P.]; and that Guidelines for the Appropriate Use of 65.) Respondent testified that some Respondent failed to refer [D.P.] for the Internet in Medical Practice,’’ people misuse and abuse the kinds of additional consultations or diagnostic entitled ‘‘Compliance with State and controlled substances that Respondent testing. (Gov’t Ex. 14 at 4.) Federal Laws and Web Standards.’’ (Tr. prescribed at UPR, particularly Respondent could not confirm or 105.) In pertinent part, that provision hydrocodone, alprazolam, oxycodone deny whether he completed the conduct reads: ‘‘Physicians who treat or and methadone. (Tr. 65.) From time to alleged in the Complaint because ‘‘this prescribe through Internet Web sites are time Respondent encountered patients PA John Protheroe wrote so many practicing medicine and must possess who abused controlled substances and prescriptions without my authorization appropriate licensure in all jurisdictions immediately dismissed them. (Tr. 65.) ‘‘I using a stamp of my signature that it where patients reside.’’ (Resp’t Ex. 9 at ferreted it out where I could.’’ (Tr. 65.) may well have been done under—under 9.) Respondent admitted that he failed Respondent, however, could not state that process.’’ (Tr. 41.) Respondent to comply with that provision. (Tr. 105.) how many of his patients were addicted explained that when he received the Asked if he was regretful and to narcotics while he was prescribing to Complaint, he had no way of looking remorseful for the role he played at UPR them. (Tr. 118.) Respondent is familiar into the patient records to determine in prescribing controlled substances, with the rising rate of oxycodone whether it was Respondent or Mr. Respondent stated: ‘‘Yes, very much. I overdose deaths, calls it a big problem Protheroe who wrote the prescriptions sincerely wish I had never been duped and ‘‘I do best to make sure that doesn’t in question. (Tr. 41–42.) into being any part of their operation at happen.’’ (Tr. 59.) Respondent stated Respondent further testified that he all.’’ (Tr. 92.) Respondent testified that that when physicians prescribe did not know the identity of ‘‘[J.N.],’’ another patient. (Tr. 42.) The Complaint in the future, he would not prescribe for correctly, doctors who prescribe alleged that [J.N.] was Respondent’s patients in jurisdictions in which he controlled substances to drug abusers do patient, located in Idaho, to whom lacks a medical license. (Tr. 111.) Asked not themselves contribute to the Respondent allegedly prescribed by counsel whether he felt remorse for pharmaceutical abuse problem. (Tr. 66.) hydrocodone, without conducting a having done so, he said ‘‘Yes. Not only (g) The Florida Department of Health face-to-face meeting or physical am I remorseful about it, but I feel rather Administrative Complaint examination, discussing the risks and foolish and stupid for doing so in Respondent testified that Florida benefits of controlled substances, retrospect.’’ (Tr. 111.) He also instituted an administrative complaint preparing and documenting an adequate deemphasized his own responsibility, (Complaint) against him arising out of treatment plan, keeping adequate stating ‘‘I was just an hourly employee. his Internet prescribing practices at medical records of treatment, or I was just a pawn in the machine.’’ (Tr. UPR.47 (Tr. 40; Gov’t Ex. 14.) The referring [J.N.] for additional 119.) Complaint alleged, inter alia, that in consultations or diagnostic testing. (Tr. (f) Quantity of Prescriptions and Extent 2004 Respondent repeatedly prescribed 42; see Gov’t Ex. 14 at 4–6.) Respondent of Diversion Avoidance at UPR hydrocodone to patient [D.P.], a resident explained that when he received the of Wyoming who had never had a face- Complaint, he did not have access to the On approximately 5000 occasions per records of patient [J.N.]. (Tr. 73–74.) Nor year or more during his tenure at UPR, trade name Valium. Under the APA, an agency did Respondent have the opportunity to Respondent issued controlled substance ‘‘may take official notice of facts at any stage in a review the records of [S.J.], another prescriptions to new or repeat proceeding—even in the final decision.’’ U.S. Dept. patient listed in the Complaint, because customers. (Tr. 53; see also Tr. 25, 32, of Justice, Attorney General’s Manual on the Administrative Procedure Act 80 (1947) (Wm. W. Respondent lacked access to those 43.) Gaunt & Sons, Inc., Reprint 1979). In accordance records, as well. (Tr. 74.) Most or many of the individuals who with the APA and DEA’s regulations, Respondent In short, Respondent does not know contacted Respondent at UPR sought is ‘‘entitled on timely request, to an opportunity to show to the contrary.’’ 5 U.S.C. 556(e); 21 CFR whether he issued any of the and ultimately received a specific 1316.59(e) (2010); see, e.g., R & M Sales Co., 75 FR prescriptions alleged in the Complaint. controlled substance. (Tr. 28, 36.) The 78,734, 78,736 n.7 (DEA 2010). Respondent can (Tr. 42, 43.) Respondent conceded, most common request was for dispute the facts of which I take official notice by however, that even if he did not hydrocodone, a Schedule III narcotic. filing a properly supported motion for reconsideration within twenty days of service of personally issue the prescriptions, he (Tr. 28.) Respondent testified that some this Recommended Decision, which shall begin on did prescribe hydrocodone to thousands patients also sought alprazolam, which the date it is mailed. See, e.g., Joseph Gaudio, M.D., of individuals without conducting face- he identified as a Schedule IV 74 FR 10,083, 10,088 (DEA 2009) (granting respondent opportunity to dispute officially noticed to-face examinations. (Tr. 43.) benzodiazepine trading under the brand Respondent explained his belief that the 46 facts within fifteen days of service). name Xanax or Valium. (Tr. 29.) 47 Respondent stated that he never received patients for whom he was prescribing correspondence from licensing boards in other already had had a face-to-face meeting 46 Respondent’s testimony that alprazolam is sold states complaining of his practice. (Tr. 39.) He did, with their primary care physicians; under the trade name Valium is incorrect. I take however, become aware of some such complaints in official notice that alprazolam sells under the trade the context of a previous proceeding against UPS. Respondent believed he was merely name Xanax and that diazepam sells under the (Tr. 40.) renewing existent prescriptions,

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continuing the course of care and not income and was unable to pay the that he is required to dispense or initiating the first treatment plan. (Tr. $3000 and $5000 cost of the courses he prescribe controlled substances only for 109.) He conceded, however, that he agreed to take. (Tr. 51.) a legitimate medical purpose in the had treated some patients who had been Per the settlement agreement, usual course of his professional dropped by their providers, whether for Respondent agreed to pay his $12,500 practice. (Tr. 62.) lack of funds or another reason. (Tr. 113, fine within two years of December 26, At his current practice at 116.) ‘‘I was continuing the treatment 2007. (Gov’t Ex. 15; Tr. 49.) Respondent Cosmopolitan, Respondent’s most plan that was first set up by their doctor acknowledged that the settlement frequently prescribed controlled who might no longer have been willing agreement and final order provided that substances are methadone and to continue that plan * * * So the Respondent would cease professional oxycodone. (Tr. 57.) Respondent patient had nowhere else to go.’’ (Tr. practice if he did not comply with the prescribes methadone to treat chronic 113.) two-year deadline for paying the fine set pain conditions unlikely to improve The Complaint resulted in a therein. (Tr. 50; see Gov’t Ex. 15 at 4.) without surgery, and oxycodone for settlement agreement, dated October 2, Respondent testified that he has not yet conditions where a short-acting 2007, implemented through a final order paid the fine in full, but has practiced medication is more appropriate. (Tr. 58– dated December 26, 2007. (Tr. 46–48; medicine continuously since the 59.) Gov’t Exs. 15 & 16.) Respondent agreed December 26, 2007 final order was (b) Respondent’s Current Patients at to pay a fine of $12,500, complete issued, in part because he was unable to Cosmopolitan continuing medical education courses secure other employment, a problem he about prescribing controlled substances attributes partially to the DEA. (Tr. 49, [D.C.] has been a patient of (‘‘drug course’’), maintaining medical 51.) Respondent testified that ‘‘unless I Respondent for approximately thirteen records (‘‘records course’’) and laws and was ordered by the Department of to fourteen months for the treatment of rules (‘‘laws and rules course’’), perform Health I wasn’t going to’’ cease degenerative spondylosis. (Resp’t Ex. 19 100 hours of community service and practicing medicine, although he had at 9 ¶¶ 1–2.) During this time, prepare a paper suitable for publishing agreed to do so in the October 2, 2007 Respondent met with [D.C.] in the Journal of the American settlement agreement. (Tr. 50.) The approximately ten times. (Id. at ¶ 6.) Osteopathic Association. (Tr. 46; Gov’t Florida Department of Health ‘‘agreed to Respondent physically examined [D.C.] Ex. 15; see also Gov’t Ex. 16.) the schedule that I’m paying it back at most visits and inquired whether Respondent’s community service was on.’’ 48 (Tr. 49.) In mitigation, [D.C.] was experiencing any new pain. to be completed by December 30, 2009, Respondent stated that he reported to a (Id. at ¶ 7.) Respondent always took time but Respondent did not complete it compliance officer who was aware of with [D.C.] to discuss treatment options until February 9, 2010. (Resp’t Ex. 18 at Respondent’s continued practice. (Tr. and [D.C.] never felt like the visit was 2; see also Tr. 72.) For instance, a 70.) rushed. (Id. at ¶ 9 & 10.) February 2, 2010 letter from the Florida [D.C.] believed [D.C.]’s former pain Department of Health states that ‘‘Dr. F. Respondent’s Family Practice at doctor was overmedicating [D.C.]. Reppy has not completed any term Cosmopolitan Respondent happily agreed to reduce the dosage of pain medication that imposed by the final order and is (a) Generally considered out of compliance at this [D.C.]’s former pain doctor was time.’’ (Gov’t Exs. 20 & 22.) At hearing, In July or August of 2010, after prescribing. (Resp’t Ex. 19 at 9 ¶¶ 3–4.) Respondent testified that he had since leaving UPR, Respondent placed an ad Respondent gradually lowered the submitted the paper he was assigned. in the local newspaper advertising his dosage over a period of months, (Tr. 72.) The paper warns practitioners new family practice at his current ensuring that [D.C.] did not experience against the dangers of Internet employer, Cosmopolitan Clinic. (Tr. 88; any new pain. (Id. at ¶ 5.) In fact, the prescribing, gives case histories and Resp’t Ex. 17.) The ad resulted in reduction in [D.C.]’s pain has been reflects on what happened to Respondent acquiring new, non-pain dramatic. (Id. at ¶ 8.) Prior to treatment Respondent. (Tr. 93.) management patients. (Tr. 88.) by Respondent, [D.C.] was taking 30 mg Respondent’s drug course was to be Respondent has acted to change his oxycodone five times per day, 10 mg completed within one year of December practice from a pain management methadone six times per day; and 2 mg 26, 2007, the date of the final order. (Tr. practice to a family practice. (Tr. 88–89.) Xanax two times per day. (Id. at ¶ 11.) 48; Gov’t Ex. 15.) Respondent did not Respondent testified as to his Presently, however, [D.C.] considers complete the drug course until documentation practices at [D.C.]’s pain to be under control and is December 9 through December 11, 2009. Cosmopolitan. (See Tr. 80–87; Resp’t Ex. taking 5 mg methadone once a day and (Tr. 48.) He did not complete the 15.) In pertinent part, he testified to one teaspoon of liquid oxycodone once records course or the laws and rules using a Consent for Chronic Opioid a day. (Id. at ¶¶ 11 & 12.) The Xanax course until after September 2010. (Tr. Therapy, and later using a Controlled prescription is no longer needed. (Id. at 48.) As of the date of the hearing, Substances Narcotic Agreement. These ¶ 12.) however, Respondent had complied documents enable Respondent to Another patient of Respondent, [C.K.], with all of his continuing education summarily dismiss any patient who likes Respondent because he is a requirements. (Tr. 71; Resp’t Ex. 18 at seeks controlled substances from other ‘‘straight up’’ sort of person; [C.K.] feels 2.) physicians (Tr. 84), or who fails to very comfortable with him. (Resp’t Ex. Explaining his failure to meet all the notify the clinic in writing upon 19 at 12 ¶ 3.) Respondent treats [C.K.] deadlines set by the settlement switching pharmacies, (Tr. 86; Resp’t for back and neck pain stemming from agreement, Respondent asserted that in Ex. 15.) Respondent testified that as of an automobile accident, and also pain 2006 DEA placed on the Internet the date of the hearing, he understood from a ‘‘bad knee,’’ for which surgery information related to his reprimand. has been recommended. (Id. at ¶¶ 4, 5 (Tr. 50.) Thereafter, Respondent 48 Respondent’s Exhibit 18, dated October 20, & 6.) Respondent examines [C.K.] on 2010, indicates that Respondent made four periodic ‘‘became essentially unemployable’’ at payments in February, May, July and September each visit and discusses treatment any hospital or large clinic. (Tr. 50.) 2010, amounting to a total of $1500 paid out of options. (Id. at ¶ 7.) Respondent has Consequently, Respondent had no $12,500 owed. (See Resp’t Ex. 18 at 2.) worked with [C.K.] to reduce the

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amount of [C.K.]’s pain medication. (Id. When Respondent sees a new patient, Respondent’s failure to do so ‘‘indicates at ¶ 6.) he takes twenty to thirty minutes or Respondent is willing to permit the longer and is very thorough. (Resp’t Ex. misuse of his DEA registration in order (c) Respondent’s Current Employees at 19 at 6 ¶ 4.) He conducts a physical to maintain his employment,’’ rendering Cosmopolitan examination and records the findings in Respondent’s registration contrary to the Respondent’s administrative the patient’s chart. (Id. at ¶ 5.) Follow- public interest. (Id.) employee Janice Vischio also submitted up visits are usually fifteen minutes but Finally, the Government argues that an affidavit. Although Ms. Vischio is not can be more. (Id. at ¶ 6.) Patients Respondent’s testimony and demeanor generally present when Respondent commonly comment that Respondent at hearing evinced a lack of remorse and consults with patients, she does witness has taken an exceptional amount of time an attempt to blame others for his parts of some conversations. (Resp’t Ex. with them and answered questions and misconduct. ‘‘Had Respondent accepted 19. at 2 ¶ 4.) She states that Respondent provided information that patients were responsibility and demonstrated personally sees patients, takes or unable to get from other doctors. (Id. at remorse for his conduct, his claims that reviews patient history and reviews ¶ 7.) Respondent returns patient phone he reformed his prescribing practices patient office forms. (Id. at ¶¶ 5–7.) calls with unusual speed, which might portend a change in conduct.’’ Moreover, Ms. Vischio has seen patients appreciate. (Id. at ¶ 8.) (Id. at 7.) Instead, the Government Respondent’s handwritten notes in Cosmopolitan Clinic often tests argues, registration is improper where patient files. (Id. at ¶ 7.) patients to ensure they are not taking ‘‘Respondent blames the legal Conceding that she has not personally medications that Respondent has not community, a lawyer who had a seen Respondent examine patients, Ms. prescribed. (Resp’t Ex. 19 at 7 ¶ 9; see financial interest in the pharmacy where Vischio states that she has witnessed also Tr. 167.) Patients who fail the Respondent’s prescriptions were filled, him performing exams on occasion and screen are often dismissed immediately; a physician’s assistant, the owner of that Respondent documents exams in others are given one, but only one, [UPS], and even DEA for his failure to his files. (Id. at ¶ 8.) Respondent takes chance. (Id. at ¶ 9.) abide by the law.’’ (Id.) twenty minutes or more with each new V. The Parties’ Contentions B. Respondent patient, and ten minutes for a follow-up Respondent disputes the quantity of visit, and sometimes exceeds the A. The Government controlled substances that Respondent allotted time limit. (Id. at ¶ 9.) The Government argues that prescribed. (Tr. 12–13.) Pointing to the Respondent discusses treatment plans Respondent prescribed controlled practitioner manual distributed by the with patients, returns their phone calls substances to thousands of individuals DEA (see Resp’t Ex. 6 at 15), Respondent and discusses their options with them. across the United States when he was also argues that of the five grounds (Id. at ¶ 10.) Ms. Vischio has worked only licensed to practice medicine in stated therein upon which a COR may with many physicians in a variety of the state of Florida, thereby violating the be revoked, the only allegation that the medical settings, and calls Respondent laws of numerous states,49 in Government has made is that thorough in his documentation and contravention of 21 CFR 1306.04 (2010). Respondent committed an act that diligent in his examinations and follow- (Gov’t Br. at 5; see Tr. 11.) Respondent would render the DEA COR inconsistent up. (Id. at ¶ 13.) often based his decision to prescribe with the public interest. (Tr. 14.) Noting Ms. Vischio also addressed the new solely on a review of medical records that 21 U.S.C. § 823 and 824 set forth patient intake process. New patients submitted by individuals who were factors for determining the public must either obtain a referral for pain seeking a controlled substance, usually interest, Respondent argues that the management or have a prescription hydrocodone, a Schedule III narcotic. Florida Board of Osteopathic Medicine history or list from six months to one (Tr. 11–12.) Respondent did not conduct has not made a recommendation year before seeing Respondent. (Resp’t physical examinations on the majority regarding the issuance of a DEA Ex. 19 at 3 ¶ 11.) New patients must fill of these individuals. (Tr. 12.) registration. (Tr. 14; Resp’t Br. at 21–22.) out new patient packet forms, including In addition, the Government argues Moreover, Respondent argues that medical history and treatment. They that Respondent completed the conduct Respondent’s experience in dispensing must also undergo an MRI or have had described above while employed by an controlled substances has not been one within two years. (Id. at ¶ 11.) All Internet pharmacy ‘‘whose sole business challenged, and in any event, MRIs are verified by the MRI facility was to allow people to visit a Web site, Respondent has such experience. (Tr. before Respondent sees them. (Id. at ask for a certain drug, get referred to a 14; Resp’t Br. at 22.) Additionally, ¶ 11.) physician who would consult with them Respondent has not been convicted Ms. Vischio stated that when by telephone, look at medical records under federal or state laws relating to appropriate, Respondent has reduced that had been submitted and then issue the manufacture, distribution or the amount of pain medication the prescribed drug to be filled by that dispensing of controlled substances. (Tr. prescribed; has instructed Ms. Vischio pharmacy.’’ (Tr. 12.) The Government 14; Resp’t Br. at 22.) to advise patients of the same; and has urges that Respondent had a legal duty As for the final factor, ‘‘such other heard patients complain that to supervise his PA, Mr. Protheroe, and conduct which may threaten the public Respondent reduced their pain as a last resort, Respondent should have safety,’’ Respondent argues that he is no medication levels. (Id. at ¶ 12.) withdrawn from his employment if Mr. threat to the public safety. (Tr. 19.) As Ms. Adele Durina, Respondent’s office Protheroe failed to comply with an initial matter, Respondent argues that manager and medical assistant, Respondent’s instructions. (Gov’t Br. at he is remorseful, has been rehabilitated submitted an affidavit stating she enjoys 6.) The Government argues that and that since discontinuing his Internet working with Respondent and has prescribing practices, ‘‘no conduct worked with him since he began 49 The Government argues in part that I should which might threaten the public health working at Cosmopolitan Clinic because give weight to findings in United Prescription and safety has been charged and Services, Inc., in which ‘‘the Deputy Administrator Respondent is considerate of his found that Dr. Reppy violated the laws of proved.’’ (Resp’t Br. at 22.) Respondent patients and office staff. (Resp’t Ex. 19 California, Tennessee, Indiana and Louisiana also notes that attorney Robert Carr at 6 ¶ 3; see also Tr. 167.) * * * .’’ (Gov’t Br. at 5–6.) assured Respondent that Respondent’s

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prescribing practices at UPR were It is unlawful for any person to possess C. The Factors To Be Considered within the scope of permitted practice. a controlled substance unless that Factors 1 and 3: The Recommendation (Tr. 16; Resp’t Exs. 3 & 4.) Additionally, substance was obtained pursuant to a of the Appropriate State Licensing Respondent argues that many of the valid prescription from a practitioner Board or Professional Disciplinary prescriptions attributed to him were acting in the course of his professional Authority and Conviction Record Under either forged or written by a PA. (Tr. 16; practice.52 In addition, I conclude that Federal or State Laws Relating to the Resp’t Br. at 24.) Moreover, Respondent the reference in 21 U.S.C. 823(f)(5) to Manufacture, Distribution or Dispensing argues that he was acting as a consultant ‘‘other conduct which may threaten the of Controlled Substances to primary care physicians and was public health and safety’’ would as a merely extending prescriptions for matter of statutory interpretation In this case, regarding Factor One, it drugs that had already been prescribed logically encompass the factors listed in is undisputed that Respondent currently by other physicians. (Tr. 17.) § 824(a).53 holds a valid medical license in Florida, Respondent further contends that he but Respondent’s medical license has acquired adequate medical history B. The Public Interest Standard been the subject of state disciplinary documentation from Ms. Messick, and The CSA, at 21 U.S.C. 824(a)(4), action in the past. As discussed in the that Respondent, ‘‘when necessary, provides, insofar as pertinent to this Evidence and Incorporated Findings of would speak by telephone with either proceeding, that the Deputy Fact section of this Recommended the patient or the patient’s primary care Administrator may revoke a COR if she Decision, the Florida Department of physician.’’ (Tr. 17–18.) finds that the registrant’s continued Health instituted an Administrative Respondent also notes that he was registration would be inconsistent with Complaint against Respondent in May compensated on an hourly basis, so the the public interest as that term is used 2007. (Tr. 40; Gov’t Ex. 14.) The number of prescriptions he wrote was in 21 U.S.C. 823(f). In determining the Complaint alleged, in sum and in not a factor in his prescribing habits. public interest, the Deputy substance, that Respondent repeatedly (Tr. 18.) Administrator is required to consider prescribed controlled substances In addition, Respondent immediately the following factors: without having face-to-face meetings terminated his Internet prescribing upon (1) The recommendation of the with patients; without performing being notified that his actions were not appropriate state licensing board or adequate patient evaluations, taking in conformity with regulations. (Tr. 16.) professional disciplinary authority. adequate medical histories, conducting He discontinued his prescribing habits (2) The applicant’s experience in adequate medical examinations, far before any notice of these dispensing or conducting research with discussing the risks and benefits of the administrative proceedings. (Tr. 18.) He respect to controlled substances. course of treatment, documenting regrets his mistakes and apologizes for (3) The applicant’s conviction record treatment plans or making appropriate them. (Tr. 16, 18.) under federal or state laws relating to referrals. (E.g., Gov’t Ex. 14 at 2–3, 14.) In the nearly four years since the manufacture, distribution or The Complaint resulted in a Respondent engaged in Internet dispensing of controlled substances. settlement agreement, dated October 2, prescribing practices at UPR, (4) Compliance with applicable state, 2007, implemented through a final order Respondent argues that he has federal or local laws relating to dated December 26, 2007. (Tr. 46–48; conformed his practice to meet all state controlled substances. Gov’t Exs. 15 & 16.) Respondent agreed and federal requirements, including (5) Such other conduct which may to pay a fine of $12,500, complete requirements of the Florida Department threaten the public health and safety. continuing medical education courses, of Health, Board of Osteopathic As a threshold matter, the factors perform 100 hours of community Medicine (Tr. 18, 19), and is converting specified in Section 823(f) are to be service and prepare a paper suitable for his pain management practice to a considered in the disjunctive: the publication. (Tr. 46; Gov’t Ex. 15; see family practice treating indigent and Deputy Administrator may properly rely also Gov’t Ex. 16.) low-income patients. (Tr. 18.) on any one or a combination of those Respondent failed to timely complete factors, and give each factor the weight the deadlines set by the settlement VI. Discussion and Conclusions she deems appropriate, in determining agreement, but as of hearing had A. The Applicable Statutory and whether a registration should be completed most of his requirements and Regulatory Provisions revoked or an application for was in the process of paying the The Controlled Substances Act (CSA) registration denied. See David H. Gillis, assessed fine. (See, e.g., Resp’t Ex. 18 at provides that any person who dispenses M.D., 58 FR 37,507, 37,508 (DEA 1993); 2 & Tr. 72 (community service); Tr. 48 (including prescribing) a controlled see also D & S Sales, 71 FR 37,607, & Gov’t Ex. 15 (drug course); Gov’t Ex. substance must obtain a registration 37,610 (DEA 2006); Joy’s Ideas, 70 FR 15 & Tr. 49, 51 ($12,500 fine).) issued by the DEA in accordance with 33,195, 33,197 (DEA 2005); Henry J. The most recent action by the Florida applicable rules and regulations.50 ‘‘A Schwarz, Jr., M.D., 54 FR 16,422, 16,424 Department of Health reflects a prescription for a controlled substance (DEA 1989). Additionally, in an action determination that Respondent, to be effective must be issued for a to revoke a registrant’s COR, the DEA notwithstanding findings of legitimate medical purpose by an has the burden of proving that the unprofessional conduct, can be individual practitioner acting in the requirements for revocation are entrusted with a medical license subject satisfied.54 The burden of proof shifts to to probationary terms and conditions. usual course of his professional 56 practice. The responsibility for the the registrant once the Government has While not dispositive, this action by proper prescribing and dispensing of made its prima facie case.55 the Florida Department of Health does controlled substances is upon the weigh against a finding that prescribing practitioner’’ with a 52 21 U.S.C. 844(a). Respondent’s continued registration 53 corresponding responsibility on the See Kuen H. Chen, M.D., 58 FR 65,401, 65,402 (DEA 1993). 56 51 Mortimer B. Levin, D.O., 55 FR 8209, 8210 pharmacist who fills the prescription. 54 21 CFR 1301.44(e) (2010). (DEA 1990) (finding DEA maintains separate 55 Medicine Shoppe—Jonesborough, 73 FR 364, oversight responsibility and statutory obligation to 50 21 U.S.C. 822(a)(2); 21 U.S.C. 802(10). 380 (DEA 2008); see also Thomas E. Johnston, 45 make independent determination whether to grant 51 21 CFR 1306.04(a). FR 72,311, 72,311 (DEA 1980). registration).

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would be inconsistent with the public More complicated is whether the differences relevant to this interest under Factor One. Cf. Robert A. Government adequately noticed proceeding.63 Leslie, M.D., 68 FR 15,227, 15,230 (DEA provisions of Florida law relevant to the The OSC also alleges violations of Fla. 2003) (under Factor One, prior supervision of PAs. The OSC alleges in Admin. Code Ann. r. 64B8–30.008(1)(a) suspension of respondent’s state pertinent part that Respondent violated (formulary requirements for PAs). That medical license held not dispositive Fla. Stat. Ann. § 458.347 (2008) provision, which falls under the subtitle where state license currently under no (‘‘Physician assistants’’), which sets of regulations applicable to allopathic restrictions). forth a regulatory framework for the physicians, provides in pertinent part Regarding Factor Three, there is no training, conduct and supervision of that PAs are not authorized to prescribe evidence that Respondent has ever been PAs.60 (See ALJ 1.) That provision is controlled substances. Fla. Admin. Code convicted under any federal or state law codified in Chapter 458, entitled Ann. r. 64B8–30.008(1)(a). But because relating to the manufacture, distribution ‘‘Medical Practice.’’ But Respondent is subtitle 64B8 of the Florida or dispensing of controlled substances. an osteopathic doctor (Tr. 20; Gov’t Ex. Administrative Code Annotated governs I therefore find that this factor, although 15 at 1), and not an allopathic doctor, matters pertinent to the Board of not dispositive, see Leslie, 68 FR at so the standards of his practice are [allopathic] Medicine, and Respondent 15,230, weighs against a finding that governed by Chapter 459 (‘‘Osteopathic is a doctor of osteopathy, the relevant Respondent’s continued registration Medicine’’) and not Chapter 458 Florida administrative provisions would be inconsistent with the public (‘‘Medical Practice’’). See Fla. Stat. Ann. governing Respondent’s conduct are interest. § 458.303 (‘‘The provisions of * * * [the located under subtitle 64B15 (‘‘Board of Florida statute noticed in the OSC, Osteopathic Medicine’’). As codified in Factors 2 and 4: Respondent’s Section] 458.347 shall have no Rule 64B15–6.0038, subtitle 64B15 Experience in Handling Controlled application to * * * [o]ther duly contains a formulary provision that Substances; and Compliance With licensed health care practitioners mirrors the formulary provision Applicable State, Federal or Local Laws * * * .’’). As codified in Section applicable to allopathic doctors actually Relating to Controlled Substances 459.022, Chapter 459 contains a PA noticed by the Government. A word-by- Respondent argues that his experience provision applicable to osteopathic word comparison of Rule 64B8– in dispensing controlled substances has doctors that substantially mirrors the PA 30.008(1)(a) (applicable to PAs under not been challenged. (Tr. 14; see Resp’t provision applicable to allopathic allopathic doctors) and Rule 64B15– Br. at 22.) doctors actually noticed by the 6.0038 (applicable to PAs under It has. As summarized above and Government. In fact, a word-by-word osteopathic doctors) as codified during discussed below, the Government comparison of § 458.347 (allopathic the relevant time period 64 reveals that challenges Respondent’s supervision of doctors) and § 459.022 (osteopathic the two provisions are textually his PA, his unauthorized practice of doctors), as codified during the relevant identical. medicine, the legitimacy of his time period,61 reveals that the language As summarized thus far, the OSC in prescribing practices and his from each provision governing a this case notices the Government’s compliance with telemedicine physician’s duty of care with respect to intention to litigate issues embracing standards, all applied to the supervising a PA is textually identical,62 supervision of Respondent’s PA and dispensing 57 of controlled substances. and the remaining provisions contain no related formulary provisions of Florida law. Although the provisions actually (a) Adequacy of Notice of PA supervised Mr. Protheroe as well as Mr. Protheroe’s noticed by the Government pertain to Supervision Issue responsibilities * * * Mr. Protheroe issued allopathic doctors and not osteopathic prescriptions for controlled substances using A threshold matter concerns whether Respondent’s DEA registration number * * * with doctors, two reasons compel the the Government adequately noticed its Respondent’s consent and under his supervision.’’ conclusion that the notice provided in contention that Respondent violated (Gov’t Supp. PHS at 4.) this instance is sufficient to apprise Florida law relating to the supervision 60 The version Fla. Stat. Ann. § 458.347 alleged in Respondent ‘‘that this allegation would the OSC is from 2008, but the relevant time period 58 of his PA, Mr. Protheroe. Before the of Respondent’s conduct was from 2004 until be litigated.’’ See CBS, 74 FR at 36,749. Agency may properly impose a sanction approximately 2006. (ALJ Ex. 1.) Consequently, the First, as discussed above, the on the basis of a given allegation, following analysis concerns the 2004 through 2006 pertinent operative sections of the Agency precedent requires that a versions of that statute. provisions actually noticed in the OSC 61 See Gov’t Ex. 5 (collecting versions of Fla. Stat. registrant be provided a ‘‘‘full and fair Ann. § 459.022 from 2004–2006); see also supra are literally identical to the duty-of-care opportunity’ to litigate both the factual note 60. provisions applicable to osteopathic and legal bases of the Government’s 62 Compare Fla. Stat. Ann. § 459.022(3) (‘‘Each doctors. Respondent therefore had not theory.’’ CBS Wholesale Distribs., 74 FR physician * * * shall be * * * responsible and just substantial notice, but truly actual liable for the performance and the acts and 36,746, 36,750 (DEA 2009). As for the omissions of the physician assistant.’’), with Fla. notice of the exact legal standards that factual basis of the Government’s Stat. Ann. § 458.347(3) (same). Compare also Fla. the Government alleges that Respondent theory, I find that the issue of Stat. Ann. § 459.022(4)(e) (‘‘A supervisory physician violated. Respondent’s relationship with his PA may delegate to a fully licensed physician assistant Second, DEA, to a certain extent, the authority to prescribe or dispense any was adequately noticed by the medication used in the supervisory physician’s adopts a ‘‘notice pleading’’ model with Government’s supplemental prehearing practice unless such medication is listed on the respect to certain matters of law. Cf. 21 statement.59 formulary created pursuant to § 458.347 * * * A U.S.C. 823(f)(4) (requiring the DEA to physician assistant must clearly identify to the assess a registrant’s ‘‘[c]ompliance with patient that she or he is a physician assistant [and] 57 Under the CSA, prescribing is included in the inform the patient that the patient has the right to definition of ‘‘dispensing.’’ 21 U.S.C. 802(10). see the physician * * *.’’), with Fla. Stat. Ann. 63 For instance, the addition of the word 58 The OSC alleges that Respondent violated Fla. § 458.347(4)(e) (same). The reference in Section ‘‘osteopathic’’ in the legislative intent headings of Stat. Ann. § 458.347 (2008) (‘‘Physician assistants’’). 459.022(4)(e) to the location of the formulary of Fla. Stat. Ann. § 459.022(1) cannot be considered a (ALJ Ex. 1.) drugs a PA may not prescribe is consistent with the material difference from the text found in Section 59 The Government noticed Respondent’s reference in Section 458.347(4)(e) to ‘‘the formulary 458.347(1). testimony: ‘‘regarding his relationship with created pursuant to paragraph (f)’’ because the 64 See Gov’t Ex. 3 (collecting Fla. Admin. Code Physician’s Assistant John Protheroe * * * He will formularies are identical. See Fla. Admin. Code Ann. rr. 64B15–6.0038 (2004), 64B8–30.008 (2005) testify generally to the manner in which he Ann. rr. 64B15–6.0038 & 64B8–30.008. and 64B15–6.0038 (2006)); see also supra note 60.

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applicable state, federal or local laws licensed physician assistant the practitioner’s COR.68 See 21 CFR relating to controlled substances’’). I authority to prescribe or dispense any 1301.22 (2010) (‘‘The requirement of find that an otherwise adequate medication used in the supervisory registration is waived for any agent or provision of notice of the substantive physician’s practice. * * *’’ id. employee of a person who is registered legal issues to be addressed is not § 459.022(4)(e), but, as emphatically to engage in any group of independent undercut by an erroneous citation, when stated in the Florida Administrative activities, if such agent or employee is the text that should have been cited is Code: acting in the usual course of his/her literally identical to the erroneously PHYSICIAN ASSISTANTS APPROVED TO business or employment.’’). This cited text and is contained within a PRESCRIBE MEDICINAL DRUGS UNDER conclusion is consistent with Agency neighboring chapter of the same code of THE PROVISIONS OF * * * 459.022(4)(E), precedent holding that a registrant must state law. F.S., ARE NOT AUTHORIZED TO adequately supervise his or her PA to Therefore, although the Government’s PRESCRIBE THE FOLLOWING MEDICINAL prevent the unlawful issuance of inaccurate noticing of the provisions of DRUGS, IN PURE FORM OR prescriptions for controlled substances. law upon which it intends to seek COMBINATION: (a) Controlled As the Administrator recently revocation of a COR could be substances.* * *’’ explained, ‘‘a registrant is strictly liable misleading in some circumstances, I Fla. Admin. Code Ann. r. 64B15– for the misconduct of those persons who find that under the circumstances of this 6.0038. In addition, a PA must ‘‘clearly he authorizes to act under his case Respondent received adequate and identify to the patient that he or she is registration.’’ Scott C. Bickman, M.D., 76 timely notice of the legal and factual a physician assistant * * * [and] must FR 17,694, 17,703 (DEA 2011); see issues surrounding Respondent’s inform the patient that the patient has Robert G. Hallermeier, M.D., 62 FR interaction with and supervision of his the right to see the physician prior to 26,818, 26,820 (DEA 1997) (failure to PA. I therefore conclude that any prescription being prescribed or supervise PA ‘‘permitted the prescribing Respondent’s interaction with and dispensed by the physician assistant.’’ of controlled substances by an supervision of his PA may properly be Id. § 459.022(4)(e)(1). unauthorized individual in violation of considered as a potential basis for Federal law also bears upon a numerous provisions of Federal and revoking Respondent’s COR and physician’s supervision of a PA. As an state laws and regulations, including 21 denying any pending applications for initial matter, 21 U.S.C. 846, a provision U.S.C. 829(b) and 841 and 21 CFR registration or renewal. noticed by the OSC in the above- 1306.03 and 1306.04(a) (1997) . * * *’’); (b) Respondent’s Supervision of His PA captioned case, imposes liability for Jay Wheeler Cranston, M.D., 59 FR attempt and conspiracy to violate 36,786, 36,789 (DEA 1994) An issue under Factors Two and Four certain provisions of the CSA.65 In (‘‘Respondent authorized physician of 21 U.S.C. 823(f) is whether pertinent part, the following statutory assistants to issue and sign controlled Respondent adequately discharged his provisions are susceptible to the sweep substance prescriptions to patients duty under Florida and federal law to of § 846. ‘‘Except as authorized by this without direct supervision of a supervise his PA, Mr. Protheroe. I find title, it shall be unlawful for any person physician in violation of 21 CFR insofar as is pertinent to this proceeding knowingly or intentionally * * * to 1306.03 and 1306.05(a) (1994).’’). See that Florida law sets forth the duties and * * * dispense[] a controlled generally Dan E. Hale, D.O., 69 FR obligations of osteopathic physicians substance.’’ 21 U.S.C. 841(a). Moreover, 69,402, 69,406 (DEA 2004) vis-a`-vis PAs, as set forth below. See ‘‘[e]very person who dispenses * * * (respondent’s grant of permission to PA generally Fla. Stat. Ann. § 459.022; Fla. any controlled substance, shall obtain to ‘‘provide controlled substances to Admin. Code Ann. r. 64B15–6.0038. from the Attorney General a patients prior to the effective date of A ‘‘physician assistant’’ is ‘‘a person registration,’’ 66 21 U.S.C. 822(a)(2), with legislation permitting such activity who is a graduate of an approved the exception of ‘‘[a]n agent or employee * * * and unauthorized utilization of a program or its equivalent or meets of any registered * * * dispenser of any physician assistant to provide standards approved by the boards and is controlled substance if such agent or controlled substances * * * to drug licensed to perform medical services employee is acting in the usual course abusing patients so they would submit delegated by the supervising of his business or employment,’’ to unnecessary medical tests, violated physician.’’ Fla. Stat. Ann. § 822(c)(1). It is illegal ‘‘to use in the laws relating to controlled substances § 459.022(2)(e). ‘‘Supervision’’ means course of * * * dispensing of a * * * [and] weighs against ‘‘responsible supervision and control. controlled substance * * * a registration’’). Except in cases of emergency, registration number * * * issued to Turning to the facts of the case at bar, supervision requires the easy another person.’’ § 843(a)(2). the record reveals that Respondent’s availability or physical presence of the Read together, I find as a matter of supervision of his PA, Mr. Protheroe, licensed physician for consultation and statutory construction that 21 U.S.C. was virtually non-existent. Respondent direction of the actions of the physician 822, 841, 843 and 846 impose on a testified that Mr. Protheroe worked assistant * * * ‘easy availability’ practitioner an affirmative duty to under Respondent’s license (Tr. 37, includes the ability to communicate by supervise his or her PA to ensure that 131), giving rise to Respondent’s legal way of telecommunication.’’ Id. the PA dispenses 67 medication only in duty to supervise him. See Fla. Stat. § 459.022(2)(f). A physician accordance with the law, and to prevent Ann. § 459.022(2)(e). Yet Respondent’s ‘‘supervising a licensed physician the unauthorized use of the testimony shows that Respondent did assistant * * * shall be * * * not supervise Mr. Protheroe. responsible and liable for the 65 Under 21 U.S.C. 846, ‘‘[a]ny person who Respondent did not hire him (see Tr. 37 performance and the acts and omissions attempts or conspires to commit any offense (‘‘he was put there by someone else’’), of the physician assistant.’’ Id. defined in this title shall be subject to the same did not need him (Tr. 37), complained § 459.022(3). Failing to adequately penalties as those prescribed for the offense, the commission of which was the object of the attempt about him repeatedly to Mr. Bollinger supervise a PA constitutes grounds for or conspiracy.’’ discipline. Id. § 459.015(1)(hh). Subject 66 See also 21 CFR 1301.11 (2010). 68 See, e.g., 21 U.S.C. 820(3) (defining ‘‘agent’’ as to certain limitations, ‘‘[a] supervisory 67 Dispensing includes, inter alia, prescribing. 21 ‘‘an authorized person who acts on behalf of or at physician may delegate to a fully U.S.C. 802(10). the direction of a * * * dispenser’’).

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and Ms. Messick (see, e.g., Resp’t Ex. 12 * * *’’ 69 Fla. Admin. Code Ann. r. authorized to prescribe controlled at 4; Tr. 131, 138–39), did not control 64B15–6.0038 (internal formatting substances by the jurisdiction in which Mr. Protheroe’s hours (see Tr. 37 (‘‘he omitted). Mr. Protheroe’s illegal conduct he is licensed to practice his was not even present most of the time is chargeable to Respondent because profession.’’ The OSC in the above- I was there’’)), did not control Mr. Respondent is ‘‘responsible and liable captioned case alleges violations of the Protheroe’s work product (see Tr. 37 for the performance and the acts and laws of Mississippi, California and (‘‘He ended up basically exploiting my omissions of the physician assistant.’’ Alabama relating to the unlicensed or license behind my back without my Fla. Stat. Ann. § 459.022(3). Accord cf. long-distance practice of medicine. (See permission.’’); Tr. 122 (Mr. Protheroe Scott C. Bickman, M.D., 76 FR at 17,703 ALJ Ex. 1 at 2.) failed to adhere to the criteria by which (holding registrant strictly liable for First at issue is the law of Mississippi. Respondent rejected patients); see also misconduct of ‘‘those persons who he As codified at Miss. Code Ann. § 73–25– Tr. 131, 138–39) and did not believe he authorizes to act under his 34(2), Mississippi has provided without could fire him (Tr. 37 (‘‘I had no power registration’’). amendment since 1997 that Respondent’s testimony that he to remove him because I did not pay his approved a few of Mr. Protheroe’s no person shall engage in the practice of salary. I could not tell him to leave.’’)). prescriptions each day (Tr. 42), read medicine across state lines (telemedicine) in I find that Respondent failed to this state, hold himself out as qualified to do together with Respondent’s admission the same, or use any title, word or exercise ‘‘responsible supervision and that ‘‘[m]ost of the prescriptions written abbreviation to indicate to or induce others control’’ over Mr. Protheroe, in violation by Mr. Protheroe were for controlled to believe that he is duly licensed to practice of Fla. Stat. Ann. § 459.022(2)(f), based substances’’ (Resp’t Ex. 12 at 2), suggests medicine across state lines in this state in part on the uncontroverted evidence Respondent attempted to confer upon unless he has first obtained a license to do that Mr. Protheroe wrote at least 14,000 Mr. Protheroe in some instances the so from the State Board of Medical Licensure. unauthorized prescriptions in authority to prescribe controlled *** Respondent’s name (Tr. 80; see substances. But Respondent lacked See 1997 Miss. Laws 436.71 generally Tr. 132; Gov’t Ex. 10 at 84–85), authority under Florida law to make In this case, the record reflects that such an authorization. ‘‘A supervising many of which while Respondent was Respondent currently holds a medical away from the office for an extended physician may delegate to a prescribing physician assistant only such license from the state of Florida. (Tr. period of time (Tr. 121–22, 132; Gov’t 20.) Respondent was previously Ex. 10 at 85, 96, 101). Because authorized medicinal drugs as are * * * not’’ controlled substances. Fla. Admin. licensed in Georgia, California and Respondent testified that he developed Hawaii, but has not held medical concerns regarding Mr. Protheroe’s Code Ann. r. 64B15–6.0038. To summarize, substantial evidence licenses in any of those states since performance before November 2003 (Tr. 1999. (Tr. 21.) Since 2000, Respondent 121), which was before Respondent supports the conclusion that Respondent allowed a PA to use has been licensed to practice medicine went on leave in 2005 (see Tr. 121–22, solely in Florida. (See, e.g., Tr. 21.) 132), it cannot reasonably be questioned Respondent’s COR to issue purported prescriptions of controlled substances to The record further reflects that during that Respondent is ‘‘responsible and Internet customers, and that Respondent the relevant time period of 2004 to 2006 liable for the performance and the acts otherwise failed to adequately supervise (ALJ Ex. 1 at 1), most of the individuals and omissions of the physician his PA. Respondent’s conduct in this to whom Respondent prescribed assistant.’’ Id. § 459.022(3). regard violated Fla. Stat. Ann. § 459.022; controlled substances became Respondent’s testimony that Fla. Stat. Ann. § 459.015(1)(hh) and Fla. Respondent’s customers through Respondent approved a few of Mr. Admin. Code Ann. r. 64B15–6.0038, as Internet Web sites. (Tr. 25.) Respondent Protheroe’s prescriptions each day (Tr. well as Respondent’s duty under federal testified that he recalled issuing 42) and supervised Mr. Protheroe during law to supervise his PA to ensure that prescriptions for controlled substances the limited times that the latter was in the PA dispenses medication only in to people located all across the United the office (see Gov’t Ex. 10 at 105) does accordance with the law, and to prevent States. (Tr. 27, 39; see Resp’t Ex. 12 at not satisfy Respondent’s duty to the unauthorized or unlawful use of 3.) Although he did not remember supervise Mr. Protheroe, nor is there Respondent’s COR, e.g., Robert G. precisely how many different states his any evidence that Respondent Hallermeier, M.D., 62 FR 26,818, 26,820 client base represented, he said the list adequately supervised Mr. Protheroe (DEA 1997); Jay Wheeler Cranston, was long. (Tr. 39.) I therefore find that telephonically as would have been M.D., 59 FR 36,786, 36,789 (DEA substantial evidence supports the OSC permissible under Fla. Stat. Ann. 1994).70 This finding weighs strongly in allegation that Respondent issued § 459.022(2)(f). Respondent’s failure to favor of a finding under Factors Two controlled substances to customers adequately supervise Mr. Protheroe and Four of 21 U.S.C. 823(f) that throughout the United States while constitutes grounds for discipline under Respondent’s continued registration licensed to practice medicine only in Florida law. Id. § 459.015(1)(hh). would be inconsistent with the public Florida. interest. The evidence further reflects that the This finding, however, does not end majority of prescriptions Mr. Protheroe (c) Unauthorized Practice of Medicine the inquiry. Respondent’s testimony wrote were for controlled substances. suggests that he did not issue Pursuant to 21 CFR 1306.03 (2010), prescriptions for controlled substances (E.g., Resp’t Ex. 12 at 2.) This evidence ‘‘[a] prescription for a controlled constitutes a flagrant violation of to individuals in Mississippi because substance may be issued only by an that state was ‘‘off limits’’ in terms of Florida law that unambiguously individual practitioner who is * * * prohibits PAs from prescribing what his telemedicine contract would permit. (Tr. 28.) The hearing transcript controlled substances under any 69 In this context the term ‘‘controlled reads: circumstances. Under the Florida substances’’ is defined by Fla. Stat. Ann. §§ 893.02 Administrative Code, ‘‘physician (2004) and 893.03 (2004) and includes hydrocodone 71 assistants * * * are not authorized to and oxycodone, among other drugs. See Fla. Stat. See 1997 MS ALS 436 (on LexisNexis) Ann. § 893.03(2)(a) (2004). (historical versions) and MS LEGIS 436 (1997) prescribe * * * [c]ontrolled substances. 70 See also supra text at notes 65 to 68. (Westlaw) (same).

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Q: Dr. Reppy, the people that you provided Turning to California, the law of that provision, with 2006 amendments service to when you worked at University, state has provided in pertinent part noted,75 reads: these were people from all over the United without amendment since 2002 that No person or entity may prescribe, States, is that correct? any person who practices or attempts to dispense, or furnish, or cause to be A: Yes. practice, or who advertises or holds himself prescribed, dispensed, or furnished, Q: And in fact you serviced people in all or herself out as practicing, any system or dangerous drugs * * * on the Internet for 50 states, didn’t you, during that time? mode of treating the sick or afflicted in this delivery to any person in this state, without A: There were some states that were off state, or who diagnoses, treats, operates for, [a good faith] an appropriate prior limits because—like—like Kentucky was one or prescribes for any * * * physical or examination and medical indication of them and Mississippi was the other one. mental condition of any person, without [therefor], except as authorized by Section Those two states had stated that they having at the time of so doing a valid, 2242. would—were against any telemedicine-type unrevoked, or unsuspended [California Id. Violators are subject to fines or of contract at all. Now, I was—I was medical license] is guilty of a public offense, civil penalties of up to $25,000 per represented by their legal counsel, by—by punishable by fine, imprisonment or both. occurrence, id. § 2242.1(b) or, ‘‘[i]f the Mr. Carr that the—that the prescribing Cal. Bus. & Prof. Code § 2052(a). person * * * is not a resident of this pharmacy was licensed in all 50 states and As is true in most contexts, ignorance state, a violation of this section shall, if therefore that covered any legal issues with of the law is no defense. The California it. That—that wasn’t true, but that’s what I applicable, be reported to the person’s was told. Court of Appeal has noted that the * * * appropriate professional ‘‘proscription of the unlicensed practice licensing authority,’’ id. § 2242.1(e). (Tr. 27–28.) The record reveals no of medicine is neither an obscure nor an In light of the existence of this statute other information specifically relating to unusual state prohibition of which prior to and during the relevant time Respondent’s Mississippi prescribing ignorance can reasonably be claimed, period (see ALJ Ex. 1 (2004 to 2006)), practices,72 and the Government called and certainly not by persons * * * who and Mr. Carr’s testimony that he shared no witnesses other than Respondent, are licensed health care providers. Nor his research on standards for Internet even though DEA Diversion Investigator can such persons reasonably claim prescribing practices with Respondent Peter Flagg, identified in the ignorance of the fact that authorization before Respondent began working for Government’s supplemental prehearing of a prescription pharmaceutical UPR, Respondent’s testimony that in statement as a witness, was present in constitutes the practice of medicine.’’ 2003 ‘‘the legal community was the courtroom.73 (Tr. 2; Gov’t Supp. PHS Hageseth v. Superior Court, 59 Cal. struggling in a gray area to determine at 1.) Although the second half of Rptr. 3d 385, 403 (Ct. App. 2007). what [those standards] would be’’ (Tr. Respondent’s testimony quoted above Here, Respondent’s unrebutted 64), at least with respect to California, lends some support to the Government’s testimony confirms that he issued is not credible. (Compare Tr. 60; see allegation that Respondent prescribed to prescriptions for controlled substances also Tr. 89–92.) When Respondent Mississippi residents, the first part of to people in California while he was issued the prescriptions at issue here, his statement, that Mississippi was off licensed to practice medicine solely in numerous states had already adopted limits, cuts evenly in the other Florida. (Tr. 21, 28.) Respondent’s laws or regulations, or had issued policy direction, leaving the evidence in witness Mr. Carr also testified that ‘‘I statements making clear, that equipoise. know California is one of the states that Respondent’s Internet prescribing we were prescribing to—or shipping practices were illegal.76 In addition, a ‘‘Under the preponderance of the drugs to.’’ (Tr. 158.) I therefore conclude 2001 Federal Register notice, offered as evidence test, the [party with the burden that substantial evidence supports a Respondent’s own exhibit, makes clear of proof] loses when the evidence is in finding that Respondent violated Cal. that practitioners ‘‘must be licensed to equipoise because he did not present Bus. & Prof. Code § 2052(a) (prohibiting prescribe controlled substances by the that slight quantum of evidence the unlicensed practice of medicine). State(s) in which they operate.’’ 77 necessary to tip the balance from In addition, Mr. Carr testified that in (Resp’t Ex. 8 at 3.) And the Model equipoise to his favor.’’ United States v. 2001 or 2002 he researched the law of Guidelines, offered as Respondent’s Rodriguez, 406 F.3d 1261, 1300 (11th all fifty states regarding telemedicine Exhibit 9, cautions that ‘‘[p]hysicians Cir. 2005) (Barkett, C.J., dissenting) (Tr. 144–45) and ‘‘left no stone who treat or prescribe through Internet (citing Nat’l Lime Ass’n v. EPA, 627 unturned,’’ compiling a file ‘‘well over Web sites are practicing medicine and F.2d 416, 453 n.139 (D.C. Cir. 1980) a foot high of documents I reviewed must possess appropriate licensure in (‘‘The standard of ordinary civil extensively. * * *’’ (Tr. 150), finding all jurisdictions where patients reside.’’ litigation, a preponderance of the that ‘‘the telemedicine * * * realm (Resp’t Ex. 9 at 12 (emphasis supplied).) evidence, demands only 51% * * * in 2001 was almost non-existent Moreover, Respondent’s suggestion certainty.’’) and Black’s Law Dictionary in any kind of regulations, statutes or that a 2002 letter from the DEA (see 1201 (7th ed. 1999)). I therefore anything.’’ (Tr. 144.) He concluded that Resp’t Ex. 4) gave him permission to conclude that substantial evidence does ‘‘the only reference you could really prescribe controlled substances to not support the conclusion that find back—back at that time was neural patients in states where he lacked a Respondent violated Miss. Code Ann. radiology in pain medicine.’’ (Tr. 144.) medical license (Tr. 60; see also Tr. 89– 74 § 73–25–34. He could not identify the effective date of California’s statute related to Internet 75 Added text is marked by underlining and 72 Even the decision in United Prescription Servs., prescribing. (Tr. 150, 157.) deleted text is marked by [brackets]. Inc., 72 FR 50,397 (DEA 2007), which the Although neither the Government nor 76 See, e.g., Cal. Bus. & Prof. Code § 2242.1(a); Government withdrew as an exhibit, does not once Tenn. Comp. R. & Regs. § 0880–2.14(7) (2003) mention the word ‘‘Mississippi.’’ Respondent addressed the matter in (‘‘Prerequisites to Issuing Prescriptions’’); Ohio 73 See supra note 21 (recounting the argument, in light of Mr. Carr’s Admin. Code § 4731–11–09(A) (2003); Oklahoma Government’s withdrawal of its other witnesses). testimony, I find it notable that State Board of Medical Licensure and Supervision, 74 To summarize: the OSC alleges that California in fact adopted an Internet Policy on Internet Prescribing (Ratified 01/25/01). Respondent violated Miss. Code Ann. § 73–25–34 77 Although Mr. Carr testified that he interpreted (ALJ Ex. 1 at 2), but the Government offered no prescribing statute at least as early as Respondent’s Internet prescribing practices as evidence to support this allegation other than the 2000. See Cal. Bus. & Prof. Code operating in the state of Florida (Tr. 160–61), testimony of Respondent. See supra note 21. § 2242.1. Pertinent parts of that Respondent offered no such testimony.

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92) is misguided. First, the DEA letter practices, if indeed he had any.79 In fact, that Respondent is entitled to a ‘‘ ‘full addressed the dispensing practices of a the word ‘‘Alabama’’ does not appear in and fair opportunity’ to litigate both the pharmacy, not the prescribing practices the entire hearing transcript.80 I factual and legal bases of the of a physician. (Tr. 97; see Resp’t Ex. 4.) therefore find that substantial evidence Government’s theory’’ (emphasis Second, the letter cautioned that DEA’s does not support a finding that supplied)). general expression of approval of the Respondent violated Ala. Code § 34–24– I also decline, for reasons more fully pharmacy came with a number of 51. discussed above,83 the Government’s caveats: ‘‘Management personnel will In its post-hearing brief, the invitation to recommend imposition of verify several elements including * * * Government identifies legal authority in a sanction on the basis of ‘‘Respondent’s professional licensure[,] DEA Tennessee, Illinois and North Carolina violation of numerous state laws [as] registration[, l]egitimate patient/ that it alleges Respondent violated. (See explained in United Prescription prescriber relationship[, p]rescriptions Gov’t Br. at 5.) Although Respondent Services, Inc., Revocation of are issued in the usual course of did admit in response to questioning by Registration, 72 FR 50,397 (August 31, professional practice, and counsel for the Government that he 2007).’’ (Gov’t Br. at 5–6.) The APA, the [p]rescriptions are issued for a issued prescriptions for controlled doctrine of res judicata and principles legitimate medical purpose.’’ (Resp’t Ex. substances to customers in these states of fair play and substantial justice 4 at 1.) Respondent therefore could not while holding a medical license only in foreclose the reliance on conclusions as reasonably have relied on the DEA’s Florida (Tr. 38–39), I do not rely on to the legality of Respondent’s conduct letter as authorizing him to prescribe these admissions as a potential basis for reached in a prior hearing where controlled substances to patients in recommending imposition of a sanction Respondent, a non-party in that states in which he lacked a medical because the issue of violations of the proceeding, lacked both the motive and license. laws of Tennessee, Illinois and North the opportunity to fully develop the Carolina was not noticed in the OSC,81 relevant issues on cross examination Nor did Respondent reasonably rely the Government’s prehearing and in fact cooperated with the on statements by Mr. Carr, given Mr. statement 82 or the Government’s Government.84 See 5 U.S.C. § 551(3) Carr’s obvious financial interest in supplemental prehearing statement. (defining ‘‘party’’) and 556(e) persuading Respondent to issue Respondent lacked adequate notice that (administrative record); see also prescriptions. (Tr. 151–52.) Indeed, if violations of these states’ laws would be Johnson v. United States, 576 F.2d 606, nothing else, Respondent should have at issue where the Government raised 614 (5th Cir. 1978) (cautioning against realized from reading a letter signed by, the factual basis of its theory for the first the use of offensive collateral estoppel). and another letter addressed to, ‘‘Robert time at hearing, and raised the legal Cf., e.g., Fed. R. Evid. 804(b)(1) (former Carr/President/United Prescription basis for the first time in its post-hearing testimony hearsay exception). Services, Inc.’’ (Resp’t Exs. 3 & 4; Tr. 60, brief. See CBS Wholesale Distribs., 74 To summarize, substantial evidence 89–92) that Mr. Carr could not be FR 36,746, 36,750 (DEA 2009) (finding supports the conclusion that counted upon to act as a disinterested Respondent violated the laws of advisor to Respondent because as 79 In adversarial proceedings such as this one, ‘‘it California by issuing prescriptions to president he had a stake in the matter. is not the ALJ’s role but rather that of the parties customers across the country while To be certain, there is substantial to develop the record; the ALJ’s role is to ensure that the parties do so in accordance with the licensed to practice medicine solely in evidence that Mr. Carr provided Agency’s rules of procedure. * * *’’ East Main the state of Florida, in violation of Cal. Respondent with incomplete Street Pharmacy, 75 FR 66,149, 66,150 n.2 (DEA Bus. & Prof. Code § 2052(a) and 21 CFR information, and possibly inaccurate 2010). 1306.03 (2010). This finding weighs in information, concerning the state of 80 In addition, although the opinion in United favor of a finding under Factors Two telemedicine law and the legality of Prescription Servs., Inc., 72 FR 50,397 (DEA 2007) indicates that a Dr. Wayne Starks issued controlled and Four of 21 U.S.C. 823(f) that Respondent’s prescribing practices at substances prescriptions to a resident of Alabama Respondent’s continued registration UPR. Even so, ignorance of the law is no in violation of 21 CFR 1306.04(a), see 72 FR at would be inconsistent with the public excuse, especially where the 50,408, that conclusion is not binding on interest. Respondent in the above-captioned case, for the proscription of the unlicensed practice reasons discussed above; and in any event, there is of medicine is hardly unique to (d) Whether Respondent Issued no indication that Dr. Starks acted in conjunction Prescriptions for Controlled Substances California. See generally Hageseth, 59 with Respondent or at his direction. Cal. Rptr. 3d at 403. 81 The OSC alleges: ‘‘You violated state laws that Without a Legitimate Medical Purpose prohibit the unauthorized practice of medicine, and Outside the Usual Course of Turning to Alabama, the law of that including unlicensed, out-of-state physicians Professional Practice state has provided since at least 1975 issuing controlled substance prescriptions to state that ‘‘[a]ny person who practices residents. See e.g. Miss. Code Ann. § 73–25–34; Cal. Another issue concerns whether Bus. & Prof. Code § 2052; Ala. Code § 34–24–51.’’ Respondent conducted his prescribing medicine or osteopathy or offers to do (ALJ Ex. 1.) This language is too vague to notice so in this state without a[n Alabama practices pursuant to a legitimate violations of the laws of Tennessee, Illinois and medical purpose and within the usual medical license] * * * shall be guilty of North Carolina because the allegation of violations a Class C felony.’’ 78 Ala. Code § 34–24– of ‘‘state laws’’ did not reasonably apprise Respondent of which other states’ laws, if any. To 83 See supra Part II(A) (finding that the APA and 51. Here, although Respondent admitted be certain, the three states cited as exempli gratia negative implications stemming from the doctrine to prescribing controlled substances to (Mississippi, California and Alabama) could of offensive collateral estoppel preclude my people located all across the United reasonably have apprised Respondent that other reliance on conclusions of law regarding States (Tr. 27, 39), and volunteered that states laws might be in contention, too; but nothing Respondent’s conduct in a case in which he was not in the OSC or other prehearing filings reasonably a named party). the list of states in which his customers apprised Respondent of which ones. 84 Tr. 78; see Resp’t Br. at 17 (‘‘Respondent’s resided was ‘‘long’’ (Tr. 39), there is no 82 While the Government’s prehearing statement testimony [in the previous UPS proceeding] was testimony or other evidence relating to notices its intent to offer into evidence controlled beneficial to and supportive of the Government’s Respondent’s Alabama prescribing substances prescriptions to individuals in Illinois position, and he also provided an affidavit of and Tennessee (Gov’t PHS at 3), the Government assistance to the Government.’’); see also United withdrew that exhibit (Tr. 6–7). More importantly, Prescription Servs., Inc., 72 FR 50,397, 50,400 (DEA 78 A 2007 amendment made changes that are not the prehearing statement did not allege violations 2007) (citing affidavit by Dr. Reppy submitted as pertinent to this Recommended Decision. of Illinois, Tennessee or North Carolina law. Government exhibit in prior proceeding).

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course of professional practice, written.’’ Mohammed F. Abdel-Hameed, drugs prescribed, dispensed or consistent with 21 CFR 1306.04(a) and M.D., 66 FR 61,366, 61,369 (DEA 2009). administered; (e) Reports of 21 U.S.C. 841(a)(1).85 To be effective, At the time of the events at issue here, consultations; and (f) Reports of and lawful, a prescription for a the CSA looked to state law to hospitalizations.’’ Fla. Admin. Code controlled substance ‘‘must be issued determine whether a physician has Ann. r. 64B15–15.004 (Dec. 22, 1997) for a legitimate medical purpose by an established a valid doctor-patient (‘‘Written Records; Minimum Content; individual practitioner acting in the relationship.87 United Prescription Retention’’).90 Finally, Florida law has usual course of his professional practice Servs., Inc., 72 FR 50,397, 50,407 (DEA provided continuously since June 19, * * * An order purporting to be a 2007). 2001,91 that prescribing controlled prescription issued not in the usual Turning to Florida, a state in which substances ‘‘inappropriately or in course of professional treatment * * * Respondent conducted business and has excessive or inappropriate quantities is is not a prescription * * * and the been licensed for at least ten years (see, not in the best interest of the patient and person knowingly filling such a e.g., Tr. 20–23, 51, 56, 68, 107), the law is not in the course of the physician’s purported prescription, as well as the of that state provided for part of the professional practice, without regard to person issuing it, shall be subject to the relevant time period 88 that ‘‘gross or his intent.’’ Fla. Stat. Ann. penalties provided for violations of the repeated malpractice or the failure to § 459.015(1)(t).92 provisions of law relating to controlled practice osteopathic medicine with that The evidence at hearing regarding substances.’’ 86 As the Supreme Court level of care, skill and treatment which Respondent’s prescribing practices recently explained, ‘‘the prescription is recognized by a reasonable prudent included testimony from Respondent requirement * * * ensures patients use similar osteopathic physician as being and Ms. Messick. As discussed above in controlled substances under the accepted under similar conditions and the Evidence and Incorporated Findings supervision of a doctor so as to prevent circumstances, constitutes grounds for of Fact section of this Recommended addiction and recreational abuse. As a discipline.’’ Fla. Stat. Ann. Decision, Respondent prescribed corollary, [it] also bars doctors from § 459.015(1)(x) (2001). hydrocodone, a controlled substance, to peddling to patients who crave the In addition, from March 2000 through thousands of patients over a four-year drugs for those prohibited uses.’’ November 2006,89 Florida required that period from 2002 to 2006 (Tr. 21–23, 43, Gonzales v. Oregon, 546 U.S. 243, 274 ‘‘complete medical history and physical 51, 53) without examining as many as (2006) (citing United States v. Moore, examination must be conducted and ninety percent of his patients (see Tr. 423 U.S. 122, 135 (1975)). documented in the medical record.’’ Fla. 25–26). Despite his claim that his As an initial matter, ‘‘[a] physician Admin. Code Ann. r. 64B15– patients ‘‘were not placing their whole who engages in the unauthorized 14.005(3)(a) (2000) (‘‘Standards for the care in my hands’’ (Tr. 110), Respondent practice of medicine is not a Use of Controlled Substances for did not consult with the majority of his ‘practitioner acting in the usual course Treatment of Pain’’). Osteopathic patients’ primary care physicians. (See, of * * * professional practice’’ as physicians have been required e.g., Tr. 34, 35 (one or two physician required by 21 CFR 1306.04(a) continuously since 1997 to ‘‘maintain consultations out of 150 patients (describing requirements for lawful written legible records on each patient. serviced in given week); see also Gov’t issuance of prescription). See, e.g., Such records shall contain * * * (a) Ex. 10 at 30, 37). In fact, Respondent United Prescription Servs., Inc., 72 FR Patient histories; (b) Examination testified that he treated patients who 50,397–01, 50,407 (DEA 2007). As noted results; (c) Test results; (d) Records of had been discharged by their providers, above, I find that Respondent engaged whether for lack of funding or another in the unauthorized practice of 87 On October 15, 2008, the President signed into reason: ‘‘I was continuing the treatment medicine by issuing prescriptions for law the Ryan Haight Online Pharmacy Consumer plan that was first set up by their doctor controlled substances to people in Protection Act of 2008, Public Law 110–425, 122 who might no longer have been willing Stat. 4820 (2008). Section 2 of the Act prohibits the to continue that plan. * * *’’ (Tr. 113; California while he was licensed to dispensing of a prescription controlled substance practice medicine solely in Florida, in ‘‘by means of the Internet without a valid see also Tr. 116.) While legitimate violation of Cal. Bus. & Prof. Code prescription,’’ and defines, in relevant part, ‘‘[t]he reasons might have justified continuing § 2052(a). I therefore conclude that term ‘valid prescription’ [to] mean[ ] a a course of treatment in some instances Respondent acted outside the usual prescription that is issued for a legitimate medical where the primary care physician purpose in the usual course of professional practice 93 course of professional practice, in by * * * a practitioner who has conducted at least refused to do so, Respondent’s violation of 21 CFR 1306.04(a). 1 in-person medical evaluation of the patient.’’ 122 Federal law further provides that Stat. 4820. Section 2 further defines ‘‘[t]he term ‘in- 90 The foregoing provisions of Florida law are revocation of a registration under the person medical evaluation’ [to] mean[ ] a medical prominently identified in the Florida evaluation that is conducted with the patient in the Administrative Complaint against Respondent public interest standard of 21 U.S.C. physical presence of the practitioner, without (Gov’t Ex. 14), which was provided to Respondent 823(f) is not limited to practitioners who regard to whether portions of the evaluation are as part of the Government’s document exchange. intentionally violate the prescription conducted by other health professionals.’’ Id. See 91 See 2001 Fla. Sess. Law Serv. Ch. 2001–277 requirement, but also includes a generally 21 U.S.C. 829 (incorporating (C.S.S.B. 1558) (West) (adopting quoted language). amendments). These provisions do not, however, 92 The OSC alleges violations of an identical ‘‘practitioner’s failure to properly apply to Respondent’s conduct, which predated provision of Florida law applicable to allopathic supervise her patients to prevent them them. doctors, Fla. Stat. Ann. § 458.331(q). See ALJ. Ex. from personally abusing controlled 88 The quoted text that follows was the law in 1. For reasons discussed above, however, I find the substances or selling them to others. Florida from June 19, 2001, to June 20, 2005. provision applicable to osteopathic doctors was * * *’’ Jeri Hassman, M.D., 75 FR 8194, Compare 2001 Fla. Sess. Law Serv. Ch. 2001–277 sufficiently noticed. (C.S.S.B. 1558) (West) (2001 amendments enacting 93 For instance, read expansively, Respondent’s 8227 (DEA 2010). A practitioner must language cited), with 2005 Fla. Sess. Law Serv. Ch. testimony suggests a doctor might legitimately also ‘‘have established a bona fide 2005–266 (C.S.S.B. 940) (West) (substantially continue a medically sound treatment plan under doctor-patient relationship with the altering Fla. Stat. Ann. § 459.015(1)(x)). which the previous provider ceased providing individual for whom the prescription is 89 See Florida Department of State: State Library treatment due to a patient’s inability to pay. (See and Archives of Florida, Florida Administrative Gov’t Ex. 10 at 19 (testifying that certain pain Weekly & Florida Administrative Code, http:// management patients could not afford monthly 85 The OSC explicitly alleges violations of 21 CFR www.flrules.org/gateway/ office visits costing $150); see also Tr. 79.) 1306.04(a) and 21 U.S.C. 841(a)(1). (ALJ Ex. 1.) RuleNo.asp?title=PRACTICE. Respondent, however, did not offer evidence that 86 21 CFR 1306.04(a) (2010). REQUIREMENTs&ID=64B15-14.005. Continued

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conduct in many instances is constituted grounds for discipline.94 See Other Florida decisions interpreting inconsistent with a continuing course of Fla. Stat. Ann. § 459.015(1)(x) (2001). Florida’s nearly identical telemedicine treatment. His conduct was outside the usual rule (Fla. Admin. Code Ann. r. 64B8– The evidence reflects Respondent did course of professional practice. See 21 9.014) 96 applicable to allopathic doctors not consult with the majority of his CFR 1306.04(a); 21 U.S.C. 841(a)(1). are consistent with this conclusion. See, patients’ primary care physicians, and In addition to testifying that he did e.g., Dep’t of Health v. Wise, No. 06– he had limited opportunity, if any, to not perform physical examinations on 2014PL, at *20, 26, 2006 Fla. Div. Adm. independently confirm why those the majority of his patients (Tr. 25–26), Hear. LEXIS 530 (Nov. 9, 2006) (‘‘simply physicians stopped treating Respondent also conceded that other relying upon what a patient reports is Respondent’s patients. Florida law physicians did not perform their blood pressure does not constitute required Respondent to take and record examinations of patients at a physical examination’’ and concluding a complete medical history and medical Respondent’s direction.95 (Tr. 36.) And ‘‘failure to conduct a physical records, see Fla. Admin. Code Ann. r. because Respondent acquired his examination * * * constituted the 64B15–14.005(3)(a) (2000); Fla. Admin. patients’ records directly from patients failure to practice medicine with that Code Ann. r. 64B15–15.004. But the and not from medical professionals (see level of care, skill, and treatment which record is silent as to the steps Tr. 34, 79–80), a practice that could lead is recognized by reasonably prudent Respondent took to independently to fraud (see generally Tr. 55–56), physicians as being acceptable under verify most of his patients’ histories. Respondent had no way to verify that similar condition and circumstances’’). I (See Tr. 32 (‘‘not the common practice’’ anyone had ever actually conducted therefore find that Respondent violated for Respondent to confer with primary physical examinations on many of his applicable Florida rules regarding care physicians).) Indeed, Respondent patients, or that any such physical physical examinations. testified that he took no additional examinations were conducted recently Respondent’s conduct also does not steps: ‘‘If you have documentation in enough to warrant a prescription for comply with standards acknowledged front of you that is signed by the controlled substances. In light of by Respondent. Respondent testified primary care doctor * * * that is Respondent’s testimony that he had that to have a valid doctor-patient usually considered sufficient.’’ (Tr. 32– noticed fraudulent alterations in some relationship, a servicing medical 33.) He added: ‘‘the error rate in records of his patients’ records (Tr. 56), there is professional must have conducted a is not particularly high.’’ (Tr. 35.) As for insufficient evidence to substantiate physical examination of the patient. those physicians he did consult, Respondent’s contention that ‘‘[p]atients (Gov’t Ex. 10 at 79–80 (‘‘Someone must Respondent provided no details as to did not make [their medical records] up have done [a physical examination]).’’) the contents of the conversations. on their own.’’ (Tr. 34.) Respondent’s For follow-up consultations, Respondent therefore had no way to conduct does not comply with Florida Respondent would not require ‘‘a new verify, nor is his testimony consistent standards, as follows. physical exam with every consult. with his assertion, that his patients When it became, in my opinion, too Although there appears to be some dated, then I would demand another ‘‘were not placing their whole care in ambiguity in Florida law regarding [Respondent’s] hands.’’ (Tr. 110.) The physical exam.’’ (Gov’t Ex. 10 at 79.) Yet whether a physical examination must be there is substantial evidence, record reflects that other doctors conducted by the prescribing physician, referred no more than approximately summarized above, that on numerous as opposed to a referring physician, occasions Respondent failed to ensure 300 patients to Respondent over the there are indications that the prescribing course of a four-year period (Tr. 35–36), that these requirements were met. physician must conduct the physical ‘‘Respondent thus routinely prescribed and that Respondent prescribed examination himself. A 2002 decision hydrocodone to thousands of without any independent assessment by the State of Florida Division of and verification of his patients’ medical individuals without a face-to-face Administrative Hearings interpreting interaction or physical examination. (Tr. complaints.’’ Ladapo O. Shyngle, M.D., the state telemedicine rule applicable to 74 FR 6056, 6057, 6058 (DEA 2009) 43; see Tr. 53.) I therefore reject in osteopathic doctors observed that substantial part Respondent’s argument (holding that Florida physician failed to ‘‘assuming that the physician had establish bona fide doctor-patient that he merely acted as a consultant to complied with the [telemedicine rule, a primary care physician and merely relationship where he ‘‘prescribed on Fla. Admin. Code Ann. r. 64B15– the basis of a telephonic consultation extended prescriptions for drugs that 14.008] by conducting a physical had already been prescribed by another and did not personally conduct a examination when the drug was physical exam and take a medical physician. (Tr. 17.) Contrary to prescribed, the requirement [of a Respondent’s claim, Respondent had no history from the patients’’). documented patient evaluation, Respondent’s failure to supervise his affiliation with most of the physicians ‘‘including history and physical PA, John Protheroe, also bears on the whose records he relied on (Tr. 36) and examination, adequate to establish the reliability of Respondent’s medical should have proceeded as if the care of diagnosis for which any drug is records. Respondent repeatedly the majority of his patients was solely in prescribed’’] would already be suggested that Respondent was part of a his own hands because, as Respondent’s satisfied.’’ Levy v. Dep’t of Health, No. process at UPR over which he lacked own testimony shows, in a meaningful 02–2308RX, at *45, 2002 Fla. Div. Adm. control. For instance, Respondent number of cases it was. His failure to do Hear. LEXIS 1443 (Dec. 3, 2002). testified that he could not differentiate so raises the specter of diversion and between prescriptions issued by Mr. improper treatment. It also constitutes a 94 See supra note 88. Protheroe in Respondent’s name and ‘‘failure to practice osteopathic 95 As Respondent explained in his testimony in prescriptions that Respondent issued medicine with [a reasonable] level of a prior proceeding, ‘‘the physical examination has himself.97 (E.g., Tr. 41–43.) Asked care, skill and treatment,’’ which under to be done by someone else in the case of Florida law from 2001 to 2005 telemedicine. [Patients] have to have seen a local doctor that actually saw them and performed the 96 See supra text at notes 99 to 101. physical examination, and gotten those notes to me, 97 Respondent testified that he did not know the most or even many of his patients were in this so that I know what was seen and have the identity of ‘‘[J.N.],’’ a patient identified in the situation. information available.’’ (Gov’t Ex. 10 at 25–26.) Florida Administrative Complaint. (Tr. 42.)

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whether Respondent completed the the person described in the medical practices.98 I find it more likely than not conduct charged in Florida’s records. A patient referral provides at that Respondent failed ‘‘to properly Administrative Complaint against him, least some degree of identity supervise [his] patients to prevent them Respondent stated: verification. But given the low rate at from personally abusing controlled I actually don’t know if I did or not, which doctors referred patients to substances or selling them to others. because as I said, this PA John Protheroe Respondent (Tr. 35–36 (approximately * * *’’ Jeri Hassman, M.D., 75 FR 8194, wrote so many prescriptions without my 300 patients over four years)) compared 8227 (DEA 2010). authorization using a stamp of my signature with the total number of Respondent’s In sum, Respondent did not verify that it may well have been done under— patients (Tr. 52–53 (150 patients per that the majority of the individuals to under that process. week, constituting at least 5000 whom he prescribed controlled (Tr. 41.) Yet, in prescribing to his own controlled substances prescriptions per substances were actually the patients repeat patients, Respondent’s testimony year)), verifying that the patient fit the listed in the medical records associated shows he relied on medical records records should have been a great with their files, constituting a departure containing previous prescriptions concern for Respondent. from the usual course of professional bearing his signature without knowing practice. Any quantity of controlled Respondent testified that some people whether he or Mr. Protheroe issued substances Respondent prescribed to misuse and abuse the kinds of those prescriptions. Respondent’s these patients was therefore testimony that he couldn’t distinguish controlled substances that Respondent ‘‘inappropriate.’’ See Fla. Stat. Ann. whether he or his PA had treated a prescribed at UPR, particularly § 459.015(1)(t). In addition to falling patient, combined with his willingness hydrocodone, alprazolam, oxycodone below Florida standards of professional to nevertheless issue follow-up and methadone. (Tr. 65.) From time to practice, Respondent’s identity prescriptions, is further evidence of time Respondent encountered patients verification practices also raise the Respondent’s failure in many instances who abused controlled substances and specter of the diversion of controlled to establish and maintain a valid doctor- immediately dismissed them. (Tr. 65.) ‘‘I substances, given that most or many of patient relationship. ferreted it out where I could.’’ (Tr. 65.) the individuals who contacted In addition to the problems noted Respondent, however, could not state Respondent at UPR sought and above, Respondent’s verification of how many of his patients were addicted ultimately received controlled patient identity was patently to narcotics while he was prescribing to substances. (Tr. 28, 36.) inadequate. Respondent had no face-to- them. (Tr. 118.) There are further examples in the face interactions with as many as ninety Without the face-to-face meetings that record indicating significant deviations percent of his patients. (Tr. 26, 55.) Respondent conducted in no more than in Respondent’s prescribing practices When ascertaining a patient’s identity approximately ten percent of from the usual course of professional before issuing a controlled substance consultations (e.g., Tr. 26, 55)), practice, but further elaboration is prescription, therefore, Respondent Respondent could not objectively assess unnecessary. Respondent ‘‘voluntarily relied almost exclusively on documents whether a person’s appearance as and openly admit[s] that he had issued prescriptions to individuals via the submitted by the patient with no recited in photo identification and Internet whom he had not examined concurrent verification of identity such medical records (to include height, and who were residents of states other as comparing a photo identification weight, sex, hair color and the like) than a state in which Respondent was with the person presenting it. matched the person presenting as a licensed. * * *’’ (Resp’t Br. at 23.) As for how he verified the identity of patient over the telephone. Because patients with whom he never physically Respondent concedes, and I so find by patients submitted their own medical a preponderance of the evidence, that interacted, Respondent testified that ‘‘I records to Respondent’s clinic (Tr. 34; used the same method of checking their ‘‘the Government has established the 79–80), and thus had both the fact that the majority of the identity as I would if they were present opportunity and the inclination to in front of me.’’ (Tr. 54.) Yet Respondent prescriptions by the Respondent during fraudulently modify them (see generally conceded that he never saw most of the his work at [UPR] were not valid.’’ Tr. 56), Respondent’s nearly exclusive people to whom he issued prescriptions (Resp’t Br. at 23.) reliance on his own ability to detect (Tr. 55), undermining the basis for his In partial mitigation, Respondent fraudulent modifications (see Tr. 56), claim. recognizes both that his reliance on Mr. Respondent explained that ‘‘I was even if Respondent was quite skilled in Carr’s advice was misplaced and also rather good at detecting fraud’’ by this regard, was unreasonable under the that Mr. Carr’s 2002 correspondence comparing font and language in circumstances. Indeed, Respondent with the DEA does not excuse his different parts of patient medical conceded that it was possible that a prescribing of controlled substances to records. (Tr. 56.) Respondent added: ‘‘If person posing as a patient could take patients residing in states where he was the state did not adequately check their the medical records and identification not licensed. (Id.) But even if identity before issuing them a driver’s of a deceased person, and Respondent Respondent’s reliance on Mr. Carr’s license * * * I had no way of would have no way of knowing whether advice were deemed to be reasonable, determining that.’’ (Tr. 54.) the person on the phone was actually and I do not so find, such reliance Respondent’s explanation entirely the person whose medical records and would not outweigh the significant misses the point. The question identification Respondent was weight properly given to his issuance of Respondent should have cared about, reviewing. (Tr. 55–56.) Respondent’s thousands of controlled substances but apparently did not, was whether the testimony suggesting that an prescriptions to patients across the person receiving treatment was actually unspecified percentage of his patients country while he was licensed to could not afford traveling to visit practice medicine solely in Florida; his Respondent does not know whether he issued any Respondent in person (e.g., Tr. 79, 116) of the prescriptions alleged in the Complaint, a does not substantially mitigate the 98 Moreover, the weight given to Respondent’s situation he attributes to the sheer number of potential for diversion inherent to testimony in this regard is diminished by prescriptions his PA wrote without authorization. Respondent’s admission that he does not know how (Tr. 41–42.) Respondent’s Internet prescribing much UPR charged. (Tr. 119.)

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routine failure to either conduct Rule 64B8–9.014 (‘‘Standards for entitled ‘‘Standards for Telemedicine physical examinations or consult with a Telemedicine Prescribing Practice’’), Practice.’’ 102 Fla. Admin. Code Ann. r. patient’s primary care physician to consistent with the OSC. (Id. at 3; ALJ 64B15–14.008. The spirit of the rule is ensure that a physical examination was Ex. 1.) I therefore find that the factual to prevent physicians from prescribing conducted recently enough to sustain a issue of Respondent’s compliance with medications with only minimal diagnosis justifying controlled applicable Florida telemedicine diagnosis and documentation. In substances; his misplaced confidence in practices was adequately noticed. addition to constituting grounds for his own ability to detect fraud in More complicated is whether the disciplinary action under Fla. Stat. Ann. medical records, which he obtained Government adequately noticed its § 459.015(1)(x) and (t), directly from patients, when he could intent to rely on provisions of Florida [p]rescribing medications based solely on an have required the records be sent law relevant to standards for electronic medical questionnaire constitutes directly from other practitioners; and telemedicine in seeking the revocation the failure to practice osteopathic medicine his related failure to acknowledge his of Respondent’s COR. As noted above, with that level of care, skill and treatment failures to sufficiently verify the identity the Government’s prehearing statement which is recognized by reasonably prudent of most patients. noticed the issue of Respondent’s osteopathic physicians as being acceptable. For the foregoing reasons, I find by compliance with Florida Administrative *** substantial evidence that Respondent Code Rule 64B8–9.014. That provision, Fla. Admin. Code Ann. r. 64B15–14.008. issued a substantial number of which falls under the subtitle of Before an osteopathic physician may prescriptions for other than a legitimate regulations applicable to allopathic ‘‘provide treatment recommendations, medical purpose or outside the usual physicians, sets forth standards for including issuing a prescription, via course of professional practice and telemedicine prescribing practice in electronic or other means,’’ the rule without establishing a bona fide doctor- Florida. Fla. Admin. Code Ann. r. 64B8– requires: patient relationship, in violation of 9.014. But because subtitle 64B8 of the (1) A documented patient evaluation, Florida law, see Fla. Stat. Ann. Florida Administrative Code governs including history and physical examination, § 459.015(1)(x) (2001); Fla. Stat. Ann. matters pertinent to the Board of adequate to establish the diagnosis for which § 459.015(1)(t) (2001); Fla. Admin. Code [allopathic] Medicine, and Respondent any drug is prescribed. Ann. rr. 64B15–14.005(3)(a) and 64B15– is a doctor of osteopathy, the relevant (2) Sufficient dialogue between the 15.004, and federal law, see 21 CFR Florida administrative provisions osteopathic physician and the patient 1306.04(a); 21 U.S.C. 841(a)(1); governing Respondent’s conduct are regarding treatment options and the risks and Mohammed F. Abdel-Hameed, M.D., 66 located under subtitle 64B15 (‘‘Board of benefits of treatment. FR 61366, 61369 (DEA 2009) and Osteopathic Medicine’’). Rule 64B15– (3) Maintenance of contemporaneous medical records meeting the requirements of Ladapo O. Shyngle, M.D., 74 FR 6056, 14.008 in that subtitle contains a Rule 64B15–15.004, F.A.C. 6057, 6058 (DEA 2009). This finding telemedicine provision that mirrors the weighs heavily in favor of a finding telemedicine provision applicable to Id. In addition to an emergency under Factors Two and Four of 21 allopathic doctors that was actually services provision not applicable here, U.S.C. 823(f) that Respondent’s noticed by the Government. A word-by- the rule finally states that it ‘‘shall not continued registration would be word comparison of Rule 64B8–9.014 be construed to prohibit patient care in inconsistent with the public interest. (telemedicine standards for allopathic consultation with another physician doctors) and Rule 64B15–14.008 who has an ongoing relationship with (e) Adequacy of Notice of Florida (telemedicine standards for osteopathic the patient, and who has agreed to Telemedicine Issue doctors), as codified during the relevant supervise the patient’s treatment, Next at issue is whether the time period of 2004 through 2006 100 including the use of any prescribed Government adequately noticed its (see ALJ Ex. 1) reveals that the two medications. * * *’’ Id. contention that Respondent violated provisions are substantially identical.101 As discussed supra, Respondent on Florida standards for telemedicine Because Respondent thus had actual numerous occasions (Tr. 53 (5000 prescribing practice.99 notice of the legal standards that the controlled substances prescriptions per Regarding the factual basis of the Government alleges that Respondent year)) ‘‘provide[d] treatment Government’s theory, the Government’s violated, I find that the notice provided recommendations, including issuing a prehearing statement calls into issue in this instance was sufficient to apprise prescription, via electronic or other ‘‘the process by which [Respondent] Respondent ‘‘that this allegation would means’’ without conducting patient authorized Internet requests for drugs’’ be litigated.’’ See CBS, 74 FR at 36749. evaluations to include physical including the information he collected, (f) Respondent’s Compliance with examinations or ensuring that such the basis of his diagnosis, his Florida Telemedicine Standards examinations were reliably conducted communication with patients and full On October 16, 2001, Florida enacted by other qualified medical professionals disclosure, among other things. (See a rule applicable to osteopathic doctors (see, e.g., supra text at note 95) and Gov’t PHS, Jun. 18, 2010, at 2–3.) without maintaining medical records Moreover, the Government’s prehearing 100 See Gov’t Ex. 4 (collecting versions of Fla. meeting the requirements of Rule statement also notices its intent to Admin. Code Ann. r. 64B15.4008 from 2004–2006); 64B15–15.004 (see supra text at notes 93 introduce as documentary evidence a see also supra note 60. to 94). Nor did Respondent in more than 101 The only notable differences are as follows. approximately 300 cases (see Tr. 35–36) copy of Florida Administrative Code First, r. 64B15–14.008 inserts the word ‘‘osteopathic’’ at various points to reflect that the out of thousands (Tr. 53) ever act in a 99 The Government’s prehearing statement alleges actor contemplated is an osteopathic physician and violations of Florida telemedicine standards, as not an allopathic physician. Second, r. 64B8–9.014 102 See Florida Department of State: State Library discussed below. Before the Agency may properly explicitly contemplates that PAs may participate in and Archives of Florida, Florida Administrative impose a sanction on the basis of a given allegation, telemedicine practices, whereas r. 64B15–14.008 Weekly & Florida Administrative Code, https:// Agency precedent requires that a registrant be does not. Finally, r. 64B8–9.014, but not r. 64B15– www.flrules.org/gateway/ruleNo.asp?id=64B15- provided a ‘‘ ‘full and fair opportunity’ to litigate 14.008, explicitly defines ‘‘telemedicine’’ as 14.008 (listing enactment date as October 16, 2001, both the factual and legal bases of the Government’s including prescribing via the Internet, telephone or and identifying sole alteration or variance since that theory.’’ CBS Wholesale Distribs., 74 FR 36746, facsimile. Compare Fla. Admin. Code Ann. r. 64B8– time as a variance granted to a Virtual Medical 36750 (DEA 2009). 9.014, with id. r. 64B15–14.008. Group, Inc. on May 26, 2006).

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consultative capacity ‘‘with another as his patients, fraudulently altered Respondent’s testimony supports an physician who ha[d] an ongoing medical files in order to obtain inference that he would continue the relationship with the patient, and who controlled substances. Respondent’s same unreliable and dangerous identity ha[d] agreed to supervise the patient’s actions constituted clear violations of verification practices if permitted to treatment, including the use of any state and federal law. maintain his registration in the future. prescribed medications,’’ Fla. Admin. In light of these essentially See Alra Laboratories, Inc. v. DEA, 54 Code Ann. r. 64B15–14.008. I therefore uncontroverted facts, a remaining issue F.3d 450, 452 (7th Cir. 1995) (an find that Respondent failed to comply in this case is whether Respondent has ‘‘agency rationally may conclude that with Fla. Admin. Code Ann. r. 64B15– adequately accepted responsibility for past performance is the best predictor of 14.008 (‘‘Standards for Telemedicine his past misconduct such that his future performance’’). Practice’’). This finding weighs in favor continued registration might Respondent’s flagrant failures to of a finding under Factors Two and Four nevertheless be consistent with the supervise his PA also bear upon a Factor of 21 U.S.C. § 823(f) that Respondent’s public interest. See Patrick W. Stodola, Five analysis. Respondent, who was continued registration would be 74 FR 20,727, 20,734 (DEA 2009). Medical Director of UPR in 2004 (Resp’t contrary to the public interest. Respondent argues that he has Ex. 12 at 2), possessed both actual ‘‘expressed considerable regret and authority and the legal duty to exercise Factor 5: Such Other Conduct Which remorse for his Internet prescribing and ‘‘responsible supervision and control’’ May Threaten the Public Health and acknowledged its impropriety. * * *’’ over Mr. Protheroe. See, e.g., Fla. Stat. Safety (Resp’t Br. 22.) But across various Ann. § 459.022(2)(e); see also, e.g., Dan Under Factor Five, the Deputy dimensions, the record reveals that E. Hale, D.O., 69 FR 69,402, 69,406 Administrator is authorized to consider Respondent has not sustained his (DEA 2004); Robert G. Hallermeier, ‘‘other conduct which may threaten the burden in this regard. M.D., 62 FR 26,818, 26,820 (DEA 1997); public health and safety.’’ 5 U.S.C. As an initial matter, I reject Jay Wheeler Cranston, M.D., 59 FR 823(f)(5). The Agency has accordingly Respondent’s contention that ‘‘no 36,786, 36,789 (DEA 1994). As held that ‘‘where a registrant has conduct which might threaten the chronicled earlier in this Recommended committed acts inconsistent with the public health and safety has been Decision, Respondent failed to exercise public interest, the registrant must charged and proved.’’ (Resp’t Br. at 22.) this supervisory authority, and at times accept responsibility for his or her Indeed, Respondent’s failure to verify failed to acknowledge that he had it. He actions and demonstrate that he or she the identity of the majority of his permitted Mr. Protheroe to work under will not engage in future misconduct. patients (see Tr. 26, 54–56), as detailed Respondent’s license but did not control Patrick W. Stodola, 74 FR 20,727, above, raises dual specters of diversion Mr. Protheroe’s hours; he did not 20,734 (DEA 2009).103 A ‘‘[r]espondent’s and polypharmacy, both of which control Mr. Protheroe’s work product; threaten the public interest. Respondent lack of candor and inconsistent he did not hire him and did not believe testified that ‘‘I used the same method explanations’’ may serve as a basis for he could fire him. (Tr. 37.) Mr. of checking [new patients’] identity as I denial of a registration. John Stanford Protheroe wrote at least 14,000 would if they were present in front of Noell, M.D., 59 FR 47,359, 47,361 (DEA unauthorized prescriptions in me.’’ (Tr. 54.) To the contrary, 1994). Additionally, ‘‘[c]onsideration of Respondent’s name (Tr. 80; see Respondent never saw most of the the deterrent effect of a potential generally Tr. 132; Gov’t Ex. 10 at 84–85), people to whom he issued sanction is supported by the CSA’s many of which for controlled substances approximately 5000 prescriptions for purpose of protecting the public (e.g., Resp’t Ex. 12 at 2), while controlled substances per year. (Tr. 52– interest.’’ Joseph Gaudio, M.D., 74 FR Respondent was away from the office 53, 55.) Moreover, patients submitted 10,083, 10,094 (DEA 2009). their own medical records to for an extended period of time (Tr. 121– As discussed above, the substance of Respondent’s clinic (Tr. 34; 79–80), and 22, 132; Gov’t Ex. 10 at 85, 96, 101), in Respondent’s conduct between 2004 they thus had both the opportunity and violation of Fla. Stat. Ann. and 2006 is relatively uncontroverted. the inclination to fraudulently modify § 459.022(4)(e) (prohibiting PAs from Respondent issued, permitted his PA to them (see generally Tr. 56). I find that prescribing controlled substances), as issue or failed to prevent his PA from Respondent’s failure to consistently well as other provisions of law. issuing in Respondent’s name verify patient identities and secure the Respondent fundamentally failed to thousands of controlled substances integrity of patient records weighs in take responsibility for his failure to prescriptions to patients around the favor of a finding that Respondent’s supervise Mr. Protheroe. Respondent country while Respondent was licensed continued registration would be conceded at hearing that he had an to practice medicine only in Florida. contrary to the public interest. obligation to properly supervise Mr. Many of these prescriptions issued Respondent has not demonstrated a Protheroe (Tr. 101; see Resp’t Ex. 9 at 5 without Respondent or a physician credible acknowledgment of his (‘‘physicians should * * * [p]roperly acting at Respondent’s direction ever inadequate patient identity verification supervise physician extenders’’)), and conducting a physical examination, let practices, nor has he demonstrated that stated that he supervised Mr. Protheroe alone seeing the patient. Respondent he will not engage in similar future during the limited times ‘‘when he was infrequently consulted with his misconduct. For example, Respondent’s in the office. * * * ’’ (Gov’t Ex. 10 at patients’ previous doctors, and routinely sole comment in this regard at hearing 105) and not working from home. accepted medical records sent in by offers valuable insight into his outlook: Although these statements show that patients, without requiring that records ‘‘If the state did not adequately check Respondent was aware of his unfulfilled be sent by medical professionals. [his patients’] identity before issuing supervision obligation, they reveal no Moreover, Respondent was aware that them a driver’s license * * * I had no acceptance of responsibility for some of his patients, or people posing way of determining that.’’ (Tr. 54.) Respondent’s failure to discharge it. To Respondent’s testimony misses the the contrary, Respondent’s testimony is 103 See also Hoxie v. DEA, 419 F.3d 477, 484 (6th consistent with blame-shifting: Cir. 2005) (decision to revoke registration point and offers no support for a finding ‘‘consistent with the DEA’s view of the importance that he has accepted responsibility for Q: And so you had an obligation to of physician candor and cooperation.’’) his prior misconduct. To the contrary, properly supervis[e] Mr. Protheroe?

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A: Yes, sir. I freely admit that he was not than the laws in the State of Florida. (Tr. Tr. 164.) Respondent ultimately adequately supervised. But he was kept away 63.) That Respondent eventually chose conceded in his testimony that Mr. from me and I did not hire or fire him. I to discontinue his illegal Internet Carr’s assurances were inaccurate. (Tr. supervised him as much as I could to my prescribing practices (Tr. 91; see also 110–11; see Resp’t Br. at 25.) ability. But, yes, I agree that it wasn’t enough. (Tr. 101.) Resp’t Br. at 24) does not, without more, But Respondent’s acknowledgements show that Respondent’s continued are too little; and because many of them Respondent testified that he regrets registration would be consistent with precede or follow Respondent’s own his relationship with Mr. Protheroe. the public interest. contradictory testimony, they arrive too ‘‘[I]t’s so soured me on the experience Respondent also attempted to shift late. On the topic of telemedicine that I’ve never hired any physician’s responsibility for his own professional standards, for example, even if assistants since and I don’t think I ever misconduct to Mr. Carr. As an initial Respondent’s equivocal statements are will.’’ (Tr. 108–09.) But even viewed in matter, Respondent’s claim that he read to acknowledge that Florida had a light most favorable to Respondent, reasonably relied on ‘‘a letter shown me enacted a telemedicine regulation as this statement offers no credible basis to from the DEA giving permission to’’ early as 2004, Respondent still has not conclude that Respondent engage in the controversial telemedicine demonstrated that he accepts acknowledges and accepts practices here at issue (Tr. 59–60, 110; responsibility for his failures to comport responsibility for his failure to see also Tr. 89–92) is not credible. The with those standards. For instance, supervise, nor is there any basis to reasonableness of Respondent’s reliance Respondent conceded that in hindsight, conclude that if again confronted with on the DEA letter is undermined by the the prescriptions he issued at UPR to the challenges of supervising a fact that the letter concerned the Internet customers ‘‘did not meet the contumacious PA, Respondent would dispensing practices of a pharmacy, not highest standard * * * and I’m sorry.’’ adequately discharge his supervisory the prescribing practices of a physician. (Tr. 63–64.) Similarly, when his obligations. The letter moreover contained caveats attorney asked him whether he now Respondent’s testimony also that ‘‘[m]anagement personnel will knows that his Internet prescribing at consistently downplayed any personal verify several elements including * * * UPR was not consistent with the law as role that Respondent played in failing to professional licensure[,] DEA it was at that time, Respondent comply, or that he should have played registration[, l]egitimate patient/ answered ‘‘Absolutely.’’ (Tr. 91–92.) But in complying, with state and federal PA prescriber relationship[, p]rescriptions Respondent undercut his own display of supervision requirements. Even if are issued in the usual course of contrition, elaborating that when he Respondent felt he couldn’t supervise professional practice, and engaged in the prescribing practices that Mr. Protheroe, as a last resort [p]rescriptions are issued for a are the subject of the OSC, he wasn’t Respondent could have withdrawn from legitimate medical purpose.’’ (Tr. 97; doing anything wrong. (Tr. 64–65.) ‘‘[I]f his employment if Mr. Protheroe failed Resp’t Ex. 4 at 1.) Additionally, I thought I was doing anything wrong, to comply with Respondent’s Respondent’s unquestioned reliance on I wouldn’t have done it.’’ (Tr. 65.) Based instructions. Respondent’s failure to do legal advice from Mr. Carr, who on Respondent’s demeanor while so indicates Respondent is willing to Respondent also knew to be president of testifying, I find that this statement, permit the misuse of his DEA UPS, undermines the credibility of along with other similar statements, registration in order to maintain his Respondent’s testimony on this issue. undermines the sincerity of employment, rendering Respondent’s Further defending his reliance on Mr. Respondent’s contrition. registration contrary to the public Carr’s advice, Respondent pointed to the Indeed, Respondent’s feelings of interest. See Alra Laboratories, 54 F.3d Model Guidelines, published by the regret are best characterized not as at 452. Federation of State Medical Boards in regret that he acted contrary to the There are additional areas in which 2002. (See Resp’t Ex. 9 at 3, 7.) public interest, but regret that his poor Respondent could have accepted Paraphrasing a sentence from that choices led to undesirable personal responsibility for his misconduct, but document, Respondent stated that ‘‘the ramifications. Asked if he was regretful didn’t. For instance, rather than admit physician/patient relationship exists and remorseful for the role he played at that, as concluded above, his whether or not there has been a personal UPR in prescribing controlled telemedicine practices were in clear encounter between the physician and substances, Respondent stated: ‘‘Yes, violation of contemporaneous standards the patient.’’ (Tr. 76; see Resp’t Ex. 9 at very much. I sincerely wish I had never (see, e.g., supra text at notes 75–76), 7.) But the Model Guidelines go on to been duped into being any part of their Respondent at hearing attempted to cast state that ‘‘[p]hysicians who treat or operation at all.’’ (Tr. 92.) Moving doubt on the clarity of the rules. prescribe through Internet Web sites are forward, Respondent promised not to Commenting on his understanding of practicing medicine and must possess prescribe for patients in jurisdictions in the patient evaluation standard of care appropriate licensure in all jurisdictions which he lacks a medical license. (Tr. for Internet prescribing practices in where patients reside.’’ (Resp’t Ex. 9 at 111.) Asked by counsel whether he felt 2002 and 2003, for instance, Respondent 12.) At hearing, Respondent conceded remorse for having done so, he said opined that today’s standard is different, that ‘‘given hindsight * * * I don’t ‘‘Yes. Not only am I remorseful about it, but that previously ‘‘the legal think I did fully understand’’ the Model but I feel rather foolish and stupid for community was struggling in a gray area Guidelines when he read them. (Tr. 98.) doing so in retrospect.’’ (Tr. 111.) This to determine what those [standards] Respondent, however, contradicted his last statement, self-serving though it is, would be and now they have decided.’’ former testimony and stated that he arguably cuts in Respondent’s favor. But (Tr. 64.) Somewhat contradicting could not confirm that he actually it is outweighed by Respondent’s himself, Respondent also testified that reviewed the Model Guidelines before subsequent de-emphasis of his own he presently understands that he has an accepting his position with UPR. (Tr. responsibility. I give significant weight obligation to prescribe or dispense 100–01.) In any event, Respondent to Respondent’s candid statement that controlled substances in accordance ultimately conceded that he was ‘‘I was just an hourly employee. I was with all applicable state laws, and that mistaken, and that statements by the just a pawn in the machine.’’ (Tr. 119.) prescribing across state lines sometimes Federation of State Medical Boards do This admission belies Respondent’s includes the application of laws other not carry legal weight. (Tr. 45; see also belief that actors other than Respondent

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are responsible for Respondent’s 19. at 3 ¶ 11); performs physical continued registration would be misconduct. Such a belief is examinations (E.g., Resp’t Ex. 19. at 2 ¶ inconsistent with the public interest. inconsistent with Agency precedent 8; id. at 6 ¶ 3, 5; id. at 19 ¶ 7); discusses requiring a registrant to accept treatment plans and spends between VII. Conclusion and Recommendation responsibility for his actions and fifteen and thirty minutes with patients After balancing the foregoing public demonstrate that he will not engage in (Resp’t Ex. 19. at 2 ¶ 10; id. at 6 ¶ 4, interest factors, I find that the future misconduct. See Patrick W. 7; id. at 9 ¶ 9, 10); reduces patient pain Government has established by Stodola, 74 FR 20,727, 20,734 (DEA medication levels and suggests alternate substantial evidence a prima facie case 2009). treatment methods (Resp’t Ex. 19 at 3 ¶ in support of revoking Respondent’s Respondent contends in mitigation 12; id. at 9 ¶¶ 3–4; see also Tr. 66, 79– COR, based on Factors Two, Four and that ‘‘no patient for whom Dr. Reppy 80); and dismisses patients who fail to prescribed over the Internet suffered any pass drug screens (Resp’t Ex. 19 at 7 ¶ Five of 21 U.S.C. 823(f). damage or harm and there were no 9.) Insomuch, therefore, as Respondent’s Once DEA has made its prima facie mortalities or morbidities, and none of current practice is relevant, Respondent case for revocation or denial, the burden them suffered overdose deaths while he has painted a generally positive picture. shifts to the respondent to show that, was treating them.’’ (Resp’t Br. 6 (citing See Paul J. Caragine, Jr., 63 FR 51,592, given the totality of the facts and Tr. 117, 118).) Although Respondent has 51,601 (DEA 1998) (citing Norman circumstances in the record, revoking or not stayed in touch with all of his Alpert, M.D., 58 FR 67,420 (DEA 1993)) denying the registration would not be patients since he left UPR (Tr. 117), no (‘‘[W]hile passage of time alone is not appropriate. See Morall v. DEA, 412 record evidence contradicts this dispositive it is a consideration in F.3d 165, 174 (D.C. Cir. 2005); assertion. Asked whether any patient assessing whether Respondent’s Humphreys v. DEA, 96 F.3d 658, 661 suffered an overdose death, Respondent registration would be inconsistent with (3d Cir. 1996); Shatz v. United States answered that ‘‘none of them did while the public interest.’’). Viewed in Dep’t of Justice, 873 F.2d 1089, 1091 I was prescribing. If it happened since isolation, Respondent’s medical practice that time, then it happened because (8th Cir. 1989); Thomas E. Johnston, 45 from approximately 2006 to the present FR 72, 311 (DEA 1980). someone else was prescribing it. I can’t weighs somewhat in favor of a finding be responsible for what some other that Respondent’s continued registration Additionally, where a registrant has doctor did.’’ (Tr. 117.) ‘‘I’m sure there would be consistent with the public committed acts inconsistent with the would have been a lawsuit if there was interest. That said, absent acceptance of public interest, he must accept one and I never received any.’’ (Tr. 123.) responsibility for the misconduct, the responsibility for his actions and Respondent ignores the possibility that passage of time alone precludes the demonstrate that he will not engage in his provision of controlled substances to issuance of even a restricted future misconduct. See Patrick W. his former Internet patients could lead registration. ‘‘DEA has long held that Stodola, 74 FR 20,727, 20,735 (DEA to adverse health consequences, for ‘[t]he paramount issue is not how much 2009). Also, ‘‘[c]onsideration of the which Respondent might ultimately time has elapsed since [his] unlawful deterrent effect of a potential sanction is share responsibility. conduct, but rather, whether during that supported by the CSA’s purpose of Respondent also downplays the time * * * Respondent has learned extent to which he could have known of protecting the public interest.’’ Joseph from past mistakes and has patient addictions, arguing that ‘‘[t]here Gaudio, M.D., 74 FR 10,083, 10,094 demonstrated that he would handle is no way to know whether or not (DEA 2009). An agency’s choice of controlled substances properly if patients became addicted’’ to controlled sanction will be upheld unless entrusted with a’ new registration.’’ substances, suggesting he had only a unwarranted in law or without Robert L. Dougherty, M.D., 76 FR 16,823, passive role in the process. (Resp’t Br. justification in fact. A sanction must be 16,835 (DEA 2011) (citing Leonardo v. 6.) Respondent’s testimony reflects a rationally related to the evidence of Lopez, M.D., 54 FR 36,915, 36,915 (DEA misunderstanding of his affirmative record and proportionate to the error 1989) and Robert A. Leslie, M.D., 68 FR responsibility as a prescribing committed. See Morall v. DEA, 412 F.3d 15,227, 15,227 (DEA 2003)). practitioner ‘‘for the proper prescribing 165, 181 (D.C. Cir. 2005). Finally, an and dispensing of controlled To be certain, Respondent’s voluntary ‘‘agency rationally may conclude that substances.’’ 104 retreat from a telemedicine pain practice past performance is the best predictor of In mitigation, more recent conduct in favor of his current practice provides future performance.’’ Alra Laboratories, at least some indication that Respondent does weigh in Respondent’s favor. First, Inc. v. DEA, 54 F.3d 450, 452 (7th Cir. will avoid, or limit, the circumstances substantial evidence supports a finding 1995). that a significant period of time has underlying the misconduct alleged in I recommend revocation of elapsed without incident since the the instant case. But beyond stating that Respondent’s COR BR5287342 and period of time embracing the unlawful the prescriptions he issued at UPR to denial of any pending applications for conduct at issue here. Two of Internet customers ‘‘did not meet the renewal or modification, and any Respondent’s employees and two of his highest standard * * * and I’m sorry’’ patients affirmed that Respondent: (Tr. 63–64), Respondent provides applications for a new COR. I find the personally sees patients and reviews limited credible assurance that if given evidence as a whole demonstrates that patient records (Resp’t Ex. 19. at 2 ¶¶ the opportunity he would not simply Respondent has not accepted 5–7); requires that new patients produce repeat the same mistakes he made in the responsibility, and Respondent’s recent prior medical records (Resp’t Ex. past. continued registration would be In light of the foregoing, Respondent’s inconsistent with the public interest. 104 21 CFR 1306.04(a) (2010); see also Fla. Admin. evidence as a whole fails to sustain his Dated: March 31, 2011 Code Ann. r. 64B15–14.005(3)(a) (2000) (‘‘complete burden to credibly accept responsibility medical history and physical examination must be for his misconduct and demonstrate that Timothy D. Wing, conducted and documented in the medical Administrative Law Judge. record.’’). See generally Fla. Admin. Code Ann. r. he will not engage in future misconduct. [FR Doc. 2011–25229 Filed 9–30–11; 8:45 am] 64B15–15.004 (Dec. 22, 1997) (‘‘Written Records; I find that Factor Five weighs in favor Minimum Content; Retention’’). of a finding that Respondent’s BILLING CODE 4410–09–P

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Part III

Department of Energy

Western Area Power Administration Loveland Area Projects—Western Area Colorado Missouri Balancing Authority—Rate Order No. WAPA–155; Notice; Republication

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DEPARTMENT OF ENERGY (970) 461–7211, e-mail losses on all real-time and prescheduled [email protected]. transactions on transmission facilities Western Area Power Administration SUPPLEMENTARY INFORMATION: The inside WACM. Loveland Area Projects—Western Area Deputy Secretary of Energy approved Ancillary Services Colorado Missouri Balancing current Rate Schedules L–NT1, L–FPT1, Authority—Rate Order No. WAPA–155 L–NFPT1, L–AS1, L–AS2, L–AS3, L– Western will provide seven ancillary AS4, L–AS5, L–AS6, and L–AS7 on services pursuant to its Tariff. These are: Republication December 30, 2003 (Rate Order No. (1) Scheduling, System Control, and WAPA–106, 69 FR 1723, January 12, Dispatch Service (L–AS1); (2) Reactive 1 Editorial Note: FR Doc. 2011–23391 was 2004). These rates became effective on Supply and Voltage Control from originally published on pages 56433–56452 March 1, 2004, with an expiration date in the issue of Tuesday, September 13, 2011. Generation or Other Sources Service (L– of February 28, 2009. The rate AS2); (3) Regulation and Frequency In that publication an incorrect version of schedules, with the exception of Rate this document was published. The corrected Response Service (L–AS3); (4) Energy Schedule L–AS3, Regulation and document is republished below in its Imbalance Service (L–AS4); (5) entirety. Frequency Response, were extended through February 28, 2011, under Rate Spinning Reserve Service (L–AS5); (6) AGENCY: Western Area Power Order No. WAPA–141.2 Rate Schedule Supplemental Reserve Service (L–AS6); Administration, DOE. L–AS3 was revised and approved under and (7) Generator Imbalance Service (L– ACTION: Notice of order concerning Rate Order No. WAPA–118,3 which AS9). Generator Imbalance Service is transmission and ancillary services became effective on June 1, 2006, with also a new rate schedule established formula rates. an expiration date of May 31, 2011. under the Tariff. Currently, Generator Under Rate Order No. WAPA–154,4 all Imbalance Service is provided under SUMMARY: The Deputy Secretary of LAP transmission and WACM ancillary Rate Schedule L–AS4, Energy Imbalance Energy has confirmed and approved services rate schedules, including L– Service. Rate Order No. WAPA–155 and Rate AS3, were extended through February Rates for LAP transmission and Schedules L–NT1, L–FPT1, L–NFPT1, 28, 2013. L–AS1, L–AS2, L–AS3, L–AS4, L–AS5, ancillary services will be recalculated L–AS6, L–AS7, L–AS9, and L–UU1, LAP Transmission Service each year to incorporate the most recent placing Loveland Area Projects (LAP) Rate Schedules L–NT1, L–FPT1, and financial, load, and schedule transmission and Western Area L–NFPT1 for LAP transmission services information and will be applicable to all Colorado Missouri (WACM) Balancing are based on a revenue requirement that transmission and ancillary services Authority ancillary services formula recovers the LAP transmission system customers. rates into effect on an interim basis. The costs for facilities associated with By Delegation Order No. 00–037.00, provisional formula rates will be in providing all transmission services as effective December 6, 2001, the effect until the Federal Energy well as the non-transmission facility Secretary of Energy delegated (1) the Regulatory Commission (FERC) costs allocated to transmission services. authority to develop power and confirms, approves, and places them These firm and non-firm LAP transmission rates to the Administrator into effect on a final basis or until they transmission service rates include the of Western; (2) the authority to confirm, are replaced by other formula rates. The costs for scheduling, system control, approve, and place such rates into effect provisional formula rates will provide and dispatch service needed to provide on an interim basis to the Deputy sufficient revenue to pay all annual the transmission service. Secretary of Energy; and (3) the Rate Schedule L–UU1, Unreserved costs, including interest expense, and to authority to confirm, approve, and place repay power investment within the Use Penalties, is a new rate schedule into effect on a final basis, to remand, allowable periods. established in accordance with Western’s Open Access Transmission or to disapprove such rates to FERC. DATES: Rate Schedules L–NT1, L–FPT1, Existing Department of Energy L–NFPT1, L–AS1, L–AS2, L–AS3, L– Tariff (Tariff). This rate will recover costs for transmission service that has procedures for public participation in AS4, L–AS5, L–AS6, L–AS7, L–AS9, power rate adjustments (10 CFR 903) and L–UU1 will be placed into effect on not been reserved or has been used in excess of the amount reserved. Rate were published on September 18, 1985 an interim basis on the first day of the (50 FR 37835). first full billing period beginning on or Schedule L–UU1 also provides for a after October 1, 2011, and will remain penalty in addition to the base charge Under Delegation Order Nos. 00– in effect until FERC confirms, approves, for the transmission service used. 037.00 and 00–001.00C, 10 CFR part and places the rate schedules into effect Previously, a penalty for unauthorized 903, and 18 CFR part 300, I hereby on a final basis for a 5-year period use of transmission was included in the confirm, approve, and place Rate Order ending September 30, 2016, or until the Point-to-Point Transmission Service, No. WAPA–155, the proposed LAP rate schedules are superseded. Rate Schedules L–FPT1 and L–NFPT1. transmission and WACM ancillary Rate Schedule L–AS7, Transmission services formula rates, into effect on an FOR FURTHER INFORMATION CONTACT: Mr. Losses Service, is designed to recover Bradley S. Warren, Regional Manager, interim basis. By this order, I am placing Rocky Mountain Customer Service 1 WAPA–106 was approved by FERC on a final the rates into effect in less than 30 days Region, Western Area Power basis on January 31, 2005, in Docket No. EF2–04– to meet contract deadlines, to avoid Administration, 5555 East Crossroads 5182–000 (110 FERC ¶ 62,084). financial difficulties, and to provide 2 WAPA–141, Extension of Rate Order No. rates for new services. The revised Rate Boulevard, Loveland, CO 80538–8986, WAPA–106 through February 28, 2011. 73 FR telephone (970) 461–7201, or Mrs. 48382, August 19, 2008. Schedules L–NT1, L–FPT1, L–NFPT1, Sheila D. Cook, Rates Manager, Rocky 3 WAPA–118 was approved by FERC on a final L–AS1, L–AS2, L–AS3, L–AS4, L–AS5, Mountain Customer Service Region, basis on November 17, 2006, in Docket No. EF–06– L–AS6, L–AS7, L–AS9, and L–UU1 will Western Area Power Administration, 5182–000 (117 FERC ¶ 62,163). be submitted promptly to FERC for 4 WAPA–154, Extension of Rate Order Nos. 5555 East Crossroads Boulevard, WAPA–106 and WAPA–118 through February 28, confirmation and approval on a final Loveland, CO 80538–8986, telephone 2013. 76 FR 1429, January 10, 2011. basis.

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Dated: September 2, 2011. functions of the Secretary of the Interior approve, and place such rates into effect Daniel B. Poneman, and the Bureau of Reclamation on an interim basis to the Deputy Deputy Secretary. (Reclamation) under the Reclamation Secretary of Energy; and (3) the Act of 1902 (ch. 1093, 32 Stat. 388), as Order Confirming, Approving, and authority to confirm, approve, and place amended and supplemented by into effect on a final basis, to remand, Placing the Loveland Area Projects subsequent laws, particularly section Transmission and Western Area or to disapprove such rates to the 9(c) of the Reclamation Act of 1939 (43 Federal Energy Regulatory Commission Colorado Missouri Balancing Authority U.S.C. 485h(c)) and section 5 of the Ancillary Services Formula Rates Into (FERC). Existing DOE procedures for Flood Control Act of 1944 (16 U.S.C. public participation in power rate Effect on an Interim Basis 825s), and other acts that specifically adjustments (10 CFR part 903) were These transmission and ancillary apply to the projects involved. services formula rates are established By Delegation Order No. 00–037.00, published on September 18, 1985. pursuant to section 302 of the effective December 6, 2001, the Acronyms/Terms and Definitions Department of Energy (DOE) Secretary of Energy delegated: (1) The Organization Act (42 U.S.C. 7152). This authority to develop power and As used in this Rate Order, the act transferred to and vested in the transmission rates to the Administrator following acronyms/terms and Secretary of Energy the power marketing of Western; (2) the authority to confirm, definitions apply:

Acronym/Term Definition

$/kW-month: Dollars per kilowatt per month. 12-cp: Rolling 12-month average of customers’ loads in excess of Federal Entitlement, coinci- dent with the Loveland Area Projects (LAP) transmission system peak. Administrator: The Administrator of the Western Area Power Administration. Area Control Error (ACE): The instantaneous difference between a Balancing Authority’s net actual and scheduled interchange, taking into account the effects of frequency bias and correction for meter error. Ancillary Services: Those services that are necessary to support the transmission of capacity and energy from resources to loads while maintaining reliable operation of the Transmission Pro- vider’s transmission system in accordance with good utility practice. ATRR: Annual transmission revenue requirement. Automatic Generation Control: Equipment that automatically adjusts generation in a Balancing Authority area from a central location to maintain the Balancing Authority’s interchange schedule plus fre- quency bias. Balancing Authority: The responsible entity that integrates resource plans ahead of time, maintains load-inter- change-generation balance within a Balancing Authority area, and supports inter- connection frequency in real time. Control Area: The term used for a Balancing Authority area in Western’s Open Access Transmission Tariff. CRSP: Colorado River Storage Project. DOE: Department of Energy. Energy Imbalance Service: The ancillary service in which the Balancing Authority corrects hourly for the difference between a customer’s energy supply and energy usage. Federal Customers: LAP customers taking delivery of long-term firm service under firm electric service con- tracts, project use, and special use contracts. Firm Electric Service Contracts: Contracts for the sale of long-term firm LAP Federal energy and capacity, pursuant to the Post-1989 General Power Marketing and Allocation Criteria (Marketing Plan). Firm Point-to-Point Transmission Service: The highest priority transmission service offered to customers on a specified path that anticipates no planned interruption. Federal Entitlements: The energy and capacity delivered to Federal Customers under Firm Electric Service Contracts. FERC: Federal Energy Regulatory Commission. Fry-Ark: Fryingpan-Arkansas Project. FY: Fiscal Year, October 1 through September 30. Generator Imbalance Service: The ancillary service in which the Balancing Authority corrects hourly for the difference between a customer’s actual generation and scheduled generation. kW: Kilowatt. The electrical unit of capacity equal to 1,000 watts. kWh: Kilowatt-hour. The electrical unit of energy equal to 1 kW produced or delivered for 1 hour. kW-month: Kilowatt-month. The electrical unit of energy equal to 1 kW produced or delivered for 1 month. LAP: Loveland Area Projects. LAP Transmission System or Service: Transmission system operated by, or service provided by, the Loveland Area Projects. LAP Transmission System Total Load: Sum of 12-cp averages for all customer loads for Network Integration Transmission Service, plus 12-month rolling average of monthly entitlements of Federal Customers, plus reserved capacity for all Long-Term Firm Point-to-Point Transmission Service. Load ratio share: Network Transmission Customer’s 12-cp load coincident with LAP’s monthly trans- mission system peak, expressed as a ratio. Load Serving Entity (LSE): An entity within the Balancing Authority that secures energy and transmission service (and related interconnected operations services) to serve the electrical demand and energy requirements of its end-use customers. Long-Term Firm Point-to-Point Transmission Service: Firm Point-to-Point Transmission Service reservation for a duration of at least 12 con- secutive months.

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Acronym/Term Definition

Losses: The reduction of power being delivered as it moves across transmission lines or other equipment, due to resistance in the conducting material. M&I: Municipal and Industrial. Mill: Unit of monetary value equal to .001 of a U.S. dollar; i.e., 1⁄10 of a cent. Mills/kWh: Mills per kilowatt-hour. Monthly Entitlements: Maximum capacity to be delivered each month under Firm Electric Service Contracts. Each monthly entitlement is a percentage of the seasonal contract-rate-of-delivery. MW: Megawatt. The unit of electrical capacity that equals 1,000 kW or 1,000,000 watts. NERC: North American Electric Reliability Corporation. Network Integration Transmission Service: Firm transmission service for the delivery of capacity and energy from designated net- work resources to designated network loads not using one specific path. Non-Firm Point-to-Point Transmission Service: Point-to-point transmission service reserved on an as-available basis for periods ranging from 1 hour to 1 year. Open Access Same Time Information System An electronic posting system that the Transmission Provider maintains for transmission (OASIS): access data that allows all transmission customers to view the data simultaneously. Operating Reserve—Spinning Reserve Service: Generation capacity needed to serve load immediately in the event of a system contin- gency. Spinning Reserve Service may be provided by generating units that are on-line and loaded at less than maximum output. Operating Reserve—Supplemental Reserve Service: Generation capacity needed to serve load in the event of a system contingency, which capacity is not available immediately to serve load but rather within a short period of time. Supplemental Reserve Service may be provided by generation units that are on- line but unloaded, by quick start generation, or by interruptible load. Provisional Formula Rate: A formula rate that has been confirmed, approved, and placed into effect on an interim basis by the Deputy Secretary. P–SMBP: Pick-Sloan Missouri Basin Program. P–SMBP—WD: Pick-Sloan Missouri Basin Program—Western Division. RMR: Rocky Mountain Customer Service Region. Reactive Supply and Voltage Control from Genera- The ancillary service under which a Balancing Authority operates generation facilities tion or Other Sources Service: under its control to produce or absorb reactive power to maintain voltages on all trans- mission facilities within acceptable limits. Reclamation: The United States Bureau of Reclamation. Regulation and Frequency Response Service: The ancillary service under which a Balancing Authority maintains moment-by-moment load-interchange-generation balance with the Balancing Authority area and supports interconnection frequency. Scheduling, System Control, and Dispatch Service: The ancillary service under which a Balancing Authority sets up an arrangement for an energy interchange transaction for delivery and receipt of energy between the two enti- ties involved in the transaction. Service Agreement: The initial agreement and any amendments or supplements entered into by a Trans- mission Customer and Western for service under the Tariff. Short-Term Firm Point-to-Point Transmission Service: Firm Point-to-Point Transmission Service for a duration of less than 12 consecutive months. Sub-Balancing Authority: An area within a Balancing Authority area which has its own boundary metering scheme and for which an ACE can be measured. Tariff: Western’s revised Open Access Transmission Service Tariff, effective December 1, 2009 (Docket NJ10–1–000). Transmission Customer: The RMR customer taking Network Integration Transmission Service or Point-to-Point Transmission Service. Transmission Losses Service: The service provided by the Balancing Authority to supply electrical losses on pre-sched- uled and real-time transmission transactions. Transmission Provider: An entity that administers a transmission tariff and provides transmission service to transmission customers under applicable transmission service agreements. Unreserved Use Penalties: The use of transmission capacity that was not reserved, or the use of transmission in ex- cess of reserved capacity. WACM: Western Area Colorado Missouri Balancing Authority. WECC: Western Electricity Coordinating Council. Western: Western Area Power Administration.

Effective Date Extensions, 10 CFR Part 903, in the questions asked at the meeting, on its development of these formula rates and Web site at http://www.wapa.gov/rm/ The Provisional Formula Rates will schedules. The steps Western took to take effect on the first day of the first ratesRM/2012/default.htm. full billing period beginning on or after involve interested parties in the rate 2. Western published a Federal October 1, 2011, and will remain in process were: Register notice on January 28, 2011 (76 effect through September 30, 2016, 1. On September 29, 2010, Western FR 5148), officially announcing the pending approval by FERC on a final held an informal meeting with proposed LAP Transmission and basis. customers and interested parties to WACM Ancillary Services formula rates discuss the proposed formula rates for Public Notice and Comment adjustment, initiating the public LAP Transmission and WACM consultation and comment period, Western has followed the Procedures Ancillary Services. Western posted all announcing the date and location of the for Public Participation in Power and information presented at the informal public information and public comment Transmission Rate Adjustments and meeting, as well as responses to

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forums, and outlining procedures for with the P–SMBP for power marketing, New Mexico, Utah, and Wyoming) public participation. operation, and repayment purposes. The while still maintaining water deliveries 3. On February 2, 2011, Western sent Colorado-Big Thompson, Kendrick, to the states of the Lower Basin a letter to all interested parties Riverton, and Shoshone Projects were (Arizona, California, and Nevada) as providing them with a copy of the combined with P–SMBP in 1954, required by the Colorado River Compact Federal Register notice published on followed by the North Platte Project in of 1922. CRSP hydroelectric facilities January 28, 2011 (76 FR 5148). 1959. These projects are known as the providing ancillary services for WACM 4. On March 9, 2011, Western held its ‘‘Integrated Projects’’ of the P–SMBP. are the Aspinall power plant (formerly public information forum in Loveland, The Riverton Project was reauthorized Curecanti) on the Gunnison River, the Colorado, where Western as a unit of the P–SMBP in 1970. Flaming Gorge power plant on the representatives explained the need for Together, the P–SMBP—WD and the Green River, the Towaoc Power Plant on the formula rates adjustment in detail Integrated Projects have 19 power the Towaoc Canal in southwestern and answered questions. plants. Colorado, and the Glen Canyon power 5. On March 9, 2011, following the There are six power plants in P– plant on the Colorado River. public information forum, Western held SMBP—WD: Glendo, Kortes, and a public comment forum in Loveland, Fremont Canyon power plants on the LAP Transmission Service Colorado, to provide an opportunity for North Platte River; Boysen and Pilot Transmission formula rates, including customers and other interested parties Butte power plants on the Wind River; those for Firm and Non-Firm Point-To- to comment for the record. At this and Yellowtail power plant on the Big Point Transmission Service and forum, one individual expressed general Horn River. The Colorado-Big Network Integration Transmission support of Western’s efforts to Thompson Project has six power plants: Service, are designed to recover the communicate with its customers well in Green Mountain power plant on the annual costs of the LAP Transmission advance of implementation of the Blue River is on the West Slope of the System. The transmission rates include proposed rates. Continental Divide; and Mary’s Lake, the cost of Scheduling, System Control, 6. Western received one written Estes, Pole Hill, Flatiron, and Big and Dispatch Service. Western will comment during the 90-day Thompson power plants along the Big continue to bundle transmission service consultation and comment period, Thompson River are on the East Slope for delivery of LAP long-term firm which ended on April 28, 2011. This of the Continental Divide. The Kendrick Federal power to Federal Customers in comment is addressed below following Project has two power plants: Alcova the firm electric service rate under the ancillary services discussion. and Seminoe power plants on the North existing Firm Electric Service Contracts All comments received have been Platte River. Power plants in the that expire in 2024. considered in the preparation of this Shoshone Project are the Shoshone, The penalty for unauthorized use of Rate Order. Buffalo Bill, Heart Mountain, and Spirit transmission, currently assessed under Mountain plants on the Shoshone River. Project Descriptions the Point-to-Point Transmission rate The only power plant in the North schedules, will now be assessed as a The Post-1989 General Power Platte Project is the Guernsey power penalty for unreserved use under a Marketing and Allocation Criteria, plant, also on the North Platte River. published in the Federal Register on separate rate schedule, L–UU1. January 31, 1986 (51 FR 4012), Fry-Ark Unreserved Use Penalties will include integrated the resources of the P– Fry-Ark is a trans-mountain diversion the basic rate for the transmission SMBP—WD and Fry-Ark. This development in southeastern Colorado service used and not reserved, plus a operational and contractual integration, authorized by the Act of Congress on penalty equal to the basic rate. known as LAP, allowed an increase in August 16, 1962 (Pub. L. 87–590, 76 Transmission losses are assessed for marketable resources, simplified Stat. 389, as amended by Title XI of the all real-time and prescheduled contract administration, and established Act of Congress on October 27, 1974 transactions on transmission facilities a blended rate for LAP power sales. (Pub. L. 93–493, 88 Stat. 1486, 1497)). inside WACM. The current loss factor, WACM offers Ancillary Services from a The Fry-Ark diverts water from the as posted on the RMR OASIS, is 4.5 combination of all LAP generation Fryingpan River and other tributaries of percent. resources and some CRSP generation the Roaring Fork River in the Colorado WACM Ancillary Services resources. River Basin on the West Slope of the Rocky Mountains to the Arkansas River Western will offer seven Ancillary P–SMBP—WD on the East Slope. The water diverted Services pursuant to its Tariff. The The P–SMBP was authorized by from the West Slope, together with seven Ancillary Services are: (1) Congress in section 9 of the Flood regulated Arkansas River water, Scheduling, System Control, and Control Act of December 22, 1944 (Pub. provides supplemental irrigation and Dispatch Service (SSCD Service); (2) L. 534, 58 Stat. 877, 891). This M&I water supplies and produces Reactive Supply and Voltage Control multipurpose program provides flood hydroelectric power. Flood control, fish from Generation or Other Sources control, M&I water supply, irrigation, and wildlife enhancement, and Service (VAR Support Service); (3) navigation, recreation, preservation and recreation are other important purposes Regulation and Frequency Response enhancement of fish and wildlife, and of Fry-Ark. The only generating facility Service (Regulation Service); (4) Energy hydroelectric power. Multipurpose in Fry-Ark is the Mt. Elbert Pumped- Imbalance Service; (5) Spinning Reserve projects have been developed on the Storage power plant on the East Slope. Service; (6) Supplemental Reserve Missouri River and its tributaries in Service; and (7) Generator Imbalance Colorado, Montana, Nebraska, North CRSP Service. Generator Imbalance Service, Dakota, South Dakota, and Wyoming. CRSP was authorized by the Colorado currently provided as part of Rate In addition to the multipurpose water River Storage Project Act, ch. 203, 70 Schedule L–AS4 for Energy Imbalance projects authorized by section 9 of the Stat. 105, on April 11, 1956. The project Service, is a new service under the Flood Control Act of 1944, certain other provides water-use developments for Tariff. The Ancillary Services formula existing projects have been integrated states in the Upper Basin (Colorado, rates are designed to recover only the

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costs incurred for providing the Comparison of Existing and Provisional and the Provisional Formula Rates for service(s). Formula Rates for Transmission and FY 2012. These rates will be Ancillary Services recalculated annually based on updated The following table displays a financial, schedule, and load data. comparison of existing formula rates

FORMULA RATE COMPARISON TABLE

Provisional Formula Rates Existing Formula Rates Class of Service Effective October 1, 2011 (FY 2012) Effective October 1, 2010 (FY 2011)

Network Integration Transmission L–NT1 L–NT1 Service Load ratio share of 1/12 of the revenue requirement Load ratio share of 1/12 of the revenue requirement of $56,775,913. of $48,000,660.

Firm Point-to-Point Transmission L–FPT1 L–FPT1 Service $3.48/kW-month $3.18/kW-month Unauthorized Use Penalty of 150% of demand charge, with a maximum of monthly service.

Non-Firm Point-to-Point Trans- L–NFPT1 L–NFPT1 mission Service Maximum of 4.77 mills/kWh Maximum of 4.17 mills/kWh Unauthorized Use Penalty of 150% of demand charge, with a maximum of monthly service.

Unreserved Use Penalties L–UU1 Provided Under Rate Schedules L–FPT1 and L– Penalized 200% of demand charge, with a maximum NFPT1 as Unauthorized Use. of monthly service.

Transmission Losses Service L–AS7 L–AS7 Transmission losses may be settled either financially Transmission losses may be settled either financially or with energy. Insufficient losses supplied will be or with energy. Insufficient losses supplied will be settled financially by default. settled financially by default. All customers will have the option to return the loss All customers will have the option to return the loss obligation for both prescheduled and real-time obligation for both prescheduled and real-time transactions 7 days later, same profile. transactions 7 days later, same profile. Pricing used is WACM weighted average hourly pur- Pricing used is LAP weighted average hourly real- chase price. time purchase price. Current loss factor as posted is 4.5%. Current loss factor as posted is 4.5%. Scheduling, System Control, and L–AS1 L–AS1 Dispatch Service $24.22 per schedule per day for non-Federal trans- $38.30 per tag per day for non- mission customers. Not applicable to schedules for Federal transmission customers. Applicable to all delivery of Losses to WACM. tags.

Reactive Supply and Voltage L–AS2 L–AS2 Control from Generation or $0.305/kW-month $0.180/kW-month Other Sources Service

Regulation and Frequency Re- L–AS3 L–AS3 sponse $0.331/kW-month $0.339/kW-month

Energy Imbalance Service L–AS4 L–AS4 —Imbalances less than or equal to 1.5% (minimum 4 —Imbalances less than or equal to 5% (minimum 4 MW) of metered load settled using WACM hourly MW) of metered load settled using WACM hourly pricing with no penalty. pricing with no penalty. —Imbalances between 1.5% and 7.5% (minimum 4 —Imbalances greater than 5% of metered load set- MW to 10 MW) of metered load settled using tled using WACM hourly pricing with a 10% pen- WACM hourly pricing with a 10% penalty. alty. —Imbalances greater than 7.5% (minimum 10 MW) —WACM aggregate imbalance dictates pricing in no- of metered load settled using WACM hourly pricing penalty band. Customer imbalance dictates pricing with a 25% penalty. in penalty band (surpluses indicate sale pricing, —WACM aggregate imbalance determines pricing in deficits indicate purchase pricing). all bands—aggregate surplus dictates sale pricing, —Intermittent resources not subject to penalties. aggregate deficit dictates purchase pricing.

Operating Reserve Service— L–AS5, L–AS6 L–AS5, L–AS6 Spinning and Supplemental Long-term Reserves are not available from WACM. Long-term Reserves are not available from WACM. Reserves may be acquired and provided at pass- Reserves may be acquired and provided at pass- through cost, plus an amount for administration. through cost, plus an amount for administration.

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FORMULA RATE COMPARISON TABLE—Continued

Provisional Formula Rates Existing Formula Rates Class of Service Effective October 1, 2011 (FY 2012) Effective October 1, 2010 (FY 2011)

Generator Imbalance Service L–AS9 Provided under Rate Schedule L–AS4. —Imbalances less than or equal to 1.5% (minimum 4 MW) of metered generation settled using WACM hourly pricing with no penalty. —Imbalances between 1.5% and 7.5% (minimum 4 MW to 10 MW) of metered generation settled using WACM hourly pricing with a 10% penalty. —Imbalances greater than 7.5% (minimum 10 MW) of metered generation settled using WACM hourly pricing with a 25% penalty. —Intermittent resources not subject to 25% penalties. —WACM aggregate imbalance determines pricing in all bands—aggregate surplus dictates sale pricing, aggregate deficit dictates purchase pricing.

Certification of Rates AS9, and L–UU1 are the lowest possible LAP Transmission Service Discussion rates consistent with sound business Western’s Administrator certified that Network Integration Transmission principles. The Provisional Formula Service the Provisional Formula Rates for LAP Rates were developed following Transmission and WACM Ancillary administrative policies and applicable The monthly charge for Network Services under Rate Schedules L–NT1, laws. Integration Transmission Service for the L–FPT1, L–NFPT1, L–AS1, L–AS2, L– Transmission Customer will be as AS3, L–AS4, L–AS5, L–AS6, L–AS7, L– follows:

The customer’s load-ratio share is the a rolling 12-month average (12 Firm Point-to-Point Transmission ratio of its network load to the LAP coincident peak average or 12-cp). Service Transmission System Total Load at the The formula rate for Firm Point-to- LAP system peak. This is calculated on Point Transmission Service is as follows:

The rates for FY 2012 are as follows:

Discussions of the ATRR and the LAP Non-Firm Point-to-Point Transmission Point-to-Point Transmission Service is Transmission System Total Load are Service available for periods ranging from 1 located below. The maximum Non-Firm Point-to- hour to 1 year. Point Transmission Service formula rate Maximum Hourly Non-Firm Rate: 4.77 is the same as the Firm Point-to-Point mills/kW of reserved capacity per Transmission Service rate. Non-Firm hour

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Annual Transmission Revenue Transmission Service. The ATRR is the charges or credits, and the prior year Requirement annual cost of the LAP Transmission true-up. The formula, with amounts System, adjusted for revenue credits, calculated for the FY 2012 rate, is as The ATRR is applicable to both costs that increase the capacity available follows: Network and Point-to-Point for transmission, other miscellaneous

The annual cost of the LAP facilities multiplied by the total annual calculation, with amounts for FY 2012, Transmission System is the ratio of costs for all facilities. Total annual costs is as follows: gross investment cost for transmission include operations and maintenance, facilities to gross investment cost for all interest, and depreciation expenses. The

The source for the annual costs is the System, these are primarily the 115-kV distribution systems, an additional formalized work plans for FY 2012 and and the 230-kV transmission lines. In facility-use charge will be assessed. All the FY 2010 Results of Operations for P– addition, portions of the Fry-Ark costs are considered generation- SMBP—WD, with certain items adjusted communication, maintenance, and related and, therefore, are excluded for projected asset capitalization or administration facilities are included in from the ATRR. historical trends. See discussion below the investment costs for transmission. System augmentation expense on ‘‘Change to Forward-Looking Only the investment costs of the includes payments made to others for Transmission Rates.’’ facilities identified as ‘‘transmission’’, The gross investment cost for including allocated costs for their systems’ augmentation of the LAP transmission facilities is determined by communication, maintenance, and Transmission System. Miscellaneous an analysis of the LAP Transmission administration facilities, are used in charges and credits will include, but System. Each LAP facility is classified developing the annual cost of the will not be limited to, Unreserved Use by function: transmission, sub- transmission system. The investment Penalties and facility use charges for transmission, distribution, or costs of facilities identified as ‘‘sub- transmission facility investments generation-related. The facilities transmission’’ and ‘‘distribution’’ are included in the revenue requirement. identified as performing the function of excluded from the ATRR, as the LAP For a description of the prior year true- transmission include all transmission sub-transmission and distribution up, see discussion below on ‘‘Change to lines that are normally operated in a systems are used primarily for delivery Forward-Looking Transmission Rates.’’ continuously-looped manner and the of Federal power to Federal Customers. associated substations and switchyard If a Transmission Customer requires the facilities. In the LAP Transmission use of the sub-transmission or

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Change to Forward-Looking LAP Transmission System Transmission Losses Service Total Load ...... 1,358,342 kW Transmission Rates Transmission Losses are assessed for Western has changed the method it Unreserved Use Penalties all real-time and prescheduled uses to calculate the ATRR to recover transactions on transmission facilities transmission expenses and investments Unreserved use of the transmission inside WACM. In the case of Network on a current basis rather than a system (Unreserved Use) occurs when a Integration Transmission Service historical basis. The change allows Transmission Customer uses Customers, transmission and Western to more accurately match cost transmission service that exceeds its transformer Losses applicable under recovery with cost incurrence. Western reserved capacity or an eligible customers’ respective contracts are will use projections to estimate customer uses transmission service that calculated as part of the customers’ transmission costs and load for the it has not reserved. Western will assess Energy Imbalance Service settlements. upcoming year in the annual rate Unreserved Use Penalties against a Other customers are allowed the option calculation, rather than using historical customer that has not secured reserved of financial settlement or energy information. The method is a change in capacity or exceeds its reserved capacity repayment. Energy repayment is either the manner in which the inputs for the at any point of receipt or any point of concurrently or 7 days later, to be rate are developed, rather than a change delivery. Unreserved Use may also delivered using the same profile as the to the formula rate itself. When actual include a Transmission Customer’s related transmission transaction. When cost information for a year becomes failure to curtail transmission when a transmission loss energy obligation is available, Western will calculate the requested. not provided (or is under-provided) by actual revenue requirement for that A customer that engages in a customer for a transmission year. Revenue collected in excess of the Unreserved Use will be assessed a transaction, the energy still owed for actual revenue requirement will be penalty charge of 200 percent of LAP’s Losses is calculated and a charge is included as a credit in the ATRR in a approved transmission service rate for assessed to the customer, based on the subsequent year. Similarly, any under- Firm Point-to-Point Transmission WACM weighted average hourly collection of the revenue requirement Service as follows: purchase price. The loss factor, will be included as a charge in the (1) The Unreserved Use penalty for a currently 4.5 percent, is updated ATRR in a subsequent year. This true- single hour of Unreserved Use will be periodically and posted on the RMR up procedure will ensure that Western based upon the rate for daily Firm OASIS Web site. recovers no more and no less than the Point-to-Point Service. actual transmission costs for any year. Transmission Service Comments For example, as FY 2012 actual (2) The Unreserved Use penalty for more than one assessment for a given RMR received no comments financial data becomes available during concerning transmission service, FY 2013, the under- or over-collection duration (e.g., daily) will increase to the next longest duration (e.g., weekly). Unreserved Use Penalties, or of revenue during FY 2012 can be Transmission Losses during the public (3) The Unreserved Use penalty determined. When the rates are consultation and comment period. recalculated for FY 2014, the charge for multiple instances of implemented rates will include an Unreserved Use (e.g., more than one Ancillary Services Discussion adjustment for revenue under- or over- hour) within a day will be based on the Pursuant to Western’s Tariff, WACM collected in FY 2012. rate for daily Firm Point-to-Point will offer seven Ancillary Services. Two Service. Multiple instances of of these services, SSCD Service and Transmission System Total Load for Unreserved Use isolated to one calendar Point-to-Point Service VAR Support Service, are services that, week will result in a penalty based on under Western’s Tariff, the The LAP Transmission System Total the charge for weekly Firm Point-to- Transmission Provider is required to Load is a 12-month average of the sum Point Service. The penalty charge for provide (or offer to arrange with the of (1) all Network Integration multiple instances of Unreserved Use Balancing Authority operator) and the Transmission Service customer loads in during more than one week during a Transmission Customer is required to excess of deliveries of Federal calendar month will be based on the purchase. Entitlements, measured at the monthly charge for monthly Firm Point-to-Point The other five Ancillary Services, LAP Transmission System peak hour, Service. Regulation Service, Energy Imbalance plus (2) the monthly entitlements of A Transmission Customer that Service, Generator Imbalance Service, Federal Customers, plus (3) the reserved exceeds its firm reserved capacity at any Operating Reserve—Spinning Reserve capacity for Long-Term Firm Point-to- point of receipt or point of delivery or Service, and Operating Reserve— Point Transmission Service. This load an eligible customer that uses Supplemental Reserve Service, are calculation is prepared once annually transmission service at a point of receipt services that the Transmission Provider and is used to calculate the point-to- or point of delivery that it has not is required to offer to provide to the point rates for the entire year. reserved will be required to pay, in Transmission Customer. The The LAP Transmission System Total addition to the Unreserved Use Transmission Customer is required to Load is calculated as follows, based Penalties, for all applicable Ancillary acquire these Ancillary Services, either upon data projected for FY 2012: Services identified in Western’s Tariff from the Transmission Provider or from Federal Customers ...... 604,639 kW based on the amount of transmission a third party, or to self-supply them. Network Transmission Cus- service it used and did not reserve. tomers ...... 743,818 kW Scheduling, System Control, and Unreserved Use Penalties collected Dispatch Service Subtotal ...... 1,348,457 kW over and above the base Point-to-Point Point-to-Point Reserved Ca- Transmission Service rate will be The formula for SSCD Service, with pacity ...... 9,885 kW included as a credit in the calculation amounts shown for FY 2012, is as of the ATRR in a subsequent year. follows:

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This rate recovers the annual operator, the costs for this service are to be included in the Federal (LAP and expenses associated with transmission bundled in the respective Federal CRSP) transmission service rates. scheduling. The annual cost of transmission rate. In cases in which the Western will not include schedules scheduling personnel and related costs Transmission Providers on the for delivery of transmission losses to is comprised of annual expenses for schedules are not the operator, WACM WACM in the calculation of the rate and personnel, facilities, equipment, and indirectly performs this service for those will not invoice for them, so that software, as well as credits representing Transmission Providers’ transmission entities delivering losses may create fees for agent services and unscheduled systems. Western has historically individual loss schedules associated flow mitigation services. This revenue invoiced the last Transmission Provider with specific transactions without requirement is divided by the number of that is inside WACM on the schedule. charge. Western will accept any number schedules (excluding schedules for Since all non-Federal Transmission of schedule changes over the course of delivery of losses to WACM) per year to a day, without additional charge, so that derive a rate per schedule per day. Providers are indirectly taking this Per Schedule 1 of Western’s Tariff, service from WACM, Western will entities attempting to follow their loads ‘‘this service can be provided only by allocate the cost of each schedule closely may do so without penalty. the operator of the Control Area in equally among all Transmission Reactive Supply and Voltage Control which the transmission facilities used Providers (Federal and non-Federal) from Generation or Other Sources for transmission service are located.’’ In listed on the schedule that are inside Service cases in which the Transmission WACM. The Federal transmission Provider (LAP and/or CRSP) directly segments will be exempt from invoicing, The formula for VAR Support Service provides the service as the Control Area as costs for these segments will continue is the following:

TARRG = Total Annual Revenue The numerator captures the percentage of has some facilities that are considered Requirement for Generation annual generation plant costs that are generation-related. Net generation plant % of Resource = Percentage of Resource Used used for this service. Most of the LAP costs are multiplied by a fixed charge for VAR Support generation plant facilities are owned and rate (FCR) for generation to determine operated by Reclamation, but Western the TARRG, where

The FCR is a methodology used to FY 2010 data provides the following assign a portion of total expenses to results: generation. Applying these formulas to

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Applying this percentage to the amount power factor rating for the LAP total revenue requirement, after of net generation plant investment generating units is 94.77 percent, so the adjusting for a small amount of VAR results in the TARRG: revenue requirement for this rate Support Service revenue on point-to- includes 5.23 percent of the TARRG. TARRG = $334,166,538 × 17.847% = point transmission transactions not in The portion of the revenue requirement $59,638,020 the rate design, is as follows: contributed by LAP plant costs is as LAP Plant Costs ...... $3,118,089 The percentage of the TARRG that is follows: × CRSP Plant Costs ...... $1,539,255 included in the revenue requirement is LAP Plant Costs = $59,638,020 PTP Revenue ...... $(53,525) based on the nameplate capability of the 5.2284% = $3,118,089 generating units with regard to reactive Plant costs for CRSP plants providing Revenue Requirement ...... $4,603,819 and real power production. The TARRG VAR Support Service are calculated is multiplied by the complement of the using identical methodology. The The load taking this service totals weighted average power factor rating for contribution to the revenue requirement 1,258,524 kW, resulting in a proposed generating units. The weighted average from CRSP plants is $1,539,255. The rate for FY 2012 of:

The rate is applicable to all Support Service may be excluded from Regulation and Frequency Response transmission transactions inside WACM the application of this rate. Any such Service in excess of any Federal Entitlements. exclusion must be documented in the The formula rate for Regulation For Federal Entitlements, the cost for customer’s Service Agreement. Service has two different applications: this service will be included in the firm 1. Load-based Assessment. The electric service rates. Customers with formula for the Load-based Assessment generators providing WACM with VAR is as follows:

The rate applies to all entities’ auxiliary trapped geographically inside another regulate is calculated by multiplying the load (total metered load less Federal balancing authority, purchases of net plant costs by the FCR for Entitlements) and also to the installed transmission required to relocate energy generation. nameplate capacity of intermittent due to regulation/load following issues, Annual Costs = 17.847% × $159,716,812 generators serving load inside WACM. and lost sales opportunities resulting The revenue requirement will include from the requirement to generate at Annual Costs = $28,504,334 costs such as plant costs, purchases of night to permit units to have ‘‘down’’ Then, the annual cost per unit of a regulation product, purchases of regulating capability. capacity for regulating plants is power in support of the generating The methodology for determining calculated by dividing the annual costs units’ ability to regulate, purchases of annual plant costs is as follows. First, for regulating plants by the capacity of transmission for regulating units that are the annual costs for plants used to those plants:

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Next, the portion of the total annual that 75 MW of capacity will be required Regulating Plant Costs (LAP) = plant costs to be recovered in the for WACM Regulation Service for FY $3,317,614 Regulation Service rate is calculated by 2012. Of this total, 55 MW will be CRSP regulating plant costs are multiplying the annual unit cost by the supplied by LAP plants and 20 MW will calculated in a similar manner. Inserting amount of capacity required for be supplied by CRSP plants. regulation. The capacity required for this and other financial data for FY 2010 × regulation is subject to re-evaluation Regulating Plant Costs (LAP) = $60.32 into the formula results in the following every year. Current analyses indicate 55,000 kW Revenue Requirement:

LAP Plant Costs ...... $3,317,614 Purchase Power Costs in Support of Regulation ...... 5,049,193 Lost Sales Opportunities from having to generate in off-peak hours ...... 1,320,110 Transmission Costs for Trapped Regulating Units ...... 1,042,800 Purchases of Transmission ...... 52,598 CRSP Plant Costs ...... 590,429

Annual Revenue Requirement ...... 11,372,744

The load inside WACM requiring nameplate capacity of intermittent 2,791,390 kW and 73,220 kW, Regulation Service and the installed resources serving load inside WACM are respectively.

2. Self-Provision Assessment. Western b. If the entity’s 1-minute average ACE output from an intermittent generator to allows entities with AGC to self-provide for the hour is greater than or equal to another Balancing Authority will be for all or a portion of their loads. 1.5 percent of its hourly average load, required to dynamically meter or Entities with AGC are known as Sub- WACM will assess full Regulation dynamically schedule that resource out Balancing Authorities (SBA) and must Service charges using the Load-based of WACM to another Balancing meet all of the following criteria: Assessment applied to the entity’s 12-cp Authority unless arrangements, load for that month. satisfactory to Western, are made for a. Have a well-defined boundary, with c. If the entity’s 1-minute average ACE that entity to acquire this service from WACM-approved revenue-quality for the hour is greater than 0.5 percent a third party or self-supply (as outlined metering, accurate as defined by NERC, of its hourly average load, but less than below). An intermittent generator is one to include MW flow data availability at 1.5 percent of its hourly average load, that is volatile and variable due to 6-second or smaller intervals; WACM will assess Regulation Service factors beyond direct operational b. Have AGC capability; and charges based on linear interpolation of control and, therefore, is not c. Have demonstrated Regulation zero charge and full charge, using the dispatchable. Service capability. Load-based Assessment applied to the 2. Self- or Third-party supply: entity’s 12-cp load for that month. Western may allow an entity to supply Self-provision will be measured by d. Western will monitor the entity’s some or all of its required regulation, or use of the entity’s 1-minute average ACE self-provision on a regular basis. If contract with a third party to do so, to determine the amount of self- Western determines that the entity has even without well-defined boundary provision. The ACE will be used to not been attempting to self-regulate, metering. This entity must have revenue calculate Regulation Service charges Western will, upon notification, employ quality metering at every load and every hour as follows: the full Load-based Assessment generation point, accurate as defined by a. If the entity’s 1-minute average ACE described above. NERC, to include MW flow data for the hour is less than or equal to 0.5 availability at 6-second or smaller percent of its hourly average load, no Alternative Arrangements intervals. WACM will evaluate the Regulation Service charges will be 1. Exporting Intermittent Resource entity’s metering, telecommunications assessed by WACM. Requirement: An entity that exports the and regulating resource, as well as the

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required level of regulation, and 2. Weighted average sale or purchase over-deliveries, WACM may experience determine whether the entity qualifies pricing for the current month (on- and some hours of zero-value sales and may to self-supply under this provision. If off-peak). eliminate credits in these hours. approved, the entity will be required to 3. Weighted average sale or purchase If WACM is unable to dispose of the enter into a separate agreement with pricing for the prior month (on- and off- entire net over-delivery and operating Western, which will specify the terms of peak). criteria for the Balancing Authority are the self-supply application. 4. Weighted average sale or purchase not met, there may be financial pricing for the month immediately prior sanctions to Western from reliability Energy Imbalance Service to the prior month (and continuing in oversight agencies, such as NERC or WACM provides Energy Imbalance this manner until sale or purchase WECC. In these cases, credits to Service using a penalty and bandwidth pricing is located) (on- and off-peak). customers will be eliminated and structure with three deviation bands as Expansion of the Bandwidth customers over-delivering may share in follows. The term ‘‘metered load’’ is the cost of the sanction. Also, there may defined to be ‘‘metered load adjusted for Expansion of the bandwidth may be be conditions under which customers losses.’’ done to accommodate the following: (1) who under-deliver may share in any 1. An imbalance of less than or equal Response to physical resource loss; (2) sanctions imposed on Western by to 1.5 percent of metered load (or 4 MW, transition of large thermal resources. reliability oversight agencies. whichever is greater) for any hour will Details are as follows: be settled financially at 100 percent of 1. Western will expand the bandwidth Generator Imbalance Service the WACM weighted average hourly during an event established by a WACM will provide Generator price. Each hour will stand on its own— Western-recognized reserve-sharing Imbalance Service to the following there will be no monthly netting. group, such as the Rocky Mountain customers: 2. An imbalance between 1.5 percent Reserve Group. A response made by a 1. Jointly-owned generators whose and 7.5 percent of metered load (or 4 to member of the reserve group will be output is shared by several entities. At 10 MW, whichever is greater) for any accounted for by an after-the-fact the written request of all entities who hour will be settled financially at 90 schedule. Normally, these events are 1– jointly own the generator’s output, percent of WACM weighted average 2 hours in duration. Since the after-the- WACM will accept allocations of the hourly price when net energy scheduled fact schedule replaces lost generation, generation among the participants. In exceeds metered load or 110 percent of no expansion will be necessary for the this situation, a participant’s share of the WACM weighted average hourly entity receiving the response. The actual generation will be included in its price when net energy scheduled is less expanded bandwidth will apply to the separate Energy Imbalance calculation. than metered load. customer that increased generation in 2. Intermittent generators. At the 3. An imbalance greater than 7.5 response to the event and will be based written request of the customer, WACM percent of metered load (or 10 MW, on the magnitude of that customer’s will include the intermittent whichever is greater) for any hour will generation response. generator(s) in the customer’s Energy be settled financially at 75 percent of 2. During transition of large base-load Imbalance calculation. The customer the WACM weighted average hourly thermal resources (capacity greater than makes this choice with the price when net energy scheduled 200 MW) between off-line and on-line understanding that the intermittent exceeds metered load or 125 percent of following a reserve sharing group generator will be subject to 3rd band (25 the WACM weighted average hourly response, Western may expand the percent) penalties (see formula rate price when net energy scheduled is less bandwidth to eliminate all penalties details below). than metered load. during hours in which the unit 3. Non-intermittent generators serving generates less than the predetermined load only outside WACM. Aggregate Imbalance, Pricing, and minimum scheduling level. Western An entity’s solely-owned non- Settlement may not have access to information intermittent generator serving load All Energy Imbalance Service necessary to determine these hours for inside WACM will be included in its provided by WACM will be accounted some generators and will not have Energy Imbalance Service calculation. for hourly and settled financially after access to information on events for WACM will provide Generator the end of each month. The WACM reserve sharing groups outside RMR. Imbalance Service using a penalty and aggregate imbalance will determine the Customers should request bandwidth bandwidth structure with three pricing used in all settlements, expansion in hours in which they deviation bands as follows: including those subject to a penalty. For believe it to be warranted. Western may 1. An imbalance of less than or equal each hour, the gross energy imbalance request additional information for its to 1.5 percent of metered generation (or for all entities inside WACM will be decision as to whether to grant the 4 MW, whichever is greater) for any totaled/netted to determine an aggregate request. Bandwidth will not be hour is settled financially at 100 percent energy imbalance for WACM. The sign expanded when ramping services have of the WACM weighted average hourly of the aggregate energy imbalance will been acquired by another entity. price. determine whether WACM sale or 2. An imbalance between 1.5 percent Balancing Authority Operating purchase pricing will be used for and 7.5 percent of metered generation Constraints settling imbalances in that hour. A (or 4 to 10 MW, whichever is greater) for calculated surplus will dictate the use of Western reserves the right to offer no any hour is settled financially at 90 sale pricing; a calculated deficit will credit for Energy Imbalance Service percent of the WACM weighted average dictate the use of purchase pricing. over-deliveries during times of WACM hourly price when actual generation When there are no real-time sales or operating constraints, such as ‘‘must- exceeds scheduled generation or 110 purchases within an hour, pricing run’’ hydrologic conditions, or times percent of the WACM weighted average defaults will be applied in the following when WACM cannot dispose of surplus hourly price when actual generation is order: energy. Due to the unpredictable nature less than scheduled generation. 1. Weighted average sale or purchase of hour-to-hour energy imbalances and 3. An imbalance greater than 7.5 pricing for the day (on- and off-peak). the very short notice for disposition of percent of metered generation (or 10

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MW, whichever is greater) for any hour Comment: The customer requested an environmental assessment or an is settled financially at 75 percent of the that, for Regulation Service, rather than environmental impact statement. WACM weighted average hourly price requiring an intermittent generator that Determination Under Executive Order when actual generation exceeds exports its output to dynamically meter 12866 scheduled generation or 125 percent of or dynamically schedule the generation the WACM weighted average hourly out of WACM, Western open Western has an exemption from price when actual generation is less communications to pursue other options centralized regulatory review under than scheduled generation. to avoid this requirement. The customer Executive Order 12866; accordingly, no Intermittent generators will be exempt expressed concern about the cost of clearance of this notice by the Office of from the 25 percent penalty band. All implementing this requirement and the Management and Budget is required. imbalances greater than 1.5 percent of effects the unexpected costs will have Submission to the Federal Energy metered generation for an intermittent on member municipalities and their Regulatory Commission generator will be subject only to a 10 customers. The customer also noted that percent penalty. these additional costs were not known The formula rates herein confirmed, The features of Energy Imbalance at the inception of its existing projects approved, and placed into effect on an Service described above under when cost analyses were being interim basis, together with supporting Aggregate Imbalance, Pricing, and performed. documents, will be submitted to FERC Settlement, Expansion of the Response: Western thanks the for confirmation and final approval. Bandwidth, and Balancing Authority customer for its comment. As noted Order Operating Constraints, also apply to above under Regulation and Frequency In view of the foregoing, and under Generator Imbalance Service. Response Service (Alternative Arrangements), Western has included as the authority delegated to me, I confirm Penalty Elimination a part of the Regulation Service rate and approve on an interim basis, In any hour, Western will charge a schedule, a condition under which an effective on the first full billing period customer a penalty for either Generator exporting intermittent generator will not on or after October 1, 2011, formula Imbalance Service or Energy Imbalance have to be dynamically removed from rates for Loveland Area Projects Service, but not both, unless the WACM. Under this condition, the entity Transmission and Western Area imbalances aggravate rather than offset must make arrangements, satisfactory to Colorado Missouri Balancing Authority each other. In an hour in which Western, to acquire Regulation and Ancillary Services under Rate penalties on offsetting imbalances Frequency Response Service from a Schedules L–NT1, L–FPT1, L–NFPT1, would exist based on the separate third party or self-supply it. Western L–AS1, L–AS2, L–AS3, L–AS4, L–AS5, imbalance calculations, Western will believes that this is a reasonable L–AS6, L–AS7, L–AS9, and L–UU1. By remove the penalty from the Generator requirement that will not place an this order, I am placing the rates into Imbalance calculation. There will be no undue burden on existing or potential effect in less than 30 days to meet penalty elimination for jointly-owned customers who will export intermittent contract deadlines, to avoid financial generators whose participants have a generation from WACM, but will difficulties, and to provide rates for new separate Energy Imbalance calculation. support the concept in Western’s Tariff services. These rate schedules shall remain in effect on an interim basis, Administrative Charge that WACM is required to provide Ancillary Services only for Load- pending FERC’s confirmation and In the Notice of Proposed Rates (76 FR Serving Entities. approval of them or substitute formula 5148), Western proposed to assess an rates on a final basis through September administrative charge on each monthly Availability of Information 30, 2016. settlement under both Energy Imbalance All brochures, studies, comments, Dated: September 2, 2011. and Generator Imbalance Services. After letters, memorandums, or other Daniel B. Poneman, further analysis and customer input, documents that Western used to Deputy Secretary. Western has decided not to implement develop the Provisional Formula Rates an administrative charge under either are available for inspection and copying Rate Schedule L–AS1 service. at the Rocky Mountain Regional Office, Schedule 1 to Tariff located at 5555 East Crossroads Operating Reserve—Spinning and October 1, 2011 Supplemental Boulevard, Loveland, Colorado. Many of these documents and supporting United States Department of Energy WACM has no long-term Reserves information are also available on Western Area Power Administration available for sale. At a customer’s Western’s Web site under the ‘‘2012 request, WACM will purchase and pass Rate Adjustment—Transmission and Rocky Mountain Region through the cost of Reserves and any Ancillary Services’’ section located at activation energy, plus a fee for Western Area Colorado Missouri http://www.wapa.gov/rm/ratesRM/ Balancing Authority administration. For all Reserves 2012/default.htm. purchased, the customer will be Scheduling, System Control, and responsible for providing the Ratemaking Procedure Requirements Dispatch Service transmission to deliver the Reserves. Environmental Compliance Applicable Ancillary Services Comments In compliance with the National Scheduling, System Control, and Western received one written Environmental Policy Act (NEPA) of Dispatch Service is required to schedule comment concerning the Ancillary 1969 (42 U.S.C. 4321 et seq.), Council the movement of power into, out of, Services during the public consultation on Environmental Quality Regulations inside, or through the Western Area and comment period. This comment has (40 CFR parts 1500–1508), and DOE Colorado Missouri Balancing Authority been paraphrased where appropriate, NEPA Regulations (10 CFR part 1021), (WACM). This service must be without compromising the meaning of Western has determined that this action purchased from the WACM operator. the comment. is categorically excluded from preparing The rate will be applied to all

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schedules, except those for the delivery will be assessed to those transmission Effective of transmission losses to WACM. providers. The charges applicable to Unless other arrangements are made Federal transmission will be included in The first day of the first full billing with Western, the rate will be divided the Federal transmission service rates. period beginning on or after October 1, equally among the transmission 2011, through September 30, 2016. WACM will accept any number of providers displayed in the schedule that Formula Rate are inside WACM. The charges scheduling changes over the course of applicable to non-Federal transmission the day without any additional charge.

Rate Rate Schedule L–AS2 each transaction on the transmission Schedule 2 to Tariff facilities. The amount of VAR Support The rate to be in effect October 1, Service supplied to the Customer’s 2011, through September 30, 2012, is October 1, 2011 (Federal Transmission Customers and $24.22 per schedule per day. A revised United States Department of Energy customers on others’ transmission rate will go into effect October 1 of each systems inside WACM) transactions will Western Area Power Administration year of the effective rate period based on be based on the VAR Support Service the formula above and updated financial Rocky Mountain Region necessary to maintain transmission and schedule data. Western will notify Western Area Colorado Missouri voltages within limits that are generally the Customer annually of the revised Balancing Authority accepted in the region and consistently rate before October 1. adhered to by WACM. The Customer Reactive Supply and Voltage Control Any change to the rate for Scheduling, must purchase this service from the from Generation or Other Sources WACM operator. System Control, and Dispatch Service Service will be listed in a revision to this rate Customers with generators providing WACM with VAR Support Service may schedule issued under applicable Applicable be excluded from the application of this Federal laws, regulations, and policies To maintain transmission voltages on rate. Any such exclusion must be and made part of the applicable service all transmission facilities within documented in the Customer’s service agreement. acceptable limits, generation facilities under the control of the Western Area agreement. Colorado Missouri Balancing Authority Effective (WACM) are operated to produce or The first day of the first full billing absorb reactive power. Thus, Reactive period beginning on or after October 1, Supply and Voltage Control from 2011, through September 30, 2016. Generation or Other Sources Service (VAR Support Service) is provided for Formula Rate

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Rate Types d. Western monitors the entity’s Self- There are two different applications of provision on a regular basis. If Western The rate to be in effect October 1, determines that the entity has not been 2011, through September 30, 2012, is: this Formula Rate: 1. Load-based Assessment: The rate attempting to self-regulate, WACM will, for the load-based assessment is upon notification, employ the Load- reflected in the Formula Rate section based Assessment described in No. 1, Monthly $0.305/kW-month and is applied to entities that take above. Weekly $0.070/kW-week Regulation Service from WACM. This Alternative Arrangements Daily $0.010/kW-day load-based rate is assessed on an entity’s Hourly $0.000418/kWh auxiliary load (total metered load less Exporting Intermittent Resource Federal entitlements) and is also Requirement: An entity that exports the output from an intermittent generator to A revised rate will go into effect October applied to the installed nameplate another balancing authority will be 1 of each year of the effective rate period capacity of all intermittent generators required to dynamically meter or based on the formula above and updated serving load inside WACM. dynamically schedule that resource out financial and load data. Western will 2. Self-provision Assessment: Western of WACM to another balancing notify the Customer annually of the allows entities with AGC to self-provide authority unless arrangements, revised rate before October 1. for all or a portion of their loads. Entities with AGC are known as Sub- satisfactory to Western, are made for Any change to the rate for VAR that entity to acquire this service from Support Service will be listed in a Balancing Authorities (SBA) and must meet all of the following criteria: a third party or self-supply (as outlined revision to this rate schedule issued below). An intermittent generator is one under applicable Federal laws, a. Have a well-defined boundary, with WACM-approved revenue-quality that is volatile and variable due to regulations, and policies and made part factors beyond direct operational of the applicable service agreement. metering, accurate as defined by the North American Electric Reliability control and, therefore, is not Rate Schedule L–AS3 Corporation (NERC), to include MW dispatchable. Self- or Third-party supply: Western Schedule 3 to Tariff flow data availability at 6-second or smaller intervals; may allow an entity to supply some or October 1, 2011 b. Have AGC capability; all of its required regulation, or contract with a third party to do so, even without United States Department of Energy c. Demonstrate Regulation Service capability; and well-defined boundary metering. This Western Area Power Administration d. Execute a contract with WACM: entity must have revenue quality Rocky Mountain Region i. Provide all requested data to metering at every load and generation WACM. point, accurate as defined by NERC, to Western Area Colorado Missouri include MW flow data availability at 6- Balancing Authority ii. Meet SBA error criteria as described under section 2.1 below. second or smaller intervals. Western Regulation and Frequency Response 2.1. Self-provision is measured by use of will evaluate the entity’s metering, Service the entity’s 1-minute average Area telecommunications and regulating resource, as well as the required level of Applicable Control Error (ACE) to determine the amount of self-provision. The ACE is regulation, and determine whether the Regulation and Frequency Response used to calculate the Regulation Service entity qualifies to self-supply under this Service (Regulation Service) is charges every hour as follows: provision. If approved, the entity is necessary to provide for the continuous a. If the entity’s 1-minute average ACE required to enter into a separate balancing of resources with obligations, for the hour is less than or equal to 0.5 agreement with Western which will and for maintaining scheduled percent of its hourly average load, no specify the terms of the self-supply interconnection frequency at sixty Regulation Service charge is assessed by application. cycles per second (60 Hz). Regulation WACM for that hour. Customer Accommodation Service is accomplished by committing b. If the entity’s 1-minute average ACE on-line generation whose output is for the hour is greater than or equal to For entities unwilling to take raised or lowered as necessary, 1.5 percent of its hourly average load, Regulation Service, self-provide it as predominantly through the use of WACM assesses Regulation Service described above, or acquire the service automatic generation control (AGC) charges to the entity’s entire auxiliary from a third party, Western will assist equipment, to follow the moment-by- load, using the hourly Load-based the entity in dynamically metering its moment changes in load. The obligation Assessment applied to the entity’s loads/resources to another balancing to maintain this balance between auxiliary 12-cp load for that month. authority. Until such time as that meter resources and load lies with the Western c. If the entity’s 1-minute average ACE configuration is accomplished, the Area Colorado Missouri Balancing for the hour is greater than 0.5 percent entity will be responsible for charges Authority (WACM) operator. Customers of its hourly average load, but less than assessed by WACM under the rate in (Federal Transmission Customers and 1.5 percent of its hourly average load, effect. customers on others’ transmission WACM assesses Regulation Service Effective systems inside WACM) must purchase charges based on linear interpolation of The first day of the first full billing this service from WACM or make zero charge and full charge, using the period beginning on or after October 1, alternative comparable arrangements to hourly Load-based Assessment applied 2011, through September 30, 2016. satisfy their Regulation Service to the entity’s auxiliary 12-cp load for obligations. that month. Formula Rate

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Rate Effective • Response to the loss of a physical The first day of the first full billing resource. The rate to be in effect October 1, • During transition of large base-load 2011, through September 30, 2012, for period beginning on or after October 1, 2011, through September 30, 2016. thermal resources (capacity greater than Nos. 1 and 2, as described above in the 200 MW) between off-line and on-line ‘‘Types’’ section of this rate schedule, is: Formula Rate following a reserve sharing group Imbalances are calculated in three response, when the unit generates less deviation bands as follows. The term than the predetermined minimum Monthly $0.331/kW-month ‘‘metered load’’ is defined to be scheduling level. Weekly $0.076/kW-week ‘‘metered load adjusted for losses.’’ During periods of balancing authority Daily $0.011/kW-day 1. An imbalance of less than or equal operating constraints, Western reserves Hourly $0.000458/kWh to 1.5 percent of metered load (or 4 MW, the right to eliminate credits for over- whichever is greater) for any hour is deliveries. The cost to Western of any A revised rate will go into effect October settled financially at 100 percent of the penalty assessed by a regulatory 1 of each year of the effective rate period WACM weighted average hourly price. authority due to a violation of operating based on the formula above and updated 2. An imbalance between 1.5 percent standards resulting from under- or over- financial and load data. Western will and 7.5 percent of metered load (or 4 to delivery of energy may be passed notify the Customer annually of the 10 MW, whichever is greater) for any through to Energy Imbalance Service revised rate before October 1. hour is settled financially at 90 percent customers. Any change to the rate for Regulation of the WACM weighted average hourly Rate Service will be listed in a revision to price when net energy scheduled The bandwidths, penalties, and this rate schedule issued under exceeds metered load or 110 percent of pricing described above are in effect applicable Federal laws, regulations, the WACM weighted average hourly October 1, 2011, through September 30, and policies and made part of the price when net energy scheduled is less 2012. applicable service agreement. than metered load. 3. An imbalance greater than 7.5 Any change to the rate for Energy Rate Schedule L–AS4 percent of metered load (or 10 MW, Imbalance Service will be listed in a revision to this rate schedule issued Schedule 4 to Tariff whichever is greater) for any hour is settled financially at 75 percent of the under applicable Federal laws, October 1, 2011 WACM weighted average hourly price regulations, and policies and made part United States Department of Energy when net energy scheduled exceeds of the applicable service agreement. Western Area Power Administration metered load or 125 percent of the Rate Schedule L–AS5 WACM weighted average hourly price Rocky Mountain Region when net energy scheduled is less than Schedule 5 to Tariff Western Area Colorado Missouri metered load. October 1, 2011 Balancing Authority All Energy Imbalance Service United States Department of Energy provided by WACM is accounted for Energy Imbalance Service hourly and settled financially. The Western Area Power Administration Applicable WACM aggregate imbalance determines Rocky Mountain Region the pricing used in all deviation bands. The Western Area Colorado Missouri A surplus dictates the use of sale Western Area Colorado Missouri Balancing Authority (WACM) provides pricing; a deficit dictates the use of Balancing Authority Energy Imbalance Service when there is purchase pricing. When no hourly data Operating Reserve—Spinning Reserve a difference between a Customer’s is available, the pricing defaults for Service (Federal Transmission Customers and sales and purchase pricing are applied Applicable customers on others’ transmission in the following order: systems inside WACM) resources and 1. Weighted average sale or purchase Spinning Reserve Service (Reserves) obligations. Energy Imbalance is pricing for the day (on- and off-peak). is needed to serve load immediately in calculated as resources minus 2. Weighted average sale or purchase the event of a system contingency. obligations (adjusted for transmission pricing for the month (on- and off-peak). Reserves may be provided by generating and transformer losses) for any 3. Weighted average sale or purchase units that are on-line and loaded at less combination of generation, scheduled pricing for the prior month (on- and off- than maximum output. The Customers transfers, transactions, or actual load peak). (Federal Transmission Customers and integrated over each hour. Customers 4. Weighted average sale or purchase customers on others’ transmission inside WACM must either obtain this pricing for the month prior to the prior system inside Western Area Colorado service from WACM or make alternative month (and continuing until sale or Missouri Balancing Authority (WACM)) comparable arrangements to satisfy their purchase pricing is located) (on- and off- must either purchase this service from Energy Imbalance Service obligation. peak). WACM or make alternative comparable This rate applies to all customers with Expansion of the bandwidth may be arrangements to satisfy their Reserves load inside WACM. allowed during the following instances: obligation.

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Effective Rate Schedule L–AS7 purchase price. When no hourly data is October 1, 2011 available, pricing defaults will be The first day of the first full billing applied in the following order: period beginning on or after October 1, United States Department of Energy 1. Weighted average purchase pricing 2011, through September 30, 2016. Western Area Power Administration for the day (on- and off-peak). Formula Rate Rocky Mountain Region 2. Weighted average purchase pricing for the current month (on- and off-peak). WACM has no long-term Reserves Western Area Colorado Missouri available for sale. At a Customer’s Balancing Authority 3. Weighted average purchase pricing request, WACM will purchase Reserves Transmission Losses Service for the prior month (on- and off-peak). and pass through the cost of Reserves 4. Weighted average purchase pricing Applicable and any activation energy, plus a fee for for the month prior to the prior month administration. The Customer will be The Western Area Colorado Missouri (and continuing until or purchase responsible for providing the Balancing Authority (WACM) provides pricing is located) (on- and off-peak). transmission to deliver the Reserves. Transmission Losses Service to all Any change to the rate for Transmission Transmission Service Providers who Losses Service will be listed in a Rate Schedule L–AS6 market transmission inside WACM. The revision to this rate schedule issued loss factor currently in effect is posted Schedule 6 to Tariff under applicable Federal laws, on the Rocky Mountain Region (RMR) regulations, and policies and made part October 1, 2011 Open Access Same-Time Information of the applicable service agreement. United States Department of Energy System (OASIS) Web site. Rate Schedule L–FPT1 Western Area Power Administration Effective The first day of the first full billing Schedule 7 to Tariff Rocky Mountain Region period beginning on or after October 1, October 1, 2011 Western Area Colorado Missouri 2011, through September 30, 2016. United States Department of Energy Balancing Authority Formula Rate Western Area Power Administration Operating Reserve—Supplemental Transmission Losses are assessed for Rocky Mountain Region Reserve Service all real-time and prescheduled Loveland Area Projects Applicable transactions on transmission facilities inside WACM. The Customer is allowed Long-Term Firm and Short-Term Firm Supplemental Reserve Service the option of energy repayment or Point-To-Point Transmission Service (Reserves) is needed to serve load in the financial repayment. Energy repayment Applicable event of a system contingency; however, may be either concurrently or seven it is not available immediately to serve days later, to be delivered using the The Transmission Customer shall load but rather within a short period of same profile as the related transmission compensate the Loveland Area Projects time. Reserves may be provided by transaction. Customers must declare (LAP) each month for Reserved Capacity generating units that are on-line but annually their preferred methodology of under the applicable Firm Point-to- unloaded, by quick-start generation, or energy payback. Point Transmission Service Agreement When a transmission loss energy by interruptible load. The Customers and the rate outlined herein. obligation is not provided (or is under- (Federal Transmission Customers and provided) by a Customer for a Discounts customers on others’ transmission transmission transaction, the energy still system inside Western Area Colorado owed for Transmission Losses is Three principal requirements apply to Missouri Balancing Authority (WACM)) calculated and a charge is assessed to discounts for transmission service as must either purchase this service from the Customer, based on the WACM follows: (1) Any offer of a discount WACM or make alternative comparable weighted average hourly purchase price. made by LAP must be announced to all arrangements to satisfy their Reserves Pricing for loss energy due 7 days eligible customers solely by posting on obligation. later, and not received by WACM, will the Rocky Mountain Region’s Open Access Same-Time Information System Effective be priced at the 7-day-later-price based on the WACM weighted average hourly web site (OASIS); (2) any customer- The first day of the first full billing purchase price. initiated requests for discounts, including requests for use by the LAP period beginning on or after October 1, There will be no financial merchant, must occur solely by posting 2011, through September 30, 2016. compensation or energy return to Customers for over-delivery of on the OASIS; and (3) once a discount Formula Rate Transmission Losses, as there should be is negotiated, details must be no condition beyond the control of the immediately posted on the OASIS. For WACM has no long-term Reserves Customer that results in overpayment. any discount agreed upon for service on available for sale. At a Customer’s a path, from Point(s) of Receipt to request, WACM will purchase Reserves Rate Point(s) of Delivery, LAP must offer the and pass through the cost of Reserves This loss factor, as posted on the RMR same discounted transmission service and any activation energy, plus a fee for OASIS, is in effect October 1, 2011, rate for the same time period to all administration. The Customer will be through September 30, 2012. Customers eligible customers on all unconstrained responsible for providing the may settle financially or with energy. transmission paths that go to the same transmission to deliver the Reserves. The pricing for this service will be the point(s) of delivery on the transmission WACM weighted average hourly system.

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Effective Formula Rate The first day of the first full billing period beginning on or after October 1, 2011, through September 30, 2016.

Rate regulations, and policies and made part follows: (1) Any offer of a discount The rate to be in effect October 1, of the applicable service agreement. made by LAP must be announced to all eligible customers solely by posting on 2011, through September 30, 2012, is: Rate Schedule L–NFPT1 Rocky Mountain Region’s Open Access Maximum of Schedule 8 to Tariff Same-Time Information System web site October 1, 2011 (OASIS); (2) any customer-initiated Yearly $41.80/kW of reserved requests for discounts, including capacity per year United States Department of Energy requests for use by the LAP merchant, Monthly $3.48/kW of reserved ca- Western Area Power Administration must occur solely by posting on the pacity per month OASIS; and (3) once a discount is Rocky Mountain Region Weekly $0.80/kW of reserved ca- negotiated, details must be immediately pacity per week Loveland Area Projects Daily $0.11/kW of reserved ca- posted on the OASIS. For any discount pacity per day Non-Firm Point-To-Point Transmission agreed upon for service on a path, from Service Point(s) of Receipt to Point(s) of A revised rate will go into effect Delivery, LAP must offer the same Applicable October 1 of each year of the effective discounted transmission service rate for rate period based on the formula above, The Transmission Customer will the same time period to all eligible updated financial and load projections, compensate Loveland Area Projects customers on all unconstrained and the true-up of previous projections. (LAP) for Non-Firm Point-to-Point transmission paths that go to the same Western will notify the Transmission Transmission Service under the point(s) of delivery on the transmission Customer annually of the revised rate applicable Non-Firm Point-to-Point system. before October 1. Transmission Service Agreement and Effective Any change to the rate for Long-Term the rate outlined herein. The first day of the first full billing Firm and Short-Term Firm Discounts period beginning on or after October 1, Transmission Service will be listed in a 2011, through September 30, 2016. revision to this rate schedule issued Three principal requirements apply to under applicable Federal laws, discounts for transmission service as Formula Rate

Rate Customer annually of the revised rate Rate Schedule L–NT1 before October 1. The rate to be in effect October 1, Schedule H to Tariff 2011, through September 30, 2012, is: Any change to the rate for Non-Firm October 1, 2011 Point-to-Point Transmission Service United States Department of Energy Maximum of will be listed in a revision to this rate schedule issued under applicable Western Area Power Administration Yearly $41.80/kW of reserved Federal laws, regulations, and policies Rocky Mountain Region capacity per year and made part of the applicable service Monthly $3.48/kW of reserved ca- agreement. Loveland Area Projects pacity per month Annual Transmission Revenue Weekly $0.80/kW of reserved ca- Requirement for Network Integration pacity per week Transmission Service Daily $0.11/kW of reserved ca- pacity per day Applicable Hourly 4.77 mills/kWh Transmission Customers will compensate the Loveland Area Projects A revised rate will go into effect each month for Network Integration October 1 of each year of the effective Transmission Service under the rate period based on the formula above, applicable Network Integration updated financial and load projections, Transmission Service Agreement and and the true-up of previous projections. the Annual Transmission Revenue Western will notify the Transmission Requirement described herein.

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Effective Formula Rate The first day of the first full billing period beginning on or after October 1, 2011, through September 30, 2016.

Rate intermittent generators serving load 2. Weighted average sale or purchase The Annual Transmission Revenue only outside WACM. pricing for the current month (on- and Requirement in effect October 1, 2011, Effective off-peak). through September 30, 2012, is 3. Weighted average sale or purchase $56,775,913. The first day of the first full billing pricing for the prior month (on- and off- A revised Annual Transmission period beginning on or after October 1, peak). Revenue Requirement will go into effect 2011, through September 30, 2016. 4. Weighted average sale or purchase October 1 of each year of the effective Formula Rate rate period based on updated financial pricing for the month prior to the prior projections and the true-up of previous Imbalances are calculated in three month (and continuing until sale or projections. Western will notify the deviation bands as follows: purchase pricing is located) (on- and off- Transmission Customer annually of the 1. An imbalance of less than or equal peak). revised Annual Transmission Revenue to 1.5 percent of metered generation (or Expansion of the bandwidth may be Requirement before October 1. 4 MW, whichever is greater) for any allowed during the following instances: Any change to the rate for Network hour is settled financially at 100 percent • Response to the loss of a physical Integration Transmission Service will be of the WACM weighted average hourly resource. listed in a revision to this rate schedule price. • issued under applicable Federal laws, 2. An imbalance between 1.5 percent During transition of large base-load regulations, and policies and made part and 7.5 percent of metered generation thermal resources (capacity greater than of the applicable service agreement. (or 4 to 10 MW, whichever is greater) for 200 MW) between off-line and on-line Rate Schedule L–AS9 any hour is settled financially at 90 following a reserve sharing group percent of the WACM weighted average response, when the unit generates less Schedule 9 to Tariff hourly price when actual generation than the predetermined minimum October 1, 2011 exceeds scheduled generation or 110 scheduling level. United States Department of Energy percent of the WACM weighted average During periods of balancing authority hourly price when actual generation is Western Area Power Administration operating constraints, Western reserves less than scheduled generation. the right to eliminate credits for over- Rocky Mountain Region 3. An imbalance greater than 7.5 deliveries. The cost to Western of any Western Area Colorado Missouri percent of metered generation (or 10 penalty assessed by a regulatory Balancing Authority MW, whichever is greater) for any hour authority due to a violation of operating is settled financially at 75 percent of the Generator Imbalance Service standards resulting from under- or over- WACM weighted average hourly price delivery of energy may be passed Applicable when actual generation exceeds through to Generator Imbalance Service The Western Area Colorado Missouri scheduled generation or 125 percent of customers. (WACM) Balancing Authority provides the WACM weighted average hourly Generator Imbalance Service when there price when actual generation is less Rate is a difference between a Customer’s than scheduled generation. Intermittent generators are exempt The bandwidths, penalties, and (Federal Transmission Customers and pricing described above are in effect customers on others’ transmission from 25 percent penalties. All imbalances greater than 1.5 percent of October 1, 2011, through September 30, systems inside WACM) resources and 2012. obligations. Generator Imbalance is metered generation are subject only to a calculated as actual generation minus 10 percent penalty. Any change to the rate for Generator scheduled generation for each hour. All Generator Imbalance Service Imbalance Service will be listed in a Customers inside WACM must either provided by WACM is accounted for revision to this rate schedule issued obtain this service from WACM or make hourly and settled financially. The under applicable Federal laws, alternative comparable arrangements to WACM aggregate imbalance determines regulations, and policies and made part satisfy their Generator Imbalance the pricing used in all deviation bands. of the applicable service agreement. Service obligation. This rate applies to A surplus dictates the use of sale all jointly-owned generators (unless pricing; a deficit dictates the use of arrangements are made to allocate actual purchase pricing. When no hourly data generation to each individual owner), is available, the pricing defaults for intermittent generators (unless sales and purchase pricing are applied arrangements are made to assess the in the following order: intermittent generator under Rate 1. Weighted average sale or purchase Schedule L–AS4), and any non- pricing for the day (on- and off-peak).

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Rate Schedule L–UU1 service assessed as follows: the with the Unreserved Use. The Customer Schedule 10 to Tariff Unreserved Use Penalty for a single will pay for ancillary services based on hour of Unreserved Use is based upon the amount of transmission service it October 1, 2011 the rate for daily firm point-to-point used and did not reserve. service. The Unreserved Use Penalty for United States Department of Energy Effective more than one assessment for a given Western Area Power Administration duration (e.g., daily) increases to the The first day of the first full billing Rocky Mountain Region next longest duration (e.g., weekly). The period beginning on or after October 1, Loveland Area Projects Unreserved Use Penalty for multiple 2011, through September 30, 2016. instances of Unreserved Use (e.g., more Unreserved Use Penalties than one hour) within a day is based on Rate Applicable the rate for daily firm point-to-point The rate for Unreserved Use Penalties service. The Unreserved Use Penalty for The Transmission Customer shall is 200 percent of LAP’s approved rate multiple instances of Unreserved Use compensate the Loveland Area Projects for firm point-to-point transmission (LAP) each month for any unreserved isolated to one calendar week is based service assessed as described above. use of the transmission system on the rate for weekly firm point-to- Any change to the rate for Unreserved (Unreserved Use) under the applicable point service. The Unreserved Use Use Penalties will be listed in a revision transmission service rates as outlined Penalty for multiple instances of to this rate schedule issued under herein. Unreserved Use occurs when an Unreserved Use during more than one applicable Federal laws, regulations, eligible customer uses transmission week in a calendar month is based on and policies and made part of the service that it has not reserved or a the rate for monthly firm point-to-point applicable service agreement. service. Transmission Customer uses [FR Doc. 2011–23391 Filed 9–12–11; 8:45 transmission service in excess of its A Transmission Customer that am] reserved capacity. Unreserved Use may exceeds its firm reserved capacity at any also include a Customer’s failure to point of receipt or point of delivery, or Editorial Note: FR Doc. 2011–23391 which curtail transmission when requested. an eligible customer that uses was originally published on pages 56433– transmission service at a point of receipt 56452 in the issue of Tuesday, September 13, Penalty Rate or point of delivery that it has not 2011 is being republished in its entirety in The penalty rate for a Transmission reserved, is required to pay for all the issue of Monday, October 3, 2011 because Customer that engages in Unreserved ancillary services that were provided by of editing errors. Use is 200 percent of LAP’s approved the Western Area Colorado Missouri [FR Doc. R1–2011–23391 Filed 9–30–11; 8:45 am] rate for firm point-to-point transmission Balancing Authority and associated BILLING CODE 6450–01–P

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Part IV

Department of Health and Human Services

42 CFR Part 73 Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review; Proposed Rule

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DEPARTMENT OF HEALTH AND Proposed Rulemaking (NPRM), we are B. Modifications to the List of Overlap HUMAN SERVICES also proposing to add two agents, Lujo Select Agents and Toxins and Chapare viruses to the list; adding C. Tiering [Docket No. CDC–2011–0012] D. Responses to Other Comments and definitions; and clarifying language Other Proposed Changes 42 CFR Part 73 concerning security, training, biosafety, i. Exclusions and incident response. These changes ii. Security RIN 0920–AA34 will increase the usability of the select iii. Select Agent Inventory agents and toxins regulations as well as iv. Definitions Possession, Use, and Transfer of providing for enhanced program v. Recombinant/Synthetic Nucleic Acids Select Agents and Toxins; Biennial oversight. vi. Toxins Review vii. Responsible Official DATES: Comments should be received on viii. Access to Select Agents and Toxins AGENCY: Centers for Disease Control and or before December 2, 2011. ix. Security Plan Prevention (CDC), Department of Health x. Biosafety Plans ADDRESSES: and Human Services (HHS). You may submit comments, xi. Restricted Experiments identified by Regulatory Information ACTION: Proposed rule. xii. Incident Response Number (RIN), 0920–AA34 in the xiii. Training SUMMARY: In accordance with the Public heading of this document by any of the xiv. Transfers Health Security and Bioterrorism following methods: xv. Records Preparedness and Response Act of 2002 • Federal eRulemaking Portal: http:// xvi. Administrative Review (the Bioterrorism Response Act), the www.regulations.gov. Follow the xvii. Guidance Documents III. Required Regulatory Analyses Centers for Disease Control and instructions for submitting comments. • A. Executive Order 12866 and 13563 Prevention (CDC) located within the Mail: Centers for Disease Control B. Regulatory Flexibility Act Department of Health and Human and Prevention, Select Agent Program, C. Paperwork Reduction Act Services (HHS) has reviewed the list of 1600 Clifton Road, NE., Mailstop A–46, D. Executive Order 12988: Civil Justice biological agents and toxins that have Atlanta, Georgia 30333, Attn: RIN 0920– Reform the potential to pose a severe threat to AA34. E. Executive Order 13132: Federalism public health and safety and is Instructions: All submissions received F. Plain Writing Act of 2010 proposing to amend and republish the must include the agency name and RIN IV. References list as required by the Bioterrorism for this rulemaking. All relevant I. Background Response Act. Further, on July 2, 2010, comments received will be posted the President signed Executive Order The Public Health Security and without change to http:// Bioterrorism Preparedness and 13546, ‘‘Optimizing the Security of www.regulations.gov, including any Biological Select Agents and Toxins in Response Act of 2002, Subtitle A personal information provided. (Department of Health and Human the United States’’ that directed the Docket Access: For access to the Secretaries of HHS and Agriculture Services) of Title II (Enhancing Controls docket to read background documents on Dangerous Biological Agents and (USDA) to designate a subset of the or comments received or to download select agents and toxins list (Tier 1) that Toxins) of Public Law 107–188 (June 12, an electronic version of the NPRM, go 2002) (42 U.S.C. 262a) (the Bioterrorism presents the greatest risk of deliberate to http://www.regulations.gov. misuse with the most significant Response Act), requires the HHS Comments will be available for public Secretary to establish by regulation a list potential for mass casualties or inspection Monday through Friday, devastating effects to the economy, of each biological agent and each toxin except for legal holidays, from 9 a.m. that has the potential to pose a severe critical infrastructure; or public until 5 p.m. at 1600 Clifton Road, NE., confidence; explore options for graded threat to public health and safety. In Atlanta, GA 30333. Please call ahead to determining whether to include an protection for these Tier 1 agents and 1–866–694–4867 and ask for a toxins to permit tailored risk agent or toxin on the list, the HHS representative in the Division of Select Secretary considers the effect on human management practices based upon Agents and Toxins to schedule your relevant contextual factors; and consider health of exposure to an agent or toxin; visit. Our general policy for comments the degree of contagiousness of the reducing the overall number of agents and other submissions from members of and toxins on the select agents and agent and the methods by which the the public is to make these submissions toxins list. E.O. 13546 also established agent or toxin is transferred to humans; available for public viewing on the the Federal Experts Security Advisory the availability and effectiveness of Internet as they are received and Panel (FESAP) to advise the HHS and pharmacotherapies and immunizations without change. USDA Secretaries on the designation of to treat and prevent illnesses resulting Tier 1 agents and toxins, reduction in FOR FURTHER INFORMATION CONTACT: from an agent or toxin; the potential for the number of agents on the Select Robbin Weyant, Director, Division of an agent or toxin to be used as a Agent List, establishment of suitability Select Agents and Toxins, Centers for biological weapon; and the needs of standards for those having access to Tier Disease Control and Prevention, 1600 children and other vulnerable 1 select agents and toxins, and Clifton Road, NE., Mailstop A–46, populations. The current list of HHS establishment of physical security and Atlanta, Georgia 30333. Telephone: select agents and toxins can be found at information security standards for Tier (404) 718–2000. 42 CFR 73.3 (HHS select agents and 1 select agents and toxins. The tiering of SUPPLEMENTARY INFORMATION: The toxins) and 42 CFR 73.4 (Overlap select the select agents and toxins list will Preamble to this notice of proposed agents and toxins). The list of HHS and allow the application of more optimized rulemaking is organized as follows: Overlap select agents and toxins is available at: http:// security measures for those select agents I. Background or toxins which pose a higher risk to II. Proposed Changes to 42 CFR Part 73, www.selectagents.gov/Select%20 public health and safety should they be Including Responses to Comments to the Agents%20and%20Toxins%20 stolen or otherwise misused. ANPRM List.html. The Bioterrorism Response In addition to addressing the FESAP A. Modifications to the List of HHS Select Act requires that the HHS Secretary recommendations in this Notice of Agents and Toxins review and republish the list of select

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agents and toxins on at least a biennial biological agents or toxins that should its recommendations to the HHS and basis. See 42 U.S.C. 262a(a)(2). be added to the HHS list; (3) whether USDA Secretaries on November 2, 2010. The HHS Secretary last republished biological agents or toxins currently on The FESAP recommendations addressed the HHS select agents and toxins list in the HHS list should be deleted from the the reduction of the list of select agents the Federal Register on October 16, list; (4) whether the HHS select agents and toxins, the identification of a subset 2008 (73 FR 61363). The HHS select and toxins list should be tiered based on of the list that includes those that agents and toxins list is divided into the relative bioterrorism risk of each presents the greatest risk of deliberate two sections. The select agents and biological agent or toxin; and (5) misuse with the most significant toxins listed in § 73.3 (HHS select agents whether the security requirements for potential for mass casualties or and toxins) are those regulated only by select agents or toxins in the highest tier devastating effects to the economy, HHS under the authority of the should be further stratified based on critical infrastructure; or public Bioterrorism Response Act. The select type of use or other factors. We confidence; and the optimization of agents and toxins listed in § 73.4 requested recommendations regarding security programs at registered entities. (Overlap select agents and toxins) are the criteria to use to designate high risk In drafting its recommendations to those regulated by HHS under the select agents and toxins and those modify and stratify the list of select authority of the Bioterrorism Response recommendations were included in the agents and toxins, the FESAP utilized Act and regulated by the USDA under interagency working group discussions expert knowledge of the agents, the authority of the Agricultural on the matter. Relevant issues raised by combined with information from the Bioterrorism Protection Act of 2002 (7 the comments are discussed below in DHS’s Material Threat Determinations U.S.C. 8401). ‘‘II. Proposed Changes to 42 CFR part of biological agents and toxins. Care was To fulfill this statutory mandate, the 73.’’ used to balance risks identified with the Center for Disease Control and Congressional mandate to ensure the Prevention’s (CDC) Division of Select On July 2, 2010, President Obama signed Executive Order (E.O.) 13546: availability of select agents and toxins Agents and Toxins (DSAT) initiated its for research and educational activities. biennial review process, which ‘‘Optimizing the Security of Biological included consultation with CDC’s Select Agents and Toxins in the United Other sources of input that we have Intragovernmental Select Agents and States’’ that directed the Secretaries of considered in the drafting of this Toxins Technical Advisory Committee HHS and USDA to (1) designate a subset Proposed Rule include the following: (ISATTAC) and other subject matter of the select agents and toxins list (Tier The National Science Advisory Board experts. The ISATTAC is comprised of 1) that presents the greatest risk of for Biosecurity, the National Academies, Federal government employees from the deliberate misuse with the most and comments received from CDC, the National Institutes of Health significant potential for mass casualties professional societies and the public in (NIH), the Food and Drug or devastating effects to the economy, response to the CDC ANPRM published Administration (FDA), the USDA/ critical infrastructure; or public on July 21, 2010. Animal and Plant Health Inspection confidence; (2) explore options for The purpose of this notice of Service (APHIS), USDA/Agricultural graded protection of Tier 1 agents and proposed rulemaking is to seek public Research Service (ARS), USDA/CVB toxins to permit tailored risk comment on (1) the appropriateness of (Center for Veterinary Biologics), the management practices based upon the current HHS and Overlap list of Department of Homeland Security relevant contextual factors; and (3) select agents and toxins including (DHS), the Department of Defense consider reducing the overall number of whether there are other agents or toxins (DOD), and the Biomedical Advanced agents and toxins on the select agents that should be added to the HHS or Research and Development Authority and toxins list. E.O. 13546 also Overlap list or whether agents or toxins (BARDA) within the Office of the established the FESAP to advise the currently on the HHS or Overlap list Assistant Secretary for Preparedness HHS and USDA Secretaries on the should be deleted from the list; (2) the and Response in HHS. designation of Tier 1 agents and toxins, appropriateness of the proposed tiering CDC also published an ANPRM in the reduction in the number of agents on of the select agents and toxins list; (3) Federal Register (75 FR 42363) (July 21, the Select Agent List, establishment of whether minimum standards for 2010 ANPRM) inviting comments personnel reliability standards for those personnel reliability, physical and cyber concerning potential changes to part 73 having access to Tier 1 select agents and security should be prescribed for of Title 42 of the Code of Federal toxins, and establishment of physical identified Tier 1 agents; and (4) any Regulations (the select agent security and information security other aspect of the proposed regulations). We solicited comments standards for Tier 1 select agents and amendments to the select agent regarding (1) the appropriateness of the toxins. E.O. 13546 is available at: regulations. current HHS list of select agents and http://edocket.access.gpo.gov/2010/pdf/ toxins; (2) whether there are other 2010-16864.pdf. The FESAP provided II. Proposed Changes to 42 CFR Part 73

PROPOSED CHANGES TO 42 CFR PART 73

Section No. Current Change

73.0 ...... Applicability and related requirements .... No change. 73.1 ...... Definitions ...... Definitions added: Adjudicated as a mental defective; alien; committed to any mental institution; controlled substance; crime punishable by imprisonment for a term exceeding 1 year; indictment; information security; lawfully admitted for permanent residence; mental institution; occupational exposure; recombinant and synthetic nucleic acids; restricted person; unlawful use of any controlled substance. 73.2 ...... Purpose and scope ...... No change. 73.3 ...... HHS select agents and toxins ...... Designates Tier 1 select agents and toxins; adds select agents and toxins; clari- fies language; deletes from the HHS list.

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PROPOSED CHANGES TO 42 CFR PART 73—Continued

Section No. Current Change

73.4 ...... Overlap select agents and toxins ...... Designates Tier 1 select agents and toxins; adds select agents and toxins; clari- fies language; deletes from the overlap list. 73.5 ...... Exemptions for HHS select agents and Amends the immediate notification list to Tier 1 agents. toxins. 73.6 ...... Exemptions for overlap select agents Amends the immediate notification list to Tier 1 agents. and toxins. 73.7 ...... Registration and related security risk as- No change. sessments. 73.8 ...... Denial, revocation, or suspension of reg- Clarifies language. istration. 73.9 ...... Responsible Official ...... Redesignates paragraphs; adds new paragraphs (a)(3), (a)(6). 73.10 ...... Restricting access to select agents and Redesignates paragraphs; adds new paragraph (e); adds clarifying language. toxins; security risk assessments. 73.11 ...... Security ...... Revises regulatory text—paragraph (b), (c)(2). Redesignates paragraphs; adds new paragraphs (c)(8), (c)(9), (c)(10), (e). 73.12 ...... Biosafety ...... Revises paragraphs (a) and (c)(1); replaces ‘‘url’’ in paragraph (c)(3); redesig- nates paragraph (d); adds new paragraph (d). 73.13 ...... Restricted experiments ...... Clarifies language. 73.14 ...... Incident response ...... Redesignates paragraphs; adds new paragraphs (d) and (e). 73.15 ...... Training ...... Revises paragraph (a); redesignates paragraphs; adds new paragraph (b). 73.16 ...... Transfers ...... Redesignates paragraphs; adds new paragraphs (f), (h), (l). 73.17 ...... Records ...... Revises paragraph (a)(1); redesignates paragraphs; adds new paragraph (a)(2). 73.18 ...... Inspections ...... No changes. 73.19 ...... Notification of theft, loss, or release ...... No changes. 73.20 ...... Administrative review ...... Revises paragraphs. 73.21 ...... Civil money penalties ...... No changes.

A. Modifications to the List of HHS can be in excess of 30 percent. Chapare infection in humans when not treated. Select Agents and Toxins virus is a recently described New World However, the commenters argued that arenavirus that is associated with fatal Herpes B virus should not be included The following changes to the list of hemorrhagic fever syndrome and is as a select agent based on the following HHS select agents and toxins are most closely related to Sabia virus, an assertions: proposed based on comments received HHS select agent (Ref 1). Based on the • The inclusion of the virus on the in response to the July 21, 2010 ISATTAC recommendation and our list will produce no significant ANPRM, recommendations from the examination of the current scientific improvements in safety for the FESAP and ISATTAC, and our review of data and risks associated with this virus, American public. current scientific data regarding select we are proposing to add Chapare to the • Given the high prevalence of agents and toxins. As we discuss below, HHS list. infection in non-human primates and we are proposing to remove 6 select The ISATTAC also recommended the the relatively few human infections that agents, add 2 select agents, and identify addition of Lujo virus to the HHS list of have been recorded, it suggests that the 11 select agents and toxins as ‘‘Tier 1’’ select agents and toxins. Based on this virus is not easily transmitted to agents to the HHS list of select agents recommendation and our examination humans. and toxins. of the current scientific data and risks • The virus is capable of being treated Proposed Addition of Lujo and Chapare associated with this virus, we are also with several available licensed antiviral Viruses proposing to add Lujo virus. The compounds. scientific determination was based on • The virus does not present a On August 19, 2009 (74 FR 41829), we the fact that the Lujo virus caused a fatal sufficient risk of infection by the aerosol proposed the addition of Chapare virus outbreak of hemorrhagic fever, has an route. to the HHS list of select agents and unprecedented high case fatality rate of • The virus is a highly unlikely toxins; we did not receive any 80 percent, has been phylogenetically candidate for a bioterrorism agent due to comments regarding that proposal. identified as an arenavirus and is its environmental instability and the Based on scientific data and risks related to those members of the Old need for direct contact for infection. The associated with this virus, the ISATTAC World arenaviridae family (Junin, argument is further enhanced by the recommended the addition of Chapare Machupo, Sabia, Flexal, Guanarito, and absence of the virus listed on the NIH’s virus to the HHS list of select agents and Lassa) listed as HHS select agents that National Institute of Allergy and toxins. The determination to add cause hemorrhagic fever and pose a Infectious Diseases lists of Category A, Chapare virus to the HHS list of select significant risk to public health and B & C Priority Pathogens or the CDC’s agents and toxins was based on the safety (Ref 2). Category A, B & C Bioterrorism Agents following scientific information. The lists. HHS list currently includes members of Proposed Removal of Cercopithecine • The virus is widely available in the arenaviridae family (Junin, Herpesvirus 1 (Herpes B Virus) nature. Machupo, Sabia, Flexal, Guanarito, and Commenters acknowledged in The ISATTAC and the FESAP also Lassa). Arenaviruses are rodent-borne response to the July 21, 2010 ANPRM recommended the removal of viruses, some of which can be that (1) the Herpes B virus naturally Cercopithecine herpesvirus 1 (Herpes B associated with large hemorrhagic fever infects many species of macaques; and virus) from the HHS list of select agents outbreaks, and untreated case fatalities (2) can produce a serious, often fatal, and toxins. We agreed with the

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commenters, ISATTAC, and FESAP and • Q fever is not contagious and is American genotype (NA EEE) and South propose to remove Cercopithecine effectively treated with licensed American genotype (SA EEE). The NA herpesvirus 1 (Herpes B virus) from the antibiotics. EEE genotype consists of strains HHS list of select agents and toxins. Our • It is generally a self-limiting obtained from North America and the rationale for this proposal is based on infection with potential control by Caribbean while SA EEE genotype the facts that this virus is not easily licensed vaccination. viruses originate in Central and South transmitted to humans, the person-to- • The ubiquitous nature of Coxiella America. Viruses in the two genotypes person transmission risk is small, the burnetii means that it can be easily are distinctly different in their genetics, numbers of recorded human infections acquired from environmental sources epidemiology, and pathogenicity. NA are low, and multiple licensed antiviral and calls into question the effectiveness EEE, which are the strains responsible treatments for Herpes B infections are and procedures for maintaining for human and equine disease, are all available. inventories of select agents. genetically very similar to each other • Person-to-person transmission of (less than 3% divergence at the Proposed Removal of Coccidioides the disease is rare and is fatal less than nucleotide level) and can be easily posadasii/Coccidioides immitis one percent of the time. distinguished from SA EEE genotype Commenters to our July 21, 2010 • A vaccine is available for this agent strains by sequencing. NA EEE genotype ANPRM argued that Coccidioides internationally, but not domestically. strains differ from SA EEE viruses by posadasii/Coccidioides immitis should • The agent is commonly found in greater than 20% at the nucleotide level not be included as a select agent based animal populations within the United and approximately 10% at the amino on the following reasons: States. acid level. Since FESAP agreed with our • The characteristics of Coccidioides However, FESAP and ISATTAC did scientific assessment that SA EEE species do not provide convincing not recommend removing this genotypes should be removed from the properties of an effective agent of bacterium from the HHS list of select HHS list of select agents and toxins, we bioterrorism. agents and toxins. We agreed with the are proposing to remove SA EEE • The fungi are endemic in the FESAP and ISATTAC recommendations genotypes from the HHS list of select southwestern United States, but do not and propose to retain Coxiella burnetii agents and toxins (Ref 4). cause large epidemics even with high on the HHS select agents and toxins list. prevalence in the air during wind The determinations to retain this agent Proposed Removal of Flexal Virus storms. on the HHS list are its robust Commenters that responded to the • Infections caused by the fungi are environmental stability, ease of July 21, 2010 ANPRM felt that Flexal easily treatable by licensed antifungal transmission to humans, extremely low virus should be removed from the HHS medicines, especially early in disease. infectious dose, and prior association of list of select agents and toxins based on • The difficulty to use Coccidioides this agent with offensive programs. CDC the lack of severity of disease and the species as a bioweapon, and hence the invites comments regarding retaining lack of significant outbreaks of disease need for strict regulation under the this agent on the HHS list of select associated with infection with this virus select agent regulations, is exemplified agents and toxins. in humans. FESAP also recommended by their non-communicability, lack of Proposed Removal of South American that Flexal virus be removed from the history of use or development as list. Since our research found a lack of successful biological weapons, and a Genotypes of Eastern Equine Encephalitis Virus (EEEV) significant outbreaks of disease relatively low incidence of symptomatic associated with Flexal virus in humans disease following natural infection. Commenters on the July 21, 2010 and that this virus would be a highly • Coccidioides species would not be ANPRM regarding the proposed unlikely candidate for a bioterrorism an effective bioterrorism weapon inclusion of EEEV on the list of select agent, we are proposing to remove because the percentage of deaths and agents and toxins argued that EEEV Flexal virus from the HHS list of select hospitalizations are low considering the should not be included as a select agent agents and toxins. number of people infected. based on the following reasons: The FESAP also recommended • The virus occurs naturally in the Proposed Retention of Monkeypox Virus removal of Coccidioides posadasii/ environment. Commenters to the July 21, 2010 Coccidioides immitis from the HHS list • Direct person-to-person ANPRM recommended that Monkeypox of select agents and toxins. We agreed transmission does not occur. virus should not be included as a select with the commenters and FESAP and • Local and State health departments agent based on the following assertions: propose to remove Coccidioides and mosquito control agencies routinely • An effective licensed vaccine is posadasii/Coccidioides immitis from the release information regarding the available. HHS list of select agents and toxins. The location of arboviral activity in the • Promising antivirals are in scientific determination was based on community, so upholding strict advanced stages of development. the availability of licensed treatments biosecurity measures in a laboratory has • The virus is inefficiently for Coccidioides infection and a little or no impact on reducing a transmitted from person-to-person. lowering of our assessment of the terrorist’s ability to acquire this agent. We examined the current scientific impact of Coccidioides infection on • Only North American strains of data and noted that there is an increased human health, as indicated by the high EEEV should be regulated because incidence of Monkeypox virus in proportion of subclinical cases observed transmission patterns limit the humans as well as studies identifying in endemic areas (Ref 3). distribution and epidemic potential of the virus being easily transmitted in South American strains, which are less Gambian rats. A recent study on an Proposed Retention of Coxiella burnetii pathogenic. outbreak in Sudan indicates there is Commenters to the July 21, 2010 We examined the current scientific much strain variation in level of ANPRM argued that Coxiella burnetii (Q data and noted that strains of EEEV can infectivity and severity of disease. fever) should be removed from the be categorized into two distinct Concern over the detection of new select agents and toxins list based on the genotypes primarily based upon lineages with increased pathogenesis following assertions: geographic distribution: North has been expressed. Another recent

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outbreak of Monkeypox virus in the recognized subtypes: Central European, number of readily available licensed United States suggested numerous Far Eastern, and Siberian. The Russian antibiotics. In addition, there is no animals could become infected Spring and Summer encephalitis possibility of eliminating their presence complicating the understanding of designation is no longer recognized (Ref in the environment. zoonotic maintenance of the virus (Ref 6). Two other viruses on the HHS list of • Potential benefits of lessening 29–33). select agents and toxins, Kyasanur restriction on research include While there has been documented Forest disease virus and Omsk improved diagnostic capabilities and cross protection against Monkeypox Hemorrhagic fever virus, are no longer better potential for vaccine virus by Vaccinia virus vaccine, the classified as TBEV. In recognition of development. decrease in the number of individuals these taxonomic changes, we are The FESAP and ISATTAC with any immunity to the virus is proposing to include these viruses on recommended keeping Rickettsia drastically declining (since smallpox the HHS list of select agents and toxins prowazekii and Rickettsia rickettsii on vaccination no longer occurs). Further, as follows: the HHS list of select agents and toxins. even though there is a stockpile of Tick-borne encephalitis virus Since we agreed with these expert Vaccinia virus vaccine available, the Far Eastern subtype panels, we are proposing to retain vaccine has numerous undesirable side- Siberian subtype Rickettsia prowazekii and Rickettsia effects that make it less than optimal for Kyasanur Forest disease virus rickettsii on the HHS select agents and mass vaccination. There are also several Omsk Hemorrhagic fever virus toxins list based on our scientific antiviral treatments for Monkeypox in determination regarding the Proposed Retention of Rickettsia advanced stages of development, but environmental stability, low infectious prowazekii and Rickettsia Rickettsii they are not currently available. Thus, dose, aerosol transmission, and clinical there is currently no specific treatment Commenters that responded to the significance of infection with these (Ref 29–33). July 21, 2010 ANPRM argued that organisms. FESAP recommended keeping Rickettsia prowazekii and Rickettsia Proposed Retention of Yersinia pestis Monkeypox virus on the HHS list of rickettsii should be removed from the select agents and toxins. HHS list of select agents and toxins Commenters that responded to the Based on the scientific determination based on the following assertions: July 21, 2010 ANPRM argued that outlined above, we are proposing to • Mimicking transmission by Yersinia pestis should not be included retain Monkeypox virus on the HHS list arthropod vectors in an effort to as a select agent based on the following of select agents and toxins. We will disperse these pathogens with the intent assertions: continue to monitor progress in the to disrupt society would be challenging • Yersinia pestis is naturally development of antivirals and other and technologically unlikely to be occurring and does not survive for long means of prevention and control of successful. outside of its rodent host because of Monkeypox virus infections and invite • Common and readily available susceptibility to heat and sunlight. comments on removing a certain clade licensed antibiotics are highly effective, • Decontamination of surfaces is of Monkeypox virus (i.e., West African and contagion is not a threat because highly effective in limiting its spread. • clade of Monkeypox virus) from the spread is determined by contact with Licensed treatments are readily HHS list of select agents and toxins. the vectors, not through person-to- available for those who may become person contact. exposed. Proposed Reorganization of Tick-Borne • Although Rickettsia prowazekii The FESAP and ISATTAC Encephalitis Complex Viruses (TBEV) may be a pathogen of military recommended that Yersinia pestis Even though we received no significance, Rickettsia rickettsii is not. remain on the HHS list of select agents comments to the July 21, 2010 ANPRM According to the commenter, and toxins. regarding the removal of these viruses propagation of the pathogens requires We agree with the FESAP and from the HHS list of select agents and growth in cultured host cells and ISATTAC, and are proposing to keep toxins, we are proposing the removal of natural infection occurs by parenteral Yersinia pestis on the HHS select agents TBEV Central European subtype from inoculation through a tick vector, so and toxins list based on our scientific the HHS list of select agents and toxins mass exposure by aerosolization or conclusion regarding the bacterium’s for the following scientific reasons: contamination of food sources is high mortality rate, ease of • The TBEV Central European Tick- unlikely to result in disease. dissemination and production, and borne subtype has been shown to be less • The potential to use this agent as a person-to-person transmission of virulent in humans than the Far Eastern platform to construct a genetically Yersinia pestis infections. engineered new pathogen would be subtype (Ref 5). Proposed Reorganization of • No TBEV vaccines are licensed or extremely difficult. Staphylococcal Enterotoxins available in the United States; however • The primary disease associated two safe, effective inactivated TBEV with Rickettsia rickettsii is Rocky Commenters to the July 21, 2010 vaccines are available internationally. Mountain Spotted Fever, and the ANPRM suggested that the regulations FESAP also recommended the symptoms are recognizable and needed a clear statement concerning removal of the TBEV Central European marketed diagnostics and treatment are staphylococcal enterotoxins (SEs) and subtype from the HHS list of select readily available. staphylococcal enterotoxin-like toxins agents and toxins. • Rickettsia rickettsii should be (SEls). Commenters stated that SEs and In addition to removing the TBEV removed because generation of even SEls have been distinguished from each Central European subtype from the HHS moderate amounts of infectious material other on the basis of emetic activity (Ref list of select agents and toxins, we is exceedingly difficult and requires 12). Commenters were confused propose to reorganize the listing of the specialized equipment. regarding whether the intent of the TBEV to reflect the current • Rickettsiae are not spread directly select agent regulations is to nomenclature given by the International from person-to-person, would not acknowledge this difference and not Committee on Taxonomy of Viruses. For survive if dispersed into the regulate SEls or to regulate both SEs and TBEV proper, there are now just three environment, and are susceptible to a SEls.

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ISATTAC recommended that we strain in 2003 because the attenuated • The primary mode of transmission amend the HHS list of select agents and strain was determined to not pose a for Brucella abortus is through contact toxins to specifically include severe threat to public health and safety, with contaminated fluids/tissues, its Staphylococcal enterotoxins A, B, C, D, animal health, or animal products. We pathogenicity is moderate, and and E in the HHS list of select agents have not excluded the plasmid-negative infections are routinely treated with and toxins. We agree with the Pasteur variant in order to prevent the antibiotics that do an effective job. The commenters and the ISATTAC combination of plasmids from Sterne commenter recommended removal of recommendation, and propose to amend and Pasteur-types of strains to create a Brucella abortus strain 1119–3 because the select agents and toxins list from wild type phenotype. the strain is identical using ‘‘Staphylococcal enterotoxins’’ to conventional typing tests to strain 19 Proposed Retention of Brucella abortus, specifically include ‘‘Staphylococcal and is used as an antigen strain in Brucella melitensis, and Brucella suis enterotoxins A, B, C, D, and E’’ in the diagnostic tests. Strain 19 and RB51 HHS list of select agents and toxins (Ref Commenters to the July 21, 2010 have been excluded as licensed vaccine 7–14). Serotypes G, H, and I should not ANPRM recommended that Brucella products, but other research strains have added to the HHS list of select agents abortus, Brucella melitensis, and not been excluded. and toxins because serotypes G, H, and Brucella suis be removed from the • Another commenter supported I are at least 10 fold less of a risk than Overlap list of select agents and toxins downgrading the risk assessment for SEE and SEA (Ref 15–16.) According to for the following reasons: vaccine strains of Brucella. The the International Nomenclature • The benefits of removal far exceed commenter was concerned that the only Committee for Staphylococcal any risk mitigated by continuing the criterion the ISATTAC accepts for Superantigens, emesis in a primate listing. In the years since the organism exclusion is licensed drug status, but model within five hours post-feeding was first listed, research and such a high standard is disadvantageous must be observed to classify an exotoxin development has been greatly to research on this pathogen. as an enterotoxin (Ref 12). If emesis is diminished. The FESAP and ISATTAC not observed in this period of time, the • As currently regulated, existing recommended that Brucella abortus, exotoxin should be classified as BSL–3 facilities do not have the Brucella melitensis, and Brucella suis enterotoxin-like rather than enterotoxin. capacity to conduct brucellosis research remain on the Overlap list of select Based on this internationally accepted with sufficient numbers of animals to agents and toxins. We made no changes standard, we are proposing serotypes J, generate statistically valid research based on these comments because we K, L, M, N, O, P, Q, T, U, U2 and V results, and it is too expensive to agreed with these expert panels that should be designated staphylococcal construct and maintain enough high Brucella abortus, Brucella melitensis, enterotoxin-like rather than enterotoxin capacity BSL–3 facilities to conduct the and Brucella suis remain on the Overlap because these serotypes have been necessary research. The commenter list of select agents and toxins based on shown to either not cause emesis in a contended that any risk currently the bacteria’s ease of production, high primate model or have not been tested mitigated by the listing is fully infectivity via the aerosol route, low for emesis (Ref 17–26). Therefore, we manageable without such listing. infectious dose, and no brucellosis are proposing serotypes J, K, L, M, N, O, • Brucella abortus and Brucella suis vaccines are currently available for P, Q, T, U, U2 and V should not added should be removed because the humans in the United States. to the HHS list of select agents and organisms are adversely affected by toxins. Proposed Retention of Burkholderia environmental conditions and can be mallei and Burkholderia pseudomallei diagnosed and controlled in animals B. Modifications to the List of Overlap Commenters to the July 21, 2010 and readily treated in humans. The Select Agents and Toxins ANPRM contended that Burkholderia classification of these bacteria as select The following changes to the list of mallei and Burkholderia pseudomallei agents has hampered research that could Overlap select agents and toxins are should not be included as select agents result in vaccines that would protect proposed based on comments received based on the following reasons: to the July 21, 2010 ANPRM, susceptible animal populations. • The agents do not rise to the same recommendations from the FESAP and Although brucellosis will remain a level of public health threat or ISATTAC, and our review of current disease of agricultural significance, feasibility for weaponization that the scientific data regarding select agents Brucella abortus and Brucella suis are other agents on the list do. and toxins. not ideal biological weapons. The • Burkholderia mallei and commenter suggested, however, that Burkholderia pseudomallei are endemic Proposed Retention of Bacillus Brucella melitensis remain on the list in a number of areas of the world. anthracis (Pasteur Strain) because it is a foreign animal disease • Disease resulting from Burkholderia A commenter to the July 21, 2010 and the most infectious of all the mallei and Burkholderia pseudomallei ANPRM stated that the Pasteur strain of species. is treatable with low mortality. Bacillus anthracis should not be • Brucella species should have their • It is questionable how they would considered a select agent because the listed status reconsidered because be used as bioweapons. strain is attenuated and used for quality human infection is rarely fatal, acute The FESAP and ISATTAC control testing in Laboratory Response brucellosis can be readily treated with recommended that Burkholderia mallei Network (LRN) laboratories. The available antibiotics, human-to-human and Burkholderia pseudomallei remain commenter argued that changing the transmission is extremely rare, and on the Overlap list of select agents and status of the Pasteur strain would wildlife carriers in the United States toxins. We made no changes based on alleviate the burden of recordkeeping often come into contact with humans these comments because we agreed with for quality control and proficiency without significant transmission. these expert panels that Burkholderia testing activities. • Naturally occurring substances such mallei and Burkholderia pseudomallei We made no changes based on this as Brucella should be removed because should remain on the Overlap list of comment. It should be noted that we infections regularly occur from natural select agents and toxins based on our excluded Bacillus anthracis Sterne exposures. scientific determination that the bacteria

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can be produced in large quantity; epidemics or epizootics. The remaining • The potential for a high mortality transmitted via aerosol; and subtypes, ID and IE, are strains rate; Burkholderia pseudomallei is highly prevalent among the existing animal • The potential for a major human stable in the environment. The mortality populations and do not represent the health impact; rate for untreated cases of both same type of risk. Other viruses within • Select agents or toxins whose melioidosis and glanders is high, and the Venezuelan equine encephalitis misuse might result in public panic or given the rarity of these diseases in the complex (subtypes IF and II through IV) other social or economic disruption; and United States, experience in their are separate viruses and are not • Select agents or toxins whose use diagnosis and treatment is limited. included in the HHS and USDA overlap might require Federal, State, and/or list of select agents and toxins. local officials to take special action in Proposed Reorganization of Venezuelan planning for major human health Equine Encephalitis Virus (VEEV) C. Tiering disasters. Commenters to the July 21, 2010 E.O. 13546 specifies that a subset of The select agents that we propose will ANPRM contended that VEEV subtypes the Select Agent List be categorized as be designated as Tier 1 are the ID and IE should not be included as ‘‘Tier 1’’ because these agents and toxins following: select agents based on the following present the greatest risk of deliberate reasons: misuse with the most significant HHS • Inclusion of VEEV subtypes as potential for mass casualties or • Ebola virus select agents should be based solely on devastating effects to the economy, • Francisella tularensis their ability to cause an epidemic or critical infrastructure, or public • Marburg virus epizootic following a bioterrorism event. confidence. All but one of the • Variola major virus This would require inclusion of only commenters to the July 21, 2010 • Variola minor virus varieties 1AB and 1C VEEV which have ANPRM who addressed the idea of a • Yersinia pestis been shown to have epidemic/epizootic tiering system based on the relative • Botulinum neurotoxin potential. bioterrorism risk of each agent or toxin • Toxin-producing strains of • The reasons for excluding 1D and favored the use of tiers. Several Clostridium botulinum 1E VEEVs from the select agent list are: commenters mentioned specific criteria OVERLAP (1) No subtype 1D or 1E VEEV have ever for tiering. A few commenters expressed caused large equine epizootics; (2) the concern that tiering could create • Bacillus anthracis Inclusion of 1D viruses because they confusion, especially for facilities with • Burkholderia mallei might be precursors to 1C viruses is not multiple Biological Select Agents and • Burkholderia pseudomallei sufficient for making 1D viruses select Toxins (BSAT) and had concerns about Regarding the Reconstructed 1918 agents. Essentially all of this evidence is additional requirements that would be Influenza virus, recent studies have laboratory based. The possibility of a 1D placed on some laboratories. Some increased our understanding of the virus mutating to a 1C virus following commenters identified specific Tier 1 public health risks associated with this a bioterrorism event is unlikely because candidates from the BSAT listed in 42 agent. Current reports indicate that 60 1D viruses are unlikely to establish CFR 73.3 and § 73.4. Most of these percent of the population in the United epidemic or epizootic transmission commenters included Variola major States is immune to the 1918 Influenza cycles in the US. Natural transmission virus and Variola minor virus, as well virus and that antiviral treatments exist cycles would likely be needed for any as Reconstructed 1918 Influenza virus, (Ref 27–28). Based on this information evolution from 1D to 1C to occur in Ebola viruses, and Marburg virus in we propose to retain the Reconstructed nature; (3) Emergency vaccination of their Tier 1 list. Two commenters also 1918 Influenza virus on the HHS list of equines with currently approved equine suggested Bacillus anthracis and Lassa select agents and toxins, but not to vaccines or humans with IND vaccines fever virus. Other commenters suggested include it in Tier 1 of this list. (e.g. TC–83) would interdict or greatly Francisella tularensis, South America Based on the information currently dampen a 1D or a 1E epizootic, based hemorrhagic fever viruses, Brucella available, we conclude that the adoption on antigenic cross-reactivities of species, Coxiella burnettii, Botulinum of the Tier 1 designation would not subtype 1 viruses; and (4) The currently neurotoxin, and Ricin as candidates for result in significant economic effects to available humanized or human anti- Tier 1. the regulated community. However, we VEEV monoclonal antibodies that could Based on E.O. 13546, a FESAP are asking for any additional data or be produced for emergency use would recommendation and our agreement comments on the potential effects of also have prophylactic, and possibly with the comments received, we are designating the above agents as Tier 1. therapeutic efficacy for all VEEV proposing to amend the select agent D. Responses to Other Comments and subtype 1 infections with which they regulations to establish a number of Other Proposed Changes cross react (includes 1D and 1E viruses). select agents and toxins as Tier 1 select The FESAP and ISATTAC agents and toxins within the lists of With respect to the remainder of the recommended removal of certain HHS and Overlap select agents and sections outlined below, we are subtypes of Venezuelan equine toxins. All select agents and toxins were proposing the following changes based encephalitis virus from the Overlap list scored against 20 criteria by over 60 on comments received in response to of select agents and toxins. Since we Subject Matter Experts representing the the July 21, 2010 ANPRM and agreed with commenters and expert Federal life sciences, public health, law recommendations from the FESAP. We panels recommendations, we are enforcement, security, and intelligence are proposing to update the Web proposing to clarify that only VEEV communities, which included: address throughout the document as all subtypes IAB and IC should remain on • The relative ease with which a information concerning the Federal the Overlap list of select agents and particular select agent or toxin might be Select Agent Program is now centralized toxins because these subtypes contain disseminated or transmitted from one on the National Select Agent Registry the only recognized strains of human to another or into the Web site at http://www.selectagents. Venezuelan equine encephalitis that environment where it could produce a gov/. We also are proposing non- have demonstrated the ability to cause deleterious effect upon human health; substantive changes throughout the

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regulations for purposes of clarity. In the exception of certain miscellaneous substance, Indictment, Information addition, HHS/CDC and USDA/APHIS changes that are detailed below. security; Lawfully admitted for made the language similar to ensure permanent residence, Mental Security of Variola Major Virus and consistency between the regulations. institution, and Unlawful user of any Variola Minor Virus controlled substance. We believe that Exclusions In recognition of the special public these definitions will assist Responsible In order to update the regulations to health risks associated with Variola Officials as well as those seeking accurately reflect the way in which we major virus and Variola minor virus, we approval to access select agents and handle the listing of exclusions, we are are also proposing to require additional toxins to better understand what status proposing to remove the language physical security measures over and or activities, past or present, might stating that exclusions will be published above those proposed for Tier 1. These prohibit such access. in the Federal Register. This change is additional requirements would be Although these terms were undefined necessary because, while we anticipated added as section 73.11(e)(5) (Security). in the Bioterrorism Response Act, it is publication of exclusions both in the We believe this change is necessary evident that Congress modeled many of Federal Register and on the Internet at because Variola major virus and Variola them after the disqualifiers that are used the time the regulations were initially minor virus were determined to pose a by the Bureau of Alcohol, Tobacco, created, we have found that publication significantly higher public health risk Firearms, and Explosives (ATF) when on the select agent Web site only has than the other agents and toxins that enforcing the Gun Control Act of 1968. served to provide the most up-to-date were proposed for the Tier 1 select Because the purpose of the Select Agent information to the regulated agents and toxins list. We also believe Program differs from ATF’s enforcement community. that it would not be appropriate to actions under the Gun Control Act, we Security require that the special security do not believe that these terms must be procedures appropriate for Variola defined exactly the same. The Gun Commenters that responded to the major virus and Variola minor virus be Control Act regulates access to firearms, July 21, 2010 ANPRM suggested made applicable to other agents or while the Bioterrorism Response Act security requirements include toxins on a Tier 1 list. regulates access to biological agents and laboratory handling only by certified, toxins that the government has Select Agent Inventory trained individuals; physical security recognized as having the potential to be systems; restricted access; and security Many commenters to the July 21, 2010 used as weapons of mass destruction by risk assessments. Commenters also ANPRM pointed out that the the wrong hands. identified some criteria for stratifying, requirement to account for individual Nevertheless, we looked at the such as making the requirements risk- vials of each pathogen is inappropriate statutory and regulatory definitions of based, considering the type of work for replicating biological agents. these terms under the Gun Control Act done at the facility, acknowledging that Commenters stated that this is a costly when drafting our definitions. With the many threats are from disgruntled and burdensome responsibility for exception of the term ‘‘crime punishable insiders, requiring review of the laboratories and their staff and that this by imprisonment for a term exceeding 1 stratification by subject matter experts, requirement should be abolished except year,’’ we decided to adopt the and taking into account the needs of the for Tier 1 agents. applicable definitions used by ATF. researchers at the facility. We are not proposing any changes to We are proposing to define a ‘‘crime Based on our agreement with the the select agent regulations based on punishable by imprisonment for a term comments received, and input from the these comments. Currently, the select exceeding 1 year’’ as ‘‘any Federal, FESAP and stakeholder groups, we are agent regulations state that an accurate, State, or foreign offense for which the proposing more specific minimum current inventory for each select agent maximum penalty, whether or not security standards for Tier 1 select (including viral genetic elements, imposed, is capital punishment or agents or toxins. These additional recombinant nucleic acids, and imprisonment in excess of 1 year. What requirements would be added as section recombinant organisms) held in long- constitutes a conviction of such a crime 73.11(e). We believe these proposed term storage (placement in a system shall be determined in accordance with minimum security standards for Tier 1 designed to ensure viability for future the law of the jurisdiction in which the select agents would serve to further use, such as in a freezer or lyophilized proceedings were held. Any conviction mitigate the potential for deliberate materials) must be maintained. The that has been set aside or nullified as a misuse of these select agents and toxins requirement to account for individual matter of law or for which a person has that could result in mass casualties or vials of each pathogen in long term been pardoned shall not be considered devastating effects to the economy, storage is necessary to ensure the a conviction for purposes of this part.’’ critical infrastructure, or public biosecurity of select agents and toxins. Contrary to definition of this term used confidence. Further guidance on this requirement under the Gun Control Act, we have These proposed changes are based on can be found at http:// decided that foreign offenses should be established security industry standards www.selectagents.gov. considered a disqualifier. In doing so we with respect to securing high risk are aware of the Supreme Court’s material and developed in accordance Definitions decision in Small v. United States, 544 with the experience and expertise of the In order to improve the clarity of the U.S. 385 (2005) in which the court, Federal Select Agent Program and in HHS Select Agent Regulations, we are interpreting the provisions of 18 U.S.C. consultation with DOD, FBI, and DHS proposing to add the following 922(g)(1), held that phrase ‘‘convicted in security experts. They are necessary in definitions to 42 CFR 73.1, to clarify the any court’’ refers only to U.S. courts, not order to further ensure the safety and terms related to the identification of a to foreign courts. In its opinion security of those select agents and Restricted person: Adjudicated as a interpreting the Gun Control Act, the toxins that are proposed to be deemed mental defective, Alien, Crime court stated that ‘‘the statute itself and Tier 1 agents. The requirements for punishable by imprisonment for a term its history offer only congressional working with all other select agents and exceeding 1 year, Committed to any silence’’ as to whether Congress toxins would remain unchanged with mental institution, Controlled considered whether the statutory

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language included foreign convictions. under domestic law or may require We are proposing to add a definition In the case of the Public Health Security more severe penalties than under for Occupational exposure based on the and Bioterrorism Preparedness and domestic law. We note that in the past, definition used in the Occupational Response Act of 2002 (Bioterrorism and courts have applied the criteria set forth Safety and Health Administration Response Act), we believe Congress in Section 482 of the Restatement (third) (OSHA) regulations found in 29 CFR spoke clearly about their desire to limit of Foreign Relations Law of the United 1910.1030. In addition, we are or deny access to select agents and States (1986) in determining whether a proposing to add the definitions for toxins for those who have committed foreign judgment should be recognized Recombinant and Synthetic Nucleic serious crimes regardless of where in the United States. That Section Acids to clarify the existing regulations, committed. provides that a court in the United as the term ‘‘recombinant nucleic acids’’ We believe that in light of the threat States may not recognize a judgment of is employed but not defined, and of bioterrorism attacks, Congress would the court of a foreign state if the synthetic nucleic acids are not currently not want to exclude an individual judgment was rendered under a judicial addressed in the HHS Select Agent convicted of a U.S. offense from having system that does not provide impartial Regulations. access to BSAT, but still allow access to tribunals or procedures compatible with Recombinant/Synthetic Nucleic Acids an individual convicted in a foreign due process of law or the court that court of a similar offense. rendered the judgment did not have In addition to adding the proposed As a part of the safeguard and security jurisdiction over the defendant in definition for Recombinant and section of the Bioterrorism Response accordance with the law of the Synthetic Nucleic Acids, we are also Act, Congress not only put select agents rendering state. It further provides that proposing to add the phrase ‘‘and/or and toxins off limits to a ‘‘restricted a court in the United States need not synthetic’’ after the word person,’’ as that term is defined by 18 recognize a judgment of the court of a ‘‘Recombinant’’ throughout 73.3 (c) and U.S.C. 175b, but to those who are foreign state if the court that rendered 73.4 (c). Current regulations regarding ‘‘reasonably suspected by any Federal the judgment did not have jurisdiction recombinant nucleic acids and law enforcement or intelligence agency of the subject matter of the action, the recombinant organisms focus solely on of’’ (1) committing a ‘‘Federal crime of defendant did not receive notice of the the use of recombinant technology in terrorism’’ transcending national proceedings in sufficient time to enable the generation of these genetic elements. boundaries (18 U.S.C. 2332b), (2) the him to defend, the judgment was Since synthetic DNA technology may also be used to generate such genetic knowing involvement with an obtained by fraud, the cause of action on elements, we are proposing to expand organization that engages in domestic or which the judgment was based, or the the category of genetic elements to international terrorism or with any other judgment itself, is repugnant to the include recombinant and/or synthetic organization that engages in public policy of the United States or of international crimes of violence; or (3) DNA. the State where recognition is sought, being an agent of a foreign power. We the judgment conflicts with another Toxins believe it would be an inconsistent final judgment that is entitled to reading of statutory authority to allow Sections in §§ 73.3 and 73.4 of 42 CFR recognition, or the proceeding in the the Secretary to limit or deny access to contain provisions for toxins regulated foreign court was contrary to an select agents and toxins to someone by HHS under part 73. In 42 CFR 73.3(e) agreement between the parties to submit identified by the Attorney General as and 73.4(e), we are proposing to clarify the controversy on which the judgment being reasonably suspected of that the ‘‘inactive form of a select toxin’’ is based to another forum. We are committing a Federal crime of terrorism may be excluded from regulation since seeking comment on whether these transcending national boundaries but to the current term, ‘‘attenuated strain of be powerless in cases where a person criteria should be applied in toxin’’ is scientifically inaccurate. had actually been convicted of a serious considering whether access to select ‘‘Attenuated’’ is a term that is applied to crime in a foreign country. We also agents and toxins should be denied living organisms and toxins are not believe that the instances of regulation based on a foreign conviction or living organisms. Since ‘‘Inactive form can be distinguished in that with regard whether other criteria or factors would of a select toxin’’ is a more accurate to the Gun Control Act of 1968, the be appropriate to consider. term, we are proposing to amend the government is regulating access to guns Also, contrary to the definition used regulations to include the correct while with respect to the Bioterrorism by ATF, we are proposing that a state terminology. Response Act, the government is offense classified by the laws of that Section 42 CFR 73.3(d)(3) specifies regulating access to biological agents state as a misdemeanor, but which has the permissible select toxin amounts and toxins that the government has a term of imprisonment exceeding one under the control of a principal recognized as having the potential to be year, should be considered a investigator, treating physician or used in the wrong hands as weapons of disqualifier—even though an individual veterinarian, or commercial mass destruction. convicted of the same offense would not manufacturer or distributor that are We specifically request comments on be disqualified under the Gun Control excluded from the requirements of the the use of a foreign conviction as a Act. Finally, we are proposing to permit select agent regulations. We are predicate for denying access to select access to BSAT to individuals who have proposing to require that the person agents and toxins. We recognize that been convicted of a disqualifying transferring toxins in amounts which there can be significant differences offense if their convictions have been would otherwise be excluded from the between foreign convictions and set aside or nullified as a matter of law provisions of the select agent domestic convictions. For example, or they have been pardoned. Although regulations would be excluded only if foreign legal systems may not provide such language was not specifically the transferor: (1) Can show that the the same due process safeguards included in the Bioterrorism Response transferor used due diligence (i.e., afforded to citizens of the United States, Act, we believe that we should take into reasonably justified by a prophylactic, including impartial tribunals and jury account certain post-conviction actions protective, bona fide research, or other trials. Additionally, foreign countries when determining whether we should peaceful purpose) to assure that the may punish conduct that is permitted deny an individual access to BSAT. recipient has a legitimate need to handle

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or use such toxins; and (2) reports to Responsible Official developing and implementing a security CDC if they detect a known or suspected The regulations found in 42 CFR 73.9 plan sufficient to safeguard select agents violation of Federal law or become set out requirements for entities or toxins against unauthorized access, aware of suspicious activity related to requesting to work with select agents theft, loss, or release. The regulations the toxin. The HHS Secretary would and toxins to designate a Responsible currently require that the security plan also retain the authority to, without Official, who ensures that the entity must be submitted by all regulated prior notification, inspect and copy or meets the requirements of the entities upon request. We are proposing request the submission of the due regulations. to amend § 73.11 to require that the diligence documentation. It should be We are proposing to add a specific security plan be submitted for initial noted that this proposed requirement requirement that all Responsible registration and renewals of registration. would not apply to toxins exempted Officials possess the appropriate Since we believe animals and plants under Section 42 CFR 73.5(c). training or expertise to execute their exposed to or infected with a select required duties. We are also proposing agent should be handled as a select We are proposing to add 42 CFR agent and safeguarded in the same 73.3(d)(4) which would state, to add a requirement that the Responsible Official’s regular place of manner as a select agent, we are ‘‘Notwithstanding section (i) above, an proposing to require that the security animal inoculated with or exposed to an employment or principal duty station must be collocated in close proximity plan include provisions to address HHS select toxin.’’ The current safeguarding of animals or plants regulations consider that an animal with the physical location of the registered entity entered in section 1A intentionally or exposed to or infected injected with or exposed to (e.g., by with select agents against unauthorized inhalation, dermal absorption, or of APHIS/CDC Form 1 (Application for Registration for Possession, Use, and access, theft, loss or release. We are not ingestion) a select toxin is a ‘‘select Transfer of Select Agents and Toxins requiring this plan to address toxin’’ itself and would need to be OMB Control No. 0579–0213, OMB procedures concerning animals exposed housed in a registered space. This Control No. 0920–0576, Expiration Date to toxins because, as discussed above, it change would allow animals injected 12/31/2011). We believe that the is highly unlikely that once introduced with or exposed to a select toxin to not Responsible Official should have a into an animal, sufficient toxin can be be considered a ‘‘select toxin.’’ physical (and not merely a telephonic or recovered to pose a significant hazard to Therefore, the animals would not need audio/visual) presence at the entity to public health and safety. We are to be housed in a registered space. This ensure that the entity is in compliance additionally proposing to add a change will eliminate an unnecessary with the select agent regulations and be requirement that the security plan burden on a registered entity because able to quickly respond to on-site include procedures for the Responsible recovering the toxin from within an incidents involving select agents and Official to immediately notify the animal subject is highly difficult and toxins. Federal Bureau of Investigation (FBI) of such removal is unlikely to produce a We are also proposing to clarify the suspicious activity that may be criminal reasonable yield of recovery. In role of Alternate Responsible Official in in nature and related to the entity, its addition, there is uncertainty as to order to definitively establish that the personnel, or its select agents or toxins. whether the toxin would remain active Alternate Responsible Official must We believe that any criminal activity of when recovered from the animal. For have the knowledge and authority to act this kind should be immediately and these reasons, it is highly unlikely that for the Responsible Official in his/her directly reported to the FBI so they can once introduced into an animal, absence. initiate an investigation or other sufficient toxin would be able to be appropriate response. recovered to pose a significant hazard to Access to Select Agents and Toxins We are proposing that the security public health. We are proposing to amend the plans of entities with select agents and regulations in 42 CFR 73.10. These toxins must include provisions for Exemptions regulations establish parameters for information security. These information security provisions would include The regulations found in 42 CFR 73.5 restricting access to select agents and network connectivity monitoring, and 73.6 requires identified select toxins and the process by which restriction of user permissions so that agents listed on the CDC’s Category A individuals may be approved by HHS/ only mission-specific files and Bioterrorism Agents list (i.e., agents that CDC or USDA/APHIS for access to applications may be accessed, measures pose a risk to national security because select agents and toxins after the to prevent network infiltration by they can be easily disseminated or completion of a security risk assessment malicious code, configuration transmitted from person to person; by the Attorney General. Specifically, management including regular patching result in high mortality rates and have we are proposing to add new provisions by which individuals may have access and system and software updates, and the potential for major public health backup security measures in the event impact; might cause public panic and to select agents and toxins at entities other than the individual’s ‘‘home’’ that access control systems and/or social disruption; and require special surveillance devices are rendered action for public health preparedness) entity. We are also proposing to decrease the inoperable. We believe that information contained in a specimen presented for maximum length of time in which a security enhancements are important diagnosis or verification to be security risk assessment will be valid because the security of records or immediately reported to APHIS or CDC from five years to three years in order information systems that could allow an by telephone, facsimile, or e-mail. to more expeditiously identify individual to gain access to the select We are proposing to amend this individuals who may have fallen into agents or toxins should be safeguarded immediate notification to only those one of the prohibited or restricted to prevent unauthorized access, theft, select agents and toxins identified as categories. loss, or release of these materials. Tier 1 agents because these agents and We are proposing to codify current toxins present the greatest risk of Security Plan practices for shipping, receiving, and deliberate misuse with the most The regulations in 42 CFR 73.11 storage of select agents and toxins to significant potential for mass casualties. establish the requirements for ensure that the entity has documented

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processes for securing and monitoring DNA. The regulations in 42 CFR 73.13 awareness and incident response the shipment, receipt, and storage of concern restricted experiments which training. We believe these additional these items. These changes would serve may not be performed unless approved training initiatives are needed to ensure to decrease the chance that such by the HHS Secretary. Furthermore, we that (1) personnel will be better trained materials would be made available to an are proposing to state that, in addition to safeguard select agents and toxins unauthorized individual or an to the existing prohibition on from thefts, losses, intentional releases, individual without a legitimate use for conducting restricted experiments or unauthorized access and (2) the material. without express approval, entities may personnel will be better trained to We are also proposing to remove the not possess the products (i.e., creation ensure that select agents and toxins are reference in 73.11(e), ‘‘Laboratory of drug resistant select agents that are safeguarded during exigent Security and Emergency Response not known to acquire the resistance circumstances that include natural and Guidance for Laboratories Working with naturally, if such acquisition could man-made disasters. We are also Select Agents’’ in Morbidity and compromise the use of the drug to proposing to clarify the language Mortality Weekly Report (December 6, control disease agents in humans, regarding the level of training that staff 2002) because we posted a security veterinary medicine, or agriculture, or and visitors would be required to information guidance document in recombinant and or synthetic DNA receive in order to establish that training March 2007 that supersedes this containing genes for the biosynthesis of for escorted personnel based on the risk reference. select toxins lethal for vertebrates at an associated with accessing areas where Biosafety Plan LD[50] < 100 ng/kg body weight select agents and toxins are used and/ resulting from restricted experiments) or stored. Currently, refresher training is We are proposing to amend the resulting from restricted experiments required to be provided once a year. We regulations in 42 CFR 73.12 to require without the express approval of the are proposing to require that such that a regulated entity’s biosafety plan HHS Secretary. We are also proposing to training also be provided if a registered address procedures concerning animals remove recombinant technology as the entity’s security, incident response, or or plants accidentally or intentionally only determining factor for a restricted biosafety plans are substantively altered. exposed to or infected with a select experiment. Current regulations Finally, we are proposing to specify that agent. We are not requiring this plan to regarding restricted experiments focus the Responsible Official ensure address procedures concerning animals solely on the use of recombinant maintenance of training records. exposed to toxins. As stated previously, technology in the generation of drug Currently, there is no particular person this is because it is highly unlikely that resistant select agents or biosynthesis of designated as the entity’s required once introduced into an animal, toxins lethal to vertebrates. Since record keeper, only that a training sufficient toxin can be recovered to pose synthetic DNA technology or selection record must be kept. a significant hazard to public health, in sublethal exposures may also be used Transfers agriculture or agriculture products. to generate such products, we are We are also proposing that the proposing to expand the category of The transportation in commerce of biosafety plan must include provisions restricted experiments to include hazardous materials, including select for the implementation of an passive selection, recombinant and/or agents and toxins, is governed by the occupational health program for synthetic DNA. United States Department of individuals with access to Tier 1 select Transportation’s Hazardous Material agents and toxins. We believe aspects of Incident Response Regulations found in Title 49 of the an individual’s health may be relevant The regulations in 42 CFR 73.14 Code of Federal Regulations, parts 100– to their suitability to access biological contain requirements for development 185. The regulations in 42 CFR 73.16 do select agents and toxins; identification of incident response plans. We are not impose requirements on the of potential health problems and review proposing to specify that each entity’s transportation in commerce of select of medication or treatment that may incident response plan be based upon a agents or toxins. We are proposing to affect security and safety is paramount; site-specific risk assessment. We believe clarify when ‘‘transportation in and, occupational health programs this change would further ensure the commerce’’ begins and ends to better should inform scientists of the types of specificity and quality of the plan. In allow registered individuals and entities medications and treatments that might addition, we are proposing that the to adequately address those situations have a potential deleterious effect on incident response procedures contain when a select agent or toxin is (1) ready working safely and securely with select specific provisions concerning animals to be packaged for transportation, (2) agents and toxins. or plants accidentally or intentionally packaged for shipment, or (3) received exposed to or infected with a select and handled by a person with approval Restricted Experiments agent. We are not requiring this plan to to access select agents and toxins. In The regulations in 42 CFR 73.13 address procedures concerning animals addition, we are proposing language to concern restricted experiments that may exposed to toxins. As stated previously, codify policies and practices into a not be performed unless approved by this is because it is highly unlikely that standard for shipping, receiving, and the HHS Secretary. We are proposing to once introduced into an animal, storage of select agents and toxins to add language in order to expand the sufficient toxin can be recovered to pose ensure that the entity has documented current ‘‘restricted experiment’’ a significant hazard to public health, processes for securing and monitoring approval requirement to include all agriculture or agriculture products. the shipment, receipt, and storage of experiments involving the creation of select agents and toxins that make it drug resistant select agents that are not Training extremely unlikely that such materials known to acquire the resistance We are proposing to amend the would be made available to an naturally, if such acquisition could regulations in 42 CFR 73.15 that contain unauthorized individual or an compromise the use of the drug to provisions of mandatory training for individual without a legitimate use for control disease agents in humans, staff and visitors who work in or visit the material. We note the concerns veterinary medicine, or agriculture and areas where select agents or toxins are identified in two HHS Office of not just those involving recombinant handled or stored to provide security Inspector General (OIG) audits regarding

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vulnerabilities that may occur during sufficient time to gather all documents documents would serve as a resource to the shipment of select agents and toxins. necessary to support an appeal. Finally, the regulated community as a whole. HHS/CDC reviewed how entities ship we are proposing to remove the select agents and toxins and evaluated provision ‘‘Where the denial, III. Required Regulatory Analyses ways to improve this process to ensure revocation, or suspension of an a. Executive Orders 12866 and 13563 they are not only safeguarded against individual’s access approval is based unauthorized access, but also against upon identification by the Attorney Executive Orders 12866 and 13563 theft, loss, or release. We believe that General, the request for review will be direct agencies to assess all costs and the proposed amendments will help forwarded to the Attorney General’’ to benefits of available regulatory address OIG’s concerns. provide clarification that the decision alternatives and, if regulation is Records regarding the appeal is determined by necessary, to select regulatory the HHS Secretary. approaches that maximize net benefits The regulations in 42 CFR 73.17 (including potential economic, address recordkeeping requirements for Guidance Documents environmental, public health and safety regulated entities as those records that We are specifically requesting relate to select agents and toxins. We are effects, distributive impacts, and comments from the regulated equity). E.O. 13563 emphasizes the proposing to clarify the current language community and any other interested importance of quantifying both costs that an accurate, current inventory persons on the development of one or and benefits, of reducing costs, of needs to be maintained for each select more guidance documents that would agent that the entity possesses including serve to provide assistance in the harmonizing rules, and of promoting synthetic select agent organisms and interpretation of the select agent flexibility. any animals or plants intentionally or regulations. Under E.O. 12866 HHS must unintentionally exposed to or infected The areas where guidance documents determine whether a regulatory action is with a select agent (including number may be developed in relation to the ‘‘significant.’’ A ‘‘significant regulatory and species, location and appropriate select agent regulations include, but are action’’ under E.O. 12866 is defined as disposition). We believe this not limited to: (1) an action that is likely to result in clarification is needed to ensure that 1. Aspects of the required security a rule that may have an annual effect on accurate, current records are maintained plan. These may include, but are not the economy of $100 million or more, or for all select agents that the entity limited to: adversely and materially affects a sector possesses. We are currently soliciting • Standards for information security; of the economy, productivity, comments from the public (as well as • Development of suitability or affected agencies) concerning our personnel reliability practices, competition, jobs, the environment, proposed information collection and including pre-access and ongoing public health or safety, or state, local or recordkeeping requirements. Please assessment processes of persons who tribal governments or communities (or send written comments to Daniel will have access to Tier 1 select agents an economically significant action); Holcomb, CDC Acting Reports Clearance or toxins; (2) creates a serious inconsistency or Officer, 1600 Clifton Road, MS–D74, • Procedures for the method by otherwise interferes with an action Atlanta, GA 30333 or send an e-mail to which an entity’s Responsible Official taken or planned by another agency; [email protected]. Please state that your will coordinate his or her efforts with (3) materially alters the budgetary comments refer to Possession, Use, and the entity’s safety and security impact of entitlements, grants, user fees Transfer of Select Agents and Toxins professionals to ensure security of Tier or loan programs or the rights and (OMB Control No. 0920–0576). 1 select agents or toxins and have access obligations of recipients; or (4) raises As previously stated, we are not to relevant information from all novel legal or policy issues. Because proposing to require regulated entities professionals dealing with biological this rulemaking proposes changes to to keep records regarding animals select agents and toxins safety and how a subset of select agents and toxins exposed to toxins because it is highly security; are protected, this rule is has been • unlikely that once introduced into an Development of a self- and peer- determined to be ‘‘significant’’ under animal, sufficient toxin can be reporting program to track incidents or E.O. 12866 and, therefore, has been recovered to pose a significant hazard to conditions that could affect an reviewed by the Office of Management public health, agriculture or agriculture individual’s ability to safely access or and Budget (OMB). products. work with Tier 1 select agents and We have prepared an economic Administrative Review toxins; and • Layered physical security analysis for this rule. The economic We are proposing to amend the protection of assets for entities housing analysis provides a cost-benefit analysis, regulations in 42 CFR 73.20 that Tier 1 select agents and toxins. as required by E.O. 12866, and an initial addresses the administrative review of 2. Aspects of the required biosafety regulatory flexibility analysis (See III.b.) an individual or entity’s denial, plan, e.g., components of an that examines the potential economic revocation, or suspension of registration occupational health program for effects of this proposed rule on small and access approval. Specifically, we individuals with access to Tier 1 select entities, as required by the Regulatory are proposing to modify the current agents and toxins; and Flexibility Act. The economic analysis regulations in order to allow individuals 3. Aspects of the required training, is summarized below. Copies of the full more time to gather the necessary e.g., best practices for development of a analysis are available by contacting the components of their appeal following security awareness training program. person listed under FOR FURTHER the denial, limitation, or revocation of We welcome public comment on the INFORMATION CONTACT or on the Federal access approval. Currently, this process use of Web sites, articles, or other Select Agent Program Web site at: must be initiated in 30 calendar days. sources that may be used to develop http://www.selectagents.gov/ or on the We are proposing to extend the deadline such documents, in addition to to 180 calendar days. We believe this suggestions as to what elements should public docket at http:// change would provide individuals with be included as useful examples. These www.regulations.gov.

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Summary of the Regulatory Impact tiered select agent list no later than conducting research and related Analysis October 2011. activities entities in possession of Tier In addition, we are proposing several 1 select agents or toxins, and, to a Certain pathogens or biological toxins amendments to the regulations, somewhat lesser extent, those entities that are released intentionally or including the addition of definitions possessing the newly added select accidentally can result in disease, wide- and clarification of language concerning agents and toxins. The economic ranging and devastating impacts on the security, training, biosafety/ analysis presents categories and economy, disruption to society, biocontainment, and incident response. information from the Department of diminished confidence in public and These changes would increase the Commerce and the Small Business private institutions, and large-scale loss applicability and effectiveness of the Administration for those entities we of life. People or livestock can be select agent regulations and provide for have identified as most likely to be exposed to these agents from inhalation, enhanced program oversight. This rule affected by this rule. While we believe through the skin, or by the ingestion of would update the USDA, HHS, and affected entities are contained within contaminated food, feed, or water. overlap select agent and toxin lists. The these categories, we are seeking further Similarly, crops can be exposed to regulation of select agents and toxins is information regarding how many biological pathogens in several ways—at intended to prevent their misuse and entities fall specifically into each the seed stage, in the field, or after thereby reduce the potential for those category, and are therefore, inviting harvest. pathogens to harm humans, animals, comments on potential effects. In The Public Health Security and animal products, plants or plant particular, we are interested in Bioterrorism Preparedness and products in the United States. Should determining the number and kind of Response Act of 2002 (Pub. L. 107–188) any select agent or toxin be small entities that may incur benefits or (the Act) provides for the regulation of intentionally or unintentionally released costs from the implementation of this certain biological agents and toxins that into the environment, the consequences proposed rule. have the potential to pose a severe would be significant. Consequences This proposed rule would update the threat to both human and animal health, could include disruption of markets, APHIS, CDC, and overlap select agent to plant health, or to animal and plant difficulties in sustaining an adequate and toxin lists. The regulation of select products. APHIS and CDC have the food and fiber supply, and the potential agents and toxins is intended to prevent primary responsibility for implementing spread of disease infestations over large their misuse and thereby reduce the the provisions of the Act within USDA areas. The entities most likely to be potential for those pathogens to harm and HHS, respectively. Within APHIS, affected by this rule would be those humans, animals, animal products, Veterinary Services (VS) select agents laboratories and other institutions plants or plant products in the United and toxins are those that have been conducting research and related States. Should any select agent or toxin determined to have the potential to pose activities that involve the use of the be intentionally or unintentionally a severe threat to animal health or newly categorized Tier 1 select agents released into the environment, the animal products, and Plant Protection and toxins. The impact of the changes consequences would be significant. and Quarantine (PPQ) select agents and to the regulations is expected to be Consequences could include disruption toxins are those that have been minimal. Based on information obtained of markets, difficulties in sustaining an determined to have the potential to pose through site-specific inspections, we adequate food and fiber supply, and the a severe threat to plant health or plant believe that very few entities would potential spread of disease infestations products. HHS select agents and toxins incur significant costs for compliance. over large areas. The entities most likely are those that have been determined to Many of the proposed changes to the to be affected by this rule would be have the potential to pose a severe regulations would impose an added those laboratories and other institutions threat to human health. APHIS and CDC time cost to measures already required conducting research and related coordinate regulatory activities for for compliance, with respect to security, activities that involve the use of the overlap select agents and toxins that biocontainment/biosafety, and incident newly categorized Tier 1 select agents have been determined to pose a severe response plans, information security, and toxins. The impact of the changes threat to human and to animal health or and ongoing background checks. While to the regulations is expected to be animal products. the total cost of the proposed minimal, however. Based on Sections 201 and 212(a)(2) of the Act regulations is estimated to range information obtained through site- requires a biennial review and between $4.9 million and $6.4 million, specific inspections, indications are that republication of the select agent and we believe many of these costs are very few entities would incur significant toxin list, with revisions as appropriate currently incurred by affected entities as costs for compliance. Many of the in accordance with this law. See generally recognized practices. Costs proposed changes to the regulations 42 U.S.C. 262a(a)(2) and 7 U.S.C. actually incurred would depend upon would impose an added cost of the time 8401(a)(2), respectively. This rule would the number of computers and facility spent on documenting measures already implement the recommendations of the systems that require the proposed required for compliance, with respect to third biennial review of the list. enhanced security. The expected security, biocontainment/biosafety, and Furthermore, revision of these benefits of strengthened safeguards incident response plans, information regulations would incorporate the against the unintentional or deliberate security, and ongoing background recommendations developed as a result release of a select agent or toxin exceed checks. While the total costs imposed by of E.O. 13546, ‘‘Optimizing the Security the estimated costs of the proposed the proposed regulations are estimated of Biological Select Agents and Toxins measures. Based on the information we to range between $5.30 million and in the United States,’’ which requires have, there is no reason to conclude that $6.95 million, including costs to that the HHS and USDA Secretaries adoption of this proposed rule would government, we believe many of these publish proposed regulations to result in any significant economic effect costs are incurred through observance of establish risk-based tiering of the select on a substantial number of small generally recognized industry standards. agent list, and revise the regulations, entities. The entities are those Costs actually incurred would depend rules, and guidance to accommodate a laboratories and other institutions upon the extent to which current facility

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practices will need to be enhanced (44 U.S.C. 3501 et seq.), the information requested as part of the registration based on the proposed requirements. collection or recordkeeping process. In addition, we will be The expected benefits of strengthened requirements included in this proposed requesting submission of their Security safeguards against the costs associated rule have been submitted for approval to Plan for our review. with unintentional or deliberate release the Office of Management and Budget APHIS and CDC are asking OMB to of select agents or toxins would greatly (OMB). Please send written comments approve, for 3 years, the use of these exceed the estimated costs of the to the Office of Information and information collections, associated with proposed measures. The cost associated Regulatory Affairs, OMB, Attention: its efforts to more closely regulate select with a single outbreak have been known Desk Officer for APHIS, Washington, DC agents or toxins that could be used to to exceed $100 million as outlined in 20503. Please state that your comments commit acts of domestic or international the Regulatory Impact Analysis. refer to Docket Nos. APHIS–2009–0070 terrorism. We are soliciting comments Deliberate introduction greatly increases and CDC–2011–0012. Please send a from the public (as well as affected the probability of a select agent or toxin copy of your comments to: (1) Docket agencies) concerning this information becoming established and causing wide- Nos. APHIS–APHIS–2009–0070 and ranging and devastating impacts on an collection activity. APHIS and CDC CDC–2011–0012, Regulatory Analysis need this outside input to help economy, loss of market access for and Development, PPD, APHIS, Station accomplish the following: consumer goods and services, 3A–03.8, 4700 River Road Unit 118, disruption to society, and diminished Riverdale, MD 20737–1238, and (2) (1) Evaluate whether the proposed confidence in public and private Clearance Officer, OCIO, USDA, room information collection is necessary for institutions. 404–W, 14th Street and Independence the proper performance of our agency’s This analysis reviews expected Avenue, SW., Washington, DC 20250. A functions, including whether the benefits and costs of the proposed rule comment to OMB is best assured of information will have practical utility; in accordance with Executive Orders having its full effect if OMB receives it (2) Evaluate the accuracy of our 12866 and 13563. Possible impacts for within 30 days of publication of this estimate of the burden of the proposed small entities are also considered as proposed rule. information collection, including the required by the Regulatory Flexibility The Bioterrorism Preparedness Act is validity of the methodology and Act, which requires agencies to prepare designed to prevent, prepare for and assumptions used; and make available for public comment respond to bioterrorism and other (3) Enhance the quality, utility, and an initial regulatory flexibility analysis public health emergencies. The law clarity of the information to be that describes expected impacts of a requires individuals possessing agents collected; and proposed rule on small businesses, or toxins deemed a severe threat to small organizations and small human, animal, or plant health, or to (4) Minimize the burden of the governmental jurisdictions. animal or plant products, to be information collection on those who are Based on the information we have, registered with the Secretary of to respond (such as through the use of there is no reason to conclude that Agriculture or the Secretary of Health appropriate automated, electronic, adoption of this proposed rule would and Human Services, unless they have mechanical, or other technological result in any significant economic effect been specifically exempted. collection techniques or other forms of on a substantial number of small This proposed rule entails the use of information technology; e.g., permitting entities. However, we do not currently a number of separate forms designed to electronic submission of responses). have all of the data necessary for a obtain critical information concerning comprehensive analysis of the effects of Estimate of burden: Public reporting individuals or entities in possession of this proposed rule on small entities. burden for this collection of information certain agents or toxins, as well as the Therefore, we are inviting comments on is estimated to average 2.3187883 hours specific characteristics of the agents or potential effects. In particular, we are per response. toxins—including name, strain, and interested in determining the number genetic information. This data is Respondents: Researchers, and kind of small entities that may needed, in part, to allow APHIS and universities, research and development incur benefits or costs from the organizations, commercial implementation of this proposed rule. CDC to determine the biosafety level of an entity as well as the entity’s manufacturers, non-profit institutions, b. Regulatory Flexibility Act biosecurity situation. This, in turn, diagnostic laboratories and other helps APHIS and CDC ensure that interested parties who possess, use, or The Regulatory Flexibility Act (RFA) transfer agents or toxins deemed a (5 U.S.C. 601 et seq.) requires an agency appropriate safeguard, containment, and severe threat to human, animal or plant to consider the potential impact of its disposal requirements commensurate health, or to animal or plant products. regulations on small entities, including with the risk of the agent or toxin are small businesses, small governmental present at the entity, thus preventing Estimated annual number of units, and small not-for-profit access to such agents and toxins for use respondents: 386. organizations. We certify that this rule in domestic or international terrorism. Estimated annual number of will not have a significant economic Facilities containing select agents will responses per respondent: 12.230569. impact on a substantial number of small be required to maintain records on Estimated annual number of entities within the meaning of the RFA. animals and plants, and revise their responses: 4,721. Therefore, a regulatory flexibility Biosafety/Biocontainment Plan and analysis as provided for under the RFA Incident Response Plan for review by Estimated total annual burden on is not required. APHIS and CDC upon request. respondents: 10,947 hours. (Due to Information to determine that averaging, the total annual burden hours c. Paperwork Reduction Act of 1995 individuals seeking to register have a may not equal the product of the annual In accordance with section 3507(d) of lawful purpose to possess, use, or number of responses multiplied by the the Paperwork Reduction Act of 1995 transfer agents or toxins will also be reporting burden per response.)

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Average Number of Number of burden per Total Section Form name respondents responses per response burden respondent (in hours) hours

9 CFR 121.5 and 6, 7 CFR 331.5, Report of Identification of a Select 161 3 1 299 43 CFR 73.5 and 6. Agent or Toxin. § 121.7, § 331.7, § 73.7 ...... Application for Registration ...... 7 1 5 35 § 121.7, § 331.7, § 73.7 ...... Amendment to a Certificate of Reg- 380 7 1 1,955 istration. § 121.11, § 331.11, § 73.11 ...... Security Plan ...... 380 1 5 1,900 § 121.12, § 331.12, § 73.12 ...... Biosafety/Biocontainment Plan ...... 380 1 8 3,040 § 121.13, § 331.13, § 73.13 ...... Request Regarding a Restricted Ex- 160 1 2 320 periment. § 121.14, § 331.14, § 73.14 ...... Incident Response Plan ...... 380 1 5 1,900 § 121.15, § 331.15, § 73.15 ...... Training ...... 380 1 1 380 § 121.16, §331.16, §73.16 ...... Request to Transfer Select Agents 290 1 2 580 and Toxins. § 121.17, § 331.17, § 73.17 ...... Records ...... 295 1 0.5 148 § 121.19, §331.19, §73.19 ...... Notification of Theft, Loss, or Re- 195 1 2 390 lease.

Copies of this information collection 2. Briese T, Paweska JT, McMullan LK, enterotoxin B. Biochemistry 4(6): 1011– can be obtained from Mrs. Celeste Hutchison SK, Street C, Palacios G, 6. Sickles, APHIS’ Information Collection Khristova ML, Weyer J, Swanepoel R, 14. Wang, S., Y. Li, et al., 2008. A broad- Egholm M, Nichol ST, Lipkin WI. spectrum inhibitory peptide against Coordinator, at (301) 851–2908. Genetic detection and characterization of staphylococcal enterotoxin superantigen d. Executive Order 12988: Civil Justice Lujo virus, a new hemorrhagic fever- SEA, SEB and SEC. Immunol Lett 121(2): Reform associated arenavirus from southern 167–72. Africa. PLoS 2009 May; 5(5):e1000455. 15. Munson, S.H., M.T. Tremaine, et al., This proposed rule has been reviewed Epub 2009 May 29. Available at http:// 1998. Identification and characterization under E.O. 12988, Civil Justice Reform. www.plospathogens.org. of staphylococcal enterotoxin types G If this proposed rule is adopted: (1) All 3. Galgiani, J.N. 1999. Coccidiomycosis: a and I from Staphylococcus aureus. Infect State and local laws and regulations that regional disease of national importance. Immun 66(7): 3337–48. are inconsistent with this rule will be Ann Intern. Med. 130:293–298. 16. H.Su, Y.C. and A.C. Wong, 1995. 4. Arrigo NC, Adams AP, Weaver SC. Identification and purification of a new preempted; (2) no retroactive effect will Evolutionary patterns of eastern equine staphylococcal enterotoxin. Appl be given to this rule; and (3) encephalitis virus in North versus South Environ Microbiol 61(4): 1438–43. administrative proceedings will not be America suggest ecological differences 17. Zhang, S., J.J. Iandolo, et al., 1998.The required before parties may file suit in and taxonomic revision. J Virol. 2010 enterotoxin D plasmid of Staphylococcus court challenging this rule. Jan; 84(2):1014–25. aureus encodes a second enterotoxin 5. Gresı´kova´ M, Kaluzova´ M, 1997. Biology determinant (sej). FEMS Microbiol Lett e. Executive Order 13132: Federalism of tick-borne encephalitis virus. Acta 168(2): 227–33. This rule has been reviewed under Virol. Apr; 41(2):115–24. 18. Orwin, P.M., J.R. Fitzgerald, et al., 2003. E.O. 13132, Federalism. The rule does 6. Ecker M, Allison SL, Meixner T, Heinz FX, Characterization of Staphylococcus not impose any regulation that would 1999. Sequence analysis and genetic aureus enterotoxin L. Infect Immun classification of tick-borne encephalitis 71(5): 2916–9. preempt State, local, and Indian Tribe viruses from Europe and Asia. J Gen 19. Orwin, P.M., D.Y. Leung, et al., 2001. requirements, or that would have any Virol. Jan; 80 (Pt 1):179–85. Biochemical and biological properties of substantial direct effects on the States, 7. Bergdoll, M. S., 1988. Monkey feeding test Staphylococcal enterotoxin K. Infect or on the distribution of power and for staphylococcal enterotoxin. Methods Immun 69(1): 360–6. responsibilities among the various Enzymol 165: 324–33. 20. Orwin, P.M., D.Y. Leung, et al., 2002. levels of government. 8. Bergdoll, M. S., C. R. Borja, et al., 1971. Characterization of a novel Identification of enterotoxin E. Infect staphylococcal enterotoxin-like f. Plain Writing Act of 2010 Immun 4(5): 593–5. superantigen, a member of the group V Under Public Law 111–274 (October 9. Borja, C. R. and M. S. Bergdoll, 1967. subfamily of pyrogenic toxins. Purification and partial characterization Biochemistry 41(47): 14033–40. 24, 2010), executive branch of enterotoxin C produced by 21. Jarraud, S., M.A. Peyrat, et al., 2001. Egc, Departments and Agencies are required Staphylococcus aureus strain 137. a highly prevalent operon of enterotoxin to use plain language in documents that Biochemistry 6(5): 1467–73. gene, forms a putative nursery of explain to the public how to comply 10. Chintagumpala, M. M., J. A. Mollick, et superantigens in Staphylococcus aureus. with a requirement the Federal al., 1991. Staphylococcal toxins bind to J Immunol 166(1): 669–77. Government administers or enforces. different sites on HLA–DR. J Immunol 22. Kuroda, M., T. Ohta, et al., 2001. Whole HHS has attempted to use plain 147(11): 3876–81. genome sequencing of meticillin- language in promulgating the proposed 11. Chu, F. S., K. Thadhani, et al., 1966. resistant Staphylococcus aureus. Lancet Purification and characterization of 357(9264): 1225–40. rule consistent with the Federal Plain staphylococcal enterotoxin A. 23. Omoe, K., K. Imanishi, et al., 2004. Writing Act guidelines. Biochemistry 5(10): 3281–9. Biological properties of staphylococcal IV. References 12. Lina, G., G.A. Bohach, et al., 2004. enterotoxin-like toxin type R. Infect Standard nomenclature for the Immun 72(6): 3664–7. 1. Delgado, Erickson, et al., 2008. Chapare superantigens expressed by 24. Ono, H.K., K. Omoe, et al., 2008. virus, a newly discovered arenavirus Staphylococcus. J Infect Dis 189(12): Identification and characterization of isolated from a fatal hemorrhagic fever 2334–6. two novel staphylococcal enterotoxins, case in Bolivia. PLoS Pathogens 13. Schantz, E.J., W.G. Roessler, et al., 1965. types S and T. Infect Immun 76(11): 4:e1000047. Purification of staphylococcal 4999–5005.

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25. Letertre, C., S. Perelle, et al., 2003. Control and Prevention, United States marijuana and scheduled depressants, Identification of a new putative Department of Health and Human stimulants, and narcotic drugs. The term enterotoxin SEU encoded by the egc Services, proposes to amend 42 CFR does not include distilled spirits, wine, cluster of Staphylococcus aureus. J Appl part 73 as follows: malt beverages, or tobacco, as those Microbiol 95(1): 38–43. 26. Thomas, D.Y., S. Jarraud, et al., 2006. terms are defined or used in Subtitle E PART 73—SELECT AGENTS AND of the Internal Revenue Code of 1986, as Staphylococcal enterotoxin-like toxins TOXINS U2 and V, two new staphylococcal amended. superantigens arising from 1. The authority citation for part 73 Crime punishable by imprisonment recombination within the enterotoxin continues to read as follows: for a term exceeding 1 year. Any gene cluster. Infect Immun 74(8): 4724– Federal, State, or foreign offense for 34. Authority: 42 U.S.C. 262a; sections 201– which the maximum penalty, whether 27. Medina RA, Manicassamy B, Stertz S, 204, 221 and 231 of Title II of Public Law 107–188, 116 Stat 637 (42 U.S.C. 262a). or not imposed, is capital punishment Seibert CW, Hai R, Belshe RB, Frey SE, or imprisonment in excess of 1 year. Basler CF, Palese P, Garcı´a-Sastre A. 2. Section 73.1 is amended by adding, What constitutes a conviction of such a Pandemic 2009 H1N1 vaccine protects in alphabetical order, definitions of against 1918 Spanish influenza virus. crime shall be determined in accordance Adjudicated as a mental defective, with the law of the jurisdiction in which Nat Commun. 2010 Jun 15;1:28. doi: Alien, Committed to any mental 10.1038/ncomms1026. the proceedings were held. Any 28. Tumpey TM, Garcı´a-Sastre A, Mikulasova institution, Controlled substance, Crime conviction that has been set aside or A, Taubenberger JK, Swayne DE, Palese punishable by imprisonment for a term nullified as a matter of law or for which P, Basler CF. Existing antivirals are exceeding 1 year, Indictment, a person has been pardoned shall not be effective against influenza viruses with Information security, Lawfully admitted considered a conviction for purposes of genes from the 1918 pandemic virus. for permanent residence, Mental this part. Proc Natl Acad Sci U S A. 2002 Oct institution, Occupational exposure, 15;99(21):13849–54. Epub 2002 Oct 4. Recombinant and synthetic nucleic * * * * * Indictment. A formal written 29. Xiao Y, Isaacs SN. Therapeutic Vaccines acids, Restricted person, and Unlawful accusation originating with a prosecutor and Antibodies for Treatment of user of any controlled substance to read Orthopoxvirus Infections. Viruses. 2010 and issued by a grand jury against a as set forth below. Oct;2(10):2381–2403. party charged with a crime. For the 30. Rimoin AW, Mulembakani PM, Johnston § 73.1 Definitions. purpose of these regulations the term SC, Lloyd Smith JO, Kisalu NK, Kinkela * * * * * indictment includes any ‘‘information’’ TL, Blumberg S, Thomassen HA, Pike that is a formal accusation of a crime, BL, Fair JN, Wolfe ND, Shongo RL, Adjudicated as a mental defective. A Graham BS, Formenty P, Okitolonda E, determination by a court, board, differing only in that it is being Hensley LE, Meyer H, Wright LL, commission, or other lawful authority presented by a competent public officer Muyembe JJ. Major increase in human that a person, as a result of marked on his oath of office, instead of a grand monkeypox incidence 30 years after subnormal intelligence, or mental jury. smallpox vaccination campaigns cease in illness, incompetency, condition, or Information security. Protecting the Democratic Republic of Congo. Proc disease is a danger to himself/herself or information and information systems Natl Acad Sci U S A. 2010 Sep to others or lacks the mental capacity to from unauthorized access, use, 14;107(37):16262–7. Epub 2010 Aug 30. disclosure, disruption, modification, or 31. Reynolds MG, Carroll DS, Olson VA, contract or manage his/her own affairs. The term includes a finding of insanity destruction in order to provide— Hughes C, Galley J, Likos A, Montgomery (1) Integrity, which means guarding JM, Suu-Ire R, Kwasi MO, Jeffrey Root J, by a court in a criminal case and those Braden Z, Abel J, Clemmons C, Regnery persons found incompetent to stand against improper information R, Karem K, Damon IK. A silent enzootic trial or found not guilty by reason of modification or destruction, and of an orthopoxvirus in Ghana, West lack of mental responsibility pursuant to includes ensuring information Africa: evidence for multi-species articles 50a and 72b of the Uniform nonrepudiation and authenticity; involvement in the absence of Code of Military Justice, 10 U.S.C. 850a, (2) Confidentiality, which means widespread human disease. Am J Trop 876b. preserving authorized restrictions on Med Hyg. 2010 Apr;82(4):746–54. Alien. Any person not a citizen or access and disclosure, including means 32. Di Giulio DB, Eckburg PB. Human for protecting personal privacy and monkeypox: an emerging zoonosis. national of the United States. * * * * * proprietary information; and Lancet Infect Dis. 2004 Jan;4(1):15–25. (3) Availability, which means 33. Hutson CL, Lee KN, Abel J, Carroll DS, Committed to any mental institution. Montgomery JM, Olson VA, Li Y, A formal commitment of a person to any ensuring timely and reliable access to Davidson W, Hughes C, Dillon M, mental institution by a court, board, and use of information. Spurlock P, Kazmierczak JJ, Austin C, commission, or other lawful authority. * * * * * Miser L, Sorhage FE, Howell J, Davis JP, The term includes a commitment to a Lawfully admitted for permanent Reynolds MG, Braden Z, Karem KL, mental institution involuntarily. The residence. The status of having been Damon IK, Regnery RL. Monkeypox term includes commitment for mental lawfully accorded the privilege of zoonotic associations: insights from residing permanently in the United laboratory evaluation of animals defectiveness or mental illness. It also associated with the multi-state US includes commitments for other States as an immigrant in accordance outbreak. Am J Trop Med Hyg. 2007 reasons, such as for drug use. The term with the immigration laws, such status Apr;76(4):757–68. does not include a person in a mental not having changed. institution for observation or a Mental institution. Includes mental List of Subjects in 42 CFR Part 73 voluntary admission to a mental health facilities, mental hospitals, Biologics, Incorporation by reference, institution. sanitariums, psychiatric facilities, and Packaging and containers, Penalties, Controlled substance. A drug or other other facilities that provide diagnoses by Reporting and recordkeeping substance, or immediate precursor, as licensed professionals of mental requirements, Transportation. defined in section 102 of the Controlled retardation or mental illness, including For the reasons stated in the Substances Act, 21 U.S.C. 802. The term a psychiatric ward in a general hospital. preamble, the Centers for Disease includes, but is not limited to, * * * * *

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Occupational exposure. Any substance in a manner other than as toxins and are subject to additional reasonably anticipated skin, eye, prescribed by a licensed physician. requirements as listed in this part. mucous membrane, or parenteral Such use is not limited to the use of (b) HHS select agents and toxins: 1 contact with blood or other potentially drugs on a particular day, or within a Abrin infectious materials or toxins that may matter of days or weeks before, but Botulinum neurotoxins* result from the performance of an rather that the unlawful use has Botulinum neurotoxin producing employee’s duties. occurred recently enough to indicate species of Clostridium* * * * * * that the individual is actively engaged Chapare Recombinant and synthetic nucleic in such conduct. A person may be an Clostridium perfringens epsilon toxin acids. unlawful current user of a controlled Conotoxins (1) Recombinant nucleic acid substance even though the substance is Coxiella burnetii molecules that are constructed by not being used at the precise time the Crimean-Congo haemorrhagic fever joining nucleic acid molecules and that person seeks to have access to a select virus can replicate in a living cell; agent or toxin. An inference of current Diacetoxyscirpenol (2) Synthetic nucleic acid molecules use may be drawn from evidence of a Eastern Equine Encephalitis virus that are chemically, or by other means, recent use or possession of a controlled (North American genotypes) synthesized or amplified nucleic acid substance or a pattern of use or Ebola virus* molecules that may wholly or partially possession that reasonably covers the Francisella tularensis* contain functional equivalents of present time, e.g., a conviction for use Lassa fever virus nucleotides; or or possession of a controlled substance Lujo (3) Molecules that result from the within the past year; multiple arrests for Marburg virus* replication of those described in such offenses within the past 5 years if Monkeypox virus paragraphs (1) or (2) of this definition. the most recent arrest occurred within Reconstructed replication competent * * * * * the past year, or persons found through forms of the 1918 pandemic influenza Restricted person. An individual who: a drug test to use a controlled substance virus containing any portion of the (1) Is under indictment for a crime unlawfully, provided that the test was coding regions of all eight gene punishable by imprisonment for a term administered within the past year. For segments (Reconstructed 1918 Influenza exceeding 1 year; a current or former member of the virus) (2) Has been convicted in any court of Armed Forces, an inference of current Ricin a crime punishable by imprisonment for use may be drawn from recent Rickettsia prowazekii a term exceeding 1 year; disciplinary or other administrative Rickettsia rickettsii (3) Is a fugitive from justice; action based on confirmed drug use, Saxitoxin (4) Is an unlawful user of any e.g., court-martial conviction, Shiga-like ribosome inactivating controlled substance (as ‘‘controlled nonjudicial punishment, or an proteins substance’’ is defined in section 102 of administrative discharge based on drug Shigatoxin the Controlled Substances Act (21 use or drug rehabilitation failure. South American Haemorrhagic Fever U.S.C. 802)); * * * * * viruses (5) Is an alien illegally or unlawfully 3. Section 73.3 is amended as follows: Guanarito in the United States; a. By adding a sentence to the end of Junin (6) Has been adjudicated as a mental paragraph (a) to read as set forth below. Machupo defective or has been committed to any b. By revising paragraph (b) to read as Sabia mental institution; set forth below. Staphylococcal enterotoxins (SE) A–E (7) Is an alien (other than an alien c. In paragraph (c), in the introductory (SEA, SEB, SEC, SED, SEE) lawfully admitted for permanent text, by adding the phrase ‘‘and/or T–2 toxin residence) who is a national of a country Synthetic’’ after the word Tetrodotoxin as to which the Secretary of State, ‘‘Recombinant’’ each time it appears. Tick-borne encephalitis virus pursuant to section 6(j) of the Export d. In paragraph (c)(2) introductory Far Eastern subtype Administration Act of 1979 (50 U.S.C. text, by adding the phrase ‘‘and/or Siberian subtype App. 2405(j)), section 620A of chapter 1 synthetic’’ after the word Kyasanur Forest disease virus of part M of the Foreign Assistance Act ‘‘Recombinant’’. Omsk hemorrhagic fever virus of 1961 (22 U.S.C. 2371), or section e. By revising paragraph (d)(3) to read Variola major virus (Smallpox virus)* 40(d) of chapter 3 of the Arms Export as set forth below. Variola minor virus (Alastrim)* Control Act (22 U.S.C. 2780d), has made f. By adding a new paragraph (d)(4) to Yersinia pestis* a determination (that remains in effect) read as set forth below. * * * * * that such country has repeatedly g. By revising paragraph (e) to read as (d) * * * provided support for acts of set forth below. (3) Except as required in § 73.16(l), international terrorism; or h. In paragraph (f)(3)(i), by removing HHS toxins under the control of a (8) Has been discharged from the the words ‘‘Lassa fever virus, South principal investigator, treating Armed Services of the United States American Haemorrhagic Fever virus physician or veterinarian, or under dishonorable conditions. (Junin, Machupo, Sabia, Flexal, commercial manufacturer or distributor, * * * * * Guanarito)’’ and by adding the words if: Unlawful user of any controlled ‘‘Botulinum neurotoxin producing (i) The aggregate amount does not, at substance. For purposes of this part, a species of Clostridium.’’ any time, exceed the following amounts: person who uses a controlled substance 100 mg of Abrin; 0.5 mg of Botulinum § 73.3 HHS select agents and toxins. and has lost the power of self-control neurotoxins; 100 mg of Clostridium with reference to the use of that (a) * * * The select agents and toxins controlled substance; and any person marked with an asterisk (*) are 1 Including all toxin derivatives, both naturally who is a current user of a controlled designated as Tier 1 select agents and occurring and synthetic, that retain function.

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perfringens epsilon toxin; 100 mg of synthetic’’ after the word § 73.6 [Amended] Conotoxins; 1,000 mg of ‘‘Recombinant’’ each time it appears. 6. Section 73.6(a)(3)(i) is amended by Diacetoxyscirpenol; 100 mg of Ricin; d. In paragraph (c)(2), by adding the removing the words ‘‘Brucella 100 mg of Saxitoxin; 100 mg of Shiga- phrase ‘‘and/or synthetic’’ after the melitensis, Hendra virus, Nipah virus, like ribosome inactivating proteins; 100 word ‘‘Recombinant’’. Rift Valley fever virus, and Venezuelan mg of Shigatoxin; 5 mg of e. By revising paragraph (e) to read as equine encephalitis virus’’ and adding Staphylococcal enterotoxins; 1,000 mg set forth below. the words ‘‘Burkholderia mallei and of T–2 toxin; or 100 mg of Tetrodotoxin. f. In paragraph (f)(3)(i), by removing Burkholderia pseudomallei’’ in their (ii) Amounts of toxins equal to or less the words ‘‘Brucella melitensis, Hendra place. than the amounts identified in virus, Nipah virus, Rift Valley fever paragraph (d)(3)(i) of this section are virus, and Venezuelan equine § 73.8 [Amended] transferred only after the transferor uses encephalitis virus’’ and adding the 7. Section 73.8 (a)(1) is amended by due diligence and documents that the words ‘‘Burkholderia mallei and removing the words ‘‘within any of the recipient has a legitimate need (i.e. Burkholderia pseudomallei’’ in their categories described in 18 U.S.C. 175b’’ reasonably justified by a prophylactic, place. and adding the words ‘‘a restricted protective, bona fide research, or other § 73.4 Overlap select agents and toxins. person’’ in their place. peaceful purpose) to handle or use such (a) * * * The select agents and toxins * * * * * toxins. Notwithstanding the provisions marked with an asterisk (*) are 8. Section 73.9 is amended as follows: of paragraph (d) of this section, the HHS designated as Tier 1 select agents and a. By redesignating paragraphs (a)(3) Secretary retains the authority to, toxins and are subject to additional through (a)(5) as paragraphs (a)(4) without prior notification, inspect and requirements as listed in this part. through (a)(6) respectively. copy or request the submission of the (b) Overlap select agents and toxins: b. By adding a new paragraph (a)(3) to due diligence documentation to the Bacillus anthracis;* read as set forth below. CDC. Brucella abortus; c. In newly redesignated paragraph (iii) The transfer of amounts of toxins Brucella melitensis; (a)(5), by removing the word ‘‘and’’. equal to or less than the amounts Brucella suis; d. By further redesignating newly identified in paragraph (d)(3)(i) of this Burkholderia mallei;* redesignated paragraph (a)(6) as section reports to CDC if they detect a Burkholderia pseudomallei;* paragraph (a)(7). known or suspected violation of Federal Hendra virus; e. By adding a new paragraph (a)(6) to law or become aware of suspicious Nipah virus; read as set forth below. Rift Valley fever virus; activity related to a toxin listed in f. By revising the first sentence of Venezuelan equine encephalitis virus: paragraph (b) to read as set forth below. section of this part. Epizootic Subtypes IAB, IC. (4) Notwithstanding paragraph g. In paragraph (c)(1), by removing the (d)(3)(i) of this section, an animal * * * * * words ‘‘Bacillus anthracis, Botulinum (e) An attenuated strain of a select inoculated with or exposed to an HHS neurotoxins, Brucella melitensis, agent or an inactive form of a select select toxin. Francisella tularensis, Ebola viruses, toxin may be excluded from the (e) An attenuated strain of a select Hendra virus, Marburg virus, Lassa fever requirements of this part based upon a agent or an inactive form of a select virus, Nipah virus, Rift Valley fever determination by the HHS Secretary or toxin may be excluded from the virus, South American Haemorrhagic Administrator that the attenuated strain requirements of this part based upon a Fever viruses (Junin, Machupo, Sabia, or inactivated toxin does not pose a determination by the HHS Secretary that Flexal, Guanarito), Variola major virus severe threat to public health and safety, the attenuated strain or inactivated (Smallpox virus), Variola minor to animal health or to animal products. toxin does not pose a severe threat to (Alastrim), Venezuelan equine (1) To apply for exclusion, an encephalitis virus and Yersina pestis’’ public health and safety. individual or entity must submit a (1) To apply for exclusion, an and adding the words ‘‘Bacillus written request and supporting anthracis, Botulinum neurotoxins, individual or entity must submit a scientific information. A written written request and supporting Botulinum neurotoxin producing decision granting or denying the request species of Clostridium, Burkholderia scientific information. A written will be issued. An exclusion will be decision granting or denying the request mallei, Burkholderia pseudomallei, effective upon notification to the Francisella tularensis, Ebola viruses, will be issued. An exclusion will be applicant. Exclusions will be listed on effective upon notification to the Marburg virus, Variola major virus the National Select Agent Registry Web (Smallpox virus), Variola minor applicant. Exclusions will be listed on site at http://www.selectagents.gov/. the National Select Agent Registry Web (Alastrim), and Yersinia pestis’’ in their (2) If an excluded attenuated strain or place. site at http://www.selectagents.gov/. inactivated toxin is subjected to any (2) If an excluded attenuated strain or (a) * * * manipulation that restores or enhances (3) Have the appropriate training and inactivated toxin is subjected to any its virulence or toxic activity, the manipulation that restores or enhances expertise to competently implement and resulting select agent or toxin will be manage the requirements of this part; its virulence or toxic activity, the subject to the requirements of this part. resulting select agent or toxin will be * * * * * * * * * * subject to the requirements of this part. (6) Have their principal duty station at * * * * * § 73.5 [Amended] the physical location of the entity; and 4. Section 73.4 is amended as follows: 5. Section 73.5(a)(3)(i) is amended by * * * * * a. By adding a sentence to the end of removing the words ‘‘Lassa fever virus, (b) An entity may designate one or paragraph (a) to read as set forth below. South American Haemorrhagic Fever more individuals to serve as an alternate b. By revising paragraph (b) to read as virus (Junin, Machupo, Sabia, Flexal, Responsible Official, who acts for the set forth below. Guanarito)’’ and by adding the words Responsible Official in his/her absence. c. In paragraph (c), in the introductory ‘‘Botulinum neurotoxin producing *** text, by adding the phrase ‘‘and/or species of Clostridium’’ in their place. * * * * *

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9. Section 73.10 is amended as and how the Responsible Official will personnel with access to a Tier 1 select follows: notify the Federal Bureau of agent or toxin. The procedures must a. By redesignating paragraphs (e) Investigation (FBI) of such activity, include: through (j) as paragraphs (f) through (k) (9) Contain provisions for information (i) Self- and peer-reporting of respectively. security that: incidents or conditions that could affect b. By adding a new paragraph (e) to (i) Ensure that all external an individual’s ability to safely have read as set forth below. connections to systems which control access to or work with select agents and c. In newly redesignated paragraph security of the facility are isolated or toxins, or to safeguard select agents and (g), by removing the words ‘‘within any have controls that permit and monitor toxins from theft, loss, or release; of the categories described in 18 U.S.C. for only authorized and authenticated (ii) The training of all entity 175b’’ and adding the words ‘‘a user access; employees on entity policies and restricted person’’ in their place. (ii) Ensure that authorized and procedures for reporting, evaluation, d. In newly redesignated paragraph authenticated users are only granted and corrective actions concerning the (j), by removing the word ‘‘five’’ and access to select agent and toxin related assessment of personnel suitability to adding the word ‘‘three’’ in its place. information, files, equipment (e.g., access Tier 1 agents and toxins; and § 73.10 Restricting access to select agents servers or mass storage devices) and (iii) The ongoing suitability and toxins; security risk assessments. applications as necessary to fulfill their monitoring of individuals with access to roles and responsibilities, and that Tier 1 select agents and toxins. * * * * * access is modified when the user’s roles (e) A person who has a valid approval (4) Entities with Tier 1 select agents and responsibilities change or when from the HHS Secretary or and toxins must prescribe and/or their access to select agent and toxin is Administrator for access to a select implement the following security suspended or revoked; agent or toxin may request the HHS enhancements: (iii) Ensure that controls are in place Secretary or Administrator to provide (i) Procedures that will limit access to that are designed to prevent malicious the person’s approval status to another registered space only to those approved code (such as, but not limited to, registered individual or entity for a by the HHS Secretary or the computer virus, worms, spyware) from specified period of time. Administrator and meet the criteria of compromising the confidentiality, the entity’s program that will ensure * * * * * integrity, or availability of information individuals with access approval to 10. Section 73.11 is amended as systems; select agents and toxins are trustworthy follows: (iv) Establish a robust configuration and behaving in a manner that upholds a. By revising paragraph (b) to read as management practice for information public health and safety, security, and set forth below. systems to include regular patching and b. By revising paragraph (c)(2) to read the integrity of the scientific enterprise. updates made to operating systems and as set forth below. (ii) Procedures that limit access to individual applications; and c. By adding new paragraphs (c)(8), laboratory and storage facilities outside (v) Establish procedures that provide (c)(9), and (c)(10) to read as set forth of normal business hours to only those backup security measures in the event below. specifically approved by the d. By redesignating paragraphs (e) and that access control systems and/or Responsible Official or designee; (f) as paragraphs (f) and (g), respectively surveillance devices are rendered (iii) Procedures for allowing visitors, and by revising redesignated paragraph inoperable. their property, and vehicles at the entry (f) to read as set forth below. (10) Contain provisions and policies and exit points to the registered space, e. By adding a new paragraph (e) to for shipping, receiving, and storage of or at other designated points of entry to read as set forth below. select agents and toxins, including the building, facility, or compound documented procedures for receiving, based on the entity’s site-specific risk § 73.11 Security. monitoring, and shipping of all select assessment; * * * * * agents and toxins. These provisions (iv) A minimum of three barriers (b) The security plan must be must provide that an entity will where each subsequent barrier is designed according to a site-specific risk properly secure containers on site and different and adds to the delay in assessment and must provide graded have a written contingency plan for reaching secured areas where select protection in accordance with the risk of unexpected shipments. agents and toxins are used or stored. the select agent or toxin, given its * * * * * Barriers must be monitored in such a intended use. A current security plan (e) In addition to the requirements way as to detect and assess intentional must be submitted for initial contained in paragraphs (c) and (d) of and unintentional circumventing of registration, renewal of registration, or this section, the security plan for an established access control measures when requested. individual or entity possessing a Tier 1 under all conditions (day/night, severe (c) * * * select agent or toxin must also: weather, etc.); (2) Contain provisions for the control (1) Describe procedures for (v) All registered space or areas that of access to select agents and toxins, conducting a pre-access suitability reasonably afford access to the including the safeguarding of animals or assessment of persons who will have registered space must be protected by an plants intentionally or accidentally access to a Tier 1 select agent or toxin; intrusion detection system (IDS) unless exposed to or infected with a select (2) Describe procedures for how an physically occupied; agent, against unauthorized access, entity’s Responsible Official will (vi) Personnel monitoring the IDS theft, loss or release. coordinate their efforts with the entity’s must be capable of evaluating and * * * * * safety and security professionals to interpreting the alarm and alerting the (8) Describe procedures for how the ensure security of Tier 1 select agents designated security response force or Responsible Official will be informed of and toxins and share, as appropriate, law enforcement; suspicious activity that may be criminal relevant information; and (vii) Provide backup power and in nature and related to the entity, its (3) Describe procedures for the energy sources to power information personnel, or its select agents or toxins; ongoing assessment of the suitability of security networks and integrated access

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controls and related systems during with support and response assets by document is available on the Internet at emergencies; way of security operations center, http://www.selectagents.gov. (viii) Response time for security forces (xi) Require that Variola major and * * * * * or local police must not exceed 15 Variola minor material in long term (d) The biosafety plan must include minutes from the time of an intrusion storage be stored in tamper-indicating an occupational health program for alarm or report of a security incident; containers, individuals with access to Tier 1 select (ix) Entities must conduct complete (xii) Require that all spaces containing agents and toxins, and those individuals inventory audits of all Tier 1 select working or permanent Variola major or must be enrolled in the occupational agents and toxins in long-term storage Variola minor stocks be locked and health program. The occupational when any of the following occur: protected by an intrusion alarm system health program may also be made (A) Upon the physical relocation of a that will alarm upon the unauthorized available to individuals without access collection or inventory of select agents entry of a person anywhere into the to Tier 1 select agents and toxins. or toxins for those Tier 1 select agents area, * * * * * or toxins in the collection or inventory; (xiii) Require that alarms required (B) Upon the departure or arrival of a pursuant to this section annunciate in a § 73.13 [Amended] principal investigator for those Tier 1 continuously manned security select agents and toxins under the 12. Section 73.13 is amended as operations center located within the follows: control of that principal investigator; or facility, (C) In the event of a theft or loss of a. In paragraph (a), in the introductory (xiv) Require that the security a Tier 1 select agent or toxin. text, by adding the phrase ‘‘, or possess (5) Entities that possess Variola major operations center shall be located products (i.e. select agents that are not virus and Variola minor virus must have within a building so that the interior is known to acquire the resistance the following additional security not visible from the perimeter of the naturally, if such acquisition could requirements: protected area. compromise the use of the drug to (i) Require personnel with access to (f) In developing a security plan, an control disease agents in humans, Variola major or Variola minor virus to individual or entity should consider the veterinary medicine, or agriculture, or have a Top Secret security clearance, documents entitled, ‘‘Select Agents and recombinant and or synthetic DNA (ii) Require Variola major or Variola Toxins Security Information Document’’ containing genes for the biosynthesis of minor virus storage locations be under and ‘‘Select Agents and Toxins Security select toxins lethal for vertebrates at an the surveillance of closed circuit Plan Template.’’ These documents are LD[50] < 100 ng/kg body weight) television that is monitored, available on the Internet at http:// resulting from,’’ after the word (iii) After hours access procedures for www.selectagents.gov/. ‘‘conduct’’ both times it appears. Variola major or Variola minor virus * * * * * b. In paragraph (b)(1), by removing the must require notification of the entity’s 11. Section 73.12 is amended as words ‘‘Experiments utilizing security staff prior to entry into the follows: recombinant DNA that involve the Variola laboratory and upon exit, a. By revising paragraph (a) to read as deliberate transfer of’’ and replacing (iv) Require that observation zones be set forth below. them with the words ‘‘Experiments that maintained in outdoor areas adjacent to b. By revising paragraph (c)(1) to read involve the deliberate transfer of, or the physical barrier at the perimeter of as set forth below. selection for,’’. the entity and be large enough to permit c. In paragraph (c)(3), by removing the c. In paragraph (b)(2), by adding the observation of the activities of people at URL ‘‘http://www.cdc.gov/’’ and adding words ‘‘synthetic or’’ before the word that barrier in the event of its in its place ‘‘http:// ‘‘recombinant.’’ penetration, www.selectagents.gov’’. 13. Section 73.14 is amended as (v) Provide for a minimum of four d. By redesignating paragraph (d) as follows: barriers for the protection of the Variola paragraph (e). major or Variola minor virus, one of a. By revising paragraph (a) to read as e. By adding a new paragraph (d) to which must be a perimeter fence, set forth below. (vi) Require a numbered picture badge read as set forth below. b. By revising paragraph (b) to read as identification subsystem to be used for § 73.12 Biosafety. set forth below. c. By redesignating paragraph (c) and all individuals who are authorized to * * * * * access Variola major or Variola minor (d) as paragraphs (d) and (f) (a) An individual or entity required to without escort, respectively. register under this part must develop (vii) Require the use, at all times, of and implement a written biosafety plan d. By adding a new paragraph (c) to properly trained, and equipped security that is commensurate with the risk of read as set forth below. force personnel able to interdict threats the select agent or toxin, given its e. By adding a new paragraph (e) to identified in the site specific risk intended use. The biosafety plan must read as set forth below. assessment, (viii) Identify security force personnel contain sufficient information and § 73.14 Incident response. documentation to describe the biosafety designated to strengthen onsite response (a) An individual or entity required to capabilities, and that will be onsite and and containment procedures for the select agent or toxin, including any register under this part must develop available at all times to carry out their and implement a written incident assigned response duties, animals or plants intentionally or accidentally exposed to or infected with response plan based upon a site specific (ix) Provide for security patrols to 2 a select agent. risk assessment. The incident response periodically check external areas of the plan must be coordinated with any registered areas to include physical * * * * * entity-wide plans, kept in the barriers and building entrances, (c) * * * (x) Require that all on-duty security (1) The CDC/NIH publication, 2 Nothing in this section is meant to supersede or force personnel shall be capable of ‘‘Biosafety in Microbiological and preempt incident response requirements imposed maintaining continuous communication Biomedical Laboratories.’’ This by other statutes or regulations.

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workplace, and available to employees threat awareness briefings on how to toxins. The HHS Secretary retains the for review. identify and report suspicious authority to, without prior notification, (b) The incident response plan must behaviors. inspect and copy or request the fully describe the entity’s response (c) Refresher training must be submission of the due diligence procedures for the theft, loss, or release provided annually or at such time as the documentation to the CDC. of a select agent or toxin; inventory registered individual or entity (2) Report to CDC any known or discrepancies; security breaches significantly amends its security, suspected violation of Federal law or (including information systems); severe incident response, or biosafety plans. suspicious activity related to the toxin. weather and other natural disasters; (d) The Responsible Official must 16. Section 73.17 is amended as workplace violence; bomb threats and ensure a record of the training provided follows: suspicious packages; and emergencies to each individual with access to select a. By revising paragraph (a)(1) such as fire, gas leak, explosion, power agents and each escorted individual introductory text to read as set forth outage, etc. (e.g., laboratory workers, visitors, etc.) is (c) The response procedures must maintained. The record must include below. account for hazards associated with the the name of the individual, the date of b. By redesignating paragraphs (a)(2) select agent or toxin and appropriate the training, a description of the training through (a)(6) as paragraphs (a)(3) actions to contain such select agent or provided, and the means used to verify through (a)(7) respectively. toxin, including any animals or plants that the employee understood the c. By adding a new paragraph (a)(2) to intentionally or accidentally exposed to training. read as set forth below. or infected with a select agent. 15. Section 73.16 is amended as § 73.17 Records. * * * * * follows: (e) Entities with Tier 1 select agents a. By redesignating paragraph (f), (g), (a) * * * and toxins must have the following (h), and (i) as paragraphs (i), (j), (k), and (1) An accurate, current inventory for additional incident response policies or (g) respectively. each select agent (including viral procedures: b. In redesignated paragraph (g), by genetic elements, recombinant and/or (1) The incident response plan must removing the words ‘‘packaging and’’. synthetic nucleic acids, and fully describe the entity’s response c. By adding a new paragraph (f) to recombinant and/or synthetic procedures for failure of intrusion read as set forth below. organisms) held in long-term storage detection or alarm system; and d. By adding a new paragraph (h) to (placement in a system designed to (2) The incident response plan must read as set forth below. ensure viability for future use, such as describe notification procedures for the e. By adding a new paragraph (l) to in a freezer or lyophilized materials), FBI in the event of a theft or suspicious read as set forth below. including: activity that may be criminal in nature § 73.16 Transfers. * * * * * involving a Tier 1 select agent or toxin. * * * * * (2) An accurate, current inventory of * * * * * (f) After authorization is provided by any animals or plants intentionally or 14. Section 73.15 is revised to read as APHIS or CDC, the select agent(s) and accidentally exposed to or infected with follows: toxin(s) are packaged for shipment in a select agent (including number and § 73.15 Training. compliance with all applicable laws species, location, and appropriate disposition); (a) An individual or entity required to concerning packaging by an individual register under this part must provide approved by the HHS Secretary or * * * * * information and training on biosafety, Administrator to have access to select 17. Section 73.20 is revised to read as security (including security awareness) agents and toxins, following a security set forth below. risk assessment by the Attorney General. and incident response: § 73.20 Administrative review. (1) To each individual with access * * * * * approval from the HHS Secretary or (h) Transportation in commerce starts (a) An individual or entity may appeal Administrator before that individual has when the select agent(s) or toxin(s) are a denial, revocation, or suspension of such access to select agents and toxins. packaged for shipment and ready for registration under this part. The appeal The training must address the particular receipt by a courier transporting select must be in writing, state the factual needs of the individual, the work they agent(s) or toxin(s) and ends when the basis for the appeal, and be submitted will do, and the risks posed by the package is received by the intended to the HHS Secretary within 30 calendar select agents or toxins. recipient who is an individual approved days of the decision. (2) To each individual not approved by the HHS Secretary or Administrator (b) An individual may appeal a for access to select agents and toxins by to have access to select agents and denial, limitation, or revocation of the HHS Secretary or Administrator toxins, following a security risk access approval under this part. The before that individual enters areas assessment by the Attorney General. appeal must be in writing, state the where select agents or toxins are * * * * * factual basis for the appeal, and be handled or stored (e.g., laboratories, (l) A registered individual or entity submitted to the HHS Secretary within growth chambers, animal rooms, transferring an amount of a HHS toxin 180 calendar days of the decision. greenhouses, storage areas, shipping/ otherwise excluded under the (c) The HHS Secretary’s decision receiving areas, production facilities, provisions of § 73.3(d) of this part must: constitutes final agency action. etc.). Training for escorted personnel (1) Transfer the HHS toxin only after Dated: September 21, 2011. must be based on the risk associated using due diligence and documenting with accessing areas where select agents that the recipient has a legitimate need Kathleen Sebelius, and toxins are used and/or stored. (reasonably justified by a prophylactic, Secretary. (b) Entities with Tier 1 select agents protective, bona fide research, or other [FR Doc. 2011–25427 Filed 9–30–11; 8:45 am] and toxins must conduct annual insider peaceful purpose) to handle or use such BILLING CODE 4163–18–P

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Part V

Department of Agriculture

Animal and Plant Health Inspection Service 7 CFR Part 331 9 CFR Part 121 Agricultural Bioterrorism Protection Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List; Amendments to the Select Agent and Toxin Regulations; Proposed Rule

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DEPARTMENT OF AGRICULTURE and Development, PPD, APHIS, Station determines has the potential to pose a 3A–03.8, 4700 River Road Unit 118, severe threat to animal or plant health, Animal and Plant Health Inspection Riverdale, MD 20737–1238. or to animal or plant products. Service Supporting documents and any Paragraph (a)(2) of section 212 requires comments we receive on this docket the Secretary to review and republish 7 CFR Part 331 may be viewed at http:// the list every 2 years and to revise the www.regulations.gov/ list as necessary. In this document, we 9 CFR Part 121 #!docketDetail;D=APHIS-2009-0070 or are proposing to amend and republish [Docket No. APHIS–2009–0070] in our reading room, which is located in the list of select agents and toxins based room 1141 of the USDA South Building, on the findings of our third biennial RIN 0579–AD09 14th Street and Independence Avenue, review of the list. SW., Washington, DC. Normal reading In determining whether to include an Agricultural Bioterrorism Protection room hours are 8 a.m. to 4:30 p.m., agent or toxin on the list, the Act Act of 2002; Biennial Review and Monday through Friday, except requires that the following criteria be Republication of the Select Agent and holidays. To be sure someone is there to considered: Toxin List; Amendments to the Select help you, please call (202) 690–2817 • The effect of exposure to the agent Agent and Toxin Regulations before coming. or the toxin on animal and plant health, AGENCY: Animal and Plant Health FOR FURTHER INFORMATION CONTACT: Mr. and on the production and marketability Inspection Service, USDA. Charles L. Divan, Branch Chief, APHIS of animal or plant products; • The pathogenicity of the agent or ACTION: Proposed rule. Agriculture Select Agent Program, APHIS, 4700 River Road Unit 2, the toxin and the methods by which the SUMMARY: In accordance with the Riverdale, MD 20737–1231; (301) 734– agent or toxin is transferred to animals Agricultural Bioterrorism Protection Act 5960. or plants; • The availability and effectiveness of of 2002, we are proposing to amend and SUPPLEMENTARY INFORMATION: republish the list of select agents and pharmacotherapies and prophylaxis to toxins that have the potential to pose a Background treat and prevent any illness caused by severe threat to animal or plant health, The Public Health Security and the agent or toxin; and • Any other criteria that the Secretary or to animal or plant products. The Act Bioterrorism Preparedness and considers appropriate to protect animal requires the biennial review and Response Act of 2002 (referred to below or plant health, or animal or plant republication of the list of select agents as the Bioterrorism Response Act) products. and toxins and the revision of the list as provides for the regulation of certain We use the term ‘‘select agents and necessary. This action would implement biological agents that have the potential toxins’’ throughout the preamble of this the findings of the third biennial review to pose a severe threat to both human proposed rule. Unless otherwise of the list. In addition, we are proposing and animal health, to animal health, to specified, the term ‘‘select agents and to reorganize the list of select agents and plant health, or to animal and plant toxins’’ will refer to all agents or toxins toxins based on the relative potential of products. The Animal and Plant Health listed by APHIS. When it is necessary to each select agent or toxin to be misused Inspection Service (APHIS) has the specify the type of select agent or toxin, to adversely affect human, plant, or primary responsibility for implementing we will use the following terms: ‘‘PPQ animal health. Such tiering of the list the provisions of the Act within the select agents and toxins’’ (for the plant would allow for the optimization of Department of Agriculture (USDA). agents and toxins listed in 7 CFR 331.3), security measures for those select agents Veterinary Services (VS) select agents ‘‘VS select agents and toxins’’ (for the or toxins that present the greatest risk of and toxins are those that have been animal agents and toxins listed in 9 CFR deliberate misuse with the most determined to have the potential to pose 121.3), or ‘‘overlap select agents and significant potential for mass casualties a severe threat to animal health or toxins’’ (for the agents and toxins listed or devastating effects to the economy, animal products. Plant Protection and critical infrastructure, or public in both 9 CFR 121.4 and 42 CFR 73.4). Quarantine (PPQ) select agents and On July 29, 2010, we published in the confidence. We are also proposing a toxins are those that have the potential number of amendments to the Federal Register (75 FR 44724–44725, to pose a severe threat to plant health Docket No. APHIS–2009–0070) an regulations, including the addition of or plant products. Overlap select agents definitions and clarification of language advance notice of proposed rulemaking and toxins are those that have been and request for comments (ANPR) 1 in concerning security, training, biosafety, determined to pose a severe threat to biocontainment, and incident response. order to announce our intention to both human and animal health or review and reorganize the select agent These changes would increase the animal products. Overlap select agents usability of the select agent regulations list. We solicited comments regarding are subject to regulation by both APHIS potential additions and deletions from as well as provide for enhanced program and the Centers for Disease Control and oversight. the list of select agents and toxins as Prevention (CDC), which has the well as comments on reorganization of DATES: We will consider all comments primary responsibility for implementing the list based on the relative potential of that we receive on or before December the provisions of the Act for the each select agent or toxin to be misused 2, 2011. Department of Health and Human to adversely affect human, plant, or ADDRESSES: You may submit comments Services (HHS). animal health. We requested Subtitle B (which is cited as the by either of the following methods: recommendations as to what criteria • ‘‘Agricultural Bioterrorism Protection Federal eRulemaking Portal: Go to should be utilized to designate high risk Act of 2002’’ and referred to below as http://www.regulations.gov/ select agents and toxins and the Act), section 212(a), provides, in #!documentDetail;D=APHIS-2009-0070- incorporated those recommendations 0001. part, that the Secretary of Agriculture • Postal Mail/Commercial Delivery: (the Secretary) must establish by 1 To view the ANPR and the comments we Send your comment to Docket No. regulation a list of each biological agent received, go to http://www.regulations.gov/ APHIS–2009–0070, Regulatory Analysis and each toxin that the Secretary #!docketDetail;D=APHIS-2009-0070.

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into the interagency working group (exotic), Bovine spongiform to which Federal, State, and/or local discussions on the matter. We solicited encephalopathy agent; Camel pox virus; officials need to take special action in comments for 30 days ending August Ehrlichia ruminantium (Heartwater); planning for a major animal health 30, 2010. We received 30 comments by Japanese encephalitis virus; Malignant disaster as a result of any of these that date. They were from scientists, catarrhal fever virus (Alcelaphine organisms is decreased in light of these scientific organizations, private herpesvirus type 1); Menangle virus; factors. Therefore, in considering these individuals, and industry groups. and Vesicular stomatitis virus (exotic): reasons as well as recommendations Suggestions in these comments were Indiana subtypes VSV–IN2, VSV–IN3. provided in previous reports such as used in order to inform our discussions The interagency working group ‘‘The Report of the Working Group on on the content of the select agent list considered each of the VS select agents Strengthening the Biosecurity of the and our determination regarding and toxins with respect to the four United States’’ 2 and the ‘‘Federal reorganization of the list. criteria for listing found in the Act and Experts Security Advisory Panel: based on the group’s analysis, APHIS Recommendations Concerning the PPQ Select Agents and Toxins has determined that the nine VS select Select Agent Program’’ 3 as well as APHIS’s PPQ program convened an agents and toxins listed above should be comments received on the ANPR, interagency working group to review the removed from the list. These agents APHIS has determined those pathogens list of PPQ select agents and toxins and were judged not to pose a significant listed here are not likely to be used as develop recommendations regarding threat to animal health, either because agroterrorism agents and no longer need possible changes to that list. Using the the disease risk is not significant (e.g., to be designated as VS select agents. four criteria for listing found in the Act, low mortality rate in the event of Overlap Select Agents and Toxins economic crop data, current Federal infection), they affect only minor (i.e., quarantine notices, and new scientific not economically significant) species, or We are also proposing to modify the information, the working group they are not likely to be used as an listing for one of the overlap select revisited the currently listed PPQ select agroterrorism agent (e.g., difficulty of agents by removing certain subtypes of agents and toxins and evaluated a transmission from animal to animal). Venezuelan equine encephalitis virus number of new plant pathogens for For example, Japanese encephalitis from the list of overlap select agents and inclusion on the list. Based on this virus primarily affects horses and pigs toxins set out in 9 CFR 121.4(b), and to review, APHIS is proposing to amend and is transmitted via a mosquito bite. clarify that only Venezuelan equine the list of PPQ select agents and toxins It is not directly contagious between encephalitis subtypes IAB and IC would listed in 7 CFR 331.3 by removing animals. Horses represent a dead-end remain on the list. These subtypes Xylella fastidiosa, citrus variegated host for the disease; mosquitoes biting contain the only recognized strains of chlorosis (CVC) strain, from the list as an infected horse will not pick up virus Venezuelan equine encephalitis that can it no longer meets the criteria for use as to transmit to any new animals. Pigs suddenly affect a large number of an agroterrorism agent. Since CVC was represent an amplifying host, but animals over a large area (i.e., first included on the list, extensive modern pig husbandry practices in the epizootic). The remaining subtypes, ID research on this select agent has been U.S. minimize exposure of the herd to and IE, are strains prevalent among completed. New scientific information mosquitoes and make it difficult to existing animal populations (i.e., has led to creation of detection methods establish and sustain a natural enzootic) and do not represent the same that provide for better early response transmission cycle. type of risk. Other viruses within the and control methods. These new Likewise, a sustained transmission Venezuelan equine encephalitis technologies can be applied regardless cycle of malignant catarrhal fever virus complex (subtypes IF and II through IV) of how the agent might be introduced, (Alcelaphine herpesevirus type 1) are separate viruses and are not including purposeful introduction for requires the presence of the reservoir included in the list of overlap select harmful purposes. Furthermore, the use host (African wildlife) in close physical agents and toxins. Accordingly, CDC of geostatistical analysis in citrus association with the susceptible will also be proposing a parallel change production areas using geographic domestic species (cattle and bison). to its overlap select agent regulations. information systems is now well- With respect to the remaining agents: • Reorganization of the Current List of developed with relation to monitoring Camel pox only affects camels, Select Agents and Toxins and facilitating a response to any which are a minor species in the US; purposeful introduction. As a result of • Akabane virus, bluetongue virus We are proposing to establish a this new research, as well as the (exotic), Ehrlichia ruminantium number of select agents and toxins as development of new regulatory systems (Heartwater), and vesicular stomatitis ‘‘Tier 1’’ select agents and toxins within for CVC, the likelihood that someone virus (exotic): Indiana subtypes VSV– the lists of VS and overlap select agents would use CVC as an agent of IN2, VSV–IN3 all utilize insect vectors and toxins. We are not including PPQ bioterrorism is reduced, and our ability as a mode of transmission and are not select agents and toxins in this proposed to manage an introduction is increased. usually spread by direct contact reorganization because none of the between animals; proposed Tier 1 select agents and toxins VS Select Agents and Toxins • Menangle virus transmission is are from the plant list. All other select APHIS’s VS program also convened associated with certain species of fruit agents and toxins would continue to be an interagency working group to review bats, which are native only to Australia subject to the current requirements the list of VS select agents and toxins and Southeast Asia; and concerning select agents and toxins. All and the list of overlap select agents and • Bovine spongiform encephalopathy select agents and toxins were scored toxins in 9 CFR part 121 in order to agent is only known to be transmitted against 20 criteria by over 60 subject update and revise the lists as necessary. through the ingestion of infected tissues. We are proposing to remove nine VS All of these circumstances make 2 Available on the Internet at http://www.phe.gov/ select agents and toxins from the list set transmission from animal-to-animal Preparedness/legal/boards/biosecurity/Documents/ difficult, which greatly lessens the biosecreportfinal102309.pdf. out in § 121.3(b). Specifically, we are 3 Available on the Internet at http://www.phe.gov/ proposing to remove the following: chance of an outbreak either accidental Preparedness/legal/boards/fesap/Documents/fesap- Akabane virus; Bluetongue virus or intentional. Consequently, the extent recommendations-101102.pdf.

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matter experts representing the Federal confidence, i.e., Tier 1 select agents and milk, artificial insemination, and life sciences, public health, law toxins. These requirements would inhalation of infectious aerosols. It is enforcement, security, and intelligence include: not found in the United States and the communities. These criteria included: • Additions regarding the assessment U.S. domestic animal population is • The relative ease with which a of persons who will have access to Tier therefore considered highly susceptible. particular select agent or toxin might be 1 select agents and toxins that would be Foot-and-mouth disease virus can cause disseminated or transmitted from one made to the security plan currently infection and disease in close to 100 animal to another or into the required to be developed by all entities percent of susceptible animals. The environment where it could produce a seeking approval for the possession, use, potential exists for severe economic deleterious effect upon animal or plant and transfer of select agents and toxins; impacts through loss of animal health; ongoing oversight of those persons with production and products and trade • The potential for high animal or access to Tier 1 select agents and toxins; restrictions. Because of these factors, plant mortality rates; and the role of the entity’s responsible • this select agent is considered to have a The potential for a major animal or official in coordinating and assuring the high potential as a weapon of plant health impact; security of Tier 1 select agents and • bioterrorism and we are therefore Select agents or toxins whose toxins; proposing to require that it be handled • misuse might result in public panic or Security enhancements that include only in high containment facilities other social or economic disruption; and provisions for security barriers, which provide enhanced biosafety and • Select agents or toxins whose use intrusion detection and monitoring, biosecurity features in order to might require Federal, State, and/or delay/response force, access control, safeguard its distribution. local officials to take special action in and information security; Rinderpest is a contagious viral planning for major animal or plant • Additions to the biosafety plan disease of cattle, buffalo, and some wild health disasters. currently required to be developed by species of cloven-hoofed animals, such APHIS and CDC determined that two all entities seeking approval for the as giraffe and wildebeest. Like foot-and- VS select agents and three overlap select possession, use, and transfer of select mouth disease virus, it is not native to agents should be given Tier 1 status. agents and toxins that would describe the United States and can cause 100 Based on the criteria listed above, we implementation of an occupational percent illness if susceptible animals are proposing to list foot-and-mouth health program for individuals with come in contact with infected animals disease virus and rinderpest virus as access to Tier 1 select agents and toxins; Tier 1 VS select agents and toxins and • Development of security policies or contaminated surfaces. As the result Bacillus anthracis, Burkholderia mallei, and procedures describing the entity’s of an extensive international campaign and Burkholderia pseudomallei as Tier response to a failure of an intrusion consisting of vaccinations, clinical 1 overlap select agents and toxins. We detection or alarm system and disease research, serological are also proposing to amend the list of notification procedures for the Federal surveillance sampling, contingency overlap select agents and toxins whose Bureau of Investigation (FBI) in the planning, and laboratory support in seizure by any Federal law enforcement event of theft or suspicious activity that affected regions, the World Organization agency requires reporting to APHIS or may be criminal in nature involving a for Animal Health declared rinderpest CDC within 24 hours (located in 9 CFR Tier 1 select agent or toxin. These to be globally eradicated in May 2011. 121.4(f)(3)(i)) to include only those policies and procedures would be Post-eradication efforts will include overlap agents designated as Tier 1. The required as part of the entity’s incident surveillance of all international current list, which is comprised of response plan; and laboratories with existing stocks of the Bacillus anthracis, Brucella melitensis, • Required annual insider threat virus, consensus regarding laboratories Hendra virus, Nipah virus, Rift Valley awareness briefings focused on how to authorized to retain the agent and the fever virus, and Venezuelan equine identify and report suspicious type of laboratory work which will encephalitis virus was initially adapted behaviors. continue, and destruction of all other from a different system of threat These changes would serve to further inventoried stocks. Also, conditions for assessment categorization. The mitigate the potential for deliberate laboratory storage will be developed in proposed changes would bring the list misuse of these select agents and toxins order to ensure biosafety and security of in line with the listing of Tier 1 agents, that could result in devastating effects to the agent. The proposed enhanced which was developed as a result of the the economy, critical infrastructure, or security measures are necessary in order experience and expertise of the select public confidence. to ensure that the United States will be agent program. These changes, in We are also proposing to add required able to maintain inventories of tandem with the enhanced practices for physical security measures in addition rinderpest virus under secure and safe physical and information security to the proposed general Tier 1 required conditions. detailed below, would serve to further security measures for those entities All of these proposed changes are mitigate the potential for deliberate working with foot-and-mouth disease based on established Government and misuse of these select agents and toxins virus and rinderpest virus due to the security industry standards with respect that could result in devastating effects to particular dangers posed by these two to securing high risk material and the economy, critical infrastructure, or viruses. developed in accordance with the public confidence. Foot-and-mouth disease is an experience and expertise of the Select Accordingly, we are also proposing extremely contagious viral disease of Agent Program. They are necessary in additions to the VS regulations that domesticated cloven-hoofed animals order to further ensure the safety and would allow for the optimization of (e.g., cattle, sheep, goats, and pigs) and security of those select agents and security measures for those select agents many wild animals. It is easily toxins that pose the most potential harm or toxins that present the greatest risk of transmissible from infected animals to to the animal and human environment. deliberate misuse with the most susceptible animals through contact As stated previously, the requirements significant potential for mass casualties with contaminated objects, for working with all other select agents or devastating effects to the economy, consumption of contaminated meat and toxins would remain unchanged critical infrastructure, or public products or ingestion of contaminated with the exception of certain

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miscellaneous changes, which are the proceedings were held. Any respect to the Bioterrorism Response detailed below. conviction which has been set aside or Act, the government is regulating access nullified as a matter of law or for which to biological agents and toxins which Miscellaneous Changes a person has been pardoned shall not be the government has recognized as We are proposing to make several considered a conviction for purposes of having the potential to be used in the smaller-scale changes to the regulations, this part.’’ Contrary to definition of this wrong hands as weapons of mass including the addition of definitions term used under the Gun Control Act, destruction. and clarification of language concerning we have decided that foreign offenses We are specifically requesting security, training, biosafety, should be considered a disqualifier. In comments on the use of a foreign biocontainment, and incident response. doing so we are aware of the Supreme conviction as a predicate for denying These changes, which are described in Court’s decision in Small v. United access to select agents and toxins. We detail below, would increase the States, 544 US 385 (2005) in which the recognize that there can be significant usability of the select agent regulations court, interpreting the provisions of 18 differences between foreign convictions as well as provide for enhanced program U.S.C. 922(g)(1), held that the phrase and domestic convictions. For example, oversight. ‘‘convicted in any court’’ refers only to foreign legal systems may not provide In 7 CFR 331.1 and 9 CFR 121.1, we U.S. courts, not to foreign courts. In its the same due process safeguards are proposing to add definitions for opinion interpreting the Gun Control afforded to citizens of the United States, adjudicated as a mental defective, alien, including impartial tribunals and jury committed to any mental institution, Act, the court stated that ‘‘the statute itself and its history offer only trials. Additionally, foreign countries controlled substance, crime punishable may punish conduct that is permitted congressional silence’’ as to whether by imprisonment for a term exceeding 1 under domestic law or may require Congress considered whether the year, indictment, lawfully admitted for more severe penalties than under statutory language included foreign permanent residence, mental domestic law. We note that in the past, convictions. In the case of the institution, restricted person, and courts have applied the criteria set forth Bioterrorism Response Act, we believe unlawful user of any controlled in Section 482 of the Restatement (third) Congress spoke clearly about their substance. We believe that these of Foreign Relations Law of the United desire to limit or deny access to select definitions would assist regulated States (1986) in determining whether a agents and toxins for those who have entities as well as those seeking foreign judgment should be recognized approval to access select agents and committed serious crimes regardless of in the United States. That Section toxins to better understand what status where those crimes were committed. As provides that a court in the United or activities, past or present, might a part of the safeguard and security States may not recognize a judgment of prohibit such access. section of the Bioterrorism Response the court of a foreign state if the Although these terms were undefined Act, Congress not only put select agents judgment was rendered under a judicial in the Bioterrorism Response Act, it is and toxins off limits to a ‘‘restricted system that does not provide impartial evident that Congress modeled many of person,’’ as that term is defined by 18 tribunals or procedures compatible with them after the disqualifiers that are used U.S.C. 175b, but to the those who are due process of law or the court that by the Bureau of Alcohol, Tobacco, ‘‘reasonably suspected by any Federal rendered the judgment did not have Firearms, and Explosives (ATF) when law enforcement or intelligence agency jurisdiction over the defendant in enforcing the Gun Control Act of 1968. of’’ (1) Committing a ‘‘Federal crime of accordance with the law of the Because the purpose of the Select Agent terrorism’’ transcending national rendering state. It further provides that Program differs from ATF’s enforcement boundaries (18 U.S.C. 2332b); (2) the a court in the United States need not actions under the Gun Control Act, we knowing involvement with an recognize a judgment of the court of a do not believe that these terms must be organization that engages in domestic or foreign state if the court that rendered defined exactly the same. The Gun international terrorism or with any other the judgment did not have jurisdiction Control Act regulates access to firearms, organization that engages in of the subject matter of the action, the while the Bioterrorism Response Act international crimes of violence; or (3) defendant did not receive notice of the regulates access to biological agents and being an agent of a foreign power. We proceedings in sufficient time to enable toxins that the government has believe it would be an inconsistent him to defend, the judgment was recognized as having the potential to be reading of statutory authority to allow obtained by fraud, the cause of action on used as weapons of mass destruction by the Secretary to limit or deny access to which the judgment was based, or the the wrong hands. select agents and toxins to someone judgment itself, is repugnant to the Nevertheless, we looked at the identified by the Attorney General as public policy of the United States or of statutory and regulatory definitions of being only reasonably suspected of the State where recognition is sought, these terms under the Gun Control Act committing a Federal crime of terrorism the judgment conflicts with another when drafting our definitions. With the transcending national boundaries but to final judgment that is entitled to exception of the term ‘‘crime punishable be powerless in cases where a person recognition, or the proceeding in the by imprisonment for a term exceeding 1 had actually been convicted of a serious foreign court was contrary to an year,’’ we decided to adopt the crime in a foreign country. We believe agreement between the parties to submit applicable definitions used by ATF. that in light of the threat of bioterrorism the controversy on which the judgment The definition of crime punishable by attacks, Congress would not want to is based to another forum. We are imprisonment for a term exceeding 1 exclude an individual convicted of a seeking comment on whether these year would be established as ‘‘any U.S. offense from having access to select criteria should be applied in Federal, State, or foreign offense for agents and toxins, but still allow access considering whether access to select which the maximum penalty, whether to an individual convicted in a foreign agents and toxins should be denied or not imposed, is capital punishment court of a similar offense. We also based on a foreign conviction or or imprisonment in excess of 1 year. believe that the instances of regulation whether other criteria or factors would What constitutes a conviction of such a can be distinguished in that with regard be appropriate to consider. crime shall be determined in accordance to the Gun Control Act the government We are also proposing to add a with the law of the jurisdiction in which is regulating access to guns while, with definition for information security to the

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regulations in 7 CFR 331.1 and 9 CFR on the select agent Web site only has for measures sufficient to contain the 121.1 as it is used but not defined. This served to provide the most up-to-date select agent or toxin (e.g., physical definition would be identical to that information to the regulated structure and features of the entity, and used in the ‘‘Information Security’’ community. We are therefore proposing operational and procedural safeguards); subchapter of the U.S. Code (44 U.S.C. to update the regulations to accurately and 3542). reflect the way in which we handle the • An incident response plan, as We are also proposing to add a listing of exclusions. described in the regulations in 7 CFR definition for occupational exposure to The regulations in 7 CFR 331.9 and 9 331.14 and 9 CFR 121.14, that provides the VS regulations in 9 CFR 121.1 as it CFR 121.9 set out requirements for for measures that the registered entity is used in the regulations but not entities requesting to work with select will implement in the event of theft, defined. This definition is based on that agents and toxins to designate a loss, or release of a select agent or toxin; used in the Occupational Safety and responsible official, who ensures that inventory discrepancies; security Health Administration regulations in 29 the entity continues to meet the breaches (including information CFR 1910.1030. We are not proposing to requirements of the regulations. We are systems); severe weather and other add a corresponding definition to the proposing to explicitly require that all natural disasters; workplace violence; PPQ regulations in 7 CFR 331.1 since designated responsible officials possess bomb threats and suspicious packages; PPQ select agents and toxins do not the appropriate training or expertise to and emergencies such as fire, gas leak, pose a severe threat to human health execute their required duties. We are explosion, power outage, etc. The and, therefore, it is unnecessary to also proposing to clarify the role of response procedures must account for address personnel safety and health. alternate responsible official in order to hazards associated with the select agent Finally, we are proposing to add a definitively establish that the alternate or toxin and appropriate actions to definition for recombinant and responsible official must have the contain such agent or toxin. synthetic nucleic acids. This addition is knowledge and authority to act for the Details of the changes we are necessary, as the term ‘‘synthetic responsible official in his/her absence. proposing to each plan individually nucleic acids’’ is employed in the Finally, we are proposing to add a may be found below. Generally, we are proposed changes to the select agent requirement that the responsible proposing to require that the security regulations. We are proposing to include official’s principal duty station be the plan, biocontainment/biosafety plan, synthetic nucleic acids in the physical location of the registered and incident response plan include regulations because, while synthetic entity. These changes would clarify the provisions to address the safeguarding nucleic acids have the same potential requirements that a person must meet in of animals or plants that have been for harm as recombinant nucleic acids, order to serve as a responsible official or intentionally or accidentally exposed to the process of production is different. alternate responsible official. or infected with select agents against We are proposing to amend 7 CFR We are proposing to amend the unauthorized access, theft, loss or 331.3(e), 9 CFR 121.3(e) and 9 CFR regulations in 7 CFR 331.10 and 9 CFR release. This would enhance the 121.4(e). These paragraphs specify that 121.10. These regulations establish comprehensiveness of the regulations as attenuated strains of select agents or parameters for restricting access to well as provide necessary guidance toxins may be excluded from the select agents and toxins and the process regarding handling of animals and requirements of the select agent by which individuals may be approved plants inoculated with select agents. We regulations subject to an official request for access to select agents and toxins would not require the plan to address and supporting scientific information. after the completion of a security risk animals and plants exposed to select We are proposing to state that the assessment by the Attorney General. toxins, however. Recovering the toxin ‘‘inactive form of a select toxin’’ may be Specifically, we are proposing to add from within an animal or plant subject excluded from regulation under each new provisions by which individuals is highly difficult and such removal respective part subject to the application may have access to select agents at does not produce a reasonable yield of procedure. This change is necessary entities other than the individual’s recovery. In addition, there is because the current term, ‘‘attenuated ‘‘home’’ entity. We are also proposing to uncertainty as to whether or not the strain of toxin,’’ is scientifically decrease the maximum length of time toxin would remain active when inaccurate. Attenuated is a term that is for which a security risk assessment will recovered from the animal or plant. For applied to living organisms, and toxins be valid from 5 years to 3 years in order these reasons it is highly unlikely that are not living organisms. ‘‘Inactive form to more expeditiously identify once introduced into an animal or plant, of a select toxin’’ is a more accurate individuals who may have fallen into a sufficient amount of toxin could be term and we are therefore proposing to one of the prohibited or restricted recovered to pose a significant hazard to amend the regulations to include the categories. public health, agriculture or agriculture correct terminology. We are also The regulations require registered products. proposing to update the Web site entities to develop and implement a Currently, the security plan described address in paragraph (e)(1) of each number of plans in order to ensure the in 7 CFR 331.11 and 9 CFR 121.11 must section as all information concerning safety and security of the select agents be developed by all regulated entities the Select Agent Program is now they handle. These are: and submitted for review only upon centralized on the National Select Agent • A security plan, as described by the request. We are now proposing to Registry Web site at http:// regulations in 7 CFR 331.11 and 9 CFR require that the security plan be www.selectagents.gov/. Finally, we are 121.11, that provides for measures submitted for initial registration and proposing to remove the language sufficient to safeguard the select agent renewals of registration as well as at any stating that exclusions will be published or toxin against unauthorized access, other time upon request. We are also in the Federal Register. This change is theft, loss, or release; proposing to add a requirement that the necessary because, while we anticipated • A biocontainment plan, in the case security plan include procedures that publication of exclusions both in the of PPQ select agents, or a biosafety plan, require the responsible official to Federal Register and on the Internet at in the case of VS select agents, as immediately notify the FBI in order to the time the regulations were initially described in the regulations in 7 CFR initiate a threat assessment process in created, we have found that publication 331.12 and 9 CFR 121.12, that provides the event that he or she becomes aware

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of suspicious activity which is criminal recombinant technology in the 121.16, which concern the transfer of in nature, related to the facility, its generation of drug resistant select agents select agents and toxins from one personnel, or select agents. This or biosynthesis of toxins lethal to registered entity to another. The addition would provide for added vertebrates. Since synthetic DNA or proposed additions would serve to security and establish a framework for other methods (e.g., selection in codify practices for shipping, receiving, communication between regulated sublethal exposures) may also be used and storage of select agents and toxins entities and the FBI. We are also to generate such products, we are and ensure that all registered entities proposing to add provisions for proposing to expand the category of have documented processes for securing information security, including the need restricted experiments to include and monitoring the shipment, receipt, for backup measures if the entity relies passive selection, recombinant, and and storage of select agents and toxins on information systems for security. synthetic DNA. Finally, we are that make it extremely unlikely that These provisions would include proposing to add language in order to such materials would be made available network connectivity monitoring, clarify the requirement that all to an unauthorized individual. restriction of user permissions so that experiments involving the creation of The regulations in 7 CFR 331.17 and only mission-specific files and drug resistant select agents must be 9 CFR 121.17 concern required applications may be accessed, measures submitted to the Select Agent Program recordkeeping procedures for regulated to prevent network infiltration by for approval. entities as those records relate to select malicious code, and configuration Additionally, we are proposing to agents and toxins. We are proposing to management including regular patching specify in 7 CFR 331.14 and 9 CFR add language to address synthetic select and system and software updates. We 121.14 that each entity’s incident agent organisms and animals and plants believe these additions are necessary in response plan be based upon a site- inoculated with select agents. This order to establish requirements for a specific risk assessment. This change change would improve oversight of the more comprehensive security plan. We would further ensure the specificity and select agent program as it relates to are also proposing to codify current quality of the plan. In addition, we are synthetic select agent organisms. We are practices for shipping, receiving, and proposing that the incident response also proposing to add recordkeeping storage of select agents and toxins to procedures contain stipulations requirements whereby regulated entities ensure that the entity has documented concerning animals and plants maintain an accurate, current inventory processes for securing and monitoring accidentally or intentionally exposed to of any animals or plants intentionally or the shipment, receipt, and storage of or infected with a select agent. This accidentally exposed to or infected with these items. These changes would serve change would provide specific guidance a select agent (including number and to decrease the chance that such and further elaborate our requirements species, location, and appropriate materials would be made available to an for incident response plans. disposition). As previously stated, we We are proposing to amend the unauthorized individual or an are not proposing to require regulated regulations in 7 CFR 331.15 and 9 CFR individual without a legitimate use for entities to keep records regarding 121.15, which concern provision of the material. Finally, we are proposing animals or plants exposed to select mandatory training for staff and visitors to amend paragraph (e) in 7 CFR 331.11 toxins. who work in or visit areas where select We are proposing to amend the and 9 CFR 121.11, which currently agents or toxins are handled or stored. regulations in 7 CFR 331.19, which directs individuals creating a security We are proposing to require all concern requirements for notification of plan to guidance for developing such registered entities to provide security theft, loss, or release of select agents. documents contained in the ‘‘Morbidity awareness and incident response Specifically, we are proposing to and Mortality Weekly Report’’ from training. This is in addition to the remove paragraph (b)(1)(vi), which December 2002. Applicants would existing training requirements, which states that an individual entity must instead be directed to the ‘‘Security are concerned with biocontainment and report certain information to APHIS or Information Document’’ and the security practices in the case of PPQ CDC immediately upon discovery of a ‘‘Security Plan Template’’ on the select select agents, and biosafety and security release of a select agent or toxin outside agents Web site. practices in the case of VS select agents. of the primary barriers of the We are proposing to update the We are also proposing to establish that biocontainment area. Currently we specific Web site address references to training for escorted personnel would be require that the number of individuals various CDC and National Institutes of based on the risk associated with potentially exposed at the entity be Health guidance publications found in 9 accessing areas where select agents and reported. We are proposing to remove CFR 331.12(c)(1) and (c)(3). The toxins are used and/or stored. Currently, this requirement as PPQ select agents regulations in 7 CFR 331.13 and 9 CFR refresher training is required to be and toxins do not pose a severe threat 121.13 concern restricted experiments, provided once a year. We are proposing to human health and, therefore, it is which are those experiments that may to require that such training also be unnecessary to address personnel safety not be performed by regulated entities provided if a registered entity’s security, and health in the same manner as they without the approval of the incident response, biosafety, or are addressed in the VS regulations. The Administrator. We are proposing to state biocontainment plans are substantively notification requirements in 9 CFR that, in addition to the existing altered. Finally, we are proposing to 121.19 would remain unchanged. prohibition on conducting restricted specify that the responsible official The regulations in 7 CFR 331.20 and experiments, entities may not possess ensure maintenance of training records. 9 CFR 121.20 concern the guidelines for the products of restricted experiments Currently there is no particular person administrative review of an individual’s without the approval of the designated as the entity’s required or entity’s denial, revocation, or Administrator. We are also proposing to record keeper, only that a training suspension of registration and access remove recombinant technology as a record must be kept. The above changes approval. We are proposing to modify determining factor for a restricted are necessary in order to provide clarity the current regulations in order to allow experiment. This is because the current and ease of use to the regulations. individuals more time to gather the regulations regarding restricted We are proposing to amend the necessary components of their appeal experiments focus solely on the use of regulations in 7 CFR 331.16 and 9 CFR following the denial, limitation, or

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revocation of access approval. 1. Aspects of the required security on a substantial number of small Currently, this process must be plan. These may include, but are not entities. The entities are those completed in 30 calendar days. We are limited to: laboratories and other institutions proposing to extend the deadline to 180 • Provisions for information security; conducting research and related calendar days. This change is necessary • Development of suitability or activities entities in possession of Tier because, thus far, all appeal requests personnel reliability practices, 1 select agents or toxins, and, to a from individuals regarding their access including pre-access and ongoing somewhat lesser extent, those entities approval have been received after the assessment of persons who will have possessing the newly added select 30-day deadline has passed. Because of access to Tier 1 select agents or toxins; agents and toxins. The economic specific program procedures, these • Procedures for the method by analysis presents categories and individuals receive no advance notice of which an entity’s responsible official information from the Department of a denial, limitation, or revocation of will coordinate his or her efforts with Commerce and the Small Business their access approval. Given this the entity’s safety and security Administration for those entities we situation and the requirements for professionals to ensure security of Tier have identified as most likely to be submitting a formal appeal, we believe 1 select agents or toxins; affected by this rule. While we believe • it is appropriate to extend the deadline Development of a self- and peer- affected entities are contained within in order to allow individuals to gather reporting program to track incidents or these categories, we are seeking further the necessary background data for their conditions that could affect an information regarding how many appeals. We are not proposing to grant individual’s ability to safely access or entities fall specifically into each a similar extension for entities which work with Tier 1 select agents and category, and are therefore, inviting have had their registration denied, toxins; and • comments on potential effects. In revoked, or suspended, as these entities Layered protection of assets for particular, we are interested in typically have had advance notice of entities housing Tier 1 select agents and determining the number and kind of such a determination and are thus able toxins. small entities that may incur benefits or to document and prepare their appeals 2. Aspects of the required biosafety costs from the implementation of this within the existing 30-day timeframe. plan, e.g., components of an proposed rule. Given that we are reorganizing 7 CFR occupational health program for This proposed rule would update the 331.20 and 9 CFR 121.20 in order to individuals with access to Tier 1 select APHIS, CDC, and overlap select agent more clearly spell out the way in which agents and toxins; and an individual or an entity may appeal 3. Aspects of the required training, and toxin lists. The regulation of select the denial, revocation, or suspension of e.g., best practices for development of a agents and toxins is intended to prevent registration and access approval, we are security awareness training program. their misuse and thereby reduce the also proposing to remove footnote 9 We welcome public comment on Web potential for those pathogens to harm from the regulations in 7 CFR 331.20 sites, articles, or other sources that may humans, animals, animal products, and corresponding footnote 15 in 9 CFR be used to develop such guidance plants or plant products in the United 121.20. This proposed change is documents, in addition to suggestions as States. Should any select agent or toxin necessary because these footnotes to what elements should be included as be intentionally or unintentionally would offer redundant information useful examples. These documents released into the environment, the concerning the appeals process in light would serve as a resource to the consequences would be significant. of both sections’ reorganization. Finally, regulated community as a whole. Consequences could include disruption of markets, difficulties in sustaining an we are proposing to remove the Executive Orders 12866 and 13563 and provision stating that a request for adequate food and fiber supply, and the Regulatory Flexibility Act review of a denial, limitation, or potential spread of disease infestations revocation of access approval will be This proposed rule has been over large areas. The entities most likely forwarded to the Attorney General by determined to be significant for the to be affected by this rule would be the Administrator for further review. purposes of Executive Order 12866 and, those laboratories and other institutions Forwarding a request for review to the therefore, has been reviewed by the conducting research and related Attorney General describes an internal Office of Management and Budget. activities that involve the use of the process. This proposed change is We have prepared an economic newly categorized Tier 1 select agents necessary because the current language analysis for this rule. The economic and toxins. The impact of the changes implies a level of decisionmaking on the analysis provides a cost-benefit analysis, to the regulations is expected to be part of the Attorney General that does as required by Executive Orders 12866 minimal, however. Based on not exist and the change would more and 13563, and an initial regulatory information obtained through site- clearly establish that the decision to flexibility analysis that examines the specific inspections, indications are that grant access approval rests solely with potential economic effects of this very few entities would incur significant the Administrator. proposed rule on small entities, as costs for compliance. Many of the required by the Regulatory Flexibility proposed changes to the regulations Guidance Documents Act. The economic analysis is would impose an added cost of the time We are specifically requesting summarized below. Copies of the full spent on documenting measures already comment from the regulated community analysis are available by contacting the required for compliance, with respect to and any other interested persons on the person listed under FOR FURTHER security, biocontainment/biosafety, and need for and desirability of guidance INFORMATION CONTACT or on the incident response plans, information documents that would serve to assist Regulations.gov Web site (see security, and ongoing background regulated entities in preparation of the ADDRESSES above for instructions for checks. While the total costs imposed by elements that comprise various aspects accessing Regulations.gov). the proposed regulations are estimated of the select agent regulations. Based on the information we have, to range between $5.30 million and The areas where such guidance there is no reason to conclude that $6.95 million, including costs to documents may be useful include, but adoption of this proposed rule would government, we believe many of these are not limited to: result in any significant economic effect costs are incurred through observance of

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generally recognized industry standards. and CDC–2011–0012. Please send a APHIS and CDC are asking OMB to Costs actually incurred would depend copy of your comments to: (1) Docket approve, for 3 years, the use of these upon the extent to which current facility Nos. APHIS–APHIS–2009–0070 and information collections, associated with practices will need to be enhanced CDC–2011–0012, Regulatory Analysis its efforts to more closely regulate select based on the proposed requirements. and Development, PPD, APHIS, Station agents or toxins that could be used to The expected benefits of strengthened 3A–03.8, 4700 River Road Unit 118, commit acts of domestic or international safeguards against the costs associated Riverdale, MD 20737–1238, and (2) terrorism. We are soliciting comments with unintentional or deliberate release Clearance Officer, OCIO, USDA, room from the public (as well as affected of select agents or toxins would greatly 404–W, 14th Street and Independence agencies) concerning this information exceed the estimated costs of the Avenue, SW., Washington, DC 20250. A collection activity. APHIS and CDC proposed measures. The cost associated comment to OMB is best assured of need this outside input to help with a single outbreak have been known having its full effect if OMB receives it accomplish the following: to exceed $100 million as outlined in within 30 days of publication of this (1) Evaluate whether the proposed the Regulatory Impact Analysis. proposed rule. information collection is necessary for Deliberate introduction greatly increases The Bioterrorism Preparedness Act is the proper performance of our agency’s the probability of a select agent or toxin designed to prevent, prepare for and functions, including whether the becoming established and causing wide- respond to bioterrorism and other information will have practical utility; ranging and devastating impacts on an public health emergencies. The law (2) Evaluate the accuracy of our economy, loss of market access for requires individuals possessing agents estimate of the burden of the proposed consumer goods and services, or toxins deemed a severe threat to information collection, including the disruption to society, and diminished human, animal, or plant health, or to validity of the methodology and confidence in public and private animal or plant products, to be assumptions used; registered with the Secretary of institutions. (3) Enhance the quality, utility, and Agriculture or the Secretary of Health clarity of the information to be Executive Order 12372 and Human Services, unless they have collected; and This program/activity is listed in the been specifically exempted. This proposed rule entails the use of (4) Minimize the burden of the Catalog of Federal Domestic Assistance information collection on those who are under No. 10.025 and is subject to a number of separate forms designed to obtain critical information concerning to respond (such as through the use of Executive Order 12372, which requires appropriate automated, electronic, intergovernmental consultation with individuals or entities in possession of certain agents or toxins, as well as the mechanical, or other technological State and local officials. (See 7 CFR part collection techniques or other forms of 3015, subpart V.) specific characteristics of the agents or toxins—including name, strain, and information technology; e.g., permitting Executive Order 12988 genetic information. This data is electronic submission of responses). This proposed rule has been reviewed needed, in part, to allow APHIS and Estimate of burden: Public reporting under Executive Order 12988, Civil CDC to determine the biosafety level of burden for this collection of information Justice Reform. If this proposed rule is an entity as well as the entity’s is estimated to average 2.3187883 hours adopted: (1) All State and local laws and biosecurity situation. This, in turn, per response. regulations that are inconsistent with helps APHIS and CDC ensure that Respondents: Researchers, this rule will be preempted; (2) no appropriate safeguard, containment, and universities, research and development retroactive effect will be given to this disposal requirements commensurate organizations, commercial rule; and (3) administrative proceedings with the risk of the agent or toxin are manufacturers, non-profit institutions, will not be required before parties may present at the entity, thus preventing diagnostic laboratories and other file suit in court challenging this rule. access to such agents and toxins for use interested parties who possess, use, or in domestic or international terrorism. transfer agents or toxins deemed a Paperwork Reduction Act Facilities containing select agents will severe threat to human, animal or plant In accordance with section 3507(d) of be required to maintain records on health, or to animal or plant products. the Paperwork Reduction Act of 1995 animals and plants, and revise their Estimated annual number of (44 U.S.C. 3501 et seq.), the information Biosafety/Biocontainment Plan and respondents: 386. collection or recordkeeping Incident Response Plan for review by Estimated annual number of requirements included in this proposed APHIS and CDC upon request. responses per respondent: 12.230569. rule have been submitted for approval to Information to determine that Estimated annual number of the Office of Management and Budget individuals seeking to register have a responses: 4,721. (OMB). Please send written comments lawful purpose to possess, use, or Estimated total annual burden on to the Office of Information and transfer agents or toxins will also be respondents: 10,947 hours. (Due to Regulatory Affairs, OMB, Attention: requested as part of the registration averaging, the total annual burden hours Desk Officer for APHIS, Washington, DC process. In addition, we will be may not equal the product of the annual 20503. Please state that your comments requesting submission of their Security number of responses multiplied by the refer to Docket Nos. APHIS–2009–0070 Plan for our review. reporting burden per response.)

Average Number of Number of burden per Total burden Section Form name respondents responses per response hours respondent (in hours)

9 CFR 121.5 and 6, 7 CFR 331.5, Report of Identification of a Select 161 3 1 299 43 CFR 73.5 and 6. Agent or Toxin. § 121.7, § 331.7, § 73.7 ...... Application for Registration ...... 7 1 5 35 § 121.7, § 331.7, § 73.7 ...... Amendment to a Certificate of Reg- 380 7 1 1,955 istration.

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Average Number of Number of burden per Total burden Section Form name respondents responses per response hours respondent (in hours)

§ 121.11, § 331.11, § 73.11 ...... Security Plan ...... 380 1 5 1,900 § 121.12, § 331.12, § 73.12 ...... Biosafety/Biocontainment Plan ...... 380 1 8 3,040 § 121.13, § 331.13, § 73.13 ...... Request Regarding a Restricted Ex- 160 1 2 320 periment. § 121.14, § 331.14, § 73.14 ...... Incident Response Plan ...... 380 1 5 1,900 § 121.15, § 331.15, § 73.15 ...... Training ...... 380 1 1 380 § 121.16, §331.16, §73.16 ...... Request to Transfer Select Agents 290 1 2 580 and Toxins. § 121.17, § 331.17, § 73.17 ...... Records ...... 295 1 0.5 148 § 121.19, §331.19, §73.19 ...... Notification of Theft, Loss, or Re- 195 1 2 390 lease.

Copies of this information collection term exceeding 1 year, indictment, include distilled spirits, wine, malt can be obtained from Mrs. Celeste information security, lawfully admitted beverages, or tobacco, as those terms are Sickles, APHIS’ Information Collection for permanent residence, mental defined or used in Subtitle E of the Coordinator, at (301) 851–2908. institution, recombinant and synthetic Internal Revenue Code of 1986, as nucleic acids, restricted person, and amended. E-Government Act Compliance unlawful user of any controlled Crime punishable by imprisonment The Animal and Plant Health substance to read as follows: for a term exceeding 1 year. Any Inspection Service is committed to Federal, State, or foreign offense for § 331.1 Definitions. compliance with the E-Government Act which the maximum penalty, whether to promote the use of the Internet and Adjudicated as a mental defective. A or not imposed, is capital punishment other information technologies, to determination by a court, board, or imprisonment in excess of 1 year. provide increased opportunities for commission, or other lawful authority What constitutes a conviction of such a citizen access to Government that a person, as a result of marked crime shall be determined in accordance information and services, and for other subnormal intelligence, or mental with the law of the jurisdiction in which purposes. For information pertinent to illness, incompetency, condition, or the proceedings were held. Any E-Government Act compliance related disease is a danger to himself/herself or conviction which has been set aside or to others or lacks the mental capacity to to this proposed rule, please contact nullified as a matter of law or for which contract or manage his/her own affairs. Mrs. Celeste Sickles, APHIS’ a person has been pardoned shall not be The term includes a finding of insanity Information Collection Coordinator, at considered a conviction for the by a court in a criminal case and those (301) 851–2908. purposes of this part. persons found incompetent to stand List of Subjects trial or found not guilty by reason of * * * * * Indictment. A formal written 7 CFR Part 331 lack of mental responsibility pursuant to articles 50a and 72b of the Uniform accusation originating with a prosecutor Agricultural research, Laboratories, Code of Military Justice, 10 U.S.C. 850a, and issued by a grand jury against a Plant diseases and pests, Reporting and 876b. party charged with a crime. For the recordkeeping requirements. * * * * * purpose of these regulations the term 9 CFR Part 121 Alien. Any person not a citizen or indictment includes an ‘‘information,’’ national of the United States. which is a formal accusation of a crime, Agricultural research, Animal differing only in that it is being diseases, Laboratories, Medical research, * * * * * Committed to any mental institution. presented by a competent public officer Reporting and recordkeeping on his oath of office, instead of a grand requirements. A formal commitment of a person to any mental institution by a court, board, jury. Accordingly, we propose to amend 7 commission, or other lawful authority. Information security. Protecting CFR part 331 and 9 CFR part 121 as The term includes a commitment to a information and information systems follows: mental institution involuntarily. The from unauthorized access, use, TITLE 7—[AMENDED] term includes commitment for mental disclosure, disruption, modification, or defectiveness or mental illness. It also destruction in order to provide: PART 331—POSSESSION, USE, AND includes commitments for other (1) Integrity, which means guarding TRANSFER OF SELECT AGENTS AND reasons, such as for drug use. The term against improper information TOXINS does not include a person in a mental modification or destruction, and institution for observation or a includes ensuring information 1. The authority citation for part 331 nonrepudiation and authenticity; continues to read as follows: voluntary admission to a mental institution. (2) Confidentiality, which means Authority: 7 U.S.C. 8401; 7 CFR 2.22, 2.80, Controlled substance. A drug or other preserving authorized restrictions on and 371.3. substance, or immediate precursor, as access and disclosure, including means 2. Section 331.1 is amended by ‘‘controlled substance’’ is defined in for protecting personal privacy and adding, in alphabetical order, section 102 of the Controlled Substances proprietary information; and definitions of adjudicated as a mental Act, 21 U.S.C. 802. The term includes, (3) Availability, which means defective, alien, committed to any but is not limited to, marijuana and ensuring timely and reliable access to mental institution, controlled substance, scheduled depressants, stimulants, and and use of information. crime punishable by imprisonment for a narcotic drugs. The term does not * * * * *

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Lawfully admitted for permanent regulation, a person who uses a Synchytrium endobioticum; residence. The status of having been controlled substance and has lost the Xanthomonas oryzae. lawfully accorded the privilege of power of self-control with reference to * * * * * residing permanently in the United the use of that controlled substance; and (e) An attenuated strain of a select States as an immigrant in accordance any person who is a current user of a agent or an inactive form of a select with the immigration laws, such status controlled substance in a manner other toxin may be excluded from the not having changed. than as prescribed by a licensed requirements of this part based upon a Mental institution. Includes mental physician. Such use is not limited to the determination that the attenuated strain health facilities, mental hospitals, use of drugs on a particular day, or or inactivated toxin does not pose a sanitariums, psychiatric facilities, and within a matter of days or weeks before, severe threat to plant health or plant other facilities that provide diagnoses by but rather that the unlawful use has products. licensed professionals of mental occurred recently enough to indicate (1) To apply for exclusion, an retardation or mental illness, including that the individual is actively engaged individual or entity must submit a a psychiatric ward in a general hospital. in such conduct. A person may be an written request and supporting * * * * * unlawful current user of a controlled scientific information. A written Recombinant and synthetic nucleic substance even though the substance is decision granting or denying the request acids. (1) Recombinant nucleic acid not being used at the precise time the will be issued. An exclusion will be molecules that are constructed by person seeks to have access to a select effective upon notification to the joining nucleic acid molecules and that agent or toxin. An inference of current applicant. Exclusions will be listed on can replicate in a living cell; use may be drawn from evidence of a the National Select Agent Registry Web (2) Synthetic nucleic acid molecules recent use or possession of a controlled site at http://www.selectagents.gov/. that are chemically, or by other means, substance or a pattern of use or (2) If an excluded attenuated strain or synthesized or amplified nucleic acid possession that reasonably covers the inactivated toxin is subjected to any molecules that may wholly or partially present time, e.g., a conviction for use manipulation that restores or enhances contain functional equivalents of or possession of a controlled substance its virulence or toxic activity, the nucleotides; or within the past year; multiple arrests for (3) Molecules that result from the resulting select agent or toxin will be such offenses within the past 5 years if subject to the requirements of this part. replication of those described in the most recent arrest occurred within * * * * * paragraph (1) or (2) of this definition. the past year, or persons found through * * * * * a drug test to use a controlled substance § 331.8 [Amended] Restricted person. An individual who: unlawfully, provided that the test was (1) Is under indictment for a crime 4. In § 331.8, paragraph (a)(1) is administered within the past year. For amended by removing the words punishable by imprisonment for a term a current or former member of the exceeding 1 year; ‘‘within any of the categories described Armed Forces, an inference of current in 18 U.S.C. 175b’’ and adding the (2) Has been convicted in any court of use may be drawn from recent a crime punishable by imprisonment for words ‘‘a restricted person’’ in their disciplinary or other administrative place. a term exceeding 1 year; action based on confirmed drug use, (3) Is a fugitive from justice; 5. Section 331.9 is amended as (4) Is an unlawful user of any e.g., court-martial conviction, follows: controlled substance (as ‘‘controlled nonjudicial punishment, or an a. By redesignating paragraphs (a)(3) substance’’ is defined in section 102 of administrative discharge based on drug through (a)(5) as paragraphs (a)(4), the Controlled Substances Act (21 use or drug rehabilitation failure. (a)(5), and (a)(7) respectively. U.S.C. 802)); * * * * * b. By adding a new paragraph (a)(3) to (5) Is an alien illegally or unlawfully 3. Section 331.3 is amended as read as set forth below. in the United States; follows: c. In newly redesignated paragraph (6) Has been adjudicated as a mental a. By revising paragraph (b) to read as (a)(5), by removing the word ‘‘and’’. defective or has been committed to any set forth below. d. By adding a new paragraph (a)(6) mental institution; b. In paragraph (c) introductory text, to read as set forth below. (7) Is an alien (other than an alien by adding the words ‘‘and/or synthetic’’ e. By revising the first sentence of lawfully admitted for permanent after the word ‘‘recombinant’’ each time paragraph (b) to read as set forth below. residence) who is a national of a country it appears. § 331.9 Responsible official. as to which the Secretary of State, c. In paragraph (c)(2) introductory pursuant to section 6(j) of the Export text, by adding the words ‘‘and/or (a) * * * Administration Act of 1979 (50 U.S.C. synthetic’’ after the word (3) Have the appropriate training or App. 2405(j)), section 620A of chapter 1 ‘‘Recombinant’’. expertise to competently implement and of part M of the Foreign Assistance Act d. By revising paragraph (e) to read as manage the requirements of this part; of 1961 (22 U.S.C. 2371), or section set forth below. * * * * * 40(d) of chapter 3 of the Arms Export (6) Have their principal duty station at Control Act (22 U.S.C. 2780(d)), has § 331.3 PPQ select agents and toxins. the physical location of the entity; and made a determination (that remains in * * * * * * * * * * effect) that such country has repeatedly (b) PPQ select agents and toxins: (b) An entity may designate one or provided support for acts of Peronosclerospora philippinensis more individuals to serve as an alternate international terrorism; or (Peronosclerospora sacchari); responsible official who acts for the (8) Has been discharged from the Phoma glycinicola (formerly responsible official in his/her absence. Armed Services of the United States Pyrenochaeta glycines); *** under dishonorable conditions. Ralstonia solanacearum, race 3, biovar * * * * * * * * * * 2; Unlawful user of any controlled Rathayibacter toxicus; 6. Section 331.10 is amended as substance. For purposes of this Sclerophthora rayssiae var. zeae; follows:

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a. By redesignating paragraphs (e) personnel, or its select agents or toxins; commensurate with the risk of the select through (i) as paragraphs (f) through (j) and how the responsible official will agent or toxin, given its intended use.4 respectively. notify the Federal Bureau of The biocontainment plan must contain b. By adding a new paragraph (e) to Investigation (FBI) of such activity; sufficient information and read as set forth below. (9) Contain provisions for information documentation to describe the c. In newly redesignated paragraph security that: containment procedures for the select (g)(1), by removing the words ‘‘within (i) Ensure that all external agent or toxin, including any animals or any of the categories described in 18 connections to systems which control plants intentionally or accidentally U.S.C. 175b’’ and adding the words ‘‘a security of the facility are isolated or exposed to or infected with a select restricted person’’ in their place. have controls that permit and monitor agent. d. In newly redesignated paragraph for only authorized and authenticated * * * * * (i), by removing the number ‘‘5’’ and user access; adding the number ‘‘3’’ in its place. (ii) Ensure that authorized and § 331.13 [Amended] authenticated users are only granted 9. Section 331.13 is amended as § 331.10 Restricting access to select access to select agent and toxin related follows: agents and toxins; security risk information, files, equipment (e.g., a. By removing footnote 5. assessments. servers or mass storage devices) and b. In paragraph (a) introductory text, * * * * * applications as necessary to fulfill their by adding the words ‘‘, or possess (e) A person who has a valid approval roles and responsibilities, and that products (i.e., select agents that are not from the HHS Secretary or access is modified when the user’s roles known to acquire the resistance Administrator for access to a select and responsibilities change or when naturally, if such acquisition could agent or toxin may request the HHS their access to select agent and toxin is compromise the use of the drug to Secretary or Administrator to provide suspended or revoked; control disease agents in humans, the person’s approval status to another (iii) Ensure that controls are in place veterinary medicine, or agriculture, or registered individual or entity for a that are designed to prevent malicious recombinant and or synthetic DNA specified period of time. code (such as, but not limited to, containing genes for the biosynthesis of * * * * * computer viruses, worms, and spyware) select toxins lethal for vertebrates at an 7. Section 331.11 is amended as from compromising the confidentiality, LD[50] < 100 ng/kg body weight) follows: integrity, or availability of information resulting from,’’ after the word a. By revising paragraph (b) to read as systems; ‘‘conduct’’. c. In paragraph (a)(1), by removing the set forth below. (iv) Establish a robust configuration words ‘‘Experiments utilizing b. By revising paragraph (c)(2) to read management practice for information recombinant DNA that involve the as set forth below. systems to include regular patching and deliberate transfer of’’ and replacing c. In paragraph (c)(6), by removing the updates made to operating systems and them with the words ‘‘Experiments that word ‘‘and’’. individual applications; and involve the deliberate transfer of, or d. In paragraph (c)(7), by removing the (v) Establish procedures that provide backup security measures in the event selection for,’’. period and adding a semicolon in its d. In paragraph (a)(2), by adding the place. that access control systems and/or surveillance devices are rendered words ‘‘synthetic or’’ before the word e. By adding new paragraphs (c)(8), ‘‘recombinant’’. (c)(9), and (c)(10) to read as set forth inoperable. (10) Contain provisions and policies below. 10. Section 331.14 is amended as for shipping, receiving, and storage of f. By revising paragraph (e) to read as follows: select agents and toxins, including set forth below. a. By redesignating footnote 6 as documented procedures for receiving, footnote 5. § 331.11 Security. monitoring, and shipping of all select b. By revising the first sentence in * * * * * agents and toxins. These provisions paragraph (a) to read as set forth below. (b) The security plan must be must provide that an entity will c. By redesignating footnote 7 as designed according to a site-specific risk properly secure containers on site and footnote 6. assessment and must provide graded have a written contingency plan for d. By revising paragraph (b) to read as protection in accordance with the risk of unexpected shipments. set forth below. the select agent or toxin, given its * * * * * e. By redesignating paragraphs (c) and intended use. A current security plan (e) In developing a security plan, an (d) as paragraphs (d) and (e), must be submitted for initial individual or entity should consider the respectively. f. By adding a new paragraph (c) to registration, renewal of registration, or documents entitled, ‘‘Select Agents and read as set forth below. when requested. Toxins Security Information Document’’ (c) * * * and ‘‘Select Agents and Toxins Security § 331.14 Incident response.5 (2) Contain provisions for the control Plan Template.’’ These documents are (a) An individual or entity required to of access to select agents and toxins, available on the Internet at http:// register under this part must develop including the safeguarding of animals or www.selectagents.gov/. and implement a written incident plants intentionally or accidentally * * * * * response plan 6 based upon a site exposed to or infected with a select 8. Section 331.12 is amended by specific risk assessment. * * * agent, against unauthorized access, revising paragraph (a) to read as follows: theft, loss or release. 4 Technical assistance and guidance may be * * * * * § 331.12 Biocontainment. obtained by contacting APHIS. (8) Describe procedures for how the (a) An individual or entity required to 5 Nothing in this section is meant to supersede or preempt incident response requirements imposed responsible official will be informed of register under this part must develop by other statutes or regulations. suspicious activity that may be criminal and implement a written 6 Technical assistance and guidance may be in nature and related to the entity, its biocontainment plan that is obtained by contacting APHIS.

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(b) The incident response plan must a. By redesignating footnote 8 as § 331.19 [Amended] fully describe the entity’s response footnote 7. 14. Section 331.19 is amended as procedures for the theft, loss, or release b. By redesignating paragraphs (e) follows: of a select agent or toxin; inventory through (h) as paragraphs (h), (i), (j), and a. By removing paragraph (b)(1)(iv). discrepancies; security breaches (f) respectively. b. By redesignating paragraphs (including information systems); severe c. By adding a new paragraph (e) to (b)(1)(v) through (b)(1)(viii) as weather and other natural disasters; read as set forth below. paragraphs (b)(1)(iv) through (b)(1)(vii), workplace violence; bomb threats and d. In newly redesignated paragraph respectively. (f), by removing the words ‘‘packaging suspicious packages; and emergencies 15. Section 331.20 is revised to read and’’. such as fire, gas leak, explosion, power as follows: outage, etc. e. By adding a new paragraph (g) to (c) The response procedures must read as set forth below. § 331.20 Administrative review. account for hazards associated with the § 331.16 Transfers. (a) An individual or entity may appeal select agent or toxin and appropriate a denial, revocation, or suspension of * * * * * actions to contain such select agent or registration under this part. The appeal (e) After authorization is provided by toxin, including any animals or plants must be in writing, state the factual APHIS or CDC, the select agent(s) or intentionally or accidentally exposed to basis for the appeal, and be submitted toxin(s) are packaged for shipment in or infected with a select agent. to the Administrator within 30 calendar compliance with all applicable laws * * * * * days of the decision. concerning packaging by an individual 11. Section 331.15 is revised to read (b) An individual may appeal a approved by the HHS Secretary or as follows: denial, limitation, or revocation of Administrator to have access to select access approval under this part. The § 331.15 Training. agents and toxins, following a security appeal must be in writing, state the (a) An individual or entity required to risk assessment by the Attorney General. factual basis for the appeal, and be register under this part must provide * * * * * submitted to the Administrator within information and training on (g) Transportation in commerce starts 180 calendar days of the decision. biocontainment, security (including when the select agent(s) or toxin(s) are (c) The Administrator’s decision security awareness), and incident packaged for shipment and ready for constitutes final agency action. response to: receipt by a courier transporting select (1) Each individual with access agent(s) or toxin(s) and ends when the TITLE 9—[AMENDED] approval from the HHS Secretary or package is received by the intended Administrator before that individual has recipient who is an individual approved PART 121—POSSESSION, USE, AND such access to select agents and toxins. by the HHS Secretary or Administrator TRANSFER OF SELECT AGENTS AND The training must address the particular to have access to select agents and TOXINS needs of the individuals, the work they toxins, following a security risk 16. The authority citation for part 121 will do, and the risks posed by the assessment by the Attorney General. continues to read as follows: select agents or toxins; and (2) Each individual not approved for * * * * * Authority: 7 U.S.C. 8401; 7 CFR 2.22, 2.80, access to select agents and toxins by the 13. Section 331.17 is amended as and 371.4. HHS Secretary or Administrator before follows: 17. Section 121.1 is amended by that individual enters areas where select a. By revising paragraph (a)(1) adding, in alphabetical order, agents or toxins are handled or stored introductory text to read as set forth definitions of adjudicated as a mental (e.g., laboratories, growth chambers, below. defective, alien, committed to any animal rooms, greenhouses, storage b. By redesignating paragraphs (a)(2) mental institution, controlled substance, areas, shipping/receiving areas, through (a)(6) as paragraphs (a)(3) crime punishable by imprisonment for a production facilities, etc.). Training for through (a)(7), respectively. term exceeding 1 year, indictment, escorted personnel must be based on the c. By adding a new paragraph (a)(2) to information security, lawfully admitted risk associated with accessing areas read as set forth below. for permanent residence, mental where select agents and toxins are used institution, occupational exposure, and/or stored. § 331.17 Records. (a) * * * recombinant and synthetic nucleic (b) Refresher training must be acids, restricted person, and unlawful provided annually or at such time as the (1) An accurate, current inventory for each select agent (including viral user of any controlled substance to read registered individual or entity as follows: significantly amends its security, genetic elements, recombinant and/or incident response, or biocontainment synthetic nucleic acids, and § 121.1 Definitions. plans. recombinant and/or synthetic Adjudicated as a mental defective. A (c) The responsible official must organisms) held in long-term storage determination by a court, board, ensure a record of the training provided (placement in a system designed to commission, or other lawful authority to each individual with access to select ensure viability for future use, such as that a person, as a result of marked agents and each escorted individual in a freezer or lyophilized materials), subnormal intelligence, or mental (e.g., laboratory workers, visitors, etc.) is including: illness, incompetency, condition, or maintained. The record must include * * * * * disease is a danger to himself/herself or the name of the individual, the date of (2) An accurate, current inventory of to others or lacks the mental capacity to the training, a description of the training any animals or plants intentionally or contract or manage his/her own affairs. provided, and the means used to verify accidentally exposed to or infected with The term includes a finding of insanity that the employee understood the a select agent (including number and by a court in a criminal case and those training. species, location, and appropriate persons found incompetent to stand 12. Section 331.16 is amended as disposition); trial or found not guilty by reason of follows: * * * * * lack of mental responsibility pursuant to

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articles 50a and 72b of the Uniform includes ensuring information as to which the Secretary of State, Code of Military Justice, 10 U.S.C. 850a, nonrepudiation and authenticity; pursuant to section 6(j) of the Export 876b. (2) Confidentiality, which means Administration Act of 1979 (50 U.S.C. * * * * * preserving authorized restrictions on App. 2405(j)), section 620A of chapter 1 Alien. Any person not a citizen or access and disclosure, including means of part M of the Foreign Assistance Act national of the United States. for protecting personal privacy and of 1961 (22 U.S.C. 2371), or section * * * * * proprietary information; and 40(d) of chapter 3 of the Arms Export Committed to any mental institution. (3) Availability, which means Control Act (22 U.S.C. 2780(d)), has A formal commitment of a person to any ensuring timely and reliable access to made a determination (that remains in mental institution by a court, board, and use of information. effect) that such country has repeatedly commission, or other lawful authority. * * * * * provided support for acts of The term includes a commitment to a Lawfully admitted for permanent international terrorism; or mental institution involuntarily. The residence. The status of having been (8) Has been discharged from the term includes commitment for mental lawfully accorded the privilege of Armed Services of the United States defectiveness or mental illness. It also residing permanently in the United under dishonorable conditions. includes commitments for other States as an immigrant in accordance * * * * * reasons, such as for drug use. The term with the immigration laws, such status Unlawful user of any controlled does not include a person in a mental not having changed. substance. For purposes of this institution for observation or a Mental institution. Includes mental regulation, a person who uses a voluntary admission to a mental health facilities, mental hospitals, controlled substance and has lost the institution. sanitariums, psychiatric facilities, and power of self-control with reference to Controlled substance. A drug or other other facilities that provide diagnoses by the use of that controlled substance; and substance, or immediate precursor, as licensed professionals of mental any person who is a current user of a defined in section 102 of the Controlled retardation or mental illness, including controlled substance in a manner other Substances Act, 21 U.S.C. 802. The term a psychiatric ward in a general hospital. than as prescribed by a licensed includes, but is not limited to, Occupational exposure. Any physician. Such use is not limited to the marijuana and scheduled depressants, reasonably anticipated skin, eye, use of drugs on a particular day, or stimulants, and narcotic drugs. The term mucous membrane, or parenteral within a matter of days or weeks before, does not include distilled spirits, wine, contact with blood or other potentially but rather that the unlawful use has malt beverages, or tobacco, as those infectious materials or toxins that may occurred recently enough to indicate terms are defined or used in Subtitle E result from the performance of an that the individual is actively engaged of the Internal Revenue Code of 1986, as employee’s duties. in such conduct. A person may be an amended. * * * * * unlawful current user of a controlled Crime punishable by imprisonment Recombinant and synthetic nucleic substance even though the substance is for a term exceeding 1 year. Any acids. (1) Recombinant nucleic acid not being used at the precise time the Federal, State, or foreign offense for molecules that are constructed by person seeks to have access to a select which the maximum penalty, whether joining nucleic acid molecules and that agent or toxin. An inference of current or not imposed, is capital punishment can replicate in a living cell; use may be drawn from evidence of a or imprisonment in excess of 1 year. (2) Synthetic nucleic acid molecules recent use or possession of a controlled What constitutes a conviction of such a that are chemically, or by other means, substance or a pattern of use or crime shall be determined in accordance synthesized or amplified nucleic acid possession that reasonably covers the with the law of the jurisdiction in which molecules that may wholly or partially present time, e.g., a conviction for use the proceedings were held. Any contain functional equivalents of or possession of a controlled substance conviction which has been set aside or nucleotides; or within the past year; multiple arrests for nullified as a matter of law or for which (3) Molecules that result from the such offenses within the past 5 years if a person has been pardoned shall not be replication of those described in the most recent arrest occurred within considered a conviction for the paragraph (1) or (2) of this definition. the past year, or persons found through purposes of this part. * * * * * a drug test to use a controlled substance * * * * * Restricted person. An individual who: unlawfully, provided that the test was Indictment. A formal written (1) Is under indictment for a crime administered within the past year. For accusation originating with a prosecutor punishable by imprisonment for a term a current or former member of the and issued by a grand jury against a exceeding 1 year; Armed Forces, an inference of current party charged with a crime. For the (2) Has been convicted in any court of use may be drawn from recent purpose of these regulations the term a crime punishable by imprisonment for disciplinary or other administrative indictment includes an ‘‘information,’’ a term exceeding 1 year; action based on confirmed drug use, which is a formal accusation of a crime, (3) Is a fugitive from justice; e.g., court-martial conviction, differing only in that it is being (4) Is an unlawful user of any nonjudicial punishment, or an presented by a competent public officer controlled substance (as defined in administrative discharge based on drug on his oath of office, instead of a grand section 102 of the Controlled Substances use or drug rehabilitation failure. jury. Act (21 U.S.C. 802)); * * * * * Information security. Protecting (5) Is an alien illegally or unlawfully information and information systems in the United States; 18. Section 121.3 is amended as from unauthorized access, use, (6) Has been adjudicated as a mental follows: disclosure, disruption, modification, or defective or has been committed to any a. By adding a new sentence at the destruction in order to provide: mental institution; end of paragraph (a) to read as set forth (1) Integrity, which means guarding (7) Is an alien (other than an alien below. against improper information lawfully admitted for permanent b. By revising paragraph (b) to read as modification or destruction, and residence) who is a national of a country set forth below.

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c. In paragraph (c) introductory text, applicant. Exclusions will be listed on decision granting or denying the request by adding the words ‘‘and/or synthetic’’ the National Select Agent Registry Web will be issued. An exclusion will be after the word ‘‘recombinant’’ each time site at http://www.selectagents.gov/. effective upon notification to the it appears. (2) If an excluded attenuated strain or applicant. Exclusions will be listed on d. In paragraph (c)(2), by adding the inactivated toxin is subjected to any the National Select Agent Registry Web words ‘‘and/or synthetic’’ after the word manipulation that restores or enhances site at http://www.selectagents.gov/. ‘‘Recombinant’’. its virulence or toxic activity, the (2) If an excluded attenuated strain or e. By revising paragraph (e) to read as resulting select agent or toxin will be inactivated toxin is subjected to any set forth below. subject to the requirements of this part. manipulation that restores or enhances f. In paragraph (f)(3)(i), by removing * * * * * its virulence or toxic activity, the the words ‘‘Newcastle disease virus 19. Section 121.4 is amended as resulting select agent or toxin will be (velogenic)’’ and adding the words follows: subject to the requirements of this part. ‘‘virulent Newcastle disease virus’’ in a. By adding a new sentence at the * * * * * their place. end of paragraph (a) to read as set forth § 121.5 [Amended] § 121.3 VS select agents and toxins. below. b. By revising paragraph (b) to read as 20. In § 121.5, paragraph (a)(3)(i) is (a) * * * The select agents and toxins set forth below. amended by removing the words marked with an asterisk (*) are c. In paragraph (c) introductory text, ‘‘bovine spongiform encephalopathy designated as Tier 1 select agents and by adding the words ‘‘and/or synthetic’’ agent,’’. toxins and are subject to additional after the word ‘‘recombinant’’ each time § 121.6 [Amended] requirements as listed in this part. it appears. (b) VS select agents and toxins: d. In paragraph (c)(2) introductory 21. In § 121.6, paragraph (a)(3)(i) is African horse sickness virus; text, by adding the phrase ‘‘and/or amended by removing the words African swine fever virus; synthetic’’ after the word ‘‘Hendra virus, Nipah virus, Rift Valley Avian influenza virus (highly ‘‘Recombinant’’. fever virus, and Venezuelan equine pathogenic); e. By revising paragraph (e) to read as encephalitis virus’’ and adding the Classical swine fever virus; set forth below. words ‘‘Burkholderia mallei, and * Foot-and-mouth disease virus; f. In paragraph (f)(3)(i), by removing Burkholderia pseudomallei’’ in their Goat pox virus; the words ‘‘Brucella melitensis, Hendra place. Lumpy skin disease virus; virus, Nipah virus, Rift Valley fever § 121.8 [Amended] Mycoplasma capricolum subspecies virus, and Venezuelan equine 22. In section 121.8, paragraph (a)(1) capripneumoniae (contagious encephalitis virus’’ and adding the is amended by removing the words caprine pleuropneumonia); words ‘‘Burkholderia mallei, and ‘‘within any of the categories described Mycoplasma mycoides subspecies Burkholderia pseudomallei’’ in their in 18 U.S.C. 175b’’ and adding the mycoides small colony (Mmm SC) place. (contagious bovine words ‘‘a restricted person’’ in their pleuropneumonia); § 121.4 Overlap select agents and toxins. place. Peste des petits ruminants virus; (a) * * * The select agents and toxins 23. Section 121.9 is amended as * Rinderpest virus; marked with an asterisk (*) are follows: Sheep pox virus; designated as Tier 1 select agents and a. By redesignating paragraphs (a)(3) Swine vesicular disease virus; toxins and are subject to additional through (a)(5) as paragraphs (a)(4), 1 Virulent Newcastle disease virus. requirements as listed in this part. (a)(5), and (a)(7) respectively. * * * * * (b) Overlap select agents and toxins: b. By adding a new paragraph (a)(3) to * Bacillus anthracis; read as set forth below. * * * * * Brucella abortus; c. In newly redesignated paragraph (e) An attenuated strain of a select Brucella melitensis; (a)(5), by removing the word ‘‘and’’. agent or an inactive form of a select Brucella suis; d. By adding a new paragraph (a)(6) toxin may be excluded from the * Burkholderia mallei; to read as set forth below. requirements of this part based upon a *Burkholderia pseudomallei; e. By revising the first sentence of determination by the Administrator that Hendra virus; paragraph (b) to read as set forth below. the attenuated strain or inactivated Nipah virus; f. By revising the first sentence of toxin does not pose a severe threat to Rift Valley fever virus; paragraph (c)(1) to read as set forth animal health or to animal products. Venezuelan equine encephalitis virus: below. (1) To apply for exclusion, an Epizootic Subtypes IAB, IC. § 121.9 Responsible official. individual or entity must submit a * * * * * written request and supporting (e) An attenuated strain of a select (a) * * * scientific information. A written agent or an inactive form of a select (3) Have the appropriate training and decision granting or denying the request toxin may be excluded from the expertise to competently implement and will be issued. An exclusion will be requirements of this part based upon a manage the requirements of this part; effective upon notification to the determination by the HHS Secretary or * * * * * Administrator that the attenuated strain (6) Have their principal duty station at 1 A virulent Newcastle disease virus (avian the physical location of the entity; and paramyxovirus serotype 1) has an intracerebral or inactivated toxin does not pose a pathogenicity index in day-old chicks (Gallus severe threat to public health and safety, * * * * * gallus) of 0.7 or greater or has an amino acid to animal health or to animal products. (b) An entity may designate one or sequence at the fusion (F) protein cleavage site that (1) To apply for exclusion, an more individuals to serve as an alternate is consistent with virulent strains of Newcastle disease virus. A failure to detect a cleavage site that individual or entity must submit a responsible official who acts for the is consistent with virulent strains does not confirm written request and supporting responsible official in his/her absence. the absence of a virulent virus. scientific information. A written ***

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(c) * * * the select agent or toxin, given its (e) In addition to the requirements (1) The identification of any of the intended use. A current security plan contained in paragraphs (c) and (d) of following select agents or toxins must be must be submitted for initial this section, the security plan for an immediately reported by telephone, registration, renewal of registration, or individual or entity possessing a Tier 1 facsimile, or e-mail: African horse when requested. select agent or toxin must also: sickness virus, African swine fever (c) * * * (1) Describe procedures for virus, avian influenza virus (highly (2) Contain provisions for the control conducting a pre-access suitability pathogenic), Bacillus anthracis, Brucella of access to select agents and toxins, assessment of persons who will have melitensis, Burkholderia mallei, including the safeguarding of animals or access to a Tier 1 select agent or toxin; plants intentionally or accidentally Burkholderia pseudomallei, classical (2) Describe procedures for how an exposed to or infected with a select swine fever virus, foot-and-mouth entity’s responsible official will agent, against unauthorized access, disease virus, virulent Newcastle coordinate their efforts with the entity’s theft, loss or release. disease virus, rinderpest virus, and safety and security professionals to swine vesicular disease virus. * * * * * * * * ensure security of Tier 1 select agents * * * * * (8) Describe procedures for how the and toxins and share, as appropriate, responsible official will be informed of relevant information; and 24. Section 121.10 is amended as suspicious activity that may be criminal (3) Describe procedures for the follows: in nature and related to the entity, its a. By redesignating paragraphs (e) personnel, or its select agents or toxins; ongoing assessment of the suitability of through (j) as paragraphs (f) through (k), and how the responsible official will personnel with access to a Tier 1 select respectively. notify the Federal Bureau of agent or toxin. The procedures must b. By adding a new paragraph (e) to Investigation (FBI) of such activity; include: read as set forth below. (9) Contain provisions for information (i) Self- and peer-reporting of c. In newly redesignated paragraph security that: incidents or conditions that could affect (g)(1), by removing the words ‘‘within (i) Ensure that all external an individual’s ability to safely have any of the categories described in 18 connections to systems which control access to or work with select agents and U.S.C. 175b’’ and adding the words ‘‘a security of the facility are isolated or toxins, or to safeguard select agents and restricted person’’ in their place. have controls that permit and monitor toxins from theft, loss, or release; d. In newly redesignated paragraph for only authorized and authenticated (ii) The training of all entity (j), by removing the number ‘‘5’’ and user access; employees on entity policies and adding the number ‘‘3’’ in its place. (ii) Ensure that authorized and procedures for reporting, evaluation, authenticated users are only granted and corrective actions concerning the § 121.10 Restricting access to select access to select agent and toxin related agents and toxins; security risk assessment of personnel suitability to assessments. information, files, equipment (e.g., access Tier 1 agents and toxins; and servers or mass storage devices) and (iii) The ongoing suitability * * * * * applications as necessary to fulfill their (e) A person who has a valid approval monitoring of individuals with access to roles and responsibilities, and that Tier 1 select agents and toxins. from the HHS Secretary or access is modified when the user’s roles Administrator for access to a select (4) Entities with Tier 1 select agents and responsibilities change or when and toxins must prescribe and/or agent or toxin may request the HHS their access to select agent and toxin is implement the following security Secretary or Administrator to provide suspended or revoked; enhancements: the person’s approval status to another (iii) Ensure that controls are in place registered individual or entity for a that are designed to prevent malicious (i) Procedures that limit access to specified period of time. code (such as, but not limited to, registered space only to those approved * * * * * computer viruses, worms, and spyware) by the HHS Secretary or the Administrator and meet the criteria of 25. Section 121.11 is amended as from compromising the confidentiality, integrity, or availability of critical the entity’s program that will ensure follows: individuals with access approval to a. By revising paragraph (b) to read as information systems; (iv) Establish a robust configuration select agents and toxins are trustworthy set forth below. and behaving in a manner that upholds b. By revising paragraph (c)(2) to read management practice for information systems to include regular patching and public health and safety, the protection as set forth below. of animal or plant health and animal or c. In paragraph (c)(6), by removing the updates made to operating systems and individual applications; and plant products, security, and the word ‘‘and’’. integrity of the scientific enterprise. In d. By adding new paragraphs (c)(8), (v) Establish procedures that provide developing these procedures, an (c)(9), and (c)(10) to read as set forth backup security measures in the event individual or entity may consider the below. that access control systems and/or guidance documents available on the e. By redesignating paragraphs (e) and surveillance devices are rendered Internet at (f) as paragraphs (f) and (g), respectively. inoperable. http://www.selectagents.gov/.; f. By adding a new paragraph (e) to (10) Contain provisions and policies read as set forth below. for shipping, receiving, and storage of (ii) Procedures that limit access to g. By revising newly redesignated select agents and toxins, including laboratory and storage facilities outside paragraph (f) to read as set forth below. documented procedures for receiving, of normal business hours to only those monitoring, and shipping of all select specifically approved by the responsible § 121.11 Security. agents and toxins. These provisions official or designee; * * * * * must provide that an entity will (iii) Procedures for allowing visitors, (b) The security plan must be properly secure containers on site and their property, and vehicles at the entry designed according to a site-specific risk have a written contingency plan for and exit points to the registered space, assessment and must provide graded unexpected shipments. or at other designated points of entry to protection in accordance with the risk of * * * * * the building, facility, or compound

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based on the entity’s site-specific risk documents entitled ‘‘Select Agents and could compromise the use of the drug assessment; Toxins Security Information Document’’ to control disease agents in humans, (iv) A minimum of three barriers and ‘‘Select Agents and Toxins Security veterinary medicine, or agriculture, or where each subsequent barrier is Plan Template.’’ These documents are recombinant and or synthetic DNA different and adds to the delay in available on the Internet at http:// containing genes for the biosynthesis of reaching secured areas where select www.selectagents.gov/. select toxins lethal for vertebrates at an agents and toxins are used or stored. * * * * * LD[50] < 100 ng/kg body weight) Barriers must be monitored in such a resulting from,’’ after the word way as to detect and assess intentional 26. Section 121.12 is amended as ‘‘conduct’’ both times it appears. and unintentional circumventing of follows: c. In paragraph (b)(1), by removing the established access control measures a. By revising paragraph (a) to read as words ‘‘Experiments utilizing under all conditions (day/night, severe set forth below. recombinant DNA that involve the weather, etc.); b. By revising paragraph (c)(1) to read deliberate transfer of’’ and adding the (v) All registered space or areas that as set forth below. words ‘‘Experiments that involve the reasonably afford access to the c. In paragraph (c)(3), by removing the deliberate transfer of, or selection for,’’ address ‘‘http://www.aphis.usda.gov./ registered space must be protected by an _ in their place. intrusion detection system (IDS) unless programs/ag selectagent/index.html’’ d. In paragraph (b)(2), by adding the physically occupied; and replacing it with the address words ‘‘synthetic or’’ before the word (vi) Personnel monitoring the IDS ‘‘http://www.selectagents.gov/’’. ‘‘recombinant’’. must be capable of evaluating and d. By redesignating paragraph (d) as 28. Section 121.14 is amended as interpreting the alarm and alerting the paragraph (e). follows: designated security response force or e. By adding a new paragraph (d) to a. In the section heading, by law enforcement; read as set forth below. redesignating footnote 11 as footnote 10. (vii) Provide backup power and § 121.12 Biosafety. b. In paragraph (a), by redesignating energy sources to power information footnote 12 as footnote 11 and revising (a) An individual or entity required to the first sentence to read as set forth security networks and integrated access register under this part must develop controls and related systems during below. and implement a written biosafety plan c. By revising paragraph (b) to read as emergencies; that is commensurate with the risk of (viii) Response time for security forces set forth below. the select agent or toxin, given its or local police must not exceed 15 d. By redesignating paragraphs (c) and intended use.9 The biosafety plan must minutes from the time of an intrusion (d) as paragraphs (d) and (f), contain sufficient information and alarm or report of a security incident; respectively. documentation to describe the biosafety (ix) Entities must conduct complete e. By adding a new paragraph (c) to and containment procedures for the inventory audits of all Tier 1 select read as set forth below. select agent or toxin, including any agents and toxins in long-term storage f. By adding a new paragraph (e) to animals or plants intentionally or when any of the following occur: read as set forth below. accidentally exposed to or infected with (A) Upon the physical relocation of a § 121.14 Incident response.10 collection or inventory of select agents a select agent. * * * * * (a) An individual or entity required to or toxins for those Tier 1 select agents register under this part must develop or toxins in the collection or inventory; (c) * * * (1) The CDC/NIH publication, and implement a written incident (B) Upon the departure or arrival of a response plan 11 based upon a site principal investigator for those Tier 1 ‘‘Biosafety in Microbiological and Biomedical Laboratories.’’ This specific risk assessment. * * * select agents or toxins under the control (b) The incident response plan must of that principal investigator; or document is available on the Internet at http://www.selectagents.gov/. fully describe the entity’s response (C) In the event of a theft or loss of procedures for the theft, loss, or release a Tier 1 select agent or toxin. * * * * * of a select agent or toxin; inventory (5) Entities that possess foot-and- (d) The biosafety plan must include discrepancies; security breaches mouth disease virus and rinderpest an occupational health program for (including information systems); severe virus must have the following individuals with access to Tier 1 select weather and other natural disasters; additional security requirements: agents and toxins, and those individuals workplace violence; bomb threats and (i) A minimum of four barriers, one of must be enrolled in the occupational suspicious packages; and emergencies which must be a perimeter security health program. The occupational such as fire, gas leak, explosion, power fence or equivalent which is monitored health program may also be made outage, etc. 24 hours a day, 7 days a week (24/7) to available to individuals without access (c) The response procedures must detect the presence of unauthorized to Tier 1 select agents and toxins. account for hazards associated with the persons, vehicles, materials, or * * * * * select agent or toxin and appropriate unauthorized activities; actions to contain such select agent or (ii) Onsite 24/7 armed security § 121.13 [Amended] toxin, including any animals or plants response force with roving patrol. 27. Section 121.13 is amended as intentionally or accidentally exposed to Response time must not exceed 5 follows: or infected with a select agent. minutes from the time of an intrusion a. In the section heading, by removing alarm or report of a security incident; footnote 10. * * * * * (e) Entities with Tier 1 select agents (iii) CCTV surveillance with 24/7 b. In paragraph (a), by adding the and toxins must have the following monitoring and recording; and words ‘‘, or possess products (i.e., select (iv) Transport vehicle with GPS agents that are not known to acquire the tracking designed to serve as a 10 Nothing in this section is meant to supersede resistance naturally, if such acquisition or preempt incident response requirements containment vehicle. imposed by other statutes or regulations. (f) In developing a security plan, an 9 Technical assistance and guidance may be 11 Technical assistance and guidance may be individual or entity should consider the obtained by contacting APHIS. obtained by contacting APHIS.

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additional incident response policies or to each individual with access to select b. By redesignating paragraphs (a)(2) procedures: agents and each escorted individual through (a)(6) as paragraphs (a)(3) (1) The incident response plan must (e.g., laboratory workers, visitors, etc.) is through (a)(7), respectively. fully describe the entity’s response maintained. The record must include c. By adding a new paragraph (a)(2) to procedures for failure of intrusion the name of the individual, the date of read as set forth below. detection or alarm system; and the training, a description of the training (2) The incident response plan must provided, and the means used to verify § 121.17 Records. describe notification procedures for the that the employee understood the (a) * * * FBI in the event of a theft or suspicious training. (1) An accurate, current inventory for activity that may be criminal in nature each select agent (including viral 30. Section 121.16 is amended as involving a Tier 1 select agent or toxin. genetic elements, recombinant and/or follows: * * * * * synthetic nucleic acids, and a. By redesignating footnote 14 as recombinant and/or synthetic 29. Section 121.15 is revised to read footnote 12. organisms) held in long-term storage as follows: b. By redesignating paragraphs (f) (placement in a system designed to through (i) as paragraphs (i), (k), and (g), § 121.15 Training. ensure viability for future use, such as respectively. (a) An individual or entity required to in a freezer or lyophilized materials), register under this part must provide c. By adding a new paragraph (f) to including: information and training on biosafety, read as set forth below. d. In newly redesignated paragraph * * * * * security (including security awareness), (2) An accurate, current inventory of and incident response to: (g), by removing the words ‘‘packaging and’’. any animals or plants intentionally or (1) Each individual with access accidentally exposed to or infected with approval from the HHS Secretary or e. By adding a new paragraph (h) to read as set forth below. a select agent (including number and Administrator before that individual has species, location, and appropriate such access to select agents and toxins. § 121.16 Transfers. disposition); The training must address the particular needs of the individuals, the work they * * * * * * * * * * will do, and the risks posed by the (f) After authorization is provided by 32. Section 121.20 is revised to read select agents or toxins; and APHIS or CDC, the select agent(s) and as follows: (2) Each individual not approved for toxin(s) are packaged for shipment in access to select agents and toxins by the compliance with all applicable laws § 121.20 Administrative review. HHS Secretary or Administrator before concerning packaging by an individual (a) An individual or entity may appeal that individual works in or otherwise approved by the HHS Secretary or a denial, revocation, or suspension of enters areas where select agents or Administrator to have access to select registration under this part. The appeal toxins are handled or stored (e.g., agents and toxins, following a security must be in writing, state the factual laboratories, growth chambers, animal risk assessment by the Attorney General. basis for the appeal, and be submitted rooms, greenhouses, storage areas, * * * * * to the Administrator within 30 calendar shipping/receiving areas, production (h) Transportation in commerce starts days of the decision. facilities, etc.). Training for escorted when the select agent(s) or toxin(s) are (b) An individual may appeal a personnel must be based on the risk packaged for shipment and ready for denial, limitation, or revocation of associated with accessing areas where receipt by a courier transporting select access approval under this part. The select agents and toxins are used and/ agent(s) or toxin(s) and ends when the appeal must be in writing, state the or stored. package is received by the intended factual basis for the appeal, and be (b) Entities with Tier 1 select agents recipient who is an individual approved submitted to the Administrator within and toxins must conduct annual insider by the HHS Secretary or Administrator 180 calendar days of the decision. threat awareness briefings on how to to have access to select agents and (c) The Administrator’s decision identify and report suspicious toxins, following a security risk constitutes final agency action. behaviors. assessment by the Attorney General. (c) Refresher training must be Done in Washington, DC, this 29th day of * * * * * provided annually or at such time as the September 2011. registered individual or entity 31. Section 121.17 is amended as Gregory L. Parham, significantly amends its security, follows: Administrator, Animal and Plant Health incident response, or biosafety plans. a. By revising paragraph (a)(1) Inspection Service. (d) The responsible official must introductory text to read as set forth [FR Doc. 2011–25520 Filed 9–30–11; 8:45 am] ensure a record of the training provided below. BILLING CODE 3410–34–P

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Part VI

The President

Memorandum of September 28, 2011—Provision of Aviation Insurance Coverage for Commercial Air Carrier Service in Domestic and International Operations

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Federal Register Presidential Documents Vol. 76, No. 191

Monday, October 3, 2011

Title 3— Memorandum of September 28, 2011

The President Provision of Aviation Insurance Coverage for Commercial Air Carrier Service in Domestic and International Operations

Memorandum for the Secretary of Transportation

By the authority vested in me as President by the Constitution and the laws of the United States, including 49 U.S.C. 44301–44310, I hereby: 1. Determine that the continuation of U.S. commercial air transportation is necessary in the interest of air commerce, national security, and the foreign policy of the United States. 2. Approve the provision by the Secretary of Transportation of insurance or reinsurance to U.S. air carriers against loss or damage arising out of any risk from the operation of an aircraft in the manner and to the extent provided in chapter 443 of title 49 of the U.S. Code until September 30, 2012, when he determines such insurance or reinsurance cannot be obtained on reasonable terms and conditions from any company authorized to conduct an insurance business in a State of the United States. You are directed to bring this determination immediately to the attention of all air carriers, as defined in 49 U.S.C. 40102(a)(2), and to arrange for its publication in the Federal Register.

THE WHITE HOUSE, Washington, September 28, 2011

[FR Doc. 2011–25649 Filed 9–30–11; 11:15 am] Billing code 4910–9–P

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Reader Aids Federal Register Vol. 76, No. 191 Monday, October 3, 2011

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FEDERAL REGISTER PAGES AND DATE, OCTOBER 61033–61248...... 3

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TABLE OF EFFECTIVE DATES AND TIME PERIODS—OCTOBER 2011

This table is used by the Office of the dates, the day after publication is A new table will be published in the Federal Register to compute certain counted as the first day. first issue of each month. dates, such as effective dates and When a date falls on a weekend or comment deadlines, which appear in holiday, the next Federal business day agency documents. In computing these is used. (See 1 CFR 18.17)

DATE OF FR 15 DAYS AFTER 21 DAYS AFTER 30 DAYS AFTER 35 DAYS AFTER 45 DAYS AFTER 60 DAYS AFTER 90 DAYS AFTER PUBLICATION PUBLICATION PUBLICATION PUBLICATION PUBLICATION PUBLICATION PUBLICATION PUBLICATION

October 3 Oct 18 Oct 24 Nov 2 Nov 7 Nov 17 Dec 2 Jan 3

October 4 Oct 19 Oct 25 Nov 3 Nov 8 Nov 18 Dec 5 Jan 3

October 5 Oct 20 Oct 26 Nov 4 Nov 9 Nov 21 Dec 5 Jan 3

October 6 Oct 21 Oct 27 Nov 7 Nov 10 Nov 21 Dec 5 Jan 4

October 7 Oct 24 Oct 28 Nov 7 Nov 14 Nov 21 Dec 6 Jan 5

October 11 Oct 26 Nov 1 Nov 10 Nov 15 Nov 25 Dec 12 Jan 9

October 12 Oct 27 Nov 2 Nov 14 Nov 16 Nov 28 Dec 12 Jan 10

October 13 Oct 28 Nov 3 Nov 14 Nov 17 Nov 28 Dec 12 Jan 11

October 14 Oct 31 Nov 4 Nov 14 Nov 18 Nov 28 Dec 13 Jan 12

October 17 Nov 1 Nov 7 Nov 16 Nov 21 Dec 1 Dec 16 Jan 16

October 18 Nov 2 Nov 8 Nov 17 Nov 22 Dec 2 Dec 19 Jan 16

October 19 Nov 3 Nov 9 Nov 18 Nov 23 Dec 5 Dec 19 Jan 17

October 20 Nov 4 Nov 10 Nov 21 Nov 25 Dec 5 Dec 19 Jan 18

October 21 Nov 7 Nov 14 Nov 21 Nov 25 Dec 5 Dec 20 Jan 19

October 24 Nov 8 Nov 14 Nov 23 Nov 28 Dec 8 Dec 23 Jan 23

October 25 Nov 9 Nov 15 Nov 25 Nov 29 Dec 9 Dec 27 Jan 23

October 26 Nov 10 Nov 16 Nov 25 Nov 30 Dec 12 Dec 27 Jan 24

October 27 Nov 14 Nov 17 Nov 28 Dec 1 Dec 12 Dec 27 Jan 25

October 28 Nov 14 Nov 18 Nov 28 Dec 2 Dec 12 Dec 27 Jan 26

October 31 Nov 15 Nov 21 Nov 30 Dec 5 Dec 15 Dec 30 Jan 30

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